WO2023125927A1

WO2023125927A1 - Ablation needle, ablation device and ablation system for myocardial ablation

Info

Publication number: WO2023125927A1
Application number: PCT/CN2022/143881
Authority: WO
Inventors: 张庭超; 丘信炯; 李阳; 王柏栋; 齐泽龙
Original assignee: 杭州诺沁医疗器械有限公司
Priority date: 2021-12-31
Filing date: 2022-12-30
Publication date: 2023-07-06

Abstract

Provided in the present application are an ablation needle, ablation device and ablation system for myocardial ablation. The ablation needle comprises an ablation section capable of puncturing myocardial tissue, wherein the ablation section is provided with an axial inner cavity, and is provided with at least one perfusion hole, which is in communication with the inner cavity thereof, and the perfusion hole is used for releasing fluid in the inner cavity into the myocardial tissue. Moreover, the ablation section has a preset difference in an axial direction, and the preset difference allows the amount of fluid released in a unit time through the perfusion hole in a middle area of the ablation section to be greater than the amount of fluid released in a unit time through a proximal-end area of the ablation section, and to be greater than the amount of fluid released in a unit time through a distal-end area of the ablation section. By means of the setting of the preset difference in the axial direction of the ablation section, the ablation needle of the present invention makes an ablation area formed by the ablation section at myocardial tissue match the morphology of the myocardial tissue, and thus reduces surgical risks and achieves a better treatment effect.

Description

An ablation needle, ablation device and ablation system for myocardial ablation

technical field

The present application relates to the technical field of medical devices, in particular to an ablation needle, an ablation device and an ablation system for myocardial ablation.

Background technique

Hypertrophic cardiomyopathy is a common autosomal dominant cardiovascular disease with an incidence of about 1:500 in the general population and a mortality rate of about 1.4%-2.2%. It is the most common cause of sudden death in young people and athletes. The main manifestation of hypertrophic cardiomyopathy is the hypertrophy of one or more segments of the left ventricle (Left Ventricular, LV), and the general diagnostic standard is that the thickness is greater than or equal to 15mm. ) moves forward during systole against the interventricular septum (IVS), resulting in stenosis or even obstruction of the left ventricular outflow tract (LVOT). Hypertrophic cardiomyopathy. As shown in Figure 1a and Figure 1b, Figure 1a and Figure 1b are schematic diagrams of the structure of the interventricular septum in a normal form and the interventricular septum in a hypertrophic form. In the most common phenotype, the interventricular septum is located near the aorta The myocardial hypertrophy and thickening of the anterior wall of the valve (Aortic Valve, AV) (the part close to the left ventricular outflow tract) is more obvious, while the posterior wall of the left ventricle has little or no hypertrophy.

At present, the treatment strategy for obstructive hypertrophic cardiomyopathy is to expand the left ventricular outflow tract to reduce the pressure difference and alleviate its obstruction. These methods do not combine the shape of the myocardial tissue to be ablated (such as the interventricular septum) to precisely control the ablation area, which easily increases the safety risk of the operation.

Explanation content

The purpose of this application is to provide an ablation needle, ablation device and ablation system for myocardial ablation, which can solve the disadvantages of the prior art that the ablation area formed by myocardial tissue is uncontrollable, resulting in high surgical risk.

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

In a first aspect, the present invention provides an ablation needle for myocardial ablation, the ablation needle includes an ablation section capable of puncturing into myocardial tissue, the ablation section punctures into the myocardial tissue through the endocardium, and can release Energy disrupts myocardial activity of said myocardial tissue;

The ablation section has an axial lumen, and the ablation section is provided with at least one perfusion hole communicating with the lumen of the ablation section, and the perfusion hole is used to transfer the fluid in the lumen of the ablation section Released to the myocardial tissue, the fluid can expand the ablation range formed by the ablation segment in the myocardial tissue;

The ablation segment has a preset difference in the axial direction, and the preset difference makes the fluid release volume of the perfusion hole in the middle area of the ablation segment greater than that in the proximal area of the ablation segment per unit time. The amount of fluid released in the ablation segment is greater than the amount of fluid released per unit time in the region of the distal end of the ablation segment.

In the second aspect, the present invention also provides an ablation device for myocardial ablation, including the above-mentioned ablation needle and a delivery tube assembly, the delivery tube assembly includes an adjustable curved sheath and is movably threaded through the Adjustable curved catheter in adjustable curved sheath;

The ablation needle is movably inserted in the adjustable bend catheter, and the distal end of the ablation needle can protrude from the distal end of the adjustable bend catheter.

In a third aspect, the present invention also provides an ablation system for myocardial ablation, including an energy generator, a fluid perfusion device, and the above-mentioned ablation device;

The energy generator is electrically connected to the ablation needle, and is used to provide energy for the ablation needle,

The fluid perfusion device is connected with the ablation needle, and is used for delivering the fluid to the lumen of the ablation needle.

In the fourth aspect, the present invention also provides an ablation system for myocardial ablation, including an energy generator, a cooling circulation device, and an ablation device;

The energy generator provides energy for the transcatheter myocardial ablation system, the cooling circulation device is used to dissipate heat to the ablation needle, and the energy generator and the cooling circulation device are respectively connected to the ablation device.

Description of drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the drawings that need to be used in the implementation manner. Obviously, the drawings in the following description are some implementation manners of the application, which are common to those skilled in the art. As far as the skilled person is concerned, other drawings can also be obtained based on these drawings on the premise of not paying creative work.

Figure 1a and Figure 1b are schematic diagrams of the structure of the interventricular septum in normal form and the interventricular septum in hypertrophic form, respectively;

Fig. 2 is a schematic cross-sectional view of the ablation section in the ablation needle provided by one embodiment of the present invention;

Fig. 3a, Fig. 3b and Fig. 3c are schematic diagrams of the structure of the perfusion holes in the ablation needle of the present invention respectively being circular, square or triangular;

Fig. 4a, Fig. 4b and Fig. 4c are schematic diagrams of the structure of the ablation needle of the present invention with the needle head being a conical pointed head, a triangular pyramid head and a bevel cutting edge head;

Fig. 5 is a schematic structural view of the ablation segment in the ablation needle of the present invention;

Fig. 6 is a schematic cross-sectional view of the ablation segment in Fig. 5;

Fig. 7 is another structural schematic diagram of the ablation segment in the ablation needle of the present invention;

Fig. 8 is a schematic cross-sectional view of the ablation segment in Fig. 7;

Fig. 9 is another schematic cross-sectional view of the ablation segment in the ablation needle of the present invention;

Fig. 10 is another schematic cross-sectional view of the ablation segment in the ablation needle of the present invention;

Fig. 11 is another schematic cross-sectional view of the ablation segment in the ablation needle of the present invention;

Fig. 12 is a schematic structural view of the ablation segment and the flexible reinforcing tube in the ablation needle of the present invention;

Fig. 13 is a schematic structural view of the ablation needle of the present invention;

Fig. 14 is a schematic cross-sectional view of the body section of the ablation needle of the present invention sleeved on the outside of the flexible reinforcing tube;

Fig. 15 is a schematic cross-sectional view of the main body segment sleeved inside the flexible reinforcing tube in the ablation needle of the present invention;

Fig. 16 is a schematic diagram of the structure of the ablation needle punctured into myocardial tissue in the ablation device of the present invention;

Fig. 17 is a schematic structural view of the ablation device of the present invention;

Fig. 18 is a schematic structural view of the adjustable catheter in the ablation device of the present invention;

Fig. 19 is a schematic structural view of the ablation area formed by the ablation needle punctured into the myocardial tissue in the ablation device of the present invention;

Figure 20 is a partially enlarged view of area A in Figure 19;

Fig. 21 is a schematic structural diagram of the ablation system of the present invention;

Fig. 22a, Fig. 22b and Fig. 22c are schematic diagrams of the operation flow of the ablation system of the present invention;

Fig. 23 is a schematic structural view of an ablation device adapted to the inner part of the heart according to another embodiment of the present invention;

Fig. 24 is a schematic diagram of the structure of the delivery tube assembly in Fig. 23 adapted to the body;

Fig. 25 is a schematic structural view of the delivery tube assembly in Fig. 24;

Fig. 26 is a schematic structural view of the adjustable curved sheath in Fig. 25;

Fig. 27 is a schematic structural view of the adjustable bend catheter in Fig. 25;

Fig. 28 is a partial sectional view of the adjustable bend catheter in Fig. 27;

Fig. 29 is a cross-sectional view of the adjustable curved catheter in Fig. 27 after the ablation needle is inserted;

Fig. 30 is a cross-sectional view of the ablation needle in Fig. 29 after extending out of the adjustable curved catheter;

Fig. 31 is a schematic structural view of the ablation needle in Fig. 23;

Fig. 32 is a cross-sectional view of the ablation needle in Fig. 31;

Fig. 33 is a schematic structural view of another embodiment of the needle of the ablation needle in Fig. 31;

34 is a cross-sectional view of another embodiment of the ablation needle of FIG. 23;

Fig. 35 is a schematic structural diagram of the transcatheter myocardial ablation system of the ablation device in Fig. 23;

36 to 38 are schematic views of the use process of the transcatheter myocardial ablation system in FIG. 35;

Fig. 39 is a schematic diagram of the application scene when the adjustable curved catheter in Fig. 38 adjusts the ablation needle to select different puncture points;

Fig. 40 is a schematic diagram of the ablation needle of the ablation device in Fig. 39 selecting different puncture points on the interventricular septum of the heart.

Among them, the reference signs have the following meanings:

1. Ablation needle; 11. Ablation section; 111. Needle; 112. Straight ablation tube; 1121. Perfusion hole; 113. Temperature sensor; 12. Flexible reinforcing tube; 121. Conductive part; 13. Main body section; Tube body assembly; 21. Adjustable bend sheath tube; 211. First support section; 212. First shaping section; 213. First bend adjustment section; 22. Adjustable bend catheter; 221. Second support section; 222 , the second molding section; 223, the second bending section; 3, the energy generator; 4, the fluid filling device; 41, the fluid storage; 42, the filling pump; 43, the fluid pipeline; 5, the handle assembly; 6, conduction Nerve; a-first ablation area; b-second ablation area; c-third ablation area.

Detailed ways

The following will clearly and completely describe the technical solutions in the embodiments of the application with reference to the drawings in the embodiments of the application. Apparently, the described embodiments are only some of the embodiments of the application, not all of them. Based on the embodiments in this application, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the scope of protection of this application.

In addition, the following descriptions of the various embodiments refer to the attached drawings to illustrate specific embodiments that the application can be used to implement. The directional terms mentioned in this application, such as "upper", "lower", "front", "rear", "left", "right", "inner", "outer", "side", etc., only is to refer to the direction of the attached drawings. Therefore, the direction terms used are for better and clearer description and understanding of the present application, rather than indicating or implying that the referred device or element must have a specific orientation, and must have a specific orientation. construction and operation, therefore should not be construed as limiting the application. The term "natural state" refers to a state in which a device or element is not subjected to external forces, such as tension or compression.

