Ablation needle, ablation device and ablation system for myocardial ablation

Abstract

The present invention discloses an ablation needle, an ablation device and an ablation system for myocardial ablation, wherein the ablation needle comprises an ablation segment capable of puncturing into myocardial tissue, the ablation segment having an axial inner cavity, and the ablation segment is provided with at least one perfusion hole connected to its inner cavity, and the perfusion hole is used to release the fluid in the inner cavity to the myocardial tissue. In addition, the ablation segment has a preset difference in the axial direction, and the preset difference makes the amount of fluid released per unit time by the perfusion holes in the middle area of ​​the ablation segment greater than the amount of fluid released per unit time by the proximal end area of ​​the ablation segment, and greater than the amount of fluid released per unit time by the distal end area of ​​the ablation segment. The ablation needle of the present invention, by setting a preset difference in the axial direction of the ablation segment, makes the ablation area formed by the ablation segment on the myocardial tissue adapt to the morphology of the myocardial tissue, reduces the surgical risk, and achieves a better treatment effect.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an ablation needle, an ablation device and an ablation system for myocardial ablation. Background Art

[0002] Hypertrophic cardiomyopathy is a common autosomal dominant cardiovascular disease with an incidence rate 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 hypertrophy of one or more segments of the left ventricle (LV). The general diagnostic criterion is a thickness greater than or equal to 15mm. When the anterior mitral valve leaflet (ATVL) moves forward during systole and abuts against the interventricular septum (IVS), causing stenosis or even obstruction of the left ventricular outflow tract (LVOT), that is, when the pressure gradient in the left ventricular outflow tract is too large, it is called obstructive hypertrophic cardiomyopathy. Figure 1a and Figure 1b As shown, Figure 1a and Figure 1b The following are structural schematic diagrams of the ventricular septum in normal morphology and in hypertrophic morphology. In the most common phenotype, the myocardial hypertrophy and thickening of the anterior wall of the ventricular septum close to the aortic valve (AV) (the part close to the left ventricular outflow tract) are more obvious, while there is little or no hypertrophy on the posterior wall of the left ventricle.

[0003] Currently, the treatment strategy for obstructive hypertrophic cardiomyopathy is to enlarge the left ventricular outflow tract to reduce the pressure gradient and alleviate its obstruction. Commonly used treatment methods include drug therapy, septal rotation and septal alcohol ablation, etc. However, these methods do not combine the morphology of the myocardial tissue to be ablated (such as the ventricular septum) to accurately control the ablation area, which easily increases the safety risk of the operation. Summary of the invention

[0004] In order to overcome at least one of the problems existing in the above-mentioned prior art, the present invention provides an ablation needle, an ablation device and an ablation system for myocardial ablation, which can solve the shortcomings of the prior art that the ablation area formed on the myocardial tissue is uncontrollable, resulting in high surgical risks.

[0005] The technical solution adopted by the present invention to solve the problem is:

[0006] In a first aspect, the present invention provides an ablation needle for myocardial ablation, the ablation needle comprising an ablation segment capable of puncturing into myocardial tissue, the ablation segment puncturing into the myocardial tissue through the endocardium and capable of releasing energy to destroy myocardial activity of the myocardial tissue;

[0007] The ablation segment has an axial inner cavity, and the ablation segment is provided with at least one perfusion hole connected to the inner cavity of the ablation segment, the perfusion hole is used to release the fluid in the inner cavity of the ablation segment into the myocardial tissue, and the fluid can expand the ablation range formed by the ablation segment in the myocardial tissue;

[0008] The ablation segment has a preset difference in the axial direction, and the preset difference makes the fluid release amount per unit time of the perfusion hole in the middle area of ​​the ablation segment greater than the fluid release amount per unit time of the proximal area of ​​the ablation segment and the fluid release amount per unit time of the distal area of ​​the ablation segment.

[0009] In a second aspect, the present invention further provides an ablation device for myocardial ablation, comprising the above-mentioned ablation needle and a delivery tube assembly, wherein the delivery tube assembly comprises an adjustable bending sheath tube and an adjustable bending catheter movably disposed in the adjustable bending sheath tube;

[0010] The ablation needle can be movably inserted into the adjustable bend catheter, and the distal end of the ablation needle can extend out of the distal end of the adjustable bend catheter.

[0011] In a third aspect, the present invention further provides an ablation system for myocardial ablation, comprising an energy generator, a fluid perfusion device and the above-mentioned ablation device;

[0012] The energy generator is electrically connected to the ablation needle and is used to provide energy to the ablation needle.

[0013] The fluid perfusion device is connected to the ablation needle and is used to deliver the fluid to the inner cavity of the ablation needle.

[0014] It can be understood that by setting a perfusion hole connected to the inner cavity of the ablation segment on the ablation segment, the perfusion hole is used to release fluid that can expand the ablation range formed by the ablation segment in the myocardial tissue, that is, the amount of fluid released is directly proportional to the ablation range formed by the ablation segment in the myocardial tissue, thereby improving the ablation efficiency and reducing the operation time. At the same time, by controlling the preset difference in the axial direction of the ablation segment, the preset difference makes the amount of fluid released in the middle area of ​​the ablation segment per unit time greater than the amount of fluid released in the proximal area of ​​the ablation segment per unit time and the amount of fluid released in the distal area of ​​the ablation segment per unit time. Since the amount of fluid released is directly proportional to the ablation range formed by the ablation segment in the myocardial tissue, and since the ablation segment enters the myocardial tissue through endocardial puncture, that is to say, the length direction of the ablation segment (that is, the puncture direction of the ablation segment) and the length direction of the myocardial tissue have an angle, which is usually 90° or close to 90°. Therefore, by making the amount of fluid released in the middle area of ​​the ablation segment per unit time greater than the amount of fluid released in the proximal area of ​​the ablation segment per unit time and the amount of fluid released in the distal area of ​​the ablation segment per unit time, The amount of fluid released makes the ablation range formed by the middle area of ​​the ablation segment larger than the ablation range formed by the proximal end area of ​​the ablation segment and the ablation range formed by the distal end area of ​​the ablation segment, so that the cross-section of the ablation area in the axial direction of the ablation segment changes from the original flat, approximately elliptical or cylindrical shape to a round or nearly round elliptical shape with a full middle part, and even the long axis direction of the ablation area can be changed from the axial direction of the ablation segment to a direction that is the same as or close to the length direction of the myocardial tissue. Therefore, the ablation area formed by the ablation needle of the embodiment of the present invention will better match the morphology of the myocardial tissue, avoiding damage to the endocardium or epicardium due to excessive ablation ranges formed by the two end areas of the ablation segment, while increasing the ablation efficiency as much as possible, and improving the safety of the operation, thereby reducing the risk of surgery and achieving better treatment effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1a and Figure 1b They are schematic diagrams of the structures of the ventricular septum in normal form and the ventricular septum in hypertrophic form;

[0016] Figure 2 is a cross-sectional schematic diagram of the ablation section in the ablation needle of the present invention;

[0017] Figure 3a , Figure 3b and Figure 3c They are schematic diagrams of structures in which the perfusion holes in the ablation needle of the present invention are circular, square or triangular respectively;

[0018] Figure 4a , Figure 4b and Figure 4cThey are schematic diagrams of the structures of the ablation needle of the present invention, wherein the needle head is a conical pointed head, a triangular pyramid head, and a beveled cutting edge head;

[0019] Figure 5 A schematic diagram of the structure of the ablation section in the ablation needle of the present invention;

[0020] Figure 6 for Figure 5 Schematic cross-section of the ablation segment;

