CN117653324A

CN117653324A - Ablation needle, ablation device and ablation system

Info

Publication number: CN117653324A
Application number: CN202211064713.5A
Authority: CN
Inventors: 齐泽龙; 丘信炯; 张庭超
Original assignee: Hangzhou Nuoqin Medical Instrument Co ltd
Current assignee: Hangzhou Nuoqin Medical Instrument Co ltd
Priority date: 2022-08-31
Filing date: 2022-08-31
Publication date: 2024-03-08
Also published as: WO2024046356A1

Abstract

The invention relates to an ablation needle, an ablation device and an ablation system, wherein the ablation needle comprises a needle body with an inner cavity, and at least one ablation section and at least two perfusion holes communicated with the inner cavity are arranged on the needle body; the ablation segment includes at least one ablation electrode configured to deliver energy to tissue, ablate tissue, to form an ablation region; the irrigation holes are configured to deliver irrigation liquid from the lumen to tissue surrounding the needle to form an irrigation area; the plane where the axial direction and the radial direction of the needle body are located is taken as a standard plane, the area S1 is the projection area of the ablation area on the standard plane, and the area S2 is the projection area of the perfusion area on the standard plane, wherein S1/S2 is more than or equal to 0.3 and less than or equal to 1. The ablation needle can ensure the safety of the ventricular septum ablation process and improve the ablation efficiency.

Description

Ablation needle, ablation device and ablation system

Technical Field

The invention relates to the technical field of medical equipment, in particular to an ablation needle, an ablation device and an ablation system.

Background

Hypertrophic cardiomyopathy (Hypertrophic Cardiomyopathy, HCM) is a common autosomal dominant inherited cardiovascular disease with a morbidity of about 1 in the general population: 500, and the fatality rate is about 1.4% -2.2%. HCM is mainly represented by hypertrophy of one or more segments of the Left Ventricle (LV), and the typical diagnostic criteria are thickness of 15mm or more, and its treatment methods mainly include drug treatment, ventricular septum excision, ventricular septum ablation, etc.

The ventricular septum ablation technology can adopt an ablation needle to puncture ventricular septum tissue and ablate the ventricular septum tissue so as to release ablation energy to the myocardial tissue with hypertrophied ventricular septum to destroy the cell activity of the tissue at the ventricular septum, so that the myocardial tissue with hypertrophied ventricular septum becomes thinner and the contraction force is reduced, thereby reducing the phenomenon of left ventricular outflow obstruction. The myocardial tissue temperature at the position can be increased by the ablation energy, and liquid is often required to be infused into the ablation region through a plurality of infusion holes arranged on the ablation needle so as to avoid tissue carbonization caused by too fast temperature rise of the ablation region, and the ablation energy can be diffused so as to enlarge the ablation range. If the perfusion flow rate is too high, the ablation efficiency is reduced; if the perfusion flow rate is too low, the risk of tissue carbonization is increased, but the flow rate of the perfusion liquid cannot be controlled in a reasonable range in the prior art, so that the ablation efficiency is improved while the tissue carbonization is not generated in the process of ablation at the inter-chamber interval.

Disclosure of Invention

Based on the above, it is necessary to provide an ablation needle, a myocardial ablation device and a system capable of controlling the flow rate of the perfusion coolant within a reasonable range, so as to improve the ablation efficiency while ensuring the safety of the ventricular septum ablation process.

An ablation needle comprises a needle body with an inner cavity, wherein at least one ablation section and at least two perfusion holes communicated with the inner cavity are arranged on the needle body; the ablation segment includes at least one ablation electrode configured to deliver energy to tissue, ablate tissue, to form an ablation region; the irrigation holes are configured to deliver irrigation liquid from the lumen to tissue surrounding the needle to form an irrigation area; the plane where the axial direction and the radial direction of the needle body are located is taken as a standard plane, the area S1 is the projection area of the ablation area on the standard plane, and the area S2 is the projection area of the perfusion area on the standard plane, wherein S1/S2 is more than or equal to 0.3 and less than or equal to 1.

In one embodiment, the pouring holes are uniformly distributed in the axial and circumferential directions of the needle body.

In one embodiment, the ablation segment is adjustable in length.

In one embodiment, at least one of the irrigation holes is provided at each of both ends of the ablation electrode in the axial direction, so that the ablation region is within the irrigation region.

In one embodiment, the perfusion region is elliptical or elliptical-like in projection onto the standard surface, with a minor axis radius in the interval 1.41mm to 69.1mm and a major axis radius in the interval 2.5mm to 15mm.

In one embodiment, the projection of the ablation region on the standard plane is elliptical or elliptical-like, with a minor axis radius interval of 1mm to 69.1mm and a major axis radius interval of 1mm to 12mm.

In one embodiment, the ratio of the area S1 to the area S2 is 0.5.ltoreq.S1/S2.ltoreq.0.85.

In one embodiment, the ratio of the area S1 to the area S2 is 0.6.ltoreq.S1/S2.ltoreq.0.75.

An ablation device comprising the ablation needle described above.

A myocardial ablation system comprising an energy generating device, a pump and the myocardial ablation device, wherein the energy generating device is electrically connected with the ablation needle and is used for delivering ablation energy to the ablation electrode; the pump is in fluid communication with the ablation needle for delivering irrigation liquid to the irrigation hole.

In one embodiment, the catheter further comprises a catheter connected with the ablation needle, wherein the wall thickness of the catheter is not less than 0.5mm.

In one embodiment, the system further comprises a delivery assembly comprising an adjustable bend sheath and an adjustable bend conduit movably disposed within the adjustable bend sheath; the ablation needle can be movably arranged in the bendable catheter in a penetrating way.

In one embodiment, the perfusion liquid is any one of a 0.9% NaCl solution, a 0.9% NaCl solution at 5 ℃, a 5% glucose solution, a heparinized 0.9% NaCl solution, a mixed solution of a 0.9% NaCl solution and a contrast agent at room temperature.

In one embodiment, the energy generating device is electrically connected with the pump, and after the pump sets the perfusion parameter, the pump transmits the perfusion parameter to the energy generating device, and the energy generating device generates the reference ablation parameter after comparing the perfusion parameter with the reference data.

In the ablation needle, the ablation section releases energy to the tissue to form an ablation region, and the perfusion hole perfuses liquid to the tissue to form a perfusion region, so that the carbonization of the tissue caused by too fast temperature rise is avoided. In addition, the ratio of the projection area S1 of the ablation area on the standard surface to the projection area S2 of the perfusion area on the standard surface is between 0.3 and 1, so that the safety of the ventricular septum ablation process can be ensured, and the ablation efficiency can be ensured.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the invention and together with the description, serve to explain the principles of the invention.

In order to more clearly illustrate the embodiments of the invention or the technical solutions of the prior art, the drawings which are used in the description of the embodiments or the prior art will be briefly described, and it will be obvious to a person skilled in the art that other drawings can be obtained from these drawings without inventive effort.

FIG. 1 is a schematic illustration of an ablation needle according to some embodiments of the present invention;

FIG. 2 is another schematic view of FIG. 1;

FIG. 3 is a schematic cross-sectional view of FIG. 2;

FIG. 4 is a schematic view of the perfusion region, the projection of the ablation region on a standard surface during ablation;

FIG. 5 is a schematic view of an ablation region in the YZ plane at the irrigation area during ablation;

FIG. 6 is a schematic diagram of an irrigated ablation exotherm;

FIG. 7 is a schematic cross-sectional view at B-B in FIG. 2;

FIG. 8 is a schematic cross-sectional view of FIG. 2 at B-B in another embodiment;

FIG. 9 is a schematic illustration of an ablation device provided in some embodiments of the invention;

FIG. 10 is a schematic view of a structure of an adjustable bend sheath according to some embodiments of the present invention in a natural state;

FIG. 11 is a schematic view of the structure of the adjustable bend sheath in a straightened transition state;

FIG. 12 is a block diagram of an adjustable bend sheath in a straightened state;

FIG. 13 is a schematic view of the structure of the adjustable curved sheath in the aorta;

FIG. 14 is a schematic view of the structure of FIG. 13 from another view angle M-M;

FIG. 15 is a schematic view of another embodiment of an adjustable bend sheath;

FIG. 16 is a schematic view of the other view of FIG. 15;

FIG. 17 is a schematic diagram of the structure of an adjustable bend catheter and an adjustable bend sheath;

FIG. 18 is a schematic view of the distal end of the adjustable bend catheter crossing the aortic valve;

FIG. 19 is a schematic view of the structure at another view angle N-N in FIG. 18;

FIG. 20 is a schematic view of the distal end bend-adjusting structure of the bendable catheter;

FIG. 21 is a schematic view of the structure of the distal contact chamber spacing of the adjustable bend conduit;

FIG. 22 is a schematic view of the structure of an ablation needle for ablating ventricular septum tissue through the aortic puncture endocardium;

FIG. 23 is a schematic view of the configuration of the distal opening selection point of the adjustable bend catheter;

FIG. 24 is a schematic diagram of a myocardial ablation system in accordance with some embodiments of the present invention;

FIG. 25 is a schematic view of an ablation needle penetrating the endocardium via another path to ablate ventricular septum tissue;

FIG. 26 is a schematic view of an ablation needle penetrating the endocardium via another path to ablate ventricular septum tissue;

FIG. 27 is a schematic view of another ablation device provided in some embodiments of the invention;

Fig. 28 is a schematic view of the ablation of ventricular septum tissue by epicardial penetration by an ablation needle.

