Ablation needle, ablation device and ablation system

Abstract

The invention provides an ablation needle, an ablation device and an ablation system.The ablation needle comprises a needle body, the needle body is provided with an inner cavity, and the needle body is provided with an ablation section and a perfusion section; the filling section comprises at least two filling holes, and each filling hole serves as an outlet of the inner cavity and is communicated with the inner cavity; the ablation section comprises at least one electrode for releasing ablation energy; the ablation section is provided with a far end, a first section is arranged between the far end and the perfusion hole closest to the far end, the length of the first section is L1, and the distance between the two perfusion holes farthest from the far end is L2 of the perfusion section; wherein L1 is smaller than or equal to L2. According to the ablation needle, the length of L1 is set to be smaller than or equal to L2, when the ablation needle is used for ablation, perfusion liquid from the perfusion section can make contact with the first section in the outer surface of the ablation section in time, and the situation that the temperature of the first section rises too fast, so that the temperature of tissue located around the first section also rises too fast, and consequently carbonization occurs is avoided.

Description

Technical Field

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

[0002] Hypertrophic cardiomyopathy (HCM) is a common autosomal dominant cardiovascular disease, which is mainly manifested by hypertrophy of one or more segments of the left ventricle (LV). The general diagnostic standard is a thickness greater than or equal to 15 mm. Its treatment methods mainly include drug therapy, surgical septal myectomy, and ventricular septal ablation.

[0003] Currently, there is a technology that uses an ablation needle with an perfusion hole to perform perfusion and ablation on tissue. The portion of the ablation needle that is not wrapped by the insulating layer and is exposed is the ablation segment. However, during the ablation process, if the distance between the perfusion hole at the farthest end of the ablation needle and the far end of the ablation segment or the distance between the perfusion hole at the nearest end of the ablation needle and the near end of the ablation segment is too large, it is easy for the tissue between the perfusion hole at the farthest end of the ablation needle and the far end of the ablation segment or between the perfusion hole at the nearest end of the ablation needle and the near end of the ablation segment to be carbonized, resulting in poor ablation effect, which is not conducive to the implementation of the ablation surgery. Summary of the invention

[0004] In order to solve the above technical problems, the present invention provides an ablation needle, including a needle body, wherein the needle body has an inner cavity, and the needle body has an ablation section and an perfusion section, and the perfusion section at least partially overlaps with the ablation section; the perfusion section includes at least two perfusion holes, each of which is connected to the inner cavity as an outlet of the inner cavity; the ablation section includes at least one electrode for releasing ablation energy; the ablation section has a distal end, and a first section is between the distal end and the perfusion hole closest to the distal end, and the length of the first section is L1, and the distance between the two perfusion holes that are farthest apart is the length L2 of the perfusion section; wherein L1 is less than or equal to L2.

[0005] In some possible implementations, the ablation segment has a proximal end, and the distance between the proximal end and the perfusion hole closest to the proximal end is L3; wherein L3 is less than or equal to L2.

[0006] The present invention also provides an ablation needle, comprising a needle body, the needle body having an inner cavity, and the needle body having an ablation section and an perfusion section, the perfusion section at least partially overlapping with the ablation section; the perfusion section comprises at least two perfusion holes, each of the perfusion holes being connected to the inner cavity as an outlet of the inner cavity; the ablation section comprises at least one electrode for releasing ablation energy; the ablation section has a proximal end, a second section is between the proximal end and the perfusion hole closest to the proximal end, the length of the second section is L3, and the distance between the two perfusion holes that are farthest apart is the length L2 of the perfusion section; wherein L3 is less than or equal to L2.

[0007] In some possible implementations, the ablation segment has a distal end, and the distance between the distal end and the perfusion hole closest to the distal end is L1; wherein L1 is less than or equal to L2.

[0008] The present invention also provides an ablation device, including an ablation needle and a delivery assembly, wherein the delivery assembly includes an adjustable bend catheter, 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.

[0009] The present invention also provides an ablation system, comprising an ablation device, an energy generating device and an irrigation device; the ablation device is connected to the energy generating device and the irrigation device respectively, the irrigation device provides irrigation liquid for the ablation device, and the energy generating device provides ablation energy for the ablation device.

[0010] When using the ablation needle of the present invention for ablation, the perfusion liquid contacts the inner surface of the first section located in the inner cavity during the process of flowing in the inner cavity of the needle body and undergoes the first cooling. After flowing out of the perfusion hole, the perfusion liquid contacts the outer surface of the first section along the outer surface of the needle body and undergoes the second cooling. By setting the length L1 of the first section to be less than or equal to L2, the time for the perfusion liquid to move from the perfusion section to the first section can be reduced, so that the perfusion liquid from the perfusion section can contact the outer surface of the first section in time, thereby avoiding the first section from heating up too quickly, causing the tissue around the first section to heat up too quickly and thus carbonize. Similarly, setting the second section to be less than or equal to L2 can avoid carbonization of the tissue around the second section during ablation. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] In order to more clearly illustrate the technical solution of the embodiment of the present invention, the drawings required for use in the implementation mode will be briefly introduced below. Obviously, the drawings described below are some implementation modes of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0012] Figure 1 is a schematic structural diagram of an ablation device in Embodiment 1 of the present invention;

[0013] Figure 2A Schematic diagram of the distal structure of the ablation needle in the first embodiment of the present invention;

[0014] Figure 2B for Figure 2A The cross-sectional view at AA in FIG.

[0015] Figure 2C is a schematic diagram of the distal structure of the ablation needle in another embodiment;

[0016] Figure 2D is a schematic diagram of the distal structure of an ablation needle in another embodiment;

[0017] Figure 2E is a schematic diagram of the distal structure of an ablation needle in another embodiment;

[0018] Figure 3 It is a schematic diagram of the distal structure of the ablation needle in another embodiment of the present invention;

[0019] Figure 4 is a schematic diagram of a bevel needle tip;

[0020] Figure 5 for Figure 4 Schematic diagram of another perspective of the needle tip;

[0021] Figure 6 A schematic diagram of a needle tip having a first edge surface and a second edge surface;

[0022] Figure 7 for Figure 6 Schematic diagram of another perspective of the needle tip;

[0023] Figure 8 It is a schematic diagram of the structure of the adjustable bending sheath tube in a natural state in some embodiments of the present invention;

[0024] Fig. 9 It is a structural schematic diagram of the adjustable bending sheath tube in a straightening transition state;

[0025] Fig.10 It is a structural diagram of the adjustable bending sheath tube in a straightened state;

[0026] Fig.11 This is a schematic diagram of the structure of the adjustable bending sheath tube located in the aorta;

[0027] Fig.12 for Fig.11 Structural diagram of the view from the middle MM;

[0028] Fig.13 It is a structural schematic diagram of another embodiment of an adjustable bending sheath tube;

[0029] Fig.14 for Fig.13 Another perspective diagram of the adjustable bending sheath tube;

[0030] Fig.15 It is a structural schematic diagram of an adjustable curved conduit;

[0031] Fig.16 It is a schematic diagram of the structure of the distal end of the adjustable curved catheter crossing the aortic valve;

[0032] Fig.17 for Fig.16 Structural diagram of the view from the NN position in the middle;

[0033] Fig.18 It is a schematic diagram of adjusting the bend of the distal end of the adjustable bend catheter;

[0034] Fig.19 A schematic diagram of the structure of an ablation system provided in Embodiment 2 of the present invention;

[0035] Fig. 20 This is a schematic diagram of the structure of an ablation system provided in Embodiment 3 of the present invention. DETAILED DESCRIPTION

[0036] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0037] The following descriptions of the various embodiments are made with reference to the attached drawings to illustrate specific embodiments in which the present invention may be implemented. The directional terms mentioned in the present invention, such as "top", "bottom", "front", "back", "left", "right", "inside", "outside", "side", etc., are only with reference to the directions of the attached drawings. Therefore, the directional terms used are for better and clearer description and understanding of the present invention, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore cannot be understood as limiting the present invention.

