Myocardial ablation device

Abstract

The present invention relates to a myocardial ablation device capable of ablating myocardial tissue point by point. The myocardial ablation device comprises a handle, an outer sleeve and a core, wherein the handle comprises an outer shell and is arranged at the proximal side of the myocardial ablation device, accommodating the proximal end of the outer sleeve and the proximal end of the core, wherein a negative pressure suction pipeline is arranged in the handle, and a negative pressure connection hole is arranged on the negative pressure suction pipeline for connecting a vacuum generating device; the outer sleeve comprises a first hollow pipe and a second hollow pipe, the proximal end of the first hollow pipe is connected to the negative pressure suction pipeline, and the distal end is provided with a negative pressure suction cup, and the negative pressure suction cup comprises a side wall and one or more negative pressure suction ports; the core comprises a third hollow pipe, the proximal end of the core is provided with an injection pipeline, an injection interface and a moving control component, and the distal end has a tip, wherein the injection pipeline is connected to the third hollow pipe and the proximal end of the injection pipeline is the injection interface, and the moving control component is arranged on the core for controlling the core to move along the second hollow pipe of the outer sleeve.

Description

Technical Field

[0001] The present invention relates to a surgical instrument for treating and mapping arrhythmias, and in particular to a myocardial ablation device capable of ablating myocardial tissue point by point. Preferably, the myocardial ablation device can also map cardiac electrical activity point by point. Background Art

[0002] Arrhythmia is a series of diseases caused by a variety of reasons in which the heart beats without its inherent rhythm. It has a high incidence rate and is extremely harmful to health. For example, the most common persistent arrhythmia in clinical practice is called atrial fibrillation (AF for short). It is caused by various pathogenic factors that lead to abnormal changes in the electrophysiological properties of atrial myocytes, causing rapid and irregular contractions of the atria and ventricles, which causes patients to have uncomfortable symptoms such as palpitations, shortness of breath, and fatigue, and increases the incidence of adverse events such as heart failure, thromboembolism, and death. At present, the total prevalence of atrial fibrillation in my country is 0.77%. It is estimated that the total number of atrial fibrillation patients in my country is close to 10 million, ranking first among all countries in the world. In addition, the prevalence of atrial fibrillation shows a significant upward trend with age, and the prevalence of the age group over 80 years old is as high as 7.5%. With the aging of today's society, the prevalence of atrial fibrillation is increasing, which seriously affects the health level of the people. For example, ventricular tachycardia (VT) and ventricular fibrillation (VF) are abnormal local electrical activity in the ventricles caused by ventricular muscle cell lesions, resulting in excessively rapid ventricular contraction frequency, inability to maintain normal blood pressure, and even sudden cardiac death. Due to the suddenness and severity of the onset, they have caused great harm to people's lives and health.

[0003] In recent years, with the gradual understanding of the pathogenesis of atrial fibrillation, it has been found that most atrial fibrillation is related to abnormal electrical activity originating from the pulmonary vein vestibule, left and right atrial tissues, and the superior and inferior vena cava. Blocking the conduction of abnormal electrical activity by various means can terminate most atrial fibrillation and prevent recurrence. Various types of medical ablation surgeries and surgical "maze" surgeries that have emerged under this theory have good clinical effects. At present, the key steps of medical ablation and surgical "modified maze" for atrial fibrillation are to cause local myocardial tissue necrosis and electrical conduction block by various methods, resulting in two complete left and right pulmonary vein vestibule isolation rings, ablation lines connecting the two pulmonary vein vestibule isolation rings at the top and bottom of the left atrium, and ablation lines located in the tricuspid isthmus, superior vena cava and other parts. Similarly, by various means, the ventricular myocytes in the local lesion can achieve coagulative necrosis and electrical isolation, which can treat or prevent the occurrence of ventricular tachycardia and ventricular fibrillation.

[0004] However, the bipolar radiofrequency ablation pen currently used for linear ablation in atrial fibrillation surgery releases radiofrequency energy close to the epicardium, making it difficult to form transmural damage to thicker myocardial tissue, especially for patients with hypertrophic cardiomyopathy. It is even more difficult to cause damage deep in the ventricular wall using such radiofrequency ablation pens, and thus the treatment effect on some atrial fibrillation and most ventricular arrhythmias is poor. Moreover, the existing bipolar radiofrequency ablation pen cannot map whether there is still electrical activity or conduction at the ablation site after ablation is completed, so it is impossible to verify the surgical effect during the operation, leaving certain hidden dangers for the recurrence of arrhythmias. In addition, the bipolar radiofrequency ablation pens currently used are all imported, with complex structures and high costs, and require a series of supporting equipment such as radiofrequency energy generators, making the cost of surgical treatment of atrial fibrillation considerable and making it impossible for some hospitals to carry out this treatment.

[0005] Therefore, there is a need in the art for a myocardial ablation device that can effectively and safely ablate myocardial tissue and map cardiac electrical activity point by point. The device should be simple to operate, efficient and fast, and capable of real-time verification. Summary of the invention

[0006] In order to solve the problems existing in the above-mentioned prior art, the inventors have designed a myocardial ablation device, which can not only penetrate deeply into the myocardial tissue while avoiding piercing the heart wall, but also ablate point by point to form an ablation line and verify the ablation effect.

[0007] Therefore, the present invention provides a myocardial ablation device, which includes a handle, an outer sleeve and a core; wherein the handle includes an outer shell and is arranged on the proximal side of the myocardial ablation device, accommodating the proximal end of the outer sleeve and the proximal end of the core, wherein a negative pressure suction pipeline is arranged in the handle, and a negative pressure connection hole is arranged on the negative pressure suction pipeline for connecting a vacuum generating device; the outer sleeve has a first hollow pipe and a second hollow pipe, the proximal end of the first hollow pipe is connected to the negative pressure suction pipeline, and the distal end is provided with a negative pressure suction cup, and the negative pressure suction cup includes a side wall and one or more negative pressure suction ports; the core has a third hollow pipe, the proximal end of the core is provided with an injection pipeline, an injection interface and a movement control component, and the distal end has a tip, wherein the injection pipeline is connected to the third hollow pipe and the proximal end of the injection pipeline is an injection interface, and the movement control component is arranged on the core for controlling the movement of the core along the second hollow pipe of the outer sleeve.