Description of the reference numerals

1. An ablation system; 3. an ablation zone; 10. an ablation device; 20. an energy generating device; 30. a perfusion device; 31. a fluid source; 32. a pump; 33. a fluid; the method comprises the steps of carrying out a first treatment on the surface of the 110. An adjustable curved sheath; 111. a first pipe section; 112. a second pipe section; 113. a third pipe section; 120. an adjustable bend conduit; 121. a main body section; 122. shaping section; 123. a bending section; 14. a control handle; 114. a first handle; 124. a second handle; 13. an ablation needle; 131. a needle tip; 132. a needle body; 134. an ablation section; 132a, a priming hole; 133. an insulating layer; 132b, lumen.

Detailed Description

For the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention, and it is apparent that the described embodiments are some embodiments of the present invention, but not all embodiments of the present invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

In the field of medical devices, "proximal" refers to the end closer to the operator, and "distal" refers to the end farther from the operator. "axial" refers to a direction parallel to the line connecting the distal center and the proximal center of the medical device, "radial" refers to a direction along a diameter or radius, wherein "radial" is perpendicular to "axial" and "circumferential" refers to a circumferential direction about the central axis. The specific meaning of the above terms in the present invention can be understood by those skilled in the art according to actual circumstances.

Referring to fig. 1-3, the present invention provides an ablation needle 13, and an ablation mode of the ablation needle 13 may be selected from radio frequency ablation, microwave ablation, alcohol ablation, etc. Taking radio frequency ablation as an example, the ablation needle 13 in the present application comprises a needle body 132 with an inner cavity 132b, wherein at least one ablation section 134 and at least two perfusion holes 132a communicated with the inner cavity 132b are arranged on the needle body 132; the ablation segment 134 includes at least one ablation electrode configured to release ablation energy to tissue, ablate tissue, to form an ablation region; the irrigation holes are configured to deliver irrigation liquid from the lumen to tissue surrounding the needle 132 to form an irrigation area; the plane where the axial direction and the radial direction of the needle 132 are located is taken as a standard plane, the area S1 is the projection area of the ablation area on the standard plane, and the area S2 is the projection area of the perfusion area on the standard plane, wherein S1/S2 is more than or equal to 0.3 and less than or equal to 1.

It should be noted that, the ablation energy in the present application may be, but is not limited to: radio frequency energy, ultrasonic energy, microwave energy, etc. It should be noted that the range of the ablation region of the ablation needle 13 has a clear relationship with the output power and the output time of the rf energy, and in a steady state, the range of the ablation region is proportional to the output power and the output time of the rf energy, and in theory, the size of the range of the ablation region can be increased by the higher output power and the longer output time. That is, in the case of the length determination of the ablation segment 134, the size of the ablation region range can be approximately determined by setting the output power and the output time.

However, once the peak temperature of the tissue exceeds a threshold of 100℃ or the temperature rise is too rapid, the tissue in contact with the ablation segment 134 may char, form a crust, adhere to the surface of the ablation segment 134, form an electrically insulating coagulum, and with a sudden increase in electrical impedance, prevent further current flow into the tissue and further heating, thereby greatly reducing the extent of the ablation zone resulting in poor ablation. Therefore, to prevent this, the risk of tissue crusting can be reduced by reducing the temperature of the ablation segment 134 at the tissue interface, increasing the ablation efficiency, increasing the extent of the ablation zone.

In order to effectively observe and control the diffusion range of the electrolyte solution 33 in the myocardial tissue in real time during operation, and prevent the excessive diffusion of the electrolyte solution, so as to prevent the risk of excessively damaging the ablation range to the conducting beam on the endocardium, preferably, the electrolyte solution 33 can be a mixed solution of cold physiological saline and a developer, and an operator can intuitively observe the diffusion condition of the electrolyte solution 33 mixed with the developer in the myocardial tissue through X-ray radiography, thereby regulating and controlling the ablation time, the perfusion flow rate, the flow velocity and the like in real time, and achieving the purpose of precisely controlling the size of the ablation region range.

The electrolyte solution 33 may be a mixed solution including, but not limited to, a 0.9% nacl solution at room temperature, a 0.9% nacl solution at 5 ℃, a 5% dextrose solution, a heparinized 0.9% nacl solution, a 0.9% nacl solution, and a contrast agent, and preferably, a 0.9% nacl solution at about 5 ℃ is used in order to reduce the temperature between the ablation segment 134 and the myocardial tissue contact interface even more effectively at the time of rf discharge.

On the one hand, the electrolyte solution 33 poured out through the pouring holes 132a can cool the ablation section 134 to a certain extent, reduce the temperature between the ablation section 134 and the tissue contact interface, and avoid the risks of burning, crusting and carbonization of the tissue caused by too fast temperature rise of the myocardial tissue around the ablation section 134, so that the temperature rise of the myocardial tissue around the ablation section 134 is relatively gentle; on the other hand, the electrolyte solution 33 will be diffused after being infused into the myocardial tissue, and the diffused electrolyte solution 33 will be used as a good transmission medium for radio frequency current to transmit the radio frequency current to the farther part of the myocardial tissue, so that the purpose of enlarging the range of the ablation area can be achieved by the principle.

Referring to fig. 2-3, the axial direction of the needle 132 is the X direction, the radial direction of the needle 132 is the Y direction, and the planes of the axial direction (X direction) and the radial direction (Y direction) of the needle are defined as standard planes. In addition, referring to fig. 5, the z direction is perpendicular to the standard plane.

Typically, prior to surgery, the ablation needle 13 has been vented and its lumen 132b is filled with irrigation fluid. The application also provides a myocardial ablation system comprising an energy generating device, a pump and the myocardial ablation device. The energy generating device is electrically connected with the ablation needle for delivering ablation energy to the ablation electrode. A pump is in fluid communication with the ablation needle for delivering irrigation liquid to the irrigation hole. The energy generating device is electrically connected with the pump. After the pump sets the perfusion parameters, the pump delivers the perfusion parameters to the energy generating device. The energy generating device generates reference ablation parameters after comparing the perfusion parameters with the reference data. It should be noted that, after the pump 32 is started, since the pump 32 is connected to the inner cavity 132b of the ablation needle 13, the total amount of the infusion liquid of the pump 32 will be equal to the total amount of the infusion liquid flowing through all the infusion holes 132a on the ablation needle 13, so that the infusion area of the ablation needle 13 is determined by the distribution length of the infusion holes 132a axially arranged on the ablation needle 13 and the infusion flow velocity v, where the axial distribution length of the infusion holes 132a is the distance between two infusion holes 132a farthest apart in the axial direction. Typically, the irrigation flow rate is in the range of 0.1-5.0mL/min, and the portion of the ablation needle 13 having the irrigation hole is 5-20mm in length. In the pouring process, the shape poured through the ablation needle 13 can be approximately an ellipsoid, and the volume calculation formula of the ellipsoid is as follows:

①

Wherein V is the volume of the ellipsoid, and a, b and c are 1/2 of the lengths of three axes of the ellipsoid respectively (namely, a, b and c correspond to the Y direction, the Z direction and the X direction respectively).

Because of the consistent muscle texture, the liquid flow is constant, so the ellipsoid can be approximated as a sphere-like surface (rotated 180 degrees from an ellipse along its long axis) in the YZ plane, i.e. a=b+.c.