In the description of this application, in the field of access to medical devices, the proximal end refers to the end that is closer to the operator, while the distal end refers to the end that is farther from the operator; the axial direction refers to the end that is parallel to the center of the distal end of the medical device. The direction of the line connecting the proximal center. Those of ordinary skill in the art can understand the specific meanings of the above terms in this application in specific situations, and the definitions are only for convenience of expression, and should not be construed as limitations on this application.

Referring to Fig. 2, the present invention firstly provides an ablation needle 1 for myocardial ablation, the ablation needle 1 includes an ablation segment 11 capable of puncturing into myocardial tissue, the ablation segment 11 penetrates into myocardial tissue through endocardium, and can The release of energy disrupts myocardial activity in myocardial tissue.

Among them, myocardial tissue includes ventricular wall, atrial wall, interventricular septum and atrial septum, etc. Therefore, the ablation needle 1 in the embodiment of the present invention can be applied to ablate hypertrophic myocardium in the ventricular wall, atrium wall, interventricular septum and atrial septum, etc. It is especially suitable for ablation of hypertrophic myocardium in the interventricular septum.

Optionally, the ablation segment 11 is made of a metal material with good electrical conductivity, such as stainless steel, nickel-titanium alloy, etc., so as to realize electrical conduction and achieve the purpose of releasing ablation energy. The ablation segment 11 includes a needle 111 with a sharp tip and a straight ablation tube 112 . Wherein, the axial length of the needle 111 may be between 0.1mm-0.5mm, and the axial length of the straight ablation tube 112 may be between 3.2mm-9.5mm. The straight ablation tube 112 has an axially through inner cavity, and at least one perfusion hole 1121 communicating with the inner cavity is opened on the straight ablation tube 112, and the perfusion hole 1121 is used for delivering fluid to the straight ablation tube 112 surrounding tissue, the fluid can expand the ablation range of the ablation segment 11 . The ablation energy may be radiofrequency energy, microwave ablation, ultrasound energy, and the like. In this embodiment, the ablation energy is radiofrequency ablation.

In other embodiments, the ablation segment 11 may only be composed of a straight ablation tube 112, that is to say, the needle 111 is a separate member relative to the ablation segment 11, and the needle 111 is not used to release ablation energy. The straight ablation tube 112 is made of conductive material (such as polymer material).

In other embodiments, the ablation section 11 can also be made of polymer material. When the ablation section 11 is a polymer material, one or more ring-shaped metal electrodes spaced apart in the axial direction can be arranged on the ablation section 11. It is fixed on the ablation segment 11 by means of welding, welding, etc., and is electrically connected to the energy generator (as shown in FIG. 21 ) through a wire. The aforementioned ring-shaped metal electrodes can be made of metal materials such as stainless steel and nickel-titanium alloy.

It should be clear that the range of the ablation region formed by the ablation needle 1 has a clear relationship with the output power, output time, tissue impedance and ablation temperature of the radiofrequency current. In a stable state, the range of the ablation zone is proportional to the temperature between the tissue and the interface of the ablation segment 11 and the output power of the radio frequency current, and the range of the ablation zone can be increased by higher output power and higher tissue temperature the size of. However, once the peak temperature of the tissue exceeds the threshold of 100°C, the tissue in contact with the ablation section 11 will be scorched and scabbed, and the scorched and scabbed tissue will adhere to the surface of the ablation section 11 and form an electrically insulating Coagulation; at the same time, with the sudden increase in electrical impedance, it prevents the current from flowing into the tissue and causes heating, thereby greatly reducing the size of the ablation area. In order to prevent this phenomenon from happening, increasing the range of the ablation area can be achieved by reducing the temperature of the contact surface between the ablation section 11 and the tissue so as to reduce the risk of scab formation.

It can be understood that the fluid released from the perfusion hole 1121 can cool the ablation section 11 to a certain extent, reduce the temperature between the ablation section 11 and the tissue contact interface, so that the energy generated by the ablation section 11 can go deeper into the myocardial tissue Transmission is performed to achieve the purpose of increasing the ablation range. On the other hand, since the fluid will diffuse after perfusion into the myocardial tissue, the diffused fluid will serve as a good radio frequency current transmission medium, and transmit the radio frequency current to the farther distance of the myocardial tissue. Through this principle, The purpose of increasing the range of the ablation area can be achieved. To sum up, the fluid can expand the ablation range formed by the ablation segment 11 in the myocardial tissue, and the release amount of the fluid is proportional to the ablation range formed by the ablation segment in the myocardial tissue.

The above-mentioned fluids may include 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 and 0.9% NaCl solution. The fluid may also be the above-mentioned solutions and A mixed solution of contrast media. At the same time, we should consider that in order to better reduce the temperature between the ablation segment 11 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 reduce the temperature more effectively. . On the other hand, in order to effectively observe and control the perfusion area of the fluid in the myocardial tissue during the operation and prevent its excessive diffusion, it is preferable that the fluid can be a mixed solution of 0.9% NaCl solution and a developer at about 5°C, Through radiography, the operator can intuitively observe the diffusion of the fluid mixed with the contrast agent in the myocardial tissue with the help of rays, so as to control the ablation time, perfusion flow rate and flow rate in real time with evidence. , so as to achieve the purpose of precisely controlling the size of the ablation area.

In other embodiments, the above-mentioned fluid can also be absolute ethanol, which can directly destroy the myocardial activity of myocardial tissue, and realize the ablation method combining energy ablation and alcohol ablation, thereby expanding the ablation range.

Referring to Figure 3a, Figure 3b and Figure 3c, the perfusion hole 1121 can be in different shapes, such as circular (as shown in Figure 3a), square (as shown in Figure 3b), triangular (as shown in Figure 3c), oval , rhombus, polygon, straight groove, S-shaped curve, keyhole groove, comma-shaped opening, teardrop-shaped opening or a combination of several, preferably circular.

Referring to Fig. 4a, Fig. 4b and Fig. 4c, the needle head 111 preferably adopts a conical pointed head (as shown in Fig. 4a), and certainly also can adopt a triangular pyramid head (as shown in Fig. 4b) and a beveled edge head (as shown in Fig. 4c). The distal end of the needle 111 is closed, and the proximal end is fixedly connected with the distal end of the straight ablation tube 112 . Preferably, the two are fixed by laser welding.

In this embodiment, the needle 111 adopts a solid structure, which makes the needle 111 have good puncture performance. In other embodiments, the needle 111 can also adopt a hollow structure, that is, the proximal end of the needle 111 has a hollow lumen, which is connected with the lumen of the straight ablation tube 112. The existence of the lumen of the needle 111 makes the fluid further Close to the needle 111 so that the outer surface of the needle 111 can be cooled more fully during ablation, thereby enhancing the ablation effect, further improving the ablation efficiency, and reducing the possibility of scab formation.

Referring to FIG. 2 again, the ablation needle 1 further includes a temperature sensor 113, which is arranged axially in the lumen of the ablation section 11, and the distal end of the temperature sensor 113 extends into the lumen of the straight ablation tube 112 And close to the needle 111 , the proximal end of the temperature sensor 113 passes through the entire ablation needle 1 and is connected to the energy generator 3 (as shown in FIG. 21 ) through wires. In other embodiments, when the needle 111 adopts a hollow structure, the distal end of the temperature sensor 113 can further extend into the inner cavity of the needle 111. Since the needle 111 has a hollow inner cavity, the temperature sensor 113 can be extended. Into the inner cavity, so that the temperature sensor 113 is closer to the needle 111, so that it can measure the temperature of the ablation needle 1 more accurately, improve the temperature measurement accuracy, and reduce the temperature measurement error.

Therefore, the existence of the temperature sensor 113 can effectively monitor the temperature of the distal end of the ablation needle 1 during ablation, and the energy generator 3 can adjust the output power/energy according to the real-time temperature feedback to prevent it from contacting the straight ablation tube 112 of the ablation needle 1 The risk of carbonization and scab formation in the tissue, resulting in the ineffective diffusion of ablation energy and the adverse effects of too small ablation range.

Specifically, the temperature sensor 113 includes a thermocouple type or a thermal resistance type. Preferably, a thermocouple type is used. Thermocouples are made of two different wire materials joined together by welding at the far ends. The thermocouple achieves the purpose of temperature measurement according to the principle that the voltage at the connection point of two different metal wires is proportional to the temperature. The type of thermocouple is not limited to K-type thermocouple, T-type thermocouple, S-type thermocouple, etc. One wire of K-type thermocouple is chromium alloy and one wire is aluminum alloy; one wire of T-type thermocouple is copper and one is constantan; one wire of S-type thermocouple is platinum-rhodium alloy and one wire is aluminum alloy. for platinum wire. In the range of 0-100 degrees Celsius, the K-type thermocouple has higher temperature measurement linearity and higher sensitivity, so the K-type thermocouple is preferably used.

Optionally, in order to enhance the visualization of the needle 111 under external imaging equipment such as CT (Computed Tomography, computerized tomography), the surface of the needle 111 can be plated with a layer of gold coating or not limited to other radiopaque coatings Material.

Please refer to FIGS. 5-11 together. The ablation section 11 has a preset difference in the axial direction, and the preset difference makes the fluid release volume per unit time of the perfusion hole in the middle area of the ablation section 11 larger than that of the ablation section 11 near the same time. The amount of fluid released per unit time at the end region and the amount of fluid released at the distal end region of the ablation segment 11 per unit time. It should be emphasized that, in the embodiment of the present invention, due to the short length of the needle 111, the proximal region, the middle region and the distal region of the straight ablation tube 112 correspond to the proximal region, the middle region and the middle region of the ablation section 11 respectively. region and the distal region.

Optionally, the number of the perfusion holes 1121 is multiple, and the multiple perfusion holes 1121 are arranged along the circumferential direction and the axial direction of the straight ablation tube 112 at the same time, so that the straight ablation tube 112 is simultaneously arranged along the axial and circumferential directions. output fluid.

In other embodiments, when the needle 111 adopts a hollow structure, the needle 111 may also define one or more perfusion holes 1121 communicating with the inner cavity of the needle 111 .

Therefore, in order to realize that the release volume of fluid per unit time in the middle area of the ablation section 11 is greater than the release volume of fluid per unit time in the proximal area of the straight ablation tube 112 and the distal area of the straight ablation tube 112 The amount of fluid released per unit time, the preset difference includes: the total fluid release area of the perfusion holes 1121 in the middle region of the ablation segment 11 is larger than the total fluid release area of the perfusion holes 1121 in the proximal region of the ablation segment 11 and the total fluid release area of the perfusion hole 1121 at the distal end region of the ablation segment 11.

Further, at least one of the opening area and density of the plurality of perfusion holes 1121 has a difference in the axial direction of the straight ablation tube 112, so that the total fluid release area of the perfusion holes 1121 in the middle region of the ablation segment 11 is larger than the ablation hole 1121 at the same time. The total fluid release area of the perfusion holes 1121 in the proximal region of the segment 11 and the total fluid release area of the perfusion holes 1121 in the distal region of the ablation segment 11, wherein the degree of density refers to the axial direction of the straight ablation tube 112 The number of perfusion holes 1121 per unit length. In order to realize that the total fluid release area of the perfusion holes 1121 in the middle region of the ablation segment 11 is larger than the total fluid release area of the perfusion holes 1121 in the proximal region of the ablation segment 11 and the perfusion holes 1121 in the distal region of the ablation segment 11 The total fluid release area of can have the following implementations:

In the first implementation mode, please refer to FIG. 5-FIG. 6. On the premise that the density of the perfusion holes 1121 of the straight ablation tube 112 is approximately the same in the axial direction, the perfusion holes located in the middle area of the straight ablation tube 112 The opening area of 1121 is larger than the opening area of the perfusion hole 1121 located in the proximal region of the straight ablation tube 112 and the opening area of the perfusion hole 1121 located in the distal region of the straight ablation tube 112 .

