Hypertrophic obstructive cardiomyopathy ablation device

Abstract

The present invention proposes a hypertrophic obstructive cardiomyopathy ablation device, which includes an adjustable bend sheath assembly, a mapping catheter, an ablation needle assembly, and an ultrasound assembly. The mapping catheter is inserted into the adjustable bend sheath assembly and can be moved along the axial direction of the adjustable bend sheath assembly to the distal end of the adjustable bend sheath assembly to exit. The mapping catheter is used to map the heart, and the ablation needle assembly is used to chemically ablate the hypertrophic portion of the ventricular septum of the right ventricle. The ultrasound assembly can be moved to the distal end of the adjustable bend sheath assembly to exit, and the ultrasound assembly is used to monitor the position of the ablation needle assembly. The hypertrophic obstructive cardiomyopathy ablation device integrates the ultrasound assembly, the ablation needle assembly, and the mapping catheter. Under the real-time image guidance of the ultrasound assembly, the ablation needle assembly is controlled to chemically ablate the hypertrophic portion of the myocardium, ensuring 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.

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. 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 leading causes of sudden death. Current treatment options involve reducing the thickness of the ventricular septum through surgery or interventional procedures to alleviate obstruction. Surgery involves resecting a portion of the ventricular septum through thoracotomy or minimally invasive procedures to reduce obstruction.

[0004] There are two main interventional approaches. One involves radiofrequency ablation of the right ventricular septum using an ablation catheter, causing partial myocardial necrosis and reducing obstruction. The other involves injecting anhydrous alcohol through the septal branches of the coronary arteries to cause myocardial necrosis and reduce obstruction. The first approach offers shallow ablation depth and is not ideal for optimal results, while the second approach relies heavily on the nonselective course of the septal branches. Summary of the Invention

[0005] The purpose of the present invention is to at least address the problem of poor efficacy of existing treatments for hypertrophic obstructive cardiomyopathy. This purpose is achieved through the following technical solutions:

[0006] A 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, which is provided in the adjustable bend sheath assembly and can be moved along the axial direction of the adjustable bend sheath assembly to the distal end of the adjustable bend sheath assembly and then pass out, and the mapping catheter is used to map the heart;

[0009] an ablation needle assembly, mounted in a telescopic manner at the distal end of the mapping catheter and used for chemically ablating the hypertrophic portion of the ventricular septum of the right ventricle;

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

[0011] The hypertrophic obstructive cardiomyopathy ablation device proposed in the first aspect of the present invention integrates an ultrasound component, an ablation needle component and a mapping catheter. The direction of the device is flexibly controlled by an adjustable curved sheath component to enter the right ventricle, and positioning is performed by a mapping catheter. Then, under the real-time image guidance of the ultrasound 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.

[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 includes:

[0014] handle;

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

[0016] The bending adjustment assembly includes a bending adjustment wire and a bending adjustment knob. 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. 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 in communication 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, passed through the catheter portion;

[0022] The propulsion adjustment slider is slidably arranged on the handle portion. The two ends of the propulsion wire are respectively connected to the ablation needle and the propulsion adjustment slider. The propulsion adjustment slider is used to adjust the length of the ablation needle extending from 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 further includes a plurality of opening and closing mechanisms, which include a hole cover portion, a connecting portion, a reset portion, and an operating portion. The hole cover portion is arranged in a one-to-one correspondence with the side hole, and 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, and 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 reset 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. The connecting portion includes a connecting wire, and 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 the two ends of the elastic wire are respectively connected to the connecting rod portion and the distal end of the ablation needle. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Various other advantages and benefits will become apparent to those skilled in the art upon reading the detailed description of the preferred embodiment below. The accompanying drawings are for illustration purposes only and are not to be considered as limiting the present invention. The same reference numerals are used throughout the accompanying drawings to denote the same components. In the accompanying drawings:

[0028] Figure 1 Schematically shows a structural diagram of a hypertrophic obstructive cardiomyopathy ablation device according to an embodiment of the present invention;

[0029] Figure 2 Schematically shows a structural diagram of a hypertrophic obstructive cardiomyopathy ablation device (ablation needle retraction) according to an embodiment of the present invention;

[0030] Figure 3 Schematically shows a structural diagram of an adjustable bending sheath tube assembly according to an embodiment of the present invention;

[0031] Figure 4 Schematically shows a structural diagram of a mapping catheter according to an embodiment of the present invention;

[0032] Figure 5 The cross-sectional structure diagram of the adjustable bending sheath tube is schematically shown;

[0033] Figure 6 Schematically shows the structure of an ablation needle;

