Hypotrophic obstructive cardiomyopathy ablation device and ablation method

Abstract

The invention provides a hypertrophic obstructive cardiomyopathy ablation device and method, the device comprises an adjustable bending sheathing canal assembly, a mapping catheter, an ablation needle assembly and an ultrasonic assembly, the mapping catheter penetrates through the adjustable bending sheathing canal assembly, and can move to the far end of the adjustable bending sheathing canal assembly along the axial direction of the adjustable bending sheathing canal assembly to penetrate out; the mapping catheter is used for mapping the heart, and the ablation needle assembly is used for conducting chemical ablation on the hypertrophy part of the ventricular septum of the right ventricle. The ultrasonic assembly can move to the far end of the adjustable bending sheath tube assembly to penetrate out, and the ultrasonic assembly is used for monitoring the position of the ablation needle assembly. According to the hypertrophy obstructive cardiomyopathy ablation device, the ultrasonic assembly, the ablation needle assembly and the mapping catheter are integrated, under the real-time image guidance of the ultrasonic assembly, the ablation needle assembly is controlled to conduct chemical ablation on the cardiac hypertrophy part, and the accuracy of the ablation position and the ablation depth are ensured; on the premise of safe ablation, alcohol ablation is given, so that myocardial necrosis in the deep layer of the ventricular septum is realized, and obstruction is relieved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a hypertrophic obstructive cardiomyopathy ablation device and an ablation method. Background Art

[0002] This section merely provides background information related to the present disclosure and is not necessarily prior art.

[0003] Hypertrophic obstructive cardiomyopathy is one of the main causes of sudden death. The current treatment method is to reduce the thickness of the ventricular septum through surgery or interventional means to alleviate obstruction. Surgery involves removing a portion of the ventricular septum through thoracotomy or minimally invasive means to reduce obstruction.

[0004] There are two main interventional methods. One is to use a catheter to perform radiofrequency ablation on the right ventricular septum to cause partial myocardial necrosis and reduce obstruction. The other is to inject anhydrous alcohol through the septal branch of the coronary artery to cause myocardial necrosis and reduce obstruction. The first method has a shallow thermal ablation depth and the effect is not ideal. The second method relies heavily on the non-selective shape of the septal branch. Summary of the invention

[0005] The purpose of the present invention is to at least solve the problem that the existing treatment methods for hypertrophic obstructive cardiomyopathy are poorly effective. This purpose is achieved through the following technical solutions:

[0006] The first aspect of the present invention provides a hypertrophic obstructive cardiomyopathy ablation device, comprising:

[0007] An adjustable sheath tube assembly, wherein the proximal end of the adjustable sheath tube assembly is used for operation by a user, and the distal end of the adjustable sheath tube assembly is used for extending into the right ventricle;

[0008] A mapping catheter is arranged in the adjustable bending sheath tube assembly and can be moved along the axial direction of the adjustable bending sheath tube assembly to the distal end of the adjustable bending sheath tube assembly and then pass out, and the mapping catheter is used to map the heart;

[0009] an ablation needle assembly, which is retractably mounted on the distal end of the mapping catheter and is used to chemically ablate the hypertrophic part of the ventricular septum of the right ventricle;

[0010] The ultrasonic component is installed in the adjustable bending sheath tube component and can move along the axial direction of the adjustable bending sheath tube component to the distal end of the adjustable bending sheath tube component and pass out. The ultrasonic component is used to monitor the position of the ablation needle assembly.

[0011] The ablation device for hypertrophic obstructive cardiomyopathy proposed in the first aspect of the present invention integrates an ultrasonic component, an ablation needle component and a mapping catheter. The device enters the right ventricle through the flexibly controlled direction of the adjustable curved sheath component, performs mapping and positioning through the mapping catheter, and then, under the guidance of the real-time image of the ultrasonic component, controls the ablation needle assembly to perform chemical ablation on the hypertrophic part of the myocardium to ensure the accuracy of the ablation position and the ablation depth. Under the premise of ablation safety, alcohol ablation is given to cause myocardial necrosis in the deep layer of the ventricular septum to relieve the obstruction.

[0012] In some embodiments of the present invention, the hypertrophic obstructive cardiomyopathy ablation device also includes a guide wire, the proximal end of the guide wire is used for user operation, the adjustable bend sheath assembly is slidably mounted on the guide wire, and the adjustable bend sheath assembly can move along the guide wire to the distal end of the guide wire.

[0013] In some embodiments of the present invention, the adjustable bending sheath tube assembly comprises:

[0014] Handlebars;

[0015] An adjustable bending sheath tube connected to the distal end of the handle;

[0016] A bending adjustment assembly comprises a bending adjustment wire and a bending adjustment knob, wherein the bending adjustment knob is rotatably arranged on the handle portion, the bending adjustment wire is arranged in the adjustable bending sheath tube and can move axially along the adjustable bending sheath tube, the two ends of the bending adjustment wire are respectively connected to the bending adjustment knob and the distal end of the adjustable bending sheath tube, and the bending adjustment assembly is used to drive the distal end of the adjustable bending sheath tube to bend radially toward the adjustable bending sheath tube.

[0017] In some embodiments of the present invention, the mapping catheter includes a handle portion, a catheter portion and a plurality of electrodes, the catheter portion is connected to the distal end of the handle portion, the plurality of electrodes are arranged on the outer peripheral surface of the distal end of the catheter portion, the electrodes are used to map the right ventricle, and the ultrasound component has an ultrasound detection portion, which is installed at the distal end of the catheter portion and is used to monitor the position of the ablation needle assembly.

[0018] In some embodiments of the present invention, the ablation needle assembly comprises:

[0019] Ablation needle;

[0020] an ethanol injection tube, which is inserted into the catheter portion, wherein the distal end of the ethanol injection tube is communicated with the ablation needle, and the proximal end of the ethanol injection tube is disposed on the handle portion and has an injection port for injecting ethanol;

[0021] A propulsion wire, inserted into the catheter portion;

[0022] The advancement adjustment slider is slidably arranged on the handle portion, and the two ends of the advancement wire are respectively connected to the ablation needle and the advancement adjustment slider, and the advancement adjustment slider is used to adjust the length of the ablation needle extending out of the catheter portion.