Wherein, the opening area of each perfusion hole 1121 varies between 0.05mm-0.3mm ² .

Preferably, in order to further precisely control the amount of fluid released, the plurality of perfusion holes 1121 can be divided into N perfusion hole groups, each perfusion hole group forms a circle in the circumferential direction, and N perfusion hole groups are ablated in a straight line The tube 112 surrounds N circles upward, and the number of perfusion holes 1121 on each circle is equal and evenly distributed. Among them, N≥3, preferably 5.

As an example, as shown in Figure 5 and Figure 6, taking the number M of perfusion holes 1121 as 20 and N as 5 as an example, each perfusion hole group includes four perfusion holes 1121, and the perfusion holes located in different perfusion hole groups 1121 are distributed at intervals in the axial direction of the straight ablation tube 112, and the distance between the two adjacent perfusion holes 1121 in the axial direction of the straight ablation tube 112 is equal, and the four perfusion holes 1121 located in the same perfusion hole group are at the same time. The straight ablation tube 112 is evenly distributed in the circumferential direction (that is, the central angle corresponding to the two perfusion holes 1121 located in the same perfusion hole group and adjacent in the circumferential direction is 90°), so that the density of the multiple perfusion holes 1121 is within The axial directions of the straight ablation tubes 112 are substantially the same. In order to facilitate the distinction, the five perfusion hole groups are arranged along the straight ablation tube 112 from the distal end to the proximal end (the order is: the first perfusion hole group, the second perfusion hole group, the third perfusion hole group, the fourth perfusion hole group) group and the fifth perfusion hole group), the opening areas of the perfusion holes 1121 from the first perfusion hole group to the fifth perfusion hole group are respectively S1, S2, S3, S4 and S5, wherein, S3>S2>S1 and S3>S4 >S5, where it can be, S2=S4, S1=S5, and it can also be: S2≠S4 and/or S1≠S5. In some other embodiments, it may also be: S3>S2=S1 and/or S3>S4=S5. In some other embodiments, it may also be: S3=S2>S1 and/or S3=S4>S5. It can be understood that the opening area of the perfusion holes 1121 in the axial direction from the middle area to the two end areas of the straight ablation tube 112 may decrease gradually or stepwise, preferably gradually decrease.

As some examples, the value of S1 can be between 0.05mm- ^0.09mm2 , the value of S2 can be between 0.1mm- ^0.15mm2 , the value of S3 can be between 0.16mm- ^0.3mm2 , S4 The value of S5 can be between 0.1mm-0.15mm ² , and the value of S5 can be between 0.05mm-0.09mm ² .

In the second implementation, please refer to FIG. 7-8. On the premise that the opening area of each perfusion hole 1121 is approximately the same in the axial direction of the straight ablation tube 112, the perfusion of the middle area of the straight ablation tube 112 The concentration of the holes 1121 is greater than the concentration of the perfusion holes 1121 in the proximal region of the straight ablation tube 112 and the concentration of the perfusion holes 1121 in the distal region of the straight ablation tube 112 .

Preferably, in order to further precisely control the release amount of the fluid, the plurality of perfusion holes 1121 can be divided into N perfusion hole groups, and the perfusion holes 1121 of each perfusion hole group form a circle in the circumferential direction, and the N perfusion hole groups N circles are formed around the straight ablation tube 112, and the number of perfusion holes 1121 on each circle is equal and evenly distributed. Among them, N≥3, preferably 5.

As an example, as shown in FIG. 7 and FIG. 8 , taking the number M of perfusion holes 1121 as 20 and N as 5 as an example, in order to facilitate the distinction, the five perfusion hole groups are arranged along the axial direction of the straight ablation tube 112 from far to Sorting from end to proximal end (in order: the first perfusion hole group, the second perfusion hole group, the third perfusion hole group, the fourth perfusion hole group and the fifth perfusion hole group), set the perfusion holes of the first perfusion hole group The axial distance between 1121 and the perfusion holes 1121 of the second perfusion hole group is L1, the axial distance between the perfusion holes 1121 of the second perfusion hole group and the perfusion holes 1121 of the third perfusion hole group is L2, and the The axial distance between the perfusion holes 1121 of the third perfusion hole group and the perfusion holes 1121 of the fourth perfusion hole group is L3. The axial distance is L4, wherein, L2=L3<L1=L4, so that the density of the perfusion holes 1121 in the middle region of the straight ablation tube 112 is greater than that of the perfusion holes 1121 in the proximal region of the straight ablation tube 112 The degree of density and the degree of density of the perfusion holes 1121 in the region of the distal end of the straight ablation tube 112 . In other embodiments, it may also be L2≠L3, L1≠L4, as long as L2<L1 and L3<L4 are guaranteed. More specifically, the value of L1 can be between 2.5mm-4mm, the value of L2 can be between 1mm-2mm, the value of L3 can be between 1mm-2mm, and the value of L4 can be between 2.5mm- between 4mm. In other embodiments, in order to realize that the concentration of perfusion holes 1121 in the middle region of the straight ablation tube 112 is greater than the concentration of perfusion holes 1121 in the proximal region of the straight ablation tube 112 and the distance of the straight ablation tube 112 at the same time, The density of the perfusion holes 1121 in the end region can also be achieved by the difference in the number of perfusion holes 1121 included in each perfusion hole group.

In the third implementation mode, please refer to FIG. 9 , the concentration of perfusion holes 1121 in the middle region of the straight ablation tube 112 is greater than the concentration and straightness of the perfusion holes 1121 in the proximal region of the straight ablation tube 112 . The concentration of perfusion holes 1121 in the distal region of the ablation tube 112, and the opening area of the perfusion holes 1121 in the middle region of the straight ablation tube 112 is larger than that of the perfusion holes 1121 in the proximal region of the straight ablation tube 112 The opening area and the opening area of the perfusion hole 1121 located at the distal end region of the straight ablation tube 112 . For the specific design of this implementation manner, reference may be made to the above-mentioned first implementation manner and second implementation manner, and details are not repeated here.

Referring to FIG. 10 , the present invention also proposes another method for achieving the release of fluid per unit time in the middle region of the ablation segment 11 while being greater than the release of fluid per unit time in the proximal region of the straight ablation tube 112 and The release amount of fluid per unit time in the region of the distal end of the straight ablation tube 112 . The preset difference includes: the cross-sectional area of the lumen in the middle region of the ablation segment 11 is smaller than the cross-sectional area of the lumen in the proximal region of the ablation segment 11 and the cross-sectional area of the lumen in the distal region of the ablation segment 11 area.

Specifically, the cross-sectional area of the lumen in the middle region of the straight ablation tube 112 is smaller than the cross-sectional area of the lumen in the proximal region of the straight ablation tube 112 and the cross-sectional area of the lumen in the distal region of the straight ablation tube 112 (the The cross-sectional area of the lumen of the straight ablation tube 112 can gradually increase from the middle area to both ends, or it can also increase in steps), so that the fluid at the liquid outlet of the perfusion hole 1121 in the middle area of the straight ablation tube 112 The pressure is greater than the fluid pressure at the liquid outlet of the perfusion hole 1121 in the proximal region of the straight ablation tube 112 and the fluid pressure at the liquid outlet of the perfusion hole 1121 in the distal region of the straight ablation tube 112, based on the pressure potential energy The principle of converting into kinetic energy, so that the release volume of fluid per unit time in the middle area of the straight ablation tube 112 is greater than the release volume of fluid per unit time in the proximal area of the straight ablation tube 112 and the volume of fluid released by the straight ablation tube 112 The amount of fluid released per unit time in the distal region of the

Further, it is considered that due to the existence of the perfusion hole 1121 , the pressure of the fluid gradually decreases from the proximal end to the distal end of the inner lumen of the straight ablation tube 112 . In order to resist this attenuation, preferably, the cross-sectional area S1 of the lumen in the middle region of the straight ablation tube 112 is smaller than the cross-sectional area S2 of the lumen in the distal end region of the straight ablation tube 112 , the straight ablation tube 112 The cross-sectional area S2 of the lumen in the distal region is smaller than the cross-sectional area S3 of the lumen in the proximal region of the straight ablation tube 112 .

In this embodiment, the ratio between the cross-sectional area S2 of the lumen at the distal end of the straight ablation tube 112 and the cross-sectional area S1 of the lumen at the middle of the straight ablation tube 112 is between 1.2-1.5 Meanwhile, the ratio between the cross-sectional area S3 of the lumen at the proximal end of the straight ablation tube 112 and the cross-sectional area S1 of the lumen at the middle of the straight ablation tube 112 is between 1.6-2.0.

More specifically, the value of S1 may be between 0.1mm- ^0.2mm2 , the value of S2 may be between 0.12mm-0.3mm2, and the value of S3 may be between 0.16mm- ^0.4mm2 .

Therefore, by setting the cross-sectional area of the lumen of the straight ablation tube 112 to have a difference in the axial direction, the fluid pressure at the liquid outlet of each perfusion hole 1121 is equal or the fluid pressure in the middle area of the straight ablation tube 112 At the same time, it is greater than the fluid pressure in the region of the proximal end of the straight ablation tube 112 and the fluid pressure in the region of the distal end of the straight ablation tube 112 .

It can be understood that when the fluid pressures at the liquid outlets of the perfusion holes 1121 are equal, the fluid flow rates of the perfusion holes 1121 are equal.

Combined with the formula Q=S·v, wherein, Q is the flow rate, S is the cross-sectional area (fluid release area), and v is the flow velocity. It can be seen from the formula that the larger the fluid release area, the greater the flow rate. Therefore, combining any one of ways 1 to 3 in FIGS. 5-9 makes the sum of the fluid release areas of the perfusion holes 1121 in the middle region of the straight ablation tube 112 larger than that at the proximal end of the straight ablation tube 112 The sum of the fluid release areas of the perfusion holes 1121 in the upper region and the sum of the fluid release areas of the perfusion holes 1121 in the far end region of the straight ablation tube 112 realizes the release amount of fluid in the middle region of the straight ablation tube 112 per unit time At the same time, it is larger than the release amount of fluid per unit time in the proximal region of the straight ablation tube 112 and the release amount of fluid in unit time in the distal region of the straight ablation tube 112 . When the fluid pressure at the fluid outlet of the perfusion hole 1121 in the middle region of the straight ablation tube 112 is greater than the fluid pressure at the fluid outlet of the perfusion hole 1121 in the proximal region of the straight ablation tube 112 and the straight ablation tube 112 farther When the fluid pressure at the liquid outlet of the perfusion hole 1121 in the end region is such that the fluid flow rate of the perfusion hole 1121 in the middle region of the straight ablation tube 112 is simultaneously greater than the fluid flow rate of the perfusion hole 1121 in the proximal region of the straight ablation tube 112 And the fluid flow rate of the perfusion hole 1121 in the distal end region of the straight ablation tube 112, combined with any one of modes 1 to 3 in Figs. The sum of the fluid release areas of the straight ablation tube 112 is greater than the sum of the fluid release areas of the perfusion holes 1121 located in the proximal and distal areas of the straight ablation tube 112, further realizing the fluid flow in the middle area of the straight ablation tube 112 per unit time. The release volume of the straight ablation tube 112 is greater than the release volume of fluid per unit time in the proximal region of the straight ablation tube 112 and the release volume of fluid in the distal region of the straight ablation tube 112 per unit time.