[0021] Figure 7 It is another structural schematic diagram of the ablation section in the ablation needle of the present invention;

[0022] Figure 8 for Figure 7 Schematic cross-section of the ablation segment;

[0023] Fig. 9 is another cross-sectional schematic diagram of the ablation segment in the ablation needle of the present invention;

[0024] Fig.10 is another cross-sectional schematic diagram of the ablation segment in the ablation needle of the present invention;

[0025] Fig.11 is another cross-sectional schematic diagram of the ablation segment in the ablation needle of the present invention;

[0026] Fig.12 It is a schematic structural diagram of the ablation section and the flexible reinforcement tube in the ablation needle of the present invention;

[0027] Fig.13 is a schematic structural diagram of the ablation needle of the present invention;

[0028] Fig.14 It is a cross-sectional schematic diagram of the main body section of the ablation needle of the present invention being sleeved on the outside of the flexible reinforcement tube;

[0029] Fig.15 It is a cross-sectional schematic diagram of the main body section of the ablation needle of the present invention being sleeved inside the flexible reinforcement tube;

[0030] Fig.16 It is a schematic diagram of the structure of the ablation needle in the ablation device of the present invention puncturing into the myocardial tissue;

[0031] Fig.17 is a schematic structural diagram of the ablation device of the present invention;

[0032] Fig.18 It is a schematic diagram of the structure of the adjustable curved catheter in the ablation device of the present invention;

[0033] Fig.19 It is a schematic structural diagram of the ablation needle in the ablation device of the present invention puncturing into the myocardial tissue and forming an ablation area;

[0034] Fig. 20 for Fig.19 A partial enlarged view of the middle A area;

[0035] Fig.21 is a schematic structural diagram of the ablation system of the present invention;

[0036] Fig.22a , Figure 22b and Fig.22c Schematic diagram of the operation flow of the ablation system of the present invention.

[0037] The meanings of the reference numerals are as follows:

[0038] 1. Ablation needle; 11. Ablation section; 111. Needle; 112. Straight ablation tube; 1121. Infusion hole; 113. Temperature sensor; 12. Flexible reinforcement tube; 121. Conductive part; 13. Main section; 2. Delivery tube assembly; 21. Adjustable bending sheath tube; 211. First support section; 212. First shaping section; 213. First bending adjustment section; 22. Adjustable bending catheter; 221. Second support section; 222. Second shaping section; 223. Second bending adjustment section; 3. Energy generator; 4. Fluid infusion device; 41. Fluid storage device; 42. Infusion pump; 43. Fluid pipeline; 5. Handle assembly; 6. Conducting nerve;

[0039] a-first ablation area; b-second ablation area; c-third ablation area. DETAILED DESCRIPTION

[0040] For better understanding and implementation, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention.

[0041] In the description of the present invention, it should be noted that the terms "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside" and "outside" etc. indicating directions or positional relationships are based on the directions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific direction, be constructed and operated in a specific direction, and therefore cannot be understood as a limitation on the present invention.

[0042] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used in the specification of the present invention herein are only for the purpose of describing specific embodiments and are not intended to limit the present invention.

[0043] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", and "set on..." should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection; it can be directly connected, or indirectly connected through an intermediate medium, or it can be an internal connection between two components. In the field of interventional medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator; the axial direction refers to the direction parallel to the line connecting the distal center and the proximal center of the medical device, the radial direction refers to the direction along the diameter or radius, the radial direction is perpendicular to the axial direction, and the circumferential direction refers to the circumferential direction around the central axis. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0044] See also Figure 2 The present invention first provides an ablation needle 1 for myocardial ablation, wherein the ablation needle 1 comprises an ablation segment 11 capable of puncturing into myocardial tissue. The ablation segment 11 punctures into the myocardial tissue through the endocardium and can release energy to destroy the myocardial activity of the myocardial tissue.

[0045] Among them, the myocardial tissue includes the ventricular wall, atrial wall, ventricular septum and atrial septum, etc. Therefore, the ablation needle 1 in the embodiment of the present invention can be used to ablate the hypertrophic myocardium in the ventricular wall, atrial wall, ventricular septum and atrial septum, etc., and is particularly suitable for ablating the hypertrophic myocardium in the ventricular septum.

[0046] Optionally, the ablation segment 11 is made of a metal material with good electrical conductivity, such as stainless steel, nickel-titanium alloy, etc., so that electrical conduction can be achieved to 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. Among them, the axial length of the needle 111 can be between 0.1mm-0.5mm, and the axial length of the straight ablation tube 112 can be between 3.2mm-9.5mm. The straight ablation tube 112 has an axially through inner cavity, and the straight ablation tube 112 is provided with at least one perfusion hole 1121 connected to its inner cavity, and the perfusion hole 1121 is used to transport fluid to the tissue around the straight ablation tube 112, and the fluid can expand the ablation range of the ablation segment 11. The ablation energy can be radio frequency energy, microwave ablation, ultrasonic energy, etc. In this embodiment, the ablation energy is radio frequency ablation.

[0047] In other embodiments, the ablation section 11 may also be composed only of the straight ablation tube 112, that is, the needle 111 is a separate component relative to the ablation section 11, and the needle 111 is not used to release ablation energy. For example, the needle 111 is made of non-conductive material (such as polymer material), and the straight ablation tube 112 is made of conductive material.

[0048] In other embodiments, the ablation segment 11 may also be made of a polymer material. When the ablation segment 11 is made of a polymer material, one or more annular metal electrodes spaced apart in the axial direction may be provided on the ablation segment 11. The metal electrodes are fixed to the ablation segment 11 by means including but not limited to bonding, welding, crimping, welding, etc., and are connected to the energy generator (such as Fig.21 The above-mentioned annular metal electrode can be made of metal materials such as stainless steel, nickel-titanium alloy, etc.

[0049] It should be clear that the range of the ablation area formed by the ablation needle 1 has a clear relationship with the output power of the radio frequency current, the output time, the impedance of the tissue and the ablation temperature. Under a stable state, the range of the ablation area is proportional to the temperature between the interface of the tissue and the ablation segment 11 and the output power of the radio frequency current. The size of the ablation area can be increased by higher output power and higher tissue temperature. However, once the peak temperature of the tissue exceeds the threshold of 100°C, the tissue in contact with the ablation segment 11 will be charred and scabbed. The charred and scabbed tissue will adhere to the surface of the ablation segment 11 and form an electrically insulating condensate; at the same time, with the sudden increase in electrical impedance, the current is prevented from flowing into the tissue and causing heat, thereby greatly reducing the size of the ablation area. In order to prevent this phenomenon from occurring, increasing the range of the ablation area can be achieved by reducing the temperature of the contact surface between the ablation segment 11 and the tissue to reduce the risk of tissue scabbing.

[0050] It can be understood that the fluid released from the perfusion hole 1121 can cool the ablation segment 11 to a certain extent, and reduce the temperature between the ablation segment 11 and the tissue contact interface, so that the energy generated by the ablation segment 11 can be transmitted to the deeper part of the myocardial tissue, so as to achieve the purpose of increasing the ablation range. On the other hand, since the fluid will diffuse after being perfused into the myocardial tissue, the diffused fluid will serve as a good transmission medium for radio frequency current, transmitting the radio frequency current to farther parts of the myocardial tissue. Through this principle, the purpose of increasing the ablation area can be achieved. In summary, the fluid can expand the ablation range formed by the ablation segment 11 in the myocardial tissue, and the amount of fluid released is directly proportional to the ablation range formed by the ablation segment in the myocardial tissue.

