WO2021208847A1

WO2021208847A1 - Ablation device and preparation method therefor

Info

Publication number: WO2021208847A1
Application number: PCT/CN2021/086580
Authority: WO
Inventors: 王永胜; 雷迪维韦克·Y; 唐闽; 刘成; 陈杰
Original assignee: 杭州德诺电生理医疗科技有限公司
Priority date: 2020-04-13
Filing date: 2021-04-12
Publication date: 2021-10-21

Abstract

Disclosed is an ablation device (10), comprising a handle (11), an inner sheath (13), an outer sheath (14) and an ablation assembly (15), wherein the proximal end of the inner sheath (13) and the proximal end of the outer sheath (14) are both connected to the handle (11), and the outer sheath (14) is arranged in a sleeving manner at the periphery of the inner sheath (13); and the ablation assembly (15) comprises a plurality of rod bodies (151) each provided with an electrode (153), with the distal ends of the plurality of rod bodies (151) being combined together, the proximal ends of the plurality of rod bodies (151) being connected to the distal end of the inner sheath (13), and each of the rod bodies (151) spirally extending around in the axial direction of the inner sheath (13). The ablation assembly (15) can be switched between a contracted state in which the ablation assembly (15) is movably accommodated in the outer sheath (14) and an expanded state in which the proximal end of the ablation assembly (15) is exposed from the distal end of the outer sheath (14) and each electrode (153) deviates from the rod body (151) where the electrode is located, and at the position with the largest spiral angle. A preparation method for the ablation device is further disclosed. The ablation device can improve compliance and adherence, thereby improving a surgical effect.

Description

Ablation device and preparation method thereof

This application is required to be submitted to the State Intellectual Property Office of China on April 13, 2020, the application number is 202010287213.2 (the application name is "ablation device and its preparation method"), the application number is 202020539132.2 (the application name is "ablation device") China The priority of the patent application, the entire content of which is incorporated in this application by reference.

Technical field

This application relates to the technical field of medical devices, and in particular to an ablation device and a preparation method thereof.

Background technique

Atrial fibrillation (AF) is abbreviated as atrial fibrillation, which is the most common persistent arrhythmia. With age, the incidence of atrial fibrillation continues to increase, reaching 10% of people over 75 years of age. In atrial fibrillation, the frequency of atrial activation is 300-600 beats/min. The heartbeat frequency is often fast and irregular, sometimes up to 100-160 beats/min. Not only is the heartbeat much faster than normal people, but it is absolutely irregular and the atria is lost. Effective contraction function. AF usually increases the risk of many potentially fatal complications, including thromboembolic stroke, dilated cardiomyopathy, and congestive heart failure. Common AF symptoms such as palpitations, chest pain, dyspnea, fatigue and dizziness can also affect the quality of life. Compared with normal people, the average morbidity of people with atrial fibrillation has increased by five times, and the mortality rate has increased by two times.

Tissue ablation is commonly used to treat various arrhythmias, including atrial fibrillation. To treat arrhythmias, ablation can be performed to modify the tissue, for example to prevent abnormal electrical transmission and/or disrupt abnormal electrical conduction through heart tissue. Ablation therapy includes many aspects: On the one hand, it relies on time-dependent conduction of heating or cooling to ablate tissues, such as radiofrequency ablation, laser ablation, microwave ablation, thermal material ablation, etc., and other studies have also shown alternative new energy sources. To ablate tissue, such as ablation using the principle of bioelectroporation.

The diameter of human blood vessels is different for each person, and because of different locations to be ablated, the diameter of blood vessels in the human body is also different. The diameter of most human blood vessels widely ranges from about 2 to about 12 mm. In the conventional technology, the expansion size of the stent of the ablation device is usually constant and cannot be adjusted according to the different diameters of blood vessels in the human body, so that the compliance and adherence of the ablation component are not high, which affects the surgical effect.

Summary of the invention

In order to solve the aforementioned problems, the present application provides an ablation device that can improve compliance and adherence to ensure the effect of ablation surgery.

In a first aspect, the present application provides an ablation device, including a handle, an inner sheath, an outer sheath, and an ablation assembly, the proximal end of the inner sheath and the proximal end of the outer sheath are both connected to the handle, The outer sheath tube is sleeved on the periphery of the inner sheath tube, the ablation assembly includes a plurality of rods provided with electrodes, the distal ends of the plurality of rods are joined together, and the proximal ends of the plurality of rods are connected At the distal end of the inner sheath, each rod extends spirally around the axial direction of the inner sheath, and the ablation assembly can be switched between a contracted state and an expanded state. In the contracted state, the The ablation assembly is movably contained in the outer sheath; in the expanded state, the proximal end of the ablation assembly is exposed from the distal end of the outer sheath, and each electrode deviates from the position where the helix angle is the largest on the rod. .

In a second aspect, the present application provides a method for preparing an ablation device, including the following steps: providing a plurality of rods shaped into a spiral shape, the distal ends of the plurality of rods are joined together, and each rod is provided with an electrode;

Connecting the proximal ends of the plurality of rods with the distal end of the inner sheath, each rod extending spirally around the axial direction of the inner sheath; and

Put the inner sheath tube into the outer sheath tube, connect the proximal end of the inner sheath tube and the proximal end of the outer sheath tube to a handle, and the ablation assembly can be switched between a contracted state and an expanded state, In the contracted state, the ablation assembly is movably contained in the outer sheath; in the expanded state, the proximal end of the ablation assembly is exposed from the distal end of the outer sheath, and each electrode deviates The position where the helix angle is the largest on the rod.

In the ablation device and the preparation method thereof provided in the present application, each rod is arranged to spirally extend around the axial direction of the inner sheath, so that the ablation component forms a spiral distribution structure. In the expanded state, the position on the rod with the largest helix angle corresponds to the radial dimension Compared with other positions on the rod body, the radial dimension is larger, that is, the radial dimension at the position of the maximum helix angle on the rod body is the largest, the radially outward protrusion degree is the greatest, and the rod body has the greatest degree of bending.