[0008] In a preferred embodiment, one or more pairs of electrodes may be provided on the tip of the core, and an electrode wire inlet may be provided on the outer shell of the handle for introducing electrode wires, wherein the electrode wires are configured to be electrically connected to the electrodes.

[0009] In one embodiment, one or more side holes and / or scales may be provided at the tip. The scale may be provided to facilitate the user to observe the position of the tip head. In this embodiment, the outer sleeve is preferably made of a transparent material to facilitate the user to observe the scale through the outer sleeve to judge the position of the tip head.

[0010] In one embodiment, the tip can be a vertical tip, an arc-shaped tip with a side bend, or a spiral tip. In a preferred embodiment, the tip can be an arc-shaped tip with a certain side bend. Preferably, the side bend has a curvature of 30-90°, most preferably 30-60°. In the present invention, the selection of the curvature of the side bend of the tip is not limited, as long as the direction of travel of the tip after piercing the heart wall is substantially parallel to the heart wall.

[0011] In one embodiment, the movement control component may include a movement controller (e.g., a mechanical knob) and a linkage member. When the movement controller is actuated, the linkage member, for example, may control the movement of the core by means of gear meshing, for example, advancing or withdrawing. Of course, other linkage methods known in the art may also be used to control the movement of the core, for example, by means of a stepper motor and a conveyor belt; by means of internal and external threads; by using ball bearings in combination with slideways; or more simply, by directly pushing or pulling the core, and so on. It should be understood that the method for achieving the movement of the core is not subject to any limitation in the present invention.

[0012] In a preferred embodiment, the inner wall of the outer sleeve may be provided with a spiral groove, and the outer wall of the core may be provided with a pulley or a ball, the size of which is suitable for sliding in the spiral groove. When the mobile control component controls the core to move forward along the second hollow pipe of the outer sleeve, the pulley or the ball on the outer wall of the core slides along the spiral groove on the inner wall of the outer sleeve, thereby driving the core to rotate along the central axis while moving forward, which is conducive to the distal tip of the core to more easily penetrate into the myocardial tissue.

[0013] In another preferred embodiment, the inner wall of the outer sleeve may be provided with an internal thread, and the outer wall of the core may be provided with an external thread matching the internal thread. When the movement control component controls the core to move forward along the second hollow channel of the outer sleeve, the external thread on the outer wall of the core moves along the internal thread on the inner wall of the outer sleeve, thereby driving the core to rotate along the central axis while moving forward, which is conducive to the distal tip of the core to more easily penetrate into the myocardial tissue.

[0014] In a preferred embodiment, the internal thread and / or external thread has one or more thread teeth, and the number of thread teeth can be determined according to the range of ablation required. It should be understood that the thread mentioned in the present invention can be a single-line thread and a multi-line thread, preferably a single-line thread, and if a multi-line thread is used, a double-line thread is preferred.

[0015] In the present invention, the thread profile is not limited, and the thread profiles well known in the art such as triangular thread, rectangular thread, arc thread, trapezoidal thread and sawtooth thread can be used, as long as a stable thread connection can be achieved.

[0016] In a preferred embodiment, the one or more negative pressure suction ports may be distributed along the circumference of the cross section of the first hollow pipe of the outer sleeve. The cross section of the negative pressure suction port may be circular, elliptical or other shapes.

[0017] In another preferred embodiment, an arc-shaped notch may be provided on the distal side wall of the negative pressure suction cup. When the distal end of the outer sleeve (i.e., the negative pressure suction cup) is placed on the surface of the heart and negative pressure is applied at the suction cup, the myocardial tissue at the negative pressure suction port is sucked into the arc-shaped notch, thereby tightening and fixing the myocardial tissue in the center of the arc-shaped notch, making it easier for the needle tip to penetrate.

[0018] It should be understood that the components of the myocardial ablation device of the present invention, especially the components that may come into contact with chemical ablative agents, for example, various hollow tubes, negative pressure suction lines, injection interfaces and other components are preferably made of materials that can withstand chemical ablative agents. The material should have suitable chemical resistance or corrosion resistance so that it can withstand chemical ablative agents (see the definition section below). The material should have a certain flexibility and hardness, so that the core, outer sleeve or negative pressure suction line and other components made of it have a certain degree of softness to facilitate bending and movement in the ablation device, and at the same time have a certain hardness to withstand the extrusion of other metal or rigid components in the ablation device without collapse, so as to avoid the liquid or gas therein flowing poorly and causing uneven pressure in the pipeline, resulting in poor, insufficient or uneven liquid discharge from the tip. Preferably, the material should have long-term durability so that it is suitable for repeated use. Most preferably, it is preferably a biocompatible material. The materials suitable for use in the present invention can be selected from medical plastics, such as polyvinyl chloride, polyurethane, polyethylene, acrylonitrile-styrene-butadiene copolymer (ABS), etc., metal materials (e.g., medical steel, such as 304L medical stainless steel, other medical metals other than medical steel, metal alloys, etc.) or any combination thereof. In the present invention, the selection of materials is not subject to any restrictions, as long as it can meet the above requirements, and those skilled in the art can select suitable materials for the manufacture of the device of the present invention based on the common knowledge in other chemical fields and medical material fields.

