A radiofrequency ablation device and a radiofrequency ablation system having the device

Abstract

This invention provides a radiofrequency ablation device and a radiofrequency ablation system incorporating the device. The radiofrequency ablation device includes a radiofrequency energy generation unit, a PID controller, and a PID parameter configuration unit. After establishing a target reference model for temperature control and an approximate mathematical model of the radiofrequency ablation system in the PID parameter configuration unit, the PID parameter configuration unit adjusts the PID parameters by combining the real-time temperature from the temperature sensor, the target temperature, and the control signal. The adjusted PID parameters are then sent to the PID controller to control the output power of the radiofrequency energy generation unit. Through this setup, during the ablation process, the PID parameter configuration unit continuously optimizes the PID parameters using the two models, ensuring that the temperature curve generated on the target tissue after the PID controller controls the output of the radiofrequency energy generation unit rises smoothly from the initial temperature of the target tissue to the target temperature and remains stable at the target temperature, reducing temperature curve oscillations.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more particularly to a radiofrequency ablation device and a radiofrequency ablation system having the device. Background Technology

[0002] Hypertrophic cardiomyopathy (HCM) is a common autosomal dominant inherited cardiovascular disease, mainly characterized by hypertrophy of one or more segments of the left ventricle (LV). The general diagnostic criteria are a thickness of ≥15 mm. Treatment methods mainly include drug therapy, septal myectomy, and ventricular septal ablation.

[0003] During ventricular septal ablation, a radiofrequency ablation device provides radiofrequency ablation energy to facilitate the ablation process. Prior art (CN103237516B) discloses a system and method for adaptive RF ablation, including an energy source in operative communication with an ablation element and a feedback sensor; and a proportional-integral-derivative (PID) controller coupled to the feedback sensor and the energy source, with selectable parameters to reduce the likelihood of clots; a target temperature can be set for the operation of the ablation element and adjusted over time during the medical treatment. The feedback sensor provides information about the current or transient state at or near the ablation element. If a difference exists between the target or required state and the actual state observed by the feedback sensor, the controller attempts to minimize this difference.

[0004] However, the PID control described above is relatively simple, which makes the tissue temperature curve generated after the PID controller output prone to oscillation (e.g. Figure 3A As shown in the figure, it is difficult to quickly stabilize the temperature of the ablation electrode or target tissue at the target temperature value. Summary of the Invention

[0005] To address the aforementioned technical problems, this invention provides a radiofrequency ablation device, comprising a radiofrequency energy generation unit, a PID controller, and a PID parameter configuration unit. The PID controller is connected to both the radiofrequency energy generation unit and the PID parameter configuration unit, and is used to output control signals to both the radiofrequency energy generation unit and the PID parameter configuration unit based on a target temperature. The radiofrequency energy generation unit is connected to the ablation device and is used to output ablation energy to the ablation device. After establishing a target reference model for temperature control and an approximate mathematical model of the radiofrequency ablation system in the PID parameter configuration unit, the PID parameter configuration unit adjusts the PID parameters by combining the real-time temperature of the temperature sensor, the target temperature, and the control signal, and sends the adjusted PID parameters to the PID controller. The PID controller is used to output control signals to the radiofrequency energy generation unit based on the adjusted PID parameters to control the output power of the radiofrequency energy generation unit.

[0006] In some possible implementations, the PID parameter configuration unit configures the PID parameters according to the following steps:

[0007] Step S101: Establish a target reference model for temperature control;

[0008] Step S102: Establish an approximate mathematical model of the radiofrequency ablation system;

[0009] Step S103: Configure the parameters of the PID controller;

[0010] Step S104: Use the configured PID controller to control the radio frequency output.

[0011] In some possible implementations, step S101 further includes a target reference model for temperature control.

[0012] A m (z -1 )y(k)=B m (z -1 )y r (k)

[0013] Among them, y r (k) represents the target temperature that the target tissue is expected to reach, y(k) represents the actual temperature measured by the temperature sensor, k represents the current sampling time, and z represents the Z-transform operator.

[0014] In some possible implementations, step S102 further includes an approximate mathematical model of the radiofrequency ablation system as follows:

[0015] A(z -1 )y(k)=B(z -1 u(k)

[0016] Where y(k) is the actual temperature measured by the temperature sensor, u(k) represents the power, i.e. the output power of the radio frequency ablation generator; and k represents the current sampling time.

[0017] In some possible implementations, step S103 further includes:

[0018] Let the mathematical model of the PID controller be:

[0019] H(z -1 u(k)=G(z) -1 )e(k)

[0020] e(k) = y r (k)-y(k)

[0021] Where k a k b k c These are the parameters to be configured for the PID controller;

[0022] G(z -1 )=k a -k b z -1 +k c z -2 H(z) -1 )=1-z -1 .

[0023] In some possible implementations, step S103 further includes:

[0024] The characteristic equation of the closed-loop temperature control system, formed by the PID controller and the approximate mathematical model of the aforementioned radiofrequency ablation system, is as follows:

[0025] A(z -1 )H(z -1 )+B(z -1 )G(z -1 )=1+b0k a +(a1-1-b0k b )z -1 +(b0k c -a1)z -2

[0026] Let the configuration coefficient be set. Let A(z) -1 )H(z -1 )+B(z -1 )G(z -1 )=A0A m (z -1 ), can be calculated This completes the configuration of the PID controller parameters.

[0027] In some possible implementations, step S104 further includes:

[0028] Step S104: Use the configured PID controller to control the RF output;

[0029] The parameter k obtained from step S103 is configured. a k b k c Substituting into the incremental formula of the PID controller u(k) = k a e(k)-k b e(k-1)+k c e(k-2)+u(k-1) controls the output power of the radio frequency energy generation unit.

[0030] The present invention also provides a radiofrequency ablation system, which includes an ablation device, a radiofrequency ablation equipment, and a temperature sensor. The temperature sensor is disposed in the part of the ablation device for releasing ablation energy. The ablation device is connected to the radiofrequency ablation equipment so that the radiofrequency ablation equipment provides ablation energy to the ablation device.

[0031] During the ablation process, when the distal end of the ablation device is punctured through the endocardium via a catheter to enter the interventricular septum and ablate the target tissue, a temperature sensor monitors the temperature of the distal end of the ablation device or the target tissue in real time and feeds it back to the PID parameter configuration unit. The PID parameter configuration unit receives the real-time temperature from the temperature sensor and the control signal from the PID controller, configures the PID parameters based on the real-time temperature, the control signal, and the target temperature, and outputs the PID parameters to the PID controller. Through this setup, during the ablation process, the PID parameter configuration unit uses the target reference model of the temperature control and the approximate mathematical model of the radiofrequency ablation system, combined with the closed-loop system characteristic equation, to calculate the PID parameters and continuously optimize them. This ensures that the temperature curve generated on the target tissue after the PID controller controls the output of the radiofrequency energy generation unit can smoothly rise from the initial temperature of the target tissue to the target temperature and remain stable at the target temperature, reducing temperature curve oscillations.

