WO2023123472A1

WO2023123472A1 - Adjustable guide sheath, ablation device, ablation system and myocardial ablation method

Info

Publication number: WO2023123472A1
Application number: PCT/CN2021/143959
Authority: WO
Inventors: 张庭超; 丘信炯; 李阳; 王柏栋; 庄镇平
Original assignee: 杭州诺沁医疗器械有限公司
Priority date: 2021-12-31
Filing date: 2021-12-31
Publication date: 2023-07-06
Also published as: WO2023124180A1; CN118541185A

Abstract

An adjustable guide sheath (11), an ablation device (1), an ablation system (100), and a myocardial ablation method, relating to the technical field of medical devices. The adjustable guide sheath (11) is used, and the guide sheath (11) comprises a pre-shaped sheath tube, so that the guide sheath (11) in a natural state has a shape matching a corresponding intervention path of a heart. Before intervention of the guide sheath (11) into a human body, an external force is applied to the sheath tube of the guide sheath (11) for straightening; and after the guide sheath tube enters the human body and reaches a target position, the external force is removed so that the sheath tube is in a natural state, and therefore, the shape of the guide sheath (11) is maintained without external force.

Description

Adjustable introducer sheath, ablation device, ablation system and myocardial ablation method

technical field

The invention relates to the technical field of medical devices, in particular to an adjustable guide sheath, an ablation device, an ablation system and a myocardial ablation method.

Background technique

Hypertrophic Cardiomyopathy (HCM) is a common autosomal dominant cardiovascular disease. The main manifestation of HCM is the hypertrophy of one or more segments of the Left Ventricle (LV). The main treatment methods are: Drug therapy, Surgical septalmyectomy, Ventricular septal ablation.

In the prior art, ablation catheters are used to enter the heart cavity through blood vessels for ablation of the interventricular septum, but the existing ablation catheters have the following defects:

1. Since the human blood vessel path is an irregular path, that is, the catheter with the ablation component needs to constantly apply external force to adjust the shape of the catheter when passing through the human blood vessel path, so that it can pass through the human blood vessel path and reach a position closer to the tissue to be ablated , after the catheter reaches the above position, the ablation assembly can ablate the interventricular septum. During this process, the catheter needs to maintain its own position, that is, it needs to constantly apply external force to the catheter to maintain its position. However, during the treatment process, the operator is It is not possible to apply external force to the catheter at all times to keep it in place during ablation therapy.

2. In addition, there is another way in the prior art. For example, the patent with the notification number CN209711827U discloses an ablation needle assembly and an ablation system. The ablation needle assembly includes a hollow outer sleeve and an ablation needle. The outer sleeve The movable sheath is outside the main body of the ablation needle; when disassembled, the sheath needle can be used as a channel for other operations such as biopsy, which avoids repeated punctures and reduces tissue damage. However, it still has some limitations:

a. Percutaneous transthoracic puncture is required. The ablation needle needs to pass through the skin, subcutaneous, chest cavity, pericardium, and myocardium. Tissue damage is unavoidable. What's more, the coronary artery is distributed on the outside of the heart. This technique is used in puncturing the epicardium. Accidental puncture of a larger branch of a coronary artery can lead to pericardial effusion or even cardiac tamponade, which can be fatal;

b. Furthermore, the ablation needle used in this technology is a rigid needle, which cannot be flexibly and controllably changed to achieve the effect of multi-point ablation, which is not conducive to fully ablation of hypertrophic myocardial tissue.

Contents of the invention

In order to overcome at least one defect of the above-mentioned prior art, the first object of the present invention is to provide an adjustable introducer sheath to optimize the problem that the existing introducer sheath needs external force to maintain its shape after entering the human body , improve the convenience of use.

The second object of the present invention is to provide an ablation device, which provides a minimally invasive treatment method for ablation of lesion tissue by puncturing the endocardium of a human heart through a catheter.

The third object of the present invention is to provide an ablation device to optimize the inconvenience of using the existing ablation device and improve the convenience of use.

The fourth object of the present invention is to provide a myocardial ablation method to optimize the inconvenience of existing myocardial ablation methods and improve treatment efficiency.

The technical scheme that the present invention adopts for solving its problem is:

According to one aspect of the present invention, the present invention provides an adjustable introducer sheath, including a guide sheath and an adjustment member, and the guide sheath includes a first tube section, a second tube section and The third pipe section; in the natural state: the second pipe section first extends away from the first pipe section, and then extends towards the direction close to the first pipe section, and the third pipe section extends toward the direction close to or away from the first pipe section; the first pipe section and The second pipe section is located on the first plane, and the third pipe section is located on the first plane or on a second plane having an included angle with the first plane; the adjustment member is connected to the guide sheath, which is used to control the guide sheath to self-align The state gradually changes to the natural state.

In some possible implementations, in a natural state, the first pipe segment is straight, or its proximal end is straight and its distal end is curved.

In some possible implementations, in a natural state, the second pipe segment is a curve, and its middle part is arched relative to the two ends.

In some possible implementations, in a natural state, the third pipe section is a curve, and when extending toward the direction close to the first pipe section, the curvature of the proximal part of the third pipe section is smaller than the curvature of the distal part of the third pipe section; or, the third pipe section When the pipe section extends away from the first pipe section, the curvature of the proximal portion of the third pipe section is greater than the curvature of the distal portion of the third pipe section.

According to another aspect of the embodiment of the present invention, this embodiment proposes another adjustable introducer sheath, including a guide sheath and an adjustment member, and the guide sheath includes a first tube section that communicates sequentially from the proximal end to the distal end , the second pipe section and the third pipe section; in the natural state, the second pipe section extends away from the first pipe section, and the third pipe section extends toward the direction close to the first pipe section; the first pipe section and the second pipe section are located on the first plane, The third pipe segment is located on the first plane or on a second plane having an included angle with the first plane; the adjusting member is connected with the guiding sheath, and is used for controlling the guiding sheath to gradually change from the straightened state to the natural state.

In some possible implementations, in a natural state, the second pipe section is a curve, and the curvature of the proximal portion thereof is greater than the curvature of the distal portion of the second pipe section.

In some possible implementation manners, in a natural state, the third pipe section is a curve, and the curvature of the proximal portion thereof is smaller than the curvature of the distal portion of the third pipe section.

In some possible implementations, the curvatures of the first pipe section, the second pipe section and the third pipe section are different, the curvature of the second pipe section is greater than that of other pipe sections, and the curvature of the third pipe section is greater than that of the first pipe section.

In some possible implementation manners, the curvature of the second pipe segment is a constant value.

In some possible implementation manners, the curvature of the second tube segment first increases and then decreases from its proximal end to its distal end.

In some possible implementation manners, the angle between the first plane and the second plane is a, where 10°≤a≤45°.

According to yet another aspect of the embodiments of the present invention, this embodiment proposes an ablation device, including a delivery assembly and an ablation assembly; the ablation assembly is movably mounted in the delivery assembly, and the ablation assembly includes an ablation needle; the delivery assembly is used for transcatheter intervention In the heart, after the ablation needle passes through the delivery assembly, it enters the myocardial tissue by puncturing the endocardium, so as to ablate the myocardial tissue.

In some possible implementations, the delivery assembly includes an introducer sheath and an adjustable curved sheath; the adjustable curved sheath is movably threaded in the guide sheath; and the ablation needle is movably threaded in the adjustable curved sheath.

In some possible implementations, the introducer sheath has a shape matching the intervening cardiac septal channel in a natural state or after being bent.

In some possible implementations, the introducer sheath is any one of the above adjustable introducer sheaths.

According to yet another aspect of the embodiments of the present invention, this embodiment proposes an ablation device, including a delivery assembly and an ablation assembly; the delivery assembly includes any of the above adjustable guide sheaths and adjustable curved sheaths; the adjustable curved sheath moves The guide sheath is threaded in the guide sheath of the adjustable guide sheath; the ablation component is movably threaded in the adjustable curved sheath; the guide sheath has a shape matching the intervening heart interventricular septal channel in a natural state.

In some possible implementation manners, the ablation assembly includes an ablation needle, and the ablation needle is used to ablate myocardial tissue.

In some possible implementations, the ablation needle is directed to different positions of the myocardial tissue by adjusting the distal end of the adjustable curved sheath.

In some possible implementations, the adjustable curved sheath includes a main body section, a shaping section and a bending section that are sequentially connected from the proximal end to the distal end. The main body section is adapted to the first tube section, and the shaping section is connected to the second tube section, The third pipe section is suitable; the distal end of the shaping section extends toward the first direction, and the bending section extends toward the second direction opposite to the above-mentioned first direction.

In some possible implementations, the ablation needle includes a needle body on which an ablation segment is at least partially disposed.

In some possible embodiments, the needle body is a hollow tubular structure; at least one perfusion hole is provided on the needle body, and the perfusion hole communicates with the inside of the needle body.

In some possible implementations, a circulation channel through which the cooling liquid circulates is provided in the ablation section.

In some possible implementations, the effective ablation length of the ablation segment can be adjusted.

In some possible implementation manners, an insulating layer is arranged on the needle body, and the insulating layer is integrally arranged with the needle body.

In some possible implementations, the ablation segment is detachably connected to the needle body.

In some possible implementations, the needle body is covered with an insulating sleeve, and the insulating sleeve and the needle body can slide relative to each other.

In some possible implementations, in a natural state, the shape of the first tube segment corresponds to the shape of the descending aorta; the shape of the second tube segment corresponds to the shape of the aortic arch; the shape of the third tube segment corresponds to the shape of the ascending aorta correspond.

In some possible implementations, in a natural state, the shape of the first tube segment corresponds to the shape of the inferior vena cava; the shape of the second tube segment corresponds to the channel from the inferior vena cava to the position of the tricuspid valve in the right atrium close to the right atrium The shape corresponds; the shape of the third tube segment corresponds to the shape of the channel from the location of the tricuspid valve in the right atrium near the right atrium to the right ventricle near the interventricular septum.

In some possible implementations, in a natural state, the shape of the first tube segment corresponds to the shape of the inferior vena cava; the shape of the second tube segment corresponds to the shape of the channel from the inferior vena cava and right atrium through the interatrial septum to the left atrium Corresponding; the shape of the third tube segment corresponds to the shape of the channel from the position of the mitral valve in the left atrium close to the left atrium.

In some possible embodiments, the myocardial tissue is the interventricular septum.

According to yet another aspect of the embodiments of the present invention, this embodiment provides an ablation system, including: any one of the above ablation devices; and an ablation energy generating device connected to the ablation device to provide energy for the ablation device.

In some possible implementations, the system further includes a perfusion device, which is used to provide liquid for the ablation device.

In some possible implementations, the ablation device includes an ablation needle, and at least one perfusion hole is provided on the ablation needle, or a circulation channel for fluid circulation is provided in the ablation needle.

According to yet another aspect of the embodiments of the present invention, this embodiment proposes a myocardial ablation method, the method including the following steps:

S1. Insert the catheter into the heart until the distal opening of the catheter touches the myocardial tissue;

S2. Extending the ablation needle from the opening at the distal end of the catheter and piercing into the myocardial tissue and delivering ablation energy for ablation.