[0019] Beneficial Effects

[0020] The myocardial tissue of the atrial wall is relatively thin, and the myocardial tissue in the left atrial pulmonary vein vestibule and other parts of the atrial wall of patients with atrial fibrillation is particularly thin due to the enlargement of the left atrium. In addition, the heart is a hollow organ, so the needle tip design similar to that of an ordinary injection needle is difficult to penetrate the atrial tissue and reach the ideal depth. Excessive force can easily pierce the atrial tissue directly, causing the needle tip to enter the heart cavity directly, making it difficult to obtain the ideal treatment effect and causing complications such as bleeding.

[0021] The cardiac ablation device of the present invention can attract the target ablation myocardial tissue through the negative pressure suction port to tighten and fix it, so that the tip can penetrate into the heart wall.

[0022] The present invention can also achieve precise control of the target depth through different tip designs. For example, the vertical tip design of the present invention allows it to rotate along the central axis while advancing, so that it is easier to penetrate into the myocardial tissue and reach a controllable target depth. Another arc-shaped tip design allows the core and the tip to not rotate along the central axis while advancing, but because the tip is in an arc shape, after the tip penetrates the myocardium, the direction of the tip advancing and exerting force gradually changes from perpendicular to the atrial wall to parallel to the atrial wall, thereby avoiding piercing the atrial wall and entering the heart cavity as the force is exerted and the tip advances.

[0023] The cardiac ablation device of the present invention may also be provided with an electrode on the tip to verify the ablation effect by mapping the electrical activity of the target ablation tissue.

[0024] The cardiac ablation device of the present invention can be applied to chemical ablation, that is, ablation is achieved using chemical ablation agents. In the case of chemical ablation, the chemical ablative agent can be injected into the hollow tube of the core through the injection interface with the aid of various infusion or injection devices, and enter the target ablation myocardial tissue through the tip distal to the core. In this way, the cardiac ablation device of the present invention can be used to achieve point-by-point ablation and then form an ablation line, and the ablation effect can be verified by setting electrodes on the tip. It can be used for the treatment of various arrhythmias such as atrial fibrillation, atrial flutter, atrial tachycardia, supraventricular tachycardia, ventricular premature beats, ventricular tachycardia, ventricular fibrillation, etc., and has many advantages such as a wide range of indications and applications, simple operation, fast and efficient, low cost, and real-time verification. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 It is a schematic diagram of ablation of the myocardium using a radiofrequency ablation pen in the prior art.

[0026] Figure 2 Schematic diagram of the principle of using chemical reagents to ablate myocardium.

[0027] Figure 3 Schematic diagram of a common injection needle puncturing the atrial wall.

[0028] Figure 4 It is a front cross-sectional view of the first embodiment of the myocardial ablation device of the present invention.

[0029] Figure 5 It is a left cross-sectional view of the first embodiment of the myocardial ablation device of the present invention.

[0030] Figure 6 The diagram is a bottom cross-sectional view of an embodiment of the negative pressure suction cup of the myocardial ablation device of the present invention.

[0031] Figure 7 The diagram is a bottom cross-sectional view of another embodiment of the negative pressure suction cup of the myocardial ablation device of the present invention.

[0032] Figure 8 It is a schematic diagram of a first working state of a first embodiment of the myocardial ablation device of the present invention. In the first working state, no negative pressure is applied and the tip is not extended.

[0033] Fig. 9 It is a schematic diagram of the second working state of the first embodiment of the myocardial ablation device of the present invention. In the second working state, negative pressure is applied and the tip is not extended.

[0034] Fig.10 It is a schematic diagram of the third working state of the first embodiment of the myocardial ablation device of the present invention. In the third working state, negative pressure is applied and the tip is extended and penetrates into the myocardial tissue.

[0035] Fig.11 It is a schematic diagram of the fourth working state of the first embodiment of the myocardial ablation device of the present invention. In the fourth working state, the tip reaches the target depth of the ablated myocardial tissue.

[0036] Fig.12 It is a front cross-sectional view of a second embodiment of the myocardial ablation device of the present invention.

[0037] Fig.13 It is a left cross-sectional view of the second embodiment of the myocardial ablation device of the present invention.

[0038] Fig.14 FIG. 4 is a schematic diagram of the operation of the second embodiment of the myocardial ablation device according to the present invention.

[0039] Fig.15 It is a front cross-sectional view of a third embodiment of the myocardial ablation device of the present invention.

[0040] Fig.16 FIG. 4 is a schematic diagram of the operation of the third embodiment of the myocardial ablation device of the present invention. DETAILED DESCRIPTION

[0041] definition

[0042] Distal: In this specification, when the device of the present invention is described with reference to the "distal side", the term refers to the side relatively away from the user.

[0043] Proximal side: In this specification, when the device of the present invention is described with reference to the "proximal side", the term refers to the side relatively close to the user.

[0044] Distal end: In this specification, when the device of the present invention is described with reference to the "distal end", the term generally refers to the end relatively far away from the user or the end relatively far away from the body (eg, handle) of the device of the present invention.

[0045] Proximal end: In this specification, when the device of the present invention is described with reference to the "proximal end", the term generally refers to the end relatively close to the user or the end relatively close to the body (eg, handle) of the device of the present invention.

[0046] Sagittal plane: The plane passing through the vertical axis and longitudinal axis of the human body (or other object) (i.e. the median sagittal plane) and all planes parallel to it are called sagittal planes, which divide the human body or object into left and right halves.

[0047] Coronal plane: The plane passing through the vertical axis and the horizontal axis of the human body (or other object) and all planes parallel to it are called coronal planes, that is, these planes divide the human body or object into front and back parts.

[0048] Thread: refers to a continuous protrusion with a specified tooth shape formed along a spiral line on the surface of a cylinder or cone, where the protrusion refers to the solid part between the two sides of the thread, also known as a tooth (see national technical standards, thread terminology GB / T14791-93).

[0049] Helix: The trajectory of a point moving along the surface of a cylinder or cone, where the axial displacement of the point is proportional to the corresponding angular displacement (see GB / T 14791-93).