[0032] Establishing a target reference model for temperature control and an approximate mathematical model for the radiofrequency ablation system can reduce calculation errors and improve parameter accuracy; in parameter k a k b k cDuring the configuration process, only the value of u(k) is relied upon, avoiding the occupation of a large amount of computing resources and storage space; during the control process, the increment of u(k) is only related to the deviation values ​​e(k), e(k-1), and e(k-2) of the three most recent samples, and does not need to use the historical accumulated value of the deviation value e(k), which greatly improves the calculation speed. Attached Figure Description

[0033] To more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0034] Figure 1 This is a schematic diagram of the radiofrequency ablation system provided in Embodiment 1 of the present invention;

[0035] Figure 2 This is a flowchart illustrating the temperature control algorithm in Embodiment 1 of the present invention;

[0036] Figure 3A It is a temperature curve generated by a PID controller in existing technology;

[0037] Figure 3B This is a temperature curve generated by the PID controller in Embodiment 1 of the present invention;

[0038] Figure 4 This is a schematic diagram of the ablation device in Embodiment 1 of the present invention;

[0039] Figure 5 This is a schematic diagram of the adjustable bend sheath in its natural state according to Embodiment 1 of the present invention;

[0040] Figure 6 A schematic diagram of the adjustable bending sheath in the straightening transition state;

[0041] Figure 7 This is a structural diagram of the adjustable bending sheath in its straightened state.

[0042] Figure 8 This is a schematic diagram of an adjustable bendable sheath located in the aorta.

[0043] Figure 9 for Figure 8 A structural diagram of the MM section from another perspective;

[0044] Figure 10 This is a schematic diagram of another embodiment of the adjustable bendable sheath;

[0045] Figure 11 for Figure 10Another perspective illustration of the adjustable curved sheath in the diagram;

[0046] Figure 12 This is a schematic diagram of the adjustable bend conduit and the adjustable bend sheath.

[0047] Figure 13 A schematic diagram of the structure of the distal end of the adjustable bend catheter crossing the aortic valve;

[0048] Figure 14 for Figure 13 A structural diagram of the NN section from another perspective;

[0049] Figure 15 This is a schematic diagram of the structure for adjusting the distal end of the adjustable conduit.

[0050] Figure 16 A schematic diagram showing the distal end of an adjustable bend catheter contacting the ventricular septum;

[0051] Figure 17 This is a schematic diagram of ablation needles used to ablate ventricular septum tissue by puncturing the endocardium through the aorta.

[0052] Figure 18 A schematic diagram of the structure for selecting the distal opening point of an adjustable bend conduit;

[0053] Figure 19 This is a schematic diagram of the ablation needle.

[0054] Figure 20 This is a schematic cross-sectional view of the ablation needle at point AA;

[0055] Figure 21 This is a schematic diagram of the radiofrequency ablation system in Embodiment 1 of the present invention;

[0056] Figure 22 This is a schematic diagram of the radiofrequency ablation system provided in Embodiment 2 of the present invention;

[0057] Figure 23 This is a temperature curve generated by the PID controller in Embodiment 2 of the present invention. Detailed Implementation

[0058] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0059] The following descriptions of the embodiments are based on the accompanying illustrations and are used to illustrate specific embodiments in which the present invention can be implemented. Directional terms used in this invention, such as "top," "bottom," "front," "rear," "left," "right," "inner," "outer," and "side," are merely directional references to the accompanying illustrations. Therefore, the use of directional terms is for the purpose of better and clearer explanation and understanding of the present invention, and is not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation; therefore, they should not be construed as limitations on the present invention.

[0060] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation", "connection", "linking", "set on", etc. should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal communication between two components.

[0061] 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 refers to the end farther from the operator; the axial direction refers to the direction parallel to the line connecting the center of the distal end and the center of the proximal end of the medical device; the circumferential direction refers to the "circumferential direction," that is, the direction around the axis of a cylindrical medical device; the radial direction refers to the direction along the diameter or radius. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0062] Example 1:

[0063] like Figure 1 As shown, Embodiment 1 of the present invention provides a radiofrequency ablation system, which includes an ablation device 10, a radiofrequency ablation equipment 20, and a temperature sensor. The temperature sensor is disposed in the part of the ablation device for releasing ablation energy. The ablation device is connected to the radiofrequency ablation equipment so that the radiofrequency ablation equipment can provide ablation energy to the ablation device.

[0064] The radiofrequency ablation device includes a radiofrequency energy generation unit, a PID controller, and a PID parameter configuration unit. The radiofrequency energy generation unit provides the radiofrequency energy required for radiofrequency ablation to the ablation device during the ablation process. The ablation device contacts the target site of the organism to release ablation energy to the target site. After establishing a target reference model for temperature control and an approximate mathematical model of the radiofrequency ablation system in the PID parameter configuration unit, the PID parameter configuration unit adjusts the PID parameters by combining the real-time temperature of the temperature sensor, the target temperature, and the control signal, and sends the adjusted PID parameters to the PID controller. The PID controller outputs a control signal to the radiofrequency energy generation unit according to the adjusted PID parameters to control the output power of the radiofrequency energy generation unit.

[0065] With the above settings, during the ablation process, the PID parameter configuration unit uses the two models mentioned above to continuously optimize the PID parameters, so that the temperature curve generated by the PID controller controlling the output of the radio frequency energy generation unit can rise smoothly from the initial temperature of the target tissue to the target temperature and remain stable at the target temperature, reducing the oscillation of the temperature curve.

[0066] Among them, the temperature sensor is used to detect the temperature value of the target part or the part of the ablation device used to release ablation energy in real time during the radiofrequency ablation process, so as to monitor the temperature value of the target tissue or the part of the ablation device used to release ablation energy and output the temperature signal to the outside in real time.

[0067] Specifically, such as Figure 2 As shown, the PID parameter configuration unit configures the PID parameters according to the following steps:

[0068] Step S101: Establish a target reference model for temperature control.

[0069] During operation, the temperature sensor monitors the real-time temperature of the target tissue or the part of the ablation device used to release ablation energy in the target tissue or ablation device. This real-time temperature is then fed back to the PID controller. The PID controller adjusts the output of the radio frequency energy generation unit based on this feedback and the target temperature, so that the real-time temperature is the same as or substantially the same as the target temperature. Therefore, a temperature error can be defined.

[0070] e(k) = y r (k)-y(k) ①

[0071] Therefore, a discrete-time target reference model for temperature control is established as follows:

[0072] A m (z -1 )y(k)=B m (z -1 )yr (k)

[0073] B m (z -1 )=b m0 -b m1 z -1 +b m2 z -2

[0074] A m (z -1 )=1+a m1 z -1 +a m2 z -2

[0075] Among them, y r (k) represents the target temperature that the target tissue is expected to reach, y(k) represents the actual temperature measured by the temperature sensor, k represents the current sampling time, z represents the Z-transform operator, and a m1 ~a m2 and b m0 ~b m2 All of these are constants, with values ​​ranging from -2 to 1. This target reference model can accurately describe the temperature control target, i.e., y(k) = y r (k).

[0076] Step S102: Establish an approximate mathematical model of the radiofrequency ablation system.

[0077] u(k) can be obtained by multiplying the measured values ​​of voltage and current, and y(k) can be obtained in real time from the temperature sensor. Therefore, u(k) and y(k) can be linked together to establish an approximate mathematical model of the radiofrequency ablation system.

[0078] A(z -1 )y(k)=B(z -1 )u(k) ②

[0079] A(z -1 )=1+a1z -1

[0080] B(z -1 )=b0

[0081] Where u(k) represents power, i.e., the output power of the radio frequency ablation generator; k represents the current sampling time.

[0082] Let positive definite matrix Where p 11 ~p 22 θ1 to θ2 are all constants, and the values ​​of these constants range from -2 to 1.

[0083] Based on the measured temperature y(k) and power u(k) recorded for each sampling, the following calculations are performed.

[0084]

[0085] in

[0086]

[0087]

[0088] and It is a vector consisting of -y(k-1) and u(k).

[0089] Then, calculate

[0090] in It is an identity matrix.

[0091] p 11 ~p 22 θ1~λ2 can be determined by the following method: Collect historical experimental data and record S={s1,s2,…,s i ,…,s n}, where s i =[y(i),u(i)] represents the sampling point recorded at time i. Where y(i) represents the temperature at time i, and u(i) represents the power at time i.