Specifically, the cross-sectional area of the lumen in the middle region of the straight ablation tube 112 is set to be smaller than the cross-sectional area of the lumen in the proximal region of the straight ablation tube 112 and the lumen in the distal region of the straight ablation tube 112. The cross-sectional area (the cross-sectional area of the lumen of the straight ablation tube 112 can gradually increase from the middle area to both ends, and can also increase in steps), so that the fluid at the perfusion hole 1121 in the middle area of the straight ablation tube 112 The pressure is greater than or equal to the fluid pressure at the perfusion hole 1121 in the proximal region of the straight ablation tube 112 and the fluid pressure at the perfusion hole 1121 in the distal region of the straight ablation tube 112, wherein, when the straight ablation tube 112 is in the middle region When the fluid pressure of the perfusion hole 1121 in the proximal region, the fluid pressure of the perfusion hole 1121 in the proximal region, and the fluid pressure in the perfusion hole 1121 in the distal region are all equal, you can combine the methods 1 to 3 in Figs. 5-9 Any one of them makes the release volume of fluid per unit time in the middle area of the straight ablation tube 112 greater than the fluid release volume per unit time in the proximal end area of the straight ablation tube 112 and the far end of the straight ablation tube 112 The amount of fluid released in the external area per unit time. When the fluid pressure at the perfusion hole 1121 in the middle region of the straight ablation tube 112 is greater than the fluid pressure at the perfusion hole 1121 in the proximal region of the straight ablation tube 112 and at the perfusion hole 1121 in the distal region of the straight ablation tube 112 When the fluid pressure is higher, any one of ways 1 to 3 in Fig. 5-Fig. The release amount of fluid per unit time in the proximal region of the ablation tube 112 and the release amount of fluid in unit time in the distal region of the straight ablation tube 112 .

In some embodiments of the present invention, the cross-sectional area of the lumen of the straight ablation tube 112 decreases stepwise from the middle area to the two end areas. It can be divided into multiple sections, such as 3 sections, 4 sections, 5 sections, 6 sections, etc., preferably singular.

Referring to FIG. 11 , as an example, the straight ablation tube 112 is divided into five sections, and the straight ablation tube includes a first section, a second section, a third section, a In the fourth section and the fifth section, the cross-sectional areas of the lumens of the first section to the fifth section are S6, S5, S4, S7, and S8 respectively, wherein, S8>S7>S6>S5>S4, wherein , the value of S6 can be between 0.18mm-0.25mm ² , the value of S5 can be between 0.12mm-0.18mm ² , the value of S4 can be between 0.1mm-0.15mm ² , the value of S7 can be It can be between 0.25mm-0.3mm ² , and the value of S8 can be between 0.3mm-0.4mm ² .

12-13, further, the ablation needle 1 further includes a flexible reinforcing tube 12 and a main body section 13, the distal end of the flexible reinforcing tube 12 is connected to the proximal end of the straight ablation tube 112, and the proximal end of the flexible reinforcing tube 12 The end is provided with a conductive part 121. The straight ablation tube 112, flexible reinforcing tube 12 and conductive part 121 can be integrally processed from the same metal round tube, or multiple different metal round tubes can be connected by welding or other fixed methods. made. Preferably, laser welding is used for fixing.

In this embodiment, the straight ablation tube 112 , the flexible reinforcing tube 12 and the conductive part 121 are cut from the same integral metal tube by laser cutting, and can realize electrical conduction.

In this embodiment, the flexible reinforcing tube 12 can be cut using a hypotube, and the cutting forms include one-side cutting of the tube body and four-way cutting of the tube body. Preferably, the four-way cutting method of the pipe body is adopted, so that the flexible reinforcing pipe 12 can be bent in a direction of 360°. Since the connecting portion of the ablation segment 11 and the main body segment 13 is at the position of the bend adjustment segment of the adjustable bend catheter 22, during the bend adjustment process of the bend adjustment segment of the adjustable bend catheter 22, the distal end of the main body segment 13 will follow the The bend-adjusting section of the bend-adjusting conduit 22 is bent, and the existence of the flexible reinforcing tube 12 can increase the bending resistance of the main body section 13 in a bent state, preventing the main body section 13 from being damaged or damaged during the bend-adjusting process of the adjustable bend conduit. break off. The conductive part 121 is used to connect the distal end of the wire (not shown in the figure), and the proximal end of the wire is connected to the energy generator 3 (as shown in Figure 21). 3; the conductive part 121 can be a connecting hole or a connecting hook to increase the firmness of the connection between the wire and the conductive part 121 and the goodness of contact. The connecting hole or connecting hook includes but is not limited to a round hole , square holes, slots, barbs and notches.

Referring to Fig. 14, the main body section 13 is sleeved on the outside of the flexible reinforcing tube 12, and the distal end of the main body section 13 should exceed the distal end of the flexible reinforcing tube 12, that is, the distal end of the main body section 13 is sleeved on the ablation section 11 The outer side of the proximal end, so that the distal end of the main body section 13 is sealed and connected to the proximal end of the ablation section 11 to ensure that the inner cavity of the straight ablation tube 112 forms an airtight space. The main body section 13 and the flexible reinforcing tube 12 are preferably bonded with glue way to fix.

Referring to Fig. 15, in other embodiments, the main body section 13 can also be sleeved inside the flexible reinforcing tube 12, and the distal end of the main body section 13 should exceed the distal end of the flexible reinforcing tube 12, that is to say, the main body section The distal end of 13 is sleeved on the outside of the proximal end of the ablation section 11, so that the distal end of the main body section 13 is hermetically connected to the proximal end of the ablation section 11 to ensure that the inner cavity of the straight ablation tube 112 forms a closed space.

Specifically, the main body section 13 has an axial inner cavity, and the main body section 13 is configured as an insulating material or a conductive material covered with an insulating layer. In this embodiment, the main body section 13 is a metal material covered with an insulating layer. The above-mentioned insulating layer can be a layer of polymer material coated on the main body section by heat shrinkage, or it can be directly sheathed on the main body section. 13, it can also be attached to the outside of the main body section 13 through a coating process. The above-mentioned insulating material should have a low friction coefficient and high insulation resistance. The low friction coefficient can endow the ablation needle 1 with good lubricity and push performance, and the high insulation resistance can make the insulation layer withstand high-frequency radio frequency current Under the action, it still maintains excellent dielectric insulation without being broken down. When the insulating layer is coated on the outside of the main body section 13 by heat shrinkage, the insulating layer preferably uses PET (Polyethylene Terephthalate, polyethylene terephthalate), PTFE (Poly Tetra Fluoroethylene, polytetrafluoroethylene), FEP ( Fluorinated Ethylene Propylene, fluorinated ethylene propylene) and other materials, when the insulating layer is fixed on the outside of the main body section 13 by sheathing, the insulating layer preferably uses PEEK (Poly-Ether-Ether-Ketone, polyether ether ketone), PI ( Polyimide, polyimide) and other materials, when the insulating material is adhered to the outside of the main body section 13 through a coating process, the insulating layer preferably uses Parylene.

In addition, the main body section 13 should have good bending resistance, pushing performance and surface lubricity. The main body section 13 can be made of metal materials including but not limited to stainless steel, nickel-titanium alloy and the like. In other embodiments, when the main body section 13 is directly made of insulating materials, it can be made of polymer materials such as polyetheretherketone and polyimide.

In other embodiments, the flexible reinforcing tube 12 may be unnecessary, and the main body section 13 may be integrally formed with the ablation section 11 . In other embodiments, the distal end surface of the main body section 13 and the proximal end surface of the ablation section 11 may be relatively fixed, or the distal end of the main body section 13 is sleeved on the outside or inside of the proximal end of the ablation section 11 in a fixed manner. Bonding, welding, crimping, welding, etc. are used.

Since the ablation segment 11 has an axial lumen and communicates with the lumen of the main body segment 13, in order to achieve electrical conductivity, the distal end of the wire (not shown) can be electrically connected to the main body segment 13 which is made of conductive material and covered with an insulating layer. connection, the proximal end of the wire is electrically connected to the energy generator 3 , so as to realize electrical conduction between the ablation section 11 and the energy generator 3 . In other embodiments, if the main body section 13 is made of non-conductive material, the distal end of the wire (not shown in the figure) can be electrically connected to the ablation section 11 through the lumen or lumen wall of the main body section 13 .

Usually, during the ablation process, all the ablation segments 11 will be inserted into the interventricular septum to ablate the hypertrophic tissue in the interventricular septum. The axial length of the ablation segment 11 may be between 3.3mm-10mm. The outer diameters of the ablation segment 11 and the main body segment 13 may be between 0.3mm-1.5mm, preferably 0.5mm.

Please refer to FIG. 16-FIG. 18 and FIG. 21 together. The present invention also provides an ablation device for myocardial ablation, including the above-mentioned ablation needle 1, delivery tube assembly 2 and handle assembly 5, the delivery tube assembly 2 It includes an adjustable curved sheath 21 and an adjustable curved catheter 22 that can be movably threaded in the adjustable curved sheath 21; the ablation needle 1 can be movably threaded in the adjustable curved catheter 22, and the ablation needle 1 The distal end of the can stretch out the distal end of the adjustable bend catheter 22.

Specifically, the adjustable curved catheter 22 is sheathed in the lumen of the adjustable curved sheath 21 , and the central axes of the adjustable curved sheath 21 and the adjustable curved catheter 22 are kept coincident under ideal conditions. During the operation, the distal end of the adjustable curved sheath tube 21 is located on the side of the aortic valve close to the aortic arch, and the adjustable curved catheter 22 protrudes from the distal end lumen of the adjustable curved sheath tube 21 and crosses the aortic valve. The arterial valve enters the left ventricle. The distal end of the adjustable curved catheter 22 abuts against the outer side of the hypertrophic interventricular septum, and the ablation needle 1 protrudes from the distal end of the adjustable curved catheter 22 to pierce the endocardium and extend a suitable length to reach the hypertrophic interventricular septum , to release ablation energy, destroy the cell activity of the myocardium in the ventricular septum, make the myocardium with hypertrophy of the ventricular septum thinner, and reduce the contractility, thereby reducing the phenomenon of left ventricular outflow tract obstruction. Wherein, the ablation energy may be radio frequency energy, microwave ablation, ultrasonic energy and the like. In this embodiment, the ablation energy is radio frequency ablation. It can be understood that the ablation energy can diffuse within a certain range in the interventricular septum to form an ablation area, and the ablation area is an area covered by the ablation energy in the interventricular septum.