The volume formula is:

②

when the ablation needle 13 punctures the endocardium or epicardium to irrigate and ablate the myocardial tissue, the loss of the irrigated liquid can be ignored due to the structure of the myocardial tissue, and under the condition of not considering the loss of the liquid, the ellipsoid volume V is the irrigation speed V multiplied by the irrigation time t; the length of the portion of the ablation needle 13 having the irrigation hole 132a is the major axis diameter 2c' of the irrigation area; the minor axis diameter of the perfusion region is 2a'. Let c=c ', a=a ', and substituting the above formula (2) yields a minor axis diameter 2a ' of the perfusion region as:

③

wherein v is the perfusion flow rate, and the value range is 0.1mL/min-5.0mL/min;

t is the ablation duration, and the value range is 1min-10min;

c ' is the major axis radius of the perfusion region, c is the major axis radius of the ablation range (half of the length of the ablation segment), typically c ' is 1-1.5 times c, and 2c has a value ranging from 5 mm to 20mm, and 2c ' has a value ranging from 5 mm to 30mm. The volume V of the perfusion region is positively correlated with the perfusion flow velocity V and the perfusion duration (ablation time) t as shown in formula (2), and the minor axis diameter 2a 'is inversely proportional to the major axis radius c' as shown in formula (3), so that when the volume V is the minimum and the major axis radius c 'is the maximum, the corresponding minor axis diameter 2a' is the minimum; when the volume V is at a maximum value and the major axis radius c 'is at a minimum value, the corresponding minor axis diameter 2a' is at a maximum value.

When v is 0.1mL/min, t is 1min,2c is 20mm, c ' =1.5×c=15 mm, the minimum value of 2a ', i.e. the minor axis diameter 2a ' of the minimum perfusion region is 2.52mm, can be calculated.

When v takes 5mL/min, t takes 10min,2c takes 5mm, c ' =c=2.5 mm, the maximum value of 2a ', i.e. the value of the minor axis diameter 2a ' of the maximum perfusion region is calculated as: 138.2mm.

The short axis diameter 2a' of the perfusion region is seen to be in the interval range of 2.52mm-138.2mm. It should be noted that, since the minor axis diameter 2a 'and the major axis diameter 2c' of the perfusion region are different values in different cases, it is possible to make the value range 2a 'larger than 2c' as described above, and the axis of the perfusion region in the Y direction is defined as the minor axis and the axis in the X direction is defined as the major axis for ease of understanding.

However, the irrigation area is not equal to the ablation area, and irrigation is an enhancement to the ablation area. This enhancement is particularly advantageous in the short axis because, for the long axis, the irrigation holes 132a are equally distributed axially over the ablation segment 134, and the length of the ablation segment 134 is the long axis diameter of the ablation zone. Whereas the perfusion direction is radial, not axial.

That is, the ablation region should be surrounded by the perfusion region (as shown in fig. 4-5), the projection area of the ablation region on the standard plane is S1, the projection area of the perfusion region on the standard plane is S2, S2 should be greater than or equal to S1, and generally 0.3.ltoreq.s1/S2.ltoreq.1. If S1/S2 is less than 0.3, the ablation area is too small relative to the perfusion area, and the perfusion liquid takes away a large amount of ablation energy, so that the ablation efficiency is low; if S1/S2 is larger than 1, the ablation area is larger than the perfusion area, and the part of the ablation area larger than the perfusion area is carbonized due to too fast temperature rise due to the thinner ablation needle, so that the ablation is not easy to carry out. Preferably 0.5.ltoreq.S1/S2.ltoreq.0.85, more preferably 0.6.ltoreq.S1/S2.ltoreq.0.75, in which case efficiency is compromised, avoiding carbonization due to too fast tissue temperature rise.

As shown in fig. 6, the temperature rise curve of the myocardial tissue at different S1/S2 ratios is shown, the larger the S1/S2 ratio is, the larger the slope of the temperature rise to the predetermined temperature T1 is, and therefore the larger the probability of tissue carbonization is, but the higher the ablation efficiency is when the tissue carbonization does not occur; the smaller the S1/S2 ratio, the smaller the slope of the rise to the predetermined temperature T1 and thus the smaller the probability of tissue carbonization, the lower the ablation efficiency. From this, it is clear that the ablation efficiency is proportional to the ratio S1/S2 when no tissue carbonization occurs, and the probability of tissue carbonization occurring is proportional to the ratio S1/S2. Specifically, the abscissa in the graph is ablation time (T/s), and the ordinate is the temperature of tissue being ablated (T/. Degree. C.). The process of heating and raising the tissue temperature from the body temperature T0 to the preset temperature T1 is a temperature raising process, and the tissue temperature needs to be maintained for a period of time after undergoing the temperature raising process to complete ablation. That is, the ablation process includes a temperature rise process and a maintenance process, the time required for the ablation process is the ablation time t, the time required for the temperature rise process is the temperature rise time ta, and the time required for the maintenance process is the maintenance time tb, so t=ta+tb. The ablation time t is generally a preset value at the time of ablation, and the temperature rise time ta and the maintenance time tb are inversely proportional to each other in the case that the ablation time t is determined, that is, the larger ta, the smaller tb, the larger ta. The greater the holding time tb without carbonization, the higher the ablation efficiency, and tissue carbonization tends to occur during the temperature rise. From the graph, the larger the S1/S2 ratio is, the smaller the temperature rise time ta is required from T0 to T1 is; the smaller the S1/S2 ratio, the greater the temperature rise time ta required from T0 to T1. When the S1/S2 ratio is 1.1, the temperature rise time t1 is smaller, so that the tissue carbonization is more likely to occur; when the S1/S2 ratio is 0.3, the temperature rise time t6 is large at this time, so that tissue carbonization is not easy to occur, but the maintenance time tb is smaller due to the large temperature rise time t6, so that the ablation efficiency is lower. In contrast, when the S1/S2 ratio is 0.7 and 0.6, the corresponding temperature rise time is t3 and t4, at the moment, tissue carbonization is not easy to occur, and meanwhile, the ablation efficiency is good, so that the purposes of taking efficiency into account and avoiding carbonization caused by too fast tissue temperature rise can be achieved.

Further, the projection of the perfusion region on said standard plane is elliptical, i.e. the area s2=pi a 'c', so that the operator can adjust the size of the area S1 according to the area S2. The area S1 is generally associated with ablation energy in the range of 1-100W, and in particular the operator can view the ablation zone under an imaging system, increase the ablation zone by increasing the ablation energy, and decrease the ablation zone by decreasing the ablation energy. Or an operator can select corresponding output power, output time and other ablation parameters after comparing according to the reference data, and the function of adjusting the size of the area S1 can be achieved. Specifically, the data in tables 1 to 4 can be referred to, for example, when it is determined that 2c is 5mm,2c' is 7.5mm, t is 3min, v is 0.5mL/min, it can be found from the above formula that S2 is 230.19mm2, and when the output power (i.e., ablation power) is 4W, S1 is 119.15mm2, so S1/S2 is 51.76%, and the ablation efficiency is the middle, but the probability of tissue carbonization is low, and the ablation effect is good. When it is determined that 2c is 10cm,2c' is 12mm, t is 5min, v is 2mL/min, according to the above formula, it can be obtained that S2 is 751.80mm2, and when the output power (i.e. the ablation power) is 22W, S1 is 772.34mm2, so that S1/S2 is 102.73%, at this time, tissue carbonization occurs, the ablation effect is poor, and based on the reference data, under the condition that the perfusion time t and the perfusion flow velocity v are unchanged, the situation that tissue carbonization occurs can be avoided by setting the ablation power to be less than or equal to 21W, the ablation efficiency is high, and a good ablation effect can be achieved.

TABLE 1

TABLE 2

TABLE 3 Table 3

TABLE 4 Table 4

In some possible embodiments, radio frequency ablation is selected, the ablation needle 13 comprising a needle body 132, the needle body 132 having an ablation segment 134 disposed at least partially thereon, the ablation segment 134 having electrical conductivity for conducting radio frequency ablation energy. The ablation needle 13 is connected to an energy generating device 20, and the energy generating device 20 is of the prior art and will not be described in detail herein. In some possible embodiments, the needle 132 is provided with at least one filling hole 132a, the filling hole 132a being in communication with the interior of the needle 132.

The ablation needle 13 can puncture endocardial or epicardial tissue under the puncture of the needle tip 131, so that the distal end of the ablation needle 13 comprises the needle tip 131, the perfusion hole 132a and an ablation section 134 which partially enters a thickening area of a ventricular septum, and the cell activity of the hypertrophic myocardial tissue is destroyed by the energy released by the ablation section 134, so that the myocardial tissue of the ventricular septum becomes thinner and the contraction force is reduced, thereby reducing the phenomenon of left ventricular outflow obstruction; simultaneously, under the perfusion of the electrolyte solution 33 in the perfusion hole 132a, the radio frequency energy is brought into the myocardial tissue at a longer distance from the ablation segment 134 by the diffusion of the solution inside the myocardial tissue, thereby achieving the purpose of expanding the ablation range.