[0038] In the description of the present invention, it should be noted that, unless otherwise clearly stipulated 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 a direct connection, or it can be indirectly connected through an intermediate medium, and it can be the internal connection of two elements.

[0039] In the field of interventional medical devices, the proximal end of a medical device refers to the end closer to the operator, while the distal end of a medical device refers to the end farther from the operator; "axial" refers to the direction parallel to the line connecting the distal and proximal centers of the medical device, "radial" refers to the direction perpendicular or substantially perpendicular to the axial direction and along the radius or diameter of the device or element, and "circumferential" refers to the direction surrounding the axial direction. . For those skilled in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0040] It should be noted that the X direction mentioned herein is the axial direction of the needle body 132 , and the Y direction is a direction perpendicular to the X direction and along the radial direction of the needle body 132 .

[0041] Embodiment 1:

[0042] See also Figure 1 The present invention provides an ablation device 10 including a delivery component and an ablation needle 13. The delivery component includes an adjustable bend catheter 120. The ablation needle 13 can be movably inserted into the adjustable bend catheter 120. The distal end of the ablation needle 13 can extend out of the distal end of the adjustable bend catheter 120.

[0043] See also Figure 1 , Figure 2A , Figure 2B , Fig.19 The ablation needle 13 includes a needle body 132, the needle body 132 has an inner cavity 132b and the needle body 132 includes an ablation section 134 and an irrigation section, the irrigation section at least partially overlaps with the ablation section 134; the irrigation section includes at least two irrigation holes 132a, each irrigation hole 132a is connected to the inner cavity 132b as an outlet of the inner cavity 132b; the ablation section 134 includes at least one electrode and is used to release ablation energy; the ablation section 134 has a distal end 1342, the first section is between the distal end 1342 and the irrigation hole 132a closest to the distal end 1342, the length of the first section is L1, the distance between the two farthest irrigation holes 132 is the length L2 of the irrigation section; wherein L1 is less than or equal to L2.

[0044] Specifically, when performing perfusion ablation, the ablation needle 13 can be movably inserted into the delivery assembly, and the delivery assembly includes an adjustable bend catheter 120 and an adjustable bend sheath tube 110 , and the adjustable bend catheter 120 can be movably inserted into the adjustable bend sheath tube 110 . During the flow of the perfusion liquid 33 in the inner cavity 132b of the needle body 132, it contacts the inner surface of the first section located in the inner cavity 132b and undergoes the first cooling. After flowing out of the perfusion hole 132a, the perfusion liquid 33 contacts the outer surface of the first section along the outer surface of the needle body 312 and undergoes the second cooling. By setting the length L1 of the first section to be less than or equal to L2, the time for the perfusion liquid 33 to move from the perfusion hole 132a to the first section is reduced, so that the perfusion liquid 33 from the perfusion section can timely contact the first section on the outer surface of the ablation section 134 to avoid the first section from heating up too quickly, causing the tissue around the first section to heat up too quickly and thus carbonize. Therefore, setting the length L1 of the first section to be less than or equal to L2 can avoid carbonization of the tissue around the first section during ablation, as shown in Table 1 (the output power during the test is 50W-70W, and the duration is 5min). The larger the ratio of L1 / L2, the easier it is for the tissue around the first segment to be carbonized; the smaller the ratio of L1 / L2, the less likely it is for the tissue around the first segment to be carbonized. As can be seen from Table 1, the critical value of the ratio is 1. The second segment is between the proximal end 1341 of the ablation segment 134 and the perfusion hole 132a closest to the proximal end 1341. The length of the second segment is L3. Similarly, setting L3 to be less than or equal to L2 can prevent the tissue around the second segment from being carbonized during ablation.

[0045] That is, the lengths of the first and second sections can be set according to the length L2 of the perfusion section. For example, when L2 is 5 mm, L1 and L3 can be set to any length less than 5 mm, thereby improving the effectiveness of the ablation needle 13. Preferably, L1 and / or L3 are less than or equal to L2*0.8; more preferably, L1 and / or L3 are less than or equal to L2*0.6. In this embodiment, the ablation section 134 has one electrode, and the length L of the ablation section 134 (L=L1+L2+L3) is the length that the electrode can contact the tissue to be treated; in some possible embodiments, the ablation section 134 has multiple electrodes, and the length L of the ablation section 134 is the distance between the two farthest electrodes. Generally, the length L of the ablation segment 134 is 3mm-20mm, the length L1 of the first segment is 0.1mm-10mm, the length L2 of the perfusion segment is 0.5mm-16mm, and the length L3 of the second segment is 0.1mm-10mm; preferably, the length L of the ablation segment 134 is 5mm-15mm, the length L1 of the first segment is 1.5mm-9mm, the length L2 of the perfusion segment is 1mm-10mm, and the length L3 of the second segment is 1.5mm-9mm; more preferably, the length L of the ablation segment 134 is 8mm-12mm, the length L1 of the first segment is 2mm-7mm, the length L2 of the perfusion segment is 2mm-10mm, and the length L3 of the second segment is 2mm-7mm.

[0046]

[0047] Table 1

[0048] In some possible implementations, such as Figure 2C As shown, the ablation section 134 partially overlaps with the irrigation section, wherein the first section is located inside the irrigation section, and the second section is located outside the irrigation section. At this time, the length L1 of the first section is obviously smaller than L2, and the outer surface of the first section can better contact with the irrigation liquid 33 during irrigation ablation, further enhancing the cooling effect of the irrigation liquid 33.

[0049] In some possible implementations, such as Figure 2D As shown, the ablation section 134 partially overlaps with the irrigation section, wherein the second section is located inside the irrigation section, and the first section is located outside the irrigation section. At this time, the length L3 of the second section is obviously smaller than L2, and the outer surface of the second section can better contact with the irrigation liquid 33 during irrigation ablation, further enhancing the cooling effect of the irrigation liquid 33.

[0050] In some possible implementations, such as Figure 2EAs shown, the ablation section 134 is entirely overlapped with the perfusion section, wherein the first section and the second section are both located within the perfusion section. At this time, the length L1 of the first section and the length L3 of the second section are both smaller than L2, and during perfusion ablation, the outer surface of the first section and the outer surface of the second section can better contact with the perfusion liquid 33, further enhancing the cooling effect of the perfusion liquid 33.

[0051] In some possible implementations, due to the different flow rates of the perfusion liquid 33, the heat dissipation effects on the first section and the second section are also different. When the flow rate of the perfusion liquid 33 is large, even if the length of the first section or the second section is greater than the length of the perfusion section, the tissue around the first section or the second section will not be carbonized during the perfusion ablation process. Specifically, the perfusion flow rate of the perfusion liquid 33 is A mL / min, the units of L1, L2, and L3 are all mm, and the carbonization coefficients are α and β, then α=L1 / (L2+A), β=L3 / (L2+A). Since there are two units of mL / min and mm in the calculation formula, but the coefficient only requires a numerical value, only the numerical value is taken in the calculation process without taking the unit. When α / β is less than or equal to 1, the tissue around the first section or the second section will not be carbonized during the perfusion ablation process; when α / β is greater than 1, the tissue around the first section or the second section may (with a high probability) be carbonized during ablation; when L1=L3, α=β, as shown in Table 2 (the output power during the test is 50W-70W, and the duration is 5min). By introducing the perfusion flow rate A, the accuracy of the carbonization coefficient α can be further ensured, providing a reference for the size of the ablation needle 13 and the parameter selection of the ablation device in the subsequent ablation process. Even if the length of the first section and / or the second section is accidentally set to be greater than the length of the perfusion section during the manufacture of the ablation needle 13, it can still be compensated by adjusting the perfusion flow rate A, thereby improving the production tolerance of the product and indirectly improving the production yield.