Please refer to FIG. 17 , the adjustable curved sheath 21 is a tubular structure with a hollow lumen, and the adjustable curved sheath 21 includes a first support section 211, a first plastic section 212 and a first support section 212 from the proximal end to the distal end. A bending section 213, in the working state, the positions of the proximal end and the distal end of the first shaping section 212 will match the starting and ending positions of the aortic arch, and the bending curvature of the first shaping section 212 is consistent with The curvature of the aortic arch is basically the same, so as to ensure that the first shaping section 212 can pass the adjustable curved sheath 21 through the aortic arch more smoothly and deliver it to the designated position, and when the adjustable curved sheath 21 reaches the designated position Finally, the first plastic section 212 can have good contact with the aortic arch in the bent state, so that the first plastic section 212 can be fixed at the position of the aortic arch, and the impact caused by the movement of the adjustable curved sheath tube 21 can be reduced as much as possible. adverse effects of surgery. In order to ensure that the first plastic section 212 has good deformation performance and can maintain good shape memory after deformation, the hardness of the material constituting the first plastic section 212 should not be too hard, and the first plastic section 212 is preferably The hardness of the material is 55D～65D. The first support section 211 mainly plays the role of supporting the first bending section 213 and the first shaping section 212, in order to ensure that the first shaping section 212 will not cause the first supporting section 211 to bend substantially during the bending process. , so the material hardness of the first supporting section 211 should be greater than the material hardness of the first molding section 212 . In some embodiments, the adjustable bendable sheath 21 adopts the structure of a composite braided mesh tube, which can maintain high bending resistance while having good flexibility, pushing performance, and twist control.

In addition, the adjustable curved sheath tube 21 also includes a first pulling wire (not shown in the figure), and the first pulling wire is movably threaded through the tube of the adjustable curved sheath tube 21 along the axial direction of the adjustable curved sheath tube 21. In the wall, the distal end of the first pulling wire is connected to the distal end of the first bending section 213 , and the proximal end of the first pulling wire is connected to the handle assembly 5 . Specifically, a channel tube (not shown) is provided in the tube wall of the adjustable curved sheath tube 21, and the channel tube extends along the axial direction of the adjustable curved sheath tube 21, and the distal end of the channel tube extends to the first The distal end of the bending section 213 and the proximal end of the channel tube extend to the proximal end of the first support segment 211 , and the first pulling wire is movably passed through the channel tube. In some embodiments, a guide groove can also be directly provided on the wall of the adjustable bend sheath tube 21, the guide groove extends along the axial direction of the adjustable bend sheath tube 21, and the distal end of the guide groove extends to the first bending section The distal end of 213 and the proximal end of the guide groove extend to the proximal end of the first support section 211, and the first pulling wire is movably threaded in the guide groove. The handle assembly 5 (as shown in FIG. 21 ) controls the bending of the first bending section 213 by controlling the axial movement of the first pulling wire. During the working process, the first bending section 213 can be bent in different directions, so as to facilitate subsequent selection of different ablation positions. In some embodiments, in order to prevent the adjustable bending sheath 21 from twisting due to the inconsistency between the pulling force direction of the first pulling wire and the bending direction of the first bending adjustment section 213, the first pulling wire should be passed through The bend-adjusting sheath 21 is close to the curved inner position of the first bend-adjusting section 213 to ensure the stability of the force-bearing direction of the adjustable-bend sheath 21 during work; that is, the passage tube or guide groove should be located in the first bend-adjusting section 213 curved medial position.

Referring to Fig. 18, the adjustable bend catheter 22 is a tubular body with a hollow lumen, and the adjustable bend catheter 22 sequentially includes a second support section 221, a second shaping section 222 and a second adjustment section from the proximal end to the distal end. Bend section 223 . The bending curvature of the second molding section 222 is basically consistent with the bending curvature of the aortic arch, which ensures that the adjustable bend catheter 22 and the adjustable bend sheath tube 21 have better adaptability in bending shape. In order to ensure that the angle of the second bending section 223 is controllable during the bending process, and will not drive the second plastic section 222 to bend substantially during the bending process, the second bending section 223 The hardness of the material should be smaller than that of the second molding section 222 . The second supporting section 221 is mainly used to support the second bending section 223 and the second shaping section 222. In order to ensure that the second shaping section 222 will not cause the second supporting section 221 to bend substantially during the bending process, Therefore, the material hardness of the second molding section 222 should be smaller than the material hardness of the second supporting section 221 . In order to ensure that the second bending section 223 does not drive the first bending section 213 to bend substantially during the bending process, the material hardness of the second bending section 223 should be smaller than that of the first bending section 213 .

In addition, the adjustable bend catheter 22 also includes a second drawing wire (not shown in the figure), the second drawing wire is movably threaded in the tube wall of the adjustable bend catheter 22 along the axial direction of the adjustable bend catheter 22, the The distal end of the second pulling wire is connected to the distal end of the second bending section 223 , and the proximal end of the second pulling wire is connected to the handle assembly 5 . Specifically, a channel tube is provided in the tube wall of the adjustable bend catheter 22, and the channel tube extends along the axial direction of the adjustable bend catheter 22, and the distal end of the channel tube extends to the distal end of the second bending section 223, The proximal end of the channel tube extends to the proximal end of the second support section 221 , and the second pulling wire is movably passed through the channel tube. In some embodiments, a guide groove can also be provided directly on the tube wall of the adjustable bend catheter 22 , the guide groove extends along the axial direction of the adjustable bend catheter 22 , and the distal end of the guide groove extends to the second bend adjustment section 223 The proximal end of the guide groove extends to the proximal end of the second support section 221, and the second pulling wire is movably passed through the guide groove. The handle assembly 5 adjusts the bending of the second bending adjustment section 223 by controlling the second pulling wire to move in the axial direction. At the same time, in some embodiments, in order to prevent the twisting of the adjustable bend catheter 22 due to the fact that the pulling force direction of the second pulling wire is inconsistent with the bending direction of the second bending adjusting section 223, the second pulling wire should be passed through In the curved inner position of the adjustable bend conduit 22 close to the second bend adjustment section 223, to ensure the stability of the force direction of the adjustable bend conduit 22 during the working process; that is, the channel pipe or guide groove should be located in the second bend adjustment section 223's curved medial position.

Referring to Fig. 19 and Fig. 20, taking the ablation of hypertrophic tissue of the interventricular septum of myocardial tissue as an example, the ablation area formed by the ablation needle 1 for myocardial ablation proposed by the present invention is more suitable for the shape of myocardial tissue The realization principle is explained.

Since the shape of the interventricular septum in patients with hypertrophic cardiomyopathy is mostly prominent hypertrophy of the left ventricular outflow tract (anterior wall), when the ablation needle 1 protrudes from the distal end of the adjustable curved catheter 22, the puncture angle of the ablation needle 1 is usually The protruding part is vertical or close to vertical to the anterior wall of the interventricular septum, and the conduction nerve 6 is arranged along the edge of the interventricular septum (the conduction nerve 6 is arranged on the lower surface of the endocardium). The ablation area formed by the existing ablation needle 1 usually forms a relatively flat ellipsoid structure or cylinder structure in the middle around the axis of the ablation segment 11, and the long axis section of the ellipsoid structure or cylinder structure is a section in the X direction, and X The direction is roughly collinear with the axis of the ablation section 11, and the shape of the section in the X direction is flat oval or cylindrical (such as the first ablation area a), and the ablation range is small, requiring multiple puncture sites for multiple ablation. Cover the desired ablation area range. The present invention provides a plurality of perfusion holes 1121 on the straight ablation tube 112, so that the straight ablation tube 112 can improve the ablation efficiency, so that the ablation area can reach an enlarged ablation range (such as the second ablation area b).

Furthermore, the present invention also sets the ablation section 11 to have a preset difference in the axial direction, so that the release volume of the fluid in the middle area of the ablation section 11 is greater than that in the distal area of the ablation section 11 per unit time. The release amount and the release amount of the fluid in the proximal end region of the ablation segment 11 within a unit time make the cross-section of the ablation region in the X direction change from a flat, nearly elliptical or cylindrical shape to a circular or nearly circular ellipse, so that The ablation area is more rounded and full (such as the third ablation area c), and even the long axis direction of the ablation area can be changed from the X direction to the same or similar direction as the length direction (Y direction) of the interventricular septum. At the same time, the ablation area can be prevented from being close to the edge of the interventricular septum, thereby avoiding damage to the endocardium or epicardium due to the excessive ablation range formed by the two end regions of the ablation segment 11 . Since the conduction nerve 6 is arranged on the edge of the interventricular septum, the above setting can further avoid damage to the conduction nerve 6 due to the excessive ablation range formed by the two end regions of the ablation section 11, causing irreversible damage to the conduction nerve 6 and affecting Heart conduction.

It can be understood that since the length direction of the myocardial tissue central chamber wall, atrial wall and interventricular septum is roughly consistent with the length direction of the interventricular septum, the ablation needle 1 for myocardial ablation proposed by the present invention can also be applied to the ventricle wall , atrial wall and atrial septum, what needs to be known is that the length direction of myocardial tissue is roughly the direction from the atrium to the ventricle.

It can be understood that since the amount of fluid released is positively correlated with the perfusion area formed by the fluid, and the perfusion area is positively correlated with the formed ablation area, that is, when the energy provided by the energy generator 3 is constant, the amount of fluid released The more the number, the larger the ablation area formed. Therefore, the present invention enables the ablation section 11 to improve the ablation efficiency by providing a plurality of perfusion holes 1121 on the ablation section 11 . And because the ablation segment 11 has a preset difference in the axial direction, the release volume of fluid per unit time in the middle area of the ablation segment 11 is greater than the release volume of fluid per unit time in the distal area of the ablation segment 11 and the proximal end area of the ablation segment 11. The release amount of fluid in the upper area per unit time, so that the fluid perfusion area in the middle area of the ablation segment 11 is larger than the fluid perfusion area in the distal area of the ablation segment 11 and the fluid perfusion area in the proximal area of the ablation segment 11. The above settings can reduce the number of repeated operations of the instrument and shorten the duration of the operation. At the same time, such an ablation area can also adapt to the anatomical structure, and at the same time can reduce the risk of surgery, so as to achieve safe thinning of the interventricular septum, relief of outflow tract obstruction, and treatment of hypertrophic cardiomyopathy. Purpose.

Referring to Fig. 21, the present invention provides an ablation system for myocardial ablation, the ablation system includes an energy generator 3, a fluid perfusion device 4 and the above-mentioned ablation device for myocardial ablation; the energy generator 3 and the ablation needle 1 Electrical connection for providing ablation energy for the ablation needle 1; the fluid perfusion device 4 includes a fluid storage 41, a perfusion pump 42 and a fluid pipeline 43, the fluid storage 41 is used to store fluid; the perfusion pump 42 is used to transfer fluid from the fluid storage 41 to the lumen of the ablation needle 1 through the fluid conduit 43 . The handle assembly 5 is connected with the adjustable curved sheath tube 21, the adjustable curved catheter 22 and the ablation needle 1. Bend and motion trajectory and the axial movement of the ablation needle 1 in the adjustable bend catheter 22.