When entering vascular tissue, such as the pulmonary vein, there is still a certain error between the outer diameter of the ablation component and the caliber of the vascular tissue. There may be a situation where the caliber of the vascular tissue is smaller than the maximum outer diameter of the ablation component. During the entry process, the maximum position of the helix angle of the rod is bound by the pulmonary vein, and the extra part of the rod in the radial direction shifts toward the proximal end along the helix direction, resulting in an increase in the outer diameter and helix angle of the proximal part of the rod. . Since the proximal ends of the multiple rods are connected to the distal end of the inner sheath, the outer diameter and helix angle are gradually reduced, which can slow down the increasing trend of the proximal outer diameter and helix angle of the rod. When the tissue calibers are not much different, the outer diameter of the proximal end of the ablation component will not exceed the caliber of the vascular tissue after the expansion, so that the helix angle of the ablation component and the proximal end have less resistance to enter the vascular tissue. It is beneficial for the ablation component to enter the vasculature smoothly, that is, the ablation component has better compliance, can better fit the target tissue area, and is beneficial to improve the effect of ablation surgery.

In addition, in the expanded state, the electrode is located on the rod body at the position where the helix angle on the rod body is the largest, that is, it deviates from the position on the ablation assembly that is the most protruding in the radial direction and has the greatest curvature, which is beneficial to reduce the resistance of the ablation assembly and the rod body when adjusting the outer diameter. , Which is beneficial to further improve the ablation device's closeness and conform to the target tissue. The position with the largest helix angle is located at the edge of the ablation component, and the deviation of the electrode from the position with the largest helix angle is also beneficial to reduce its resistance when moving relative to the target tissue, and is also beneficial to further improve the ablation device's abutment and conform to the target tissue.

Description of the drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only These are some implementations of the present application. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative work.

Fig. 1 is a side view of the ablation device provided by the first embodiment of the application;

Fig. 2 is an enlarged schematic diagram of a partial area of the ablation device shown in Fig. 1;

Figure 3 is a cross-sectional view of the inner sheath and the outer sheath;

Figure 4 is a cross-sectional view of the rod body;

FIG. 5 is an application scenario diagram of an ablation component provided by an embodiment of this application;

FIG. 6 is a schematic diagram of a possible structure of an ablation component provided by an embodiment of this application;

7-9 are schematic diagrams of possible structures of the ablation device provided by the second embodiment of this application;

10 is a schematic diagram of a part of the structure of the ablation device provided by the third embodiment of this application;

FIG. 11 is a schematic diagram of a part of the structure of the ablation device provided by the fourth embodiment of this application;

Figure 12 is a schematic cross-sectional view of the distal end of the ablation assembly and the sleeve;

FIG. 13 is a schematic diagram of an application scene of the ablation device shown in FIG. 11 for ablating myocardial hypertrophy patients;

FIG. 14 is a flow chart of the method for preparing the ablation device provided by this application;

Fig. 15 is a flowchart of step 101 shown in Fig. 14.

Detailed ways

The technical solutions in the embodiments of the present application will be described clearly and completely in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all of them. Based on the implementation manners in this application, all other implementation manners obtained by those of ordinary skill in the art without creative work shall fall within the protection scope of this application.

In the following description, for the purpose of explanation, many specific details are set forth in order to provide a thorough understanding of the present application. However, it is obvious to those skilled in the art that this application can be implemented without these specific details or with equivalent arrangements.

In the case where a numerical range is disclosed in this application, unless otherwise specified, the range is continuous and includes the minimum and maximum values of the range and each value between these minimum and maximum values. Furthermore, in the case where the range refers to an integer, there are only integers including the minimum value to and including the maximum value of this range. In addition, where multiple ranges are provided to describe features or characteristics, such ranges can be combined.

The "and/or" in the text is only an association relationship describing the associated objects, indicating that there can be three relationships, for example, A and/or B, which can mean: A alone exists, A and B exist at the same time, and B exists alone These three situations. In addition, in the description of the embodiments of the present application, "plurality" refers to two or more than two.

As used in this application, the terms "distal" and "proximal" define the position or orientation of the handle (e.g., handle assembly) relative to the clinician or clinician. "Remotely" or "remotely" refers to a position away from the clinician or clinician's handle or in a direction away from the clinician or clinician. "Proximal" or "proximally" refers to a position close to or in a direction toward the clinician or clinician's handle.

In addition, the direction of the central axis of rotation of objects such as cylinders and tubes is defined as the axial direction, and the direction perpendicular to the axial direction is defined as the radial direction. These definitions are only for the convenience of presentation and do not constitute a restriction on this application.

1 to 3, the ablation device 10 provided in the first embodiment of the present application is used to ablate a target tissue area with pulse energy to achieve the effect of electrical isolation. The target tissue area may be located in the heart, including but not limited to pulmonary veins, or combined with typical atrial flutter, triggering lesions of non-pulmonary vein origin (such as left atrial appendage, superior vena cava, coronary sinus ostium), etc. It can be understood that the target tissue area is not limited to be located on the heart, and may also be located on other body tissues, which is not limited here.

The ablation device 10 includes a handle 11, an inner sheath 13, an outer sheath 14 (as shown in FIG. 3), and an ablation assembly 15. For the convenience of description, the outer sheath 14 is omitted in FIG. The outer sheath 14 is sleeved on the periphery of the inner sheath 13, and the proximal end of the outer sheath 14 and the proximal end of the inner sheath 13 are both connected with the handle 11. The ablation assembly 15 includes a plurality of rods 151 provided with electrodes 153. The distal ends of the plurality of rods 151 are joined together. The proximal ends of the plurality of rods 151 are connected to the distal end of the inner sheath 13. Switch between the expanded states. In the contracted state, the ablation assembly 15 is movably contained in the outer sheath 14; in the expanded state, the proximal end of the ablation assembly 15 is exposed from the distal end of the outer sheath 14, and each electrode 153 deviates It is located at the position where the helix angle of the rod 151 is the largest.

