Transcatheter myocardial ablation device and transcatheter myocardial ablation system

Abstract

The present invention provides a transcatheter myocardial ablation device and a transcatheter myocardial ablation system. The ablation device includes a delivery tube body component and an ablation component. The delivery tube body component includes an adjustable bend sheath tube and an adjustable bend catheter movably arranged in the adjustable bend sheath tube. The adjustable bend sheath tube includes a first bend adjustment section located at the distal end. The adjustable bend catheter includes a second bend adjustment section located at the distal end. The second bend adjustment section extends out of the distal end of the first bend adjustment section. The first bend adjustment section bends along a first direction. The second bend adjustment section bends along a second direction. The first direction is different from the second direction. The ablation component includes an ablation needle movably arranged in the adjustable bend catheter. The distal end of the ablation needle can extend out of the distal end of the adjustable bend catheter. The direction of the ablation needle is adjusted by adjusting the first bend adjustment section and / or the second bend adjustment section. The present invention drives the ablation needle to different ablation points by adjusting the bending direction and angle of the adjustable bend sheath tube and the adjustable bend catheter, thereby achieving ablation with low trauma, high controllability, and multiple points.

Description

Technical Field

[0001] The present application relates to the field of medical equipment and devices, and in particular to a transcatheter myocardial ablation device and a transcatheter myocardial ablation system including the transcatheter myocardial ablation device. Background Art

[0002] Hypertrophic cardiomyopathy is a common autosomal dominant cardiovascular disease with an incidence of about 1:500 in the general population and a mortality rate of about 1.4%-2.2%. It is the most common cause of sudden death in young people and athletes. The main manifestation of hypertrophic cardiomyopathy is hypertrophy of one or more segments of the left ventricle, and the general diagnostic standard is a thickness greater than or equal to 15mm. When the anterior leaflet of the mitral valve moves forward during systole and abuts against the ventricular septum, causing stenosis or even obstruction of the left ventricular outflow tract, that is, when the pressure gradient in the left ventricular outflow tract is too large, it is called obstructive hypertrophic cardiomyopathy.

[0003] Currently, the treatment strategy for obstructive hypertrophic cardiomyopathy is to enlarge the left ventricular outflow tract to reduce the pressure gradient and alleviate its obstruction. Commonly used treatment methods include drug therapy, ventricular septal rotation and ventricular septal alcohol ablation, but these methods have disadvantages such as high surgical risks or poor treatment effects.

[0004] In recent years, some new technologies for treating obstructive hypertrophic cardiomyopathy have been disclosed, such as using a radiofrequency ablation needle to enter the myocardium through the apical pathway for radiofrequency ablation, or using a radiofrequency ablation electrode to enter the cardiac cavity through the vascular pathway for radiofrequency ablation. Although these methods have certain advantages over traditional methods, these ablation devices with radiofrequency ablation function are more traumatic during the ablation operation, have low controllability, and cannot accurately achieve multi-point ablation. Summary of the invention

[0005] The object of the present invention is to provide a transcatheter myocardial ablation device capable of adjusting the ablation position to accurately achieve multi-point ablation, and a transcatheter myocardial ablation system comprising the transcatheter myocardial ablation device.

[0006] In order to solve the above technical problems, the present invention provides a transcatheter myocardial ablation device, which includes a delivery tube body component and an ablation component. The delivery tube body component includes an adjustable bend sheath and an adjustable bend catheter movably disposed in the adjustable bend sheath, the adjustable bend sheath includes a first bend adjustment section located at the distal end, the adjustable bend catheter includes a second bend adjustment section located at the distal end, the second bend adjustment section extends out of the distal end of the first bend adjustment section, the first bend adjustment section bends along a first direction, the second bend adjustment section bends along a second direction, and the first direction is different from the second direction; the ablation component includes an ablation needle movably disposed in the adjustable bend catheter, the distal end of the ablation needle can extend out of the distal end of the adjustable bend catheter, and the direction of the ablation needle can be adjusted by bending the first bend adjustment section and / or the second bend adjustment section.

[0007] In some embodiments, the first direction is opposite to the second direction.

[0008] In some embodiments, the transcatheter myocardial ablation device is used to ablate the ventricular septum, and when the delivery tube assembly is located at the aortic arch, the first bending section and / or the second bending section are bent to drive the ablation needle to point to different positions of the ventricular septum.

[0009] In some embodiments, the first direction is a direction close to the inner side of the aortic arch, and the second direction is a direction toward the outer side of the aortic arch.

[0010] In some embodiments, the adjustable bending sheath further comprises a first positioning segment located proximal to the first bending adjustment segment, and an angle between a distal tangent of the first positioning segment and a distal tangent of the first bending adjustment segment ranges from 0° to 180°.

[0011] In some embodiments, the adjustable bend catheter further comprises a second positioning segment located at the proximal end of the second bending adjustment segment, and an angle between a distal tangent of the second positioning segment and a distal tangent of the second bending adjustment segment ranges from 0° to 90°.

[0012] In some embodiments, when the ablation needle points to the ventricular septum, the curvature of the first positioning segment is substantially consistent with the curvature of the aortic arch, and the curvature of the second positioning segment is substantially consistent with the curvature of the aortic arch.