[0052]

[0053]

[0054] Table 2

[0055] The perfusion liquid 33 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, a mixed solution of 0.9% NaCl solution and contrast agent, etc. Preferably, 0.9% NaCl solution at about 5°C is used.

[0056] When the ablation segment 134 begins to ablate, the temperature of the ablation segment 134 and the surrounding tissues will rise due to the radio frequency energy, and the perfusion liquid 33 perfused through the perfusion hole 132a can cool the ablation segment 134 and the tissues, so that the temperature rise rate of the ablation segment 134 and the tissues is slowed down; after the temperature of the ablation segment 134 reaches a predetermined value, the perfusion liquid 33 will continue to take away the excess heat generated by the ablation segment 134. On the one hand, the predetermined value is sufficient to deform the protein of the myocardial tissue, and on the other hand, the tissue will not be carbonized and scabbed due to the high temperature, so that the energy generated by the ablation segment 134 can be transmitted to the deeper part of the myocardial tissue, so as to achieve the purpose of increasing the ablation range, and after the perfusion liquid 33 enters the myocardial tissue, it will diffuse inside the myocardial tissue along the direction of the muscle fibers to the surrounding of the myocardial tissue. This is because the conduction of radio frequency current in the human body mainly relies on the movement of charged ions. When radio frequency current flows through human tissue, the rapid change of magnetic field causes the positive and negative ions in the cells to move rapidly. Due to the different sizes, masses, charges and movement speeds of ions, the friction between ions and other molecules and ions in the cells causes the tissue cells to heat up, causing the water inside and outside the cells to evaporate, dry, shrink and fall off, resulting in aseptic necrosis. The perfusion liquid 33 itself carries a large number of ions, which can increase the concentration of ions in myocardial tissue. Therefore, the perfusion liquid 33 can be used as a good transmission medium for radio frequency current. As the perfusion liquid 33 diffuses, the radio frequency current is transmitted to farther parts of the myocardial tissue, and the probability of frictional collision of ions is increased, causing the cells to heat up and rupture and coagulative necrosis. Through the above principles, perfusion ablation can achieve the purpose of increasing the range of the ablation area and make the ablation effect more efficient.

[0057] In some possible implementations, the needle body 132 may be made of a polymer material. In this case, the ablation section 134 should be an independent component with good electrical conductivity fixed on the needle body 132. The ablation section 134 can be electrically connected to the energy generating device 20, so as to release energy into the tissue through the ablation section 134. The polymer material used to make the needle body 132 should have excellent strength, hardness, high elastic modulus and good bending resistance, and should not break or plastically deform under repeated bending. On the other hand, in order to ensure that the needle body 132 has excellent pushing performance during the forward and backward movement along the central axis of the adjustable curved catheter 120, the material should have a low surface friction coefficient, which can reduce the pushing resistance of the ablation needle 13 in the lumen of the adjustable curved catheter 120. At the same time, in order to ensure the insulation of the needle body 132, the material should have excellent dielectric insulation, high insulation resistance, small dielectric constant, and high voltage resistance. In summary, the needle body 132 is preferably made of polymer materials such as polypropylene PP, high-density polyethylene HDPE, and polytetrafluoroethylene PTFE.

[0058] At this time, the ablation segment 134 should be one or more ring-shaped metal electrodes of a certain length, which are fixed to the distal end of the needle body 132 by means including but not limited to bonding, welding, crimping, welding, etc., and are electrically connected to the energy generating device 20 through a wire. The ring-shaped metal electrode is preferably made of a radiopaque metal material such as platinum-iridium alloy, cobalt-chromium alloy, tantalum, etc., so that it has excellent conductive properties and can also have a development effect under radiation, which helps the operator to confirm the position of the ablation segment 134.

[0059] In some possible embodiments, Figure 3 As shown, when the needle body 132 is made of a metal tube with good biocompatibility, the ablation section 134 exists as a part of the needle body 132. At this time, an insulating layer 133 should be attached to the outer surface of the needle body 132, and the exposed area of ​​the distal end of the needle body 132 that is not covered with insulating material serves as the ablation section 134 that releases radio frequency energy. Preferably, the needle body 132 is made of nickel-titanium alloy.

[0060] The insulating layer 133 can be a layer of polymer material wrapped on the needle body 132 by heat shrinking, or can be directly sleeved on the outside of the needle body 132, or can be attached to the outside of the needle body 132 by a coating process. The outer surface of the insulating layer 133 should have a low friction coefficient and a high insulation resistance. The low friction coefficient can give the ablation needle 13 good lubricity and pushing performance, and the high insulation resistance can make the insulating layer 133 still maintain excellent dielectric insulation without being broken down under the action of high-frequency radio frequency current.

[0061] When the insulating layer 133 is wrapped on the outside of the needle body 132 by heat shrinking, the insulating material is preferably PET (polyethylene terephthalate), PTFE (polytetrafluoroethylene), FEP (fluorinated ethylene propylene) and other materials. When the insulating layer 133 is fixed to the outside of the needle body 132 by sleeve installation, the insulating layer 133 is preferably made of PEEK (polyetheretherketone), PI (polyimide) and other materials. When the insulating layer 133 is adhered to the outside of the needle body 132 by a coating process, the insulating material is preferably Parylene.

[0062] Specifically, in some possible embodiments, the length of the ablation segment 134 is fixed, that is, the relative position between the needle body 132 and the insulating layer 133 is fixed. At this time, in the same set of ablation needles 13, the length L of the ablation segment 134 is a certain fixed value. By setting ablation segments 134 with different lengths L, a plurality of ablation needles 13 of different models and specifications can be designed to meet the use requirements of different patients with different tissue morphologies and sizes.

[0063] In some possible embodiments, the relative position between the needle body 132 and the insulating layer 133 can be adjusted to achieve different exposed lengths of the needle body 132 , thereby achieving the purpose of adjusting different lengths L of the ablation segment 134 .

[0064] Specifically, an insulating sleeve is provided on the outer sleeve of the needle body 132, and the insulating sleeve is used as the above-mentioned insulating layer 133. The insulating sleeve and the needle body 132 can slide relative to each other, and the length L of the ablation section 134 can be controlled by controlling the relative movement between the needle body 132 and the insulating layer 133. Specifically, the ablation needle 13 is correspondingly provided with an ablation operation handle 14, and the ablation operation handle 14 is provided with a pushing structure (not shown in the figure), which is connected to the insulating sleeve and can drive the insulating sleeve to slide relative to the needle body 132, thereby adjusting the length of the needle body 132 exposed outside the insulating sleeve. Specifically, when the insulating layer 133 and the ablation segment 134 partially overlap, the junction of the insulating layer 133 and the ablation segment 134 is the proximal end 1341 of the ablation segment 134. The insulating layer 133 is adjusted to change the length of the overlapping portion thereof, that is, the length of the second segment in the ablation segment 134 is adjusted in disguise, which can be regarded as adjusting the length L of the ablation segment 134. A locking structure may also be provided on the ablation operation handle 14, and the locking structure is connected to the needle body 132 for locking and fixing the needle body 132.