[0034] Figure 7 Schematically shows a cross-sectional structural diagram of an ablation needle (with an opening and closing mechanism closing the side hole);

[0035] Figure 8 Schematically shows a cross-sectional structural diagram of an ablation needle (with the opening and closing mechanism opening the side hole);

[0036] Figure 9 The figure schematically shows the process of inserting the adjustable curved sheath assembly into the right atrium via the guide wire;

[0037] Figure 10 The figure schematically shows the adjustable curved sheath assembly entering the right ventricle after adjustment;

[0038] Figure 11 The figure schematically shows a schematic diagram of a mapping catheter entering the right ventricle through an adjustable curved sheath assembly;

[0039] Figure 12 The diagram schematically shows the ablation needle assembly performing chemical ablation on a myocardial hypertrophy portion;

[0040] The reference numerals are as follows:

[0041] 100, right atrium; 200, right ventricle; 300, left atrium; 400, left ventricle; 500, veins; 600, hypertrophy; 700, tricuspid valve;

[0042] 10. Adjustable bending sheath assembly; 11. Handle; 12. Adjustable bending sheath; 121. First lumen; 122. Second lumen; 123. Third lumen; 13. First bending adjustment wire; 14. First bending adjustment knob; 15. Second bending adjustment wire; 16. Second bending adjustment knob;

[0043] 20. Mapping catheter; 21. Handle; 22. Catheter; 23. Electrode; 24. Third bending knob; 25. Ultrasound assembly;

[0044] 30. Ablation needle assembly; 31. Ablation needle; 310. Side hole; 311. Opening and closing mechanism; 312. Hole cover; 3121. Ring portion; 3122. Connecting rod; 313. Connecting wire; 314. Elastic wire; 315. Operating unit; 316. Fixing unit; 32. Ethanol injection tube;

[0045] 40. Guide wire. DETAILED DESCRIPTION

[0046] Exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although 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. Rather, these embodiments are provided 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.

[0047] It should be understood that the terms used herein are for the purpose of describing specific example embodiments only 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 "comprise", "include", "contain" and "have" are inclusive and therefore specify the presence of stated features, steps, operations, elements and / or parts, but do not exclude the presence 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 to be construed as necessarily requiring them to be performed in the specific order described or illustrated, unless the order of execution is clearly indicated. It should also be understood that additional or alternative steps may be used.

[0048] 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 otherwise, 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.

[0049] For ease of description, spatially 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 figures, such as "inside," "outside," "inside," "outside," "below," "beneath," "above," and the like. Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is flipped, an element described as "below" or "beneath" another element or feature would then be oriented as "above" or "above" the other element or feature. Thus, the example term "below" can encompass both above and below orientations. The device may be otherwise oriented (rotated 90 degrees or in other orientations) and the spatially relative descriptors used herein are interpreted accordingly.

[0050] like Figures 1 to 12 As shown, the first aspect of the present invention proposes a hypertrophic obstructive cardiomyopathy ablation device, which is characterized by comprising 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 passed through 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 through, the mapping catheter 20 is used to map the heart, the ablation needle assembly 30 is installed in a telescopic manner at the distal end of the mapping catheter 20, and is used to chemically ablate the ventricular septum hypertrophy portion 600 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 through, the ultrasound assembly 25 is used to monitor the position of the ablation needle assembly 30.

[0051] 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 thereof 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 bend sheath 12 has a bend adjustment wire. One end of the bend adjustment wire is fixedly connected to the distal end of the adjustable bend sheath 12, and the other end is located at the proximal end of the adjustable bend sheath 12 and is fixedly connected to an adjustment button movably provided at the proximal end of the adjustable bend sheath 12. When the user moves the adjustment button, the bend adjustment wire is pulled, and the distal end of the adjustable bend sheath 12 is driven and bent, 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 bend sheath 12. When the adjustable bend sheath 12 moves into the heart, the mapping catheter 20 is delivered to the heart through the inner cavity of the adjustable bend sheath 12, and the heart is mapped through the electrode 23. The ablation needle assembly 30 includes an ablation needle 31, which is located at the distal end of the mapping catheter 20 and connected to the proximal end of the mapping catheter 20 via a tube. This allows the operator to infuse anhydrous ethanol from the proximal end to chemically ablate the patient's myocardial hypertrophy 600. An ultrasound assembly 25, located at the distal end of the mapping catheter 20, monitors the position of the ablation needle assembly 30 using ultrasound technology to improve the accuracy of the ablation location. Under the guidance of ultrasound images, the ablation needle assembly 30 can be accurately punctured deeper into the myocardium, ensuring the safety of the ablation procedure.