In the contracted state, the inner sheath 13 and the ablation assembly 15 are movably housed in the outer sheath 14. The ablation assembly 15 is bound by the outer sheath 14. The outer diameter of the ablation assembly 15 is small, and its maximum outer diameter is the first outer diameter In the expanded state, both the distal and proximal ends of the ablation assembly 15 are exposed (released) from the distal end of the outer sheath 14, and the ablation assembly 15 is approximately lantern-shaped, that is, the ablation assembly 15 includes an axial direction away from it The section projecting outward in the direction of the ablation component 15 has the largest degree of protruding at the position of the rod 151 with the largest helix angle, and has the largest outer diameter. The largest outer diameter is the second outer diameter, and the first outer diameter is smaller than the second outer diameter. In the expanded state, each electrode 153 deviates from the position where the helix angle of the rod 151 is the largest.

Specifically, the rod body 151 has a first position point P. In the expanded state, the helix angle of the first position point P is greater than the helix angles of the other positions of the rod body 151, that is, the helix angle of the rod body 151 at the first position point P is the maximum helix angle of the rod body 151, and the first position point P corresponds to The maximum radial dimension on the rod 151 has the largest curvature. The position other than the first position point P on the rod 151 has a small helix angle, a small radial dimension, and a small curvature relative to the first position point P. The ablation component 15 is in the first position A point P has the largest outer diameter to form the most protruding part in the radial direction.

Each rod 151 extends spirally around the axial direction of the inner sheath 13, and the axial size of the plurality of rods 151 can be changed to adjust the radial dimension at the position of the maximum helix angle on the rod 151, so that the position of the maximum helix angle on the rod 151 The corresponding outer diameter of the location also changes, so that the axial size and the maximum radial size of the ablation component 15 can be changed to match the size of the target ablated tissue area, and the electrode 153 is used to ablate the target ablated tissue. During the change of the axial dimension of the rod body 151, it is ensured that the first position point P at the maximum helix angle has the maximum outer diameter on the rod body 151, so as to make full use of the first position point P or the distance between the first position point P and the rod body 151. The arc formed by the end ablates the mouth or inside of the vascular tissue, and improves the degree of fit with the target ablated tissue.

In the expanded state, before performing ablation, by adjusting the distance between the proximal end and the distal end of the rod 151, the axial size of the rod 151 is changed to adjust the ablation assembly 15 axial size and the outer position at the maximum helix angle. The maximum diameter of the ablation component 15 (the radial dimension at the maximum position of the helix angle of the rod 151) and the position where the electrode 153 forms the electric field match the target ablated tissue. Specifically, the distance between the proximal end and the distal end of the rod 151 increases, the axial size of the rod 151 increases, the axial size of the ablation assembly 15 increases, and the maximum outer diameter of the ablation assembly 15 decreases; The distance between the proximal end and the distal end decreases, the axial size of the rod 151 decreases, the axial size of the ablation assembly 15 decreases, and the maximum outer diameter of the ablation assembly 15 increases.

Each rod 151 spirally extends around the axial direction of the inner sheath 13 so that the ablation assembly 15 forms a spiral distribution structure. When entering the vascular tissue, such as the pulmonary vein, the adjusted outer diameter of the ablation assembly 15 and the caliber of the vascular tissue are also There is a certain error. There may be a situation where the caliber of the vascular tissue is smaller than the maximum outer diameter of the ablation assembly 15. During the entry process, the maximum position of the helix angle of the rod 151 is under the restraint of the pulmonary vein, and there is more in the radial direction. Part of the rod 151 is offset toward the proximal end in the direction of the helix, resulting in an increase in the outer diameter and helix angle of the proximal part of the rod 151. Since the proximal ends of the plurality of rods 151 are connected to the distal end of the inner sheath 13, The outer diameter gradually decreases, so it can slow down the increasing trend of the proximal outer diameter and helix angle of the rod 151. When the adjusted outer diameter of the ablation assembly 15 is not much different from the caliber of the vascular tissue, the proximal end of the ablation assembly 15 After the diameter is enlarged, it will not exceed the caliber of the vascular tissue, so that the outer diameter of the ablation assembly 15 (the helix angle is the largest) and the proximal end have less resistance to enter the vascular tissue, which is conducive to the smoothness of the ablation assembly 15 Into the vasculature, that is, the ablation component 15 has better compliance and can better fit the target tissue area, which is beneficial to improve the surgical effect.

The electrode 153 has a certain length (a dimension extending along the length of the rod 151). It is arranged on the spiral rod 151, especially the electrode 153 with a larger hardness and a longer length, which will reduce the compliance of the position where the electrode 153 is arranged on the rod 151. The flexibility, that is, the flexibility of the position where the electrode 153 is set is relatively poor, and a certain resistance will be brought about when the ablation assembly 15 (rod 151) changes its outer diameter. In the ablation device 10 provided in the present application, in the expanded state, the electrode 153 is located on the rod 151 where the helix angle, outer diameter, and curvature of the rod 151 are the largest, which is beneficial to reduce the ablation assembly 15 and the adjustment of the rod 151. Resistance at the time of the run. The position with the largest helix angle is located at the edge of the ablation component 15, and the deviation of the electrode 153 from the position with the largest helix angle is also beneficial to reduce the resistance when it moves relative to the target tissue, and it is also beneficial to further improve the ablation device 100's abutment and compliance with the target. organization.

In this embodiment, the first position point P is located at the center of the rod 151. The shaft 151 includes a proximal section 1511, a distal section 1513, and an intermediate section 1515 located between the proximal section 1511 and the distal section 1513. The proximal section 1511 includes the most proximal end of the rod body 151. The distal section 1513 includes the most distal end of the shaft 151. The first position point P is a position starting from the closest end of the rod 151 to one half of the length of the rod 151. In the expanded state, the helix angle of the proximal end of the rod 151 and the helix angle of the most distal end of the rod 151 are smaller than the helix angle of the first position of the rod 151. In the expanded state, the angle of the helix angle of the rod 151 is symmetrically distributed along the rod 151 on both sides of the first position point P. The electrode 153 is arranged deviating from the first position of the rod 151, that is, the electrode 153 is not arranged at the first position of the rod 151, so that in the expanded state of the ablation assembly 15, the electrode 153 deviates from the position where the rod 151 has the greatest curvature.