[0065] During the specific implementation process, the needle body 132 and the insulating sleeve can be kept in a relatively fixed state, that is, the length L of the ablation segment 134 remains unchanged, and the endocardial tissue can be pierced together and penetrated into the ventricular septum myocardial tissue. When the length L of the ablation segment 134 needs to be adjusted, the needle body 132 can be locked by the locking structure of the ablation operation handle so that it can remain fixed in the direction of the central axis of the adjustable curved catheter 120, and then the pushing structure that is fixedly connected to the ablation operation handle and the insulating sleeve can be pushed so that the insulating sleeve can achieve relative forward and backward movement along the central axis of the needle body 132, so as to control the portion of the needle body 132 exposed outside the insulating sleeve, thereby changing the length L of the ablation segment 134.

[0066] In some other possible embodiments, the locking structure is connected to the insulating sleeve to lock and fix the insulating sleeve, and the pushing structure is connected to the needle body 132 to drive the needle body 132 to slide relative to the insulating sleeve.

[0067] Similarly, while maintaining no relative movement between the needle body 132 and the insulating sheath, the endocardial tissue is pierced together and penetrates into the ventricular septum myocardial tissue. When the length L of the ablation segment 134 needs to be changed, the locking structure is controlled to keep the insulating sheath fixed in the direction of the central axis of the needle body 132, and then the pushing structure is pushed to enable the needle body 132 to achieve relative movement forward and backward in the direction of the central axis of the insulating sheath, thereby controlling the portion of the needle body 132 exposed outside the insulating sheath, thereby changing the length L of the ablation segment 134.

[0068] The ablation needle 13 includes a needle tip 131, which can puncture the endocardium or epicardium tissue under the puncture of the needle tip 131, so that the distal end of the ablation needle 13 including the needle tip 131, the perfusion hole 132a and the ablation segment 134 or the needle tip 131, the perfusion hole 132a, the ablation segment 134 and a part of the insulating layer 133 enters the hypertrophic area of ​​the ventricular septum, and releases energy through the ablation segment 134 to destroy the cell activity of the hypertrophic myocardial tissue, so that the hypertrophic myocardial tissue of the ventricular septum becomes thinner and the contractile force decreases, thereby reducing the phenomenon of left ventricular outflow tract obstruction; at the same time, the perfusion liquid 33 flows out to the myocardial tissue through the perfusion hole 132a, and diffuses inside the myocardial tissue, bringing the radio frequency energy to the myocardial tissue farther away from the ablation segment 134, thereby achieving the purpose of expanding the ablation range.

[0069] The needle tip 131 of the ablation needle 13 is a closed and sharp tip structure, and its shape includes but is not limited to a cone, a triangular pyramid, a quadrangular pyramid, a single-bevel cutting edge, etc. The shape of the needle tip 131 can provide the ablation needle 13 with a sufficiently sharp needle tip 131 structure, so that it can pierce the endocardial or epicardial tissue with a smaller puncture force, thereby smoothly entering the ventricular septum myocardial tissue.

[0070] In some possible implementations, such as Figure 4-5 As shown, the needle tip 131 is a beveled structure and is provided with a first blade surface 1311. The first blade surface 1311 forms a first angle γ with the axial direction (i.e., the X direction) of the needle body 132. The above arrangement can enhance the sharpness of the needle tip 131, so that the operator only needs to apply a small force to the ablation needle to puncture the endocardium or epicardium to ablate the ventricular septum tissue. The first angle γ is 10°-45°, preferably the first angle γ is 15°-40°, and more preferably the first angle γ is 20°-35°.

[0071] In some embodiments, Figure 6-7As shown, the distal end of the first blade surface 1311 is also provided with two second blade surfaces 1312 symmetrical with respect to the first blade surface 1311, and the distal ends of the second blade surfaces 1312 intersect at the farthest end of the first blade surface 1311, and each second blade surface 1312 forms a second angle δ with the axial direction of the ablation needle body, so that the first blade surface 1311 and the second blade surface 1312 are located in different planes. Through the above arrangement, during the puncture of the needle tip 131, the two second blade surfaces 1312 cut the tissue on their planes respectively, and the first blade surface 1311 cuts the tissue on another plane, thereby forming at least 3 incisions in the tissue, which is convenient for the perfusion liquid 33 to enter the tissue through the above incisions during perfusion ablation and diffuse to a farther part, which is beneficial to enhancing the ablation range; at the same time, the first blade surface 1311 and the second blade surface 1312 cut the tissue in different directions, thereby further enhancing the sharpness of the needle tip 131 and allowing the needle tip 131 to puncture the tissue more quickly. The second angle δ is 10-45°, preferably 15-40°, more preferably 20-35°. In addition, the surface of the needle tip 131 may be coated with a layer of gold coating or other non-radio-opaque coating materials to enhance the visualization of the needle tip 131 under external imaging equipment.

[0072] See also Figure 1 , Figure 8 , below, taking the adjustable curved sheath 110 entering the left ventricle through the aorta as an example, when other pathways are used to ablate the ventricular septum tissue, the structure of the adjustable curved sheath 110 can be adaptively adjusted with reference to the corresponding pathways.

[0073] The adjustable bending sheath tube 110 includes a handle 114, wherein the adjustable bending sheath tube 110 is a prefabricated pipe having certain rigidity and flexibility. The handle 114 adjusts the shape of the adjustable bending sheath tube 110 by applying a force to the adjustable bending sheath tube 110. After the force of the handle 114 is eliminated, the adjustable bending sheath tube 110 can gradually return to its natural state. The adjustable bending sheath tube 110 has a hollow inner cavity. The adjustable bending sheath tube 110 includes a first pipe section 111, a second pipe section 112, and a third pipe section 113 which are sequentially connected from the proximal end to the distal end.

[0074] As a possible implementation, in a natural state, the first tube segment 111, the second tube segment 112 and the third tube segment 113 are all located on the same plane, the second tube segment 112 first extends in a direction away from the first tube segment, and then extends in a direction close to the first tube segment 111, and the third tube segment 113 extends in a direction close to the first tube segment 111, so that the first tube segment 111 is adapted to the shape of the descending aorta of the human body, the second tube segment 112 is adapted to the shape of the aortic arch of the human body, and the third tube segment 113 is adapted to the shape of the ascending aorta of the human body, and the distal end of the third tube segment 113 is close to the middle part of the aortic valve of the human body. Therefore, the adjustable curved sheath tube 110 under this implementation has a predetermined shape in a natural state, which matches the shape of the human aorta, and is convenient for entering the left ventricle from the aorta across the aortic valve to treat the myocardial tissue.