[0051] The above-mentioned fluid may include, but is 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 a mixed solution of the above-mentioned solution and a contrast agent. At the same time, we should consider that in order to better reduce the temperature between the contact interface between the ablation segment 11 and the myocardial tissue during radiofrequency discharge, it is preferred to use a 0.9% NaCl solution at about 5°C, and cold saline can more effectively reduce the temperature. On the other hand, in order to effectively observe and control the perfusion area of ​​the fluid in the myocardial tissue during surgery to prevent its excessive diffusion, it is preferred that the fluid can be selected as a mixed solution of a 0.9% NaCl solution at about 5°C and a developer. Through radiographic imaging, the operator can intuitively observe the diffusion of the fluid mixed with the developer in the myocardial tissue with the help of the rays, so as to adjust the ablation time and the perfusion flow and flow rate in real time based on the evidence, so as to achieve the purpose of accurately controlling the size of the ablation area.

[0052] In other embodiments, the fluid may also be anhydrous ethanol, which can directly destroy the myocardial activity of myocardial tissue, thereby achieving an ablation method that combines energy ablation and alcohol ablation, thereby expanding the ablation range.

[0053] See also Figure 3a , Figure 3b and Figure 3c The injection hole 1121 can be in different shapes, such as a circle (such as Figure 3a As shown), square (as Figure 3b As shown), triangle (as Figure 3c As shown), one or a combination of an ellipse, a diamond, a polygon, a straight groove, an S-shaped curve, a keyhole groove, a comma-shaped opening, a teardrop-shaped opening, preferably a circle.

[0054] See also Figure 4a , Figure 4b and Figure 4c The needle 111 preferably adopts a conical tip (such as Figure 4a As shown), of course, a triangular pyramid head (such as Figure 4b as shown) and beveled cutting edge (as shown Figure 4c The distal end of the needle 111 is closed, and the proximal end is fixedly connected to the distal end of the straight ablation tube 112. Preferably, the two are fixed by laser welding.

[0055] In this embodiment, the needle 111 adopts a solid structure, and the solid structure enables the needle 111 to 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 inner cavity, which is connected to the inner cavity of the straight ablation tube 112. The existence of the inner cavity of the needle 111 allows the fluid to be closer to the needle 111, so that the outer surface of the needle 111 can be more fully cooled during ablation, thereby enhancing the ablation effect, further improving the ablation efficiency, and reducing the possibility of scab formation.

[0056] See also Figure 2 The ablation needle 1 also includes a temperature sensor 113, which is axially arranged in the inner cavity of the ablation section 11, and the distal end of the temperature sensor 113 extends into the inner cavity of the straight ablation tube 112 and is 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 (such as Fig.21 In other embodiments, when the needle 111 adopts a hollow structure, the distal end of the temperature sensor 113 can be further extended 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 more accurately measure the temperature of the ablation needle 1, improve the temperature measurement accuracy, and reduce the temperature measurement error.

[0057] Therefore, the presence 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 based on real-time temperature feedback to prevent the risk of carbonization and scabbing of the tissue in contact with the straight ablation tube 112 of the ablation needle 1, resulting in the inability to effectively diffuse the ablation energy and the adverse effects of a small ablation range.

[0058] Specifically, the temperature sensor 113 includes a thermocouple type or a thermal resistor type. Preferably, a thermocouple type is used. The thermocouple is made of two different metal wires and connected together at the far end by welding. The thermocouple achieves the purpose of temperature measurement based on the principle that the voltage at the connection point of two different metal wires is proportional to the temperature. The models of thermocouples are but not limited to K-type thermocouples, T-type thermocouples, S-type thermocouples, etc. The K-type thermocouple has one wire of chromium alloy and one wire of aluminum alloy; the T-type thermocouple has one wire of copper and one wire of constantan; the S-type thermocouple has one wire of platinum-rhodium alloy and one wire of platinum. In the range of 0-100 degrees Celsius, the temperature measurement linearity of the K-type thermocouple is higher and the sensitivity is higher, so it is preferred to use a K-type thermocouple.

[0059] Optionally, in order to enhance the visualization of the needle 111 under external imaging equipment such as CT (Computed Tomography), the surface of the needle 111 may be coated with a layer of gold coating or other non-radio-transmissive coating materials, including but not limited to.

[0060] Please also read Figure 5-Figure 11 , the ablation section 11 has a preset difference in the axial direction, and the preset difference makes the fluid release amount of the perfusion hole in the middle area of ​​the ablation section 11 per unit time greater than the fluid release amount of the proximal area of ​​the ablation section 11 per unit time and the fluid release amount of the distal area of ​​the ablation section 1 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 area, middle area and distal area of ​​the straight ablation tube 112 correspond to the proximal area, middle area and distal area of ​​the ablation section 11, respectively.

[0061] Optionally, there are multiple perfusion holes 1121 , 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 can output fluid along the axial direction and the circumferential direction at the same time.

[0062] In other embodiments, when the needle 111 adopts a hollow structure, the needle 111 may also be provided with one or more perfusion holes 1121 communicating with the inner cavity of the needle 111 .

[0063] Therefore, in order to achieve that the amount of fluid released per unit time in the middle area of ​​the ablation segment 11 is simultaneously greater than the amount of fluid released per unit time in the proximal area of ​​the straight ablation tube 112 and the amount of fluid released per unit time in the distal area of ​​the straight ablation tube 112, the above-mentioned preset differences include: the total fluid release area of ​​the perfusion holes 1121 in the middle area of ​​the ablation segment 11 is simultaneously greater than the total fluid release area of ​​the perfusion holes 1121 in the proximal area of ​​the ablation segment 11 and the total fluid release area of ​​the perfusion holes 1121 in the distal area of ​​the ablation segment 11.

[0064] Further, at least one of the opening area and density of the plurality of perfusion holes 1121 is different 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 greater 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 holes 1121 in the distal region of the ablation segment 11, wherein the density refers to the number of perfusion holes 1121 per unit length in the axial direction of the straight ablation tube 112. In order to achieve that the total fluid release area of ​​the perfusion holes 1121 in the middle region of the ablation segment 11 is greater 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 holes 1121 in the distal region of the ablation segment 11, the following implementation methods may be used:

[0065] In the first implementation, see Figure 5-Figure 6 On the premise that the density of the perfusion holes 1121 of the straight ablation tube 112 is roughly the same in the axial direction, the opening area of ​​the perfusion holes 1121 located in the middle area of ​​the straight ablation tube 112 is simultaneously larger than the opening area of ​​the perfusion holes 1121 located in the proximal end area of ​​the straight ablation tube 112 and the opening area of ​​the perfusion holes 1121 located in the distal end area of ​​the straight ablation tube 112.

[0066] The opening area of ​​each injection hole 1121 is 0.05 mm 2 -0.3mm 2 Changes between.

[0067] Preferably, in order to further accurately control the amount of fluid released, the multiple perfusion holes 1121 can be divided into N perfusion hole groups, each perfusion hole group forms a circle in the circumferential direction, and the N perfusion hole groups form N circles in the circumferential direction of the straight ablation tube 112, and the number of multiple perfusion holes 1121 on each circle is equal and evenly distributed. Wherein, N≥3, preferably 5.