S1. Select the corresponding adjustable guide sheath according to the path involved in the human heart, and the adjustable guide sheath is a pre-shaped structure;

S2. Straighten the adjustable guide sheath and insert it into the corresponding path;

S3. Reduce the external force applied to the adjustable guide sheath according to the shape of the path until the adjustable guide sheath returns to its natural state;

S4, protruding the distal end portion of the adjustable curved sheath from the distal opening of the adjustable introducer sheath so that the distal opening of the adjustable curved sheath touches the target tissue;

S5, protruding the ablation needle from the distal opening of the adjustable curved sheath and piercing into the target tissue and delivering ablation energy for ablation;

The adjustable introducer sheath is any one of the above adjustable introducer sheaths.

According to yet another aspect of the embodiments of the present invention, this embodiment proposes a myocardial ablation method, which is characterized in that the method includes the following steps:

S1. Select the corresponding adjustable introducer sheath according to the path involved in the human heart, and insert the adjustable introducer sheath into the path until the adjustable introducer sheath reaches the target position;

S2. Protruding the distal part of the adjustable curved sheath from the distal opening of the adjustable introducer sheath so that the distal opening of the adjustable curved sheath touches the myocardial tissue;

S3, protruding the ablation needle from the distal opening of the adjustable curved sheath and piercing into the myocardial tissue and delivering ablation energy for ablation;

In some possible implementations, in step S1, before inserting the adjustable introducing sheath into the path, the adjustable introducing sheath is firstly adjusted to be straight.

In some possible implementations, the path for myocardial ablation is one of path a, path b, and path c;

Route a: reach the left ventricle through the femoral artery and aortic arch;

Route b: through the inferior vena cava, right atrium, to the right ventricle;

Route c: through the inferior vena cava, right atrium, atrial septum, and left atrium to the left ventricle.

It can be seen from the above technical solutions that the embodiments of the present invention have at least the following advantages and positive effects:

1) After the adjustable guide sheath enters the body and reaches the target position, its sheath is in a natural state, and no external force is required to maintain the shape of the guide sheath;

2) It can intervene in the human heart through the catheter to ablate the myocardial tissue by puncturing the endocardium, realizing minimally invasive treatment;

3) By adjusting the shape of the distal end of the bending sheath, the ablation needle can be directed to different positions of the myocardial tissue, which is convenient for multi-point ablation;

4) The ablation needle in the ablation system can adjust the effective length of the ablation segment according to the needs of the ablation point, so as to meet the needs of actual use.

Description of drawings

Fig. 1 is a schematic diagram of the structure of the guide sheath of the introducer sheath in one embodiment of the present invention;

2 is a schematic diagram of the guiding sheath of the guiding sheath in an aortic vessel in one embodiment of the present invention;

3 is a schematic diagram of the guide sheath of the guide sheath adjusted in the aortic vessel in one embodiment of the present invention;

Fig. 4 is the sectional view of M-M plane among Fig. 3;

Fig. 5 is a schematic diagram of the distal end of the guiding sheath close to the aortic valve in one embodiment of the present invention;

Fig. 6 is a schematic diagram of the structure of the guide sheath of the introducer sheath in one embodiment of the present invention;

Fig. 7 is a schematic diagram of another perspective of Fig. 6;

Fig. 8 is a schematic diagram of the structure of the guiding sheath of the guiding sheath in one embodiment of the present invention;

Fig. 9 is a schematic diagram of the distal end of the adjustable curved sheath tube of the introducer sheath entering the right ventricle in one embodiment of the present invention;

Fig. 10 is a schematic structural diagram of the adjustable curved sheath tube of the introducer sheath in one embodiment of the present invention;

Figure 11 is a side view of Figure 10;

Figure 12 is a top view of Figure 10;

Fig. 13 is a schematic structural diagram of the adjustable curved sheath tube of the introducer sheath in one embodiment of the present invention;

Fig. 14 is a schematic diagram of the distal end of the adjustable sheath tube of the introducer sheath entering the left atrium through the right atrium in one embodiment of the present invention;

Fig. 15 is a schematic diagram of the structure of the introducer sheath of the introducer sheath in one embodiment of the present invention;

Figure 16 is a side view of Figure 15;

Figure 17 is a top view of Figure 16;

Fig. 18 is a schematic diagram of the sheath tube structure of the bending sheath in one embodiment of the present invention;

Fig. 19 is a structural schematic diagram of the sheath tube distal end of the bending sheath protruding from the distal end of the introducer sheath through the aortic valve and entering the left ventricle in one embodiment of the present invention;

Figure 20 is a sectional view of the N-N plane in Figure 19;

Fig. 21 is a schematic diagram of the direction adjustment of the distal end of the guide sheath of the introducer sheath and the distal end of the sheath of the bend-adjusting sheath in the aortic vessel in one embodiment of the present invention;

Fig. 22 is a schematic diagram of the sheath tube of the adjustable sheath entering the left ventricle in one embodiment of the present invention;

Fig. 23 is a schematic diagram of the adjustment direction of the distal end of the sheath of the bending sheath in one embodiment of the present invention;

Fig. 24 is a schematic diagram of an ablation needle puncturing the endocardium through the guiding sheath and the bending sheath to ablate myocardial tissue in one embodiment of the present invention;

Figure 25 is a sectional view of the H-H plane in Figure 24;

Figure 26 is a schematic diagram of the distal end of the sheath tube entering the right ventricle of the bending sheath in one embodiment of the present invention;

Fig. 27 is a schematic diagram of the adjustment direction of the distal end of the guiding sheath of the introducing sheath and the distal end of the sheath of the bending adjustment sheath in one embodiment of the present invention;

Fig. 28 is a schematic diagram of an ablation needle guided by an introducer sheath and a bending sheath to puncture the endocardium to ablate myocardial tissue in one embodiment of the present invention;

Fig. 29 is a schematic diagram of the sheath tube distal end of the bending sheath passing through the mitral valve and entering the left ventricle in one embodiment of the present invention;

Fig. 30 is a schematic diagram of the direction of adjustment of the distal end of the guiding sheath of the introducing sheath and the distal end of the sheath of the bending adjustment sheath in one embodiment of the present invention;

Fig. 31 is a schematic diagram of an ablation needle puncturing the endocardium through the guiding sheath and the bending sheath to ablate myocardial tissue in one embodiment of the present invention;

Fig. 32 is a schematic structural view of the ablation needle in one embodiment of the present invention;

Fig. 33 is a schematic diagram of another viewing angle of Fig. 32;

Figure 34 is a sectional view of the A-A plane in Figure 33;

Figure 35 is a sectional view of the B-B plane in Figure 33;

Fig. 36 is a sectional view of another embodiment of the B-B side in Fig. 33;

Fig. 37 is a schematic diagram of a state in which the effective length of the ablation section of the ablation needle is short in one embodiment of the present invention;

Fig. 38 is a schematic cross-sectional view of an ablation needle with a longer effective length of the ablation section in one embodiment of the present invention;

Fig. 38 is a schematic structural view of the ablation system in one embodiment of the present invention.

Among them, the reference signs have the following meanings:

100. Ablation system; 1. Ablation device; 2. Ablation energy generating device; 3. Perfusion device; 31. Electrolyte solution; 11. Guide sheath; 111. First tube section; 112. Second tube section; 113. Third tube section ;12, adjustable curved sheath; 121, main body section; 122, shaping section; 123, adjustable bending section; 13, ablation needle; 131, needle tip; 132, needle body; 132a, perfusion hole; 132b, inner cavity; 133 , insulating layer; 134, ablation segment; 14, handle; 41, descending aorta; 42, aortic arch; 43, ascending aorta; 5, aortic valve; 61, left ventricle; 62, right ventricle; 63, interventricular septum; 64. Left ventricular outflow tract; 71. Inferior vena cava; 81. Right atrium; 82. Left atrium; 91. First plane; 92. Second plane; 10. Atrial septum.

Detailed ways

For better understanding and implementation, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention.

It should be noted that, in the field of medical devices, the end close to the operator is usually referred to as the "proximal end", and the end far away from the operator is referred to as the "distal end".

In the description of the present invention, it should be noted that the terms "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", The orientation or positional relationship indicated by "bottom", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying the referred device or positional relationship. Elements must have certain orientations, be constructed and operate in certain orientations, and therefore should not be construed as limitations on the invention.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the technical field of the invention. The terms used herein in the description of the present invention are for the purpose of describing specific embodiments only, and are not intended to limit the present invention.

Please refer to Figs. 1 to 5 and Figs. 18 to 25, the present invention discloses an adjustable introducer sheath 11, including a guide sheath and an adjustment member (not marked in the figure), wherein the guide sheath is The prefabricated shape of the tube has certain rigidity and flexibility. The adjustment member adjusts the shape of the guide sheath by applying force to the guide sheath. After the force of the adjustment member is eliminated, the guide sheath can gradually return to its natural position. state, the introducer sheath has a hollow lumen.

The guiding sheath includes a first tube section 111 , a second tube section 112 and a third tube section 113 which are sequentially communicated from the proximal end to the distal end.

As a possible implementation, in the natural state, the first pipe section 111, the second pipe section 112 and the third pipe section 113 are all located on the same plane, and the second pipe section 112 first extends away from the first pipe section, and then moves closer to The direction of the first pipe section 111 extends, and the third pipe section 113 extends towards the direction close to the first pipe section 111, so that the first pipe section 111 matches the shape of the descending aorta 41 of the human body, and the second pipe section 112 matches the shape of the aortic arch 42 of the human body. The shape of the third pipe section 113 is adapted to the shape of the ascending aorta 43 of the human body, and the distal end of the third pipe section 113 is close to the middle part of the aortic valve 5 of the human body. Therefore, the guiding sheath in this embodiment has a predetermined shape in a natural state, which matches the shape of the human aorta, and is convenient for entering the left ventricle to treat myocardial tissue.

The adjusting member is connected with the guiding sheath, and is used for adjusting the shape of the guiding sheath. By operating the adjusting member, the guiding sheath can be switched between a straightened state and a natural state. The above-mentioned straightening state refers to a state in which the shape of the adjustable curved sheath tube is approximated to a straight line by the above-mentioned adjusting member, that is, the shape of the adjustable curved sheath tube is changed from the natural state by applying an external force to the adjustable curved sheath tube by operating the adjusting member. The curved shape transforms into a nearly straight shape. Therefore, before intervening in the human body, the guiding sheath should be adjusted to the straightening state, and as the guiding sheath goes deeper, the self-aligning state will gradually change to the natural state, and finally return to the natural state.

By setting in this way, the guide sheath in the natural state fits the shape of the aorta, wherein the shape of the first tube section 111 is similar to or the same as that of the descending aorta 41, and the shape of the second tube section 112 is similar to or equal to that of the aortic arch 42. Similarly, the shape of the third pipe section 113 is similar to that of the ascending aorta 43, so that when the guide sheath is inserted into the aorta and restored to its natural state, the distal portion of the third pipe section 113 will be close to the aortic valve 5 middle part.

In practical application, before the guiding sheath enters the aorta, the operator needs to apply external force to the above-mentioned first tube section 111, second tube section 112 and third tube section 113 through the adjustment member to adjust the guiding sheath to a straight line Or approximately straight line, in the process of the guiding sheath passing through the descending aorta 41, the aortic arch 42 and reaching the ascending aorta 43, the external force exerted by the adjustment member is gradually reduced, so that the above-mentioned first tube section 111, second tube section 112 and third tube section 112 The tube section 113 gradually returns to the natural state, so that the interference between the guide sheath and the blood vessel wall of the aorta is reduced, and the damage to the blood vessel wall caused by the friction of the guide sheath is reduced; and, when the guide sheath reaches the target position, there is no need to The shape of the introducer sheath can be maintained by applying external force to the introducer sheath.