Referring to Fig. 22a-Fig. 22c, as an example, taking the ablation of hypertrophic tissue of interventricular septum as an example, the operation mode of an ablation system for myocardial ablation of the present invention is as follows:

1. Under the guidance of imaging equipment such as ultrasound/CT, the femoral artery is punctured, guided by a guide wire (not shown), and the adjustable curved sheath 21 is delivered to the side of the aortic valve close to the aortic arch through the aortic arch, As shown in Figure 22a.

2. By operating the handle assembly 5, when the adjustable curved sheath tube 21 reaches the target position, the adjustable curved catheter 22 is transported along the lumen of the adjustable curved sheath tube 21 to the side of the aortic valve close to the upper part of the aortic arch, And under the guidance of imaging equipment such as ultrasound/CT, it can cross the aortic valve without damaging the aortic valve. By operating the handle assembly 5, the bending direction and the bending angle of the adjustable bending section of the adjustable bending sheath tube 21 and the adjustable bending catheter 22 are controlled, so that the distal end of the adjustable bending catheter 22 can be well attached to the hypertrophic The expected first puncture ablation point on the interventricular septal wall, as shown in Figure 22b.

3. By operating the handle assembly 5, control the ablation needle 1 to protrude from the direction along the distal end of the adjustable curved catheter 22, puncture the interventricular septum, and reach the hypertrophic muscle tissue inside the interventricular septum. Under the double judgment of the upper scale mark, the angle and depth of its penetration are controlled, as shown in Figure 22c.

4. After the above steps are completed, start the perfusion pump 42, and the perfusion pump 42 will perfuse the fluid into the inner cavity of the ablation needle 1 through the fluid pipeline 43, and then turn on the energy generator 3, and perform ablation on the hypertrophic myocardial tissue at the desired ablation site through the ablation section 11. ablation.

5. Through contrast image observation, when the ablation range reaches the ideal size, stop the energy output of the external energy generator 3 and stop the fluid perfusion of the perfusion pump 42, and operate the handle assembly 5 to return the ablation needle 1 to the adjustable curved catheter 22 . Wherein, when there are multiple desired ablation points, the operations of steps S2-S4 may be repeated one or more times until the puncture and ablation of all desired ablation points are completed.

Please refer to Fig. 23 to Fig. 27 together. The structure of the ablation device provided by another embodiment of the present invention is similar to that of the above-mentioned ablation device. Specifically, the ablation device includes a delivery tube assembly for adjusting the ablation position and a The ablation component of the ablation. The adjustable bend catheter 22 of the delivery tube assembly is movably passed through the adjustable bend sheath 21 . The first bending section 213 is located at the distal end of the adjustable bending sheath 21, the second bending section 223 is located at the distal end of the adjustable bending catheter 22, and the second bending section 223 can extend out of the first bending section in the axial direction At the distal end of 213, the first bending section 213 can be bent along the first direction A, and the second bending section 223 can be bent along the second direction B, and the first direction A is different from the second direction B; the ablation needle 1 can move Penetrated in the adjustable bend catheter 22, the distal end of the ablation needle 1 can extend out of the distal end of the adjustable bend catheter 22 in the axial direction; Adjust the direction of ablation needle 1. Since the ablation needle can be driven to different ablation points through the cooperation of the adjustable curved sheath tube and the adjustable curved catheter, the target myocardial tissue can be ablated, making the operation process of the myocardial ablation operation flexible and controllable. Low trauma, precise, multi-point ablation, and speed up the procedure. In this embodiment, the ablation device adopts the path through the aortic arch to ablate the interventricular septum 10, so when the delivery tube assembly is located at the aortic arch, the first bending section and/or the second bending section are adjusted to drive the The ablation needle is pointed and inserted into different locations of the interventricular septum 10 . It can be understood that the ablation device can also take other paths to reach the ventricle, and ablate myocardial tissue at different locations as required.

The central axis of the adjustable curved sheath tube 21 is consistent with the central axis of the adjustable curved catheter 22 , that is, the central axes of the two coincide. It can be understood that, in other embodiments, the central axis of the adjustable curved sheath 21 and the central axis of the adjustable curved catheter 22 may be in the same direction but not consistent. For example, the adjustable curved sheath 21 is a multi-lumen tube with multiple There are two axially extending cavities, and the adjustable bend catheter 22 is passed through one of the cavities, and the central axes of the two do not coincide at this time.

The angle between the first direction A and the second direction B is greater than 0° and less than 360°, so that the selected point can be selected during the process of adjusting the first bending section 213 and/or the second bending section 223 The range is wider, thereby increasing the flexibility in the operation of myocardial ablation surgery. Preferably, the first direction A and the second direction B point oppositely, that is, the angle between the first direction A and the second direction B is 180°.

Please refer to Fig. 26, the adjustable bending sheath tube 21 is a tubular body with a hollow lumen, the proximal end of the first bending section 213 is connected with the distal end of the first molding section 212, and the proximal end of the first molding section 212 The end is connected with the distal end of the first support segment 211. In the working state, the positions of the proximal end and the distal end of the first shaping section 212 will match the starting and ending positions of the bending of the aortic arch, and the bending curvature of the first shaping section 212 is basically consistent with the bending curvature of the aortic arch , to ensure that the first plastic section 212 can pass through the aortic arch more smoothly and reach the designated position, and after the adjustable curved sheath tube 21 reaches the designated position, the first plastic section 212 can Maintaining continuous and good contact with the aortic arch allows the first shaping section 212 to be fixed at the position of the aortic arch, minimizing adverse effects on the operation caused by the movement of the adjustable curved sheath 21 . In order to ensure that the first plastic section 212 has good deformation performance and maintain good shape memory after deformation, the hardness of the material for making the first plastic section 212 is preferably 55-65D. In order to ensure that the angle of the first bending section 213 is controllable during the bending, and will not drive the first shaping section 212 to undergo large-scale bending during the bending process, the first bending section 213 The material hardness should be smaller than that of the first molding section 212 . The first supporting section 211 mainly plays the role of supporting the first bending section 213 and the first shaping section 212. In order to ensure that the first shaping section 212 will not cause the first supporting section 211 to bend substantially during the bending process, Therefore, the material hardness of the first supporting section 211 should be greater than the material hardness of the first molding section 212 .

In some embodiments, the adjustable bendable sheath tube 21 adopts the structure of a composite braided mesh tube, which can maintain high bending resistance while having good flexibility, push performance, and twist control.

The adjustable curved sheath tube 21 also includes a first pulling wire (not shown in the figure), and the first pulling wire is movably threaded in the outer peripheral wall of the adjustable curved sheath tube 21 along the axial direction of the adjustable curved sheath tube 21 , the distal end of the first pulling wire is connected to the distal end of the first bending section 213, and the proximal end of the first pulling wire is connected to the handle assembly 5 (see FIG. 35 ). Specifically, a channel tube is provided in the outer peripheral wall of the adjustable bend sheath tube 21, the channel tube extends along the axial direction of the adjustable bend sheath tube 21, and the distal end of the channel tube extends to the first bending section 213 the distal end of the channel tube, the proximal end of the channel tube extends to the proximal end of the first support section 211, and the first pulling wire is movably threaded in the channel tube; A guide groove is provided on the peripheral wall of the bend-adjusting sheath 21, and the guide groove extends axially along the adjustable bend sheath 21, and the distal end of the guide groove extends to the distal end of the first bend-adjusting section 213. The proximal end of the guide groove extends to the proximal end of the first support section 211 , and the first pulling wire is movably passed through the guide groove. The handle assembly 5 adjusts the bending direction of the first bending adjustment section 213 by controlling the first pulling wire to move in the axial direction. During the working process, the bending direction of the first bending section 213 is a first direction A, and the first direction A is a direction close to the inner side of the aortic arch. The ability of the first bending section 213 to bend toward the first direction A ensures that the distal end of the first bending section 213 can approach or move away from the interventricular septum 10 , which is convenient for subsequent selection of different ablation positions. During the bending adjustment process of the first bending adjustment section 213 , the included angle between the distal tangent of the first bending adjustment section 213 and the distal tangent of the first shaping section 212 ranges from 0° to 180°. In some embodiments, in order to prevent the twisting of the adjustable bending sheath 21 due to the inconsistency between the pulling force direction of the first pulling wire and the bending direction of the first bending adjustment section 213, the first pulling wire should be passed through The adjustable bend sheath tube 21 is close to the bend inner position of the first bend adjustment section 213, that is, the channel tube or guide groove should be located at the bend inner position of the first bend adjust section 213, so as to ensure that the adjustable bend sheath tube 21 is in the working process. Stability in the direction of force.

Please refer to Fig. 27, the adjustable bending catheter 22 is a tubular body with a hollow lumen, the proximal end of the second bending section 223 is connected to the distal end of the second molding section 222, and the proximal end of the second molding section 222 is connected to the distal end of the second molding section 222. The distal end of the second support segment 221 is connected. The curvature of the second molding section 222 is basically the same as the curvature of the aortic arch, which ensures that the adjustable curved catheter 22 and the adjustable curved sheath 21 have better adaptability in the curved shape, and avoids the mutual interaction between the two. influence interference. In order to ensure that the angle of the second bending section 223 is controllable during the bending process, and will not drive the second plastic section 222 to bend substantially during the bending process, the second bending section 223 The hardness of the material should be smaller than that of the second molding section 222 . The second support section 221 is mainly used to support the second bending section 223 and the second molding section 222. In order to ensure that the second molding section 222 will not drive the second support section 221 to be greatly bent during the bending process, therefore The material hardness of the second molding section 222 should be smaller than that of the second supporting section 221 . In order to ensure that the second bending section 223 does not drive the first bending section 213 to bend substantially during the bending process, the material hardness of the second bending section 223 should be smaller than that of the first bending section 213 .

The adjustable bend catheter 22 also includes a second pulling wire (not shown in the figure), and the second pulling wire is movably threaded in the outer peripheral wall of the adjustable bend catheter 22 along the axial direction of the adjustable bend catheter 22. The distal end of the second pulling wire is connected to the distal end of the second bending section 223 , and the proximal end of the second pulling wire is connected to the handle assembly 5 . Specifically, a channel tube is provided in the outer peripheral wall of the adjustable bend catheter 22, and the channel tube extends along the axial direction of the adjustable bend catheter 22, and the distal end of the channel tube extends to the far end of the second bending section 223. end, the proximal end of the channel tube extends to the proximal end of the second support section 221, and the second pulling wire is movably threaded in the channel tube; Guide grooves are provided on the peripheral wall of the conduit 22, and the guide grooves extend axially along the adjustable bend conduit 22, and the guide grooves of the guide grooves extend to the far end of the second bending section 223. The end extends to the proximal end of the second support section 221, and the second pulling wire is movably passed through the guide groove. The handle assembly 5 adjusts the bending of the second bending section 223 by controlling the second pulling wire to move in the axial direction. At the same time, in order to adapt to the bending direction of the second bending section 223, the second drawing wire should be passed through the bendable inner position of the adjustable bending catheter 22 close to the second bending section 223, that is, the catheter or the The guide groove should be located at the curved inner side of the second bending section 223 . During the working process, the bending direction of the second bending section 223 is the second direction B, and the second direction B is the direction that the aortic arch faces the outside of the arch. The second bending section 223 can be bent in the second direction B to ensure that the distal end of the second bending section 223 can approach or move away from the interventricular septum 10 , which facilitates subsequent selection of different ablation positions. During the bending adjustment process of the second bending adjustment section 223, the angle C between the distal tangent line of the second bending adjustment section 223 and the distal tangent line of the second shaping section 222 ranges from 0° to 90°. The angle C between the distal tangent of the second bending section 223 and the distal tangent of the second shaping section 222 is 45°.