[0075] See also Figure 8 , the adjustable bending sheath tube 110 is in a natural state. The handle 114 is connected to the proximal end of the adjustable bending sheath tube 110, and the adjustable bending sheath tube 110 can be adjusted in a straight state (such as Fig.10 shown) and the natural state (as Figure 8 The straightening state refers to a state in which the shape of the adjustable bending sheath tube 110 is approximately a straight line by the handle 114. Specifically, the shape of the adjustable bending sheath tube 110 is changed from the natural state (as shown) to the straightening state by operating the handle 114 to apply an external force opposite to the direction C to the adjustable bending sheath tube. Figure 8 The curved shape under the transition state (as shown) Fig. 9 As shown) into an approximately straight line shape (i.e., a straightened state, such as Fig.10As shown). Therefore, before intervening in the human body, the adjustable bending sheath tube 110 is first adjusted from the natural state to the straightened state. As the adjustable bending sheath tube 110 goes deeper, the self-straightened state gradually changes to the natural state, and finally restores the natural state. Then, the distal end of the adjustable bending sheath tube 110 can also be bent by operating the handle 114. At this time, the adjustable bending sheath tube 110 is in the bent state. Specifically, an anchor ring is provided at the distal end of the third tube section 113 of the above-mentioned adjustable bending sheath tube 110, and the above-mentioned anchor ring is connected to the distal end of the traction wire built into the above-mentioned adjustable bending sheath tube 110, and the proximal end of the above-mentioned traction wire is connected to the above-mentioned handle 114. Therefore, the handle 114 can adjust the degree of curvature of the third tube segment 113 by pushing and pulling the traction wire. When the third tube segment 113 is bent away from the first tube segment 111 to a certain degree, it can continue to adjust. At this time, it can affect the second tube segment 112 and gradually straighten the second tube segment 112, and finally adjust the first tube segment 111, the second tube segment 112, and the third tube segment 113 to a straight line or a state of approximate straight lines. Therefore, the adjustable bending sheath tube 110 can be put into a straightened state by operating the handle 114. Since the adjustable bending sheath tube 110 is straightened by operating the handle 114, the third tube segment 113 of the adjustable bending sheath tube 110 in the straightened state during this operation will be partially bent, but this part does not affect the overall entry of the adjustable bending sheath tube 110 into the relevant blood vessel path. As the adjustable bending sheath tube 110 goes deeper, the external force applied to the handle 114 is gradually reduced so that the self-straightening state of the adjustable bending sheath tube 110 gradually changes to the natural state, and finally restores the natural state. Alternatively, in some embodiments, the operator can also insert a dilator into the adjustable bending sheath tube 110, and use the dilator to straighten the adjustable bending sheath tube 110, so that the first tube segment 111, the second tube segment 112, and the third tube segment 113 are adjusted to a straight line or a nearly straight line state, and then as the adjustable bending sheath tube 110 goes deeper, the dilator is gradually withdrawn so that the self-straightening state gradually changes to the natural state, and finally restores the natural state, and then the distal end of the adjustable bending sheath tube 110 can be adjusted by operating the handle 114, and the adjustable bending sheath tube 110 is in a bending state. Furthermore, a guide wire can be inserted into the dilator, and then withdrawn together with the dilator during the process of withdrawing the dilator.

[0076] By such a configuration, the adjustable bend sheath tube 110 in a natural state fits the shape of the aorta, wherein the first tube segment 111 is similar to or the same as the shape of the descending aorta, the second tube segment 112 is similar to or the same as the shape of the aortic arch, and the third tube segment 113 is similar to the shape of the ascending aorta, so that when the adjustable bend sheath tube 110 is inserted into the aorta and restored to its natural state, the distal end of the third tube segment 113 will be close to the middle part of the aortic valve. When the distal opening of the third tube segment 113 is not facing the aortic valve or a predetermined direction, the direction of the distal opening of the third tube segment 113 can be adjusted by operating the handle 114, and at this time, the adjustable bend sheath tube 110 is in a bending state.

[0077] In the prior art, the adjustable bending sheath tube 110 is a straight line or an approximately straight line as a whole in a natural state, and the operator applies external force through the handle to adjust the bending degree of the distal end of the adjustable bending sheath tube 110, and the handle state needs to be maintained after the adjustable bending sheath tube 110 becomes the target shape; in the present embodiment, the adjustable bending sheath tube 110 is a predetermined shape in a natural state, that is, the third tube segment 113, the second tube segment 112 and the first tube segment 111 are located in the same spatial plane, the second tube segment 112 first extends in a direction away from the first tube segment 111 and then extends in a direction toward the first tube segment 111, and the third tube segment 113 extends in a direction toward the first tube segment 111. Before the adjustable bending sheath tube 110 enters the aorta, the operator applies external force through the handle 114 or in the adjustable bending sheath tube 110 Insert the dilator to adjust the adjustable sheath tube 110 to a straight line or an approximate straight line. In the process of passing through the descending aorta, the aortic arch and reaching the ascending aorta, gradually reduce the straightening external force applied by the handle 114 to the adjustable sheath tube 110 or withdraw the dilator, so that the first tube segment 111, the second tube segment 112 and the third tube segment 113 of the adjustable sheath tube 110 gradually return to a natural state. At this time, in the adjustable sheath tube 110 after entering the heart, the distal end of the third tube segment 113 reaches the ascending aorta and its opening points to the direction of the aortic valve close to the mitral valve, the second tube segment 112 is located in the aortic arch, and the first tube segment 111 is located in the descending aorta. The operator does not need to apply any external force to the handle 114, thereby improving the surgical efficiency, avoiding the operator from pulling the handle 114 for a long time, and reducing the possibility of misoperation. If the distal opening of the third tube segment 113 is not facing the aortic valve or the predetermined direction, the direction of the distal opening of the third tube segment 113 can be adjusted by operating the handle 114, and the adjustable sheath tube 110 is in a bending state.

[0078] The shape of the third tube segment 113 in the natural state can ensure that the distal end of the third tube segment 113 moves in two directions close to the ventricular septum or away from the ventricular septum, thereby facilitating the subsequent selection of different puncture sites and providing different treatment positions for the adjustable bend catheter 120 and the ablation needle 13 installed in the adjustable bend sheath 110.

[0079] See also Fig.11 , Fig.12 Furthermore, the swing of the third tube segment 113 can be controlled by the handle 114 to control the circumferential rotation of the adjustable bending sheath tube 110 to control the direction of the distal opening of the third tube segment 113; specifically, when the adjustable bending sheath tube 110 is controlled to rotate clockwise by the handle 114, the third tube segment 113 will swing toward the side of the aortic arch close to the chest cavity. It can be known that when the adjustable bending sheath tube 110 is controlled to rotate counterclockwise, the third tube segment 113 will swing toward the side of the aortic arch close to the back.

[0080] By controlling the swing of the third tube segment 113, the different orientations of the distal opening of the third tube segment 113 can be controlled, and the adjustable bend catheter 120 inserted in the adjustable bend sheath tube 110 can be controlled to extend from the distal opening of the third tube segment 113 at different angles.

[0081] In some possible implementations, in a natural state, the first tube segment 111 is in a straight line.

[0082] In some possible implementations, the proximal end of the first tube segment 111 is straight, and the distal end is curved.

[0083] In some possible implementations, the curved portion of the third tube segment 113 may be in a regular or irregular curve shape, preferably in an arc shape.

[0084] In some possible implementations, in a natural state, the second pipe segment 112 is curved, and the middle portion thereof is arched relative to the two ends. Further, the second pipe segment 112 may be in a regular or irregular curved shape, and the second pipe segment 112 is preferably in an arc shape, so that the connection transition between the first pipe segment 111 and the third pipe segment 113 is smooth.

[0085] In some possible implementations, in a natural state, the third tube segment 113 is curved, and the curvature of the proximal portion of the third tube segment 113 is smaller than the curvature of the distal portion of the third tube segment 113, that is, the degree of curvature of the distal portion of the third tube segment 113 is greater than the degree of curvature of the proximal portion. Under the premise that the distal portion of the second tube segment 112 and the third tube segment 113 extend toward the first tube segment 111, the distal portion of the third tube segment 113 will move closer to the first tube segment 111.