Specifically, the third tube section 113, the second tube section 112, and the first tube section 111 of the guiding sheath are located on the same spatial plane, and the second tube section 112 first extends away from the first tube section 111 and then toward the first tube section 111. The pipe section 111 extends in the direction, and the third pipe section 113 extends in the direction of the first pipe section 111 , that is, the third pipe section 113 extends in the direction C (pointing to the direction of the first pipe section 111 ).

Straightening is performed by controlling the adjusting member of the guiding sheath, so that the guiding sheath is in a straightening state, that is, applying an external force to the first tube section 111, the second tube section 112 and the third tube section 113 of the guiding sheath 11 to adjust it to A straight line or an approximate straight line.

In the prior art, the guide sheath is a straight line or an approximate straight line in its natural state, and the operator applies external force through the handle to adjust the bending degree of the distal end of the guide sheath, and the guide sheath becomes the target shape Afterwards, the state of the handle needs to be maintained; and in this embodiment, the guiding sheath is in a predetermined shape in a natural state, that is, the above-mentioned third tube section 113, the second tube section 112 and the first tube section 111 are located in the same space plane, and the above-mentioned The second pipe section 112 first extends away from the first pipe section 111 and then extends toward the first pipe section 111, and the third pipe section 113 extends toward the first pipe section 111 before the guiding sheath enters the aorta , the operator applies an external force through the adjustment member to adjust the guide sheath to a straight line or an approximate straight line, and gradually reduces the guide sheath of the adjustment member during the process of passing through the descending aorta 41, the aortic arch 42 and reaching the ascending aorta 43. The straightening external force exerted by the introducing sheath tube makes the first tube section 111, the second tube section 112 and the third tube section 113 of the guiding sheath gradually return to the natural state. The distal end of the three tube sections 113 reaches the ascending aorta 43 and its opening points to the direction of the aortic valve 5 close to the mitral valve, the second tube section 112 is located in the aortic arch 42, and the first tube section 111 is located in the descending aorta 41, and the operation The operator does not need to apply any external force to the adjustment member, thereby improving the operation efficiency, preventing the operator from pulling the adjustment member for a long time, and reducing the possibility of misoperation.

The shape of the third tube section 113 in the natural state can ensure that the distal end of the third tube section 113 can move in two directions of being close to the interventricular septum 63 or away from the interventricular septum 63, thereby facilitating the subsequent selection of different puncture sites for dressing A medical device within the introducer sheath, such as the adjustable curved sheath 12, provides different treatment positions.

The adjustment member includes a handle assembly and a traction piece, wherein the handle assembly includes an inner core, a shell sleeved on the inner core, a bending adjustment component rotatably sleeved on the inner core, a fixed seat and a driving piece arranged at the proximal end of the inner core , wherein the proximal end of the first pipe section 111 is fixedly connected to the inner core, the driving member is fixedly connected to the inner core, and the driving member is rotatably connected to the fixing seat, the pulling member includes a pulling wire and an anchoring ring arranged at the distal end of the pulling wire, wherein the anchoring The ring is fixed to the adjustable bending part in the first pipe section 111, the second pipe section 112 and the third pipe section 113, and the proximal end of the pulling wire is connected to the bending adjustment part, so that the pulling wire pulls the guide sheath by operating the bending adjustment part. Straight, reduce the traction applied to the guiding sheath in the bending part, so that the guiding sheath can return to its natural state by itself.

The bending adjusting part includes a sliding part and a bending adjusting part sleeved on the sliding part. The proximal end of the pulling wire is fixedly connected to the sliding part. The bending parts are screwed together, and the sliding part is driven to move along the axial direction of the inner core by rotating the bending adjustment part, so as to drive the pulling wire to pull the guiding sheath to bend or restore the guiding sheath to straightness.

For the specific adjustment process of the adjusting member to the guiding sheath, reference may be made to the Chinese patent with the publication number of CN214286246U in the prior art document, which will not be repeated here.

Referring to Fig. 3 and Fig. 4, further, the rotation of the guiding sheath in the circumferential direction can be controlled by the adjusting member to control the swing of the third tube segment 113 to control the direction of the opening at the distal end of the third tube segment 113; specifically, when adjusting When the member controls the guiding sheath to rotate clockwise, the third pipe section 113 will swing to the side of the aortic arch 42 near the Anterior (that is, the side of the aortic arch 42 close to the chest cavity). It can be known that when the controlling guiding sheath moves along the When turning counterclockwise, the third tube section 113 will swing to the side of the aortic arch 42 close to the Posterior (that is, the side of the aortic arch 42 close to the back).

By controlling the swing of the third tube section 113, it is possible to control the different orientations of the opening of the distal end of the third tube section 113, and then control the subsequent medical devices inserted in the guide sheath, such as the adjustable curved sheath 12 from the third The distal openings of the tube segments 113 protrude at different angles.

In some possible implementations, in a natural state, the first pipe segment 111 is a straight line.

In some possible implementations, the proximal end of the first pipe segment 111 is straight, and the distal end is curved.

In some possible implementations, the curved part of the third pipe segment 113 may adopt a regular or irregular curve, preferably a circular arc.

In some possible implementations, in a natural state, the second pipe segment 112 is a curve, and its middle part is arched relative to the two ends.

The second pipe section 112 can adopt a regular or irregular curve, and the second pipe section 112 is preferably a circular arc, so that the connection transition between the first pipe section 111 and the third pipe section 113 is smooth.

In some possible implementations, in a natural state, the third tube segment 113 is a curve, and the curvature of the proximal part of the third tube segment 113 is smaller than the curvature of the distal part of the third tube segment 113, that is to say, the degree of curvature of the distal part of the third tube segment 113 larger than the proximal portion. On the premise that the distal end portion of the second pipe segment 112 and the third pipe segment 113 extend toward the first pipe segment, the distal end portion of the third pipe segment 113 will move closer to the first pipe segment 111 .

Through the above setting, when the third pipe section 113 is located in the ascending aorta 43 in a natural state, the distal end of the third pipe section 113 is located near the middle part of the aortic valve and close to the side of the descending aorta 41, that is, the third pipe section 113 The distal end of the third pipe section 113 is far away from the interventricular septum, thereby increasing the distance from the distal end of the third tube section 113 to the interventricular septum 63, thereby increasing the selection range of the introducer sheath and the adjustable curved sheath.

In some possible implementations, the curvatures of the first pipe section 111, the second pipe section 112 and the third pipe section 113 are different, and the curvature of the second pipe section 112 is greater than the curvature of the first pipe section 111 and the third pipe section 113, and the curvature of the third pipe section 113 The curvature is greater than that of the first pipe section 111 .

In some possible implementations, the curvature of the second tube section 112 may remain unchanged, or may be set such that: from the proximal end to the distal end, the curvature of the second tube section 112 first increases and then decreases, or gradually increases.

When the curvature of the second tube section 112 remains unchanged, the second tube section 112 basically does not interfere with the aortic arch 42 , and the damage to the vessel wall is minimal.

When the curvature of the second tube segment 112 first increases and then decreases, the second tube segment 112 partially interferes with the aortic arch 42 and the area of conflict is small, and the force provided by the vessel wall to the second tube segment 112 can assist the guiding sheath to maintain its position .

When the curvature of the third tube segment 112 gradually increases, the second tube segment 112 partially conflicts with the aortic arch 42 and the conflict area is large, which can increase the force used for positioning the second tube segment 112 .

Please refer to Figures 6-7 and Figures 18-25. In some embodiments, some changes are made to the shape of the guiding sheath, and the only difference from the above-mentioned embodiments is:

In a natural state, the first tube section 111 and the second tube section 112 of the adjustable bend sheath are located on the first plane 91 , and the third tube section 113 is located on the second plane 92 having an included angle with the first plane 91 .

Specifically, considering that the aortic arch is not a planar structure, but presents a three-dimensional spatial structure, therefore, according to the actual shape of the aortic arch, in this embodiment, the third tube section 113 of the guide sheath, the second tube section 112 and the first pipe section 111 are also correspondingly arranged in a three-dimensional space structure, wherein the second pipe section 112 and the first pipe section 111 are located in the same plane M, and the third pipe section 113 is located in a plane L forming a certain angle with the plane .

According to the shape of the actual aortic arch 42, the bending direction C of the third pipe segment 113 should be adjusted toward the direction of the aortic arch 42 close to the chest of the human body, that is, the bending in the Anterior direction. Through the above settings, the guide sheath can be more suitable for the aortic arch The shape of the part.

In some possible implementation manners, the included angle between the first plane 91 and the second plane 92 is a, where 10°≤a≤45°.

Further, a is preferably 15°, 20°, 25°, 30°, 35° or 40°.

Please refer to Figs. 8-9, 26-28, some embodiments disclose another adjustable introducer sheath 11:

In the natural state, the first tube section 111, the second tube section 112 and the third tube section 113 of the guiding sheath 11 are all located on the same plane, and the second tube section 112 first extends away from the first tube section 111 and then toward the first tube section 111 The third pipe section 113 extends in a direction away from the first pipe section 111 .

By setting in this way, the guide sheath tube 11 in a natural state conforms to the shape from the inferior vena cava 71 through the right atrium 81 to the right ventricle 62, wherein the shape of the first tube section 111 is similar to or the same as that of the inferior vena cava 71, The shape of the second tube section 112 is similar to or identical to the connecting channel from the inferior vena cava 71 to the right ventricle 62 , and the third tube section 113 is located in the right ventricle 62 , wherein the distal end of the third tube section 113 is close to the interventricular septum 63 .

Before introducing the guide sheath 11 into the inferior vena cava 71, the operator applies an external force to the first pipe section 111, the second pipe section 112, and the third pipe section 113 of the guide sheath 11 through the adjustment member to adjust the guide sheath 11. It is a straight line or an approximate straight line. In the process of passing through the inferior vena cava 71, the right atrium 81, and reaching the right ventricle 62, the external force exerted by the adjustment member on the guide sheath 11 is gradually reduced, so that the first step of the guide sheath 11 The first tube section 111, the second tube section 112 and the third tube section 113 gradually return to the natural state, so that the interference between the guiding sheath tube 11 and the tissue wall of the right atrium 81 is reduced, and the damage to the tissue wall caused by the friction of the guiding sheath tube 11 is reduced ;

Moreover, since the guiding sheath 11 has the characteristic of self-recovery deformation, when the guiding sheath 11 reaches the target position, it can maintain its natural shape without applying external force to the guiding sheath 11 .

Specifically, the third pipe section 113, the second pipe section 112, and the first pipe section 111 of the guiding sheath are located on the same spatial plane, and the second pipe section 112 first extends away from the first pipe section 111 and then faces the first pipe section 111. Extending, the third pipe section 113 extends away from the first pipe section 111 .

In some possible embodiments, the third pipe section 113 may extend toward the direction J.

The guide sheath 11 is straightened by the adjustment member, so that the guide sheath 11 is in a straightened state, that is, an external force is applied to the first pipe section 111, the second pipe section 112 and the third pipe section 113 to adjust them to a straight line or Approximate to a straight line.

In the prior art, the guide sheath is a straight line or an approximate straight line in its natural state, and the operator applies external force through the handle to adjust the bending degree of the distal end of the guide sheath, and the guide sheath becomes the target shape After that, keep the handle.