[0068] As an example, Figure 5 and Figure 6As shown, taking the number M of perfusion holes 1121 as 20 and N as 5 as an example, each perfusion hole group includes 4 perfusion holes 1121, and the perfusion holes 1121 located in different perfusion hole groups are spaced apart in the axial direction of the straight ablation tube 112, and the spacing between two adjacent perfusion holes 1121 in the axial direction of the straight ablation tube 112 is equal. At the same time, the four perfusion holes 1121 located in the same perfusion hole group are evenly distributed in the circumferential direction of the straight ablation tube 112 (that is, the central angle corresponding to two perfusion holes 1121 located in the same perfusion hole group and adjacent in the circumferential direction is 90°), thereby achieving that the density of the multiple perfusion holes 1121 is roughly the same in the axial direction of the straight ablation tube 112. For the convenience of distinction, the five perfusion hole groups are arranged from the distal end to the proximal end along the straight ablation tube 112 (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), and the opening areas of the perfusion holes 1121 from the first perfusion hole group to the fifth perfusion hole group are S1, S2, S3, S4 and S5, respectively, wherein S3>S2>S1 and S3>S4>S5, wherein S2=S4, S1=S5, and also S2≠S4 and / or S1≠S5. In some other embodiments, it can also be: S3>S2=S1 and / or S3>S4=S5. In some other embodiments, it can also be: S3=S2>S1 and / or S3=S4>S5. It can be understood that the opening area of ​​the perfusion holes 1121 of the straight ablation tube 112 from the middle area to the two end areas in the axial direction can be gradually reduced or stepped, preferably gradually reduced.

[0069] As some examples, the value of S1 can be 0.05 mm. 2 -0.09mm 2 The value of S2 can be between 0.1mm 2 -0.15mm 2 The value of S3 can be between 0.16mm 2 -0.3mm 2 The value of S4 can be between 0.1mm 2 -0.15mm 2 The value of S5 can be between 0.05mm 2 -0.09mm 2 between.

[0070] In the second implementation, see Figure 7-Figure 8 On the premise that the opening areas of each perfusion hole 1121 are roughly the same in the axial direction of the straight ablation tube 112, the density of the perfusion holes 1121 in the middle area of ​​the straight ablation tube 112 is simultaneously greater than the density of the perfusion holes 1121 in the proximal area of ​​the straight ablation tube 112 and the density of the perfusion holes 1121 in the distal area of ​​the straight ablation tube 112.

[0071] 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. The perfusion holes 1121 in each perfusion hole group form a circle in the circumferential direction. The N perfusion hole groups form N circles in the circumferential direction of the straight ablation tube 112. The number of the plurality of perfusion holes 1121 on each circle is equal and evenly distributed. Wherein, N≥3, preferably 5.

[0072] As an example, as Figure 7 and Figure 8 shown, taking the number M of the perfusion holes 1121 as 20 and N as 5 as an example, for the convenience of distinction, the five perfusion hole groups are sorted axially from the distal end to the proximal end along the straight ablation tube 112 (in sequence: 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). Let the axial distance between the perfusion holes 1121 of the first perfusion hole group and the perfusion holes 1121 of the second perfusion hole group be L1, let 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 be L2, let 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 be L3, let the axial distance between the perfusion holes 1121 of the fourth perfusion hole group and the perfusion holes 1121 of the fifth perfusion hole group be L4. Wherein, L2 = L3 < L1 = L4, so as to realize 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 end region of the straight ablation tube 112 and that of the perfusion holes 1121 in the distal end region of the straight ablation tube 112 at the same time. In other embodiments, it can also be L2≠L3, L1≠L4, as long as L2 < L1 and L3 < L4 are ensured. More specifically, the value of L1 can be between 2.5 mm and 4 mm, the value of L2 can be between 1 mm and 2 mm, the value of L3 can be between 1 mm and 2 mm, and the value of L4 can be between 2.5 mm and 4 mm. In other embodiments, in order to realize 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 end region of the straight ablation tube 112 and that of the perfusion holes 1121 in the distal end region of the straight ablation tube 112 at the same time, it can also be realized by the difference in the number of the perfusion holes 1121 included in each perfusion hole group.

[0073] In the third implementation manner, please refer to Fig. 9, the density of the perfusion holes 1121 in the middle area of ​​the straight ablation tube 112 is greater than the density of the perfusion holes 1121 in the proximal area of ​​the straight ablation tube 112 and the density of the perfusion holes 1121 in the distal area of ​​the straight ablation tube 112, and the opening area of ​​the perfusion holes 1121 in the middle area of ​​the straight ablation tube 112 is greater than the opening area of ​​the perfusion holes 1121 in the proximal area of ​​the straight ablation tube 112 and the opening area of ​​the perfusion holes 1121 in the distal area of ​​the straight ablation tube 112. The specific design of this implementation method can refer to the first implementation method and the second implementation method mentioned above, which will not be repeated here.

[0074] See also Fig.10 The present invention also proposes another method for achieving that the amount of fluid released per unit time in the middle area of ​​the ablation segment 11 is greater than the amount of fluid released per unit time in the proximal area of ​​the straight ablation tube 112 and the amount of fluid released per unit time in the distal area of ​​the straight ablation tube 112. The preset difference includes: the cross-sectional area of ​​the inner cavity of the middle area of ​​the ablation segment 11 is smaller than the cross-sectional area of ​​the inner cavity of the proximal area of ​​the ablation segment 11 and the cross-sectional area of ​​the inner cavity of the distal area of ​​the ablation segment 11.

[0075] Specifically, the cross-sectional area of ​​the inner cavity in the middle region of the straight ablation tube 112 is smaller than the cross-sectional area of ​​the inner cavity in the proximal region and the cross-sectional area of ​​the inner cavity in the distal region of the straight ablation tube 112 (the cross-sectional area of ​​the inner cavity of the straight ablation tube 112 may gradually increase from the middle region to both ends, or may increase in a step-wise manner), so that the fluid pressure at the outlet of the perfusion hole 1121 in the middle region of the straight ablation tube 112 is greater than the fluid pressure at the outlet of the perfusion hole 1121 in the proximal region of the straight ablation tube 112 and the fluid pressure at the outlet of the perfusion hole 1121 in the distal region of the straight ablation tube 112. Based on the principle of converting pressure potential energy into kinetic energy, the amount of fluid released per unit time in the middle region of the straight ablation tube 112 is greater than the amount of fluid released per unit time in the proximal region of the straight ablation tube 112 and the amount of fluid released per unit time in the distal region of the straight ablation tube 112.

[0076] Furthermore, considering that the pressure of the fluid gradually decreases from the proximal end to the distal end of the inner cavity of the straight ablation tube 112 due to the presence of the perfusion hole 1121. In order to resist such attenuation, preferably, the cross-sectional area S1 of the inner cavity in the middle region of the straight ablation tube 112 is smaller than the cross-sectional area S2 of the inner cavity in the distal region of the straight ablation tube 112, and the cross-sectional area S2 of the inner cavity in the distal region of the straight ablation tube 112 is smaller than the cross-sectional area S3 of the inner cavity in the proximal region of the straight ablation tube 112.

[0077] In this embodiment, the ratio of the cross-sectional area S2 of the inner lumen in the distal end region of the straight ablation tube 112 to the cross-sectional area S1 of the inner lumen in the middle region of the straight ablation tube 112 is between 1.2-1.5, and the ratio of the cross-sectional area S3 of the inner lumen in the proximal end region of the straight ablation tube 112 to the cross-sectional area S1 of the inner lumen in the middle region of the straight ablation tube 112 is between 1.6-2.0.

[0078] More specifically, the value of S1 can be 0.1 mm 2 -0.2mm 2 The value of S2 can be between 0.12mm 2 -0.3mm 2 The value of S3 can be between 0.16mm 2 -0.4mm 2 between.