The needle tip 131 of the ablation needle 13 is a closed and sharp tip structure having a shape including, but not limited to, a cone, triangular pyramid, rectangular pyramid, single bevel edge, etc., the shape of the needle tip 131 being capable of providing the ablation needle 13 with a sufficiently sharp needle tip 131 structure so that it can pierce endocardial tissue with a small piercing force to smoothly enter ventricular septum myocardial tissue.

The needle tip 131 is secured to the distal end of the needle body 132 by means of a connection including, but not limited to, adhesive, laser welding, fusion, etc. The needle 132 is a hollow long tubular structure having a lumen 132b therethrough. The pump 32 fills the inner cavity 132b of the needle 132 with the electrolyte solution 33, and the electrolyte solution 33 flows out from the filling hole 132a through the inner cavity 132b of the needle 132.

Referring to fig. 7, the cross-section of the needle 132 is preferably circular. In other embodiments, referring to fig. 8, the cross-section of the needle 132 may be elliptical. It should be clear that the outer wall of the needle 132 should be smooth, without obvious protrusions or corners, to prevent it from scratching tissues such as the intima of a blood vessel during entry into a target site of the human body. The needle 132 is preferably made of a metallic material having a good electrical conductivity so that it can release rf energy through the excellent electrical conductivity of the needle 132 itself, and the ablation segment 134 is formed as a part of the needle 132. Needle 132 material may be used including, but not limited to, metal tubing such as stainless steel tubing, nitinol.

Referring to fig. 21, on the other hand, when performing ablation through a catheter path, since the ablation needle 13 needs to reach the target position of the inter-ventricular space through a complex and tortuous peripheral vascular path, and in order to ensure a good puncture angle, the distal end portion of the ablation needle 13 will simultaneously pass through the flexible sheath 110 and the long path of the flexible catheter 120, and possibly scratch and rub, so that besides the factor of good electrical conductivity, good mechanical and mechanical properties of the needle 132 should be considered; the ablation needle 13 is preferably made of a metal tube with high biocompatibility, specifically, since the nickel-titanium alloy has excellent biocompatibility, high strength, good shaping and mechanical properties of super elasticity after heat treatment, the needle body 132 made of the nickel-titanium alloy can maintain good rebound performance after passing through a complicated and tortuous vascular path and after repeated bending adjustment, and no shaping deformation occurs, so that the system can reach a target position through a blood vessel more smoothly without increasing the passing resistance due to plastic deformation of the needle body 132. In other possible embodiments, the needle 132 may be made of a polymeric material, in which case the ablation segment 134 would be a separate component with good electrical conductivity attached to the needle 132.

When the needle 132 is made of a polymer material, the polymer material used should have excellent strength, hardness, higher elastic modulus and good bending resistance, and not break and plastically deform under repeated bending, on the other hand, in order to ensure that the needle 132 has excellent pushing performance in the process of moving back and forth along the central axis of the adjustable bend catheter 120, the material should have a lower surface friction coefficient, and can reduce the pushing resistance of the ablation needle 13 in the lumen of the adjustable bend catheter 120, and meanwhile, in order to ensure insulation of the needle 132, the material should have excellent dielectric insulation, high insulation resistance, small dielectric constant and high pressure resistance. In summary, the needle 132 is preferably made of a polymer material such as polypropylene PP, high density polyethylene HDPE, polytetrafluoroethylene PTFE, or the like.

At least one ablation segment 134 is disposed at the distal end of the ablation needle 13, the ablation segment 134 being in electrical communication with the energy generating device 20 to release energy through the ablation segment 134 into the tissue. As mentioned above, when the needle 132 is a metal tube, the ablation section 134 should be present as a part of the needle 132, specifically, at this time, an insulating layer 133 should be attached to the outer surface of the needle 132, and the exposed area of the distal end of the needle 132, which is not covered with the insulating material, is used as the ablation section 134 for releasing radio frequency energy.

The insulating layer 133 may be a layer of polymer material coated on the needle body 132 by thermal shrinkage, or may be directly sleeved on the outer side of the needle body 132, or may be attached on the outer side 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, and the low friction coefficient can provide good lubricity and pushing performance for the ablation needle 13, and the high insulation resistance can enable the insulating layer 133 to still maintain excellent dielectric insulation under the effect of high-frequency radio-frequency current without breakdown.

When the insulating layer 133 is heat-shrinkable over the outside of the needle body 132, the insulating material is preferably PET (polyethylene terephthalate), PTFE (polytetrafluoroethylene), FEP (fluorinated ethylene propylene), or the like. When the insulating layer 133 is fixed to the outside of the needle 132 by a sleeve, the insulating layer 133 is preferably made of PEEK (polyether ether ketone), PI (polyimide), or the like. When the insulating layer 133 is adhered to the outer side of the needle 132 by a coating process, the insulating material preferably uses Parylene. In view of the foregoing, when the needle 132 is a polymeric tubing, the ablation segment 134 should be a separate component with good electrical conductivity that is secured to the outside of the needle 132.

Specifically, the ablation segment 134 should be one or more annular metal electrodes that are secured to the distal end of the needle 132 by means including, but not limited to, adhesive, welding, crimping, soldering, etc., and are in electrical communication with an external energy generating device via a wire. The annular metal electrode is preferably made of a radiopaque metal material such as platinum iridium alloy, cobalt chromium alloy, tantalum and the like, so that the annular metal electrode has excellent conductive performance and can also have a developing effect under rays, and the annular metal electrode plays a role in helping an operator to confirm the position of the ablation section 134. The effective length 2c of the ablation section 134 refers to the length exposed outside the insulating layer 133 that can be contacted with the tissue to be treated, and the effective length 2c of the ablation section 134 is preferably 5mm to 15mm.

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 insulation layer 133 is fixed, at this time, the effective length of the ablation segment 134 in the same set of ablation needles 13 is a determined fixed value, and multiple types of ablation needles 13 with different specifications can be designed by setting the ablation segments 134 with different effective lengths, so as to meet the use requirements of different patients with different tissue morphology sizes.

In some possible embodiments, the relative position between the needle 132 and the insulating layer 133 may be adjusted to achieve different exposed lengths of the needle 132 for the purpose of adjusting different effective lengths of the ablation segment 134.

In some possible embodiments, the needle body 132 is sleeved with an insulating sleeve, the insulating sleeve is used as the insulating layer 133, the insulating sleeve and the needle body 132 can slide relatively, the effective length 2C of the ablation section 134 can be controlled by controlling the relative movement between the needle body 132 and the insulating layer 133, it is known that too short the ablation section 134 can make the range of the ablation area too small, which is insufficient to achieve the purpose of reducing the left outflow tract pressure difference, or to achieve the purpose, multiple ablations are needed, and the duration of the operation is increased; while an excessively long ablation segment 134 would excessively increase the extent of the ablation zone, there is a risk of damaging the conductive bundle distributed over the endocardium. Specifically, the ablation needle 13 is correspondingly provided with an ablation operation handle (not shown in the figure), the ablation operation handle is provided with a pushing structure, and the pushing structure is connected with the insulation sleeve and can drive the insulation sleeve to slide relative to the needle body 132, so that the length of the needle body 132 exposed outside the insulation sleeve is adjusted, namely, the effective length 2C of the ablation section 134 is adjusted; the ablation operating handle is also provided with a locking structure which is connected with the needle body 132 and is used for locking and fixing the needle body 132.

In a specific implementation process, under the condition that the needle 132 and the insulating sleeve are kept relatively fixed, namely, the effective length of the ablation section 134 is unchanged, endocardial tissues are punctured together and pricked into ventricular septum myocardial tissues, when the effective length of the ablation section 134 needs to be adjusted, the needle 132 can be locked by a locking structure of an ablation operation handle so as to keep the needle 132 fixed in the direction along the central axis of the adjustable curved catheter 120, and then the insulating sleeve can realize front-back relative movement along the central axis of the needle 132 by pushing a pushing structure fixedly connected with the ablation operation handle so as to control the extension or shortening of the ablation section 134 exposed outside the insulating sleeve, thereby changing the effective length of the ablation section 134.

In other possible embodiments, a locking structure is associated with the insulating sleeve for locking the insulating sleeve, and a pushing structure is associated with the needle 132 capable of driving the needle 132 to slide relative to the insulating sleeve.