It can be understood that the first position point is not limited to the rod center of the rod 151, and the helix angle of each section on the rod 151 is controlled to be other positions of the rod 151, such as one-third of the length of the rod 151 and so on.

It can be understood that in this embodiment, in the expanded state, the helix angle of the proximal section 1511 and the helix angle of the distal section 1513 are smaller than the helix angle of the middle section 1515; the angle of the helix angle of the rod 151 is along the rod. 151 are symmetrically distributed on both sides of the middle section 1515, and further, symmetrically distributed on both sides of the first position point P along the rod body 151.

It can be understood that the helix angle of the proximal section 1511 and the helix angle of the distal section 1513 are not limited, but are smaller than the helix angle of the middle section 1515, that is, the helix angle of each position of the rod body 151 is not limited.

Taking the process of the ablation assembly 15 deep into the pulmonary vein as an example, if the diameter of the pulmonary vein is smaller than the outer contour formed at the maximum position (maximum outer diameter position) of the spiral angle of the rod 151, the maximum outer diameter of the rod 151 will be The position is bound by the pulmonary vein, and the extra part of the rod 151 in the radial direction shifts toward the proximal end of the rod 151 in the direction of the spiral, resulting in an increase in the outer diameter of the proximal part of the rod 151, so that the pulmonary vein compresses the rod 151 The far end. Because the ablation assembly 15 spirals in the radial direction, the pressure of the pulmonary vein forces the helix angle of the proximal end of the rod 151 to increase, that is, the twist angle in the circumferential direction increases, combining the proximal ends of the plurality of rods 151 and the distal end of the inner sheath 13 Connected, the proximal outer diameter of the ablation assembly 15 is reduced, which can effectively slow down the increasing trend of the proximal outer diameter of the rod 151 without causing the contour of the plurality of rods 151 to significantly exceed the diameter of the pulmonary vein at the proximal end, making the ablation assembly 15 can enter the pulmonary vein smoothly, so as to better conform to the anatomical structure of the target tissue area, and the radial support force is improved, which is conducive to a closer fit with the target tissue area, thereby improving the surgical effect.

The first position points P of all rods 151 are arranged on the same plane perpendicular to the axial direction of the inner sheath 13 at intervals, that is, the first position points P of all rods 151 are formed on the same plane perpendicular to the axial direction of the inner sheath 13 The geometry is discrete. The geometric shapes formed by the first position points P of all the rod bodies 151 are symmetrical figures, for example, circular, elliptical, semi-circular or any other geometric non-linear shapes, which are not limited herein. The number of rods 151 is not limited, for example, the number of rods 151 is 4-10. In this embodiment, the first position points P of the plurality of rods 151 are evenly distributed on the same plane perpendicular to the axial direction of the inner sheath 13; the diameter of the most protruding position of the ablation assembly 15 in the natural state ranges from 6 to 25 mm. It can be understood that the first position points P of the plurality of rods 151 are not limited to be uniformly distributed on the same plane perpendicular to the axial direction of the inner sheath 13; the diameter range of the most protruding position of the ablation assembly 15 in the natural state is not limited.

In this embodiment, the proximal ends of the plurality of rod bodies 151 are fixedly housed in the distal end of the inner sheath 13.

The closest end of the same rod 151 and the most distal end of the rod 151 are twisted at an angle of 30 to 70 degrees in the circumferential direction of the inner sheath 13. In other embodiments, the twist angle can be selected in the range of 0 to 540 degrees. The ablation device 10 also includes a connector 16 connected to the handle 11, the connector 16 is electrically connected to the electrode 153, and the connector 16 is used to connect to a pulse signal source and deliver pulse signals to the electrode 153 for the electrode 153 to ablate the target tissue area .

The ablation device 10 further includes a traction guide rod 17, the traction guide rod 17 movably penetrates the inner sheath 13, the inner sheath 13 is a hollow tube, and the proximal end of the traction guide rod 17 is connected to the handle 11. The distal end of the traction guide rod 17 is combined with the distal ends of a plurality of rod bodies 151. Each rod body 151 is spirally extended around the traction guide rod 17, and the handle 11 is used to pull the traction guide rod 17 to adjust the axial direction of the ablation assembly 15. Length and outer diameter dimensions. In this embodiment, the traction guide rod 17 extends along the axial direction of the inner sheath tube 13, the axial direction of the ablation assembly 15 is the same as the extension direction of the traction guide rod 17, and the traction guide rod 17 is a steel cable. The pulling guide rod 17 can be a hollow flexible polyimide (PI) tube, a fluorinated polyethylene (PDFE) tube, a stainless steel tube, or other polymer materials.

The ablation device 10 controls the traction guide rod 17 to pull the rods 151 of the ablation assembly 15 through the handle 11 to adjust the outer diameter of the ablation assembly 15. When the traction guide rod 17 moves from the distal end to the proximal direction relative to the inner sheath 13 The outer diameter of the large ablation component 15 is reduced when the traction guide rod 17 moves from the proximal end to the distal direction relative to the inner sheath 13. The outer diameter of the ablation assembly 15 is flexibly adjusted by the traction guide rod 17, so that the ablation assembly 15 can adapt to blood vessels of different diameters (such as pulmonary veins) or other body tissues, and can perform the target ablation area under any appropriate outer diameter conditions. The ablation is not limited to the case where the ablation component 15 must be ablated under the maximum axial compression, which improves the adaptability to the anatomical morphology of different target ablation regions, facilitates the operation of the ablation device 10, and has a good ablation effect. For example, when the ablation device 10 is in operation, the outer diameter of the ablation assembly 15 can be increased by adjusting the electrode 153 to generate an electric field at the pulmonary vein orifice to ablate tissue, or the outer diameter of the ablation assembly 15 can be reduced by adjusting. The electrode 153 is placed in the pulmonary vein to ablate tissue.