[0023] In some embodiments of the present invention, the ablation needle has a top hole and multiple side holes, the top hole is arranged at the distal end of the ablation needle, the multiple side holes are arranged on the circumferential side of the ablation needle and are spaced apart along the axial direction of the ablation needle, and the top hole and the side holes are both connected to the ethanol injection tube.

[0024] In some embodiments of the present invention, the ablation needle assembly also includes a plurality of opening and closing mechanisms, which include a hole cover portion, a connecting portion, a resetting portion and an operating portion. The hole cover portion is arranged in a one-to-one correspondence with the side hole, the hole cover portion is arranged at the side hole in an openable and closable manner, and is connected to the ablation needle. The operating portion is arranged on the handle portion, the operating portion is connected to the hole cover portion through the connecting portion, and is used to control the opening of the hole cover portion. The resetting portion is connected to the hole cover portion, and is used to drive the hole cover portion to close.

[0025] In some embodiments of the present invention, the hole cover portion is arranged inside the ablation needle and is connected to the ablation needle in a manner that can slide along the axial direction of the ablation needle. On the sliding path of the hole cover portion, the hole cover portion has a first position for closing the side hole and a second position for opening the side hole. The operating portion is rotatably connected to the handle portion, and the connecting portion includes a connecting wire. The two ends of the connecting wire are respectively connected to the hole cover portion and the operating portion. The operating portion can drive the connecting wire to move axially along the catheter portion by its own rotation to drive the hole cover portion to open. The reset portion includes an elastic member connected to the hole cover portion, and the elastic member is constructed to drive the hole cover to close by its own elastic force.

[0026] In some embodiments of the present invention, the hole cover portion includes an annular portion and a connecting rod portion, the annular portion is coaxially arranged with the ablation needle, and the annular portion is connected to the ablation needle in a manner that can slide along the axial direction of the ablation needle, the connecting rod portion is connected to the annular portion, and is arranged in the space surrounded by the annular portion, the connecting wire is coaxially arranged on one axial side of the annular portion and connected to the connecting rod portion, and the reset member includes an elastic wire coaxially arranged on the other axial side of the annular portion, and both ends of the elastic wire are respectively connected to the connecting rod portion and the distal end of the ablation needle.

[0027] The second aspect of the present invention provides a method for ablation of hypertrophic obstructive cardiomyopathy, which is implemented according to the hypertrophic obstructive cardiomyopathy ablation device provided in the first aspect of the present invention, and is characterized in that the method for ablation of hypertrophic obstructive cardiomyopathy comprises the following steps:

[0028] The adjustable curved sheath assembly is delivered into the right atrium via the femoral vein;

[0029] Adjust the direction of the adjustable curved sheath tube assembly so that the adjustable curved sheath tube assembly enters the right ventricle through the tricuspid valve;

[0030] Delivering a mapping catheter carrying an ultrasound component into the right ventricle through an adjustable curved sheath assembly;

[0031] Mapping of the heart via a mapping catheter;

[0032] According to the image signal of the ultrasound component, the ablation needle component is controlled to perform chemical ablation on the ventricular septal hypertrophy area.

[0033] The ablation method for hypertrophic obstructive cardiomyopathy proposed in the second aspect of the present invention is implemented by an ablation device for hypertrophic obstructive cardiomyopathy that integrates an ultrasonic component, an ablation needle component and a mapping catheter. The adjustable curved sheath component is flexibly controlled to enter the right ventricle, and the mapping catheter is used for mapping and positioning. Then, under the real-time image guidance of the ultrasonic component, the ablation needle component is controlled to perform chemical ablation on the hypertrophic part of the myocardium to ensure the accuracy of the ablation position and the ablation depth. Under the premise of ablation safety, alcohol ablation is given to cause myocardial necrosis in the deep layer of the ventricular septum to relieve the obstruction. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Various other advantages and benefits will become apparent to those of ordinary skill in the art by reading the detailed description of the preferred embodiments below. The accompanying drawings are only for the purpose of illustrating the preferred embodiments and are not to be considered as limiting the present invention. Moreover, the same reference numerals are used throughout the accompanying drawings to represent the same components. In the accompanying drawings:

[0035] Figure 1 The structure diagram of the ablation device for hypertrophic obstructive cardiomyopathy according to an embodiment of the present invention is schematically shown;

[0036] Figure 2 The schematic diagram of the structure of the hypertrophic obstructive cardiomyopathy ablation device (ablation needle contraction) according to the embodiment of the present invention is schematically shown;

[0037] Figure 3 The structure diagram of the adjustable bending sheath tube assembly according to the embodiment of the present invention is schematically shown;

[0038] Figure 4 The structure diagram of the mapping catheter according to the embodiment of the present invention is schematically shown;

[0039] Figure 5 The cross-sectional structure diagram of the adjustable bending sheath tube is schematically shown;

[0040] Figure 6 The schematic diagram of the structure of the ablation needle is shown schematically;

[0041] Figure 7 The cross-sectional structure diagram of the ablation needle (the opening and closing mechanism closes the side hole) is schematically shown;

[0042] Figure 8 The cross-sectional structure diagram of the ablation needle (the opening and closing mechanism opens the side hole) is schematically shown;

[0043] Fig. 9 The schematic diagram of the adjustable curved sheath assembly entering the right atrium through the guide wire is shown schematically;

[0044] Fig.10 The schematic diagram of the adjustable curved sheath tube assembly entering the right ventricle after adjustment is shown schematically;

[0045] Fig.11 The schematic diagram shows a mapping catheter entering the right ventricle through the adjustable curved sheath assembly;

[0046] Fig.12 The schematic diagram of the ablation needle assembly performing chemical ablation on a myocardial hypertrophy portion is schematically shown;

[0047] The reference numerals are as follows:

[0048] 100, right atrium; 200, right ventricle; 300, left atrium; 400, left ventricle; 500, vein; 600, hypertrophic part; 700, tricuspid valve;

[0049] 10. Adjustable bending sheath tube assembly; 11. Handle; 12. Adjustable bending sheath tube; 121. First tube cavity; 122. Second tube cavity; 123. Third tube cavity; 13. First bending adjustment wire; 14. First bending adjustment knob; 15. Second bending adjustment wire; 16. Second bending adjustment knob;

[0050] 20. Mapping catheter; 21. Handle; 22. Catheter; 23. Electrode; 24. Third bending knob; 25. Ultrasonic component;

[0051] 30. Ablation needle assembly; 31. Ablation needle; 310. Side hole; 311. Opening and closing mechanism; 312. Hole cover; 3121. Ring part; 3122. Connecting rod; 313. Connecting wire; 314. Elastic wire; 315. Operating part; 316. Fixing part; 32. Ethanol injection tube;

[0052] 40. Guide wire. DETAILED DESCRIPTION

[0053] The exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present disclosure are shown in the accompanying drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided in order to enable a more thorough understanding of the present disclosure and to fully convey the scope of the present disclosure to those skilled in the art.