In this embodiment, the guiding sheath is in a predetermined shape in a natural state, that is, the third tube section 113, the second tube section 112 and the first tube section 111 are located on the same space plane, and the second tube section 112 first moves away from the first tube section 111. After extending in the direction of the first pipe section 111, the third pipe section 113 extends away from the first pipe section 111. Before the guide sheath 11 enters the inferior vena cava 71, the operator needs to apply an external force through the adjustment member to adjust the guide sheath. The guiding sheath tube 11 is a straight line or an approximate straight line. In the process of passing through the inferior vena cava 71, the right atrium 81 and reaching the right ventricle 62, the external force of the adjustment member is gradually reduced, so that the first step of the guiding sheath tube 11 The pipe section 111, the second pipe section 112 and the third pipe section 113 gradually return to the natural state. At this time, the distal end of the third pipe section 113 is located in the right ventricle 62 and its opening points to the direction of the interventricular septum 63. The second pipe section 112 spans the lower The vena cava 71, the right atrium 81, and the right ventricle 62. The first tube section 111 is located in the inferior vena cava 71. In addition, the operator does not need to apply any external force to the handle. The shape of the third tube section 113 in the natural state can ensure the third tube section 113 The distal end moves in two directions: approaching the interventricular septum 63 or away from the interventricular septum 63 , thereby facilitating the selection of different treatment sites for the adjustable curved sheath 12 subsequently passed through the guide sheath 11 .

In some possible implementations, the curvature of the proximal portion of the third tube segment 113 is greater than the curvature of the distal portion of the third tube segment 113 . Through this setting, the proximal part of the third pipe section 113 is bent quickly, and then the distal end of the third pipe section 113 faces the expected direction (that is, the direction toward the interventricular septum 63), which is the guide sheath 11 and the guide sheath that passes through the guide sheath. The adjustable curved sheath 12 in the 11 leaves a larger operating space, which is convenient for subsequent position selection.

When the curvature of the second tube section 112 remains unchanged, the second tube section 112 basically does not interfere with the right atrium 81 , and the damage to the tissue wall of the right atrium 81 is minimal.

When the curvature of the second pipe section 112 gradually increases, the shape of the second pipe section 112 is similar to a J shape, and the area of partial interference between the second pipe section 112 and the right atrium 81 is small, and the tissue wall of the right atrium 81 faces the second pipe section 112 Provides force to help maintain the introducer sheath in place.

When the curvature of the second tube section 112 first increases and then decreases, the area of partial conflict between the second tube section 112 and the right atrium 81 is larger, and the force provided by the tissue wall of the right atrium 81 to the second tube section 112 can further assist the introducer sheath The tube remains in place.

Referring to Figs. 10-12 and Figs. 26-28, another adjustable introducer sheath 11 is disclosed in some embodiments. The difference between this embodiment and the above-mentioned embodiment of transcaval vein to right ventricle is only in that: In a natural state, the first tube section 111 and the second tube section 112 of the guiding sheath are located on the first plane 91 , and the third tube section 113 is located on the second plane 92 having an included angle with the first plane 91 .

Considering that the channel from the inferior vena cava 71 to the right ventricle 62 is a three-dimensional channel, the guide sheath in the natural state is further fitted to pass from the inferior vena cava 71 to the right atrium 81 compared with the above-mentioned embodiment. The shape of the right ventricle 62 is reached, wherein the shape of the first tube segment 111 is similar to or the same as that of the inferior vena cava 71, the shape of the second tube segment 112 is similar to or the same as the shape of the connecting channel from the inferior vena cava 71 to the right ventricle 62, and the third The tube segment 113 is located in the right ventricle 62 , wherein the distal portion of the third tube segment 113 is close to the interventricular septum 63 .

In some possible implementation manners, the included angle between the first plane 91 and the second plane 92 is a, wherein, preferably: 10°≤a≤45°.

Further, a is preferably 15°, 20°, 25°, 30°, 35° or 40°.

Please refer to Figures 13-14, Figures 29-31, some embodiments disclose another adjustable introducer sheath:

In the natural state, the first pipe section 111, the second pipe section 112 and the third pipe section 113 of the guiding sheath 11 are all located on the same plane, the second pipe section 112 extends away from the first pipe section 111, and the third pipe section 113 faces the first pipe section 113. A pipe section 111 extends in the direction.

By setting in this way, the guiding sheath in the natural state conforms to the shape from the inferior vena cava 71 to the left atrium 82 through the right atrium 81, wherein the first pipe segment 111 is similar to or identical to the shape of the inferior vena cava 71, and the second The pipe section 112 is similar to or identical to the blood vessel shape of the path of "inferior vena cava 71-right atrium 81-atrial septum 10-left atrium 82", and the third pipe section 113 is located in the left atrium 82, wherein the distal end of the third pipe section 113 part near the middle part of the mitral valve.

Before the guiding sheath enters the inferior vena cava 71, the operator needs to apply an external force to the first tube segment 111, the second tube segment 112, and the third tube segment 113 through the adjustment member to adjust the guiding sheath to a straight line or an approximate straight line, In the process of passing through the inferior vena cava 71, the right atrium 81 and reaching the left atrium 82, the external force exerted by the adjustment member is gradually reduced, so that the first tube section 111, the second tube section 112 and the third tube section 113 of the guiding sheath gradually recover To the natural state, the interference between the guiding sheath and the tissue wall of the interatrial septum 10 is reduced, and the damage to the tissue wall caused by the friction of the guiding sheath is reduced; Applying external force maintains the shape of the introducing sheath.

Specifically, the third pipe section 113, the second pipe section 112 and the first pipe section 111 of the guiding sheath are located on the same space plane, the second pipe section 112 extends away from the first pipe section 111, and the third pipe section 113 extends away from the first pipe section 113. The direction of the pipe section 111 extends.

In some possible embodiments, the third pipe section 113 may extend towards the direction X.

The guide sheath is straightened by the adjustment member, so that the guide sheath 11 is in a straightened state, that is, an external force is applied to the first tube section 111, the second tube section 112 and the third tube section 113 of the guide sheath, and it is adjusted to A straight line or an approximate straight line.

In the prior art, the guide sheath 11 is a straight line or an approximate straight line in its natural state. The operator applies external force through the handle to adjust the bending degree of the distal end of the guide sheath 11, and the guide sheath 11 becomes the target shape. After that, keep the handle.

In this embodiment, the introducer sheath 11 is in a predetermined shape in a natural state, that is, the third tube section 113, the second tube section 112 and the first tube section 111 of the guide sheath are located in the same space plane, and the second tube section 112 is along the distance from The direction of the first pipe section 111 extends, and the third pipe section 113 extends away from the first pipe section 111. Before the introducer sheath 11 enters the inferior vena cava 71, the operator needs to apply an external force through the adjustment member to adjust the introducer sheath 11 to one In a straight line or an approximate straight line, in the process of passing through the inferior vena cava 71, the right atrium 81 and reaching the left atrium 82, the straightening external force of the adjustment member is gradually reduced, so that the first tube section 111, the second tube section 112 and the first tube section 112 of the guiding sheath The third pipe section 113 gradually returns to the natural state, at this time the third pipe section 113 is located in the left atrium 82 and the distal end portion of the third pipe section 113 is close to the middle part of the mitral valve, and the operator does not need to apply any external force to the handle, naturally In this state, the shape of the third tube section 113 can ensure that the distal end of the third tube section 113 can move in two directions close to the interventricular septum 63 or away from the interventricular septum 63, thereby facilitating the follow-up introducer sheath and adjustable curved sheath 12 for different Choice of treatment site.

The curved part of the third pipe section 113 may adopt a regular or irregular curve, preferably an arc.

In some possible implementations, in a natural state, the second pipe segment 112 is a curve, and the curvature of the proximal end of the second pipe segment 112 is greater than the curvature of the distal end of the second pipe segment 112 . Through the above arrangement, the second tube segment 112 is quickly bent toward the interatrial septum 10 so that the distal end of the second tube segment 112 passes through the interatrial septum 10 .

In some possible implementations, in a natural state, the third pipe section 113 is a curve, and the curvature of the proximal end of the third pipe section 113 is smaller than the curvature of the distal end of the third pipe section 113 . Through the above setting, the proximal part of the third tube section 113 extends along the extension direction of the distal part of the second tube section 112, and by increasing the curvature of the distal part of the third tube section 113, the distal end of the third tube section 113 faces the middle of the mitral valve part.

In some possible implementations, the curvature of the second pipe section 112 can remain unchanged, or it can be set such that: from the proximal end to the distal end, the curvature of the second pipe section 112 first increases and then decreases, or gradually increases.

When the curvature of the second tube section 112 remains unchanged, the second tube section 112 basically does not interfere with the right atrium 81 , and the tissue wall of the interatrial septum 10 is minimally damaged.

When the curvature of the second tube segment 112 first increases and then decreases, the area of partial conflict between the second tube segment 112 and the tissue wall of the atrial septum 10 is small, and the force provided by the tissue wall of the atrial septum 10 to the second tube segment 112 can assist in guiding The sheath remains in place.

When the curvature of the third tube segment 112 gradually increases, the area of partial conflict between the second tube segment 112 and the tissue wall of the atrial septum 10 is larger, further enhancing the force provided by the tissue wall of the atrial septum 10 to the second tube segment 112 .

Referring to Figures 15-17 and Figures 29-31, some embodiments disclose another adjustable introducer sheath 11. The difference between this embodiment and the above-mentioned embodiment of transcaval vein to the left ventricle is only in that:

In a natural state, the first tube section 111 and the second tube section 112 of the guiding sheath are located on the same plane, and the third tube section 113 is located on the second plane 92 having an included angle with the first plane 91 .

There is an angle a between the first plane 91 and the second plane 92, preferably: 10°≤a≤45°.

Further, a is preferably 15°, 20°, 25°, 30°, 35° or 40°.

Considering that the channel from the inferior vena cava 71 to the left atrium 82 is a three-dimensional channel, by setting it in this way, the guiding sheath in the natural state can be further fitted to pass from the inferior vena cava 71 to the right Atrium 81 reaches the shape of left atrium 82, wherein, the shape of the first pipe section 111 is similar to or the same as that of the inferior vena cava 71, and the second pipe section 112 is similar to the shape of "inferior vena cava 71-right atrium 81-atrial septum 10-left atrium 82". The shape of the blood vessels of the first path is similar or the same, and the third tube segment 113 is located in the left atrium 82, wherein the distal part of the third tube segment 113 is close to the middle part of the mitral valve.

Before the introducer sheath 11 enters the inferior vena cava 71, the operator needs to apply an external force to the first tube segment 111, the second tube segment 112, and the third tube segment 113 through the adjustment member to adjust the guide sheath to a straight line or an approximate straight line, In the process of passing through the inferior vena cava 71, the right atrium 81 and reaching the left atrium 82, the external force applied by the adjustment member is gradually reduced, so that the first tube segment 111, the second tube segment 112 and the third tube segment 113 of the introducer sheath 11 are gradually recovered. To the natural state, the interference between the guiding sheath and the tissue wall of the interatrial septum 10 is reduced, and the damage to the above-mentioned tissue wall caused by the friction of the guiding sheath is reduced; The shape of the introducer sheath can be maintained by applying external force to the tube.

Referring to Figures 18 to 31, some embodiments disclose an ablation device 1, including a delivery component (not marked in the figure) and an ablation component (not marked in the figure); the ablation component is movably worn in the delivery component, and the ablation component includes The ablation needle 13 ; the delivery assembly is used to intervene in the heart through a catheter. After passing through the delivery assembly, the ablation needle 13 enters the myocardial tissue by puncturing the endocardium to perform ablation on the myocardial tissue.