[0079] Therefore, by setting the cross-sectional area of ​​the inner cavity of the straight ablation tube 112 to have a difference in the axial direction, the fluid pressure at the outlet of each perfusion hole 1121 is equal or the fluid pressure in the middle area of ​​the straight ablation tube 112 is greater than the fluid pressure in the proximal area of ​​the straight ablation tube 112 and the fluid pressure in the distal area of ​​the straight ablation tube 112.

[0080] It can be understood that when the fluid pressures at the fluid outlets of the various perfusion holes 1121 are equal, the fluid flow rates of the various perfusion holes 1121 are equal.

[0081] Combined with the formula Q = S·v, where Q is the flow rate, S is the cross-sectional area (fluid release area), and v is the flow velocity. From the formula, we can see that the larger the fluid release area, the greater the flow rate. Figure 5-Figure 9Any one of the methods 1 to 3 makes the sum of the fluid release areas of the perfusion holes 1121 in the middle region of the straight ablation tube 112 greater than the sum of the fluid release areas of the perfusion holes 1121 in the proximal region of the straight ablation tube 112 and the sum of the fluid release areas of the perfusion holes 1121 in the distal region of the straight ablation tube 112, so that the amount of fluid released per unit time in the middle region of the straight ablation tube 112 is greater than the amount of fluid released per unit time in the proximal region of the straight ablation tube 112 and the amount of fluid released per unit time in the distal region of the straight ablation tube 112. When the fluid pressure at the outlet of the perfusion hole 1121 in the middle area of ​​the straight ablation tube 112 is greater than the fluid pressure at the outlet of the perfusion hole 1121 in the proximal area of ​​the straight ablation tube 112 and the fluid pressure at the outlet of the perfusion hole 1121 in the distal area of ​​the straight ablation tube 112, the fluid flow rate of the perfusion hole 1121 in the middle area of ​​the straight ablation tube 112 is greater than the fluid flow rate of the perfusion hole 1121 in the proximal area of ​​the straight ablation tube 112 and the fluid flow rate of the perfusion hole 1121 in the distal area of ​​the straight ablation tube 112. Figure 5-Figure 9 Any one of the methods 1 to 3 makes the sum of the fluid release areas of the perfusion holes 1121 in the middle area of ​​the straight ablation tube 112 simultaneously greater than the sum of the fluid release areas of the perfusion holes 1121 located in the proximal and distal end areas of the straight ablation tube 112, further achieving that the amount of fluid released per unit time in the middle area of ​​the straight ablation tube 112 is simultaneously greater than the amount of fluid released per unit time in the proximal and distal end areas of the straight ablation tube 112.

[0082] Specifically, the cross-sectional area of ​​the inner cavity in the middle region of the straight ablation tube 112 is set to be smaller than the cross-sectional area of ​​the inner cavity in the proximal region of the straight ablation tube 112 and the cross-sectional area of ​​the inner cavity in the distal region of the straight ablation tube 112 (the cross-sectional area of ​​the inner cavity of the straight ablation tube 112 can gradually increase from the middle region to both ends, or can increase in a step-like manner), so that the fluid pressure at the perfusion hole 1121 in the middle region of the straight ablation tube 112 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 fluid pressure of the perfusion hole 1121 in the middle region of the straight ablation tube 112, the fluid pressure of the perfusion hole 1121 in the proximal region and the fluid pressure of the perfusion hole 1121 in the distal region are equal, it can be combined Figure 5-Figure 9Any one of the methods 1 to 3 in the above method makes the amount of fluid released per unit time in the middle area of ​​the straight ablation tube 112 greater than the amount of fluid released per unit time in the proximal area of ​​the straight ablation tube 112 and the amount of fluid released per unit time in the distal area of ​​the straight ablation tube 112. When the fluid pressure at the perfusion hole 1121 in the middle area of ​​the straight ablation tube 112 is greater than the fluid pressure at the perfusion hole 1121 in the proximal area of ​​the straight ablation tube 112 and the fluid pressure at the perfusion hole 1121 in the distal area of ​​the straight ablation tube 112, the above method may be combined or not combined. Figure 5-Figure 9 Any one of the methods 1 to 3 makes the amount of fluid released in the middle area of ​​the straight ablation tube 112 per unit time greater than the amount of fluid released in the proximal area of ​​the straight ablation tube 112 per unit time and the amount of fluid released in the distal area of ​​the straight ablation tube 112 per unit time.

[0083] In some embodiments of the present invention, the cross-sectional area of ​​the inner cavity of the straight ablation tube 112 decreases in a step-like manner from the middle area to the two end areas. The straight ablation tube 112 can be divided into multiple sections according to the cross-sectional areas of the inner cavity, such as 3 sections, 4 sections, 5 sections, 6 sections, etc., preferably an odd number.

[0084] See also Fig.11 As an example, the straight ablation tube 112 is divided into 5 sections, and the straight ablation tube includes a first section, a second section, a third section, a fourth section and a fifth section from the distal end to the proximal end. The cross-sectional areas of the inner cavities 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 0.18 mm 2 -0.25mm 2 The value of S5 can be between 0.12mm 2 -0.18mm 2 The value of S4 can be between 0.1mm 2 -0.15mm 2 The value of S7 can be between 0.25mm 2 -0.3mm 2 The value of S8 can be between 0.3mm 2 -0.4mm 2 between.

[0085] See also Figure 12-13Further, the ablation needle 1 further comprises a flexible reinforcement tube 12 and a main body section 13, the distal end of the flexible reinforcement tube 12 is connected to the proximal end of the straight ablation tube 112, the proximal end of the flexible reinforcement tube 12 is provided with a conductive part 121, the straight ablation tube 112, the flexible reinforcement tube 12 and the conductive part 121 can be integrally processed from the same metal round tube, or can be formed by connecting a plurality of different metal round tubes by welding or other fixing methods. Preferably, laser welding is used for fixing.

[0086] In this embodiment, the straight ablation tube 112 , the flexible reinforcement tube 12 and the conductive part 121 are cut from the same integral metal round tube by laser cutting, and can achieve electrical conduction.

[0087] In this embodiment, the flexible reinforcement tube 12 can be cut using a sea wave tube, and the cutting forms include single-side cutting of the tube body and four-way cutting of the tube body. Preferably, the four-way cutting method of the tube body is adopted so that the flexible reinforcement tube 12 can achieve 360° bending. Since the connection portion between the ablation segment 11 and the main body segment 13 is located at the position of the bending section of the adjustable bending catheter 22, during the bending process of the bending section of the adjustable bending catheter 22, the distal end of the main body segment 13 will bend following the bending section of the adjustable bending catheter 22, and the presence of the flexible reinforcement tube 12 can increase the bending resistance of the main body segment 13 in the bent state, and prevent the main body segment 13 from being damaged or broken during the bending process of the adjustable bending catheter. The conductive portion 121 is used to connect the distal end of the wire (not shown), and the proximal end of the wire is connected to the energy generator 3 (such as Fig.21 ) connection, the flexible reinforcement tube 12 has conductive properties, so as to realize the electrical connection between the ablation segment 11 and the energy generator 3; the conductive part 121 can be a connecting hole or a connecting hook to increase the firmness of the connection and the good contact between the wire and the conductive part 121, and the connecting hole or the connecting hook includes but is not limited to a round hole, a square hole, a groove, a barb and a notch.