[0050] External thread: refers to the thread formed on the outer surface of a cylinder or cone (see GB / T14791-93).

[0051] Internal thread: refers to the thread formed on the inner surface of a cylinder or cone (see GB / T14791-93).

[0052] Single-line thread: refers to the thread formed along a spiral line (see GB / T 14791-93).

[0053] Right-hand thread: refers to the thread that is screwed in when rotated clockwise (see GB / T 14791-93).

[0054] Left-hand thread: refers to the thread that is screwed in when rotated counterclockwise (see GB / T 14791-93).

[0055] Crest height: refers to the distance from the crest to the mid-diameter line in the direction perpendicular to the thread axis on the thread profile (see GB / T 14791-93).

[0056] Root height: refers to the distance from the root of the thread to the center diameter line in the direction perpendicular to the thread axis on the thread profile (see GB / T 14791-93).

[0057] Tooth profile height: refers to the distance from the top to the bottom of the thread on the thread profile in the direction perpendicular to the thread axis.

[0058] Pitch: The axial distance between two points corresponding to two adjacent teeth on the mid-diameter line. In short, it is the axial distance between the first and second teeth of the thread.

[0059] Lead: The axial distance between two points on the median diameter of two adjacent teeth on the same helical line. In short, it is the axial distance moved by one rotation of the thread. If the thread is a single-line or single-start thread, the pitch is equal to the lead. If the thread is a double-line or double-start thread, the lead is twice the pitch, and so on.

[0060] Tooth profile: The profile shape of the thread on the section passing through the thread axis (see GB / T14791-93).

[0061] Engagement length: The thread engagement length is the length of the engaged parts of two mating threads along the thread axis (see GB / T 14791-93).

[0062] Chemical ablation reagents: various chemical reagents or reagent combinations that can cause coagulative necrosis of myocardial tissue, such as anhydrous ethanol, anhydrous propyl alcohol, glycerol, iopromide mixed solution, or mixtures thereof.

[0063] The preferred embodiments of the present invention are described below in conjunction with the accompanying drawings. It will be appreciated by those skilled in the art that the embodiments or examples described below in conjunction with the accompanying drawings are only used to illustrate the best mode for implementing the present invention, rather than limiting the scope of the present invention to these embodiments. The present invention can make various improvements and variations on the basis of the following embodiments. These improvements and variations are all included within the scope of the present invention. Between the various embodiments shown in the accompanying drawings of the present invention, similar reference numerals indicate similar parts.

[0064] Figure 1 This is a schematic diagram of the radiofrequency ablation pen currently widely used in clinical practice ablating the myocardial surface. Figure 1In the figure, 1 is myocardial tissue, 2 is epicardium, 3 is endocardium, and 4 is the electrode at the distal end of the radiofrequency ablation pen. During ablation, the radiofrequency ablation electrode 4 releases radiofrequency energy through the contact point 5 with the epicardium 2, causing coagulative necrosis foci 6 to the myocardial tissue near the contact point 5. It can be seen that the range of the coagulative necrosis foci is an approximate sphere with the contact point 5 as the center (in this two-dimensional plane cross-sectional diagram, it is a circle with the contact point 5 as the center). It can be seen that the coagulative necrosis foci 6 produced by the radiofrequency ablation pen in ablation of myocardial tissue 1 is difficult to reach the endocardium 3 from the epicardium 2, that is, it is difficult to penetrate the wall, resulting in incomplete myocardial ablation, and there is a potential basis for the appearance of electrical isolation "gaps" after radiofrequency ablation and new arrhythmias. Increasing the radiofrequency ablation energy or prolonging the ablation time will make the coagulative necrosis foci 6 large enough to reach the endocardium 3 from the epicardium 2, which will cause an excessively large necrosis range at the epicardium 2, which may cause complications such as coronary artery and vein injury.

[0065] Figure 2 This is a simplified schematic diagram of the principle of using chemical reagents to ablate myocardial tissue. For ease of understanding, Figure 2 Only some necessary parts are shown. 1 is myocardial tissue, 2 is epicardium, 3 is endocardium, and 7 is syringe needle. During ablation, syringe needle 7 penetrates into myocardial tissue 1, releases chemical ablation reagent from the pinhole 8 of needle 7, and chemical ablation reagent diffuses from myocardial tissue near pinhole 8 to the surrounding area, forming coagulative necrosis 9 of approximately spherical range with pinhole 8 as the center (in this two-dimensional plane cross-sectional diagram, it is a circle with pinhole 8 as the center). Because the site for releasing chemical ablation is approximately the central part 8 inside myocardial tissue 1, and chemical ablation reagent diffuses to the surrounding area to form coagulative necrosis, the chemical ablation reagent diffuses more evenly to epicardium 2 and endocardium 3, and it is easier to form full-thickness transmural necrosis 9 of myocardium from epicardium 2 to endocardium 3, while completely ablating the myocardial tissue at this location, avoiding the disadvantages of excessive ablation range on one side of the epicardium or endocardium of the radiofrequency ablation pen causing complications and too small ablation range on the other side making it difficult to penetrate the wall.