[0092] Then P(0)=(Φ T Φ) -1 ,θ(0)=(Φ T Φ) -1 Φ T Y, where

[0093] The model parameters at the current sampling time can be obtained through the above calculations:

[0094] a1=θ(k)[0], b0=θ(k)[1].

[0095] Step S103: Configure PID controller parameters.

[0096] Let the mathematical model of the PID controller be:

[0097] H(z -1 u(k)=G(z) -1 )e(k)

[0098] Where G(z) -1 )=k a -k bz -1 +k c z -2 H(z) -1 )=1-z -1 ;k a k b k c These are the configurable parameters for the incremental PID controller. Combining the mathematical model of the PID controller described above with formulas ① and ②, we can obtain...

[0099]

[0100] The characteristic equation of the closed-loop temperature control system, formed by the PID controller and the approximate mathematical model of the radiofrequency ablation system described above, is as follows:

[0101] A(z -1 )H(z -1 )+B(z -1 )G(z -1 )=1+b0k a +(a1-1-b0k b )z -1 +(b0k c -a1)z -2

[0102] Let the configuration coefficient be set. Let A(z) -1 )H(z -1 )+B(z -1 )G(z -1 )=A0A m (z -1 ), can be calculated Because of a m1 a m2 Since a1 and b0 are both determined, the PID controller parameter k can be configured. a k b and k c .

[0103] Step S104: Use the configured PID controller to control the RF output.

[0104] The parameter k obtained from step S103 is configured. a k b k c Substituting into the incremental PID controller u(k) = k a e(k)-k b e(k-1)+k c e(k-2)+u(k-1) controls the output power of the radio frequency energy generation unit.

[0105] By establishing the target reference model for temperature control and the approximate mathematical model for the radiofrequency ablation system through the above settings, calculation errors can be reduced and parameter accuracy improved; in parameter k a k b k c During the configuration process, only the value of u(k) is relied upon, avoiding the occupation of a large amount of computing resources and storage space; during the control process, the increment of u(k) is only related to the deviation values ​​e(k), e(k-1), and e(k-2) of the three most recent samples, and does not need to use the historical accumulated value of the deviation value e(k), which greatly improves the calculation speed.

[0106] like Figures 3A-3B As shown, Figure 3A The tissue temperature curve generated by the output of the existing PID controller is quite oscillating. The temperature of the target tissue or the temperature of the part of the ablation device used to release ablation energy is difficult to stabilize at the target temperature (taking 60℃ as an example), but oscillates back and forth between about 57℃ and 63℃.

[0107] Figure 3B The tissue temperature curve generated after using the PID controller output of this embodiment shows that after a small oscillation in the early stage, the tissue temperature curve is basically stable at the target temperature (taking 60°C as an example). Therefore, the above settings enable the part of the target tissue or ablation device used to release ablation energy after the output of the above radiofrequency ablation system to reach and stabilize at the target temperature, without frequent oscillations.

[0108] like Figure 4 As shown, the ablation device includes a delivery tube assembly and an ablation needle 13. A temperature sensor is provided at the distal end of the ablation needle 13. The delivery tube assembly includes an adjustable bend sheath 110 and an adjustable bend catheter 120 movably inserted within the adjustable bend sheath 110. The ablation needle 13 is movably inserted within the adjustable bend catheter 120, and the distal end of the ablation needle 13 can extend beyond the distal end of the adjustable bend catheter 120. The temperature sensor can be disposed on the inner or outer surface of the ablation needle 13 to monitor the temperature of the ablation needle 13 and / or the target tissue.

[0109] Please see Figure 5 The following example uses an adjustable bendable sheath 110 that enters the left ventricle via the aorta. When other pathways are used to ablate the interventricular septum, the structure of the adjustable bendable sheath 110 can be adapted by referring to the corresponding pathway.

[0110] The adjustable bend sheath 110 includes a handle 114. The adjustable bend sheath 110 is a pre-formed tube with a certain degree of rigidity and flexibility. The handle 114 applies force to the adjustable bend sheath 110 to adjust its shape. After the force of the handle 114 is removed, the adjustable bend sheath 110 can gradually return to its natural state. The adjustable bend sheath 110 has a hollow inner cavity.

[0111] like Figure 5 As shown, the adjustable bendable sheath 110 includes a first tube segment 111, a second tube segment 112, and a third tube segment 113 connected sequentially from the proximal end to the distal end.

[0112] In one possible implementation, in its natural state, the first segment 111, the second segment 112, and the third segment 113 are all located on the same plane. The second segment 112 extends first away from the first segment, and then extends towards the first segment 111. The third segment 113 extends towards the first segment 111, so that the first segment 111 is adapted to the shape of the descending aorta, the second segment 112 is adapted to the shape of the aortic arch, and the third segment 113 is adapted to the shape of the ascending aorta. The distal end of the third segment 113 is close to the middle portion of the aortic valve. Therefore, the adjustable sheath 110 in this implementation has a predetermined shape in its natural state, matching the shape of the aorta, facilitating entry into the left ventricle from the aorta across the aortic valve to treat myocardial tissue.

[0113] Please see Figure 5 The adjustable curved sheath 110 is in its natural state. A handle 114 is connected to the proximal end of the adjustable curved sheath 110; by operating the handle 114, the adjustable curved sheath 110 can be straightened (e.g., ...). Figure 7 (as shown) and natural state (such as) Figure 5 The adjustable curved sheath 110 is switched between the two states (as shown). The aforementioned straightening state refers to the state where the shape of the adjustable curved sheath 110 is approximately straight using the handle 114. Specifically, by operating the handle 114, an external force opposite to direction C is applied to the adjustable curved sheath, causing the shape of the adjustable curved sheath 110 to change from its natural state (as shown) to its current state. Figure 5 The curved shape shown in the figure undergoes a transition state (such as...) Figure 6 As shown, it transforms into an approximately straight line shape (i.e., a straightened state, such as...). Figure 7(As shown). Therefore, before intervention in the human body, the adjustable bending sheath 110 is first adjusted from its natural state to a straightened state. As the adjustable bending sheath 110 is inserted deeper, it gradually transitions from its straightened state back to its natural state and eventually returns to its natural state. Then, by operating the handle 114, the distal end of the adjustable bending sheath 110 can be bent, at which point the adjustable bending sheath 110 is in a bent state. Specifically, the distal end of the third segment 113 of the adjustable bending sheath 110 is provided with an anchoring ring, which is connected to the distal end of the traction wire built into the adjustable bending sheath 110. The proximal end of the traction wire is connected to the handle 114. Therefore, the handle 114 can adjust the 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 extent, further adjustment can affect the second tube segment 112, causing it to gradually straighten. Ultimately, the first tube segment 111, the second tube segment 112, and the third tube segment 113 are adjusted to a straight or nearly straight state. Thus, by operating the handle 114, the adjustable curved sheath 110 can enter a straightened state. Since the adjustable curved sheath 110 is straightened by operating the handle 114, the third tube segment 113 of the adjustable curved sheath 110 will have a partial bend in the straightened state during this operation. However, this bend does not affect the overall entry of the adjustable curved sheath 110 into the relevant vascular pathway. As the adjustable curved sheath 110 is inserted deeper, the external force applied to the handle 114 is gradually reduced, causing the adjustable curved sheath 110 to gradually transition from its self-straightening state to its natural state, and eventually return to its natural state. Alternatively, in some embodiments, the operator can insert an expander into the adjustable curved sheath 110 to straighten it, adjusting the first segment 111, the second segment 112, and the third segment 113 to a straight or near-straight state. Then, as the adjustable curved sheath 110 is inserted deeper, the expander is gradually withdrawn, causing the self-straightening state to gradually transition to its natural state, and eventually return to its natural state. The distal end of the adjustable curved sheath 110 can then be bent by operating the handle 114, at which point the adjustable curved sheath 110 is in a bent state. Furthermore, a guide wire can be inserted into the expander and withdrawn along with it during the withdrawal process.