[0013] In some embodiments, the delivery tube assembly further includes a first traction wire and a second traction wire, wherein the first traction wire is inserted through the inner side of the bend of the adjustable bend sheath tube close to the first bend adjustment section, the distal end of the first traction wire is connected to the distal end of the adjustable bend sheath tube, and the first traction wire pulls the adjustable bend sheath tube to bend along a first direction, and the second traction wire is inserted through the inner side of the bend of the adjustable bend catheter tube close to the second bend adjustment section, the distal end of the second traction wire is connected to the distal end of the adjustable bend catheter tube, and the second traction wire pulls the adjustable bend catheter tube to bend along a second direction. In some embodiments, the adjustable bend catheter tube further includes a stopper, wherein the stopper is connected to the distal end of the second bend adjustment section, and the stopper has a smooth distal end surface.

[0014] In some embodiments, the ablation needle includes a needle assembly, a main body tube and a liquid inlet tube. The needle assembly includes a needle, a straight ablation portion, a flexible reinforcement portion and a conductive portion. The distal end of the straight ablation portion is connected to the proximal end of the needle, and the proximal end of the straight ablation portion is connected to the distal end of the flexible reinforcement portion. The conductive portion is arranged at the proximal end of the flexible reinforcement portion. The main body tube is made of insulating material, and the main body tube is sleeved and connected to the flexible reinforcement portion. The liquid inlet tube is axially penetrated through the main body tube and the needle assembly, and the liquid inlet tube is used to transport a cooling medium to cool the needle assembly.

[0015] In some embodiments, the needle has a hollow inner cavity, which is connected to the inner cavity of the main tube, and the needle is selected from at least one of a triangular pyramid head, a bevel blade head, or a conical pointed head.

[0016] In some embodiments, the straight ablation portion and the flexible reinforcement portion are the same tube body, or are formed by connecting different tube bodies, and the inner cavity of the straight ablation portion is connected to the hollow inner cavity of the needle.

[0017] In some embodiments, the flexible reinforcement portion is formed by cutting a hypotube.

[0018] In some embodiments, the ablation needle further includes a temperature sensor, which is connected to the ablation needle and is used to measure the temperature of the ablation needle.

[0019] The present invention also provides a transcatheter myocardial ablation system, comprising an energy generator, a cooling circulation device and the transcatheter myocardial ablation device, wherein the energy generator provides energy for the transcatheter myocardial ablation system, the cooling circulation device is used to dissipate heat from the ablation needle, and the energy generator and the cooling circulation device are respectively connected to the transcatheter myocardial ablation device.

[0020] In some embodiments, the cooling circulation device includes a cooling medium reservoir, a cooling medium collecting tank, a circulation pump, an inflow tube and an outflow tube. The cooling medium reservoir is used to store cooling medium, the cooling medium collecting tank is used to recover used cooling medium, the circulation pump is used to transport the cooling medium from the cooling medium reservoir to the interior of the ablation needle through the inflow tube, the proximal end of the inflow tube is connected to the circulation pump, the distal end of the inflow tube is connected to the transcatheter myocardial ablation device, the proximal end of the outflow tube is connected to the cooling medium collecting tank, and the distal end of the outflow tube is connected to the transcatheter myocardial ablation device.

[0021] The transcatheter myocardial ablation device and transcatheter myocardial ablation system of the present invention can drive the ablation needle to different ablation points by adjusting the bending direction and angle of the adjustable bending sheath and the adjustable bending catheter in the delivery tube assembly, thereby achieving the technical effect of low trauma, high controllability, precision, and multi-point ablation during the ablation operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In order to more clearly illustrate the technical solution of the embodiment of the present invention, the drawings required for use in the implementation mode will be briefly introduced below. Obviously, the drawings described below are some implementation modes of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0023] Figure 1 It is a schematic diagram of the structure of the transcatheter myocardial ablation device provided by the present invention adapted to the inner part of the heart;

[0024] Figure 2 yes Figure 1 A schematic diagram of the structure in which the delivery tube assembly is adapted to fit within the body;

[0025] Figure 3 yes Figure 2 A schematic diagram of the structure of the conveying pipe body assembly;

[0026] Figure 4 yes Figure 3 A schematic diagram of the structure of the adjustable bending sheath tube;

[0027] Figure 5 yes Figure 3 A schematic diagram of the structure of the adjustable curved conduit;

[0028] Figure 6 yes Figure 5 A partial cross-sectional view of the adjustable curved conduit in FIG.

[0029] Figure 7 yes Figure 5 A cross-sectional view of the adjustable curved catheter after the ablation needle is inserted;

[0030] Figure 8 yes Figure 7 A cross-sectional view of the ablation needle after it extends out of the adjustable curved catheter;

[0031] Fig. 9 yes Figure 1 Schematic diagram of the structure of the ablation needle;

[0032] Fig.10 yes Fig. 9 A cross-sectional view of an ablation needle in FIG.

[0033] Fig.11 yes Fig. 9 A schematic structural diagram of another embodiment of the needle tip of the ablation needle;

[0034] Fig.12 yes Figure 1 A cross-sectional view of another embodiment of the ablation needle in FIG.