[0066] Figure 3 This is a schematic diagram of a common injection needle puncturing the atrial wall. Figure 3As shown, when the injection needle 10 of a common syringe punctures the relatively thin atrial wall 1, the needle tip 11 of the injection needle is easy to puncture the atrial wall 1. Because the atrial wall 1 is usually relatively thin, especially the atrial wall 1 of most arrhythmia patients is thinner than that of ordinary people, the distance between the epicardium 2 and the endocardium 3 is very close; and the atrium is a hollow organ, the inner side of the atrial wall 1 is the atrial cavity and blood, and there is no supporting or fixed object. Therefore, when the injection needle 10 of a common syringe punctures the atrial wall 1, the atrial wall is first compressed, so that the epicardium 2 at the needle tip 11 is close to the endocardium 3 and bulges into the heart cavity together, and the atrial wall at this location is extremely compressed. Once the needle tip 11 of the injection needle 10 pierces the epicardium 2, the epicardium 2 elastically retracts after being punctured, causing the myocardial tissue 1 and the endocardium 3 to retract together. It is very easy for the needle tip 11 to pierce the endocardium 3 at the same time, thereby piercing the myocardial tissue 1, and the injection needle enters the heart cavity, making it impossible to inject the chemical ablation agent into the myocardial tissue, or the chemical ablation agent penetrates into the heart cavity, resulting in poor ablation effect or the chemical ablation agent enters non-target ablation tissue and causes secondary damage.

[0067] Figure 4 It is a front cross-sectional view of the first embodiment 100 of the myocardial ablation device of the present invention. The myocardial ablation device 100 includes a handle 101, an outer sleeve 102 and a core 103. The handle 101 includes an outer shell and is arranged on the proximal side of the myocardial ablation device 100, accommodating the proximal end of the outer sleeve 102 and the proximal end of the core 103. A negative pressure suction pipeline 107 is arranged in the handle 101, and a negative pressure connecting hole 106 is arranged on the negative pressure suction pipeline 107 for connecting a vacuum generating device (not shown in the figure). The outer sleeve 102 has a first hollow channel 121 and a second hollow channel 122. The first hollow channel 121 is connected to the negative pressure suction pipeline 107 at the proximal end. The distal end of the outer sleeve 102 is provided with a negative pressure suction cup 110. The negative pressure suction cup 110 includes a side wall 119 and one or more negative pressure suction ports (not shown in the figure, see Figure 6 and Figure 7 ), a notch 111 is also provided on the distal side wall of the negative pressure suction cup 110. The core 103 has a third hollow pipe 123, and a liquid injection interface 105 is provided at the proximal end of the core 103 for connecting a liquid supply source. The core 103 is also provided with a movement control component 108 for controlling the movement of the core 103 along the second hollow pipe 122 of the outer sleeve 102. The distal end of the core 103 has a tip 104, and a scale 109 is also provided on the tip 104 to facilitate the operator to judge the depth of the tip 104 piercing the target ablation myocardial tissue.

[0068] exist Figure 4In the embodiment, the movement control component 108 includes a movement controller (shown as a mechanical knob) and a linkage member, and the linkage of the movement controller and the linkage member controls the core 103 to move forward and backward relative to the handle 101 in the second hollow channel 122 of the outer sleeve 102. The linkage method can be a gear combined with a rack, an electromagnetic spring, a linear stepping motor, etc. In use, the user controls the movement control component 108 (for example, a mechanical knob and a gear rack) on the core 103, thereby driving the core 103 to move forward and backward relative to the handle 101 and the outer sleeve 102.

[0069] Figure 5 FIG. 1 is a left cross-sectional view of the first embodiment 100 of the myocardial ablation device of the present invention. Figure 5 As shown, a liquid injection pipeline 116 is provided in the core 103, and the proximal end of the liquid injection pipeline 116 is connected to the liquid injection interface 105, and the distal end is connected to the core 103. In this embodiment, the tip 104 has a certain lateral curvature, and the curvature of the lateral curvature is preferably 30-90°, and most preferably 30-60°. In this way, after the tip 104 pierces the myocardium, the direction of the head moving forward and the force gradually changes from perpendicular to the atrial wall to parallel to the atrial wall, thereby avoiding piercing the atrial wall and entering the heart cavity as the force is applied and the needle tip moves forward. A pair of proximal electrodes 112, a pair of distal electrodes 114 and one or more injection side holes 113 are provided on the tip 104. After the tip 104 penetrates the target ablation tissue, a chemical ablation agent can be injected through the injection port 105. The chemical ablation agent enters the target ablation tissue through the injection port 105, the injection pipeline 116, the core 103, the tip 104, and the injection side hole 113, and chemically ablates the target ablation myocardial tissue to achieve the treatment purpose. The function of the electrodes 112 and 114 is to detect the myocardial electrical activity in the ablation area. An electrode wire inlet 120 is also provided in the handle 101, and the electrode wire 115 is introduced into the electrodes 112 and 114 through the electrode wire inlet 120. The electrode wire 115 can be connected to an external expansion device, such as a display, a processor, a stimulator, etc. When the myocardial ablation device performs ablation, the tip 104 at the distal end of the core 103 penetrates into the target ablation tissue, and the proximal electrode 112 and the distal electrode 114 contact the myocardial tissue on both sides of the injection side hole 113, respectively, and the ECG activity before, during and after ablation at the location can be measured. The electrode wire 115 is connected to external devices such as a display and a processor, and the ECG activity before, during and after ablation at the location measured can be transmitted to the processor for ECG signal processing and displayed on the display. If the electrode wire 115 is connected to a stimulator, the stimulator can also emit electrical stimulation to the myocardial tissue at the contact site of the proximal electrode 112 and the distal electrode 114, and record the ECG activity, so as to perform electrophysiological examination of cardiac lesions and immediately verify the ablation effect.

[0070] Figure 6FIG. 1 is a schematic bottom cross-sectional view of an embodiment of a negative pressure suction cup of a myocardial ablation device of the present invention. Figure 6 As shown in FIG. 1 , on the bottom cross section of the negative pressure suction cup 20, from outside to inside are the suction cup outer wall 21, the negative pressure suction port 23, the suction cup inner wall 24, the core outer wall 25, and the core tip 22. In this embodiment, the negative pressure suction cup has only one negative pressure suction port, which is the first hollow channel of the outer sleeve (corresponding to Figure 4 and Figure 5 The distal opening of the first hollow channel 121) in the embodiment.