Please refer to FIG. 4, the rod body 15 further includes a main rod 154 and an insulating sleeve 155, and the insulating sleeve 155 is sleeved outside the main rod 154. The cross-sectional shape of the main rod 154 can be a circle, a semicircle, a round drum, or other shapes, and is not limited herein. In this embodiment, the main rod 154 is made of nickel-titanium wire, so that the main rod 154 has excellent elastic properties and strength, so as to be able to closely adhere to the target tissue. It can be understood that the main rod 154 may be made of other materials, such as stainless steel or polymer materials. The electrode 153 is fixed on the outer wall of the insulating sleeve 155. In this embodiment, the material of the insulating sleeve 155 is Pebax or heat shrinkable tube (such as FEP heat shrinkable tube) or other insulating polymer materials, which ensures the insulation between the electrode 153 and the main rod 154. The insulating sleeve 155 may be one layer, two layers or multiple layers.

The electrode 153 is fixed to the outer wall of the insulating sleeve 155 by curing glue. The electrode 153 is made of platinum-iridium alloy or gold or other platinum alloys, and the shape of the electrode 153 conforms to the shape of the rod 151. The number of electrodes 153 of each rod 15 may be one, two or more. The electrodes 153 on each rod 15 have the same polarity and are opposite in polarity to the electrodes 153 on the adjacent rod 15. Each electrode 153 can be configured with different parameters such as voltage, pulse width, repetition frequency, duty cycle and pulse number, single-phase or dual-phase pulse. The electrode 153 may map the cardiac electrophysiological signal and/or be used to perform other functions such as cardiac pacing. For example, in one period, all the electrodes 153 are used for ablation, and in another period, all of the electrodes 153 are used for mapping, or some of the electrodes 153 are always used for ablation, and some of the electrodes 153 are always used for mapping.

In this application, each electrode 153 can be independently addressed, that is, an electrical pulse signal can be output to any electrode as needed to ablate the target tissue area.

In this embodiment, each rod 151 is provided with two electrodes 153 (FIGS. 2 and 4). The two electrodes 153 are located on both sides of the first position point P and the positions of the two electrodes 153 are asymmetrical, that is, one electrode 153 is located at the first position. On the proximal side of the position point P, the other electrode 153 is located on the distal side of the first position point P. In the expanded state, a plurality of electrodes 153 on the distal side of the plurality of rods 151 surround a first ring. For forming a first electric field, the plurality of electrodes 153 on the proximal side of the plurality of rods 151 surround a second circular ring for forming a second electric field. The diameter of the first circular ring is smaller than that of the second circular ring. , The diameter of the first electric field is smaller than that of the second electric field. In a control method, according to the size of the target tissue area, you can choose to control the electrode 153 on the first circle to perform ablation, or choose to control the electrode 153 on the second circle to perform ablation alone, or choose to control the first circle. Perform ablation together with the electrode 153 on the second ring.

Please refer to FIG. 5, which is an application scenario diagram of the ablation component of the ablation device provided in an embodiment of this application for ablating the pulmonary vein ostium (not intrapulmonary vein). The position of the electrode in the embodiment in FIG. 5 is different from that in the previous embodiment. The two electrodes on each rod 151 are arranged on the distal side corresponding to the first position point P of the rod 151, and the mouth 2011 of the pulmonary vein 201 shown in FIG. 5 is relatively large. A circle of electrodes composed of the electrodes 153 on the plurality of rods 151 closer to the distal end of the rod 151 is called the far circle electrode 1531, and a circle of electrodes 153 on the plurality of rods 151 closer to the proximal end of the rod 151 is composed of one circle. The circle electrode is called the near circle electrode 1533. The distance between the far circle electrode 1531 and the mouth 2011 cannot be ablated, the near circle electrode 1533 fits the mouth 2011 better, the proximal circle electrode 1533 is controlled for ablation, and the far circle electrode 1531 can be controlled to close Or used for mapping. If the caliber of the mouth 2011 of the pulmonary vein 201 is small, the far circle electrode 1531 is selected for ablation.

In the application scenario of internal pulmonary vein ablation, two circles of electrodes can be selectively used as needed. Please refer to FIGS. 1, 2 and 4 together. The ablation device 10 further includes a wire 158, which is inserted through the inner sheath 13 and the insulating sleeve 155, and the proximal end of the wire 158 is electrically connected to the connector 16. The distal end of the wire 158 is electrically connected to the electrode 153. The wire 158 and the main pole 154 are insulated from each other. The electrode 153 and the wire 158 are connected by welding or other processes.

The lead 158 includes a first lead (not shown), the first lead is connected to an external pulse signal source through the connector 16, and the electrode 153 connected to the first lead uses the electrical energy provided by the pulse signal source to ablate the target tissue; And/or the lead 158 includes a second lead (not shown). The electrode 153 connected to the second lead is used to collect electrophysiological signals of the target tissue area to generate an electrocardiogram, etc., and the second lead will collect the electrophysiological signals. The signal is transmitted to the external processor through the connector 16, on the one hand, it is beneficial to the positioning of the complex cardiac anatomy, which can improve the efficiency of the operation and reduce the radiation of the surgeon and the patient. On the other hand, it can also monitor the completion of the ablation operation and fully control the ablation. The progress of the operation improves the safety of the operation.

It can be understood that the ablation device 10 of the present application can be connected to an external radio frequency source or other energy delivery equipment through the connector 16.