[0035] Fig.13 It is a schematic structural diagram of the transcatheter myocardial ablation system provided by the present invention;

[0036] Figures 14 to 16 is a schematic diagram of the use process of the transcatheter myocardial ablation system provided by the present invention;

[0037] Fig.17 yes Fig.13 Schematic diagram of application scenario when the adjustable curved catheter is used to adjust the ablation needle to select different puncture points;

[0038] Fig.18 yes Fig.17 Schematic diagram of the ablation needle of the transcatheter myocardial ablation device selecting different puncture points on the ventricular septum of the heart. DETAILED DESCRIPTION

[0039] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0040] References throughout the specification to "one embodiment," "an embodiment," "in another embodiment," or "in certain embodiments" mean that at least one embodiment includes the specific referenced elements, structures, or features described in connection with that embodiment. Thus, the phrases "in one embodiment," "in an embodiment," "in another embodiment," or "in certain embodiments" appearing in different places throughout the specification do not necessarily all refer to the same embodiment. Furthermore, the specific elements, structures, or features may be combined in any appropriate manner in one or more embodiments.

[0041] In addition, the following descriptions of the various embodiments are made with reference to the attached drawings to illustrate specific embodiments in which the present invention may be implemented. The directional terms mentioned in the present invention, such as "top", "bottom", "front", "back", "left", "right", "inside", "outside", "side", etc., are only with reference to the directions of the attached drawings. Therefore, the directional terms used are for better and clearer description and understanding of the present invention, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore cannot be understood as limiting the present invention.

[0042] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", and "set on..." should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection; it can be directly connected, or indirectly connected through an intermediate medium, or it can be internal communication between two components. In the field of access medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator; the axial direction refers to the direction parallel to the line connecting the distal center and the proximal center of the medical device. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0043] Please also read Figures 1 to 5 The transcatheter myocardial ablation device provided by the present invention includes a delivery tube body component for adjusting the ablation position and an ablation component for myocardial ablation. Specifically, the delivery tube body component includes an adjustable bending sheath tube 20 and an adjustable bending catheter tube 30, and the adjustable bending catheter tube 30 is movably arranged in the adjustable bending sheath tube 20.

[0044] The adjustable bending sheath 20 includes a first bending section 21 located at the distal end, and the adjustable bending catheter 30 includes a second bending section 31 located at the distal end, the second bending section 31 can be extended axially out of the distal end of the first bending section 21, the first bending section 21 can be bent along a first direction A, and the second bending section 31 can be bent along a second direction B, and the first direction A is different from the second direction B; the ablation assembly includes an ablation needle 40 movably inserted into the adjustable bending catheter 30, and the distal end of the ablation needle 40 can be extended axially out of the distal end of the adjustable bending catheter 30; the direction of the ablation needle 40 is adjusted by bending the first bending section 21 and / or the second bending section 31. Since the adjustable bending sheath and the adjustable bending catheter can cooperate to drive the ablation needle to different ablation points, the target myocardial tissue can be ablated, so that the operation process of the myocardial ablation surgery is flexible and controllable, the surgical trauma is low, and the ablation is accurate and multi-point, and the surgery speed is accelerated. In this embodiment, the transcatheter myocardial ablation device adopts a path through the aortic arch to ablate the ventricular septum 10, so when the delivery tube assembly is located at the aortic arch, the first bending section and / or the second bending section are bent to drive the ablation needle to point to and insert into different positions of the ventricular septum 10. It can be understood that the transcatheter myocardial ablation device can also take other paths to reach the ventricle and ablate myocardial tissue at different positions as needed.

[0045] The central axis of the adjustable bend sheath tube 20 is consistent with the central axis of the adjustable bend catheter 30, that is, the central axes of the two coincide. It is understandable that in other embodiments, the central axis of the adjustable bend sheath tube 20 and the central axis of the adjustable bend catheter 30 can be in the same direction but not in accordance with each other. For example, the adjustable bend sheath tube 20 is a multi-lumen tube having multiple cavities extending in the axial direction, and the adjustable bend catheter 30 is disposed in one of the cavities, in which case the central axes of the two do not coincide.

[0046] The angle between the first direction A and the second direction B is greater than 0° and less than 360°, so that a wider range of points can be selected in the process of bending the first bending section 21 and / or the second bending section 31, thereby increasing the flexibility of the myocardial ablation surgery during the operation. Preferably, the first direction A and the second direction B are in opposite directions, that is, the angle between the first direction A and the second direction B is 180°.