[0086] Through the above-mentioned arrangement, when the third tube segment 113 is located in the ascending aorta in a natural state, the distal end of the third tube segment 113 is located close to the middle part of the aortic valve and biased towards the descending aorta, that is, the distal end of the third tube segment 113 is away from the ventricular septum, thereby increasing the distance from the distal end of the third tube segment 113 to the ventricular septum, thereby increasing the selection range of the adjustable bend sheath tube 110 and the adjustable bend catheter 120.

[0087] In some possible implementations, the first pipe segment 111 , the second pipe segment 112 , and the third pipe segment 113 have different curvatures, and the curvature of the second pipe segment 112 is greater than that of the first pipe segment 111 and the third pipe segment 113 , and the curvature of the third pipe segment 113 is greater than that of the first pipe segment 111 .

[0088] In some possible implementations, the curvature of the second tube segment 112 may remain unchanged, or may be configured such that, from the proximal end to the distal end, the curvature of the second tube segment 112 first increases and then decreases, or gradually increases.

[0089] When the curvature of the second tube segment 112 remains unchanged, the second tube segment 112 has substantially no conflict with the aortic arch, and the damage to the blood vessel wall is minimal.

[0090] When the curvature of the second tube segment 112 increases first and then decreases, the second tube segment 112 partially contacts the aortic arch and the contact area is small. The force provided by the blood vessel wall to the second tube segment 112 can help the adjustable sheath tube 110 maintain its position.

[0091] When the curvature of the third tube segment 112 gradually increases, the second tube segment 112 partially interferes with the aortic arch and the interference area is relatively large, which can increase the force provided for positioning the second tube segment 112 .

[0092] See also Figure 13-14 In some embodiments, the shape of the adjustable bending sheath tube 110 is changed, and the difference from the above embodiments is only that:

[0093] In a natural state, the first tube section 111 and the second tube section 112 of the adjustable bending sheath tube 110 are located on a first plane 91 , and the third tube section 113 is located on a second plane 92 having an included angle with the first plane 91 .

[0094] Specifically, considering that the aortic arch is not a planar structure but a three-dimensional spatial structure, therefore, according to the actual shape of the aortic arch, in this embodiment, the third tube segment 113, the second tube segment 112 and the first tube segment 111 of the adjustable bend sheath tube 110 are also correspondingly set to a three-dimensional spatial structure, wherein the second tube segment 112 and the first tube segment 111 are located in the same plane 91, and the third tube segment 113 is located in a plane 92 that forms a certain angle with the plane 91.

[0095] According to the actual shape of the aortic arch, the bending direction C of the third tube segment 113 should be bent toward the side of the aortic arch close to the human chest. The above setting can make the adjustable sheath tube 110 better fit the shape of the aortic arch.

[0096] In some possible implementations, an included angle between the first plane 91 and the second plane 92 is θ, where 10°≤θ≤45°.

[0097] Further, θ is preferably 15°, 20°, 25°, 30°, 35° or 40°.

[0098] In some embodiments, the ablation device can perform endocardial puncture and ablation on the ventricular septum via a path such as the inferior vena cava-right atrium-right ventricle or the inferior vena cava-right atrium-atrial septum-left atrium-left ventricle, and the structure of the adjustable sheath 110 can be adaptively adjusted with reference to this embodiment.

[0099] The structure of the adjustable curved sheath tube 110 that enters the left ventricle through the aorta is used as an example below to illustrate the structure of the adjustable curved catheter 120. When other paths are used to ablate the ventricular septum, the structure of the adjustable curved catheter 120 is adaptively adjusted with reference to this embodiment.

[0100] See also Fig.15 The adjustable bend catheter 120 has at least a main section 121, a shaping section 122 and a bend adjustment section 123 from the proximal end to the distal end. The shape of the main section 121 is adapted to the shape of the first section 111 of the adjustable bend sheath tube 110, and the shape of the shaping section 122 is adapted to the shapes of the second section 112 and the third section 113 of the adjustable bend sheath tube 110, so as to achieve better adaptability of the adjustable bend catheter 120 and the adjustable bend sheath tube 110 in terms of structural morphology. The adjustable bend catheter 120 is disposed in the hollow inner cavity of the adjustable bend sheath tube 110, and can realize relative movement with the adjustable bend sheath tube 110 along the central axis direction.

[0101] Specifically, when the adjustable bending sheath tube 110 of the above embodiment is used, the distal end portion of the shaping section 122 extends in the direction away from the interventricular septum, and the bending adjustment section 123 extends in the direction toward the interventricular septum.

[0102] See also Figure 15-18When the adjustable bend sheath tube 110 is located in the aorta and is in a natural state, the adjustable bend catheter 120 is transported through the inner cavity of the adjustable bend sheath tube 110, and the bend section 123 will extend from the distal opening of the third tube section 113 of the adjustable bend sheath tube 110, and cross the aortic valve to reach the position of the LVOT (left ventricular outflow tract). At this time, the adjustable bend catheter 120 is in an unbendable state. The adjustable bend catheter 120 is connected to a handle 124, and the circumferential swing of the bend section 123 of the adjustable bend catheter 120 can be controlled by operating the handle 124. Through the joint rotation of the third tube section 113 of the adjustable bend sheath tube 110 and the bend section 123 of the adjustable bend catheter 120, different directions of the bend section 123 of the adjustable bend catheter 120 can be achieved, thereby achieving point selection at different positions on the ventricular septum.

[0103] like Fig.18 As shown, the bending direction D of the bending section 123 can be toward the outside of the aortic arch, that is, toward the ventricular septum. By controlling the bending handle of the adjustable catheter 120, the bending section 123 can be bent toward the outside of the aortic arch, thereby ensuring that the distal end of the bending section 123 is always toward the side of the ventricular septum, so that the ablation needle 13 has the correct needle removal angle and direction during puncture. When the bending section 123 is bent to a suitable angle in the D direction, the distal end of the bending section 123 will contact the left ventricular side wall of the ventricular septum, thereby preparing for subsequent needle removal.

[0104] The distal end of the shaping section 122 extends in the direction away from the interventricular septum, and the bending adjustment section 123 extends in the direction of the interventricular septum, that is, the shape of the distal end of the adjustable bend catheter 120 is set in a manner of first moving away from and then approaching the interventricular septum. Compared with the prior art method of setting the shape of the distal end of the adjustable bend catheter 120 directly approaching the interventricular septum, the method of first moving away from and then approaching the interventricular septum can increase the bending angle of the bending adjustment section 123.

[0105] Embodiment 2:

[0106] like Fig.19 As shown, the present invention provides an ablation system 1 including the ablation device 10, a delivery component, an energy generating device 20 and an irrigation device 30 in Example 1, wherein the energy generating device 20 and the irrigation device 30 are respectively connected to the ablation device 10; the irrigation device 30 includes a pump and a liquid source, and the pump is used to transport the irrigation liquid 33 in the liquid source to the ablation device 10, and the irrigation liquid 33 flows out from the irrigation hole 132a through the inner cavity of the needle body 132; the energy generating device 20 is used to provide ablation energy for the ablation device 10.

[0107] Specifically, the method for performing myocardial ablation using the ablation system 1 includes the following steps:

[0108] S1, inserting the adjustable bend sheath tube 110 and the adjustable bend catheter 120 into the heart until the distal end opening of the adjustable bend catheter 120 contacts the myocardial tissue;

[0109] S2, extending the ablation needle 13 from the distal opening of the adjustable bend catheter 120 and piercing into the myocardial tissue, starting the radiofrequency ablation device and the perfusion device 30 and delivering ablation energy and perfusion liquid respectively for perfusion ablation until the ablation is completed.