[0088] See also Fig.14 The main body segment 13 is sleeved on the outside of the flexible reinforcement tube 12, and the distal end of the main body segment 13 should exceed the distal end of the flexible reinforcement tube 12, that is, the distal end of the main body segment 13 is sleeved on the outside of the proximal end of the ablation segment 11, so that the distal end of the main body segment 13 is sealed and connected to the proximal end of the ablation segment 11 to ensure that the inner cavity of the straight ablation tube 112 forms a closed space. The main body segment 13 and the flexible reinforcement tube 12 are preferably fixed by glue bonding.

[0089] See also Fig.15In other embodiments, the main body segment 13 may also be sleeved on the inner side of the flexible reinforcement tube 12, and the distal end of the main body segment 13 should exceed the distal end of the flexible reinforcement tube 12, that is, the distal end of the main body segment 13 is sleeved on the outer side of the proximal end of the ablation segment 11, so that the distal end of the main body segment 13 is sealed and connected to the proximal end of the ablation segment 11 to ensure that the inner cavity of the straight ablation tube 112 forms a closed space.

[0090] 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 with an insulating layer on the surface. In this embodiment, the main body section 13 is a metal material with an insulating layer on the surface, and the insulating layer can be a layer of polymer material coated on the main body section by heat shrinking, or it can be directly sleeved on the outside of the main body section 13, and 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 a high insulation resistance. The low friction coefficient can give the ablation needle 1 good lubricity and pushing performance, and the high insulation resistance can make the insulating layer still maintain excellent dielectric insulation without being broken down under the action of high-frequency radio frequency current. When the insulating layer is wrapped on the outside of the main section 13 by heat shrinkage, the insulating layer preferably uses PET (Polyethylene Terephthalate), PTFE (Poly Tetra Fluoroethylene), FEP (Fluorinated Ethylene Propylene) and other materials; when the insulating layer is fixed on the outside of the main section 13 by sleeve installation, the insulating layer preferably uses PEEK (Poly-Ether-Ether-Ketone), PI (Polyimide) and other materials; when the insulating material is adhered to the outside of the main section 13 by a coating process, the insulating layer preferably uses Parylene.

[0091] 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, etc. In other embodiments, when the main body section 13 is directly made of insulating material, it can be made of polymer materials such as polyetheretherketone and polyimide.

[0092] In other embodiments, the flexible reinforcing tube 12 may be optional, 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 may be sleeved on the outer side or inner side of the proximal end of the ablation section 11, and the fixing method may be bonding, welding, crimping, welding, etc.

[0093] Since the ablation segment 11 has an axial inner cavity and is connected to the inner cavity 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 made of conductive material and covered with an insulating layer, and the proximal end of the wire is electrically connected to the energy generator 3, thereby achieving electrical conduction between the ablation segment 11 and the energy generator 3. In other embodiments, if the main body segment 13 is made of non-conductive material, the distal end of the wire (not shown) can be electrically connected to the ablation segment 11 through the inner cavity or inner cavity wall of the main body segment 13.

[0094] Typically, during ablation, the entire ablation segment 11 is inserted into the ventricular septum and ablates the ventricular septal hypertrophy tissue. The axial length of the ablation segment 11 may be between 3.3 mm and 10 mm. The outer diameter of the ablation segment 11 and the main body segment 13 may be between 0.3 mm and 1.5 mm, preferably 0.5 mm.

[0095] Please also read Figure 16-18 and Fig.21 The present invention also provides an ablation device for myocardial ablation, comprising the above-mentioned ablation needle 1, a delivery tube body assembly 2 and a handle assembly 5, wherein the delivery tube body assembly 2 comprises an adjustable bend sheath 21 and an adjustable bend catheter 22 movably inserted into the adjustable bend sheath 21; the ablation needle 1 is movably inserted into the adjustable bend catheter 22, and the distal end of the ablation needle 1 can extend out of the distal end of the adjustable bend catheter 22.

[0096] Specifically, the adjustable curved catheter 22 is sleeved in the inner cavity of the adjustable curved sheath tube 21, and the central axes of the adjustable curved sheath tube 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 extends from the distal inner cavity of the adjustable curved sheath tube 21 and crosses the aortic valve into the left ventricle. The distal end of the adjustable curved catheter 22 is attached to the outside of the hypertrophic ventricular septum, and the ablation needle 1 extends from the distal end of the adjustable curved catheter 22, punctures the endocardium and extends a suitable length to reach the position of the hypertrophic ventricular septum to release ablation energy, destroy the cell activity of the ventricular septum myocardial tissue, make the hypertrophic myocardial tissue of the ventricular septum thinner, and reduce the contractile force, thereby reducing the phenomenon of left ventricular outflow tract obstruction. Among them, the ablation energy can be radio frequency energy, microwave ablation, ultrasonic energy, etc. 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 the area covered by the ablation energy in the interventricular septum.

[0097] See also Fig.17The adjustable bending sheath tube 21 is a tubular structure with a hollow inner cavity. The adjustable bending sheath tube 21 includes a first supporting section 211, a first shaping section 212 and a first bending adjustment section 213 from the proximal end to the distal end. In the working state, the positions of the proximal and distal ends of the first shaping section 212 will match the starting and ending positions of the aortic arch bending, and the bending curvature of the first shaping section 212 is basically consistent with the bending curvature of the aortic arch, so as to ensure that the first shaping section 212 can more smoothly pass the adjustable bending sheath tube 21 through the aortic arch and transport it to the designated position, and after the adjustable bending sheath tube 21 reaches the designated position, the first shaping section 212 can have good contact with the aortic arch in the bending state, so that the first shaping section 212 can be fixed at the position of the aortic arch, minimizing the adverse effects of the movement of the adjustable bending sheath tube 21 on the operation. In order to ensure that the first shaping section 212 has good deformation performance and can maintain good shape memory after deformation, the hardness of the material constituting the first shaping section 212 should not be too hard, and the preferred material hardness of the first shaping section 212 is 55D to 65D. The first support section 211 mainly supports the first bending section 213 and the first shaping section 212. In order to ensure that the first shaping section 212 does not cause the first support section 211 to bend significantly during the bending process, the material hardness of the first support section 211 should be greater than the material hardness of the first shaping section 212. In some embodiments, the adjustable bending sheath tube 21 adopts a composite braided mesh tube structure, which can maintain high anti-bending performance while having good flexibility, pushing performance, and torsion control.

[0098] In addition, the adjustable bending sheath tube 21 further includes a first traction wire (not shown in the figure), which is movably arranged in the tube wall of the adjustable bending sheath tube 21 along the axial direction of the adjustable bending sheath tube 21, the distal end of the first traction wire is connected to the distal end of the first bending adjustment section 213, and the proximal end of the first traction wire is connected to the handle assembly 5. Specifically, a channel tube (not shown in the figure) is provided in the tube wall of the adjustable bending sheath tube 21, the channel tube extends along the axial direction of the adjustable bending sheath tube 21, the distal end of the channel tube extends to the distal end of the first bending adjustment section 213, and the proximal end of the channel tube extends to the proximal end of the first support section 211, and the first traction wire is movably arranged in the channel tube. In some embodiments, a guide groove may be directly formed on the wall of the adjustable bending sheath tube 21, the guide groove extends along the axial direction of the adjustable bending sheath tube 21, the distal end of the guide groove extends to the distal end of the first bending adjustment section 213, and the proximal end of the guide groove extends to the proximal end of the first support section 211, and the first traction wire is movably arranged in the guide groove. Fig.21As shown) the bending of the first bending adjustment section 213 is controlled by controlling the axial movement of the first traction wire. During operation, the first bending adjustment section 213 can be bent in different directions to facilitate the subsequent selection of different ablation positions. In some embodiments, in order to prevent the adjustable sheath 21 from twisting due to the inconsistency between the pulling direction of the first traction wire and the bending direction of the first bending adjustment section 213, the first traction wire should be passed through the inner side of the bend of the adjustable sheath 21 close to the first bending adjustment section 213 to ensure the stability of the force direction of the adjustable sheath 21 during operation; that is, the channel tube or guide groove should be located at the inner side of the bend of the first bending adjustment section 213.