[0052] 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 device to enter the right ventricle 200, and the mapping catheter 20 is used to perform mapping positioning. 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 myocardial hypertrophy part 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.

[0053] 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.

[0054] It is understandable that the function of the guide wire 40 is to be delivered to the heart via the femoral vein 500 before the adjustable bend sheath assembly 10. The guide wire 40 is made of a relatively soft metal wire material or a polymer compound material, and its distal end is relatively soft. It can be delivered to the coronary vein 500 via the femoral vein 500 during surgery, serving as a guide path for the adjustable bend sheath assembly 10, so that after the guide wire 40 is in place, the adjustable bend sheath assembly 10 is slid along the guide wire 40 and delivered to the heart. The assembly relationship between the guide wire 40 and the adjustable bend sheath 12 can be achieved by either 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 bend sheath 12 to achieve assembly between the two. The adjustable bend 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 bend sheath 12 can slide along the guide wire 40 to the coronary vein 500. A plurality of fixing portions 316 can also be provided along the axial direction 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 can have a notch or a perforation for the guide wire 40 to pass through.

[0055] 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 the first direction.

[0056] 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 snapping or screwing. 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, with a portion of the first bending knob 14 located within the handle 11 and connected to one end of the first bending wire 13. The other portion of the first bending knob 14 protrudes from the handle 11 to facilitate operator manipulation. The other end of the first bending wire 13 is fixedly connected to the distal end of the adjustable sheath 12, so that when the operator rotates the first bending knob 14, the first bending knob 14 winds up the first bending wire 13, thereby bending the distal end of the adjustable sheath 12. Based on the curvature of the blood vessel, the rotation angle of the first bending knob 14 can be controlled in conjunction with external ultrasound or other positioning monitoring equipment, thereby controlling the curvature of the adjustable sheath 12 to adapt to the curvature of the blood vessel. Reversing the rotation of the first bending knob 14 restores the first bending wire 13 to its original curvature.

[0057] 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.

[0058] 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 providing 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 a portion of the second bending adjustment knob 16 is located inside the handle portion 11. This portion is connected to one end of the second bending adjustment wire 15, and the other portion of the second bending adjustment knob 16 protrudes from the handle portion 11 to facilitate the operator's manipulation. 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 apart 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 can be rotated. The second bending knob 16 winds up the second bending wire 15, thereby pulling the distal end of the adjustable sheath tube 12 to bend. Based on the curvature of the blood vessel, the first bending knob 14 can be rotated in conjunction with an in vitro ultrasound or other positioning monitoring device to first bend the distal end of the adjustable sheath tube 12 to a certain degree. The second bending knob 16 can then be rotated to further bend the distal end of the adjustable sheath tube 12 closer to the end, thereby shaping the adjustable sheath tube 12 so that the curvature of the adjustable sheath tube 12 is more closely aligned with the direction of the blood vessel. Reversing the second bending knob 16 restores the second bending wire 15 to its original direction.

[0059] 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 ultrasonic component 25 has an ultrasonic detection portion, which is installed at the distal end of the catheter portion 22 and is used to monitor the position of the ablation needle assembly 30.

[0060] It can be understood that another cavity independent of the cavity for inserting the guide wire 40 or the first and second bending wires 13 and 15 can be set in the adjustable bending sheath 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 has a tubular structure. Multiple electrodes 23 are mounted on the outer surface of the distal end of the catheter portion 22. The electrodes 23 can be distributed in a dotted pattern on the outer surface of the catheter portion 22, or arranged in a circular pattern around the axis of the catheter portion 22, with multiple electrodes 23 spaced axially along the catheter portion 22. The catheter portion 22 and the handle portion 21 can be coaxially arranged, with the catheter portion 22 positioned within the adjustable bend sheath 12, and at least a portion of the handle portion 21 positioned within the grip portion 11. During use, the handle portion 21 can be pushed to slide the catheter portion 22 axially along the adjustable bend sheath 12 and out through the distal end of the adjustable bend sheath 12. During mapping, the electrodes 23 are moved through the adjustable bend sheath 12 into the coronary vein 500 and electrically connected to an electrocardiograph. When heart muscle cells contract and relax, they generate electrical signals. These signals are captured by the electrodes 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 and received by the ultrasonic component 25, and converted into electrical signals. The 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.

[0061] In some embodiments of the present invention, the mapping and ablation assembly further includes a third bending adjustment assembly, 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.