[0047] See also Figure 4The adjustable bending sheath tube 20 is a tube body with a hollow inner cavity, and the adjustable bending sheath tube 20 also includes a first positioning section 22 and a first supporting section 23. The proximal end of the first bending adjustment section 21 is connected to the distal end of the first positioning section 22, and the proximal end of the first positioning section 22 is connected to the distal end of the first supporting section 23. In the working state, the positions of the proximal and distal ends of the first positioning section 22 will match the positions where the aortic arch bends start and end, and the bending curvature of the first positioning section 22 is basically consistent with the bending curvature of the aortic arch, so as to ensure that the first positioning section 22 can pass through the aortic arch more smoothly and reach the designated position, and after the adjustable bending sheath tube 20 reaches the designated position, the first positioning section 22 can maintain continuous good contact with the aortic arch in the bending state, so that the first positioning section 22 can be fixed at the position of the aortic arch, and the adverse effects of the movement of the adjustable bending sheath tube 20 on the operation are minimized. In order to ensure that the first positioning section 22 has good deformation performance and can maintain good shape memory after deformation, the hardness of the material used to make the first positioning section 22 is preferably 55-65D. In order to ensure that the angle of the first bending section 21 is controllable during bending, and does not cause the first positioning section 22 to bend significantly during the bending process, the material hardness of the first bending section 21 should be less than the material hardness of the first positioning section 22. The first supporting section 23 mainly supports the first bending section 21 and the first positioning section 22. In order to ensure that the first positioning section 22 does not cause the first supporting section 23 to bend significantly during the bending process, the material hardness of the first supporting section 23 should be greater than the material hardness of the first positioning section 22.

[0048] In some embodiments, the adjustable bending sheath tube 20 adopts a composite braided mesh tube structure, which has good flexibility, pushing performance, and twist control while maintaining high anti-bending performance.

[0049] The adjustable bending sheath tube 20 further includes a first traction wire (not shown), which is movably arranged in the outer peripheral wall of the adjustable bending sheath tube 20 along the axial direction of the adjustable bending sheath tube 20, and the distal end of the first traction wire is connected to the distal end of the first bending adjustment section 21, and the proximal end of the first traction wire is connected to the control handle 50 (see Fig.13) connection. Specifically, a channel tube is provided in the outer peripheral wall of the adjustable bending sheath tube 20, and the channel tube extends along the axial direction of the adjustable bending sheath tube 20, the distal end of the channel tube extends to the distal end of the first bending adjustment section 21, and the proximal end of the channel tube extends to the proximal end of the first supporting section 23, and the first traction wire is movably arranged in the channel tube; in some embodiments, a guide groove can also be directly opened on the outer peripheral wall of the adjustable bending sheath tube 20, and the guide groove extends along the axial direction of the adjustable bending sheath tube 20, the distal end of the guide groove extends to the distal end of the first bending adjustment section 21, and the proximal end of the guide groove extends to the proximal end of the first supporting section 23, and the first traction wire is movably arranged in the guide groove. The control handle 50 adjusts the bending direction of the first bending adjustment section 21 by controlling the first traction wire to move axially. During operation, the bending direction of the first bending adjustment section 21 is the first direction A, and the first direction A is the direction close to the inner side of the aortic arch. The first bending section 21 can be bent in the first direction A, which ensures that the distal end of the first bending section 21 can be close to or away from the ventricular septum 10, which is convenient for the subsequent selection of different ablation positions. During the bending process of the first bending section 21, the angle between the distal tangent of the first bending section 21 and the distal tangent of the first positioning section 22 is in the range of 0° to 180°. In some embodiments, in order to prevent the adjustable sheath 20 from twisting due to the inconsistency between the pulling direction of the first traction wire and the bending direction of the first bending section 21, the first traction wire should be passed through the inner side of the bend of the adjustable sheath 20 close to the first bending section 21, that is, the channel tube or the guide groove should be located at the inner side of the bend of the first bending section 21 to ensure the stability of the force direction of the adjustable sheath 20 during operation.

[0050] See also Figure 5The adjustable bend catheter 30 is a tube body with a hollow inner cavity, and the adjustable bend catheter 30 also includes a second positioning segment 32 and a second support segment 33. The proximal end of the second bend adjustment segment 31 is connected to the distal end of the second positioning segment 32, and the proximal end of the second positioning segment 32 is connected to the distal end of the second support segment 33. The bending curvature of the second positioning segment 32 is basically consistent with the bending curvature of the aortic arch, which ensures that the adjustable bend catheter 30 and the adjustable bend sheath tube 20 have good adaptability in bending form and avoid mutual influence and interference between the two. In order to ensure that the angle of the second bend adjustment segment 31 during the bending process is controllable and does not cause the second positioning segment 32 to bend significantly during the bending process, the material hardness of the second bend adjustment segment 31 should be less than the material hardness of the second positioning segment 32. The second support section 33 is mainly used to support the second bending section 31 and the second positioning section 32. In order to ensure that the second positioning section 32 does not cause the second support section 33 to bend significantly during the bending process, the material hardness of the second positioning section 32 should be less than the material hardness of the second support section 33. In order to ensure that the second bending section 31 does not cause the first bending section 21 to bend significantly during the bending process, the material hardness of the second bending section 31 should be less than the material hardness of the first bending section 21.