Similarly, in a state that no relative movement is kept between the needle 132 and the insulating sleeve, the needle 132 and the insulating sleeve pierce endocardial tissue together and pierce the ventricular septum myocardial tissue, when the effective length of the ablation section 1341 needs to be changed, the insulating sleeve is kept to be fixed along the direction of the central axis of the needle 132 by controlling the locking structure, and the needle 132 can realize the front-back relative movement along the direction of the central axis of the insulating sleeve by pushing the pushing structure, so that the purpose of controlling the extension or shortening of the ablation section 134 exposed outside the insulating sleeve is achieved, and the effective length of the ablation section 134 is changed.

The ablation needle 13 is preferably provided with at least one or more irrigation holes 132a, and is uniformly distributed in the axial and circumferential directions of the needle body 132. The shape of the pouring hole 132a may be circular, elliptical, or the like. The pour hole 132a is preferably formed using laser cutting. The structure of the ablation needle 13 using the ablation mode such as microwave ablation is substantially the same as that of the ablation needle 13 using radio frequency ablation, and will not be described here.

In one embodiment, to meet the perfusion needs, the output capacity of the perfusion pump 32 should at least meet 0.1-5.0mL/min. Since the pump is required to continuously supply fluid to the ablation needle 13 through the catheter 34 during the irrigated ablation process, the catheter 34 is required to have a certain size to avoid deformation and rupture caused by the too thin tube wall when the ablation needle 13 with a small bore diameter outputs the desired flow. Taking 5.0mL/min as an example, at a wall thickness of less than 0.5mm, the conduit 34 is easily deformed and ruptured, so that at a wall thickness of not less than 0.5mm, the conduit 34 will not be deformed and ruptured, preferably the conduit 34 has a wall thickness of not less than 0.65mm, more preferably not less than 1mm. The conduit 34 may also be comprised of two different sized hoses, say a first conduit section of 2.5mm outside diameter, 1.2mm inside diameter (0.65 mm single side wall thickness), and a second conduit section of 4.0mm outside diameter, 0.8mm inside diameter (1.6 mm single side wall thickness), provided the wall thickness is no less than 0.5 mm.

Referring to fig. 9 and 27, the present invention provides an ablation device including an ablation needle according to the above-described embodiments.

Referring to fig. 9, in some embodiments, the ablation device 10 includes a delivery tube assembly and an ablation needle 13, the delivery tube assembly includes an adjustable curved sheath 110 and an adjustable curved catheter 120 movably disposed through the adjustable curved sheath 110, the ablation needle 13 is movably disposed through the adjustable curved catheter 120, and a distal end of the ablation needle 13 is capable of extending out of a distal end of the adjustable curved catheter 120.

Referring to fig. 27-28, in some embodiments, an ablation device includes an ablation needle 42, the ablation needle 42 being operable to ablate ventricular septum tissue epicardially through a cardiac tip without a delivery assembly. For performing an ablation procedure. The ablation device further comprises an outer cannula 41 and an ablation handle 40. The outer sleeve 41 is movably sleeved outside the ablation needle 42 and is detachably and rotatably connected with the ablation handle 40. The outer sleeve 41 is at least partially insulated. In other words, the outer sleeve 41 may be fully or partially insulated. The distal end of the ablation needle 42 extends out of the outer sleeve 41, and when the outer sleeve 41 is completely insulated, the part of the ablation needle 42 extending out of the outer sleeve 41 performs an ablation operation; when the outer cannula 41 is partially insulated, the portion of the ablation needle 42 extending beyond the outer cannula 41 and the portion of the outer cannula 41 not insulated perform an ablation operation.

Referring to fig. 10, taking the above adjustable curved sheath 110 entering the left ventricle through the aorta as an example, when the ventricular septum tissue is ablated by other routes, the structure of the adjustable curved sheath 110 can be adaptively adjusted with reference to the corresponding route.

The adjustable curved sheath 110 includes an adjustable curved sheath 110 and an adjusting member (not shown), wherein the adjustable curved sheath 110 is a prefabricated pipe, has a certain rigidity and flexibility, the adjusting member adjusts the shape of the adjustable curved sheath 110 by applying a force to the adjustable curved sheath 110, and the adjustable curved sheath 110 can gradually return to its natural state after the force of the adjusting member is removed, and the adjustable curved sheath 110 has a hollow inner cavity.

The adjustable bend sheath 110 includes a first tube segment 111, a second tube segment 112, and a third tube segment 113 that communicate sequentially in a proximal to distal direction.

As a possible embodiment, in a natural state, the first tube section 111, the second tube section 112 and the third tube section 113 are all located on the same plane, the second tube section 112 extends in a direction away from the first tube section, then extends in a direction toward the first tube section 111, and the third tube section 113 extends in a direction toward the first tube section 111, so that the first tube section 111 is adapted to the shape of the descending aorta of the human body, the second tube section 112 is adapted to the shape of the aortic arch of the human body, the third tube section 113 is adapted to the shape of the ascending aorta of the human body, and the distal end of the third tube section 113 is adjacent to the middle portion of the aortic valve of the human body. Therefore, the adjustable curved sheath 110 in this embodiment has a predetermined shape in its natural state that matches the shape of the human aorta to facilitate treatment of myocardial tissue from the aorta across the aortic valve and then into the left ventricle.

Referring to fig. 10, the adjustable curved sheath 110 is in a natural state. An adjustment member is connected to the adjustable curved sheath 110 for adjusting the shape of the adjustable curved sheath 110, and the adjustable curved sheath 110 can be switched between a straightened state (as shown in fig. 12) and a natural state (as shown in fig. 10) by operating the adjustment member. The straightened state refers to a state in which the shape of the adjustable curved sheath is made approximately straight by the adjustment member, and specifically, the shape of the adjustable curved sheath is changed from a curved shape in a natural state (as shown in fig. 10) through a transitional state (as shown in fig. 11) to an approximately straight shape (i.e., a straightened state, as shown in fig. 12) by applying an external force opposite to the direction C to the adjustable curved sheath by operating the adjustment member. Therefore, before the insertion into the human body, the adjustable curved sheath 110 is adjusted from the natural state to the straightened state, the straightened state of the adjustable curved sheath 110 is gradually changed to the natural state as the adjustable curved sheath 110 goes deep, and finally the natural state is restored, and then the distal end of the adjustable curved sheath 110 can be adjusted and curved by operating the adjusting member, so that the adjustable curved sheath 110 is in the curved state (as shown in fig. 10). Specifically, the distal end of the third tube section 113 of the adjustable bend sheath 110 is provided with an anchor ring, the anchor ring is connected to the distal end of a pulling wire built in the adjustable bend sheath 110, and the proximal end of the pulling wire is connected to the adjustment member. Therefore, the adjusting means can adjust the bending degree of the third tube segment 113 by pushing and pulling the pulling wire, and when the third tube segment 113 is bent to a certain degree away from the first tube segment 111, the adjusting means 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 nearly straight line state, so that the adjustable bent sheath tube 110 can be brought into a straightened state by operating the adjusting means. Since the adjustable curved sheath 110 is straightened by manipulating the adjustment member, there will be a portion of the third tube segment 113 of the adjustable curved sheath 110 in the straightened state during this manipulation that does not affect the overall access of the adjustable curved sheath 110 to the relevant vascular path. As the adjustable bending sheath 110 goes deep, the external force applied to the adjusting member is gradually reduced, so that the self-alignment state of the adjustable bending sheath 110 is gradually changed to a natural state, and finally the natural state is restored. Alternatively, in some embodiments, the operator may insert a dilator into the adjustable curved sheath 110, straighten the adjustable curved sheath 110 by using the dilator, so that the first tube section 111, the second tube section 112, and the third tube section 113 are adjusted to be in a straight or approximately straight state, gradually withdraw the dilator from the adjustable curved sheath 110 as the adjustable curved sheath 110 goes deep, gradually change the self-straightened state to a natural state, and finally restore the natural state, and then further adjust the distal end of the adjustable curved sheath 110 by operating the adjusting member, where the adjustable curved sheath 110 is in the bent state. Further, a guidewire may be inserted into the dilator and then withdrawn along with the dilator during withdrawal of the dilator.

By arranging such that the adjustable curved sheath 110 in a natural state conforms to the shape of the aorta, wherein the first tube section 111 approximates or is identical to the shape of the descending aorta, the second tube section 112 approximates or is identical to the shape of the aortic arch, and the third tube section 113 approximates or is identical to the shape of the ascending aorta, such that when the adjustable curved sheath 110 is inserted into the aorta and restored to a natural state, the distal end portion of the third tube section 113 will be close to the middle portion of the aortic valve, and when the distal end opening of the third tube section 113 is not oriented to the aortic valve or a predetermined direction, the distal end opening orientation of the third tube section 113 can be adjusted by operating the adjusting member, and the adjustable curved sheath 110 is in an adjusted curved state.

