System for radiofrequency ablation renal sympathetic nerve removal and nerve excitability measurement

Abstract

The invention discloses a system for radiofrequency ablation renal sympathetic nerve removal and nerve excitability measurement, and relates to the technical field of medical instruments. The device comprises a control handle, the end of the control handle is connected with a guide pipe, the free end of the guide pipe is connected with a bent section, and the upper portion of the control handle is rotationally connected with an adjusting handle; the ablation monitoring unit is connected to the tail end of the control handle through a cable and used for monitoring and controlling the ablation temperature; and the nerve excitability monitoring unit is connected to the bottom end of the control handle through a cable and is used for monitoring nerve excitability. By adopting a mode of combining temperature sensor acquisition and nerve excitability monitoring, real-time and visual nerve excitability change feedback and temperature feedback are provided for doctors, the ablation effect is accurately judged in an assisted manner, and the operation flexibility and safety are improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a radiofrequency ablation procedure for renal sympathectomy and a system for measuring nerve excitability. Background Technology

[0002] Refractory hypertension is common in clinical practice, with numerous causative factors, an unclear pathogenesis, and poor response to drug treatment. The medical community has long believed that renal sympathetic nerve excitation is closely related to elevated blood pressure, and the renal sympathetic nervous system has long been proven to be a cause of hypertension's occurrence and maintenance. A recent report on the Sympulcity HTN-2 study, conducted using the Medtronic Ardian renal sympathectomy catheter system, demonstrates the safety and efficacy of percutaneous catheter ablation for refractory hypertension. In this study, researchers used the Sympulcity catheter system to deliver radiofrequency (RF) energy from within the renal artery lumen to ablate the renal afferent and efferent nerves in the adventitia of the artery. The results were compared with those of patients whose blood pressure was controlled solely by medication. This demonstrates the safety and efficacy of percutaneous catheter ablation for refractory hypertension, representing a significant advancement in translating physiological knowledge into specific therapeutic goals.

[0003] In existing technologies, to improve the ablation effect, the ablation temperature of the electrode catheter is controlled to avoid insufficient or excessive ablation. However, the ablation temperature is usually controlled by monitoring the real-time ablation temperature with a temperature sensor, and feedback from the renal sympathetic nerves cannot be obtained. Therefore, the accuracy of ablation temperature control is easily poor due to errors in one-sided monitoring data.

[0004] Therefore, this invention proposes a system for measuring nerve excitability during radiofrequency ablation of the renal sympathetic nerve. Summary of the Invention

[0005] The purpose of this invention is to provide a system for measuring nerve excitability in radiofrequency ablation of the renal sympathetic nerve. By using a combination of temperature sensor acquisition and nerve excitability monitoring, it provides doctors with real-time and intuitive feedback on changes in nerve excitability and temperature, helping to accurately judge the ablation effect and improve the flexibility and safety of the surgery.

[0006] To achieve the above objectives, the present invention provides the following technical solution: a system for radiofrequency ablation of the renal sympathetic nerve and a system for measuring nerve excitability, comprising: A control handle, with a conduit connected to one end of the control handle and a curved section connected to the free end of the conduit; and an adjustment handle rotatably connected to the top of the control handle. An ablation monitoring unit is connected to the end of a control handle via a cable and is used to monitor and control the ablation temperature. A neural excitability monitoring unit is connected to the bottom of the control handle via a cable and is used to monitor neural excitability.

[0007] Furthermore, the ablation monitoring unit includes an ablation electrode, a first connector, a second connector, and a first monitor; The ablation electrode is disposed on the curved section. The ablation electrode is connected to the first connector via a first electrode wire, which passes through a conduit and a control handle in sequence. The first connector is connected to the first monitor via a cable and a second connector. A temperature sensor is bonded inside the ablation electrode with medical adhesive. The temperature sensor is connected to the first connector via a sensor wire that passes through a catheter and a control handle in sequence, and is used to provide real-time temperature feedback to the first monitor.

[0008] Furthermore, the neural excitability monitoring unit includes a neural excitability stimulation electrode, a third connector, a fourth connector, and a second monitor; The number of nerve excitability stimulation electrodes is two, and both nerve excitability stimulation electrodes are set on the curved section. The nerve excitability stimulation electrodes are connected to the third connector in sequence through the second electrode wire, the conduit, and the control handle. The third connector is connected to the second monitor through the cable and the fourth connector, which is used to realize the monitoring of renal sympathetic nerve excitability.