[0099] See also Fig.18 The adjustable curved catheter 22 is a tube body with a hollow inner cavity, and the adjustable curved catheter 22 includes a second support section 221, a second shaping section 222 and a second bending section 223 from the proximal end to the distal end. The bending curvature of the second shaping section 222 is substantially consistent with the bending curvature of the aortic arch, ensuring that the adjustable curved catheter 22 and the adjustable curved sheath tube 21 have good adaptability in bending form. In order to ensure that the angle of the second bending section 223 during the bending process is controllable and does not cause the second shaping section 222 to bend significantly during the bending process, the material hardness of the second bending section 223 should be less than the material hardness of the second shaping 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 does not cause the second supporting section 221 to bend significantly during the bending process, the material hardness of the second shaping section 222 should be less than the material hardness of the second supporting section 221. In order to ensure that the second bending section 223 does not cause the first bending section 213 to bend significantly during the bending process, the material hardness of the second bending section 223 should be smaller than the material hardness of the first bending section 213 .

[0100] In addition, the adjustable curved catheter 22 also includes a second traction wire (not shown in the figure), which is movably arranged in the tube wall of the adjustable curved catheter 22 along the axial direction of the adjustable curved catheter 22, the distal end of the second traction wire is connected to the distal end of the second bending adjustment section 223, and the proximal end of the second traction wire is connected to the handle assembly 5. Specifically, a channel tube is provided in the tube wall of the adjustable curved catheter 22, the channel tube extends along the axial direction of the adjustable curved catheter 22, the distal end of the channel tube extends to the distal end of the second bending adjustment section 223, the proximal end of the channel tube extends to the proximal end of the second support section 221, and the second traction wire is movably arranged in the channel tube. In some embodiments, a guide groove can also be directly opened on the tube wall of the adjustable curved catheter 22, the guide groove extends along the axial direction of the adjustable curved catheter 22, the distal end of the guide groove extends to the distal end of the second bending adjustment section 223, the proximal end of the guide groove extends to the proximal end of the second support section 221, and the second traction wire is movably arranged in the guide groove. The handle assembly 5 adjusts the bending of the second bending adjustment section 223 by controlling the second traction wire to move axially. At the same time, in some embodiments, in order to prevent the adjustable bending catheter 22 from twisting due to the inconsistency between the pulling force direction of the second traction wire and the bending direction of the second bending adjustment section 223, the second traction wire should be inserted into the inner side of the bending of the adjustable bending catheter 22 close to the second bending adjustment section 223 to ensure the stability of the force direction of the adjustable bending catheter 22 during operation; that is, the channel tube or guide groove should be located at the inner side of the bending of the second bending adjustment section 223.

[0101] See also Fig.19 and Fig. 20 , below, taking the ablation of the hypertrophic tissue of the ventricular septum of the myocardial tissue as an example, the realization principle of the ablation area formed by the ablation needle 1 for myocardial ablation proposed by the present invention to be more adapted to the morphology of the myocardial tissue is explained.

[0102] Since the morphology of the ventricular septum of patients with hypertrophic cardiomyopathy is mostly prominent hypertrophy of the left ventricular outflow tract (anterior wall), when the ablation needle 1 is extended from the distal end of the adjustable curved catheter 22, the puncture angle of the ablation needle 1 is usually perpendicular or close to perpendicular to the protruding part of the anterior wall of the ventricular septum, and the conduction nerve 6 is arranged along the edge of the ventricular 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 an ellipsoid structure or a cylindrical structure with a relatively flat middle part around the axis of the ablation segment 11. The long axis section of the ellipsoid structure or the cylindrical structure is the section in the X direction. The X direction is roughly colinear with the axis of the ablation segment 11. The shape of the section in the X direction is a flat ellipse or cylinder (such as the first ablation area a). The ablation range is small, and multiple puncture sites are required for multiple ablations to cover the desired ablation area range. In the present invention, a plurality of perfusion holes 1121 are provided on the straight ablation tube 112 , so that the straight ablation tube 112 can improve the ablation efficiency and increase the ablation range of the ablation area (such as the second ablation area b).

[0103] Furthermore, the present invention also sets the ablation segment 11 with a preset difference in the axial direction, so that the amount of fluid released per unit time in the middle area of ​​the ablation segment 11 is greater than the amount of fluid released per unit time in the distal end area of ​​the ablation segment 11 and the amount of fluid released per unit time in the proximal end area of ​​the ablation segment 11, so that the cross-section of the ablation area in the X direction changes from the original flat, approximately elliptical or cylindrical shape to a circular or nearly circular elliptical shape, making the ablation area 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 ventricular septum. While increasing the ablation range as much as possible, it can avoid the ablation area being close to the edge of the ventricular septum, thereby avoiding damage to the endocardium or epicardium due to the excessive ablation range formed by the two end areas of the ablation segment 11. Since the conduction nerves 6 are arranged at the edge of the ventricular septum, the above arrangement can further avoid damaging the conduction nerves 6 due to the excessive ablation range formed by the two end regions of the ablation segment 11, causing irreversible damage to the conduction nerves 6 and affecting ECG conduction.

[0104] It can be understood that since the length direction of the ventricular wall, atrial wall and atrial septum in the myocardial tissue is roughly consistent with the length direction of the ventricular septum, the ablation needle 1 for myocardial ablation proposed in the present invention can also be applied to the ventricular wall, atrial wall and atrial septum. It should be noted that the length direction of the myocardial tissue is roughly the direction from the atrium to the ventricle.

[0105] 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 ablation area formed, that is, when the energy provided by the energy generator 3 is constant, the more the amount of fluid released, the larger the ablation area formed. Therefore, the present invention provides a plurality of perfusion holes 1121 on the ablation segment 11, so that the ablation segment 11 can improve the ablation efficiency. In addition, since the ablation segment 11 has a preset difference in the axial direction, the amount of fluid released in the middle area of ​​the ablation segment 11 per unit time is greater than the amount of fluid released in the distal end area of ​​the ablation segment 11 and the amount of fluid released in the proximal end area per unit time, so that the perfusion area of ​​the fluid in the middle area of ​​the ablation segment 11 is greater than the perfusion area of ​​the fluid in the distal end area of ​​the ablation segment 11 and the perfusion area of ​​the fluid in the proximal end area of ​​the ablation segment 11. The above settings can reduce the number of repeated operations of the device and shorten the operation time. At the same time, such an ablation area can adapt to the anatomical structure and reduce the surgical risk, so as to achieve the purpose of safely thinning the ventricular septum, alleviating outflow tract obstruction, and treating hypertrophic cardiomyopathy.

[0106] See also Fig.21The present invention provides an ablation system for myocardial ablation, the ablation system comprises an energy generator 3, a fluid perfusion device 4 and the above-mentioned ablation device for myocardial ablation; the energy generator 3 is electrically connected to the ablation needle 1, and is used to provide ablation energy for the ablation needle 1; the fluid perfusion device 4 comprises a fluid storage device 41, a perfusion pump 42 and a fluid pipeline 43, the fluid storage device 41 is used to store fluid; the perfusion pump 42 is used to transport the fluid from the fluid storage device 41 to the inner cavity of the ablation needle 1 through the fluid pipeline 43. The handle assembly 5 is connected to the adjustable bending sheath tube 21, the adjustable bending catheter 22 and the ablation needle 1, and the handle assembly 5 is used to control the bending and movement trajectory of the adjustable bending sheath tube 21, the bending and movement trajectory of the adjustable bending catheter 22, and the axial movement of the ablation needle 1 in the adjustable bending catheter 22.