[0114] By configuring the adjustable bend sheath 110 in its natural state, it conforms to the shape of the aorta. Specifically, the first segment 111 is similar to or the same as the shape of the descending aorta, the second segment 112 is similar to or the same as the shape of the aortic arch, and the third segment 113 is similar to the shape of the ascending aorta. This ensures that when the adjustable bend sheath 110 is inserted into the aorta and returned to its natural state, the distal portion of the third segment 113 will be close to the middle portion of the aortic valve. If the distal opening of the third segment 113 is not facing the aortic valve or the predetermined direction, the orientation of the distal opening of the third segment 113 can be adjusted by operating the handle 114. At this time, the adjustable bend sheath 110 is in the bend adjustment state.

[0115] In the prior art, the adjustable bend sheath 110 is a straight line or approximately a straight line in its natural state. The operator applies external force through the handle to adjust the degree of curvature of the distal end of the adjustable bend sheath 110. After the adjustable bend sheath 110 reaches the target shape, the handle must be held in the same position. However, in this embodiment, the adjustable bend sheath 110 has a predetermined shape in its natural state, that is, the aforementioned third segment 113, second segment 112, and first segment 111 are located in the same spatial plane. The second segment 112 first extends away from the first segment 111 and then extends toward the first segment 111. The third segment 113 extends toward the first segment 111. Before the adjustable bend sheath 110 enters the aorta, the operator applies external force through the handle 114 or within the adjustable bend sheath 110. An dilator is inserted to adjust the adjustable curved sheath 110 into a straight or near-straight line. As it passes through the descending aorta, aortic arch, and reaches the ascending aorta, the straightening force applied to the adjustable curved sheath 110 by the handle 114 is gradually reduced or the dilator is withdrawn. This allows the first segment 111, the second segment 112, and the third segment 113 of the adjustable curved sheath 110 to gradually return to their natural state. At this point, in the adjustable curved sheath 110 after entering the heart, the distal end of the third segment 113 reaches the ascending aorta, and its opening points towards the aortic valve near the mitral valve. The second segment 112 is located within the aortic arch, and the first segment 111 is located within the descending aorta. The operator does not need to apply any external force to the handle 114, thereby improving surgical efficiency, avoiding prolonged pulling of the handle 114, 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 orientation of the distal opening of the third tube segment 113 can be adjusted by operating the handle 114. At this time, the adjustable sheath 110 is in the adjustment state.

[0116] In its natural state, the shape of the third segment 113 allows the distal end of the third segment 113 to move in two directions, either close to or far from the ventricular septum, which helps to select different puncture sites and provide different treatment positions for the adjustable catheter 120 and ablation needle 13 inserted in the adjustable sheath 110.

[0117] See Figure 8 , Figure 9 Furthermore, the direction of the distal opening of the third segment 113 can be controlled by rotating the adjustable curved sheath 110 circumferentially through the handle 114. Specifically, when the adjustable curved sheath 110 is rotated clockwise through the handle 114, the third segment 113 will swing toward the aortic arch towards the chest cavity. It can be known that when the adjustable curved sheath 110 is rotated counterclockwise, the third segment 113 will swing toward the aortic arch towards the back.

[0118] By controlling the swing of the third tube segment 113, different orientations of the distal opening of the third tube segment 113 can be controlled, thereby controlling the adjustable bend conduit 120 inserted in the adjustable bend sheath 110 to extend from the distal opening of the third tube segment 113 at different angles.

[0119] In some possible implementations, the first pipe section 111 is straight in its natural state.

[0120] In some possible implementations, the proximal end of the first pipe segment 111 is straight, while the distal end is curved.

[0121] In some possible implementations, the curved portion of the third pipe section 113 may be a regular or irregular curve, preferably an arc shape.

[0122] In some possible implementations, the second pipe segment 112 is curved in its natural state, with its middle portion arched relative to both ends. Further, the second pipe segment 112 can be a regular or irregular curve, and is preferably an arc shape, so that the connection between the first pipe segment 111 and the third pipe segment 113 is smooth.

[0123] In some possible implementations, in its natural state, the third pipe segment 113 is curved, with the curvature of the proximal portion of the third pipe segment 113 being less than the curvature of the distal portion; that is, the degree of curvature of the distal portion of the third pipe segment 113 is greater than that of the proximal portion. Given that the distal portion of the second pipe segment 112 and the third pipe segment 113 extend towards the first pipe segment 111, the distal portion of the third pipe segment 113 will converge towards the first pipe segment 111.

[0124] The above configuration ensures that when the third segment 113 is located in the ascending aorta in its natural state, the distal end of the third segment 113 is positioned close to the middle part of the aortic valve and biased towards the descending aorta. That is, the distal end of the third segment 113 is far from the interventricular septum, thereby increasing the distance from the distal end of the third segment 113 to the interventricular septum, and thus increasing the selection range of the adjustable bending sheath 110 and the adjustable bending catheter 120.

[0125] In some possible implementations, the curvatures of the first pipe segment 111, the second pipe segment 112, and the third pipe segment 113 are different, 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.

[0126] In some possible implementations, the curvature of the second pipe segment 112 can remain constant, or it can be set such that, from the proximal end to the distal end, the curvature of the second pipe segment 112 first increases and then decreases, or gradually increases.

[0127] When the curvature of the second segment 112 remains unchanged, the second segment 112 has virtually no contact with the aortic arch, resulting in minimal damage to the vessel wall.

[0128] When the curvature of the second segment 112 first increases and then decreases, the second segment 112 partially contacts the aortic arch and the contact area is small. The force provided by the vessel wall to the second segment 112 can help the adjustable sheath 110 maintain its position.

[0129] As the curvature of the third segment 112 gradually increases, the second segment 112 partially contacts the aortic arch with a large contact area, which can increase the force used for positioning the second segment 112.

[0130] Please see Figures 10-11 In some embodiments, the shape of the adjustable bend sheath 110 is modified, differing from the embodiments described above only in that:

[0131] In its natural state, the first section 111 and the second section 112 of the adjustable bending sheath 110 are located on the first plane 91, and the third section 113 is located on the second plane 92, which has an angle with the first plane 91.

[0132] Specifically, considering that the aortic arch is not a planar structure but a three-dimensional spatial structure, in this embodiment, the third segment 113, the second segment 112, and the first segment 111 of the adjustable sheath 110 are also set as three-dimensional spatial structures, according to the actual shape of the aortic arch. The second segment 112 and the first segment 111 are located in the same plane 91, while the third segment 113 is located in a plane 92 that forms a certain angle with the plane 91.

[0133] Based on the actual shape of the aortic arch, the bending direction C of the third segment 113 should be bent towards the side of the aortic arch closer to the chest. This setting allows the adjustable sheath 110 to better fit the shape of the aortic arch.

[0134] In some possible implementations, the angle between the first plane 91 and the second plane 92 is α, where 10°≤α≤45°.

[0135] Further, 'a' is preferably 15°, 20°, 25°, 30°, 35° or 40°.

[0136] In some embodiments, the ablation device can perform endocardial puncture and ablation of the interventricular septum via pathways such as inferior vena cava-right atrium-right ventricle or inferior vena cava-right atrium-atrial septum-left atrium-left ventricle. In such cases, the structure of the adjustable sheath 110 can be adapted to this embodiment.