[0009] Furthermore, the curved section is made of a soft medical polymer material.

[0010] Furthermore, the adjusting handle is connected to a traction wire, which is connected to the free end of the curved section to adjust the curvature of the curved section so that the ablation electrode and the nerve excitatory stimulation electrode are flat against the renal artery wall.

[0011] Furthermore, the temperature sensor is configured as a thermistor or a thermocouple.

[0012] Furthermore, both the nerve excitatory stimulation electrode and the ablation electrode are bonded to the curved section using medical adhesive.

[0013] Furthermore, the traction wire is made of stainless steel or nickel-titanium material.

[0014] Furthermore, the conduit is a composite tube made of polytetrafluoroethylene tube and stainless steel wire mesh.

[0015] Furthermore, both the control handle and the adjustment handle are made of polytetrafluoroethylene, and the adjustment handle is rotatably connected to the control handle via a pin.

[0016] This invention has at least the following beneficial effects: 1. The present invention, through the ablation electrode monitoring unit, can output corresponding radio frequency current and energy to the ablation electrode according to the temperature information transmitted from the temperature sensor, and adjust accordingly. In this way, the ablation temperature can be controlled to avoid insufficient ablation temperature or excessive ablation.

[0017] 2. The present invention controls the bending section by setting an adjustment handle, which can not only closely fit the renal artery wall and ensure uniform coverage of the ablation area, but also protect the blood vessel, reduce local pressure, and reduce the risk of perforation or damage.

[0018] 3. This invention, through its neural excitability monitoring unit, can accurately capture changes in neural excitability and provide doctors with real-time and intuitive feedback on neural excitability changes through multi-point signals, helping to accurately judge the ablation effect and improve the flexibility and safety of the surgery.

[0019] Of course, any product implementing this invention does not necessarily need to achieve all of the advantages described above at the same time. Attached Figure Description

[0020] Figure 1 This is a schematic diagram of the overall structure of the present invention; Figure 2 This is a schematic diagram of the ablation electrode of the present invention.

[0021] Figure label: 1. Control handle; 2. Catheter; 3. Bending section; 4. Adjustment handle; 5. Ablation monitoring unit; 51. Ablation electrode; 52. First connector; 53. Second connector; 54. First monitor; 55. First electrode lead; 56. Temperature sensor; 6. Nerve excitability monitoring unit; 61. Nerve excitability stimulation electrode; 62. Third connector; 63. Fourth connector; 64. Second monitor; 65. Second electrode lead; 7. Traction wire. Detailed Implementation

[0022] The technical solutions of the embodiments of this disclosure will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this disclosure, and not all embodiments. Based on the embodiments of this disclosure, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this disclosure.

[0023] Please see Figures 1-2 This invention provides a technical solution: a system for measuring nerve excitability during radiofrequency ablation of the renal sympathetic nerve, comprising: Control handle 1, with a conduit 2 connected to the end of control handle 1, and a curved section 3 connected to the free end of conduit 2; and an adjustment handle 4 rotatably connected to the top of control handle 1. Ablation monitoring unit 5, the monitoring unit is connected to the end of control handle 1 via a cable, and is used to monitor and control the ablation temperature; The neural excitability monitoring unit 6 is connected to the bottom of the control handle 1 via a cable and is used to monitor neural excitability.

[0024] Regarding the technical solution of this embodiment, the ablation monitoring unit 5 includes an ablation electrode 51, a first connector 52, a second connector 53, and a first monitor 54; The ablation electrode 51 is disposed on the bent section 3. The ablation electrode 51 can be made of conductive metal material, such as gold, platinum or medical stainless steel. This embodiment does not make a specific limitation, and can be selected according to the actual situation. The ablation electrode 51 is connected to the first connector 52 via the first electrode wire 55, which passes through the conduit 2 and the control handle 1 in sequence. The first connector 52 is connected to the first monitor 54 via the cable and the second connector 53. A temperature sensor 56 is bonded to the inside of the ablation electrode 51 with medical adhesive. The temperature sensor 56 is set as a thermistor or thermocouple. The temperature sensor 56 is connected to the first connector 52 through the sensor wire passing through the conduit 2 and the control handle 1 in sequence. It is used to provide real-time feedback temperature signals to the first monitor 54. The first monitor 54 outputs corresponding radio frequency current and energy to the ablation electrode 51 according to the temperature information from the temperature sensor 56 and makes corresponding adjustments. In this way, the ablation temperature can be controlled to avoid insufficient ablation temperature or over-ablation.