[0107] See also Figure 22a-22c For example, taking the ablation of the hypertrophic tissue of the ventricular septum as an example, the operation mode of an ablation system for myocardial ablation of the present invention is as follows:

[0108] 1. Under the guidance of ultrasound / CT and other imaging equipment, the femoral artery is punctured and guided by a guide wire (not shown) to deliver the adjustable curved sheath tube 21 through the aortic arch to the position of the aortic valve near the aortic arch, such as Fig.22a shown.

[0109] 2. By operating the handle assembly 5, when the adjustable sheath tube 21 reaches the target position, the adjustable catheter 22 is transported along the inner cavity of the adjustable sheath tube 21 to the upper side of the aortic valve near the aortic arch, and under the guidance of ultrasound / CT and other imaging equipment, the aortic valve is crossed without damaging the aortic valve. By operating the handle assembly 5, the bending direction and the bending angle of the adjustable sheath tube 21 and the adjustable catheter 22 are controlled, so that the distal end of the adjustable catheter 22 can be well attached to the first puncture and ablation point expected on the hypertrophic ventricular septum, such as Figure 22b shown.

[0110] 3. By operating the handle assembly 5, the ablation needle 1 is controlled to extend from the distal end of the adjustable curved catheter 22, puncture the ventricular septum, and reach the hypertrophic muscle tissue inside the ventricular septum. The angle and depth of insertion are controlled under the dual judgment of the ultrasound / CT image and the scale mark on the handle, such as Fig.22c shown.

[0111] 4. After completing the above steps, start the perfusion pump 42, which perfuses fluid into the inner cavity of the ablation needle 1 through the fluid pipeline 43, and then turns on the energy generator 3 to ablate the hypertrophic myocardial tissue at the desired ablation point through the ablation segment 11.

[0112] 5. When the ablation range reaches the ideal size through contrast imaging observation, the energy output of the external energy generator 3 is stopped, and the fluid perfusion of the perfusion pump 42 is stopped, and the handle assembly 5 is operated to retract the ablation needle 1 into the adjustable curved catheter 22. When there are multiple points to be ablated, steps S2-S4 can be repeated once or multiple times until the puncture and ablation of all the points to be ablated are completed.

[0113] The technical means disclosed in the scheme of the present invention are not limited to the technical means disclosed in the above-mentioned implementation mode, but also include technical schemes composed of any combination of the above-mentioned technical features. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications are also regarded as the protection scope of the present invention.

Claims

1. An ablation needle for myocardial ablation, characterized in that: The ablation needle comprises an ablation segment capable of puncturing into myocardial tissue, wherein the ablation segment punctures into the myocardial tissue through the endocardium and is capable of releasing energy to destroy the myocardial activity of the myocardial tissue; The ablation segment has an axial inner cavity, and the ablation segment is provided with at least one perfusion hole connected to the inner cavity of the ablation segment, the perfusion hole is used to release the fluid in the inner cavity of the ablation segment into the myocardial tissue, and 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 amount per unit time of the perfusion hole in the middle area of ​​the ablation segment greater than the fluid release amount per unit time of the proximal end area of ​​the ablation segment, and greater than the fluid release amount per unit time of the distal end area of ​​the ablation segment; The preset difference includes: the total fluid release area of ​​the perfusion holes in the middle region of the ablation segment is larger than the total fluid release area of ​​the perfusion holes in the proximal region of the ablation segment, and is also larger than the total fluid release area of ​​the perfusion holes in the distal region of the ablation segment.

2. The ablation needle for myocardial ablation according to claim 1, characterized in that: The myocardial tissue is the ventricular septum, and the ablation segment enters the ventricular septum through the left ventricle or the right ventricle and then through endocardial puncture.

3. The ablation needle for myocardial ablation according to claim 1, characterized in that: There are multiple perfusion holes, and the multiple perfusion holes are arranged along the circumference and axial direction of the ablation section at the same time.

4. The ablation needle for myocardial ablation according to claim 3, characterized in that: The opening area of ​​the perfusion holes located in the middle region of the ablation segment is larger than the opening area of ​​the perfusion holes located in the proximal region of the ablation segment, and is also larger than the opening area of ​​the perfusion holes located 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 larger than the density of the perfusion holes in the proximal region of the ablation segment, and is also larger 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 larger than the total fluid release area of ​​the proximal region of the ablation segment, and is also larger than the total fluid release area of ​​the perfusion holes in the distal region of the ablation segment.

5. The ablation needle for myocardial ablation according to any one of claims 1 to 4, characterized in that: The preset difference includes: the cross-sectional area of ​​the lumen in the middle region of the ablation segment is smaller than the cross-sectional area of ​​the lumen in the proximal region of the ablation segment, and is also smaller than the cross-sectional area of ​​the lumen in the distal region of the ablation segment.

6. The ablation needle for myocardial ablation according to claim 5, characterized in that: The cross-sectional area of ​​the lumen in the distal end region of the ablation segment is smaller than the cross-sectional area of ​​the lumen in the proximal end region of the ablation segment.

7. The ablation needle for myocardial ablation according to claim 1, characterized in that: The ablation section comprises a needle and a straight ablation tube, wherein the needle is connected to the distal end of the straight ablation tube, and the needle is one of a triangular pyramid head, a beveled blade head, and a conical pointed head.

8. The ablation needle for myocardial ablation according to claim 1, characterized in that: The ablation needle also includes a flexible reinforcement tube, a conductive part and a main body segment. The proximal end of the ablation segment is connected to the distal end of the flexible reinforcement tube. The conductive part is arranged at the proximal end of the flexible reinforcement tube. The conductive part is used to be electrically connected to an energy generator to provide energy to the ablation segment. The main body segment is made of insulating material. The main body segment is sleeved on the outside or inside of the flexible reinforcement tube, and the distal end of the main body segment is sealed and connected to the proximal end of the ablation segment.

9. The ablation needle for myocardial ablation according to claim 1, characterized in that: The ablation needle further includes a temperature sensor, which is disposed on the ablation needle and is used to measure the temperature of the ablation needle.

10. An ablation device for myocardial ablation, comprising the ablation needle according to any one of claims 1 to 9 and a delivery tube assembly, wherein the delivery tube assembly comprises an adjustable bending sheath tube and an adjustable bending catheter movably disposed in the adjustable bending sheath tube; The ablation needle can be movably inserted into the adjustable bend catheter, and the distal end of the ablation needle can extend out of the distal end of the adjustable bend catheter.

11. An ablation system for myocardial ablation, comprising an energy generator, a fluid perfusion device, and the ablation device for myocardial ablation according to claim 10; The energy generator is electrically connected to the ablation needle and is used to provide energy to the ablation needle. The fluid perfusion device is connected to the ablation needle and is used to deliver the fluid to the inner cavity of the ablation needle.

12. The ablation system for myocardial ablation according to claim 11, characterized in that: The fluid perfusion device comprises: a fluid storage device, a perfusion pump and a fluid pipeline; The fluid storage device is used to store the fluid; The irrigation pump is used to transport the fluid from the fluid reservoir to the inner cavity of the ablation needle through the fluid pipeline.

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