[0062] 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. A portion of the third bending knob 24 is located within the handle 21 and connected to one end of the third bending wire. Another portion of the third bending knob 24 protrudes from the handle 21 to facilitate manipulation by the operator. The other end of the third bending wire is fixedly connected to the distal end of the catheter 22. When the operator turns the third bending knob 24, the third bending knob 24 winds up the third bending wire, thereby bending the distal end of the catheter 22. Based on the curvature of the blood vessel, the angle of rotation of the third bending knob 24 can be controlled in conjunction with external ultrasound or other positioning monitoring equipment, thereby adjusting the curvature of the catheter 22 to suit the vessel's curvature. Reversing the third bending knob 24 restores the third bending wire to its original curvature.

[0063] 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 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 11 and has an injection port for infusing ethanol.

[0064] 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 passed through the adjustable bend sheath assembly 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. After 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.

[0065] In some embodiments of the present invention, the ablation needle assembly 30 also includes a propulsion wire and a propulsion adjustment slider. The propulsion adjustment slider is slidably arranged on the handle portion 21. The two ends of the propulsion wire are respectively connected to the ablation needle 31 and the propulsion adjustment slider. The propulsion adjustment slider is used to adjust the length of the ablation needle 31 extending from the mapping ablation assembly.

[0066] 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 set to be installed in the catheter part 22 in a retractable manner. Specifically, by providing a propulsion adjustment slider on the handle part 21 that can slide along the axial direction of the handle part 21, a propulsion wire is passed 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 the ablation needle 31 is pushed forward to the outside 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.

[0067] In some embodiments of the present invention, the adjustable bend sheath 12 has 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 bend adjustment wire 13, the third lumen 123 is used for the passage of the second bend adjustment wire 15, and the ethanol injection tube 32 is used to deliver anhydrous alcohol to the ablation needle 31.

[0068] 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, and the multiple side holes 310 are arranged on the circumferential side of the ablation needle 31 and are spaced apart 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.

[0069] It is understood that the ablation needle 31 has a needle-shaped body with a top hole at its distal end. Anhydrous alcohol can be injected through the top hole and injected into the myocardial hypertrophy portion 600 along the axial direction of the ablation to chemically ablate it. To increase the ablation range and directional 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. This allows anhydrous alcohol to be injected into the myocardial hypertrophy portion 600 along the circumferential side of the ablation needle 31 to chemically ablate it, thereby improving ablation efficiency and ablation range.

[0070] 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 mechanism 311 includes 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.

[0071] It is understood that to improve the controllability of the injection of anhydrous ethanol by the ablation needle 31, an opening and closing mechanism 311 can be provided to control the opening and closing of the side hole 310. When the side hole 310 is not required to be opened, the opening and closing mechanism 311 closes the side hole 310. When the side hole 310 is required to be opened at a specific location, the opening and closing mechanism 311 opens the side hole 310, 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 by a hinged or sliding connection. The connecting part can be a wire structure, and the operating part 315 is rotatably arranged on the handle and connected to the hole cover part 312 through the connecting part. When the operating part 315 is rotated, the operating part 315 coils the connecting part so that the hole cover part 312 is driven to open by the connecting part. In addition, a reset part is also provided at the hole cover. The reset part can be a reset spring at the connection between the hole cover part 312 and the ablation needle 31. When the operating part 315 is released, the elastic force of the reset part drives the hole cover part 312 to close the side hole 310, thereby realizing the flexible opening of the side hole 310. Specifically, according to actual needs, the side hole 310 can be opened to inject anhydrous ethanol to flexibly ablate the myocardial hypertrophy part 600.

[0072] In some embodiments of the present invention, the hole cover portion 312 is arranged inside the ablation needle 31 and is connected to the ablation needle 31 in a manner that can 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. The two 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.

[0073] It is understandable that the hole cover portion 312 can be slidably connected to 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 portion can be set on the sliding path to prevent the hole cover portion 312 from deviating from the path. Under the pull of the connecting wire 313, the hole cover portion 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 portion 315 can be coaxially connected to the handle portion 21, and the connecting wire 313 can be coiled on the rotating shaft of the operating portion 315, so that the connection portion rotates to drive the connecting wire 313 to coil, thereby pulling the hole cover portion 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 portion 312 can open and close the side hole 310 by sliding. The reset portion can be an elastic member, such as an elastic wire 314 or a spring. The reset portion is disposed within the ablation needle 31, and its elastic force is configured to pull the hole cover portion 312 axially toward the distal end of the ablation needle 31. When the operating portion 315 is released, the reset portion drives the hole cover portion 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 of the connecting rod portion 3122 to restrict the radial movement of the connecting wire 313 and the elastic wire 314, thereby improving stability.