[0051] The adjustable bend catheter 30 also includes a second traction wire (not shown in the figure), which is movably arranged in the outer peripheral wall of the adjustable bend catheter 30 along the axial direction of the adjustable bend catheter 30, the distal end of the second traction wire is connected to the distal end of the second bend adjustment section 31, and the proximal end of the second traction wire is connected to the control handle 50. Specifically, a channel tube is provided in the outer peripheral wall of the adjustable bend catheter 30, the channel tube extends along the axial direction of the adjustable bend catheter 30, the distal end of the channel tube extends to the distal end of the second bend adjustment section 31, the proximal end of the channel tube extends to the proximal end of the second support section 33, and the second traction wire is movably arranged in the channel tube; in some embodiments, a guide groove can also be directly opened on the outer peripheral wall of the adjustable bend catheter 30, the guide groove extends along the axial direction of the adjustable bend catheter 30, the guide groove of the guide groove extends to the distal end of the second bend adjustment section 31, the proximal end of the guide groove extends to the proximal end of the second support section 33, and the second traction wire is movably arranged in the guide groove. The control handle 50 adjusts the curvature of the second bending section 31 by controlling the axial movement of the second traction wire. At the same time, in order to adapt to the bending direction of the second bending section 31, the second traction wire should be inserted into the inner side of the bending of the adjustable catheter 30 close to the second bending section 31, that is, the catheter or the guide groove should be located at the inner side of the bending of the second bending section 31. During operation, the bending direction of the second bending section 31 is the second direction B, and the second direction B is the direction of the aortic arch toward the outside of the arch. The second bending section 31 can be bent in the second direction B to ensure that the distal end of the second bending section 31 can be close to or away from the ventricular septum 10, which is convenient for subsequent selection of different ablation positions. During the bending process of the second bending section 31, the angle C between the distal tangent of the second bending section 31 and the distal tangent of the second positioning section 32 is in the range of 0° to 90°. Preferably, the angle C between the distal tangent of the second bending section 31 and the distal tangent of the second positioning section 32 is 45°.

[0052] Please also read Figures 6 to 8The adjustable bend catheter 30 also includes a limiter 34, which is disposed at the distal end of the second bend adjustment section 31. During the specific working process, the second bend adjustment section 31 bends in the second direction B and approaches the ventricular septum 10, and then the limiter 34 is closely attached to the outer membrane of the ventricular septum 10, providing support for the ablation needle 40 to puncture the outer membrane of the ventricular septum 10, while ensuring that the ablation needle 40 will not move significantly during the puncture process, thereby ensuring that the puncture point can be accurately controlled. The limiter 34 has a smooth distal surface to avoid damaging the inner wall of the adjustable bend sheath 20 and the human body's endocardium, valves and other heart tissues. The limiter 34 can be a hemisphere disposed at the distal end of the adjustable bend catheter 30, and the spherical surface of the hemisphere is disposed in a direction away from the distal surface of the second bend adjustment section 31. In this embodiment, the stopper 34 is a boss, the outer diameter of the distal end of the boss is larger than the outer diameter of the proximal end, and the proximal end of the boss is embedded in the inner cavity 311 of the second bending section 31. The fixing methods include but are not limited to bonding and welding, and the proximal end of the boss can also be subjected to subsequent processing such as sandblasting, hollowing, punching, and grooving to increase the connection firmness between it and the inner cavity 311. The stopper 34 includes a central through hole 341 that completely penetrates along the axial direction. The central through hole 341 is connected to the inner cavity 311. The diameter D1 of the central through hole 341 should be smaller than the diameter D2 of the inner cavity 311, and the maximum outer diameter D3 of the ablation needle 40 (see Fig.10 ) should be smaller than the diameter D1 of the central through hole 341 to ensure that the distal end of the ablation needle 40 located in the inner cavity 311 can extend out of the distal end of the stopper 34 through the central through hole 341. The stopper 34 is made of materials including but not limited to stainless steel, polyoxymethylene, polycarbonate, etc., and is made by machining or injection molding.

[0053] Please also read Figures 7 to 10The ablation needle 40 includes a needle assembly 41, a main body tube 42, a temperature sensor 43 and a liquid inlet tube 44. Specifically, the needle assembly 41 includes a needle 411, a straight ablation portion 412, a flexible reinforcement portion 413, a conductive portion 414 and an inner cavity 415. The proximal end of the needle 411 is connected to the distal end of the straight ablation portion 412, and the proximal end of the needle 411 is in a boss shape, and the boss portion is embedded in the inner cavity 415 in the straight ablation portion 412. Preferably, laser welding is used for fixed connection; the proximal end of the straight ablation portion 412 is connected to the distal end of the flexible reinforcement portion 413, so that the connection between the needle assembly 41 and the main body tube 42 can be smoothly transitioned, and the conductive portion 414 is arranged at the proximal end of the flexible reinforcement portion 413. The straight ablation portion 412, the flexible reinforcement portion 413 and the conductive portion 414 can be made of the same integral metal round tube, or can be made of two different metal round tubes connected by welding or other fixing methods. Preferably, laser welding is used for fixing. In this embodiment, the straight ablation portion 412, the flexible reinforcement portion 413 and the conductive portion 414 are cut from the same integral metal round tube by laser cutting. The needle assembly 41 is made of a metal material with good conductive properties and can achieve electrical conduction. Preferably, the needle assembly 41 is made of stainless steel.

