Renal sympathetic nerve ablation system and use method thereof

Abstract

The invention discloses a renal sympathetic nerve ablation system and a use method thereof, and relates to the technical field of renal sympathetic nerve ablation systems. The purpose of the present invention is to improve prevention and treatment of cardiovascular diseases; comprising an imaging module used for real-time and high-resolution imaging of renal arteries and surrounding tissues, and imaging modes comprise intravascular ultrasound and optical coherence tomography (OCT); the ablation algorithm module is used for monitoring a renal artery anatomical structure, sympathetic nerve distribution and temperature and pressure parameters in an ablation process based on an intelligent ablation algorithm; the monitoring module integrates various sensors and a data processing unit and monitors key parameters such as temperature, pressure and ablation depth in the ablation process in real time. Real-time and high-resolution imaging of the renal artery and surrounding tissues is achieved through intravascular ultrasound and optical coherence tomography (OCT) technologies, and it is guaranteed that medical staff clearly observe the anatomical structure of the renal artery and the position and angle of an ablation catheter.

Description

Technical Field

[0001] The present invention relates to the technical field of renal sympathetic nerve ablation systems, and in particular to a renal sympathetic nerve ablation system and a method of using the same. Background Art

[0002] In the existing technology, cardiovascular disease is a major health problem worldwide. Traditional treatment methods include drug therapy and surgical treatment. Currently, with the continuous advancement of medical technology, renal sympathetic nerve ablation is gradually gaining attention as an emerging treatment method. Renal sympathetic nerve ablation is a treatment method that reduces the activity of the sympathetic nervous system by ablating the renal sympathetic nerves. The ablation catheter is introduced into the renal artery through percutaneous catheter minimally invasive surgery to accurately ablate the renal sympathetic nerves. However, the current renal sympathetic nerve ablation system has problems such as poor imaging effect and low ablation accuracy, which limit the effect and safety of ablation treatment.

[0003] In order to solve the above problems, the present invention proposes a novel renal sympathetic nerve ablation system and its use method, which, by combining imaging technology, real-time monitoring technology and intelligent ablation algorithm, can achieve real-time, high-resolution imaging of the renal artery and surrounding tissues, accurately locate the ablation target, and monitor the key parameters in the ablation process. The ablation strategy can be automatically adjusted according to the real-time monitoring data to ensure the accuracy and stability of the ablation. Summary of the invention

[0004] The purpose of the present invention is to solve the shortcomings of the prior art and to propose a renal sympathetic nerve ablation system and a method of using the same.

[0005] In order to achieve the above object, the present invention adopts the following technical solutions:

[0006] A renal sympathetic nerve ablation system, comprising:

[0007] An imaging module for real-time, high-resolution imaging of the renal artery and surrounding tissues using intravascular ultrasound and optical coherence tomography (OCT);

[0008] The ablation algorithm module monitors the renal artery anatomical structure, sympathetic nerve distribution, and temperature and pressure parameters during ablation based on an intelligent ablation algorithm;

[0009] The monitoring module integrates multiple sensors and data processing units to monitor key parameters during the ablation process in real time, such as temperature, pressure, and ablation depth.

[0010] Preferably: the imaging module further comprises:

[0011] an endoscopic camera to capture images of the inside of the renal arteries;

[0012] Endoscope light source, providing lighting for the camera;

[0013] The display control circuit board processes and analyzes the image data captured by the camera and displays it on the screen.

[0014] Furthermore: the ablation algorithm module uses CT scanning and MRI technology when monitoring the anatomical structure of the renal artery.

[0015] Furthermore: the monitoring module also includes an over-temperature protection device and a pressure monitoring protection device, which automatically adjusts the ablation strategy or stops ablation when the system temperature or pressure exceeds the set value.

[0016] A method for using a renal sympathetic nerve ablation system comprises the following steps:

[0017] Preoperative preparation, including assessment of the patient's condition and renal arteriography;

[0018] The surgical procedure includes puncturing the artery, introducing the ablation catheter into the renal artery, and selecting appropriate ablation parameters for ablation; during the ablation process, the patient's vital signs and ablation parameters are continuously monitored;

[0019] Postoperative care: observe the patient's vital signs and the condition of the surgical site.