In the prior art, the adjustable curved sheath 110 is integrally formed as a straight line or an approximate straight line in a natural state, an operator applies an external force to adjust the bending degree of the distal end of the adjustable curved sheath 110 through a handle, and the handle state is required to be maintained after the adjustable curved sheath 110 is changed into a target shape; in this embodiment, the adjustable curved sheath 110 is in a predetermined shape in a natural state, that is, the third tube 113, the second tube 112 and the first tube 111 are located in the same space plane, the second tube 112 extends in a direction away from the first tube 111 and then extends toward the first tube 111, the third tube 113 extends toward the first tube 111, before the adjustable curved sheath 110 enters the aorta, an operator applies an external force to the adjustable curved sheath 110 or inserts an expander into the adjustable curved sheath 110 to adjust the adjustable curved sheath 110 to a straight line or an approximate straight line, during the process of passing through the descending aorta and the aortic arch and reaching the ascending aorta, the external force or the expander applied to the adjustable curved sheath 110 by the adjusting member is gradually reduced, so that the first tube 111, the second tube 112 and the third tube 113 of the adjustable curved sheath 110 gradually return to the natural state, at this time, the distal end of the third tube 113 reaches the ascending valve and is directed toward the opening of the ascending aorta, and any error in the direction of the descending aorta is avoided, and the operator can avoid the error in the descending aorta and the operation is not required to apply an external force to the adjustable sheath 110. If the distal opening of the third tube segment 113 is not oriented in the aortic valve or in a predetermined direction, the distal opening of the third tube segment 113 can be adjusted by operating the adjusting member while the adjustable bend sheath 110 is in the bend-adjusted state.

The shape of the third tube segment 113 in its natural state ensures that the distal end of the third tube segment 113 moves in both directions toward and away from the ventricular septum, thereby facilitating the subsequent selection of different puncture sites to provide different treatment positions for the adjustable bend catheter 120 and the ablation needle 13 that are threaded into the adjustable bend sheath 110.

Correspondingly, the proximal end of the bendable sheath 110 is connected to the first handle 114, the proximal end of the bendable catheter 120 is connected to the second handle 124, and the first handle 114 and the second handle 124 can respectively adjust the bending degree of the distal ends of the bendable sheath 110 and the bendable catheter 120.

Referring to fig. 13 and 14, further, the adjustable curved sheath 110 can be controlled to rotate along the circumferential direction by the adjusting member to control the swing of the third pipe section 113 so as to control the direction of the distal opening of the third pipe section 113; specifically, when the adjustable curved sheath 110 is controlled to rotate clockwise by the adjusting member, the third tube segment 113 will swing toward the aortic arch on the side of the Anterior (i.e., the side of the aortic arch near the thoracic cavity), and it is known that when the adjustable curved sheath 110 is controlled to rotate counterclockwise, the third tube segment 113 will swing toward the aortic arch on the side of the Posterior (i.e., the side of the aortic arch near the back).

By controlling this swinging of the third tube segment 113, it is possible to control the different orientations of the distal opening of the third tube segment 113, and thus the extension of the adjustable bend catheter 120 through the adjustable bend sheath 110 from the distal opening of the third tube segment 113 at different angles.

In some possible embodiments, the first tube section 111 is rectilinear in nature.

In some possible embodiments, the proximal portion of the first tube segment 111 is rectilinear and the distal portion is curved.

In some possible embodiments, the curved portion of the third pipe section 113 may take the form of a regular or irregular curve, preferably arranged in the shape of a circular arc.

In some possible embodiments, the second tube segment 112 is curved in nature with its central portion arched relative to the ends. Further, the second pipe section 112 may have a regular or irregular curve shape, and the second pipe section 112 is preferably circular arc-shaped, so that the connection transition between the first pipe section 111 and the third pipe section 113 is smooth.

In some possible embodiments, the third tube segment 113 is curved in nature, and the curvature of the proximal portion of the third tube segment 113 is less 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. With the distal portion of the second tube segment 112 and the third tube segment 113 extending toward the first tube segment xxx, the distal portion of the third tube segment 113 will be drawn toward the first tube segment 111.

By the arrangement, when the third tube section 113 is located in the ascending aorta in a natural state, the distal end of the third tube section 113 is located close to the middle part of the aortic valve and is biased to one side of the descending aorta, i.e. the distal end of the third tube section 113 is far away from the ventricular septum, so that the distance from the distal end of the third tube section 113 to the ventricular septum is increased, and the selection range of the adjustable curved sheath 110 and the adjustable curved catheter 120 is further increased.

In some possible embodiments, the curvatures of the first tube section 111, the second tube section 112, and the third tube section 113 are different, and the curvature of the second tube section 112 is greater than the curvatures of the first tube section 111, the third tube section 113, and the curvature of the third tube section 113 is greater than the curvature of the first tube section 111.

In some possible embodiments, the curvature of the second tube segment 112 may remain unchanged or may be configured to: the curvature of the second tube segment 112 increases and then decreases, or gradually increases, in a proximal to distal direction.

When the curvature of the second tube segment 112 remains unchanged, the second tube segment 112 is substantially free of interference with the aortic arch with minimal damage to the vessel wall.

When the curvature of the second tube segment 112 is increased and then decreased, the second tube segment 112 has partial interference with the aortic arch and a smaller interference area, and the force provided by the vessel wall to the second tube segment 112 can assist the adjustable curved sheath 110 in maintaining the position.

When the curvature of the third tube segment 112 is gradually increased, the second tube segment 112 may have a partial interference with the aortic arch and a larger interference area, which may increase the force provided to the second tube segment 112 for positioning.

Referring to fig. 15-16, in some embodiments, variations are made to the shape of the adjustable curved sheath 110, which differ from the above embodiments only in that:

in a natural state, the first tube section 111 and the second tube section 112 of the adjustable bend sheath 110 are located in a first plane 91, and the third tube section 113 is located in a second plane 92 having an angle with the first plane 91.

Specifically, considering that the aortic arch is not a planar structure but a three-dimensional spatial structure, according to the actual aortic arch shape, the third tube segment 113 and the second tube segment 112 of the adjustable curved sheath 110 are also correspondingly configured as a three-dimensional spatial structure with respect to the first tube segment 111, 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 forming an angle with the plane 91.

According to the shape of the actual aortic arch, the bending direction C of the third tube section 113 should be bent in the direction of the aortic arch near the chest of the human body, that is, in the bending direction of the Anterior direction, so that the adjustable curved sheath 110 can be more matched with the shape of the aortic arch through the above arrangement.

In some possible embodiments, the first plane 91 is at an angle a to the second plane 92, where 10 A.ltoreq.a.ltoreq.45.

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

In some embodiments, the ablation device may perform post-endocardial ablation of the ventricular septum via a path such as inferior vena cava-right atrium-right ventricle or inferior vena cava-right atrium-atrial septum-left atrium-left ventricle, and the configuration of the adjustable curved sheath 110 may be adapted with reference to this embodiment.

Taking the above adjustable curved sheath 110 entering the left ventricle through the aorta as an example, the structure of the adjustable curved catheter 120 is illustrated, and when the ventricular septum is ablated by other routes, the structure of the adjustable curved catheter 120 is adaptively adjusted with reference to this embodiment.

Referring to fig. 17, the adjustable catheter 120 has at least a main body section 121, a shaping section 122 and a bending section 123 from the proximal end to the distal end, wherein the shape of the main body section 121 is adapted to the shape of the first tube section 111 of the adjustable sheath 110, and the shape of the shaping section 121 is adapted to the shape of the second tube section 112 and the third tube section 113 of the adjustable sheath 110, so as to achieve better structural compatibility of the adjustable catheter 120 and the adjustable sheath 110. The adjustable bend catheter 120 is disposed in the hollow lumen of the adjustable bend sheath 110 and can perform a relative movement with the adjustable bend sheath 110 along the direction of the central axis.

Specifically, when the adjustable bend sheath 110 of the above embodiment is employed, the distal end portion of the shaping segment 121 extends away from the direction of the compartment, and the bending segment 123 extends toward the direction of the compartment.

Referring to fig. 18-22, when the adjustable bend sheath 110 is positioned within the aorta and in a natural state, the adjustable bend catheter 120 is delivered through the lumen of the adjustable bend sheath 110, and the bending section 123 will extend from the distal open position of the third tube section 113 of the adjustable bend sheath 110 and across the aortic valve to a position of LVOT (left ventricular outflow tract), at which point the adjustable bend catheter 120 is in a natural state (non-adjusted bend).