[0054] See also Fig.10 The distal end of the needle 411 is closed, and the proximal end has a hollow inner cavity 4111. The inner cavity 4111 is connected to the inner cavity 415 of the needle assembly 41. The temperature sensor 43 can extend into the inner cavity 4111, so that the temperature sensor 43 can more accurately measure the temperature of the distal end of the needle assembly 41, improve the accuracy of temperature measurement, and reduce the error of temperature measurement. At the same time, the coolant can enter the inner cavity 4111 to improve the heat dissipation efficiency of the needle 411, thereby improving the ablation efficiency during the ablation process and reducing the possibility of scab formation at the ablation site. Optionally, the surface of the needle 411 can be coated with a layer of gold coating or other non-radiopaque coating materials to enhance the visualization of the needle 411 under CT. The distal end of the needle 411 has a sharp tip. Preferably, the needle 411 adopts a triangular pyramid head. Please refer to Fig.11 In some embodiments, the needle head 411 may also be a beveled blade head 411b or a conical pointed head 411c.

[0055] See also Fig. 9 and Fig.10The flexible reinforcement portion 413 can be cut using a sea wave tube, and the cutting forms include single-side cutting of the tube body and four-way cutting of the tube body. Preferably, the four-way cutting of the tube body is adopted so that the flexible reinforcement portion 413 can achieve 360° bending. Since the connection portion between the needle assembly 41 and the main tube 42 is located at the second bending adjustment section 31, during the bending process of the second bending adjustment section 31, the distal end of the main tube will follow the second bending adjustment section to bend, and the presence of the flexible reinforcement portion 413 can increase the anti-bending performance of the main tube 42 in the bending state, thereby preventing the main tube 42 from bending during the bending process of the adjustable bending catheter 30. The conductive portion 414 is used to connect the distal end of a wire (not shown in the figure), and the proximal end of the wire is connected to the energy generator 60 (please refer to Fig.13 ) connection, thereby realizing the electrical connection between the needle assembly 41 and the energy generator 60, the conductive part 414 can be a connecting hole or a connecting hook to increase the firmness of the connection and the good contact between the wire and the conductive part 414, and the connecting hole or connecting hook includes but is not limited to a round hole, a square hole, a groove, a barb and a notch.

[0056] See also Fig.10 The main body tube 42 is sleeved on the outside of the flexible reinforcement part 413, and the distal end of the main body tube 42 should exceed the distal end of the flexible reinforcement part 413 to ensure that the inner cavity of the ablation needle 40 forms a closed space. The main body tube 42 and the flexible reinforcement part 413 are preferably fixed by glue bonding. The main body tube 42 is made of insulating material and should have good anti-bending performance, pushing performance, surface lubrication performance and bending performance. The preferred insulating material includes but is not limited to polymer materials such as polyetheretherketone and polyimide.

[0057] The temperature sensor 43 is axially arranged in the inner cavity 415, the distal end of the temperature sensor 43 is located in the inner cavity 4111, and the proximal end of the temperature sensor 43 passes through the control handle 50 and is connected to the energy generator 60 through a wire. The temperature sensor 43 can monitor the temperature of the distal end of the ablation needle 40 during the ablation process, and adjust the output power / energy of the energy generator 60 through real-time temperature feedback to prevent carbonization, scab and other phenomena of the myocardial tissue contacted by the distal end of the ablation needle 40, resulting in the ablation energy cannot be effectively diffused, and the ablation range is too small. The adverse effect. Optionally, the temperature sensor 43 can be arranged in the inner cavity 441 of the liquid inlet tube 44, or it can be arranged outside the liquid inlet tube 44. The temperature sensor 43 includes a thermocouple type and a thermal resistor type. Preferably, the temperature sensor 43 adopts a thermocouple type. The temperature sensor 43 includes but is not limited to a K-type thermocouple, a T-type thermocouple and an S-type thermocouple. Preferably, the temperature sensor 43 adopts a K-type thermocouple to ensure that the temperature measurement linearity and sensitivity of the temperature sensor 43 are high.

[0058] The liquid inlet tube 44 is a hollow tube that passes through the main tube 42 and the needle assembly 41 and is used to transport a cooling medium to cool the needle assembly 41. The distal end of the liquid inlet tube 44 is close to the proximal end of the needle 411, and the proximal end of the liquid inlet tube 44 passes through the control handle 50 and is connected to the inlet tube 72 (see Fig.13 ), the inlet pipe 44 serves as the inflow channel of the cooling medium, and the gap between the outer wall of the inlet pipe 44 and the inner cavity 415 serves as the outflow channel of the cooling medium, and the outflow channel is connected to the outflow pipe 73 (see Fig.13 ), and the inflow channel and the outflow channel merge and intersect in the inner cavity 4111.

[0059] See also Fig.12 In some embodiments, the structure of the ablation needle 40b is basically the same as that of the ablation needle 40, except that the main body tube 42 is sleeved on the inner side of the flexible reinforcement portion 413, and the distal end of the main body tube 42 should exceed the distal end of the flexible reinforcement portion 413 to ensure that the inner cavity of the ablation needle 40b forms a closed space.