In this embodiment, the voltage range of the pulse signal received by the electrode 153 is 900V-2400V, including all the values and sub-ranges therebetween; the pulse frequency is 1kHz-500kHz, including all the values and sub-ranges therebetween, and the pulse signal source can be unipolar. The pulse high voltage power supply can also be a bipolar high voltage pulse power supply. The waveform of the bipolar high voltage pulse signal is alternating between positive and negative pulses in each cycle. Correspondingly, the maximum voltage that the wire can withstand is 3000V; the all electrodes 153 Can be divided into one or more positive-negative sets.

Please refer to FIG. 2 again. The ablation assembly 15 further includes an installation sleeve 157, and the distal end of the traction guide rod 17 is fixed in the installation sleeve 157. The distal end of each rod 151 is fixed to the mounting sleeve 157 so that the distal ends of the plurality of rods 151 are joined together. In this embodiment, the distal end of the rod body 151 extends from the proximal end of the installation sleeve 157 into the installation sleeve 157. By installing the sleeve 157 to connect the distal ends of the plurality of rods 151 together, it is beneficial to improve the connection strength of the distal ends of the rods 151. The distal end of the sleeve 157 has a rounded structure, which is beneficial to reduce the damage to the target tissue caused by the device, and also allows the ablation assembly 15 to conform to the target tissue area (such as the left atrial appendage).

It can be understood that the angle of the spiral angle of the rod 151 is not limited, and is symmetrically distributed along the rod 151 on both sides of the first position point P; it is not limited that all the rods 151 have the same spiral shape, as shown in FIG. 6.

Referring to FIG. 7, the difference between the ablation device provided in the second embodiment of the present application and the ablation device 10 provided in the first embodiment is that the ablation device further includes an elastic support structure 37, which is connected to two adjacent rods. The distance between the two adjacent rods 151 is used to keep the distance between the two adjacent rods 151 to prevent the electrode 153 from generating arcs or sparks due to the too small distance between the rods 151 during the operation of the ablation device 30, which may cause interference. The breakdown damage of the target tissue. In this embodiment, the elastic support structure 37 is a mesh structure, and the elastic support structure 37 is arranged along the circumferential direction of the ablation assembly 15. The elastic support structure 37 covers the distal end section 1513 of the rod body 151. The elastic support structure 37 is connected to all the rod bodies 151. The elastic support structure 37 can change its shape along with the outer diameter of the ablation component 15. In this embodiment, the elastic support structure 37 is made of nickel-titanium wire to have excellent elastic properties and high strength.

It can be understood that the number of elastic support structures 37 is not limited. As shown in FIG. 8, the number of elastic support structures 37 is two. One elastic support structure 37 covers the proximal section 1511, and the other elastic support structure 37 covers In the distal section 1513, the elastic support structure 37 can also cover all the rods 151 of the ablation assembly 15, as shown in FIG. 9. The elastic support structure 37 covers at least one of the proximal section 1511, the distal section 1513 and the middle section 1513 of the rod body 151.

It can be understood that the elastic support structure 37 may also be other supports, such as support bars/rods arranged between adjacent rods 151, and components for isolation between electrodes arranged on the rods 151.

It can be understood that the elastic support structure 37 is provided at at least one of the proximal end of the ablation component 15, the distal end of the ablation component 15, and the middle of the ablation component 15, and the middle of the ablation component 15 is located between the proximal end of the ablation component 15 and the The area between the far ends.

10, the ablation device provided by the third embodiment of the present application has substantially the same structure as the ablation device provided by the first embodiment, except that the traction guide rod 57 is provided with a traction channel (not shown) in the axial direction. The traction channel is used to pierce the guide wire 301, and the mapping electrode 303 at the distal end of the guide wire 301 can be exposed from the most distal end of the traction guide rod 57 for mapping electrophysiological signals. Since a special traction channel is provided with the mapping electrode 303 for mapping the electrophysiological signal, it is convenient to use and control the ablation device.

Referring to FIGS. 11 and 12, the ablation device provided by the fourth embodiment of the present application has substantially the same structure as the ablation device provided by the first embodiment, except that the distal end of the rod 151 extends from the distal end of the sleeve 157 The sleeve 157 is installed, that is, the distal end of the rod 151 is folded in the proximal direction.

The mounting sleeve 157 includes an inner sleeve 1571 and an outer sleeve 1573, the inner sleeve 1571 is fixedly sleeved on the distal end of the traction guide rod 17, the outer sleeve 1573 is sleeved on the inner sleeve 1571, and the distal end of the rod body 151 The fixing clamp is arranged between the inner sleeve 1571 and the outer sleeve 1573. It can be understood that the distal end of the rod 151 is not limited to be fixed by installing a sleeve 157, and the distal ends of all the rods 151 can also be fixed together in other ways, for example, the distal ends of all the rods 151 are directly glued by curing glue. Together.

The distal end of the rod body 151 extends from the distal end of the installation sleeve 157 into the installation sleeve 157 to form a round turn-up structure 103. The turn-up structure 103 can effectively reduce the mechanical damage of the ablation component 15 to the target tissue, and better conform to the target tissue.

Please refer to FIG. 13, which is a schematic diagram of an application scenario of the ablation device provided by the fourth embodiment for ablating a patient with myocardial hypertrophy. When the left atrial appendage 1015 is used as the target tissue, the ablation component 15 enters the right atrium 1013 from the inferior vena cava 1011 of the heart along with the distal end of the inner sheath 13, and then enters the left atrial appendage 1015 through the left atrium 1014. The traction guide rod 17 is controlled by a handle (not shown in FIG. 13), and the outer diameter of the ablation assembly 15 is adjusted to fit the size of the inner cavity of the left atrial appendage 1015. The electrode 153 is energized to generate an electric field to ablate the left atrial appendage 1015.

Taking the end of the left ventricle 1016 away from the left atrium 1011 as the target tissue, the ablation assembly 15 along with the distal end of the inner sheath 13 enters the right atrium 1013 from the inferior vena cava 1011 of the heart, and then enters the left ventricle 1016 through the left atrium 1014. The traction guide rod 17 is controlled by the handle 11, and the outer diameter of the ablation assembly 15 is adjusted to fit the inner cavity size of the end of the left ventricle 1016 away from the left atrium 1011. The electrode 153 is energized to generate an electric field to ablate the inner cavity of the end of the left ventricle 1016 away from the left atrium 1011.