[0025] Regarding the technical solution of this embodiment, the neural excitability monitoring unit 6 includes a neural excitability stimulation electrode 61, a third connector 62, a fourth connector 63, and a second monitor 64; There are two nerve excitability stimulation electrodes 61. Both nerve excitability stimulation electrodes 61 are set on the curved section 3. The nerve excitability stimulation electrodes 61 are connected to the third connector 62 in sequence through the conduit 2 and the control handle 1 via the second electrode wire 65. The third connector 62 is connected to the second monitor 64 via the cable and the fourth connector 63, which is used to realize the monitoring of renal sympathetic nerve excitability. Specifically, the two electrodes are symmetrically or spaced apart on the curved segment 3, covering multiple directions of the renal artery to ensure no monitoring blind spots, accurately capture changes in nerve excitability, and provide doctors with real-time and intuitive feedback on changes in nerve excitability through multi-point signals, helping to accurately judge the ablation effect and improve the flexibility and safety of the surgery.

[0026] Furthermore, the first monitor 54 uses the SYMPIONEER S1 renal artery radiofrequency ablation device from SYMPIONEER Medical. This system is equipped with advanced temperature monitoring and energy regulation functions, which can monitor the temperature of the ablation electrode in real time and adjust the radiofrequency energy output as needed to ensure the safety and effectiveness of the ablation process. The specific structure and principle of the radiofrequency ablation system are existing technologies and will not be described in detail here.

[0027] Furthermore, the second monitor 64 uses Medtronic's NIM-Response 3.0 neuromonitor, which is commonly used for clinical neuroexcitability testing. The specific structure and principle of the neuromonitor are existing technologies and will not be described in detail here.

[0028] By monitoring the excitability of the renal sympathetic nerves, the surgeon can control the degree of ablation based on the nerve excitability, avoiding both over-ablation and incomplete ablation. The specific details of monitoring renal sympathetic nerve excitability are as follows: 1. Core objective: To identify the ablation target. The renal sympathetic nerves are wrapped around the adventitia of the renal artery and are not visible to the naked eye. Traditional RDN surgery relies on anatomical mapping, in which doctors ablate the intima of the renal artery in a pre-set pattern (such as spiral), assuming that there are nerves beneath these areas.

[0029] Without monitoring: Similar to "blind ablation", it is impossible to know whether there is a nerve below a certain point, or whether the nerve has been successfully inhibited, which may lead to ineffective ablation or over-ablation.

[0030] In cases where monitoring is available: the nerve excitatory stimulation electrode 61 can provide electrical stimulation to the target point before ablation.

[0031] If blood pressure rises significantly after stimulation (monitored in real time via a pressure catheter in the femoral artery): this indicates the presence of an active sympathetic nerve below the point, making it an ideal ablation target.

[0032] If there is no change in blood pressure after stimulation, it indicates that there may be no important nerves at that point, which can avoid unnecessary ablation, save time, and reduce the risk of vascular damage.

[0033] Results: This represents a leap from "anatomical ablation" to "functionally guided ablation," making the surgery more targeted.

[0034] 2. Real-time assessment of ablation effect This is one of the most important functions of neural excitability monitoring. After selecting the target site and performing ablation, the doctor will perform electrical stimulation again at the same location.

[0035] If the blood pressure rise response disappears or significantly weakens after stimulation, it indicates that the sympathetic nerve conduction at this location has been successfully blocked, and the ablation is effective.

[0036] If the blood pressure response persists after stimulation, it indicates that the ablation was incomplete and nerve function is still present. The doctor can perform supplementary ablation at or near the point to ensure the effect.

[0037] Results: Provides "instant therapeutic feedback" to ensure that each ablation point achieves the expected results, avoiding the situation where hypertension treatment fails due to incomplete ablation after the operation.

[0038] 3. Personalized treatment and prediction of long-term efficacy Due to individual anatomical differences, the distribution and density of nerves around the renal artery vary from patient to patient. Monitoring technology allows surgery to be customized according to each patient's physiological response.