[0020] As a further solution of the present invention: the ablation parameters include the selection of ablation catheter, the power and time of radio frequency energy, and the ablation position and range.

[0021] As a further solution of the present invention: the ablation catheter has a polyurethane main body, and contains a plurality of braided layers made of stainless steel wires or nickel-titanium alloy. The catheter surface is smoothed and equipped with a contact force sensor and an electrocardiogram feedback function.

[0022] On the basis of the above scheme: the electrode of the ablation catheter is made of platinum material, and a plurality of electrodes are provided at the end of the electrode. The size and shape of the electrode are designed according to the ablation effect, safety and the anatomical structure of the patient.

[0023] On the basis of the above scheme: during the ablation process, the temperature and pressure changes of the ablation area are monitored in real time by temperature sensors and pressure sensors.

[0024] The beneficial effects of the present invention are:

[0025] 1. A renal sympathetic nerve ablation system and its use method, which realizes real-time, high-resolution imaging of the renal artery and surrounding tissues through intravascular ultrasound and optical coherence tomography (OCT) technology, ensuring that medical staff can clearly observe the anatomical structure of the renal artery, the distribution of sympathetic nerves, and the position and angle of the ablation catheter, thereby improving the accuracy and safety of the operation.

[0026] 2. A renal sympathetic nerve ablation system and its use method, which uses an ablation algorithm combined with electrophysiological monitoring to accurately evaluate the anatomical structure of the renal artery and the distribution of the sympathetic nerves. At the same time, it can monitor key parameters such as temperature and pressure during the ablation process in real time, adjust the energy output, position and angle of the ablation catheter, and ensure the accuracy and stability of the ablation.

[0027] 3. A renal sympathetic nerve ablation system and its use method. During the ablation process, the system provides comprehensive ablation parameter settings, such as the power and time of radiofrequency energy, and the selection and design of ablation catheters, to meet the treatment needs of different patients. The system can also monitor the patient's vital signs and electrocardiogram indicators in real time to ensure the safety and effectiveness of the operation.

[0028] 4. A renal sympathetic nerve ablation system and its use method. The ablation catheter body is made of polyurethane material and contains a stainless steel wire or nickel-titanium alloy braided layer inside, which provides good support and torsional stability. The catheter surface is smoothed to reduce friction with the blood vessel wall and reduce surgical risks. It is equipped with a contact force sensor and electrocardiogram feedback function to further improve the accuracy and safety of the operation.

[0029] 5. A renal sympathetic nerve ablation system and its use method, which can cut off energy output or adjust ablation strategy when the system temperature or pressure exceeds the set value through a built-in over-temperature protection device and a pressure monitoring and protection device, effectively preventing surgical risks that may be caused by overheating of the device or excessive pressure BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 It is a flow chart of a method for using a renal sympathetic nerve ablation system proposed by the present invention. DETAILED DESCRIPTION

[0031] The technical solution of this patent is further described in detail below in conjunction with specific implementation methods.

[0032] The embodiments of the present invention are described in detail below, and examples of the embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and cannot be understood as limiting the present invention.

[0033] Embodiment 1:

[0034] A renal sympathetic nerve ablation system includes an imaging module. The imaging methods of the imaging module include intravascular ultrasound and optical coherence tomography (OCT). The above imaging methods can realize real-time, high-resolution imaging of the renal artery and surrounding tissues, so as to clearly display the anatomical structure of the renal artery, the distribution of sympathetic nerves, and the position and angle of the ablation catheter. The tools required for imaging include:

[0035] Endoscopic camera: captures images of the inside of the renal artery;

[0036] Endoscope light source: provides lighting for the camera;

[0037] Image control circuit board: processes and analyzes the image data captured by the camera and displays it on the screen so that medical staff can read the image data;

[0038] Ablation algorithm module: Based on the intelligent ablation algorithm, it monitors the renal artery anatomical structure, sympathetic nerve distribution, and parameters such as temperature and pressure during the ablation process, and adjusts the energy output, position and angle of the ablation catheter to ensure the accuracy and stability of the ablation;

[0039] During the monitoring process, the ablation algorithm monitors the renal artery anatomy in the following ways:

[0040] CT scan: can clearly show the anatomical structures such as the shape, diameter, number of renal arteries and the presence of accessory renal arteries;

[0041] MRI: provides soft tissue information;

[0042] During the monitoring of sympathetic nerve distribution, the method used is:

[0043] Electrophysiological monitoring: recording and analyzing the activity potential of renal nerves and evaluating the distribution and activity of sympathetic nerves;

[0044] Imaging combined with anatomical knowledge: based on CT or MRI, the distribution of sympathetic nerves around the renal artery can be inferred;

[0045] The method used to monitor the temperature is:

[0046] Temperature sensor: real-time monitoring of temperature information at the probe position;

[0047] Imaging-assisted temperature measurement: Ultrasound imaging can be used to monitor the temperature changes in the ablation area in real time;

[0048] In the process of monitoring pressure parameters, the monitoring methods include:

[0049] Pressure monitoring catheter: real-time monitoring of the pressure between the catheter and the blood vessel wall;

[0050] Indirect evaluation: Observe other parameters (such as temperature, impedance, etc.) during the ablation process to indirectly evaluate the changes in pressure;

[0051] Monitoring module: Integrates multiple sensors and data processing units to monitor key parameters during ablation in real time, such as temperature, pressure, ablation depth, etc., and feeds the data back to the doctor;

[0052] Including over-temperature protection device: when the system temperature exceeds the set value, it automatically cuts off the energy output to prevent the equipment from overheating;

[0053] Pressure monitoring and protection device: When the pressure exceeds the set value, the ablation strategy is automatically adjusted or ablation is stopped.

[0054] Embodiment 2;

[0055] A method for using a renal sympathetic nerve ablation system comprises the following steps:

[0056] S1: Preoperative treatment:

[0057] S11: Preoperative preparation

[0058] Assess the patient's blood pressure, renal function and other relevant organ conditions, and allergy history;

[0059] S12: Preoperative examination:

[0060] Perform renal artery angiography to determine the anatomical structure of the renal artery and whether there is stenosis

[0061] S2: Surgical Procedure

[0062] S21: Under local anesthesia, puncture the patient's femoral artery or renal artery, insert the catheter sheath, introduce the ablation catheter into the renal artery through the catheter sheath, and use contrast agent to confirm the position and shape of the catheter;

[0063] S22: According to the patient's specific situation and surgical plan, select appropriate ablation parameters, such as the power and time of radiofrequency energy, start from the distal bifurcation of the renal artery, apply energy to the vessel wall, and use a special ablation catheter to slowly rotate along the vessel wall. After each ablation, withdraw the catheter a certain distance (such as 1-2 cm) and perform circular rotation ablation again. Repeat the above steps until the opening of the renal artery. The operation method is the same on both sides.

[0064] S23: During the ablation process, the patient's vital signs and electrocardiogram (ECG) and other indicators are continuously monitored. Monitoring equipment such as temperature sensors and pressure sensors are used to monitor parameters such as temperature and pressure during the ablation process in real time.

[0065] S3: Postoperative care

[0066] Observe the patient's vital signs and the condition of the surgical site, and pay attention to whether the patient is bleeding;

[0067] The ablation parameters of step S22 are as follows:

[0068] Ablation catheter:

[0069] Choose a cold saline irrigated catheter, which can prevent thrombosis on the electrode surface, lower the ablation temperature on the electrode surface, and safely release more power to ablate deeper tissues;

[0070] Ablation energy and frequency:

[0071] The radiofrequency energy was selected between 6 and 8 W, and each ablation lasted for 2 minutes;

[0072] Ablation location and range:

[0073] Ablation starts from the distal bifurcation of the renal artery, and the catheter is slowly rotated along the vessel wall and repeated multiple times (such as 4-6 times) until the opening of the renal artery is reached.

[0074] Monitoring and Evaluation:

[0075] During surgery, monitor the patient's blood pressure, heart rate and other vital signs;

[0076] During the ablation process of S23, the design parameters of the ablation catheter are as follows:

[0077] 1. Material selection

[0078] The ablation catheter body is made of polyurethane, and the interior of the catheter contains a braided layer made of multiple stainless steel wires or nickel-titanium alloy;

[0079] It can provide the necessary support and torsional stability, allowing the catheter to move freely in the complex vascular network and accurately locate the target treatment area.