[0054] It should be understood that the terms used herein are only for the purpose of describing specific example embodiments and are not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms "one", "an" and "said" as used herein may also be meant to include plural forms. The terms "include", "comprise", "contain", and "have" are inclusive, and therefore specify the existence of stated features, steps, operations, elements and / or parts, but do not exclude the existence or addition of one or more other features, steps, operations, elements, parts, and / or combinations thereof. The method steps, processes, and operations described herein are not interpreted as necessarily requiring them to be performed in the specific order described or illustrated, unless the execution order is clearly indicated. It should also be understood that additional or alternative steps may be used.

[0055] Although the terms first, second, third, etc. can be used in the text to describe multiple elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms can only be used to distinguish an element, component, region, layer or section from another region, layer or section. Unless the context clearly indicates, terms such as "first", "second" and other numerical terms do not imply order or sequence when used in the text. Therefore, the first element, component, region, layer or section discussed below can be referred to as the second element, component, region, layer or section without departing from the teaching of the example embodiments.

[0056] For ease of description, spatial relative terms may be used herein to describe the relationship of one element or feature relative to another element or feature as shown in the figure, such as "inside", "outside", "inner side", "outer side", "below", "below", "above", "above", etc. Such spatial relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figure. For example, if the device in the figure is turned over, then the elements described as "below other elements or features" or "below other elements or features" will subsequently be oriented as "above other elements or features" or "above other elements or features". Therefore, the example term "below..." can include both upper and lower orientations. The device can be oriented otherwise (rotated 90 degrees or in other directions) and the spatial relative descriptors used in the text are interpreted accordingly.

[0057] like Figures 1 to 12 As shown, the first aspect of the present invention proposes a hypertrophic obstructive cardiomyopathy ablation device, characterized in that it includes an adjustable sheath tube assembly 10, a mapping catheter 20, an ablation needle assembly 30 and an ultrasonic assembly 25, the proximal end of the adjustable sheath tube assembly 10 is used for user operation, the distal end of the adjustable sheath tube assembly 10 is used to extend into the right ventricle 200, the mapping catheter 20 is inserted into the adjustable sheath tube assembly 10, and can be moved along the axial direction of the adjustable sheath tube assembly 10 to the adjustable sheath The distal end of the tube assembly 10 is passed out, the mapping catheter 20 is used to map the heart, the ablation needle assembly 30 is installed at the distal end of the mapping catheter 20 in a telescopic manner, and is used to chemically ablate the thickened portion 600 of the ventricular septum of the right ventricle 200, the ultrasound assembly 25 is passed through the adjustable bend sheath assembly 10, and can be moved along the axial direction of the adjustable bend sheath assembly 10 to the distal end of the adjustable bend sheath assembly 10 and pass out, the ultrasound assembly 25 is used to monitor the position of the ablation needle assembly 30.

[0058] It can be understood that the heart cavity mainly includes the right atrium 100, the right ventricle 200, the left atrium 300 and the left ventricle 400. The characteristic of hypertrophic obstructive cardiomyopathy is ventricular hypertrophy, especially the ventricular septum between the left ventricle 400 and the right ventricle 200. The hypertrophic obstructive cardiomyopathy ablation device is used to ablate the hypertrophic part 600 of the ventricular septum. The adjustable bending sheath tube assembly 10 may include at least one adjustable bending sheath tube 12. The adjustable bending sheath tube 12 is a hollow tubular structure, and the interior of the sheath tube can be used for the mapping catheter 20 and the guide catheter 20. The guide wire 40 passes through, and the interior of the adjustable bending sheath tube 12 is provided with a bending wire, one end of the bending wire is fixedly connected to the distal end of the adjustable bending sheath tube 12, and the other end is located at the proximal end of the adjustable bending sheath tube 12, and is fixedly connected to an adjustment button movably arranged at the proximal end of the adjustable bending sheath tube 12. When the user moves the adjustment button, the bending wire can be pulled, and the distal end of the adjustable bending sheath tube 12 is driven to bend, so that it adapts to the internal shape of the blood vessels and the heart, and is smoothly delivered into the heart without damaging the blood vessels and the inner wall of the heart. The mapping catheter 20 is a catheter-type structure with an electrode 23. The mapping catheter 20 is inserted into the adjustable bending sheath tube 12. When the adjustable bending sheath tube 12 moves into the heart, the mapping catheter 20 is delivered to the heart through the inner cavity of the adjustable bending sheath tube 12, and the heart is mapped through the electrode 23. The ablation needle assembly 30 has an ablation needle 31, which is located at the distal end of the mapping catheter 20 and is connected to the proximal end of the mapping catheter 20 through a pipeline, so that the operator can infuse anhydrous ethanol from the proximal end to chemically ablate the patient's myocardial hypertrophy 600. The ultrasound assembly 25 can be set at the distal end of the mapping catheter 20, and the position of the ablation needle assembly 30 can be monitored by ultrasound technology to improve the accuracy of the ablation position, and under the guidance of the ultrasound image, the ablation needle assembly 30 can be accurately punctured to a deeper position of the myocardium to ensure the safety of ablation.