Please refer to FIG. 14. This application also provides a method for preparing the ablation device as described above, which includes the following steps:

Step 101: Provide a plurality of rods shaped into a spiral shape, the distal ends of the plurality of rods are combined together, and each of the rods is provided with an electrode.

Step 103: Connect the proximal ends of the plurality of rods with the distal ends of the inner sheath, each of the rods spirally extending around the axial direction of the inner sheath.

Step 105: Put the inner sheath tube into the outer sheath tube, connect the proximal end of the inner sheath tube and the proximal end of the outer sheath tube to the handle, and the ablation assembly can be in a contracted state and an expanded state. In the contracted state, the ablation assembly is movably contained in the outer sheath; in the expanded state, the proximal end of the ablation assembly is exposed from the distal end of the outer sheath, and each Each electrode deviates from the position with the largest helix angle on the rod where it is located.

Please refer to Figure 12, step 101, which specifically includes the following steps:

Step 1011, cutting the base material to form a plurality of prefabricated rods, a cutting slit is formed between two adjacent prefabricated rods, and the cutting slit extends from the first end of the base material and penetrates the second end of the base material. The end face of the end makes the distal ends of the plurality of main rods joined together.

In other words, the substrate, such as a tube, is cut into multiple prefabricated rods, and the proximal end of the substrate is not cut, that is, the proximal ends of all the prefabricated rods are fixedly connected together; or, the distal end of the substrate is not Cutting, that is, the distal ends of all prefabricated rods are fixedly connected together. The prefabricated rod is a straight rod, and the base material is made of nickel-titanium alloy, stainless steel or polymer materials. It can be understood that the prefabricated rods are not limited to straight rods. It is understandable that a plurality of independent and separate prefabricated rods can be formed by cutting the substrate. For example, in one embodiment, the prefabricated rod is a piece of nickel-titanium alloy wire, and there is no need to cut the tubular substrate in the axial direction. . Cut the nickel-titanium alloy wire into multiple sections.

Step 1012, heat setting the prefabricated rod material into a spiral shape by a heat setting process to form a main rod, the main rod being helically extended along the axial direction of the inner sheath, and the distal ends of a plurality of the main rods are joined together .

In this embodiment, each prefabricated rod is heat-set by a heat-setting tool. Heat setting each prefabricated rod to the required helix angle step by step through the heat setting tool, such as the first setting to 45 degrees, the second setting to 90 degrees..., and the final setting to the required helix angle to prevent one-off Shaping to the required helix angle causes the prefabricated rod to break and/or twist. It can be understood that in the embodiment where the prefabricated rod material is a piece of nickel-titanium alloy wire, the required rod body can be formed in one step by a heat setting tool.

It can be understood that it is not limited to use a heat setting tool to process the prefabricated rod to form the main rod, and it can also be prepared by other methods.

Step 1013, fix and electrically connect the electrode and the wire. In this embodiment, the electrode and the wire are welded together. It can be understood that the electrode and the wire can also be connected in other ways, for example, a glue connection.

Step 1014, opening a through hole at the position of the pre-installed electrode of the insulating sleeve, the through hole deviating from the position where the rod body has the greatest degree of curvature.

Step 1015: Pass the proximal end of the wire through the through hole and out of the proximal opening of the insulating sleeve.

Step 1016: Fix the electrode on the pre-installed electrode position of the insulating sleeve.

In step 1017, the main rod is inserted into the insulating sleeve fixed with the electrode, and the wire is clamped between the inner wall of the insulating sleeve and the main rod and insulated from each other to form the rod body.

In step 101, if prefabricated rods are already prepared, step 1011 is omitted.

The step 103, that is, the connecting the proximal ends of the plurality of rods with the distal end of the inner sheath includes: the distal end of the wire penetrates from the distal end of the inner sheath and exits from the proximal end of the inner sheath, and It is electrically connected with the connector on the handle, and the proximal end of the main rod is fixedly connected with the distal end of the inner sheath.

It can be understood that, in some embodiments, before step 105 and after step 103, or after step 105, it further includes the step of: piercing the traction guide rod through the inner sheath and exposing the distal end of the inner sheath, the The distal ends of the plurality of rods are fixed together with the distal ends of the traction guide rods.

It should be noted that the above step labels, such as 101, 1015, etc., are introduced for the sake of simplicity, and the above step labels are not used to limit the sequence of steps.

The preparation method further includes the step of: arranging an elastic support structure on at least one of the proximal end of the ablation component, the distal end of the ablation component, and the middle of the ablation component, where the middle of the ablation component is located in the ablation component. The area between the proximal end of the ablation component and the distal end of the ablation component is used to keep two adjacent rods at a distance from each other to prevent electrodes from being caused by the small distance between the rods during the operation of the ablation device Produce electric arcs or sparks, causing breakdown damage to the target tissue. The elastic support structure can be arranged on the ablation component by bonding or welding.

In this embodiment, the elastic support structure is a mesh structure made of nickel-titanium wire, and the elastic support structure is arranged along the circumferential direction of the ablation component. The elastic support structure covers the distal end section of the rod body. The elastic support structure is connected with all the rod bodies. The elastic support structure can change shape along with the outer diameter of the ablation component.

It can be understood that the elastic support structure may also be other supports, such as support bars/rods arranged between adjacent rods, and components for isolation between electrodes arranged on the rods.

The above-disclosed are only the preferred implementations of the application, which of course cannot be used to limit the scope of rights of the application. Therefore, equivalent changes made in accordance with the claims of the application still fall within the scope of the application.