[0071] Figure 7 FIG. 2 is a schematic bottom cross-sectional view of another embodiment of the negative pressure suction cup of the myocardial ablation device of the present invention. Figure 7 As shown in the figure, on the bottom cross section of the negative pressure suction cup 20', from outside to inside are the suction cup outer wall 21', the negative pressure suction cup bottom plate 23', the negative pressure suction hole 26', the suction cup inner wall 24', the core outer wall 25', and the core tip 22'. In this embodiment, the distal end of the first hollow channel of the outer sleeve is connected to the outside only at the negative pressure suction hole, and the rest is closed by the negative pressure suction cup bottom plate 23'.

[0072] Figure 8 FIG. 1 is a schematic diagram of a first working state of a first embodiment 100 of the myocardial ablation device of the present invention. In the first working state, no negative pressure is applied and the tip is not extended. Figure 8 As shown, in the first working state, no negative pressure suction is applied at the negative pressure connection hole 106 , so the epicardium of the target ablated myocardial tissue 32 is not attracted to the negative pressure suction cup 111 . At this time, the tip 104 is still in the outer sleeve 102 .

[0073] Fig. 9 FIG. 2 is a schematic diagram of a second working state of the first embodiment of the myocardial ablation device of the present invention. In the second working state, negative pressure is applied and the tip is not extended. Fig. 9 As shown, negative pressure is applied at the negative pressure connecting hole 106, and the negative pressure attraction force is transmitted to the notch 111 on the negative pressure suction cup 110 through the negative pressure connecting hole 106, the negative pressure suction pipeline 107, the outer sleeve 102, and the negative pressure suction cup 110, so that the epicardium and part of the myocardial tissue under the epicardium at the contact part of the notch 111 are sucked into and tightly adhere to the notch 111, and the inner and outer walls of the notch 111 tighten the epicardium 32 at the target ablation tissue and fix it to the negative pressure suction cup 110, so that the tip 104 can penetrate into the target ablation tissue for convenience.

[0074] Fig.10 FIG. 1 is a schematic diagram of the third working state of the first embodiment of the myocardial ablation device of the present invention. In the third working state, negative pressure is applied and the needle is extended and penetrates the myocardial tissue. Fig.10As shown, after negative pressure is applied to tighten the epicardium of the target ablation tissue and fix it to the negative pressure suction cup 110, the control component 108 ( Fig.10 The core 103 is driven by the handle 101 and the outer sleeve 102 to move toward the distal side of the device 101, so that the tip 104 at the distal end of the core 103 extends out of the outer sleeve 102 and pierces the target ablation tissue. Since the tip 104 has a certain lateral curvature, when the tip 104 pierces the target ablation myocardial tissue, the direction of the tip head's advancement and force generation gradually changes from perpendicular to the atrial wall to parallel to the atrial wall, so that the force direction of the epicardium 32 that contacts and deforms with the tip head 104 also gradually changes from perpendicular to the atrial wall to parallel to the atrial wall, thereby preventing the tip head 104 from piercing the atrial wall and entering the heart cavity. After the negative pressure suction cup 110 tightens and fixes the epicardium at the target ablation tissue, the target ablation myocardial tissue is firmly supported, making it easier for the tip head 104 to penetrate the target ablation myocardial tissue, and further preventing the tip head 104 from piercing the atrial wall.

[0075] Fig.11 This is a schematic diagram of the fourth working state of the first embodiment of the myocardial ablation device of the present invention. In the fourth working state, the tip reaches the target depth of the ablated myocardial tissue. For the judgment of the target depth, those skilled in the art can make an artificial judgment based on experience, for example, preliminary experiments in experimental animals, or based on the experience of autopsy. Preferably, it can be judged based on the scale 109 on the tip 104. More preferably, the outer sleeve 102 is transparent, so that it is easy to observe the scale 109 on the tip 104 of the core 103. In the fourth working state, the chemical ablation agent is injected through the injection interface 105, and the chemical ablation agent enters the target ablation tissue through the injection interface 105, the injection pipeline 116, the core 103, the tip 104, and the injection side hole 113, and chemical ablation is performed on the target ablation myocardial tissue. When ablation is performed, the proximal electrode 112 and the distal electrode 114 are in contact with the myocardial tissue on both sides of the injection side hole 113, respectively, so that the ECG activity before, during and after ablation can be measured at the location. The ECG activity before, during and after ablation at the location measured can be transmitted to the processor for ECG signal processing and displayed on the display by connecting the electrode wire 115 to an external device such as a display and a processor. If the electrode wire 115 is connected to a stimulator, the stimulator can also emit electrical stimulation to the myocardial tissue at the contact site of the proximal electrode 112 and the distal electrode 114, and record the ECG activity, so as to perform electrophysiological examination of cardiac lesions and immediately verify the ablation effect.

[0076] Fig.12It is a front cross-sectional view of the second embodiment 200 of the myocardial ablation device of the present invention. The myocardial ablation device 200 includes a handle 201, an outer sleeve 202 and a core 203. The handle 201 includes an outer shell and is arranged on the proximal side of the myocardial ablation device 200, accommodating the proximal end of the outer sleeve 202 and the proximal end of the core 203. A negative pressure suction pipeline 207 is provided on the core 203, and a negative pressure connecting hole 206 is provided on the negative pressure suction pipeline 207 for connecting a vacuum generating device (not shown in the figure). The outer sleeve 202 has a first hollow channel 221 and a second hollow channel 222, and the first hollow channel 221 is connected to the negative pressure suction pipeline 207 at the proximal end, and a negative pressure suction cup 210 is provided at the distal end of the outer sleeve 202, and the negative pressure suction cup 210 includes a side wall and one or more negative pressure suction ports (not shown in the figure, see Figure 6 and Figure 7 ), a notch 211 is also provided on the distal side wall 219 of the negative pressure suction cup 210. The core 203 has a third hollow pipe 223, and a liquid injection interface 205 is provided at the proximal end of the core 203 for connecting a liquid supply source. The core 203 is also provided with a movement control component 208 for controlling the movement of the core 203 along the second hollow pipe 222 of the outer sleeve 202. The distal end of the core 203 has a tip 204, and a scale 209 is also provided on the tip 204 to facilitate the operator to judge the depth of the tip 204 piercing the target ablation myocardial tissue.