Further, the delivery assembly includes an introducer sheath 11 and an adjustable curved sheath 12 ; the adjustable curved sheath 12 is movably threaded in the introducer sheath 11 ; and the ablation needle 13 is movably threaded in the adjustable curved sheath 12 .

The introducer sheath 11 is a tubular structure with a hollow lumen, and its lumen serves as a channel for the adjustable curved sheath 12 to pass through. The distal end of the ablation needle 13 can extend out of the distal end of the adjustable curved sheath 12; The sheath 12 is bent to drive the ablation needle 13 to point to and insert into different positions of the interventricular septum 63 .

In some possible implementations, the introducer sheath 11 has a shape matching the intervening heart interventricular septum 63 channel in a natural state or after being bent.

In some possible implementations, the introducer sheath 11 is any one of the adjustable introducer sheaths 11 in the above-mentioned embodiments.

In some possible implementations, the adjustable curved sheath 12 is disposed in the hollow lumen of the introducer sheath 11 and can move relative to the introducer sheath 11 along the direction of the central axis.

The adjustable curved sheath 12 has at least a main body section 121, a shaping section 121 and a bending section 123 from the proximal end to the distal end, the shape of the main body section 121 is adapted to the shape of the first tube section 111 of the adjustable introducer sheath 11, The shape of the shaping section 121 is adapted to the shape of the second pipe section 112 and the third pipe section 113 of the adjustable introducer sheath 11, so that the adjustable curved sheath 12 and the adjustable introducer sheath 11 are more structurally correct. Good fit.

Taking the above adjustable introducer sheath 11 that enters the left ventricle through the aorta as an example, the structure of the adjustable curved sheath 12 is illustrated below. When the adjustable introducer sheath 11 of other embodiments is used, the adjustable curved The structure of the sheath 12 is adaptively adjusted with reference to this embodiment.

Specifically, when the adjustable introducer sheath 11 of the above embodiment is used, the distal portion of the shaping section 121 extends away from the direction of the interventricular septum 63 , and the bending section 123 extends toward the direction of the interventricular septum 63 .

Referring to Figures 18-21, when the adjustable introducer sheath 11 is located in the aorta and is in a natural state, the adjustable bend sheath 12 is delivered through the lumen of the adjustable introducer sheath 11, and the bend-adjusting section 123 will move from the adjustable The third pipe section 113 of the introducer sheath 11 stretches out from the opening of the distal end, and crosses the aortic valve 5 to reach the position of the LVOT (left ventricular outflow tract 64). At this time, the adjustable curved sheath 12 is in a natural state ( not bent).

The adjustable bending sheath 12 is connected with a bending handle, and by controlling the rotation of the bending adjusting handle of the adjustable bending sheath 12, the circumferential swing of the bending section 123 of the adjustable bending sheath 12 can be controlled. Specifically, when the bending adjustment handle is rotated in the clockwise direction, the bending adjustment section 123 will exhibit a slight swing in the counterclockwise direction, and swing at an angle in the direction of the aortic arch 42 towards the back (Posterior direction);

When controlling the rotation of the bending adjustment handle in the counterclockwise direction, the bending adjustment section 123 will exhibit a slight clockwise swing and an angled swing toward the aortic arch 42 toward the chest (Anterior direction).

Under the joint rotation of the third pipe section 113 of the introducer sheath 11 and the bending section 123 of the adjustable bending sheath 12, different directions of the bending section 123 of the adjustable bending sheath 12 can be realized, thereby achieving points at different locations.

The bending direction D of the bending section 123 can be directed toward the outside of the aortic arch 42, that is, toward the interventricular septum 63. By controlling the bending handle of the adjustable bending sheath 12, the bending section 123 can be adjusted to the outside of the aortic arch 42. Or release the bending adjustment, so as to ensure that the distal end of the bending adjustment section 123 is always facing the side of the interventricular septum 63, so that the ablation needle 13 has a correct needle exit angle and direction when puncturing.

When the bending section 123 is bent to a proper angle in the D direction, the distal end of the bending section 123 will contact the left ventricle side wall of the interventricular septum 63, thereby preparing for subsequent needle withdrawal.

The distal part of the shaping section 121 extends away from the direction of the interventricular septum 63, and the bending adjustment section 123 extends towards the direction of the interventricular septum 63, that is, the distal end of the adjustable bending sheath 12 is set in a manner that is far away from and then close to the interventricular septum 63 Compared with the shape of the distal part of the adjustable curved sheath 12 that is directly close to the interventricular septum 63 in the prior art, the needle exit angle of the adjustable bending section 123 can be increased by first moving away from the interventricular septum 63 and then approaching the interventricular septum 63 .

The ablation method of the ablation needle 13 can be selected from radiofrequency ablation, microwave ablation, alcohol ablation and the like.

In some possible implementations, radiofrequency ablation is selected, please refer to Figures 32 to 38, the ablation needle 13 includes a needle body 132, and an ablation segment 134 is at least partially provided on the needle body 132, and the ablation segment 134 is conductive and used to conduct radio frequency Ablation energy.

The ablation needle 13 is connected to the ablation energy generating device 2, which is a prior art (refer to CN204683760U, CN106264711B, US20140364850A1), and will not be repeated here.

In some possible implementations, the needle body 132 is provided with at least one perfusion hole 132 a, and the perfusion hole 132 a communicates with the inside of the needle body 132 .

The ablation needle 13 can puncture the endocardial tissue under the puncture of the needle tip 131, so that the distal end of the ablation needle 13, including the needle tip 131, the perfusion hole 132a, and the ablation section 134, enters the hypertrophic area of the interventricular septum 63, and releases energy through the ablation section 134 to destroy the The cell activity of the hypertrophic myocardial tissue makes the hypertrophic myocardial tissue of the interventricular septum 63 thinner and the contraction force decreases, thereby reducing the obstruction of the left ventricular outflow tract 64; at the same time, under the perfusion of the electrolyte solution 31 in the perfusion hole 132a, the solution in the myocardium The diffusion inside the tissue brings the radio frequency energy to the myocardial tissue that is farther away from the ablation section 134, thereby achieving the purpose of expanding the ablation range.

The needle tip 131 of the ablation needle 13 is a closed and sharp tip structure, and its shape includes but is not limited to shapes such as cones, triangular pyramids, quadrangular pyramids, single-slope cutting edges, etc. The purpose of the shape of the needle tip 131 is to provide a sharp enough The structure of the needle tip 131 enables it to puncture the endocardial tissue with a small puncture force, thereby smoothly entering the myocardial tissue of the interventricular septum 63 .

The needle tip 131 is fixed to the distal end of the needle body 132 through connection methods including but not limited to bonding, laser welding, welding and the like.

The needle body 132 is a hollow long tubular structure with a completely through cavity inside.

The ablation needle 13 can perfuse the corresponding electrolyte solution 31 through the proximal end of the needle body 132, and the electrolyte solution 31 is transported to the distal end of the ablation needle 13 through the lumen 132b of the needle body 132, and is set on the ablation segment 134 by the distal end of the ablation needle 13. The perfusion hole 132a is released.

In some possible embodiments, the ablation needle 13 is not provided with a perfusion hole 132a, but a circulation channel is provided in the ablation needle 13, and a cooling liquid circulates in the circulation channel, and the cooling liquid flows in the channel, thereby cooling the ablation needle 13 , to avoid local tissue overheating and even tissue damage caused by high temperature.

Please refer to FIG. 35 , the cross section of the needle body 132 is preferably a cylindrical structure.

In other embodiments, please refer to FIG. 36 , the needle body 132 may also have an elliptical structure.

What needs to be clarified is that the outer wall of the needle body 132 should be smooth without obvious protrusions and edges and corners, so as to prevent it from scratching tissues such as the vascular intima when it enters the target position of the human body.

The needle body 132 is preferably made of a metal material with good electrical conductivity, so that it can achieve the purpose of releasing radio frequency energy through the excellent electrical conductivity of the needle body 132 itself. At this time, the above-mentioned ablation section 134 should be used as the needle body Part of 132.

The material of the needle body 132 may include, but not limited to, metal pipes such as stainless steel pipes and nickel-titanium alloys.

On the other hand, we should also take into account that since the ablation needle 13 needs to reach the target position of the interventricular septum 63 through a complicated and tortuous peripheral vascular path, and in order to ensure a good puncture angle, the distal part of the ablation needle 13 must also There will be a long passage through the guide sheath 11 and the adjustable curved sheath 12, and possible scratches and frictions. Therefore, in addition to the factor of excellent electrical energy conduction performance, we should also consider the good performance of the needle body 132. The mechanical and mechanical properties; the ablation needle 13 is preferably made of a metal tube with high biocompatibility, specifically, because nickel-titanium alloy has excellent biocompatibility, and has high strength, good shape, and after heat treatment It can reflect the mechanical properties of superelasticity, so the needle body 132 made of nickel-titanium alloy can maintain good rebound performance after going through complex and tortuous blood vessel paths and repeated bending adjustments, without plastic deformation. Therefore, the system can pass through the blood vessel more smoothly to reach the target position without increasing the passing resistance due to the plastic deformation of the needle body 132 .

In some other possible embodiments, the needle body 132 may also be made of a polymer material. In this case, the ablation segment 134 should be an independent component fixed on the needle body 132 with good electrical conductivity.

When the needle body 132 is made of polymer materials, the polymer materials used should have excellent strength, hardness, high elastic modulus and good bending resistance, and can not break and plasticity under repeated bending. Deformation, on the other hand, in order to ensure that the needle body 132 has excellent pushing performance in the process of moving back and forth along the central axis of the adjustable curved sheath 12, the material should have a low surface friction coefficient, which can reduce the friction of the ablation needle 13. Adjust the pushing resistance inside the lumen of the curved sheath 12, and at the same time, in order to ensure the insulation of the needle body 132, the material should have excellent dielectric insulation, high insulation resistance, small dielectric constant, and high voltage resistance.

To sum up, the needle body 132 is preferably made of polymer materials such as PP, HDPE, PTFE and the like.

At least one ablation section 134 is arranged at the distal end of the ablation needle 13 , and the ablation section 134 can realize electrical conduction with the ablation energy generating device 2 , so as to release energy into the tissue through the ablation section 134 .

Referring to the above, when the needle body 132 is a metal tube, the ablation section 134 should exist as a part of the needle body 132. Specifically, at this time, a layer of insulating layer 133 should be attached to the outside of the needle body 132, and the needle body 132 should be far away from the The exposed area where the end is not covered with insulating material serves as the ablation segment 134 for releasing radiofrequency energy.

The insulating layer 133 can be a layer of polymer material coated on the needle body 132 by heat shrinkage, or can be directly sleeved on the outside of the needle body 132 , or can be attached to the outside of the needle body 132 through a coating process.

The outer surface of the insulating layer 133 should have a lower coefficient of friction and a higher insulation resistance. The lower coefficient of friction can endow the ablation needle 13 with good lubricity and pushability, and the higher insulation resistance can make the insulating layer 133 work at high temperature. Under the action of high-frequency radio frequency current, it still maintains excellent dielectric insulation without being broken down.

When the insulating layer 133 is coated on the outside of the needle body 132 by heat shrinkage, the insulating material preferably uses materials such as PET (polyethylene terephthalate), PTFE (polytetrafluoroethylene), and FEP (fluorinated ethylene propylene). .

When the insulating layer 133 is fixed on the outside of the needle body 132 by sheathing, the insulating layer 133 is preferably made of materials such as PEEK (polyether ether ketone), PI (polyimide), and the like.