[0137] The following example uses the adjustable bendable sheath 110 that enters the left ventricle via the aorta to illustrate the structure of the adjustable bendable catheter 120. When other routes are used to ablate the ventricular septum, the structure of the adjustable bendable catheter 120 can be adapted with reference to this embodiment.

[0138] Please see Figure 12 The adjustable bendable conduit 120 has at least a main body section 121, a shaping section 122, and an adjusting section 123 from proximal to distal. The shape of the main body section 121 is adapted to the shape of the first section 111 of the adjustable bendable sheath 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 bendable sheath 110, thereby achieving a better structural fit between the adjustable bendable conduit 120 and the adjustable bendable sheath 110. The adjustable bendable conduit 120 is disposed within the hollow cavity of the adjustable bendable sheath 110 and can move relative to the adjustable bendable sheath 110 along the central axis.

[0139] Specifically, when the adjustable bending sheath 110 of the above embodiment is used, the distal portion of the shaping section 122 extends away from the interventricular septum, and the bending section 123 extends toward the interventricular septum.

[0140] See Figure 13-17 When the adjustable bending sheath 110 is located in the aorta and in its natural state, the adjustable bending catheter 120 is delivered through the lumen of the adjustable bending sheath 110. The bending segment 123 will extend from the distal opening of the third segment 113 of the adjustable bending sheath 110, cross the aortic valve, and reach the LVOT (left ventricular outflow tract). At this time, the adjustable bending catheter 120 is in an unadjusted state.

[0141] The adjustable bendable conduit 120 is connected to a handle 124, and the circumferential swing of the bend section 123 of the adjustable bendable conduit 120 can be controlled by operating the handle 124.

[0142] like Figure 18 As shown, under the combined rotation of the third section 113 of the adjustable bending sheath 110 and the bending section 123 of the adjustable bending catheter 120, different directions of the bending section 123 of the adjustable bending catheter 120 can be achieved, thereby enabling the selection of different positions on the interventricular septum.

[0143] like Figure 15 As shown, the bending direction D of the bending segment 123 can be towards the lateral side of the aortic arch, that is, towards the ventricular septum. By controlling the bending handle of the adjustable catheter 120, the bending segment 123 can be bent towards the lateral side of the aortic arch, thereby ensuring that the distal end of the bending segment 123 always faces the ventricular septum, so that the ablation needle 13 has the correct needle exit angle and direction when puncturing.

[0144] Once the bending segment 123 is bent to the appropriate angle in direction D, the distal end of the bending segment 123 will come into contact with the left ventricular lateral wall of the interventricular septum, thus preparing for subsequent needle withdrawal.

[0145] The distal portion of the shaping section 122 extends away from the ventricular septum, while the bending section 123 extends toward the ventricular septum. That is, the shape of the distal portion of the adjustable catheter 120 is set in a way that moves away from the ventricular septum first and then closer to it. Compared with the prior art method of setting the shape of the distal portion of the adjustable catheter 120 directly close to the ventricular septum, the bending angle of the bending section 123 can be increased by adopting the method of moving away from the ventricular septum first and then closer to it.

[0146] like Figure 4 , Figures 19-20 As shown, the ablation needle 13 includes a needle body 132 with an inner cavity 132b. The needle body 132 has at least one ablation section 134 and at least one infusion port 132a communicating with the inner cavity 132b. The inner cavity 132b is configured as a channel for delivering electrolyte liquid, and the infusion port 132a is configured as the outlet of the channel. The ablation section 134 includes at least one ablation electrode, configured to release ablation energy into the tissue to ablate the tissue and form an ablation area. A temperature sensor 135 is disposed in the inner cavity 132b for monitoring the real-time temperature at that location.

[0147] The ablation method of the ablation needle 13 can be selected as radiofrequency ablation, microwave ablation, etc. The following explanation will take radiofrequency ablation as an example. Specifically, the ablation needle 13 includes a needle tip 131, which can puncture the endocardium or epicardium, allowing the needle tip 131, perfusion port 132a, ablation segment 134, and other parts of the ablation needle 13 to enter the hypertrophic region of the interventricular septum. Energy is released through the ablation segment 134 to destroy the cell activity of the hypertrophic myocardial tissue, causing the hypertrophic myocardial tissue of the interventricular septum to thin and its contractility to decrease, thereby reducing the phenomenon of left ventricular outflow tract obstruction. At the same time, electrolyte liquid 33 flows out from the lumen 132b through the perfusion port 132a to the surface of the ablation needle 13 and the myocardial tissue around the ablation needle 13. This can avoid carbonization of the myocardial tissue around the ablation needle 13 due to excessively rapid temperature rise of the ablation needle 13. Through the diffusion of electrolyte liquid 33 inside the myocardial tissue, radiofrequency energy is carried to myocardial tissue at a greater distance from the ablation segment 134, thereby achieving perfusion ablation and expanding the ablation range.

[0148] Electrolyte solutions may include, but are not limited to, 0.9% NaCl solution at room temperature, 0.9% NaCl solution at 5°C, 5% glucose solution, heparinized 0.9% NaCl solution, and mixed solutions of 0.9% NaCl solution and contrast agent, with 0.9% NaCl solution at around 5°C being preferred.

[0149] When ablation begins in ablation segment 134, the temperature of ablation segment 134 and the surrounding tissue will rise due to radiofrequency energy. The electrolyte liquid 33 infused through perfusion port 132a can cool ablation segment 134 and the tissue, thus slowing down the rate of temperature rise in ablation segment 134 and the tissue. After the temperature of ablation segment 134 reaches a predetermined value, electrolyte liquid 33 will continuously remove excess heat generated by ablation segment 134. This predetermined value is sufficient to denature the proteins in myocardial tissue, but it will not cause carbonization and scab formation due to excessive temperature. This allows the energy generated by ablation segment 134 to be transferred to deeper parts of myocardial tissue, thereby increasing the ablation range. After electrolyte liquid 33 enters myocardial tissue, it will diffuse along the direction of muscle fibers within the myocardial tissue to the surrounding areas. This is because the conduction of radiofrequency current in the human body mainly relies on the movement of charged ions. When radiofrequency current flows through human tissue, the rapid changes in the magnetic field cause positive and negative ions within the cells to move rapidly. Due to differences in ion size, mass, charge, and movement speed, friction between ions and with other molecules and ions within the cells causes the tissue cells to heat up, leading to evaporation, drying, shrinkage, and shedding of intracellular and extracellular water, ultimately resulting in aseptic necrosis. Electrolyte liquid 33 itself contains a large number of ions, which can increase the ion concentration in myocardial tissue. Therefore, electrolyte liquid 33 can serve as a good medium for transmitting radiofrequency current. As electrolyte liquid 33 diffuses, it transmits the radiofrequency current to more distant areas of myocardial tissue, while simultaneously increasing the probability of ion friction and collision, causing cell heating, rupture, and coagulative necrosis. Through these principles, perfusion ablation can increase the ablation area and make the ablation effect more efficient.

[0150] Meanwhile, it is understandable that the perfusion flow rate also has a significant impact on the ablation effect. The perfusion flow rate determines the amount of perfusion injected from the perfusion orifice 132a per unit time, and the amount of perfusion will affect the cooling efficiency of the electrolyte liquid 33 on the ablation segment 134 and the tissue during ablation. During radiofrequency ablation, myocardial tissue cells will only begin coagulative necrosis and cause irreversible damage when the temperature exceeds 50°C. However, when the tissue is excessively heated, resulting in a high tissue temperature, it will cause carbonization and scab formation, leading to a sharp increase in tissue impedance. When the tissue temperature exceeds 100°C, the cells will vaporize, producing bubbles and forming perforations. Uncontrolled vaporization and perforation will damage the myocardial tissue, leading to unpredictable risks. Generally, the predetermined temperature of the ablation needle is 50°C-90°C, preferably 55°C-80°C, and more preferably 60°C-70°C.