[0060] See also Figure 7-Figure 8 In the initial state, the ablation needle 40 is received in the inner cavity 311 of the adjustable curved catheter 30, and the distal end of the ablation needle 40 does not exceed the distal end of the stopper 34, so as to ensure that the adjustable curved catheter 30 provided with the ablation needle 40 will not damage the inner wall of the adjustable curved sheath tube 20 and the human body's endocardium, valve and other cardiac tissues during the transportation process, but the needle 411 should not completely withdraw from the central through hole 341 and enter the inner cavity 311. In the working state, the control handle 50 can control the ablation needle 40 to extend from the inner cavity 311 along the axial direction of the adjustable curved catheter 30.

[0061] See also Fig.13 The present invention also provides a transcatheter myocardial ablation system 100, which includes a control handle 50, an energy generator 60, a cooling circulation device 70 and the aforementioned transcatheter myocardial ablation device. The energy generator 60 provides energy for the transcatheter myocardial ablation system, and the cooling circulation device 70 is used to dissipate heat from the ablation needle 40. The energy generator 60 and the cooling circulation device 70 are respectively connected to the transcatheter myocardial ablation device.

[0062] The cooling circulation device 70 includes a circulation pump 71, an inflow tube 72, an outflow tube 73, a cooling medium collecting tank 74 and a cooling medium storage 75. The circulation pump 71 and the cooling medium storage 75 are connected by a catheter. The proximal end of the inflow tube 72 is connected to the circulation pump 71, and the distal end is connected to the transcatheter myocardial ablation device. The proximal end of the outflow tube 73 is connected to the cooling medium collecting tank 74, and the distal end is connected to the transcatheter myocardial ablation device. Specifically, the cooling medium storage 75 is used to store the cooling medium; the cooling medium collecting tank 74 is used to recycle the used cooling medium; the circulation pump 71 is used to transport the cooling medium from the cooling medium storage 75 to the inside of the ablation needle 40 through the inflow tube 72; the inflow tube 71 is used to provide a transport channel for the inflow of the cooling medium; and the outflow tube 73 is used to provide a transport channel for the outflow of the cooling medium.

[0063] Please also read Figures 14 to 18 The following will take the working process of hypertrophic myocardial ablation as an example to illustrate the operation method of the transcatheter myocardial ablation system 100, which mainly includes the following steps:

[0064] Step 1: Under the guidance of ultrasound or CT, the patient's femoral artery is punctured and the adjustable sheath tube 20 is inserted. Guided by a guide wire (not shown), the adjustable sheath tube 20 is delivered along the aortic arch to a position on one side of the aortic valve close to the aortic arch.

[0065] Step 2: When the adjustable bend sheath 20 reaches the position of the aortic valve close to the aortic arch, operate the operating handle 50 to transport the adjustable bend catheter 30 along the inner cavity of the adjustable bend sheath 20 to the position of the aortic valve close to the aortic arch, and cross the aortic valve under the guidance of ultrasound / CT without damaging the aortic valve.

[0066] Step 3: operate the control handle 50 to bend the first bending section 21 and / or the second bending section 31 so that the distal end of the limiting member 34 can be in close contact with the outer surface of the myocardial tissue 10 to be ablated.

[0067] Step 4: Operate the control handle 50 to control the ablation needle 40 to extend from the inner cavity 311 along the axial direction of the adjustable curved catheter 30. The ablation needle 40 pierces the epicardium and reaches the inside of the ventricular septum 10. Under the dual judgment of the ultrasound image and the scale mark on the control handle 50, control the angle and depth of the ablation needle 40 penetrating the target tissue.

[0068] Step 5: After completing the above four steps, start the circulation pump 71 first, and the cooling medium circulates inside the cooling circulation device 70 for a few seconds. Then, turn on the energy generator 60 to ablate the target hypertrophic myocardial tissue through the distal end of the ablation needle 40.

[0069] Step 6: When the target hypertrophic myocardial tissue is ablated to a reasonable size by the ablation needle 40 , turn off the energy generator 60 , turn off the circulation pump 71 , and use the control handle 50 to retract the ablation needle 40 into the inner cavity 311 along the axial direction of the adjustable bend catheter 30 .

[0070] Step 7: Operate the control handle 50 to release the first bending section 21 and / or the second bending section 31, so that the distal end of the limiter 34 is away from the outer membrane of the ventricular septum 10 wall. Then operate the control handle 50 to select the next target puncture point on the wall membrane of the ventricular septum 10. At this time, the distal end of the adjustable bend catheter 30 will swing in an arc from point E to point F. Within a suitable range, select 1, 2, 3, 4 or even more puncture sites. When the next target puncture site is selected, repeat the above steps 3 to 6 until all preset points are selected, punctured and ablated.

[0071] Step 8: After the ablation is completed, a plurality of continuous ablation areas will be left on the hypertrophic ventricular septum 10, and the plurality of ablation areas can be connected together to form a long strip of continuous ablation range.

[0072] The above is a preferred embodiment of the present application. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present application. These improvements and modifications are also considered to be within the scope of protection of the present application.