Please refer to Fig. 28 to Fig. 30 together, the adjustable bending catheter 22 also includes a stopper 224, and the stopper 224 is arranged at the far end of the second bending section 223, and in the specific working process, the second bending section 223 bends to the second direction B and approaches the interventricular septum 10, and then the stopper 224 is closely attached to the adventitia of the interventricular septum 10 to provide support for the ablation needle 1 to puncture the interventricular septum 10 adventitia, while ensuring that the ablation needle 1 There will be no significant movement during the puncture, thus ensuring that the puncture point can be accurately controlled. The limiting member 224 has a rounded distal end surface to avoid damage to the inner wall of the adjustable curved sheath tube 21 and heart tissues such as endocardium and valves of the human body. The limiting member 224 may be a hemisphere disposed at the distal end of the adjustable bending catheter 22 , and the spherical surface of the hemisphere is disposed in a direction away from the distal surface of the second bending section 223 . In this embodiment, the limiting member 224 is a boss, the outer diameter of the distal end of the boss is larger than the outer diameter of the proximal end, and the proximal end of the boss is nested into the inner cavity 2231 of the second bending section 223, and the fixing method is Including but not limited to bonding, welding, and the proximal end of the boss can also be subjected to subsequent processing such as sandblasting, hollowing out, drilling, and grooving to increase the firmness of its connection with the inner cavity 2231 . The stopper 224 includes a central through hole 2241 completely penetrating in the axial direction, the central through hole 2241 is connected with the inner cavity 2231, the diameter D1 of the central through hole 2241 should be smaller than the diameter D2 of the inner cavity 2231, and the largest outer diameter of the ablation needle 1 The diameter D3 (see FIG. 32 ) should be smaller than the diameter D1 of the central through hole 2241, so as to ensure that the distal end of the ablation needle 1 located in the lumen 2231 can extend out of the distal end of the stopper 224 through the central through hole 2241. The limiting member 224 is made of materials including but not limited to stainless steel, polyoxymethylene, polycarbonate, etc., and is made by machining or injection molding.

Please refer to FIGS. 29 to 32 together. The ablation needle 1 includes a needle assembly, a main body tube 15 , a temperature sensor 113 and a liquid inlet tube 16 . Specifically, the needle assembly includes a needle 111 , a straight ablation tube 112 , a flexible reinforcing tube 12 , a conductive part 121 and an inner cavity 115 . Wherein, the proximal end of the needle 111 is connected to the distal end of the straight ablation tube 112, and the proximal end of the needle 111 is in the shape of a boss, and the boss is partially nested into the lumen 115 of the straight ablation tube 112. Preferably, Laser welding is used for fixed connection; the proximal end of the straight ablation tube 112 is connected to the distal end of the flexible reinforcing tube 12, so that the connection between the needle assembly and the main tube 15 can ease the transition, and the conductive part 121 is arranged on the flexible reinforcing tube Proximal end of 12. The straight ablation tube 112, the flexible reinforcing tube 12 and the conductive part 121 can be processed by the same integral metal round tube, or two different metal round tubes can be connected by welding or other fixed methods. Preferably, laser Fixing method by welding. In this embodiment, the straight ablation tube 112, the flexible reinforcing tube 12 and the conductive part 121 are cut from the same integral metal tube by laser cutting. The needle assembly is made of a metal material with good electrical conductivity, which can realize electrical conduction. Preferably, the needle assembly is made of stainless steel.

Please refer to Fig. 32, the distal end of the needle 111 is closed, and the proximal end has a hollow lumen 1111, the lumen 1111 is connected with the lumen 115 of the needle assembly, the temperature sensor 113 can extend into the lumen 1111, so that the temperature sensor 113 can Measure the temperature of the distal end of the needle assembly more accurately, improve the accuracy of temperature measurement, and reduce the error of temperature measurement. At the same time, the cooling liquid can enter the inner cavity 1111 to improve the heat dissipation efficiency of the needle 111, thereby improving the temperature during the ablation process. Ablation efficiency, reducing the possibility of scab formation at the ablation site. Optionally, the surface of the needle 111 may be plated with a layer of gold coating or not limited to other radiopaque coating materials to enhance the visualization of the needle 111 under CT. The distal end of the needle 111 has a sharp point, preferably, the needle 111 adopts a triangular pyramid head. Please refer to FIG. 33 , in some embodiments, the needle 111 can also be a beveled edge head 111b or a conical pointed head 111c.

Please refer to Fig. 31 and Fig. 32, the flexible reinforcing pipe 12 can be cut by using a hypotube, and the cutting forms include one-side cutting of the pipe body and four-way cutting of the pipe body. Preferably, the cutting method of four-way cutting of the pipe body is adopted, so that The flexible reinforcing tube 12 can be bent in a direction of 360°. Since the connecting portion of the needle assembly and the main body tube 15 is at the position of the second bending section 223, during the bending process of the second bending section 223, the distal end of the main tube will follow the second bending section to bend, and the flexible The presence of the reinforcing tube 12 can increase the bending resistance of the main tube 15 in a bent state, and prevent the main tube 15 from being bent during the bending adjustment process of the adjustable bend conduit 22 . The conductive part 121 is used to connect the far end of the wire (not shown in the figure), and the proximal end of the wire is connected to the energy generator 3 (see FIG. 13 ), so as to realize the electrical connection between the needle assembly and the energy generator 3. Connection, the conductive part 121 can be a connecting hole or a connecting hook to increase the firmness of the connection between the wire and the conductive part 121 and the goodness of contact. The connecting hole or connecting hook includes but is not limited to a round hole, a square hole , slots, barbs and notches.

Please refer to Figure 32. The main body tube 15 is sleeved on the outside of the flexible reinforcing tube 12. The distal end of the main tube 15 should exceed the distal end of the flexible reinforcing tube 12 to ensure that the inner cavity of the ablation needle 1 forms a closed space. The main body tube 15 It is preferably fixed with the flexible reinforcing pipe 12 by means of glue bonding. The main body tube 15 is made of insulating material, and should have good bending resistance, push performance, surface lubrication performance and bending performance. The preferred insulating materials include but are not limited to polymer materials such as polyetheretherketone and polyimide. .

The temperature sensor 113 is arranged axially in the inner cavity 115 , the distal end of the temperature sensor 113 is located in the inner cavity 1111 , and the proximal end of the temperature sensor 113 passes through the handle assembly 5 and is connected to the energy generator 3 through wires. The temperature sensor 113 can monitor the temperature of the distal end of the ablation needle 1 during the ablation process, and adjust the output power/energy of the energy generator 3 through real-time temperature feedback, so as to prevent carbonization and scarring of the myocardial tissue contacted by the distal end of the ablation needle 1 And other phenomena, causing the ablation energy cannot be effectively diffused, and the ablation range is too small for adverse effects. Optionally, the temperature sensor 113 can be arranged in the inner cavity 161 of the liquid inlet pipe 16 , or can be arranged outside the liquid inlet pipe 16 . Temperature sensor 113 includes thermocouple type and thermal resistance type, preferably, temperature sensor 113 adopts thermocouple type, temperature sensor 113 includes but not limited to K-type thermocouple, T-type thermocouple and S-type thermocouple, preferably, temperature sensor 113 uses a K-type thermocouple to ensure that the temperature sensor 113 has a high temperature measurement linearity and high sensitivity.

The liquid inlet pipe 16 is a hollow pipe body, which passes through the main body pipe 15 and the needle assembly, and is used for delivering cooling medium to cool the needle assembly. The far end of the liquid inlet tube 16 is close to the proximal end of the needle 111, the proximal end of the liquid inlet tube 16 passes through the handle assembly 5 and is connected with the far end of the fluid pipeline 43 (see Figure 35), and the liquid inlet tube 16 is used as a cooling medium The inflow channel, the gap between the outer wall of the liquid inlet pipe 16 and the inner cavity 115 is used as the outflow channel of the cooling medium, and the outflow channel is connected with the distal end of the outflow tube 45 (see FIG. 35 ) in the handle assembly 5, the The inflow channel merges with the outflow channel in the lumen 1111 .

Please refer to Fig. 34. In some embodiments, the structure of the ablation needle 1b is basically the same as that of the ablation needle 1, except that the main tube 15 is sleeved inside the flexible reinforcing tube 12, and the distal end of the main tube 15 should be beyond the distal end of the flexible reinforcing tube 12 to ensure that the inner cavity of the ablation needle 1b forms a closed space.

Please refer to Figures 29-30, in the initial state, the ablation needle 1 is stored in the lumen 2231 of the adjustable curved catheter 22, and the distal end of the ablation needle 1 does not exceed the distal end of the stopper 224, so as to ensure that The adjustable curved catheter 22 of the ablation needle 1 will not damage the inner wall of the adjustable curved sheath tube 21 and the endocardium and valves of the human body during delivery, but the needle 111 should not completely retreat from the central through hole 2241 And enter the inner cavity 2231 . In the working state, the handle assembly 5 can control the ablation needle 1 to protrude from the inner cavity 2231 along the axis direction of the adjustable curved catheter 22 .

Please refer to FIG. 35 , the present invention also provides a transcatheter myocardial ablation system 100. The transcatheter myocardial ablation system 100 includes a handle assembly 5, an energy generator 3, a fluid perfusion device 4 and the aforementioned ablation device. The energy generator 3 is The transcatheter myocardial ablation system provides energy, the fluid perfusion device 4 is used to dissipate heat from the ablation needle 1 , and the energy generator 3 and the fluid perfusion device 4 are respectively connected to the ablation device.

Wherein, the fluid perfusion device 4 includes a perfusion pump 42 , a fluid pipeline 43 , an outflow tube 45 , a cooling medium collection tank 47 and a fluid storage 41 . The perfusion pump 42 is connected to the fluid reservoir 41 through a catheter, the proximal end of the fluid pipeline 43 is connected to the perfusion pump 42, the distal end is connected to the ablation device, the proximal end of the outflow tube 45 is connected to the cooling medium collection tank 47, and the distal end is connected to the cooling medium collection tank 47. The ablation device is connected. Specifically, the fluid storage 41 is used to store the cooling medium; the cooling medium collection tank 47 is used to recover the used cooling medium; the perfusion pump 42 is used to transport the cooling medium from the fluid storage 41 to the ablation needle 1 through the fluid pipeline 43 The inflow tube 71 is used to provide a delivery channel for the cooling medium to flow in; and the outflow tube 45 is used to provide a delivery channel for the cooling medium to flow out.