[0059] The hypertrophic obstructive cardiomyopathy ablation device proposed in the first aspect of the present invention integrates an ultrasonic component 25, an ablation needle component 30 and a mapping catheter 20. The adjustable bend sheath component 10 is used to flexibly control the direction of the ablation needle component 30 to enter the right ventricle 200, and the mapping catheter 20 is used to perform mapping and positioning. Then, under the guidance of the real-time image of the ultrasonic component 25, the ablation needle component 30 is controlled to perform chemical ablation on the hypertrophic part of the myocardium 600 to ensure the accuracy of the ablation position and the ablation depth. Under the premise of ablation safety, alcohol ablation is given to cause myocardial necrosis in the deep layer of the ventricular septum to relieve the obstruction.

[0060] In some embodiments of the present invention, the hypertrophic obstructive cardiomyopathy ablation device also includes a guide wire 40, the proximal end of the guide wire 40 is used for user operation, the adjustable bend sheath assembly 10 is slidably connected to the guide wire 40, and the adjustable bend sheath assembly 10 can move along the guide wire 40 to the distal end of the guide wire 40.

[0061] It is understandable that the function of the guide wire 40 is to be delivered to the heart through the femoral vein 500 before the adjustable sheath assembly 10. The guide wire 40 is made of a relatively soft metal wire material or a polymer compound material, and the distal end is relatively soft. It can be delivered to the coronary vein 500 through the femoral vein 500 during surgery, and serves as a guide path for the adjustable sheath assembly 10, so that after the guide wire 40 is in place, the adjustable sheath assembly 10 is slid along the guide wire 40 to the heart. The assembly relationship between the guide wire 40 and the adjustable sheath 12 can be achieved by the guide wire 40 being built in or the guide wire 40 being passed through, that is, the guide wire 40 can be passed through the adjustable sheath 12 to achieve the assembly of the two. The adjustable sheath 12 is provided with a sliding cavity for the guide wire 40 to pass through. The guide wire 40 is passed through the sliding cavity, and the adjustable sheath 12 can slide along the guide wire 40 to the coronary vein 500. A plurality of fixing portions 316 may be axially arranged on the adjustable bending sheath tube 12, and the guide wire 40 is slidably connected to the plurality of fixing portions 316 in sequence to realize the connection between the guide wire 40 and the adjustable bending sheath tube 12. The fixing portion 316 may have a notch or a perforation for the guide wire 40 to pass through.

[0062] In some embodiments of the present invention, the adjustable bending sheath tube assembly 10 includes a handle portion 11, an adjustable bending sheath tube 12 and a first bending adjustment assembly. The adjustable bending sheath tube 12 is coaxially connected to the distal end of the handle portion 11. The first bending adjustment assembly includes a first bending adjustment wire 13 and a first bending adjustment knob 14. The first bending adjustment knob 14 is rotatably arranged on the handle portion 11. The first bending adjustment wire 13 is arranged in the adjustable bending sheath tube 12 and can move axially along the adjustable bending sheath tube 12. The two ends of the first bending wire 13 are respectively fixedly connected to the first bending adjustment knob 14 and the distal end of the adjustable bending sheath tube 12. Along the radial direction of the adjustable bending sheath tube 12, the first bending adjustment assembly is used to drive the distal end of the adjustable bending sheath tube 12 to bend in a first direction.

[0063] It can be understood that the handle portion 11 can be a tubular structure with a cavity inside, and the adjustable bending sheath tube 12 is also a tubular structure with a cavity inside. The adjustable bending sheath tube 12 is coaxially connected to the handle portion 11, and one axial end of the adjustable bending sheath tube 12 can be fixedly connected to the handle portion 11 by means of a snap connection or a screw connection. The adjustable bending sheath tube 12 is a flexible tube and can be made of a tube body woven with steel wire to facilitate bending under the traction of the first bending wire 13. The first bending knob 14 can be coaxially arranged with the handle 11, and part of the first bending knob 14 is located inside the handle 11, and the part is connected to one end of the first bending wire 13, and the other part of the first bending knob 14 protrudes from the handle 11 to facilitate the operator to turn it, and the other end of the first bending wire 13 is fixedly connected to the distal end of the adjustable bending sheath tube 12, so that when the operator turns the first bending knob 14, the first bending knob 14 rolls up the first bending wire 13, and then pulls the distal end of the adjustable bending sheath tube 12 to bend. According to the bending direction of the blood vessel, the rotation angle of the first bending knob 14 can be controlled under the cooperation of positioning monitoring equipment such as extracorporeal ultrasound, and then the bending degree of the adjustable bending sheath tube 12 can be controlled, so that its bending degree adapts to the direction of the blood vessel. When the first bending knob 14 is rotated in the opposite direction, the first bending wire 13 can be restored to its original direction.

[0064] In some embodiments of the present invention, the adjustable bending sheath tube assembly 10 also includes a second bending adjustment assembly, which includes a second bending adjustment wire 15 and a second bending adjustment knob 16. The second bending adjustment knob 16 is rotatably arranged on the handle portion 11. The second bending adjustment wire 15 is passed through the adjustable bending sheath tube 12 and can move axially along the adjustable bending sheath tube 12. The two ends of the second bending adjustment wire 15 are respectively fixedly connected to the second bending adjustment knob 16 and the distal end of the adjustable bending sheath tube 12. Along the radial direction of the adjustable bending sheath tube 12, the second bending adjustment assembly is used to drive the distal end of the adjustable bending sheath tube 12 to bend in a direction away from the first direction.