The bending adjustment handle is connected to the bending adjustment catheter 120, and the circumferential swing of the bending adjustment section 123 of the bending adjustment catheter 120 can be controlled by controlling the rotation of the bending adjustment handle of the bending adjustment catheter 120. Specifically, when the flex handle is rotated in a clockwise direction, the flex section 123 will exhibit a slight oscillation in a counterclockwise direction, and an angular oscillation toward the aortic arch in a direction toward the back (Posterior direction); when the turn handle is controlled to rotate in a counter-clockwise direction, the turn section 123 will exhibit a slight oscillation in a clockwise direction and an angular oscillation toward the aortic arch toward the chest (Anterior direction).

As shown in fig. 23, by the rotation of the third tube section 113 of the adjustable sheath tube 110 and the bending section 123 of the adjustable catheter 120 together, different orientations of the bending section 123 of the adjustable catheter 120 can be achieved, thereby achieving the selection of points at different positions on the inter-chamber space.

As shown in fig. 20, the bending direction D of the bending section 123 may be directed to the outer side of the aortic arch, i.e. to the ventricular septum direction, and by controlling the bending handle of the bending catheter 120, the bending section 123 may be bent to the outer side of the aortic arch 42, so as to ensure that the distal end of the bending section 123 always faces to the ventricular septum side, so that the ablation needle 13 has a correct needle outlet angle and direction when performing puncture.

When the bending section 123 is bent to the appropriate angle in the direction D, the distal end of the bending section 123 will contact the ventricular septum left ventricular sidewall, thereby providing for subsequent needle delivery.

The distal end portion of the shaping segment 121 extends in a direction opposite to the compartment space, and the bending segment 123 extends in a direction toward the compartment space, i.e., the shape of the distal end portion of the adjustable bend catheter 120 is set in a manner of being away from and closer to the compartment space first, and the needle-out angle of the bending segment 123 can be increased in a manner of being away from and closer to the compartment space first, compared to the shape of the distal end portion of the adjustable bend catheter 120 being set in a manner of being directly closer to the compartment space in the prior art.

Referring to fig. 24, some embodiments disclose an ablation system 1 including the ablation device 10 of the above-described embodiments; and an energy generating device 20, wherein the energy generating device 20 is electrically connected with the ablation device 10 to provide energy for the ablation device 10. The above embodiments show that the ablation device 10 includes a delivery assembly and an ablation needle 13; the ablation needle 13 is movably arranged in the conveying component in a penetrating way; the delivery assembly is used to access the heart via a catheter approach, and after the ablation needle 13 is passed out of the delivery assembly, it is passed through the endocardium into the myocardial tissue, and then the energy generating device 20 provides energy to the ablation needle 13 to ablate the myocardial tissue.

Further, the ablation system 1 further comprises an irrigation device 30, the irrigation device 30 being adapted to provide the ablation device 10 with a liquid, which is the above-mentioned electrolyte solution 33. As previously described, the ablation needle 13 is provided with an irrigation hole 132a, and the electrolyte solution can be used to cool the myocardial tissue to avoid too rapid a temperature rise of the myocardial tissue and to expand the ablation scope.

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

s1, inserting the adjustable bending sheath 110 and the adjustable bending catheter 120 into the heart until the distal end opening of the adjustable bending catheter 120 abuts against myocardial tissue;

S2, the ablation needle 13 is extended out of the distal opening of the adjustable bending catheter 120 and is penetrated into myocardial tissue, and ablation energy is delivered for ablation.

The method can ablate myocardial tissue, so that on one hand, the minimally invasive treatment is realized in a true sense, and a treatment mode of relatively large trauma to a patient such as chest opening operation is not needed, and on the other hand, the endocardium can be punctured to ablate in multiple points.

Further, the myocardial tissue is the ventricular septum.

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

path a: through the femoral artery, aortic arch to the left ventricle;

path b: through the inferior vena cava, right atrium, and right ventricle;

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

When path a is selected, the adjustable curved sheath 110 of the adjustable curved sheath 110 is straightened by the first handle 114 or the dilator and inserted into the aorta, the external force applied to the adjustable curved sheath 110 by the first handle 114 is gradually reduced or the dilator is gradually withdrawn as the adjustable curved sheath 110 is further advanced, and after the third tube segment 113 of the adjustable curved sheath 110 reaches the target position, i.e., the ascending aorta, the external force applied to the adjustable curved sheath 110 by the first handle 114 is removed or the dilator is withdrawn, so that the adjustable curved sheath 110 returns to the natural state.

Next, the adjustable bend catheter 120 is extended from the distal opening of the third tube segment 113 of the adjustable bend sheath 110, and the shape of the adjustable bend catheter 120 is adjusted such that the distal opening of the adjustable bend catheter 120 abuts the ventricular septum.

Next, the ablation needle 13 is extended from the distal opening of the adjustable bend catheter 120 and the endocardium is penetrated into the inter-ventricular tissue, ablation energy is delivered for ablation, and after the ablation is finished, the ablation needle 13, the adjustable bend catheter 120 and the adjustable bend sheath 110 are sequentially withdrawn.

Specifically, a developing component, such as a developing ring or a coated developing material, with a metal material is disposed on the third tube section 113 of the adjustable curved sheath 110 or the ablation needle 13, and the adjustable curved sheath 110 is guided by a guide wire (not shown) through the aortic arch to a position of the aortic valve near the aortic arch under the guidance of ultrasonic imaging/CT, as shown in fig. 13.

By angiography, it is determined whether the position of the adjustable curved sheath 110 is correctly placed, and after the distal opening of the third tube segment 113 of the adjustable curved sheath 110 reaches the target position, the guidewire is withdrawn, the adjustable curved catheter 120 is delivered along the lumen of the adjustable curved sheath 110 to the side of the aortic valve above the aortic arch and is passed over the aortic valve under ultrasound/CT guidance without damaging the aortic valve, as shown in fig. 18.

By adjusting the bending direction and the bending angle of the bending section 123 of the adjustable bending sheath 110 and the adjustable bending catheter 120, the distal end of the adjustable bending catheter 120 can be well abutted against the puncture ablation point expected by the ventricular septum.

The control handle 14 is operated to control the ablation needle 13 to extend along the central axis direction of the adjustable curved sheath tube 110, puncture the ventricular septum, reach the hypertrophic myocardial tissue of the ventricular septum, and control the penetration angle and depth under the double judgment of the ultrasonic image and the scale marks on the control handle 14, as shown in fig. 22.

After the above steps are completed, the perfusion device 30 is started first, the perfusion flow rate is set, so that the electrolyte solution 33 reaches the position of the perfusion hole 132a through the inner cavity 132b of the ablation needle 13 and is perfused outside the tissue for a period of time, then the ablation energy generating device 20 is started, the hypertrophic myocardial tissue is ablated through the ablation section 134 of the ablation needle 13, the size of the ablation range is judged through ultrasound and/or radiography, and the purpose of controlling the ablation region can be achieved by adjusting the length of the ablation section 134 according to the actual size of the ablation region.

When the ablation range is at the desired size, the energy output of the energy generating device 20 is stopped, the infusion of the electrolyte solution 33 is stopped, the ablation needle 13 is withdrawn into the adjustable bend catheter 120, the bending section 123 of the adjustable bend catheter 120 is adjusted to bring its distal end out of contact with the ventricular septum, and then the adjustable bend catheter 120 is operated to pick up the next point, at which point the distal end of the adjustable bend catheter 120 will assume an arcuate swing from point E to point F, as shown in fig. 23, and 1, 2, 3, 4 or even more puncture sites are selected within the desired range.

When the adjustable bend catheter 120 is turned to the next puncture site, the above operation is repeated until the selection, puncture and ablation of all points is completed, as shown in fig. 23.

After ablation is completed, a plurality of continuous ablation areas are left on the hypertrophic ventricular septum, ideally, the plurality of ablation areas can be connected together to form a strip-shaped continuous ablation range, after all puncture points are punctured and ablated, the ablation needle 13, the adjustable curved catheter 120 and the adjustable curved sheath 110 are sequentially withdrawn, and vascular suturing and puncture point skin suturing are completed.

If path b is selected, then: the adjustable curved sheath 110 is guided by a guide wire (not shown) through the femoral vein puncture under ultrasound/CT guidance, passed through the inferior vena cava, right atrium and into the right ventricle position, angiographically determined if the position of the adjustable curved sheath 110 is correctly placed, and after the adjustable curved sheath 110 reaches the target position, the guide wire is withdrawn and the adjustable curved catheter 120 is delivered to the right ventricle along the lumen of the adjustable curved sheath 110. The bending direction and the bending angle of the bending section 123 of the adjustable bending sheath 110 and the adjustable bending catheter 120 are controlled so that the distal end of the adjustable bending catheter 120 can be well abutted against the expected puncture ablation point on the ventricular septum.