When the insulating layer 133 is adhered to the outside of the needle body 132 through a coating process, the insulating material is preferably Parylene.

The insulating layer 133 can be provided only at the distal end of the needle body 132 , or can run through the entire needle body 132 of the ablation needle 13 .

Referring to the foregoing, when the needle body 132 is a polymer tube, the ablation segment 134 should be an independent component fixed on the outside of the needle body 132 with good electrical conductivity.

Specifically, at this time, the ablation section 134 should be one or more ring-shaped metal electrodes, which are fixed on the distal end of the needle body 132 by means including but not limited to bonding, welding, crimping, welding, etc. The wire is electrically connected with the external energy generating device.

The ring-shaped metal electrode is preferably made of radiopaque metal materials such as platinum-iridium alloy, cobalt-chromium alloy, and tantalum. In this way, while having excellent electrical conductivity, it can also have a developing effect under radiation, which helps the operator The effect of the position of the ablation segment 134 is confirmed.

The effective length L of the ablation section 134 refers to the length exposed outside the insulating layer 133 and capable of contacting the tissue to be treated, and the effective length L of the ablation section 134 is preferably 5mm-15mm.

Specifically, in some possible embodiments, the length of the ablation section 134 is fixed, that is, the relative position between the needle body 132 and the insulating layer 133 is fixed. At this time, the effective length of the ablation section 134 in the same set of ablation needles 13 is With a certain fixed value, a variety of ablation needles 13 of different models and specifications can be designed by setting ablation segments 134 of different effective lengths, so as to meet the use requirements of different patients with different tissue shapes and sizes.

In some possible embodiments, no perfusion hole is provided on the ablation needle 13, and a circulation channel (not shown in the figure) is provided inside the needle body, and the circulation channel is used for circulating cooling liquid to take away the heat of the ablation needle 13 , to avoid local tissue overheating and even tissue damage caused by high temperature. Further, a circulation channel is also provided in the ablation segment of the ablation needle.

Referring to Figures 37-38, in some possible embodiments, the relative position between the needle body 132 and the insulating layer 133 can be adjusted, so as to achieve different exposed lengths of the needle body 132 and achieve the effective adjustment of different ablation segments 134. length purpose.

Different from the method in which the effective length of the ablation segment 134 is fixed, in some possible implementations, an insulating sleeve is provided outside the needle body 132, and the insulating sleeve is used as the above-mentioned insulating layer 133, and the insulating sleeve and the needle body 132 can slide relative to each other, and the effective length L of the ablation section 134 can be controlled by controlling the relative movement between the needle body 132 and the insulating layer 133. It is known that the ablation section 134 that is too short will make the ablation area too small , is not enough to achieve the purpose of reducing the left ventricular outflow tract 64 pressure difference, or in order to achieve this purpose, it is necessary to perform multiple ablations, which increases the duration of the operation; and an excessively long ablation segment 134 will excessively increase the scope of the ablation area, resulting in damage Risk of conduction tracts distributed on the endocardium.

Specifically, the ablation needle 13 is correspondingly provided with an ablation operation handle (not shown in the figure), and a push structure is provided on the ablation operation handle, and the push structure is connected with the insulating sleeve, which can drive the insulation sleeve to slide relative to the needle body 132, thereby Adjust the length of the needle body 132 exposed outside the insulating sleeve, that is, adjust the effective length L of the ablation section 134; the ablation operation handle is also provided with a locking structure, which is connected with the needle body 132 for locking and fixing The needle body 132 restricts relative movement between the needle body 132 and the insulating sleeve.

During the specific implementation process, when the needle body 132 and the insulating sleeve remain relatively fixed, that is, the effective length of the ablation section 134 remains unchanged, the endocardial tissue can be punctured and inserted into the myocardial tissue of the interventricular septum 63, When it is necessary to adjust the effective length of the ablation segment 134, the needle body 132 can be locked by the locking structure of the ablation operation handle so that it remains fixed along the central axis of the adjustable curved sheath 12, and then the ablation operation can be performed by pushing The pushing structure in which the handle is fixedly connected to the insulating sleeve enables the insulating sleeve to move back and forth relative to the central axis of the needle body 132, so as to control the elongation or shortening of the ablation section 134 exposed outside the insulating sleeve. This changes the effective length of the ablation segment 134 .

In some other possible embodiments, the locking structure is connected with the insulating sleeve for locking and fixing the insulating sleeve, and the pushing structure is connected with the needle body 132 and can drive the needle body 132 to slide relative to the insulation sleeve.

Similarly, in a state where there is no relative movement between the needle body 132 and the insulating sleeve, the endocardial tissue is pierced together and inserted into the myocardial tissue of the interventricular septum 63. When the effective length of the ablation section 1341 needs to be changed, By controlling the locking structure, the insulating sleeve remains fixed along the direction of the central axis of the needle body 132, and then by pushing the pushing structure, the needle body 132 can achieve relative movement back and forth along the direction of the central axis of the insulating sleeve, thereby The purpose of controlling the elongation or shortening of the ablation section 134 exposed outside the insulating sleeve is achieved, thereby changing the effective length of the ablation section 134 .

The ablation needle 13 is preferably provided with at least one or more perfusion holes 132a, and the perfusion holes 132a are preferably disposed outside the ablation section 134 and evenly distributed in the axial and circumferential directions of the needle body 132 .

The shape of the perfusion hole 132a can be a circle, an ellipse or the like.

The perfusion hole 132a is preferably processed and shaped by laser cutting.

The function of the perfusion hole 132a is to perfuse the electrolyte solution 31 into the tissue, and the used electrolyte solution 31 is transported through the lumen 132b of the needle body 132 .

It should be known that the range of the ablation area of the ablation needle 13 has a clear relationship with the output power, output time, tissue impedance and ablation temperature of the radiofrequency current. The temperature between them is proportional to the output power of the radiofrequency current. In theory, the size of the ablation area can be increased through higher output power and higher tissue temperature. However, once the peak temperature of the tissue exceeds the threshold of 100°C, the tissue in contact with the ablation segment 134 will be scorched and scabbed, and the scorched and scabbed tissue will adhere to the surface of the ablation segment 134 to form an electrically insulating coagulum , accompanied by a sudden increase in electrical impedance, which prevents further current from flowing into the tissue and further heating, thereby greatly reducing the range of the ablation area. Therefore, in order to prevent this phenomenon, improve the ablation efficiency, and increase the range of the ablation area, the risk of tissue scarring can be reduced by reducing the temperature of the contact surface between the ablation segment 134 and the tissue.

On the one hand, the electrolyte solution 31 perfused through the perfusion hole 132a can cool the ablation segment 134 to a certain extent, reduce the temperature between the ablation segment 134 and the tissue contact interface, so that the energy generated by the ablation segment 134 can go deeper into the myocardial tissue On the other hand, since the electrolyte solution 31 will diffuse after perfusion into the myocardial tissue, the diffused electrolyte solution 31 will serve as a good transmission medium for radiofrequency current, The radio frequency current is transmitted to the farther distance of the myocardial tissue, and through this principle, the purpose of increasing the range of the ablation area can also be achieved.

The above electrolyte solution 31 can be used including but not limited to 0.9% NaCl solution at room temperature, 0.9% NaCl solution at 5°C, 5% glucose solution, heparinized 0.9% NaCl solution, a mixed solution of 0.9% NaCl solution and contrast agent , at the same time, we should consider that, in order to better reduce the temperature between the ablation segment 134 and the myocardial tissue contact interface during radio frequency discharge, it is preferable to use 0.9% NaCl solution at about 5°C, and cold saline can more effectively reduce temperature.

On the other hand, in order to be able to effectively observe and control the diffusion range of the electrolyte solution 31 in the myocardial tissue in real time during the operation, to prevent its excessive diffusion and cause the risk of damage to the supraendocardial conduction bundle due to excessive ablation range, it is preferable to , the electrolyte solution 31 can be a mixed solution of cold physiological saline + contrast agent, through X-ray contrast, the operator can intuitively observe the diffusion of the electrolyte solution 31 mixed with contrast agent in the myocardial tissue, so as to control the ablation process in real time Time, perfusion flow and flow rate, etc., so as to achieve the purpose of accurately controlling the size of the ablation area.

The structure of the ablation needle 13 using microwave ablation, alcohol ablation and other ablation methods is basically the same as that of the ablation needle 13 using radiofrequency ablation, and will not be repeated here.

Referring to FIG. 39 , some embodiments disclose an ablation system 100, which includes the ablation device 1 in the above embodiments; and also includes an ablation energy generating device 2, which is connected to the ablation device 1 to provide the ablation device 1 with energy. From the above embodiments, it can be seen that the ablation device 1 includes a delivery assembly and an ablation assembly; the ablation assembly is movably worn in the delivery assembly, and the ablation assembly includes an ablation needle 13; After that, enter the myocardial tissue by puncturing the endocardium, and then the ablation energy generating device 2 provides energy for the ablation needle 13 to perform ablation on the myocardial tissue.

Further, the ablation system 100 further includes a perfusion device 3 , which is used to provide liquid for the ablation device 1 , and the liquid is the above-mentioned electrolyte solution 31 . In some embodiments, the ablation needle 13 is provided with a perfusion hole, and the electrolyte solution can be used to expand the ablation range. In some embodiments, the ablation needle is not provided with a perfusion hole, but a cooling channel is provided inside the needle body, through which the electrolyte solution can cool the needle body.

Some embodiments disclose a method of myocardial ablation, the method comprising the following steps:

S1, inserting the catheter into the heart until the distal opening of the catheter touches the myocardial tissue;

S2, protruding the ablation needle 13 from the opening at the distal end of the catheter and piercing into the myocardial tissue, delivering ablation energy for ablation.

Ablation of myocardial tissue by this method, on the one hand, achieves minimally invasive treatment in the true sense, without the need for thoracotomy and other traumatic treatment methods for patients; on the other hand, it can also puncture the endocardium for multi-point At the same time, it avoids the risk of piercing blood vessels or even piercing the heart when puncturing the epicardium in transapical ablation.

Further, the myocardial tissue is the interventricular septum 63 .

Further, the path for myocardial ablation is one of path a, path b, and path c;

Route a: reach the left ventricle 61 through the femoral artery and the aortic arch 42;

Route b: via inferior vena cava 71 , right atrium 81 , to right ventricle 62 ;

Route c: through the inferior vena cava 71 , the right atrium 81 , the atrial septum 10 and the left atrium 82 , to reach the left ventricle 61 .

Some embodiments disclose another method of myocardial ablation, the method comprising the steps of:

S1. Select the corresponding adjustable introducer sheath 11 according to the path involved in the human heart, and the adjustable introducer sheath 11 is a pre-shaped structure;

S2. Straighten the adjustable guide sheath 11 and insert it into the corresponding path;

S3. Reduce the external force applied to the adjustable guide sheath 11 according to the shape of the path until the adjustable guide sheath 11 returns to its natural state;

S4. Extend the distal end portion of the adjustable curved sheath 12 from the distal opening of the adjustable introducer sheath 11 and make the distal opening of the adjustable curved sheath 12 contact the target tissue;

S5. Stretch out the ablation needle 13 from the distal opening of the adjustable curved sheath 12 and penetrate into the target tissue to deliver ablation energy for ablation;

The adjustable introducer sheath 11 adopts any one of the above-mentioned embodiments.

Further, the myocardial tissue is the interventricular septum 63 .