[0080] Structural design

[0081] The catheter body is designed to be highly flexible and plastic, and the catheter surface is smoothed to reduce friction with the blood vessel wall. Some catheters are specially designed, such as ring, lattice sphere, and balloon, to meet different treatment needs;

[0082] Sensors and functions

[0083] The ablation catheter is equipped with a contact force sensor to measure tissue contact during cardiac ablation, and the catheter has an integrated electrocardiogram feedback function;

[0084] 2. Electrode Design

[0085] Material selection

[0086] Electrodes and electrode tips are made of precious metals such as platinum and iridium;

[0087] Quantity and layout

[0088] The end of the catheter is equipped with multiple electrodes, which expands the coverage of the treatment area and facilitates the adjustment of energy output between different electrodes;

[0089] The electrodes can be used alone or in combination to create myocardial ablation lines or surfaces of specific shapes to more accurately block abnormal electrical signal conduction pathways;

[0090] Size and shape

[0091] The size and shape of the electrode have an important influence on the ablation effect. When designing the electrode, factors such as ablation effect, safety and the patient's anatomical structure should be considered.

[0092] The above is a preferred specific implementation manner of the present invention, and the protection scope of the present invention is not limited thereto. Any modification, equivalent substitution and improvement made by any technician familiar with the field within the technical scope disclosed by the present invention in combination with the prior art or public common sense, within the spirit and principle of the present invention, shall be covered by the protection scope of the present invention.

Claims

1. A renal sympathetic nerve ablation system, characterized in that: include: An imaging module for real-time, high-resolution imaging of the renal artery and surrounding tissues using intravascular ultrasound and optical coherence tomography (OCT); The ablation algorithm module monitors the renal artery anatomical structure, sympathetic nerve distribution, and temperature and pressure parameters during ablation based on an intelligent ablation algorithm; The monitoring module integrates multiple sensors and data processing units to monitor key parameters during the ablation process in real time, such as temperature, pressure, and ablation depth.

2. A renal sympathetic nerve ablation system according to claim 1, characterized in that: The imaging module further comprises: an endoscopic camera to capture images of the inside of the renal arteries; Endoscope light source, providing lighting for the camera; The display control circuit board processes and analyzes the image data captured by the camera and displays it on the screen.

3. A renal sympathetic nerve ablation system according to claim 2, characterized in that: The ablation algorithm module uses CT scanning and MRI technology when monitoring the anatomical structure of the renal artery.

4. A renal sympathetic nerve ablation system according to claim 3, characterized in that: The monitoring module also includes an over-temperature protection device and a pressure monitoring protection device. When the system temperature or pressure exceeds a set value, the ablation strategy is automatically adjusted or ablation is stopped.

5. A method for using the renal sympathetic nerve ablation system according to any one of claims 1 to 4, characterized in that: The following steps are involved: Preoperative preparation, including assessment of the patient's condition and renal arteriography; The surgical procedure includes puncturing the artery, introducing the ablation catheter into the renal artery, and selecting appropriate ablation parameters for ablation; during the ablation process, the patient's vital signs and ablation parameters are continuously monitored; Postoperative care: observe the patient's vital signs and the condition of the surgical site.

6. The method for using the renal sympathetic nerve ablation system according to claim 5, characterized in that: The ablation parameters include the selection of ablation catheter, the power and time of radio frequency energy, and the ablation position and range.

7. The method for using the renal sympathetic nerve ablation system according to claim 6, characterized in that: The ablation catheter is made of polyurethane as the main body, and contains a braided layer of multiple stainless steel wires or nickel-titanium alloy inside. The catheter surface is smoothed and equipped with a contact force sensor and electrocardiogram feedback function.

8. The method for using the renal sympathetic nerve ablation system according to claim 7, characterized in that: The electrode of the ablation catheter is made of platinum, and a plurality of electrodes are arranged at the end of the electrode. The size and shape of the electrode are designed according to the ablation effect, safety and the anatomical structure of the patient.

9. A method for using a renal sympathetic nerve ablation system according to claim 8, characterized in that: During the ablation process, the temperature and pressure changes in the ablation area are monitored in real time through temperature sensors and pressure sensors.

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