Please refer to FIG. 36 to FIG. 40 together. The operation method of the transcatheter myocardial ablation system 100 will be described below by taking the working process of hypertrophic myocardial ablation as an example, which mainly includes the following steps:

Step 1: Under the guidance of ultrasound or CT, puncture the femoral artery of the patient and place the adjustable curved sheath 21, and guide the adjustable curved sheath 21 along the aortic arch to the aortic The position of the aortic valve on the side of the aortic arch.

Step 2: When the adjustable curved sheath tube 21 reaches the position of the aortic valve close to the aortic arch, operate the operating handle 50 to transport the adjustable curved catheter 22 along the lumen of the adjustable curved sheath tube 21 to the position of the aortic valve close to the side of the aortic arch, and cross the aortic valve under the guidance of ultrasound/CT without damaging the aortic valve.

Step 3: Operate the handle assembly 5 to bend the first bending section 213 and/or the second bending section 223 so that the distal end of the stopper 224 can be in close contact with the outer surface of the myocardial tissue 10 to be ablated.

Step 4: Operate the handle assembly 5 to control the ablation needle 1 to protrude from the inner cavity 2231 along the axial direction of the adjustable curved catheter 22. The ablation needle 1 pierces the epicardium and reaches the inside of the interventricular septum 10. The angle and depth at which the ablation needle 1 penetrates into the target tissue is controlled under the double judgment of the scale mark on the handle assembly 5 .

Step 5: After completing the above four steps, first start the perfusion pump 42, the cooling medium circulates inside the fluid perfusion device 4 for a few seconds, and then turn on the energy generator 3, and perform the treatment on the target hypertrophic myocardial tissue through the distal end of the ablation needle 1 ablation.

Step 6: When the target hypertrophic myocardial tissue is ablated to a reasonable size by the ablation needle 1, turn off the energy generator 3, turn off the perfusion pump 42, and return the ablation needle 1 to the inside along the axial direction of the adjustable curved catheter 22 through the handle assembly 5 Inside cavity 2231.

Step 7: Operate the handle assembly 5 to release the bending of the first bending section 213 and/or the second bending section 223 , so that the distal end of the stopper 224 is away from the adventitia of the interventricular septum 10 wall. Then the handle assembly 5 is operated to select the next target puncture point on the wall membrane of the interventricular septum 10 . At this time, the distal end of the adjustable curved catheter 22 will present an arc swing from point E to point F, within a suitable range, select 1, 2, 3, 4 or even more puncture sites. When the next target puncture site is selected, repeat the operations from the third step to the sixth step until the selection, puncture and ablation of all preset points are completed.

Step 8: After the ablation is completed, a plurality of continuous ablation zones will be left on the hypertrophic interventricular septum 10, and the multiple ablation zones can be connected together to form a long continuous ablation range.

The above is the implementation of the embodiment of the present application. It should be pointed out that for those of ordinary skill in the art, without departing from the principle of the embodiment of the present application, some improvements and modifications can also be made. These improvements and modifications are also It is regarded as the scope of protection of this application.

Claims

An ablation needle for myocardial ablation, characterized in that the ablation needle includes an ablation section capable of puncturing into myocardial tissue, the ablation section punctures into the myocardial tissue through the endocardium, and can release energy to destroy the Myocardial activity of myocardial tissue;

The ablation section has an axial lumen, and the ablation section is provided with at least one perfusion hole communicating with the lumen of the ablation section, and the perfusion hole is used to transfer the fluid in the lumen of the ablation section Released to the myocardial tissue, the fluid can expand the ablation range formed by the ablation segment in the myocardial tissue;

The ablation segment has a preset difference in the axial direction, and the preset difference makes the fluid release volume of the perfusion hole in the middle area of the ablation segment greater than that in the proximal area of the ablation segment per unit time. The amount of fluid released in the ablation segment is greater than the amount of fluid released per unit time in the region of the distal end of the ablation segment.
The ablation needle for myocardial ablation according to claim 1, wherein the myocardial tissue is an interventricular septum, and the ablation segment is punctured into the interventricular septum through the left ventricle or the right ventricle, and then through the endocardium.
The ablation needle for myocardial ablation according to claim 1, wherein the number of the perfusion holes is multiple, and the multiple perfusion holes are arranged along the circumferential direction and the axial direction of the ablation section at the same time.
The ablation needle for myocardial ablation according to claim 2, wherein the preset difference includes: the total fluid release area of the perfusion hole in the middle region of the ablation segment is larger than the proximal end of the ablation segment The total fluid release area of the perfusion holes in the region is greater than the total fluid release area of the perfusion holes in the distal region of the ablation section.
The ablation needle for myocardial ablation according to claim 3, wherein the opening area of the perfusion hole located in the middle region of the ablation section is larger than the opening area of the perfusion hole located in the proximal region of the ablation section , while being larger than the opening area of the perfusion holes in the distal region of the ablation segment, and/or the density of the perfusion holes in the middle region of the ablation segment is greater than that of the perfusion holes in the proximal region of the ablation segment The degree of density is greater than the density of the perfusion holes in the distal region of the ablation segment, so that the total fluid release area of the perfusion holes in the middle region of the ablation segment is greater than the fluid in the proximal region of the ablation segment The total area of release is simultaneously greater than the total area of fluid release of the perfusion holes in the region of the distal end of the ablation segment.
The ablation needle for myocardial ablation according to any one of claims 1-5, wherein the preset difference includes: the cross-sectional area of the lumen in the middle region of the ablation segment is smaller than the ablation The cross-sectional area of the lumen in the proximal region of the segment is smaller than the cross-sectional area of the lumen in the distal region of the ablation segment.
The ablation needle for myocardial ablation according to claim 6, characterized in that, the cross-sectional area of the lumen in the region of the distal end of the ablation segment is smaller than the transverse area of the lumen in the region of the proximal end of the ablation segment cross-sectional area.
The ablation needle for myocardial ablation according to claim 1, wherein the ablation segment includes a needle and a straight ablation tube, the needle is connected to the distal end of the straight ablation tube, and the needle is One of triangular pyramid head, bevel edge head or conical pointed head.
The ablation needle for myocardial ablation according to claim 8, characterized in that, the ablation needle further comprises a flexible reinforcing tube, a conductive part, and a main body segment, and the proximal end of the ablation segment is connected to the distal end of the flexible reinforcing tube. end connection, the conductive part is provided at the proximal end of the flexible reinforcing tube, the conductive part is used to electrically connect with the energy generator to provide energy for the ablation segment, the main body segment is made of insulating material, the The main body section is sleeved on the outside or inside of the flexible reinforcing tube, and the distal end of the main body section is sealingly connected to the proximal end of the ablation section.
The ablation needle for myocardial ablation according to claim 9, wherein the proximal end of the straight ablation part is connected to the distal end of the flexible reinforcing tube, and the straight ablation part is connected to the flexible reinforcing tube. The part is the same tube body, or is formed by connecting different tube bodies, and the lumen of the straight ablation part communicates with the hollow lumen of the needle.
The ablation needle for myocardial ablation according to claim 1, wherein the ablation needle further comprises a temperature sensor, the temperature sensor is arranged on the ablation needle, and the temperature sensor is used to measure the temperature of the ablation needle. temperature.
An ablation device for myocardial ablation, comprising the ablation needle according to any one of claims 1-11 and a delivery tube assembly, the delivery tube assembly includes an adjustable curved sheath tube and is movably worn on an adjustable bend catheter in the adjustable bend sheath;

The ablation needle is movably inserted in the adjustable bend catheter, and the distal end of the ablation needle can protrude from the distal end of the adjustable bend catheter.
The ablation device for myocardial ablation according to claim 12, characterized in that, the adjustable bend sheath includes a first bend-adjusting section located at the distal end, and the adjustable bend catheter includes a second bend-adjusting section located at the distal end. a bending section, the second bending section extends from the distal end of the first bending section, the first bending section bends along a first direction, and the second bending section bends along a second direction, The first direction is different from the second direction; the ablation device further includes an ablation assembly, the ablation assembly includes an ablation needle that is movably inserted in the adjustable bend catheter, and the distal end of the ablation needle The distal end of the adjustable bendable catheter can be extended; and the direction of the ablation needle can be adjusted by bending the first bend-adjusting section and/or the second bend-adjusting section.
The ablation device for myocardial ablation according to claim 13, wherein the first direction and the second direction point oppositely.
The ablation device for myocardial ablation according to claim 13, wherein the ablation device is used for ablation of interventricular septum, and when the delivery tube assembly is located at the aortic arch, the first bending section and the /or the second bending section to drive the ablation needle to point to different positions of the interventricular septum.
The ablation device for myocardial ablation according to claim 15, wherein the first direction is a direction close to the inside of the aortic arch, and the second direction is a direction toward the outside of the aortic arch.
The ablation device for myocardial ablation according to claim 15, characterized in that, the adjustable bendable sheath further comprises a first plastic section located at the proximal end of the first bending section, and the first plastic section The angle range between the distal tangent of the profile segment and the distal tangent of the first bending section is 0°-180°.
The ablation device for myocardial ablation according to claim 17, wherein the adjustable bend catheter further comprises a second shaping section located at the proximal end of the second bending adjustment section, and the second shaping section The angle between the tangent line at the distal end of the segment and the tangent line at the distal end of the second bending adjustment segment ranges from 0° to 90°.
The ablation device for myocardial ablation according to claim 18, characterized in that, when the ablation needle points to the interventricular septum, the curvature of the first shaping section is basically consistent with the curvature of the aortic arch, so The bending curvature of the second shaping section is basically consistent with the bending curvature of the aortic arch.
An ablation system for myocardial ablation, comprising an energy generator, a fluid perfusion device, and the ablation device for myocardial ablation according to any one of claims 12-19;

The energy generator is electrically connected to the ablation needle, and is used to provide energy for the ablation needle,

The fluid perfusion device is connected with the ablation needle, and is used for delivering the fluid to the lumen of the ablation needle.
The ablation system for myocardial ablation according to claim 20, wherein the fluid perfusion device comprises: a fluid storage, a perfusion pump and a fluid pipeline;

the fluid reservoir is used to store the fluid;

The perfusion pump is used to deliver the fluid from the fluid reservoir to the lumen of the ablation needle through the fluid conduit.
An ablation system for myocardial ablation, comprising an energy generator, a cooling circulation device, and the ablation device according to any one of claims 12-19;

The energy generator provides energy for the transcatheter myocardial ablation system, the cooling circulation device is used to dissipate heat to the ablation needle, and the energy generator and the cooling circulation device are respectively connected to the ablation device.
The ablation system for myocardial ablation according to claim 22, characterized in that it comprises:

a fluid storage, the fluid storage is used to store cooling medium;

A cooling medium collection tank, the cooling medium collection tank is used to recycle the used cooling medium;

an infusion pump, the infusion pump is used to deliver the cooling medium from the cooling medium storage to the inside of the ablation needle through the inflow tube;

a fluid conduit, the proximal end of the fluid conduit is connected to the perfusion pump, and the distal end of the fluid conduit is connected to the ablation device; and

An outflow tube, the proximal end of the outflow tube is connected to the cooling medium collection tank, and the distal end of the outflow tube is connected to the ablation device.