[0077] exist Fig.12 In the embodiment, the mobile control component 208 includes a mobile controller (shown as a mechanical knob) and a linkage member, and the linkage control core 203 of the mobile controller and the linkage member moves forward and backward relative to the handle 201 in the second hollow channel 222 of the outer sleeve 202. The linkage method can be a gear combined with a rack, an electromagnetic spring, a linear stepping motor, etc. In this embodiment, the tip 204 is vertical. A pair of proximal electrodes 212, a pair of distal electrodes 214 and one or more injection side holes 213 are provided on the tip 204. An electrode wire inlet 220 is also provided in the handle 201, and an electrode wire 215 is introduced into the electrodes 212 and 214 through the electrode wire inlet 220.

[0078] In this embodiment, a slide groove or guide rail 218 is provided in the outer sleeve 202, and a protrusion (e.g., ball) 217 ​​that matches the slide groove or guide rail 218 is provided on the core 203. In use, the user drives the core 203 to rotate laterally relative to the outer sleeve 202 by moving the control component 208 (e.g., a mechanical knob and a gear rack) on the core 203, thereby the protrusion 217 on the core 203 moves distally along the slide groove 218 in the outer sleeve 202, thereby driving the core 203 to move forward (i.e., distally) in the slide groove 218 in a spiral trajectory. During the process of the core 203 moving forward in a spiral shape, the tip 204 on the distal side of the core 203 rotates around the longitudinal axis of the core 203, so that after the negative pressure suction cup 210 stretches the epicardium at the target ablation tissue and fixes it at the notch 211, the tip 204 can overcome the tension of the epicardium more quickly and penetrate into the target ablation tissue more easily, thereby avoiding complications of puncturing the heart wall caused by the rebound of an ordinary needle after puncturing the epicardium.

[0079] Fig.13 FIG. 2 is a left cross-sectional view of a second embodiment 200 of the myocardial ablation device of the present invention. Fig.13 As shown, a liquid injection pipeline 216 is provided on the core 203 , the proximal end of the liquid injection pipeline 216 is connected to the liquid injection interface 205 , and the distal end is connected to the third hollow pipe 223 of the core 203 . Fig.12 and 13 The other components of the illustrated embodiment have the same functions as the corresponding components in embodiment 100 and are not described in detail here.

[0080] Fig.14 FIG. 2 is a schematic diagram of the operation of the second embodiment 200 of the myocardial ablation device of the present invention. The operation process of the myocardial ablation device 200 is substantially similar to the operation process of the myocardial ablation device 100 described above, and will not be described in detail herein. Fig.14Shown is a schematic diagram of the myocardial ablation device 200 in the fourth working state. For the judgment of the target depth, those skilled in the art can make an artificial judgment based on experience, for example, preliminary experiments in experimental animals, or based on the experience of autopsy. Preferably, it can be judged based on the scale 209 on the tip 204. More preferably, the outer sleeve 202 is transparent, so as to facilitate the observation of the scale 209 on the tip 204 of the core 203. In the fourth working state, as described above, the tip 204 has penetrated the epicardium and reached the target depth. At this time, the chemical ablation agent is injected through the injection interface 205, and the chemical ablation agent enters the target ablation tissue through the injection interface 205, the injection pipeline 216, the core 203, the tip 204, and the injection side hole 213, and chemical ablation is performed on the target ablation myocardial tissue 32. When ablation is performed, the proximal electrode 212 and the distal electrode 214 are in contact with the myocardial tissue on both sides of the injection side hole 213, respectively, so that the ECG activity before, during and after ablation can be measured at the location. The ECG activity before, during and after ablation at the location measured can be transmitted to the processor for ECG signal processing and displayed on the display by connecting the electrode wire 215 to an external device such as a display and a processor. If the electrode wire 215 is connected to a stimulator, the stimulator can also send electrical stimulation to the myocardial tissue at the contact site of the proximal electrode 212 and the distal electrode 214, and record the ECG activity, so as to perform electrophysiological examination of cardiac lesions and immediately verify the ablation effect.

[0081] Fig.15 It is a front cross-sectional view of the third embodiment 300 of the myocardial ablation device of the present invention. The myocardial ablation device 300 includes a handle 301, an outer sleeve 302 and a core 303. The handle 301 includes an outer shell and is arranged on the proximal side of the myocardial ablation device 300, accommodating the proximal end of the outer sleeve 302 and the proximal end of the core 303. A negative pressure suction line 307 is provided on the core 303, and a negative pressure connection hole 306 is provided on the negative pressure suction line 307 for connecting a vacuum generating device (not shown in the figure). The outer sleeve 302 has a first hollow channel 321 and a second hollow channel 322, and the first hollow channel 321 is connected to the negative pressure suction line 307 at the proximal end, and a negative pressure suction cup 310 is provided at the distal end of the outer sleeve 302, and the negative pressure suction cup 310 includes a side wall and one or more negative pressure suction ports (not shown in the figure, see Figure 6 and Figure 7), a notch 311 is also provided on the distal side wall 319 of the negative pressure suction cup 310. The core 303 has a third hollow pipe 323, and a liquid injection interface 305 is provided at the proximal end of the core 303 for connecting a liquid supply source. The core 303 is also provided with a movement control component 308 for controlling the movement of the core 303 along the second hollow pipe 322 of the outer sleeve 302. The distal end of the core 303 has a tip 304, and a scale 309 is also provided on the tip 304 to facilitate the operator to judge the depth of the tip 304 piercing the target ablation myocardial tissue.