Further, the path for myocardial ablation is one of path a, path b, and path c;

Route b: via inferior vena cava 71 , right atrium 81 , to right ventricle 62 ;

Path a corresponds to the use of the adjustable introducer sheath 11 through the aorta in the above embodiment; path b corresponds to the use of the adjustable introducer sheath 11 through the inferior vena cava, right atrium, and right ventricle in the above embodiment; path c corresponds to The adjustable introducer sheath 11 through the inferior vena cava, right atrium, and left atrium in the above-mentioned embodiment is used.

For the convenience of expression, the handle 14 is defined below as an operating component for the guiding sheath, adjustable curved sheath 12 and ablation needle 13, including but not limited to bending degree, direction adjustment and pushing. Its structure is the prior art, and the specific structure You can refer to other documents of the prior art, such as publications whose publication numbers are CN214286246U and CN203447358U.

When path a is selected, straighten the guide sheath through the handle 14 and insert it into the aorta, and gradually reduce the external force applied by the handle to the guide sheath as the guide sheath goes deeper. After the third tube segment 113 reaches the target position, ie, the ascending aorta 43, the external force exerted by the handle on the introducer sheath 11 is removed, so that the guide sheath returns to its natural state.

Next, extend the adjustable curved sheath 12 from the distal opening of the third tube section 113 of the guiding sheath, and adjust the shape of the adjustable curved sheath 12 so that the distal opening of the adjustable curved sheath 12 touches the target tissue.

In the next step, the ablation needle 13 is extended from the distal opening of the adjustable curved sheath 12 and pierced into the target tissue to deliver ablation energy for ablation. After the ablation is completed, the ablation needle 13, adjustable curved sheath 12 and Introducer sheath 11.

Specifically, on the third tube section 113 of the guide sheath or on the ablation needle 13, a developing component, such as a developing ring made of metal or a smeared developing material, is placed on the third tube section 113 of the guiding sheath or smeared with a developing material. (not shown in the figure) guide, and send the guide sheath through the aortic arch 42 to the position of the aortic valve 5 near the aortic arch 42, as shown in FIG. 5 .

Through angiography, determine whether the position of the guide sheath is correct. When the guide sheath reaches the target position, the guide wire is withdrawn, and the adjustable curved sheath 12 is delivered to the aortic valve along the lumen of the guide sheath. 5 is close to the upper side of the aortic arch 42 and crosses the aortic valve 5 without damaging the aortic valve 5 under the guidance of ultrasound/CT, as shown in FIG. 22 .

By operating the handle 14, the bending direction and the bending angle of the adjustable guide sheath 11 and the bending section 123 of the adjustable bending sheath 12 are controlled, so that the distal end of the adjustable bending sheath 12 can be well attached to the The interventricular septum 63 is at the expected puncture ablation point.

Operate the handle 14 to control the ablation needle 13 to protrude along the central axis of the introducer sheath 11, puncture the interventricular septum 63, and reach the hypertrophic myocardial tissue of the interventricular septum 63, and make double judgments on the ultrasound image and the scale marks on the ablation operating handle Next, control the angle and depth of its penetration, as shown in Figure 24.

After completing the above steps, first start the perfusion device 3, set the perfusion flow rate, so that the electrolyte solution 31 reaches the position of the perfusion hole 132a through the inner cavity 132b of the ablation needle 13 and perfuse it outside the tissue for a period of time, then turn on the ablation energy generating device, through The ablation section 134 of the ablation needle 13 performs ablation on the hypertrophic myocardial tissue, and the size of the ablation range is judged by ultrasound and/or radiography, and the length of the ablation section 134 can be adjusted by controlling the handle according to the actual size of the ablation area to achieve The purpose of controlling the ablation zone.

When the ablation range is in the ideal size, stop the energy output of the energy generating device, stop the perfusion of the electrolyte solution 31, return the ablation needle 13 to the adjustable curved sheath 12, and release the bending section 123 of the adjustable curved sheath 12 to make it far away. The end of the adjustable curved sheath 12 is out of contact with the interventricular septum 63, and then the adjustable curved sheath 12 is operated to select the next point. At this time, the distal end of the adjustable curved sheath 12 will present an arc swing from point E to point F, as shown in Figure 23 As shown, within the appropriate range, select 1, 2, 3, 4 or even more puncture sites.

When the adjustable curved sheath 12 rotates to the next puncture site, repeat the above operations until the selection, puncture and ablation of all sites are completed, as shown in Figure 25.

After the ablation is completed, multiple continuous ablation zones will be left on the hypertrophic interventricular septum 63. Ideally, multiple ablation zones can be connected together to form a long continuous ablation range, and all puncture points are punctured And after the ablation, withdraw the ablation needle 13, the adjustable curved sheath 12, and the guide sheath 11 in sequence, and complete the blood vessel suture and the skin suture at the puncture point.

If route b is selected, then: under the guidance of ultrasound/CT, puncture through the femoral vein, guided by a guide wire (not shown), pass the adjustable introducer sheath 11 through the inferior vena cava 71, the right atrium 81 and enter the right The position of the ventricle 62 is shown in FIG. 9 .

Through angiography, determine whether the position of the introducer sheath 11 is correct, when the adjustable introducer sheath 11 reaches the target position, withdraw the guide wire, and put the adjustable curved sheath 12 along the lumen of the adjustable introducer sheath 11 Delivered to the right ventricle 62 as shown in FIG. 26 .

By operating the handle 14, the bending direction (direction J, direction K) and the size of the bending angle of the adjustable guide sheath 11 and the bending section 123 of the adjustable bending sheath 12 are controlled, so that the distance of the adjustable bending sheath 12 is The end can be well attached to the expected puncture and ablation point on the interventricular septum 63 .

Operate the handle 14 to control the ablation needle 13 to protrude along the central axis direction of the adjustable introducer sheath 11, puncture the interventricular septum 63, and reach the hypertrophic myocardial tissue of the interventricular septum 63, and the scale mark on the ultrasonic image and the handle 14 Under double judgment, control the angle and depth of its penetration, as shown in Figure 28.

After completing the above steps, first start the perfusion device 3, set the perfusion flow rate, so that the electrolyte solution 31 reaches the position of the perfusion hole 132a through the inner cavity 132b of the ablation needle 13 and perfuse it outside the tissue for a period of time, then turn on the ablation energy generating device, through The ablation section 134 of the ablation needle 13 performs ablation on hypertrophic myocardial tissue. The size of the ablation range is judged by ultrasound and/or contrast, and the length of the ablation section 134 can be adjusted through the control handle 14 according to the actual size of the ablation area, so as to achieve the purpose of controlling the ablation area.

When the ablation range is in an ideal size, the energy output of the energy generating device is stopped, the perfusion of the electrolyte solution 31 is stopped, and the ablation needle 13 is returned to the adjustable curved sheath 12 . Release the bending section 123 of the adjustable bending sheath 12, so that its distal end is out of contact with the interventricular septum 63, and then operate the adjustable bending sheath 12 to select the next point. At this time, the distal end of the adjustable bending sheath 12 will appear An arc swing from point E to point F (as shown in Figure 23), within a suitable range, select 1, 2, 3, 4 or even more puncture sites.

When the adjustable curved sheath 12 rotates to the next puncture site, repeat the above operations until the selection, puncture and ablation of all points are completed, as shown in FIG. 25 .

After the ablation is completed, multiple continuous ablation zones will be left on the hypertrophic interventricular septum 63 . Ideally, the multiple ablation zones can be connected together to form a strip-shaped continuous ablation range.

After the puncture and ablation of all puncture points are completed, the ablation needle 13, the adjustable curved sheath 12, and the guide sheath 11 are sequentially withdrawn, and blood vessel suture and skin suture at the puncture point are completed.

If path c is selected, then: Under the guidance of ultrasound/CT, transfemoral vein puncture, guided by a guide wire (not shown), the adjustable introducer sheath 11 passes through the inferior vena cava 71, the right atrium 81 and through the interatrial septum 10 into the position of the left atrium 82, as shown in FIG. 14 .

Through angiography, determine whether the position of the adjustable introducer sheath 11 is correct, when the adjustable introducer sheath 11 reaches the target position, withdraw the guide wire, and put the adjustable curved sheath 12 along the adjustable introducer sheath 11 The lumen of the left atrium 82 is delivered to the side above the mitral valve, and under the guidance of ultrasound/CT, it crosses the mitral valve without damaging the mitral valve, as shown in FIG. 29 .

By operating the handle 14, the bending direction (direction X, direction Y) and the size of the bending angle of the adjustable guide sheath 11 and the bending section 123 of the adjustable bending sheath 12 are controlled, so that the distance of the adjustable bending sheath 12 The end can be well attached to the expected puncture and ablation point on the interventricular septum 63 .

Operate the handle 14 to control the ablation needle 13 to protrude along the central axis direction of the adjustable introducer sheath 11, puncture the interventricular septum 63, and reach the hypertrophic myocardial tissue of the interventricular septum 63, and the scale mark on the ultrasonic image and the handle 14 Under double judgment, control the angle and depth of its penetration, as shown in Figure 31.

After completing the above steps, first start the perfusion device 3, set the perfusion flow rate, so that the electrolyte solution 31 reaches the position of the perfusion hole 132a through the inner cavity 132b of the ablation needle 13 and perfuse it outside the tissue for a period of time, then turn on the ablation energy generating device, through The ablation segment 134 at the distal end of the ablation needle 13 performs ablation of hypertrophic myocardial tissue.

The size of the ablation range is judged by ultrasound and/or contrast, and the length of the ablation section 134 can be adjusted through the control handle 14 according to the actual size of the ablation area, so as to achieve the purpose of controlling the ablation area.

When the ablation range is in an ideal size, the energy output of the energy generating device is stopped, the perfusion of the electrolyte solution 31 is stopped, and the ablation needle 13 is returned to the adjustable curved sheath 12 .

Release the bending section 123 of the adjustable bending sheath 12, make its distal end out of contact with the outer wall of the interventricular septum 63, then operate the adjustable bending sheath 12 to select the next point, at this time, the distal end of the adjustable bending sheath 12 will Present an arc swing from point E to point F (as shown in Figure 23), within a suitable range, select 1, 2, 3, 4 or even more puncture sites.

Some embodiments disclose another method of myocardial ablation, the method comprising the following steps:

S1. Select the corresponding adjustable introducer sheath 11 according to the path involved in the human heart, and insert the adjustable introducer sheath 11 into the path until the adjustable introducer sheath 11 reaches the target position;

S2, protruding the distal end portion of the adjustable curved sheath 12 from the distal opening of the adjustable introducer sheath 11, and making the distal opening of the adjustable curved sheath 12 contact the myocardial tissue;

S3, protruding the ablation needle 13 from the distal opening of the adjustable curved sheath 12 and piercing into the myocardial tissue, delivering ablation energy for ablation;

The adjustable introducer sheath 11 adopts any adjustable introducer sheath 11 in any of the above-mentioned embodiments.

Further, in the S1 step, before the adjustable guide sheath 11 is inserted into the path, the adjustable guide sheath 11 is first straightened.

Further, the myocardial tissue is the interventricular septum 63 .

Further, the path for myocardial ablation is one of path a, path b, and path c;

Route b: via inferior vena cava 71 , right atrium 81 , to right ventricle 62 ;

For the operation process of selecting path a, path b, or path c to perform myocardial ablation, reference may be made to the above-mentioned embodiments.

In summary, the adjustable introducer sheath 11 provided by the present invention is pre-shaped so that the introducer sheath can match the path of entering the heart in a natural state. After the adjustable introducer sheath 11 enters the body and It is in a natural state after reaching the target position, and maintains the shape of the introducer sheath 11 without applying external force;

Further, by setting different curvatures of the second tube section 112 , it is possible to reduce tissue wall or blood vessel wall damage and provide positioning support for the introducer sheath 11 .