[0039] By mapping the neural response of the entire renal artery, doctors can identify all the key "hot spots" for ablation in each patient, achieving truly personalized treatment.

[0040] Effects: It transforms RDN from a standardized operation into personalized precision medicine and helps predict patients' long-term prognosis.

[0041] 4. Enhance surgical safety While RDN surgery is generally safe, over-ablation may increase the risk of vascular complications such as renal artery stenosis. By monitoring and identifying the targets that truly require ablation, unnecessary ablation in "ineffective" areas is avoided, thereby reducing the overall surgical risk.

[0042] Regarding the technical solution of this embodiment, the curved section 3 is made of a soft medical polymer material with good adhesion, which can closely adhere to the renal artery wall to ensure uniform coverage of the ablation area. In addition, it can also protect blood vessels, reduce local pressure, and reduce the risk of perforation or damage.

[0043] Regarding the technical solution of this embodiment, a traction wire 7 is connected to the adjustment handle 4. The traction wire 7 is connected to the free end of the curved section 3 and is used to adjust the curvature of the curved section 3 so that the ablation electrode 51 and the nerve excitability stimulation electrode 61 are flat against the renal artery wall. Specifically, by turning the adjustment handle 4 clockwise or counterclockwise, the adjustment handle 4 will rotate around the pin. Since the traction wire 7 is connected to the adjustment handle 4, the deflection of the adjustment handle 4 can drive the traction wire 7 to move. For example, when the adjustment handle 4 rotates clockwise, it will drive the traction wire 7 to move closer to the first connector 52, thereby pulling the ablation electrode 51 on the curved section 3, realizing better bending of the curved section 3, so that the ablation electrode 51 can better fit on the renal artery, ensuring a good ablation effect and avoiding perforation or suspension of the ablation electrode 51 during the operation.

[0044] In this embodiment, both the nerve excitatory stimulation electrode 61 and the ablation electrode 51 are bonded to the bending segment 3 with medical adhesive.

[0045] Regarding the technical solution of this embodiment, the traction wire 7 is made of stainless steel or nickel-titanium material. It can not only provide tension to drive the bending section 3 to bend and wrap around the renal artery when the adjustment handle 4 is deflected clockwise, but also push the traction wire 7 to open the bending section 3 when the adjustment handle 4 is deflected counterclockwise due to the rigidity of the traction wire 7. Furthermore, by rotating the overall position of the device, bending and opening at multiple angles can be achieved, adapting to various operating conditions.

[0046] Regarding the technical solution of this embodiment, the catheter 2 is a composite tube made of polytetrafluoroethylene (PTFE) and stainless steel wire mesh. PTFE gives the catheter 2 flexibility, allowing it to easily pass through complex blood vessels in the human body; the stainless steel wire mesh provides the necessary support to prevent the catheter 2 from deforming or breaking under stress, thus balancing flexibility and mechanical strength. In addition, PTFE has good insulation properties, which can reduce radio frequency signal leakage and interference; the stainless steel wire mesh can block external electromagnetic interference, ensuring the connection stability of the first monitor, the second monitor, the ablation electrode 51, and the nerve excitability electrode, thereby improving the ablation effect and monitoring accuracy.

[0047] In this embodiment, both the control handle 1 and the adjustment handle 4 are made of polytetrafluoroethylene (PTFE), and the adjustment handle 4 is rotatably connected to the control handle 1 via a pin. The pin connection structure is simple and reliable, easy to maintain, and combined with the corrosion-resistant properties of PTFE, it reduces the risk of failure and ensures long-term stable operation of the equipment.

[0048] The principle and process of using this invention: When renal artery ablation is required, catheter 2 is first inserted into the operating site via control handle 1. Then, adjustment handle 4 is rotated clockwise to move traction wire 7 closer to the first connector 52, thereby moving the ablation electrode 51 on the curved section 3 and bending the curved section 3 to fit against the renal artery, so that the ablation electrode 51 is flat against the renal artery wall. Then, radiofrequency energy is output through the first monitor 54, and the renal artery sympathetic nerve can be ablated using the ablation electrode 51. At the same time, the target point is electrically stimulated by the nerve excitability stimulation electrode 61. By observing the changes in blood pressure after stimulation, the doctor is provided with real-time and intuitive feedback on the changes in nerve excitability, which helps to accurately judge the ablation effect and improve the flexibility and safety of the operation.