[0074] 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 to 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 to 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. The reset member includes an elastic wire 314 coaxially arranged on the other axial side of the annular portion 3121. 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.

[0075] It can be understood that the annular portion 3121 is annular 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 is connected to the connecting wire 313. The ring portion 3121 is connected to the connecting rod 3122 at the center of the ring portion 3121. The resetting member is an elastic wire 314 located on the side of the ring portion 3121 facing away from the connecting wire 313. The ends of the elastic wire 314 are respectively connected to the connecting rod 3122 and the fixing portion 316 at the distal end of the ablation needle 31. The elastic wire 314 uses its own elastic force to drive the ring portion 3121 toward the distal end of the ablation needle 31 when the operating portion 315 is not in use, thereby closing the side hole 310. The coaxial arrangement of the ring portion 3121 and the connecting wire 313 with the ablation needle 31 enhances the overall structural stability, especially the stability of the hole cover 312 during sliding. The provision of the elastic wire 314 allows the side hole 310 to be closed when the operating portion 315 is released. In addition, a locking structure can be provided at the operating part 315, so that the operating part 315 is locked with the locking structure when the side hole 310 is opened. 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.

[0076] A second aspect of the present invention provides a method for ablation of hypertrophic obstructive cardiomyopathy, which is implemented using the hypertrophic obstructive cardiomyopathy ablation device provided in the first aspect of the present invention. The method is characterized in that the method comprises the following steps:

[0077] Deliver the adjustable curved sheath assembly 10 into the right atrium 100 via the femoral vein 500;

[0078] 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;

[0079] The mapping catheter 20 carrying the ultrasound component 25 is delivered into the right ventricle 200 through the adjustable sheath assembly 10;

[0080] Mapping the heart using a mapping catheter 20;

[0081] 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.

[0082] The ablation method for hypertrophic obstructive cardiomyopathy proposed in the second aspect of the present invention is implemented through a hypertrophic obstructive cardiomyopathy ablation device that integrates an ultrasonic component 25, an ablation needle component 30 and a mapping catheter 20. The adjustable sheath component 10 flexibly controls its direction 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.

[0083] The above description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any changes or substitutions that can be easily conceived by a person skilled in the art within the technical scope disclosed in the present invention should be included in the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be based on the scope of protection 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, which is provided in the adjustable sheath assembly and can be moved axially along the adjustable sheath assembly to the distal end of the adjustable sheath assembly and then pass out, and the mapping catheter is used to map the right ventricle; an ablation needle assembly, mounted in a telescopic manner at the distal end of the mapping catheter and used for chemically ablating the hypertrophic portion of the ventricular septum of the right ventricle; an ultrasonic assembly, which is provided in the adjustable bending sheath assembly and can be moved along the axial direction of the adjustable bending sheath assembly to the distal end of the adjustable bending sheath assembly and then pass out, and the ultrasonic assembly is used to monitor the position of the ablation needle assembly; 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 circumference of the distal end of the catheter portion. The electrodes are used to map the right ventricle. The ultrasound assembly includes an ultrasound detector portion, which is installed at the distal end of the catheter portion and is used to monitor the position of the ablation needle assembly. 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 in communication 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, passed through the catheter portion; An advancement adjustment slider is slidably disposed on the handle portion, and both 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 from the catheter portion; The ablation needle has a top hole and a plurality of side holes, wherein the top hole is arranged at the distal end of the ablation needle, and the plurality of 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; The ablation needle assembly further includes a plurality of opening and closing mechanisms, each of which includes a hole cover portion, a connecting portion, a reset portion, and an operating portion. The hole cover portion is provided in a one-to-one correspondence with the side hole, the hole cover portion is provided at the side hole in an openable and closable manner, and is connected to the ablation needle. The operating portion is provided 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 reset portion is connected to the hole cover portion, and is used to drive the hole cover portion to close. 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 that closes the side hole and a second position that opens the side hole. The operating portion is rotatably connected to the handle portion. The connecting portion includes a connecting wire, and 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 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.

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 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.

3. The hypertrophic obstructive cardiomyopathy ablation device according to claim 1, characterized in that: The adjustable curved sheath tube assembly comprises: handle; An adjustable sheath tube is 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 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 is connected to the connecting rod portion, the reset member includes an elastic wire coaxially arranged on the other axial side of the annular portion, and the two ends of the elastic wire are respectively connected to the connecting rod portion and the distal end of the ablation needle.

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