[0151] See Figure 21As can be seen from the above embodiments, the ablation device 10 includes a delivery tube assembly and an ablation needle 13; the ablation needle 13 is movably inserted into the delivery tube assembly; the delivery tube assembly is used for intervention in the heart via a catheter, and after the ablation needle 13 passes through the delivery tube assembly, it can enter the myocardial tissue by puncturing the endocardium, and then the radiofrequency ablation device 20 provides energy to the ablation needle 13 to ablate the myocardial tissue.

[0152] Furthermore, the ablation system 1 also includes a perfusion device 30, which includes a perfusion pump 32 and a liquid source 31. The liquid source 31 provides electrolyte liquid 33 to the ablation device 10 via the perfusion pump 32. As previously described, the ablation needle 13 has an inner cavity and a perfusion port 132a. The electrolyte liquid 33 flows out through the inner cavity from the perfusion port 132a to cool the myocardial tissue, prevent the myocardial tissue from overheating, and expand the ablation area.

[0153] In some embodiments, to meet the perfusion requirements, the output capacity of the perfusion pump 32 should be at least 0.1-5.0 mL / min. Since the perfusion pump 32 needs to continuously supply liquid to the ablation needle 13 through the conduit 34 during the perfusion ablation process, the conduit 34 needs to have a certain size to avoid deformation or breakage due to excessively thin walls when outputting the expected flow rate with the small-aperture, small-inner-diameter ablation needle 13. Taking 5.0 mL / min as an example, when the wall thickness is less than 0.5 mm, the conduit 34 is prone to deformation and breakage. Therefore, when the wall thickness of the conduit 34 is not less than 0.5 mm, the conduit 34 will not deform or break. Preferably, the wall thickness of the conduit 34 is not less than 0.65 mm, and more preferably not less than 1 mm. The catheter 34 can also be composed of two different sizes of tubing, such as a first catheter segment with an outer diameter of 2.5 mm and an inner diameter of 1.2 mm (single-sided wall thickness of 0.65 mm) and a second catheter segment with an outer diameter of 4.0 mm and an inner diameter of 0.8 mm (single-sided wall thickness of 1.6 mm), as long as the wall thickness is not less than 0.5 mm.

[0154] The method for performing myocardial ablation using ablation system 1 includes the following steps:

[0155] S1. Insert the adjustable bend sheath 110 and the adjustable bend catheter 120 into the heart until the distal opening of the adjustable bend catheter 120 contacts the myocardial tissue.

[0156] S2. Extend the ablation needle 13 from the distal opening of the adjustable bendable catheter 120 and insert it into the myocardial tissue. Start the radiofrequency ablation device 20, set the target temperature, and then the radiofrequency ablation device 20 delivers ablation energy for ablation.

[0157] S3. The PID parameter configuration unit in the radio frequency ablation device receives the temperature signal from the temperature sensor to adjust the PID parameters, and sends the adjusted PID parameters to the PID controller. The PID controller is used to output a control signal to the radio frequency energy generation unit according to the above PID parameters to control the output power of the radio frequency energy generation unit until the ablation is completed.

[0158] This method of ablation of myocardial tissue achieves truly minimally invasive treatment, eliminating the need for more traumatic procedures like open-heart surgery. Furthermore, it allows for multi-point ablation via endocardial puncture. In addition, because the radiofrequency ablation device employs a PID parameter configuration unit to set the PID parameters, the temperature profile of the target tissue can smoothly transition to and stabilize at the target temperature, enhancing the ablation effect.

[0159] Furthermore, the myocardial tissue is the interventricular septum.

[0160] Furthermore, the pathway used for ventricular septal myocardial ablation can be one of pathway a, pathway b, and pathway c;

[0161] Pathway a: via the femoral artery and aortic arch to the left ventricle;

[0162] Pathway b: via the inferior vena cava and right atrium to the right ventricle;

[0163] Pathway c: via the inferior vena cava, right atrium, interatrial septum, and left atrium, to the left ventricle.

[0164] When path a is selected, the adjustable curved sheath 110 is straightened and inserted into the aorta using the handle 114 or the dilator. As the adjustable curved sheath 110 is inserted deeper, the external force applied to the adjustable curved sheath 110 by the handle 114 is gradually reduced or the dilator is gradually withdrawn. After the third segment 113 of the adjustable curved sheath 110 reaches the target position, namely the ascending aorta, the external force applied to the adjustable curved sheath 110 by the handle 114 is removed or the dilator is withdrawn, so that the adjustable curved sheath 110 returns to its natural state.

[0165] Next, the adjustable bend catheter 120 is extended from the distal opening of the third segment 113 of the adjustable bend sheath 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 interventricular septum.

[0166] Next, the ablation needle 13 is extended from the distal opening of the adjustable-bend catheter 120 and punctures the endocardium to reach the interventricular septum tissue. Ablation energy is delivered for ablation. After ablation, the ablation needle 13, the adjustable-bend catheter 120, and the adjustable-bend sheath 110 are withdrawn in sequence.

[0167] Specifically, a contrast-enhancing component, such as a metallic contrast ring or a contrast agent, is placed on the third segment 113 of the adjustable bending sheath 110 or the ablation needle 13. Under ultrasound / CT guidance, the adjustable bending sheath 110 is guided via femoral artery puncture and a guidewire (not shown in the figure) through the aortic arch to a position on the aortic valve near the aortic arch. Figure 8 As shown.

[0168] Angiography was used to confirm the correct placement of the adjustable bendable sheath 110. Once the distal opening of the third segment 113 of the adjustable bendable sheath 110 reached the target position, the guidewire was withdrawn, and the adjustable bendable catheter 120 was advanced along the lumen of the adjustable bendable sheath 110 to the side of the aortic valve near the aortic arch. Under ultrasound / CT guidance, the catheter was then crossed over the aortic valve without damaging it. Figure 16 As shown.

[0169] By adjusting the bending direction and bending angle of the adjustable bending sheath 110 and the adjustable bending catheter 120's bending section 123, the distal end of the adjustable bending catheter 120 can be well attached to the desired puncture and ablation point of the interventricular septum.

[0170] Operating the control handle 14 controls the ablation needle 13 to extend along the central axis of the adjustable curved sheath 110, piercing the interventricular septum and reaching the hypertrophic myocardial tissue within the septum. The angle and depth of insertion are controlled based on both ultrasound imaging and the markings on the control handle 14. Figure 17 As shown.

[0171] After completing the above steps, first start the perfusion device 30, set the perfusion flow rate, so that the electrolyte liquid 33 reaches the perfusion hole 132a through the inner cavity 132b of the ablation needle 13 and perfuses the tissue for a period of time. Then turn on the ablation radiofrequency ablation device 20, and ablate the hypertrophic myocardial tissue through the ablation section 134 of the ablation needle 13. The size of the ablation range is determined by ultrasound and / or angiography.

[0172] When the ablation area is within the ideal size, stop the energy output of the radiofrequency ablation device 20, stop the infusion of electrolyte solution 33, retract the ablation needle 13 into the adjustable bend catheter 120, adjust the bend section 123 of the adjustable bend catheter 120 so that its distal end is no longer in contact with the ventricular septum, and then operate the adjustable bend catheter 120 to select the next point. At this time, the distal end of the adjustable bend catheter 120 will exhibit an arc swing from point E to point F, as shown. Figure 18 As shown, within a suitable range, select one, two, three, four, or even more puncture sites.