[0049] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article, or apparatus.

[0050] For those skilled in the art, the specific meaning of the above terms in this invention can be understood according to the specific circumstances. When an element is referred to as being "assembled on," "mounted on," "fixed to," or "set on" another element, it may be directly on the other element or there may be an intermediate element present. When an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be an intermediate element present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible embodiments.

[0051] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

[0052] In the description of this specification, references to terms such as "an embodiment," "example," "specific example," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of this disclosure. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

Claims

1. A system for measuring nerve excitability during radiofrequency ablation of the renal sympathetic nerve, characterized in that: include: A control handle (1) is provided, with a conduit (2) connected to the end of the control handle (1) and a curved section (3) connected to the free end of the conduit (2). An adjustment handle (4) is rotatably connected to the top of the control handle (1). Ablation monitoring unit (5), which is connected to the end of control handle (1) via a cable, is used to monitor and control the ablation temperature; A neural excitability monitoring unit (6) is connected to the bottom of a control handle (1) via a cable and is used to monitor neural excitability.

2. The radiofrequency ablation system for renal sympathectomy and the system for measuring nerve excitability according to claim 1, characterized in that: The ablation monitoring unit (5) includes an ablation electrode (51), a first connector (52), a second connector (53), and a first monitor (54); The ablation electrode (51) is set on the curved section (3). The ablation electrode (51) passes through the conduit (2) and the control handle (1) in sequence via the first electrode wire (55) and is connected to the first connector (52). The first connector (52) is connected to the first monitor (54) via the cable and the second connector (53). The ablation electrode (51) has a temperature sensor (56) bonded inside with medical adhesive. The temperature sensor (56) is connected to the first connector (52) by passing through the conduit (2) and the control handle (1) in sequence via a sensor wire, and is used to provide real-time temperature feedback to the first monitor (54).

3. The radiofrequency ablation system for renal sympathectomy and the system for measuring nerve excitability according to claim 2, characterized in that: The neural excitability monitoring unit (6) includes a neural excitability stimulation electrode (61), a third connector (62), a fourth connector (63), and a second monitor (64); The number of the nerve excitability stimulation electrodes (61) is two, and both nerve excitability stimulation electrodes (61) are set on the curved section (3). The nerve excitability stimulation electrodes (61) are connected to the third connector (62) in sequence through the conduit (2) and the control handle (1) via the second electrode wire (65). The third connector (62) is connected to the second monitor (64) via the cable and the fourth connector (63) to realize the monitoring of renal sympathetic nerve excitability.

4. The radiofrequency ablation sympathectomy and nerve excitability measurement system according to claim 3, characterized in that: The curved section (3) is made of a soft medical polymer material.

5. The radiofrequency ablation sympathectomy and nerve excitability measurement system according to claim 4, characterized in that: The adjustment handle (4) is connected to a traction wire (7), which is connected to the free end of the curved section (3) to adjust the curvature of the curved section (3) so that the ablation electrode (51) and the nerve excitatory stimulation electrode (61) are flat against the renal artery wall.

6. The radiofrequency ablation system for renal sympathectomy and the system for measuring nerve excitability according to claim 4, characterized in that: The temperature sensor (56) is configured as a thermistor or a thermocouple.

7. The radiofrequency ablation system for renal sympathectomy and the system for measuring nerve excitability according to claim 5, characterized in that: Both the nerve excitatory stimulation electrode (61) and the ablation electrode (51) are bonded to the bending section (3) with medical adhesive.

8. The radiofrequency ablation system for renal sympathectomy and the system for measuring nerve excitability according to claim 7, characterized in that: The traction wire (7) is made of stainless steel or nickel-titanium material.

9. The radiofrequency ablation system for renal sympathectomy and the system for measuring nerve excitability according to claim 8, characterized in that: The conduit (2) is a composite tube made of polytetrafluoroethylene tube and stainless steel wire mesh.

10. The radiofrequency ablation system for renal sympathectomy and the system for measuring nerve excitability according to claim 9, characterized in that: Both the control handle (1) and the adjustment handle (4) are made of polytetrafluoroethylene, and the adjustment handle (4) is rotatably connected to the control handle (1) by a pin.

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