[0110] By using this method to ablate myocardial tissue, on the one hand, it achieves truly minimally invasive treatment without the need for open-chest surgery and other treatment methods that are more traumatic to the patient. On the other hand, it can also puncture the endocardium for multi-point ablation.

[0111] Further, the myocardial tissue is the ventricular septum.

[0112] Further, the path used for ventricular septal myocardial ablation may be one of path a, path b and path c;

[0113] Route a: via the femoral artery and aortic arch to the left ventricle;

[0114] Path b: through the inferior vena cava, right atrium, to the right ventricle;

[0115] Path c: through the inferior vena cava, right atrium, atrial septum and left atrium, to the left ventricle.

[0116] When path a is selected, the adjustable sheath tube 110 is straightened and inserted into the aorta by the handle 114 or the dilator. As the adjustable sheath tube 110 goes deeper, the external force applied by the handle 114 to the adjustable sheath tube 110 is gradually reduced or the dilator is gradually withdrawn. After the third tube segment 113 of the adjustable sheath tube 110 reaches the target position, i.e., the ascending aorta, the external force applied by the handle 114 to the adjustable sheath tube 110 is removed or the dilator is withdrawn, so that the adjustable sheath tube 110 returns to its natural state.

[0117] Next, the adjustable bend catheter 120 is extended from the distal opening of the third tube section 113 of the adjustable bend sheath tube 110 , and the shape of the adjustable bend catheter 120 is adjusted so that the distal opening of the adjustable bend catheter 120 abuts against the ventricular septum.

[0118] Next, the ablation needle 13 is extended from the distal opening of the adjustable bend catheter 120 and punctures the endocardium to reach the ventricular septum tissue, delivering ablation energy for ablation. After the ablation is completed, the ablation needle 13, the adjustable bend catheter 120 and the adjustable bend sheath 110 are withdrawn in sequence.

[0119] Specifically, a developing component, such as a developing ring with a metal material or a smear developing material, is provided on the third tube section 113 of the adjustable bending sheath tube 110 or the ablation needle 13. Under the guidance of ultrasound imaging / CT, the adjustable bending sheath tube 110 is punctured through the femoral artery and guided by a guide wire (not shown in the figure) to pass through the aortic arch to the position of the aortic valve near the aortic arch side, such as Fig.11 shown.

[0120] Through angiography, determine whether the position of the adjustable sheath tube 110 is correctly placed. When the distal opening of the third tube segment 113 of the adjustable sheath tube 110 reaches the target position, withdraw the guide wire, and transport the adjustable catheter 120 along the inner cavity of the adjustable sheath tube 110 to the side of the aortic valve near the upper aortic arch, and cross the aortic valve without damaging the aortic valve under the guidance of ultrasound / CT. Fig.16 shown.

[0121] By adjusting the bending direction and the bending angle of the adjustable sheath tube 110 and the bending section 123 of the adjustable catheter 120 , the distal end of the adjustable catheter 120 can be well attached to the expected puncture and ablation point of the ventricular septum.

[0122] The control handle 14 is operated to control the ablation needle 13 to extend along the central axis of the adjustable curved catheter 120, puncture the ventricular septum, and reach the hypertrophic myocardial tissue of the ventricular septum. The angle and depth of insertion are controlled based on the dual judgment of the ultrasound image and the scale mark on the control handle 14.

[0123] After completing the above steps, start the perfusion device 30, set the perfusion flow rate, so that the perfusion liquid 33 passes through the inner cavity of the ablation needle 13 to reach the position of the perfusion hole 132a and perfuse the tissue for a period of time, then start the ablation radiofrequency ablation device 20, and ablate the hypertrophic myocardial tissue through the ablation segment 134 of the ablation needle 13, and determine the size of the ablation range through ultrasound and / or angiography.

[0124] When the ablation range is in the ideal size, the energy output of the radiofrequency ablation device 20 is stopped, the perfusion of the perfusion liquid 33 is stopped, the ablation needle 13 is withdrawn into the adjustable curved catheter 120, the bending section 123 of the adjustable curved catheter 120 is adjusted to make the distal end of the adjustable curved catheter 120 out of contact with the ventricular septum, and then the adjustable curved catheter 120 is operated to select the next point. When the adjustable curved catheter 120 rotates to the next puncture site, the above operation is repeated until all points are selected, punctured and ablated.

[0125] After ablation is completed, multiple continuous ablation areas will be left on the hypertrophic ventricular septum. Ideally, multiple ablation areas can be connected together to form a long continuous ablation range. After puncture and ablation are completed at all puncture points, the ablation needle 13, the adjustable curved catheter 120, and the adjustable curved sheath 110 are withdrawn in turn, and the blood vessels and the skin at the puncture points are sutured.

[0126] If path b is selected, then: under the guidance of ultrasound / CT, the femoral vein is punctured and guided by a guide wire (not shown), the adjustable sheath tube 110 is passed through the inferior vena cava, the right atrium and into the right ventricle. Through angiography, it is determined whether the adjustable sheath tube 110 is correctly placed. When the adjustable sheath tube 110 reaches the target position, the guide wire is withdrawn, and the adjustable curved catheter 120 is transported to the right ventricle along the inner cavity of the adjustable sheath tube 110. The bending direction and the bending angle of the adjustable sheath tube 110 and the bending section 123 of the adjustable curved catheter 120 are controlled so that the distal end of the adjustable curved catheter 120 can be well attached to the expected puncture and ablation point on the ventricular septum.

[0127] Operate the control handle 14 to control the ablation needle 13 to extend along the central axis of the adjustable curved sheath 110, pierce the endocardium, and reach the hypertrophic myocardial tissue of the ventricular septum. Control the angle and depth of insertion based on the dual judgment of the ultrasound image and the scale markings on the control handle 14.

[0128] After completing the above steps, the perfusion device 30 is first started, and the perfusion flow rate is set so that the perfusion liquid 33 passes through the inner cavity of the ablation needle 13 to reach the position of the perfusion hole 132a and perfuse the tissue for a period of time, and then the ablation radiofrequency ablation device 20 is turned on to ablate the hypertrophic myocardial tissue through the ablation segment 134 of the ablation needle 13. The size of the ablation range is determined by ultrasound and / or angiography, and the length of the ablation segment 134 can be adjusted by the control handle 14 according to the actual size of the ablation area, so as to achieve the purpose of controlling the ablation area.

[0129] When the ablation range is at an ideal size, stop the energy output of the radiofrequency ablation device, stop the perfusion of the perfusion liquid 33, and retract the ablation needle 13 into the adjustable curved catheter 120. Adjust the bending section 123 of the adjustable curved catheter 120 so that its distal end is out of contact with the ventricular septum, and then operate the adjustable curved catheter 120 to select the next point. When the adjustable curved catheter 120 rotates to the next puncture site, repeat the above operation until all points are selected, punctured, and ablated. After the ablation is completed, multiple continuous ablation zones will be left on the hypertrophic ventricular septum. Ideally, multiple ablation zones can be connected together to form a long continuous ablation range. After all puncture points are punctured and ablated, withdraw the ablation needle 13, the adjustable curved catheter 120, and the adjustable curved sheath 110 in turn, and complete the vascular suture and puncture point skin suture.