[0173] As the adjustable catheter 120 is rotated to the next puncture site, the above procedure is repeated until all sites have been selected, punctured, and ablated. Figure 18 As shown.

[0174] After ablation, multiple ablation zones will be left on the thickened ventricular septum. Ideally, these zones should be connected to form a long, continuous ablation range. After all puncture points have been punctured and ablated, the ablation needle 13, the adjustable bend catheter 120, and the adjustable bend sheath 110 are withdrawn in sequence, and the vascular suture and puncture point skin suture are completed.

[0175] If path b is chosen, then: Under ultrasound / CT guidance, via femoral vein puncture and guided by a guidewire (not shown), the adjustable bendable sheath 110 is passed through the inferior vena cava, right atrium, and into the right ventricle. Angiography is used to confirm the correct placement of the adjustable bendable sheath 110. Once the adjustable bendable sheath 110 reaches the target position, the guidewire is withdrawn, and the adjustable bendable catheter 120 is advanced into the right ventricle along the lumen of the adjustable bendable sheath 110. The bending direction and angle of the bendable segment 123 of the adjustable bendable sheath 110 and the adjustable bendable catheter 120 are controlled so that the distal end of the adjustable bendable catheter 120 is well abutted against the desired puncture and ablation point on the interventricular septum.

[0176] The ablation needle 13 is extended along the central axis of the adjustable curved sheath 110 by operating the control handle 14, piercing the endocardium and reaching the hypertrophic myocardial tissue of the interventricular septum. The angle and depth of insertion are controlled by both ultrasound imaging and the scale markings on the control handle 14.

[0177] After completing the above steps, first start the perfusion device 30, set the perfusion flow rate, so that the electrolyte liquid 33 passes through the inner cavity 132b of the ablation needle 13 to the perfusion port 132a and perfuses the tissue for a period of time. Then, turn on the radiofrequency ablation device 20, and ablate the hypertrophic myocardial tissue through the ablation segment 134 of the ablation needle 13. The size of the ablation area 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 to achieve the purpose of controlling the ablation area.

[0178] When the ablation area is within the ideal size, stop the energy output of the radiofrequency ablation device, stop the infusion of electrolyte solution 33, and retract the ablation needle 13 into the adjustable bend catheter 120. Adjust the bend section 123 of the adjustable bend catheter 120 so that its distal end is no longer in contact with the ventricular septum. Then, operate the adjustable bend catheter 120 to select the next point. At this time, the distal end of the adjustable bend catheter 120 will exhibit an arc swing from point E to point F (e.g., Figure 18 As shown in the figure, within a suitable range, select 1, 2, 3, 4 or even more puncture sites.

[0179] When the adjustable bendable catheter 120 is rotated to the next puncture site, the above operation is repeated until all sites have been selected, punctured, and ablated.

[0180] After ablation, multiple ablation zones will be left on the thickened ventricular septum. Ideally, these zones should be connected to form a long, continuous ablation area.

[0181] After all puncture sites were punctured and ablated, the ablation needle 13, the adjustable bendable catheter 120, and the adjustable bendable sheath 110 were withdrawn in sequence, and the vascular suture and puncture site skin suture were completed.

[0182] If path c is selected, then: under ultrasound / CT guidance, via femoral vein puncture, guided by a guidewire (not shown), the adjustable curved sheath 110 is passed through the inferior vena cava, right atrium, and interatrial septum to the left atrium. Angiography is used to confirm whether the position of the adjustable curved sheath 110 is correct. Once the adjustable curved sheath 110 reaches the target position, the guidewire is withdrawn, and the adjustable curved catheter 120 is delivered along the lumen of the adjustable curved sheath 110 to the left atrium near the mitral valve. Under ultrasound / CT guidance, it crosses the mitral valve without damaging it.

[0183] By controlling the bending direction and bending angle of the adjustable bending sheath 110 and the bending section 123 of the adjustable bending catheter 120, the distal end of the adjustable bending catheter 120 can be well attached to the expected puncture and ablation point on the ventricular septum.

[0184] The ablation needle 13 is extended along the central axis of the adjustable and bendable catheter 120 by operating the control handle 14, piercing the endocardium and reaching the hypertrophic myocardial tissue of the interventricular septum. The angle and depth of insertion are controlled by both ultrasound imaging and the scale markings on the control handle 14.

[0185] After completing the above steps, first start the perfusion device 30, set the perfusion flow rate, so that the electrolyte liquid 33 passes through the inner cavity 132b of the ablation needle 13 to the position of the perfusion hole 132a and perfuses the tissue for a period of time. Then turn on 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.

[0186] The size of the ablation area can be determined by ultrasound and / or contrast imaging, and the length of the ablation segment 134 can be adjusted according to the actual size of the ablation area to control the ablation area.

[0187] When the ablation range is within the ideal size, stop the energy output of the radiofrequency ablation device, stop the infusion of electrolyte liquid 33, and retract the ablation needle 13 into the adjustable bendable catheter 120.

[0188] Adjust the bend section 123 of the adjustable bend catheter 120 so that its distal end is no longer in contact with the ventricular septum. Then, operate the adjustable bend catheter 120 to select the next point. At this time, the distal end of the adjustable bend catheter 120 will exhibit an arc-shaped swing from point E to point F (e.g., Figure 18 As shown in the figure, within a suitable range, select 1, 2, 3, 4 or even more puncture sites.

[0189] When the adjustable bendable catheter 120 is rotated to the next puncture site, the above operation is repeated until all sites have been selected, punctured, and ablated.

[0190] After ablation, multiple ablation zones will be left on the thickened ventricular septum. Ideally, these zones should be connected to form a long, continuous ablation area.

[0191] After all puncture sites were punctured and ablated, the ablation needle 13, the adjustable bendable catheter 120, and the adjustable bendable sheath 110 were withdrawn in sequence, and the vascular suture and puncture site skin suture were completed.

[0192] Example 2:

[0193] like Figure 22 As shown, Embodiment 2 of the present invention provides a radiofrequency ablation system, which differs from the radiofrequency ablation system of Embodiment 1 only in that the PID parameter configuration unit introduces a flow rate value to adjust the PID parameters when configuring the PID parameters.

[0194] Specifically, in perfusion ablation, the electrolyte liquid 33 has the function of cooling the ablation needle 13 and the target tissue. The cooling effect varies depending on the perfusion volume of the electrolyte liquid 33 per unit time.

[0195] Therefore, in this embodiment, the PID parameter configuration unit configures the PID parameters according to the following steps:

[0196] Step S101: Establish a target reference model for temperature control.

[0197] During operation, the temperature sensor monitors the real-time temperature of the target tissue or ablation segment 134 and feeds this real-time temperature back to the PID controller. The PID controller then adjusts the output of the radio frequency energy generation unit based on this feedback and the target temperature, ensuring that the real-time temperature is the same as or substantially the same as the target temperature. Therefore, a temperature error can be defined.

[0198] e(k) = y r (k)-y(k) ①

[0199] Therefore, a discrete-time target reference model for temperature control is established as follows:

[0200] A m (z -1 )y(k)=B m (z -1 )y r (k)

[0201] B m (z -1 )=b m0 -b m1 z -1 +b m2 z -2

[0202] A m (z -1 )=1+a m1 z -1 +a m2 z -2

[0203] Among them, y r (k) represents the target temperature that the target tissue is expected to reach, y(k) represents the actual temperature measured by the temperature sensor, k represents the current sampling time, z represents the Z-transform operator, and a m1 ~a m2 and b m0 ~b m2 All of these are constants, and the values ​​of these constants range from -2 to 1.

[0204] Step S102: Establish an approximate mathematical model of the radiofrequency ablation system.