Claims

1. A transcatheter myocardial ablation device, characterized in that: include: A delivery tube assembly, the delivery tube assembly comprising an adjustable bending sheath and an adjustable bending catheter movably arranged in the adjustable bending sheath, the adjustable bending sheath comprising a first bending section and a first positioning section at the distal end, the proximal end of the first bending section is connected to the distal end of the first positioning section, the positions of the proximal end and the distal end of the first positioning section will match the positions where the aortic arch bend starts and ends, the adjustable bending catheter comprises a second bending section at the distal end and a second positioning section at the proximal end of the second bending section, the second bending section extends out of the distal end of the first bending section, the first bending section bends along a first direction, the second bending section bends along a second direction, the first direction is opposite to the second direction, the first direction is a direction close to the inner side of the aortic arch, and the second direction is a direction toward the outer side of the aortic arch; the angle between the distal tangent of the first positioning section and the distal tangent of the first bending section is in the range of 0° to 180°; the angle between the distal tangent of the second positioning section and the distal tangent of the second bending section is in the range of 0° to 90°; and an ablation assembly, the ablation assembly comprising an ablation needle movably disposed in the adjustable bend catheter, the distal end of the ablation needle being able to extend out of the distal end of the adjustable bend catheter; The direction of the ablation needle is adjusted by bending the first bending adjustment segment and / or the second bending adjustment segment; the transcatheter myocardial ablation device is used to ablate the ventricular septum, and when the delivery tube assembly is located in the aortic arch, the first bending adjustment segment and / or the second bending adjustment segment are bent to drive the ablation needle to point to different positions of the ventricular septum; when the ablation needle points to the ventricular septum, the bending curvature of the first positioning segment is basically consistent with the bending curvature of the aortic arch, and the bending curvature of the second positioning segment is basically consistent with the bending curvature of the aortic arch.

2. The transcatheter myocardial ablation device according to claim 1, characterized in that: The delivery tube assembly further includes a first traction wire and a second traction wire; The first traction wire is inserted into the inner side of the bend of the adjustable bending sheath tube close to the first bending section, the distal end of the first traction wire is connected to the distal end of the adjustable bending sheath tube, and the first traction wire pulls the adjustable bending sheath tube to bend along a first direction; The second traction wire is passed through the inner side of the bend of the adjustable bend catheter close to the second bend adjustment section, the distal end of the second traction wire is connected to the distal end of the adjustable bend catheter, and the second traction wire pulls the adjustable bend catheter to bend along the second direction.

3. The transcatheter myocardial ablation device according to claim 1, characterized in that: The adjustable bending conduit further includes a limiting member, which is connected to the distal end of the second bending adjustment section and has a smooth distal end surface.

4. The transcatheter myocardial ablation device according to any one of claims 1 to 3, characterized in that: The ablation needle comprises: A needle assembly, the needle assembly comprising a needle, a straight ablation portion, a flexible reinforcement portion, a conductive portion and an inner cavity, the proximal end of the needle being connected to the distal end of the straight ablation portion, the proximal end of the straight ablation portion being connected to the distal end of the flexible reinforcement portion, the conductive portion being arranged at the proximal end of the flexible reinforcement portion, and the inner cavity being arranged in the needle assembly; A main body tube, the main body tube is made of an insulating material, and the main body tube is sleeve-connected with the flexible reinforcement part; and A liquid inlet pipe is axially arranged through the main body tube and the needle assembly, and is used for conveying a cooling medium to cool the needle assembly.

5. The transcatheter myocardial ablation device according to claim 4, characterized in that: The needle head has a hollow inner cavity, the hollow inner cavity is connected to the inner cavity of the main body tube, and the needle head is selected from at least one of a triangular pyramid head, a bevel blade head, or a conical pointed head.

6. The transcatheter myocardial ablation device according to claim 4, characterized in that: The straight ablation portion and the flexible reinforcement portion are the same tube body, or are formed by connecting different tube bodies, and the inner cavity of the straight ablation portion is connected to the hollow inner cavity of the needle.

7. The transcatheter myocardial ablation device according to claim 4, characterized in that: The flexible reinforcement portion is formed by cutting a hypotube.

8. The transcatheter myocardial ablation device according to claim 1, characterized in that: The ablation needle further includes a temperature sensor, which is connected to the ablation needle and is used to measure the temperature of the ablation needle.

9. A transcatheter myocardial ablation system, characterized in that: include: An energy generator, a cooling circulation device, and a transcatheter myocardial ablation device as claimed in any one of claims 1 to 8; The energy generator provides energy for the transcatheter myocardial ablation system, and the cooling circulation device is used to dissipate heat from the ablation needle. The energy generator and the cooling circulation device are respectively connected to the transcatheter myocardial ablation device.

10. The transcatheter myocardial ablation system according to claim 9, characterized in that: The cooling circulation device comprises: A cooling medium storage device, wherein the cooling medium storage device is used to store cooling medium; A cooling medium collecting tank, wherein the cooling medium collecting tank is used to recover the used cooling medium; a circulation pump, the circulation pump being used to transport the cooling medium from the cooling medium reservoir to the interior of the ablation needle via the inflow tube; an inflow tube, wherein a proximal end of the inflow tube is connected to the circulation pump, and a distal end of the inflow tube is connected to the transcatheter myocardial ablation device; and An outflow tube, wherein the proximal end of the outflow tube is connected to the cooling medium collecting tank, and the distal end of the outflow tube is connected to the transcatheter myocardial ablation device.

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