[0082] exist Fig.15 In the embodiment shown, the tip 304 is vertical. A pair of proximal electrodes 312, a pair of distal electrodes 314 and one or more injection side holes 313 are provided on the tip 304. An electrode wire inlet 320 is also provided in the handle 301, and an electrode wire 315 is introduced into the electrodes 312 and 314 through the electrode wire inlet 320.

[0083] In this embodiment, an internal thread 318 is provided in the outer sleeve 302, and an external thread 317 that matches the internal thread 318 is provided on the core 303. In use, the user rotates the movement control component 308 on the core 303 (for example, a dial or other structure that can rotate counterclockwise or clockwise), thereby driving the core 303 to rotate laterally relative to the outer sleeve 302, whereby the external thread 317 on the core 303 moves distally along the internal thread 318 in the outer sleeve 302, thereby driving the core 303 to move forward (i.e., distally) in a spiral trajectory. As the core 303 moves forward in a spiral shape, the tip 304 on the distal side of the core 303 rotates around the longitudinal axis of the core 303. In this way, after the negative pressure suction cup 310 stretches the epicardium at the target ablation tissue and fixes it in the notch 311, the tip 304 can overcome the tension of the epicardium more quickly and penetrate into the target ablation tissue more easily, thereby avoiding complications of puncturing the heart wall caused by the rebound of an ordinary needle after puncturing the epicardium.

[0084] Fig.16 FIG. 3 is a schematic diagram of the operation of the third embodiment 300 of the myocardial ablation device of the present invention. The operation process of the myocardial ablation device 300 is substantially similar to the operation process of the myocardial ablation device 100 described above, and will not be described in detail here. Fig.16Shown is a schematic diagram of the myocardial ablation device 300 in the fourth working state. For the judgment of the target depth, those skilled in the art can make an artificial judgment based on experience, for example, preliminary experiments in experimental animals, or based on the experience of autopsy. Preferably, it can be judged based on the scale 309 on the tip 304. More preferably, the outer sleeve 302 is transparent, so that it is easy to observe the scale 309 on the tip 304 of the core 303. In the fourth working state, as described above, the tip 304 has penetrated the epicardium and reached the target depth. At this time, the chemical ablation agent is injected through the injection interface 305, and the chemical ablation agent enters the target ablation tissue through the injection interface 305, the core 303, the tip 304, and the injection side hole 313 to chemically ablate the target ablation myocardial tissue. When ablation is performed, the proximal electrode 312 and the distal electrode 314 are in contact with the myocardial tissue on both sides of the injection side hole 313, respectively, so that the ECG activity before, during and after ablation can be measured at the location. The ECG activity before, during and after ablation at the location measured can be transmitted to the processor for ECG signal processing and displayed on the display by connecting to an external device such as a display and a processor through the electrode wire 315. If the electrode wire 315 is connected to a stimulator, the stimulator can also send electrical stimulation to the myocardial tissue at the contact site of the proximal electrode 312 and the distal electrode 314, and record the ECG activity, so as to perform electrophysiological examination of cardiac lesions and immediately verify the ablation effect.

[0085] Although specific embodiments of the present invention have been illustrated and described, it will be apparent to those skilled in the art that various other changes and modifications may be made without departing from the spirit and scope of the present invention. Therefore, all such changes and modifications within the scope of the present invention are intended to be included in the appended claims.

Claims

1. A myocardial ablation device, comprising a handle, an outer sleeve and a core, characterized in that: The handle comprises a shell and is arranged at the proximal side of the myocardial ablation device, accommodating the proximal end of the outer sleeve and the proximal end of the core, wherein a negative pressure suction pipeline is arranged in the handle, and a negative pressure connection hole is arranged on the negative pressure suction pipeline for connecting a vacuum generating device; The outer sleeve has a first hollow pipe and a second hollow pipe, the proximal end of the first hollow pipe is connected to the negative pressure suction pipeline, and the distal end is provided with a negative pressure suction cup, and the negative pressure suction cup includes a side wall and one or more negative pressure suction ports; The core has a third hollow pipe, a liquid injection pipeline, a liquid injection interface and a movement control component are arranged at the proximal end of the core, and a tip is arranged at the distal end, wherein the liquid injection pipeline is connected to the third hollow pipe and the proximal end of the liquid injection pipeline is the liquid injection interface, and the movement control component is arranged on the core to control the movement of the core along the second hollow pipe of the outer sleeve; The one or more negative pressure suction ports are distributed along the circumference of the cross section of the first hollow pipe of the outer sleeve; An arc-shaped notch is arranged on the distal side wall of the negative pressure suction cup.

2. The myocardial ablation device according to claim 1, characterized in that One or more pairs of electrodes are arranged on the tip of the core, and an electrode wire inlet is also arranged on the outer shell of the handle for introducing electrode wires, and the electrode wires are configured to be electrically connected to the electrodes.

3. The myocardial ablation device according to claim 1, characterized in that A side hole and / or scales are provided at the tip.

4. The myocardial ablation device according to claim 3, characterized in that The tip is a vertical tip, an arc-shaped tip with a side bend, or a spiral tip.

5. The myocardial ablation device according to claim 4, characterized in that The tip is an arc-shaped tip with a side bend.

6. The myocardial ablation device according to any one of claims 1 to 5, characterized in that The movement control component includes a movement controller and a linkage member.

7. The myocardial ablation device according to any one of claims 1 to 5, characterized in that The inner wall of the outer sleeve is provided with a spiral groove, and a pulley or a ball is arranged on the outer wall of the core. The size of the pulley or the ball is suitable for sliding in the spiral groove.

8. The myocardial ablation device according to any one of claims 1 to 5, characterized in that The inner wall of the outer sleeve is provided with an internal thread, and the outer wall of the core is provided with an external thread matching with the internal thread.

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