[0065] It can be understood that in order to improve the adaptability of the adjustable bending sheath tube 12 to the direction of the blood vessel, the adjustable bending sheath tube 12 is designed as a bidirectional adjustable bending sheath tube 12 by setting a second bending adjustment component. Specifically, the second bending adjustment component includes a second bending adjustment wire 15 for pulling the adjustable bending sheath tube 12 and a second bending adjustment knob 16 for winding the wire. The second bending adjustment knob 16 can be coaxially arranged with the handle portion 11. The second bending adjustment knob 16 is located between the first bending adjustment knob 14 and the proximal end of the adjustable bending sheath tube 12, and part of the second bending adjustment knob 16 is located inside the handle portion 11. The part is connected to one end of the second bending adjustment wire 15, and the other part of the second bending adjustment knob 16 protrudes from the handle portion 11 to facilitate the operator to turn it. The other end of the second bending adjustment wire 15 is fixedly connected to the distal end of the adjustable bending sheath tube 12, and the connection position is spaced from the distal end of the first bending adjustment wire 13, so that when the operator turns the second bending adjustment knob 16, the second bending adjustment knob 16 The second bending knob 16 rolls up the second bending wire 15, and then pulls the distal end of the adjustable bending sheath tube 12 to bend. According to the bending direction of the blood vessel, the first bending knob 14 can be rotated in coordination with positioning monitoring equipment such as in vitro ultrasound to first control the rotation angle of the first bending knob 14 to bend the distal end of the adjustable bending sheath tube 12 to a certain extent, and then the second bending knob 16 is controlled to rotate, and then the distal end of the adjustable bending sheath tube 12 after bending is further bent at a position closer to the end, so that the adjustable bending sheath tube 12 is bent into a shape, so that the bending degree of the adjustable bending sheath tube 12 is more adapted to the direction of the blood vessel. When the second bending knob 16 is rotated in the opposite direction, the second bending wire 15 can be restored to its original direction.

[0066] In some embodiments of the present invention, the mapping catheter 20 includes a handle portion 21, a catheter portion 22 and a plurality of electrodes 23, the catheter portion 22 is connected to the distal end of the handle portion 21, the plurality of electrodes 23 are arranged on the outer peripheral surface of the distal end of the catheter portion 22, the electrodes 23 are used to map the right ventricle 200, the ultrasound component 25 has an ultrasound detection portion, the ultrasound detection portion is installed at the distal end of the catheter portion 22, and is used to monitor the position of the ablation needle assembly 30.

[0067] It can be understood that another cavity independent of the cavity for inserting the guide wire 40 or the first bending wire 13 and the second bending wire 15 can be set in the adjustable bending sheath tube 12 to facilitate the insertion of the catheter portion 22 of the mapping and ablation component. The function of the mapping and ablation component is to map the inside of the heart through the electrode 23, and after mapping, the target area is thermally ablated by discharging the electrode 23 to treat abnormal points of deep premature beats of the heart. Specifically, the catheter portion 22 is a tubular structure, and a plurality of electrodes 23 can be installed on the outer surface of the distal end of the catheter portion 22. The electrodes 23 can be distributed in a dotted manner on the outer surface of the catheter portion 22, or can be arranged in a ring shape around the axis of the catheter portion 22, and a plurality of electrodes 23 can be arranged at intervals along the axial direction of the catheter portion 22. The catheter portion 22 and the handle portion 21 can be coaxially arranged, and the catheter portion 22 is located inside the adjustable bending sheath tube 12. At least part of the handle portion 21 is located inside the handle portion 11. When in use, the handle portion 21 can be pushed to slide the catheter portion 22 along the axial direction of the adjustable bending sheath tube 12 and pass through the distal end of the adjustable bending sheath tube 12. During mapping, the electrode 23 moves to the coronary vein 500 through the adjustable bending sheath tube 12, and the electrode 23 is electrically connected to the electrocardiograph. When the heart muscle cells contract and relax, electrical signals are generated. These electrical signals can be captured by the electrode 23 and transmitted to the electrocardiograph for recording and analysis, thereby determining whether the patient has heart disease. The ultrasonic detection part can be an ultrasonic transducer, which can generate ultrasonic signals inside the heart. The ultrasonic signals are reflected by the ablation needle 31, received by the ultrasonic component 25, and converted into electrical signals. The electrical signals are transmitted to the external analysis equipment through the wiring harness in the catheter part 22, thereby enabling the position of the ablation needle 31 to be monitored in real time, thereby improving the position accuracy and safety of the ablation needle 31 during chemical ablation.

[0068] In some embodiments of the present invention, the mapping and ablation component also includes a third bending adjustment component, which includes a third bending adjustment wire and a third bending adjustment knob 24. The third bending adjustment knob 24 is rotatably arranged on the handle portion 21, and the third bending adjustment wire is arranged in the catheter portion 22 in a manner that can move axially along the catheter portion 22, and the two ends of the third bending adjustment wire are respectively fixedly connected to the third bending adjustment knob 24 and the distal end of the catheter portion 22.

[0069] It can be understood that the handle portion 21 can be a tubular structure with a cavity inside, and the catheter portion 22 can also be a tubular structure with a cavity inside. The catheter portion 22 is coaxially connected to the handle portion 21, and one axial end of the catheter portion 22 can be fixedly connected to the handle portion 21 by snapping or screwing. The catheter portion 22 is a flexible tube and can be made of a tube body woven with steel wire to facilitate bending under the traction of the third bending wire. The third bending knob 24 can be coaxially arranged with the handle 21, and part of the third bending knob 24 is located inside the handle 21, and is connected to one end of the third bending wire. The other part of the third bending knob 24 protrudes from the handle 21 to facilitate the operator to turn it. The other end of the third bending wire is fixedly connected to the distal end of the catheter 22, so that when the operator turns the third bending knob 24, the third bending knob 24 rolls up the third bending wire, and then pulls the distal end of the catheter 22 to bend. According to the bending direction of the blood vessel, the rotation angle of the third bending knob 24 can be controlled under the cooperation of positioning monitoring equipment such as extracorporeal ultrasound, and then the bending degree of the catheter 22 can be controlled, so that its bending degree adapts to the direction of the blood vessel. When the third bending knob 24 is turned in the opposite direction, the third bending wire can be restored to its original direction.

[0070] In some embodiments of the present invention, the ablation needle assembly 30 includes an ablation needle 31 and an ethanol injection tube 32. The ethanol injection tube 32 is sequentially inserted into the adjustable bend sheath tube assembly 10 and the mapping ablation assembly. The distal end of the ethanol injection tube 32 is connected to the ablation needle 31. The proximal end of the ethanol injection tube 32 is arranged on the handle portion 11 and has an injection port for infusing ethanol.