Claims

An ablation device, which is characterized in that it comprises a handle, an inner sheath, an outer sheath, and an ablation component. The proximal end of the inner sheath and the proximal end of the outer sheath are both connected to the handle, and the outer sheath The sheath is sleeved on the periphery of the inner sheath, the ablation assembly includes a plurality of rods provided with electrodes, the distal ends of the plurality of rods are joined together, and the proximal ends of the plurality of rods are connected to the At the distal end of the inner sheath, each of the rods spirally extends around the axial direction of the inner sheath, and the ablation assembly can be switched between a contracted state and an expanded state. In the contracted state, the ablation The component is movably contained in the outer sheath; in the expanded state, the proximal end of the ablation component is exposed from the distal end of the outer sheath, and each electrode deviates from the largest helix angle on the rod. Location.
The ablation device according to claim 1, wherein the ablation device further comprises a traction guide rod, the traction guide rod movably passes through the inner sheath, and the proximal end of the traction guide rod is connected to the inner sheath. The handle is connected, the distal end of the traction guide rod is combined with the distal ends of a plurality of the rod bodies, each of the rod bodies is spirally extended around the traction guide rod, and the handle is used to pull the traction guide The rod realizes the adjustment of the outer diameter of the ablation component.
The ablation device according to claim 2, wherein the traction guide rod is provided with a traction channel along its axial direction, the traction channel is used for piercing a guide wire, and the mapping electrode at the distal end of the guide wire can It is exposed from the most distal end of the traction guide rod.
The ablation device of claim 1, wherein the rod body includes a proximal section, a distal section, and an intermediate section between the proximal section and the distal section, and in the expanded state , The helix angle of the proximal section and the helix angle of the distal section are smaller than the helix angle of the middle section.
The ablation device according to claim 4, wherein, in the expanded state, the helix angle decreases from the middle section of the rod body to the proximal end section of the rod body and the distal end section of the rod body.
The ablation device according to claim 4 or 5, wherein the angle of the helix angle of the rod body is symmetrically distributed on both sides of the middle section along the rod body.
The ablation device according to claim 1, wherein the rod body comprises a main rod and an insulating sleeve, the insulating sleeve is sleeved outside the main rod, and the electrode is fixedly arranged on the insulating sleeve The electrode is used to ablate the target tissue area through ablation, the ablation device further includes a connector and a wire, the connector is provided on the handle, and the wire is passed through the insulating sleeve The tube and the inner sheath tube, the wire and the main rod are insulated from each other, and the wire is electrically connected between the electrode and the connector.
The ablation device according to claim 7, wherein the lead includes a first lead, the first lead is connected to an external pulse signal source through the connector, and the electrode connected to the first lead Use the electrical energy provided by the pulse signal source to ablate the target tissue; and/or the lead includes a second lead, and the electrode connected to the second lead is used to collect electrophysiological signals of the target tissue area, the first The two wires transmit the collected electrophysiological signals to the external processor through the connector.
The ablation device according to claim 1, wherein the ablation device further comprises an elastic support structure, and the elastic support structure is connected between two adjacent rods.
The ablation device according to claim 9, wherein the elastic support structure is a mesh structure.
The ablation device according to claim 10, wherein the elastic support structure is provided at at least one of the proximal end of the ablation component, the distal end of the ablation component, and the middle of the ablation component, and the The middle of the ablation component is located in the area between the proximal end of the ablation component and the distal end of the ablation component.
The ablation device according to claim 1, wherein the ablation device further comprises a mounting sleeve, and the distal end of each rod is fixed to the mounting sleeve, so that the distal end of a plurality of the rods Ends together.
The ablation device according to claim 12, wherein the rod body extends into the installation sleeve from the proximal end or the distal end of the installation sleeve.
A method for preparing an ablation device is characterized in that it comprises the following steps:

Providing a plurality of rods shaped into a spiral shape, the distal ends of the plurality of rods are joined together, and each of the rods is provided with an electrode;

Connecting the proximal ends of the plurality of rods with the distal ends of the inner sheath, each of the rods spirally extending around the axial direction of the inner sheath; and

Put the inner sheath tube into the outer sheath tube, connect the proximal end of the inner sheath tube and the proximal end of the outer sheath tube to a handle, and the ablation assembly can be switched between a contracted state and an expanded state, In the contracted state, the ablation assembly is movably contained in the outer sheath; in the expanded state, the proximal end of the ablation assembly is exposed from the distal end of the outer sheath, and each The electrode deviates from the position with the largest helix angle on the rod where it is located.
The preparation method according to claim 14, wherein said providing a plurality of rods shaped into a spiral comprises the following steps:

Heat-setting the prefabricated rod material into a spiral shape by a heat setting process to form a main rod, and the distal ends of a plurality of the main rods are joined together;

Fix and electrically connect the electrode and the wire;

Opening a through hole at the position of the pre-installed electrode of the insulating sleeve, the through hole deviating from the position with the greatest degree of curvature;

Pass the proximal end of the wire through the through hole and pass through the proximal opening of the insulating sleeve;

Fixing the electrode to the pre-installed electrode position of the insulating sleeve;

The main rod is inserted into the insulating sleeve fixed with the electrode, and the wire is clamped between the inner wall of the insulating sleeve and the main rod and insulated from each other to form the rod body.
The preparation method according to claim 15, characterized in that, before the heat setting process is used to heat-set the preformed rod material into a spiral shape to form the main rod, the preparation method further comprises the step of cutting the base material to form a plurality of For prefabricated rods, a cutting seam is formed between two adjacent prefabricated rods, and the cutting seam extends from the first end of the base material and penetrates the end surface of the second end of the base material, so that a plurality of the main rods The distal ends of the rods are joined together.
The preparation method according to claim 16, wherein the heat setting the prefabricated rod into a spiral shape to form the main rod by a heat setting process comprises: stepwise heat setting each prefabricated rod by a heat setting tool Into the required helix angle.
The preparation method according to claim 14, wherein the preparation method further comprises the steps:

The elastic support structure is arranged at least one of the proximal end of the ablation component, the distal end of the ablation component, and the middle of the ablation component, and the middle of the ablation component is located between the proximal end of the ablation component and the middle part of the ablation component. The area between the distal ends of the ablation component.