In addition, in the ablation device 1 provided by the present invention, the electrolyte solution 31 can cool down the temperature of the contact interface between the ablation section 134 and the tissue through perfusion ablation, which reduces the probability of tissue scarring and enables the temperature to be transmitted deeper into the tissue. Thereby expanding the scope of ablation.

Moreover, through perfusion ablation, the electrolyte solution 31 can be used as an energy transfer medium, and through its diffusion inside the tissue, the energy can be transferred to a deeper tissue, thereby expanding the range of ablation.

In addition, the ablation section 134 of the ablation needle 13 is set to be adjustable. For patients with hypertrophic cardiomyopathy with different degrees of hypertrophy or different types of hypertrophy, in the same operation, for different puncture sites, it is possible to expand the ablation site A longer ablation section 134 is required, or a shorter ablation section 134 may be required in order to avoid excessively large ablation areas and avoid damage to the conduction beam. The efficiency of ablation is improved, and the safety of ablation is increased.

The technical means disclosed in the solutions of the present invention are not limited to the technical means disclosed in the above embodiments, but also include technical solutions composed of any combination of the above technical features. It should be pointed out that those skilled in the art can make some improvements and modifications without departing from the principle of the present invention, and these improvements and modifications are also considered as the protection scope of the present invention.

Claims

An adjustable introducer sheath, characterized in that the adjustable introducer sheath includes a guide sheath and an adjustment member, and the guide sheath includes a first tube section sequentially communicated from the proximal end to the distal end, the second pipe section and the third pipe section;

In a natural state: the second pipe section first extends in a direction away from the first pipe section, and then extends in a direction close to the first pipe section, and the third pipe section moves in a direction close to or away from the first pipe section Extending; the first pipe section and the second pipe section are located on a first plane, and the third pipe section is located on the first plane or on a second plane having an included angle with the first plane;

The adjusting member is connected to the guiding sheath, and is used for controlling the guiding sheath to gradually transform from the straightened state to the natural state.
The adjustable introducer sheath according to claim 1, characterized in that:

In a natural state, the first pipe section is straight, or its proximal end is straight and its distal end is curved.
The adjustable introducer sheath according to any one of claims 1-2, characterized in that:

In a natural state, the second pipe section is curved with a middle portion arched relative to the two ends.
The adjustable introducer sheath according to any one of claims 1-3, characterized in that:

In a natural state, the third pipe section is a curve, and when extending toward the direction close to the first pipe section, the curvature of the proximal part of the third pipe section is smaller than the curvature of the distal part of the third pipe section;

Alternatively, when the third pipe section extends away from the first pipe section, the curvature of the proximal end portion of the third pipe section is greater than the curvature of the distal end portion of the third pipe section.
An adjustable introducer sheath, characterized in that the adjustable introducer sheath includes a guide sheath and an adjustment member, and the guide sheath includes a first tube section sequentially communicated from the proximal end to the distal end, A second pipe section and a third pipe section; in a natural state, the second pipe section extends away from the first pipe section, and the third pipe section extends in a direction close to the first pipe section;

The first pipe section and the second pipe section are located on a first plane, and the third pipe section is located on the first plane or on a second plane having an included angle with the first plane;

The adjusting member is connected to the guiding sheath, and is used for controlling the guiding sheath to gradually transform from the straightened state to the natural state.
The adjustable introducer sheath according to claim 5, characterized in that:

In a natural state, the first pipe section is straight, or its proximal end is straight and its distal end is curved.
The adjustable introducer sheath according to any one of claims 5-6, characterized in that:

In a natural state, the second pipe section is a curve, and the curvature of the proximal portion thereof is greater than the curvature of the distal portion of the second pipe section.
The adjustable introducer sheath according to any one of claims 5-7, characterized in that:

In a natural state, the third pipe section is a curve, and the curvature of the proximal portion thereof is smaller than the curvature of the distal portion of the third pipe section.
The adjustable introducing sheath according to any one of claims 1-8, wherein the curvatures of the first pipe section, the second pipe section and the third pipe section are different, and the curvature of the second pipe section The curvature of the third pipe section is greater than the curvature of the other pipe sections.
The adjustable introducing sheath according to any one of claims 1-9, characterized in that the curvature of the second tube section is a constant value.
The adjustable introducing sheath according to any one of claims 1-10, characterized in that, the curvature of the second tube segment first increases and then decreases from the proximal end to the distal end thereof.
The adjustable introducing sheath according to any one of claims 1-11, wherein the angle between the first plane and the second plane is a, where 10°≤a≤45°.
An ablation device, characterized in that it includes a delivery assembly and an ablation assembly; the ablation assembly is movably worn in the delivery assembly, and the ablation assembly includes an ablation needle; the delivery assembly is used to intervene in the heart through a catheter, After the ablation needle passes through the delivery assembly, it enters the myocardium by puncturing the endocardium, so as to ablate the myocardium.
The ablation device according to claim 13, characterized in that: the delivery assembly includes a guide sheath and an adjustable curved sheath; the adjustable curved sheath is movably threaded in the guide sheath; the ablation needle is movable It is installed in the adjustable curved sheath.
The ablation device according to claim 14, characterized in that: the introducer sheath has a shape matching the intervening cardiac interventricular septal channel in a natural state or after being bent.
The ablation device according to any one of claims 14-15, wherein the guide sheath is the adjustable guide sheath according to any one of claims 1-12.
An ablation device, characterized in that it includes a delivery assembly and an ablation assembly; the delivery assembly includes the adjustable guide sheath and the adjustable curved sheath according to any one of claims 1-12; the adjustable curved sheath The ablation assembly is movably threaded in the guide sheath of the adjustable introducer sheath; the ablation assembly is movably threaded in the adjustable curved sheath;

In a natural state, the guiding sheath has a shape matching the interventricular septal channel of the intervening heart.
The ablation device according to claim 17, characterized in that:

The ablation assembly includes an ablation needle, and the ablation needle is used to ablate myocardial tissue.
The ablation device according to claim 18, characterized in that:

By adjusting the distal end of the adjustable curved sheath, the ablation needle is directed to different positions of the myocardial tissue.
The ablation device according to any one of claims 13-19, wherein the adjustable curved sheath comprises a main body section, a shaping section and a bending section connected in sequence from the proximal end to the distal end, the main body section and the The first pipe section is suitable, the shaping section is suitable for the second pipe section and the third pipe section; the distal end of the shaping section extends toward the first direction, and the bending section The second direction opposite to the first direction extends.
The ablation device according to any one of claims 13-20, wherein the ablation needle comprises a needle body, and an ablation section is at least partially provided on the needle body.
The ablation device according to claim 21, wherein the needle body is a hollow tubular structure;

The needle body is provided with at least one perfusion hole, and the perfusion hole communicates with the inside of the needle body.
The ablation device according to any one of claim 21, characterized in that, a circulation channel through which cooling liquid circulates is provided in the ablation section.
The ablation device according to any one of claims 21-23, characterized in that the effective ablation length of the ablation section can be adjusted.
The ablation device according to any one of claims 21-24, wherein an insulating layer is provided on the needle body, and the insulating layer is integrally provided with the needle body.
The ablation device according to any one of claims 21-25, wherein the ablation segment is detachably connected to the needle body.
The ablation device according to any one of claims 21-24, 26, characterized in that an insulating sleeve is provided outside the needle body, and the insulating sleeve and the needle body can slide relative to each other.
The ablation device according to any one of claims 16-27, characterized in that,

In a natural state, the shape of the first tube segment corresponds to the shape of the descending aorta;

The shape of the second tube segment corresponds to the shape of the aortic arch;

The shape of the third pipe section corresponds to the shape of the ascending aorta.
The ablation device according to any one of claims 16-27, characterized in that,

In a natural state, the shape of the first pipe segment corresponds to the shape of the inferior vena cava;

The shape of the second pipe segment corresponds to the shape of the channel from the inferior vena cava to the position of the tricuspid valve in the right atrium close to the right atrium;

The shape of the third pipe segment corresponds to the shape of the channel from the position of the tricuspid valve in the right atrium close to the right atrium to the right ventricle close to the interventricular septum.
The ablation device according to any one of claims 16-27, characterized in that,

In a natural state, the shape of the first pipe segment corresponds to the shape of the inferior vena cava;

The shape of the second pipe segment corresponds to the shape of the passage from the inferior vena cava and right atrium through the interatrial septum to the left atrium;

The shape of the third pipe section corresponds to the shape of the passage from the left atrium near the mitral valve position of the left atrium.
The ablation device according to any one of claims 13-30, characterized in that,

The myocardial tissue is the interventricular septum.
An ablation system, characterized in that it comprises:

The ablation device according to any one of claims 13-31;

The ablation energy generating device is connected with the ablation device and provides energy for the ablation device.
The system of claim 32, wherein:

The system also includes an irrigation device for providing fluid to the ablation device.
The system of claim 33, wherein:

The ablation device includes an ablation needle, and the ablation needle is provided with at least one perfusion hole or a circulation channel for liquid circulation is provided in the ablation needle.
A method for myocardial ablation, characterized in that the method comprises the following steps:

S1, inserting the catheter into the heart until the distal opening of the catheter touches the myocardial tissue;

S2. Extending the ablation needle from the opening at the distal end of the catheter and piercing the myocardial tissue and delivering ablation energy for ablation.
A method for myocardial ablation, characterized in that the method comprises the following steps:

S1. Select the corresponding adjustable introducer sheath according to the path involved in the human heart, and the adjustable introducer sheath is a pre-shaped structure;

S2. Straighten the adjustable guide sheath and insert it into the corresponding path;

S3. Reduce the external force applied to the adjustable guide sheath according to the shape of the path until the adjustable guide sheath returns to a natural state;

S4. Extend the distal end portion of the adjustable curved sheath from the distal opening of the adjustable introducer sheath and make the distal opening of the adjustable curved sheath contact the target tissue;

S5. Extend the ablation needle from the distal opening of the adjustable curved sheath and penetrate into the target tissue and deliver ablation energy for ablation;

The adjustable guiding sheath is the adjustable guiding sheath according to any one of claims 1-12.
A method for myocardial ablation, characterized in that the method comprises the following steps:

S1. Select the corresponding adjustable introducer sheath according to the path involved in the human heart, and insert the adjustable introducer sheath into the path until the adjustable introducer sheath reaches the target position;

S2. Extend the distal end portion of the adjustable curved sheath from the distal opening of the adjustable introducer sheath and make the distal opening of the adjustable curved sheath contact the myocardial tissue;

S3, protruding the ablation needle from the distal opening of the adjustable curved sheath and piercing into the myocardial tissue and delivering ablation energy for ablation;

The adjustable guiding sheath is the adjustable guiding sheath according to any one of claims 1-12.
The method of claim 37, wherein:

In step S1, before inserting the adjustable introducer sheath into the path, the adjustable introducer sheath is firstly straightened.
The method according to any one of claims 35-38, characterized in that:

The myocardial tissue is the interventricular septum.
The method according to any one of claims 35-39, characterized in that:

The path used for myocardial ablation is one of path a, path b, and path c;

Route a: reach the left ventricle through the femoral artery and aortic arch;

Route b: through the inferior vena cava, right atrium, to the right ventricle;

Route c: through the inferior vena cava, right atrium, atrial septum, and left atrium to the left ventricle.