[0071] It can be understood that the ablation needle 31 can be set at the distal end of the mapping and ablation component, and the ablation needle 31 is supplied with anhydrous alcohol through the ethanol injection tube 32. The ethanol injection tube 32 can be a hose structure that is passed through the adjustable bend sheath tube component 10 and the mapping and ablation component. The distal end of the ethanol injection tube 32 can be fixedly connected to the distal end of the mapping and ablation component, and the ablation needle 31 is also set at the distal end of the mapping and ablation component. When the mapping and ablation component completes thermal ablation, if abnormal myocardial discharge is still detected, the ablation needle 31 can be sent into the target blood vessel to continue chemical ablation, so that the anhydrous alcohol is transported to the ablation needle 31 through the ethanol injection tube 32, and then infused into the blood vessel through the pinhole on the ablation needle 31.

[0072] In some embodiments of the present invention, the ablation needle assembly 30 also includes a push wire and a push adjustment slider. The push adjustment slider is slidably arranged on the handle portion 21. Both ends of the push wire are respectively connected to the ablation needle 31 and the push adjustment slider. The push adjustment slider is used to adjust the length of the ablation needle 31 extending out of the mapping ablation assembly.

[0073] It can be understood that in order to reduce the damage of the ablation needle 31 to the blood vessel wall, the ablation needle 31 can be configured to be installed in the catheter part 22 in a retractable manner. Specifically, by providing a propulsion adjustment slider that can slide along the axial direction of the handle part 21 on the handle part 21, and passing a propulsion wire through the handle part 21 and the catheter part 22. The propulsion wire connects the propulsion adjustment slider and the ablation needle 31. When chemical ablation is not required, the ablation needle 31 is located inside the catheter part 22 and does not protrude from the distal end of the catheter part 22. When chemical ablation is required, the propulsion adjustment slider is pushed, and then the ablation needle 31 is driven forward and pushed out of the catheter part 22 by the propulsion wire, thereby realizing the retractable function of the ablation needle 31 to better protect the patient's blood vessels.

[0074] In some embodiments of the present invention, the adjustable bending sheath 12 comprises a first lumen 121, a second lumen 122, a third lumen 123 and an ethanol injection tube 32 extending along its axial direction. The first lumen 121 is used to accommodate the passage of the mapping and ablation component, the second lumen 122 is used for the passage of the first bending adjustment wire 13, the third lumen 123 is used for the passage of the second bending adjustment wire 15, and the ethanol injection tube 32 is used to deliver anhydrous alcohol to the ablation needle 31.

[0075] In some embodiments of the present invention, the ablation needle 31 has a top hole and multiple side holes 310. The top hole is arranged at the distal end of the ablation needle 31. The multiple side holes 310 are arranged on the circumferential side of the ablation needle 31 and are arranged at intervals along the axial direction of the ablation needle 31. The top hole and the side holes 310 are both connected to the ethanol injection tube 32.

[0076] It is understandable that the main body of the ablation needle 31 is in the shape of a needle, and a top hole is provided at its distal end, and anhydrous alcohol can be injected through the top hole and injected into the myocardial hypertrophy part 600 along the axial direction of ablation to chemically ablate it. In order to improve the ablation range and direction range of the ablation needle 31, multiple side holes 310 can be provided on the circumferential side of the ablation needle 31. Multiple side holes 310 can be provided at intervals along the circumferential direction of the ablation needle 31, and multiple side holes 310 can also be provided at intervals along the axial direction of the ablation needle 31, so that the circumferential side of the ablation needle 31 can also be injected with anhydrous alcohol into the myocardial hypertrophy part 600 to chemically ablate it, thereby improving the ablation efficiency and ablation range.

[0077] In some embodiments of the present invention, the ablation needle assembly 30 also includes a plurality of opening and closing mechanisms 311, the opening and closing mechanisms 311 include a hole cover portion 312, a connecting portion, a resetting portion and an operating portion 315, the hole cover portion 312 is arranged in a one-to-one correspondence with the side hole 310, the hole cover portion 312 is arranged at the side hole 310 in an openable and closable manner, and is connected to the ablation needle 31, the operating portion 315 is arranged on the handle portion 21, the operating portion 315 is connected to the hole cover portion 312 through the connecting portion, and is used to control the opening of the hole cover portion 312, the resetting portion is connected to the hole cover portion 312, and is used to drive the hole cover portion 312 to close.

[0078] It is understandable that in order to improve the controllability of the injection of anhydrous ethanol by the ablation needle 31, the opening and closing of the side hole 310 can be controlled by setting an opening and closing mechanism 311. When the side hole 310 does not need to be opened, the side hole 310 is closed by the opening and closing mechanism 311. When the side hole 310 at a specific position needs to be opened, the side hole 310 is opened by the opening and closing mechanism 311, thereby improving the flexibility and safety during chemical ablation. Specifically, the opening and closing mechanism 311 includes a hole cover portion 312, a connecting portion, a reset portion, and an operating portion 315. The hole cover portion 312 can be connected to the ablation needle 31 in a hinged or sliding manner. The connecting portion may be a wire structure, and the operating portion 315 is rotatably arranged on the handle and connected to the hole cover portion 312 through the connecting portion. When the operating portion 315 is rotated, the operating portion 315 coils the connecting portion so that the hole cover portion 312 is driven to open by the connecting portion. In addition, a reset portion is also provided at the hole cover, and the reset portion may be a reset spring at the connection between the hole cover portion 312 and the ablation needle 31. When the operating portion 315 is released, the elastic force of the reset portion drives the hole cover portion 312 to close the side hole 310, thereby realizing flexible opening of the side hole 310. Specifically, the side hole 310 can be opened according to actual needs to inject anhydrous ethanol to flexibly ablate the myocardial hypertrophic part 600.

[0079] In some embodiments of the present invention, the hole cover portion 312 is disposed inside the ablation needle 31 and is connected to the ablation needle 31 in a manner that allows it to slide along the axial direction of the ablation needle 31. On the sliding path of the hole cover portion 312, the hole cover portion 312 has a first position for closing the side hole 310 and a second position for opening the side hole 310. The operating portion 315 is rotatably connected to the handle portion 21. The connecting portion includes a connecting wire 313, and both ends of the connecting wire 313 are respectively connected to the hole cover portion 312 and the operating portion 315. The operating portion 315 can drive the connecting wire 313 to move axially along the ablation needle 31 by its own rotation to drive the hole cover portion 312 to open. The reset portion includes an elastic member connected to the hole cover portion 312, and the elastic member is constructed to drive the hole cover to close by its own elastic force.