The control handle 14 is operated to control the ablation needle 13 to extend along the central axis direction of the adjustable curved sheath 110, puncture the ventricular septum, reach the hypertrophic myocardial tissue at the ventricular septum, and control the penetration angle and depth under the double judgment of the ultrasonic image and the scale marks on the control handle 14, as shown in fig. 25.

After the above steps are completed, the perfusion device 30 is started, the perfusion flow rate is set, so that the electrolyte solution 33 reaches the position of the perfusion hole 132a through the inner cavity 132b of the ablation needle 13 and is perfused outside the tissue for a period of time, and then the ablation energy generation device xx is started, and the hypertrophic myocardial tissue is ablated through the ablation section 134 of the ablation needle 13. The size of the ablation range is judged by ultrasound and/or radiography, and the length of the ablation section 134 can be adjusted by the control handle 14 according to the actual size of the ablation region, so as to achieve the purpose of controlling the ablation region.

When the ablation range is at the desired size, the energy output of the energy generating device is stopped, the infusion of the electrolyte solution 33 is stopped, and the ablation needle 13 is withdrawn into the adjustable bend catheter 120. The bending section 123 of the adjustable bend 120 is adjusted so that its distal end is out of contact with the space between the chambers, and then the adjustable bend 120 is operated to select the next point, at which point the distal end of the adjustable bend 120 will exhibit an arcuate swing from point E to point F (as shown in fig. 23), and 1, 2, 3, 4 or more puncture sites are selected within the appropriate range.

When the adjustable bend catheter 120 is turned to the next puncture site, the above operation is repeated until the selection, puncture and ablation of all sites is completed.

After ablation is completed, a continuous plurality of ablation zones will remain on the hypertrophic ventricular septum, and desirably the plurality of ablation zones can be connected together to form an elongated continuous ablation zone.

After the puncture and ablation of all puncture points are completed, the ablation needle 13, the adjustable curved catheter 120 and the adjustable curved sheath 110 are withdrawn in sequence, and vascular suturing and skin suturing of the puncture points are completed.

If path c is selected, then: the adjustable curved sheath 110 is guided by a guide wire (not shown) through the inferior vena cava, right atrium and through the atrial septum into the left atrium under ultrasound/CT guidance, the placement of the adjustable curved sheath 110 is determined by angiography to be correct, after the adjustable curved sheath 110 reaches the target site, the guide wire is withdrawn, the adjustable curved catheter 120 is delivered along the lumen of the adjustable curved sheath 110 to the side of the left atrium adjacent to the superior mitral valve, and spans the mitral valve under ultrasound/CT guidance without damaging the mitral valve.

The bending direction and the bending angle of the adjustable bending sheath 110 and the bending section 123 of the adjustable bending catheter 120 are controlled so that the distal end of the adjustable bending catheter 120 can be well abutted against the expected puncture ablation point on the ventricular septum.

The control handle 14 is operated to control the ablation needle 13 to extend along the central axis direction of the adjustable bent catheter 120, puncture the ventricular septum, reach the hypertrophic myocardial tissue of the ventricular septum, and control the penetration angle and depth under the double judgment of the ultrasonic image and the scale marks on the control handle 14, as shown in fig. 26.

After the above steps are completed, the infusion device 30 is started first, the infusion flow rate is set so that the electrolyte solution 33 reaches the position of the infusion hole 132a through the inner cavity 132b of the ablation needle 13 and is infused outside the tissue for a period of time, and then the ablation energy generation device xx is started, and the hypertrophic myocardial tissue is ablated through the ablation segment 134 at the distal end of the ablation needle 13.

The size of the ablation range is judged by ultrasound and/or radiography, and the aim of controlling the ablation region can be achieved by controlling and adjusting the length of the ablation section 134 according to the actual size of the ablation region.

When the ablation range is at the desired size, the energy output of the energy generating device is stopped, the infusion of the electrolyte solution 33 is stopped, and the ablation needle 13 is withdrawn into the adjustable bend catheter 120.

The bending section 123 of the adjustable bend 120 is adjusted so that its distal end is out of contact with the space between the chambers, and then the adjustable bend 120 is operated to select the next point, at which point the distal end of the adjustable bend 120 will exhibit an arcuate swing from point E to point F (as shown in fig. 23), and 1, 2, 3, 4 or more puncture sites are selected within the appropriate range.

It should be noted that references in the specification to "one embodiment," "an example embodiment," "some embodiments," etc., indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to effect such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described.

It should be readily understood that the terms "on … …", "above … …" and "above … …" in this disclosure should be interpreted in the broadest sense such that "on … …" means not only "directly on something", but also includes "on something" with intermediate features or layers therebetween, and "above … …" or "above … …" includes not only the meaning "on something" or "above" but also the meaning "above something" or "above" without intermediate features or layers therebetween (i.e., directly on something).

Further, spatially relative terms, such as "below," "beneath," "above," "over," and the like, may be used herein for ease of description to describe one element or feature's relationship to another element or feature as illustrated. Spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. The device may have other orientations (rotated 90 degrees or at other orientations), and the spatially relative descriptors used herein interpreted accordingly.

It should be noted that in this document, relational terms such as "first" and "second" and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Moreover, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one … …" does not exclude the presence of other like elements in a process, method, article, or apparatus that comprises the element.

Finally, it should be noted that: the above embodiments are only for illustrating the technical solution of the present invention, and not for limiting the same; although the invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some or all of the technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit of the invention.

Claims

1. An ablation needle is characterized by comprising a needle body with an inner cavity, wherein at least one ablation section and at least two perfusion holes communicated with the inner cavity are arranged on the needle body;

the ablation segment includes at least one ablation electrode configured to deliver energy to tissue, ablate tissue, to form an ablation region;

the irrigation holes are configured to deliver irrigation liquid from the lumen to tissue surrounding the needle to form an irrigation area;

the plane where the axial direction and the radial direction of the needle body are located is taken as a standard plane, the area S1 is the projection area of the ablation area on the standard plane, and the area S2 is the projection area of the perfusion area on the standard plane, wherein S1/S2 is more than or equal to 0.3 and less than or equal to 1.

2. The ablation needle of claim 1, wherein the irrigation holes are uniformly distributed in an axial, circumferential direction of the needle body.

3. The ablation needle of claim 1, wherein the length of the ablation segment is adjustable.

4. The ablation needle of claim 1, wherein at least one of the irrigation holes is provided at each of both ends of the ablation electrode in the axial direction such that the ablation region is within the irrigation region.

5. The ablation needle of claim 1, wherein the irrigation area is elliptical or elliptical-like in projection onto the standard surface with a minor axis radius interval of 1.41mm to 69.1mm and a major axis radius interval of 2.5mm to 15mm.

6. The ablation needle of claim 1, wherein the projection of the ablation region onto the standard surface is elliptical or elliptical-like with a minor axis radius interval of 1mm to 69.1mm and a major axis radius interval of 1mm to 12mm.

7. The ablation needle of any of claims 1-6, wherein the ratio of the area S1 to the area S2 is 0.5 ∈s1/s2 ∈0.85.

8. The ablation needle of any of claims 1-6, wherein the ratio of the area S1 to the area S2 is 0.6 ∈s1/s2 ∈0.75.

9. An ablation device comprising an ablation needle as claimed in any one of claims 1 to 8.

10. The ablation device of claim 9, further comprising a catheter connected to the ablation needle, the catheter having a wall thickness of no less than 0.5mm.

11. A myocardial ablation system comprising an energy generating device, a pump, and the ablation device of claim 9, the energy generating device being electrically connected to the ablation needle for delivering ablation energy to the ablation electrode; the pump is in fluid communication with the ablation needle for delivering irrigation liquid to the irrigation hole.

12. The myocardial ablation system of claim 11, further comprising a delivery assembly comprising an adjustable bend sheath and an adjustable bend catheter movably disposed within the adjustable bend sheath; the ablation needle can be movably arranged in the bendable catheter in a penetrating way.

13. The myocardial ablation system of claim 11, wherein the perfusion liquid is any one of a 0.9% nacl solution, a 0.9% nacl solution at 5 ℃, a 5% glucose solution, a heparinized 0.9% nacl solution, a mixed solution of a 0.9% nacl solution and a contrast agent at room temperature.

14. The myocardial ablation system as set forth in claim 11 wherein the energy generating device is electrically connected to the pump, the pump delivering the perfusion parameter to the energy generating device after the pump sets the perfusion parameter, the energy generating device generating a reference ablation parameter based on a comparison of the perfusion parameter to reference data.