[0205] As shown in step S101, the output power u1(k) can be calculated based on the temperature error e(k). Since u1(k), u2(k), and y(k) are related, and y(k) can be obtained in real-time from the temperature sensor, an approximate mathematical model of the radiofrequency ablation system can be established by linking u1(k), u2(k), and y(k).

[0206] A(z -1 )y(k)=B(z -1 )u1(k)+C(z -1 )u2(k) ③

[0207] A(z -1 )=1+a1z -1

[0208] B(z -1 )=b0

[0209] C(z -1 )=c0

[0210] Where y(k) is the actual temperature measured by the temperature sensor; u1(k) represents the power, i.e. the input of the radiofrequency ablation system; u2(k) represents the flow rate, i.e. the perfusion volume of electrolyte liquid 33; and k represents the current sampling time.

[0211] Let positive definite matrix Where p 11 ~p 33 θ1 to θ3 are all constants, and the values ​​of these constants range from -2 to 1.

[0212] Based on the measured temperature y(k) and power u1(k) and u2(k) recorded for each sampling, the following calculations are performed.

[0213]

[0214] in

[0215]

[0216]

[0217] and It is a vector consisting of -y(k-1), u1(k), and u2(k).

[0218] Then, calculate

[0219] in It is an identity matrix.

[0220] Parameter p 11 ~p 33 θ1 to θ3 can be determined by the following method: Collect historical data records S = {s1, s2, ..., s i ,…,s n}, where s i =[y(i),u1(i),u2(i)] represents the sampling point recorded at time i, y(i) represents the temperature at time i, u1(i) represents the power at time i, and u2(i) represents the flow rate at time i;

[0221] but in

[0222] Thus, the model parameters at the current sampling time are obtained.

[0223] a1=θ(k)[0], b0=θ(k)[1], c0=θ(k)[2];

[0224] With the above settings, the flow rate is reflected in the above formula during perfusion ablation. By filtering u2(k) in u(k) and accurately calculating u1(k), the influence of u2(k) on u1(k) can be reduced, thereby decoupling u2(k) and improving the accuracy of parameters a1 and b0, thus reducing calculation errors.

[0225] Step S103: Configure PID controller parameters.

[0226] Since the PID controller can only control the output power of the radio frequency ablation generator and not the flow rate of the electrolyte liquid 33, the mathematical model of the PID controller is set as follows:

[0227] H(z -1 u1(k)=G(z) -1 )e(k)

[0228] Where G(z) -1 )=k a -k b z -1 +k c z -2 H(z) -1 )=1-z -1 ;k a k b k c These are the configurable parameters for the incremental PID controller. Combining the mathematical model of the PID controller described above with formulas ① and ③, we can obtain...

[0229]

[0230] Similarly, the characteristic equation of the closed-loop temperature control system, formed by the PID controller and the approximate mathematical model of the radiofrequency ablation system described above, is:

[0231] A(z -1 )H(z -1 )+B(z -1 )G(z -1 )=1+b0k a +(a1-1-b0k b )z -1 +(b0k c -a1)z -2

[0232] Let the configuration coefficient be set. Let A(z) -1 )H(z -1 )+B(z -1 )G(z -1 )=A0A m (z -1 ), can be calculated This completes the configuration of the PID controller parameters.

[0233] Step S104: Use the configured PID controller to control the RF output.

[0234] The parameter k obtained from step S103 is configured. a k b k c Substitute this into the incremental PID controller u1(k) = k a e(k)-k b e(k-1)+k c e(k-2)+u1(k-1) controls the output power of the radio frequency energy generation unit.

[0235] By introducing flow rate to configure the parameters of the PID controller, oscillations in the tissue temperature curve generated after the PID controller output can be suppressed.

[0236] like Figure 23 The tissue temperature curve generated after using the PID controller output of this embodiment 2 shows that after the initial temperature rise stage reaches the target temperature (taking 60℃ as an example), the tissue temperature curve basically stabilizes at the target temperature (taking 60℃ as an example). Therefore, through the above settings, the part of the target tissue or ablation device used to release ablation energy after the above radiofrequency ablation system outputs radiofrequency energy can further reach and stabilize at the target temperature without oscillation.

[0237] The above description represents the preferred embodiments of the present invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principles of the present invention, and these improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. A radiofrequency ablation device, characterized in that, It includes a radio frequency energy generation unit, a PID controller, and a PID parameter configuration unit; the PID controller is connected to the radio frequency energy generation unit and the PID parameter configuration unit respectively, and the PID controller is used to output control signals to the radio frequency energy generation unit and the PID parameter configuration unit according to the target temperature; The radio frequency energy generating unit is connected to the ablation device and is used to output ablation energy to the ablation device. After establishing the target reference model for temperature control and the mathematical model of the radio frequency ablation system in the PID parameter configuration unit, the PID parameter configuration unit adjusts the PID parameters by combining the real-time temperature of the temperature sensor, the target temperature, and the control signal, and sends the adjusted PID parameters to the PID controller. The PID controller is used to output a control signal to the radio frequency energy generating unit according to the adjusted PID parameters to control the output power of the radio frequency energy generating unit. The PID parameter configuration unit configures the PID parameters according to the following steps: Step S101: Establish a target reference model for temperature control; Step S102: Establish the mathematical model of the radiofrequency ablation system; Step S103: Configure the PID parameters of the PID controller; Step S104: Use the configured PID controller to control the radio frequency output; Step S102 further includes: the mathematical model of the radiofrequency ablation system is... in The actual temperature measured by the temperature sensor; ; Represents the current sampling time; Represents a transformation operator; All of these are coefficients to be estimated.

2. The radiofrequency ablation device according to claim 1, characterized in that, Step S101 further includes: the target reference model for temperature control is... in, The target temperature that the target organization hopes to achieve. The actual temperature measured by the temperature sensor. Represents the current sampling time; All of these are constants, and the values ​​of these constants range from -2 to 1.

3. The radiofrequency ablation device according to claim 1, characterized in that, Step S103 further includes: Let the mathematical model of the PID controller be: in , , These are the parameters to be configured for the PID controller; ， 。 4. The radiofrequency ablation device according to claim 3, characterized in that, Step S103 further includes: The characteristic equation of the closed-loop temperature control system, formed by the mathematical model of the PID controller and the radiofrequency ablation system, is as follows: Let the configuration coefficient be set. ,make It can be found that , , .

5. The radiofrequency ablation device according to claim 4, characterized in that, Step S104 further includes: configuring the parameters according to step S103. , , Substitute into the PID controller The output power of the radio frequency energy generating unit is controlled.

6. A radiofrequency ablation system, characterized in that, It includes an ablation device, a radiofrequency ablation device as described in any one of claims 1-5, and a temperature sensor, wherein the temperature sensor is disposed in a portion of the ablation device for releasing ablation energy; The ablation device is connected to the radio frequency ablation equipment so that the radio frequency ablation equipment can provide ablation energy to the ablation device.

7. The radiofrequency ablation system according to claim 6, characterized in that, The ablation device includes a delivery tube assembly and an ablation needle; the ablation needle is movably inserted into the delivery tube assembly; the delivery tube assembly is used for intervention in the heart via a catheter, and after the ablation needle exits from the delivery tube assembly, it enters the myocardial tissue through a puncture of the endocardium, and then the radiofrequency ablation device provides energy to the ablation needle to ablate the myocardial tissue.

8. The radiofrequency ablation system according to claim 7, characterized in that, It also includes an infusion device, which includes an infusion pump and a liquid source. The liquid source provides electrolyte liquid to the ablation device via the infusion pump. The ablation needle has an inner cavity and an infusion hole, and the electrolyte liquid flows out from the infusion hole through the inner cavity.

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