[0080] It can be understood that the hole cover part 312 can be slidably connected with the ablation needle 31 through the sliding groove on the inner wall of the ablation needle 31, and its sliding direction can be set to be along the axial direction of the ablation needle 31, and a limit part can be set on the sliding path to prevent the hole cover part 312 from slipping out of the path. Under the pull of the connecting wire 313, the hole cover part 312 can slide along the axial direction of the ablation needle 31, and close the side hole 310 in the first position, and fully open the side hole 310 in the second position. The operating part 315 can be coaxially connected to the handle part 21, and the connecting wire 313 can be wound on the rotating shaft of the operating part 315, so that the connection part rotates to drive the connecting wire 313 to be wound, thereby pulling the hole cover part 312 to slide along the axial direction of the ablation needle 31 toward the proximal end of the ablation needle 31, so that the hole cover part 312 can open and close the side hole 310 by sliding. The reset part can be an elastic member, such as an elastic wire 314 or a spring, which is disposed inside the ablation needle 31, and its elastic force direction is configured to pull the hole cover part 312 along the axial direction of the ablation needle 31 toward the distal end of the ablation needle 31, so that when the operating part 315 is released, the reset part drives the hole cover part 312 to slide toward the distal end of the ablation needle 31 to close the side hole 310. In addition, the connecting wire 313 and the elastic wire 314 can pass through the through hole on the connecting rod part 3122 to restrict the radial movement of the connecting wire 313 and the elastic wire 314 and improve stability.

[0081] In some embodiments of the present invention, the hole cover portion 312 includes an annular portion 3121 and a connecting rod portion 3122, the annular portion 3121 is coaxially arranged with the ablation needle 31, and the annular portion 3121 is connected with the ablation needle 31 in a manner that can slide along the axial direction of the ablation needle 31, the connecting rod portion 3122 is connected with the annular portion 3121, and is arranged in the space surrounded by the annular portion 3121, the connecting wire 313 is coaxially arranged on one axial side of the annular portion 3121, and is connected to the connecting rod portion 3122, and the reset member includes an elastic wire 314 coaxially arranged on the other axial side of the annular portion 3121, and the two ends of the elastic wire 314 are respectively connected to the connecting rod portion 3122 and the distal end of the ablation needle 31.

[0082] It can be understood that the annular portion 3121 is in the shape of a circular ring and has a certain length along the axial direction of the ablation needle 31. The annular portion 3121 is inserted into the ablation needle 31 and is coaxially arranged with the ablation needle 31. The annular portion 3121 can slide along the axial direction of the ablation needle 31 to switch between the first position and the second position. The connecting rod portion 3122 can extend along the radial direction of the annular portion 3121, and the two ends of the connecting rod portion 3122 are respectively connected to the radial sides of the annular portion 3121, and the connecting wire 313 It is connected to the connecting rod portion 3122, and the connection position is located at the center of the annular portion 3121. The reset member is an elastic wire 314, which is located on the side of the annular portion 3121 away from the connecting wire 313. The two ends of the elastic wire 314 are respectively connected to the connecting rod portion 3122 and the fixing portion 316 at the distal end of the ablation needle 31. The elastic wire 314 drives the annular portion 3121 to move toward the distal end of the ablation needle 31 when the operating portion 315 is not in use through its own elastic force to close the side hole 310. The coaxial arrangement of the annular portion 3121 and the connecting wire 313 with the ablation needle 31 makes the overall structure more stable, especially the stability of the hole cover portion 312 when sliding. The side hole 310 can be closed when the operating portion 315 is released by the arrangement of the elastic wire 314. In addition, a locking structure can be provided at the operating part 315, so that when the operating part 315 opens the side hole 310, it is locked with the locking structure. The user does not need to continue to control the operating part 315, and the position of the operating part 315 can be maintained. When the side hole 310 needs to be closed, the operating part 315 is moved out of the locking structure, and under the drive of the elastic wire 314, the hole cover part 312 closes the side hole 310.

[0083] The second aspect of the present invention provides a method for ablation of hypertrophic obstructive cardiomyopathy, which is implemented according to the hypertrophic obstructive cardiomyopathy ablation device provided in the first aspect of the present invention, and is characterized in that the method for ablation of hypertrophic obstructive cardiomyopathy comprises the following steps:

[0084] Deliver the adjustable curved sheath assembly 10 into the right atrium 100 via the femoral vein 500;

[0085] Adjust the direction of the adjustable sheath tube assembly 10 so that the adjustable sheath tube assembly 10 enters the right ventricle 200 through the tricuspid valve 700;

[0086] The mapping catheter 20 carrying the ultrasound component 25 is delivered into the right ventricle 200 through the adjustable bending sheath tube component 10;

[0087] Mapping the heart via a mapping catheter 20;

[0088] According to the image signal of the ultrasound component 25, the ablation needle component 30 is controlled to perform chemical ablation on the ventricular septal hypertrophy area.

[0089] The ablation method for hypertrophic obstructive cardiomyopathy proposed in the second aspect of the present invention is implemented by an ablation device for hypertrophic obstructive cardiomyopathy that integrates an ultrasonic component 25, an ablation needle component 30 and a mapping catheter 20. The adjustable curved sheath component 10 is flexibly controlled to enter the right ventricle 200, and is mapped and positioned by the mapping catheter 20. Then, under the real-time image guidance of the ultrasonic component 25, the ablation needle component 30 is controlled to perform chemical ablation on the hypertrophic part 600 of the myocardium to ensure the accuracy of the ablation position and the ablation depth. Under the premise of ablation safety, alcohol ablation is given to cause myocardial necrosis in the deep layer of the ventricular septum to relieve the obstruction.