[0130] If path c is selected, then: under the guidance of ultrasound / CT, through femoral vein puncture, guided by a guide wire (not shown), the adjustable sheath tube 110 is passed through the inferior vena cava, the right atrium and the atrial septum to the position of the left atrium, and angiography is used to determine whether the adjustable sheath tube 110 is correctly positioned. When the adjustable sheath tube 110 reaches the target position, the guide wire is withdrawn, and the adjustable catheter 120 is transported along the inner cavity of the adjustable sheath tube 110 to the left atrium near the upper side of the mitral valve, and under the guidance of ultrasound / CT, it crosses the mitral valve without damaging the mitral valve.

[0131] The bending direction and the bending angle of the adjustable sheath tube 110 and the bending section 123 of the adjustable catheter 120 are controlled so that the distal end of the adjustable catheter 120 can be well attached to the expected puncture and ablation point on the ventricular septum.

[0132] Operate the control handle 14 to control the ablation needle 13 to extend along the central axis of the adjustable curved catheter 120, pierce the endocardium, and reach the hypertrophic myocardial tissue of the ventricular septum. Under the dual judgment of the ultrasound image and the scale marking on the control handle 14, control the angle and depth of insertion.

[0133] After completing the above steps, first start the perfusion device 30, set the perfusion flow rate, so that the perfusion liquid 33 passes through the inner cavity of the ablation needle 13 to reach the position of the perfusion hole 132a and perfuse the tissue for a period of time, then start the ablation radiofrequency ablation device 20, and ablate the hypertrophic myocardial tissue through the ablation segment 134 at the distal end of the ablation needle 13.

[0134] The size of the ablation range is determined by ultrasound and / or angiography, and the ablation range can be controlled by adjusting the length of the ablation segment 134 according to the actual size of the ablation area. When the ablation range is at an ideal size, the energy output of the radiofrequency ablation device is stopped, the perfusion of the perfusion liquid 33 is stopped, and the ablation needle 13 is retracted into the adjustable curved catheter 120.

[0135] Adjust the bending section 123 of the adjustable curved catheter 120 so that its distal end is out of contact with the ventricular septum, and then operate the adjustable curved catheter 120 to select the next point. When the adjustable curved catheter 120 rotates to the next puncture site, repeat the above operation until all points are selected, punctured and ablated. After the ablation is completed, multiple continuous ablation areas will be left on the hypertrophic ventricular septum. Ideally, multiple ablation areas can be connected together to form a long continuous ablation range. After all puncture points are completed with puncture and ablation, withdraw the ablation needle 13, the adjustable curved catheter 120, and the adjustable curved sheath 110 in turn, and complete the vascular suture and puncture point skin suture.

[0136] Embodiment three:

[0137] See also Fig. 20 Compared with the second embodiment, this embodiment differs in that the ablation system 2 of the third embodiment adopts a transapical epicardial puncture route to ablate the ventricular septum, wherein the ablation device 10 does not need to use a delivery component.

[0138] Specifically, the ablation system 2 includes the ablation needle 13, the energy generating device 20 and the irrigation device 30 in the first embodiment, the energy generating device 20 and the irrigation device 30 are respectively connected to the ablation device 10; the irrigation device 30 includes a pump and a liquid source, the pump is used to deliver the irrigation liquid 33 in the liquid source to the ablation device 10, and the irrigation liquid 33 flows out from the irrigation hole 132a through the inner cavity of the needle body 132; the energy generating device 20 is used to provide ablation energy for the ablation device 10. Among them, since the path of transapical puncture of the epicardium is adopted, the delivery component is no longer needed, and only the ablation needle 13 is used.

[0139] The above is a preferred embodiment of the present invention. It should be pointed out that a person skilled in the art can make several improvements and modifications without departing from the principle of the present invention. These improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. An ablation needle, characterized in that: It includes a needle body, which has an inner cavity, and the needle body has an ablation section and an irrigation section, and the irrigation section at least partially overlaps with the ablation section; the irrigation section includes at least two irrigation holes, each of which is connected to the inner cavity as an outlet of the inner cavity; the ablation section includes at least one electrode for releasing ablation energy; the ablation section has a distal end, and the first section is between the distal end and the irrigation hole closest to the distal end, the length of the first section is L1, and the distance between the two irrigation holes that are farthest apart is the length L2 of the irrigation section; wherein L1 is less than or equal to L2.

2. The ablation needle according to claim 1, characterized in that: The ablation segment has a proximal end, and the distance between the proximal end and the perfusion hole closest to the proximal end is L3; wherein L3 is less than or equal to L2.

3. The ablation needle according to claim 1, characterized in that: L1 is 0.1mm-10mm.

4. An ablation needle, characterized in that: The needle body comprises a needle body, the needle body has an inner cavity, and the needle body has an ablation section and an irrigation section, the irrigation section at least partially overlaps with the ablation section; the irrigation section comprises at least two irrigation holes, each of the irrigation holes is connected to the inner cavity as an outlet of the inner cavity; the ablation section comprises at least one electrode for releasing ablation energy; the ablation section has a proximal end, a second section is between the proximal end and the irrigation hole closest to the proximal end, the length of the second section is L3, and the distance between the two irrigation holes that are farthest apart is the length L2 of the irrigation section; Wherein L3 is less than or equal to L2.

5. The ablation needle according to claim 4, characterized in that: The ablation segment has a distal end, and the distance between the distal end and the perfusion hole closest to the distal end is L1; wherein L1 is less than or equal to L2.

6. The ablation needle according to claim 4, characterized in that: L3 is 0.1mm-10mm.

7. An ablation device, characterized in that: It comprises an ablation needle and a delivery assembly as described in any one of claims 1-6, wherein the delivery assembly comprises an adjustable bend catheter, 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.

8. The ablation device according to claim 7, characterized in that: Under the guidance of the delivery component, the ablation needle punctures the endocardium through the left ventricle or the right ventricle to reach the ventricular septum.

9. An ablation device, characterized in that: The ablation needle comprises the ablation needle as claimed in any one of claims 1 to 6, wherein the ablation section of the ablation needle has a length of 3 mm to 20 mm.

10. The ablation device according to claim 9, characterized in that: The ablation needle punctures the epicardium through the apex to reach the ventricular septum.

11. An ablation system, characterized in that: It comprises an ablation device, an energy generating device and an irrigation device as described in any one of claims 7 to 10; the ablation device is connected to the energy generating device and the irrigation device respectively, the irrigation device provides irrigation liquid for the ablation device, and the energy generating device provides ablation energy for the ablation device.

12. An ablation system, characterized in that: It comprises an ablation device, an energy generating device and an irrigation device; the ablation device is connected to the energy generating device and the irrigation device respectively, the irrigation device provides irrigation liquid for the ablation device, and the energy generating device provides ablation energy for the ablation device; The ablation device includes an ablation needle, which includes a needle body, the needle body has an inner cavity, and the needle body has an ablation section and an irrigation section, the irrigation section at least partially overlaps with the ablation section; the irrigation section includes at least two irrigation holes, each of which is connected to the inner cavity as an outlet of the inner cavity; the ablation section includes at least one electrode for releasing ablation energy; the ablation section has a proximal end and a distal end, the distal end and the irrigation hole closest to the distal end are a first section, the length of the first section is L1, the distance between the two irrigation holes farthest apart is the length of the irrigation section L2, the proximal end and the irrigation hole closest to the proximal end are a second section, the length of the second section is L3; the irrigation flow rate of the irrigation liquid is A, wherein L1<L2+A and / or L3<L2+A.

13. The ablation system according to claim 12, characterized in that: L1 and / or L3 are 0.1mm-10mm.

Images