[0090] The above is only a preferred specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily thought of by a person skilled in the art within the technical scope disclosed by the present invention should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims

1. A hypertrophic obstructive cardiomyopathy ablation device, characterized in that: include: An adjustable sheath tube assembly, wherein the proximal end of the adjustable sheath tube assembly is used for operation by a user, and the distal end of the adjustable sheath tube assembly is used for extending into the right ventricle; A mapping catheter is arranged in the adjustable bending sheath tube assembly and can be moved along the axial direction of the adjustable bending sheath tube assembly to the distal end of the adjustable bending sheath tube assembly and then pass out, and the mapping catheter is used to map the right ventricle; an ablation needle assembly, which is retractably mounted on the distal end of the mapping catheter and is used to chemically ablate the hypertrophic part of the ventricular septum of the right ventricle; The ultrasonic component is installed in the adjustable bending sheath tube component and can move along the axial direction of the adjustable bending sheath tube component to the distal end of the adjustable bending sheath tube component and pass out. The ultrasonic component is used to monitor the position of the ablation needle assembly.

2. The hypertrophic obstructive cardiomyopathy ablation device according to claim 1, characterized in that: The hypertrophic obstructive cardiomyopathy ablation device also includes a guide wire, the proximal end of the guide wire is used for user operation, the adjustable bend sheath tube assembly is slidably mounted on the guide wire, and the adjustable bend sheath tube assembly can move along the guide wire to the distal end of the guide wire.

3. The hypertrophic obstructive cardiomyopathy ablation device according to claim 1, characterized in that: The adjustable bending sheath tube assembly comprises: Handlebars; An adjustable bending sheath tube connected to the distal end of the handle; The first bending adjustment component includes a first bending adjustment wire and a first bending adjustment knob. The first bending adjustment knob is rotatably arranged on the handle portion. The first bending adjustment wire is arranged in the adjustable bending sheath tube and can move axially along the adjustable bending sheath tube. The two ends of the first bending adjustment wire are respectively connected to the first bending adjustment knob and the distal end of the adjustable bending sheath tube. The first bending adjustment component is used to drive the distal end of the adjustable bending sheath tube to bend radially toward the adjustable bending sheath tube.

4. The hypertrophic obstructive cardiomyopathy ablation device according to claim 1, characterized in that: The mapping catheter includes a handle portion, a catheter portion and a plurality of electrodes, wherein the catheter portion is connected to the distal end of the handle portion, and the plurality of electrodes are arranged on the outer peripheral surface of the distal end of the catheter portion, and the electrodes are used to map the right ventricle. The ultrasound component has an ultrasound detection portion, which is installed at the distal end of the catheter portion and is used to monitor the position of the ablation needle assembly.

5. The hypertrophic obstructive cardiomyopathy ablation device according to claim 4, characterized in that: The ablation needle assembly comprises: Ablation needle; an ethanol injection tube, which is inserted into the catheter portion, wherein the distal end of the ethanol injection tube is communicated with the ablation needle, and the proximal end of the ethanol injection tube is disposed on the handle portion and has an injection port for injecting ethanol; A propulsion wire, inserted into the catheter portion; The advancement adjustment slider is slidably arranged on the handle portion, and the two ends of the advancement wire are respectively connected to the ablation needle and the advancement adjustment slider, and the advancement adjustment slider is used to adjust the length of the ablation needle extending out of the catheter portion.

6. The hypertrophic obstructive cardiomyopathy ablation device according to claim 5, characterized in that: The ablation needle has a top hole and multiple side holes, the top hole is arranged at the distal end of the ablation needle, the multiple side holes are arranged on the circumference of the ablation needle and are spaced apart along the axial direction of the ablation needle, and the top hole and the side holes are both connected to the ethanol injection tube.

7. The hypertrophic obstructive cardiomyopathy ablation device according to claim 6, characterized in that: The ablation needle assembly also includes a plurality of opening and closing mechanisms, which include a hole cover portion, a connecting portion, a resetting portion and an operating portion. The hole cover portion is arranged in a one-to-one correspondence with the side hole, the hole cover portion is arranged at the side hole in an openable and closable manner, and is connected to the ablation needle. The operating portion is arranged on the handle portion, the operating portion is connected to the hole cover portion through the connecting portion, and is used to control the opening of the hole cover portion. The resetting portion is connected to the hole cover portion, and is used to drive the hole cover portion to close.

8. The hypertrophic obstructive cardiomyopathy ablation device according to claim 7, characterized in that: The hole cover portion is arranged inside the ablation needle and is connected to the ablation needle in a manner that can slide along the axial direction of the ablation needle. On the sliding path of the hole cover portion, the hole cover portion has a first position for closing the side hole and a second position for opening the side hole. The operating portion is rotatably connected to the handle portion. The connecting portion includes a connecting wire, and both ends of the connecting wire are respectively connected to the hole cover portion and the operating portion. The operating portion can drive the connecting wire to move along the axial direction of the catheter portion by its own rotation to drive the hole cover portion to open. The reset portion includes an elastic member connected to the hole cover portion, and the elastic member is constructed to drive the hole cover to close by its own elastic force.

9. The hypertrophic obstructive cardiomyopathy ablation device according to claim 8, characterized in that: The hole cover portion includes an annular portion and a connecting rod portion, the annular portion is coaxially arranged with the ablation needle, and the annular portion is connected to the ablation needle in a manner that can slide along the axial direction of the ablation needle, the connecting rod portion is connected to the annular portion, and is arranged in the space surrounded by the annular portion, the connecting wire is coaxially arranged on one axial side of the annular portion and connected to the connecting rod portion, and the reset member includes an elastic wire coaxially arranged on the other axial side of the annular portion, and both ends of the elastic wire are respectively connected to the connecting rod portion and the distal end of the ablation needle.

10. A method for ablation of hypertrophic obstructive cardiomyopathy, implemented by the hypertrophic obstructive cardiomyopathy ablation device according to any one of claims 1 to 9, characterized in that: The ablation method for hypertrophic obstructive cardiomyopathy comprises the following steps: The adjustable curved sheath assembly is delivered into the right atrium via the femoral vein; Adjust the direction of the adjustable curved sheath tube assembly so that the adjustable curved sheath tube assembly enters the right ventricle through the tricuspid valve; Delivering a mapping catheter carrying an ultrasound component into the right ventricle through an adjustable curved sheath assembly; Mapping of the heart via a mapping catheter; According to the image signal of the ultrasound component, the ablation needle component is controlled to perform chemical ablation on the ventricular septal hypertrophy area.

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