CN114767263A - Renal artery ablation system - Google Patents

Abstract

The invention relates to the field of medical instruments, in particular to a renal artery ablation system. The invention provides a renal artery ablation system, which comprises an ablation device and a voltage pulse device, wherein the ablation device comprises a near-end handle, a far-end ablation electrode and a catheter connected to the handle, the voltage pulse device is electrically connected with the ablation electrode through the handle, the ablation electrode is a plurality of pairs of electrode rings arranged on a thin tube capable of being controlled to bend through the handle, the thin tube penetrates through the catheter, the plurality of pairs of electrode rings are distributed on the thin tube from the front end part to the back along the length direction of the thin tube, each pair of electrode rings comprises an adjacent positive electrode ring and an adjacent negative electrode ring, and the renal artery ablation system further comprises an electrical stimulation recorder, an electrophysiological recorder and an electrophysiological stimulator. The invention can enter a thinner renal artery branch, perform accurate positioning and electrical stimulation ablation, and can evaluate an ablation result in real time.

Description

Renal artery ablation system

Technical Field

The invention relates to the field of medical instruments, in particular to a renal artery ablation system.

Background

The autonomic innervation on the wall of the renal artery blood vessel (including in and around the blood vessel and adventitia) has great significance in ascertaining the distribution and classification of the nerves in and around the blood vessel wall, because the nerves in and around the wall of the renal artery blood vessel are autonomic nerves capable of causing the physiological reaction of the whole body of the human body, the sites of the nerves in and around the blood vessel wall can be accurately positioned by applying energy to the nerves, and the autonomic nerve distribution around the local sites can be reflected by monitoring the physiological parameters related to the autonomic nervous system, such as blood pressure and heart rate activity change. Sympathetic and parasympathetic nerves in the autonomic nervous system typically produce opposite effects in the human body, such as effects on blood pressure and heart rate.

The renal artery sympathetic nerves are divided into renal artery sympathetic afferent nerves and efferent nerves, which play an extremely critical role in the development and progression of refractory hypertension, both of which are densely distributed in the renal artery adventitia in a net shape. Percutaneous catheter renal sympathetic nerve radio frequency ablation (RDN) technology for treating refractory hypertension by cutting off renal sympathetic nerves through radio frequency ablation. The Chinese medicinal composition has obvious curative effect in the treatment of intractable hypertension. The existing RDN (remote desktop network) technology has the defects that 1, an ablation target point cannot be accurately determined; 2. evaluating ablation effectiveness immediately after no definite ablation; 3. the ablation site is limited to the main renal artery and is difficult to reach the second-level renal artery and the third-level renal artery; 4. radiofrequency current, with the risk of causing renal artery thrombosis, spasm, perforation. Currently, most of the clinical meidonglity spinal multi-pole catheters and other commercially available multi-pole catheters are designed for renal artery trunk ablation, and have the defects of large outer diameter and unsuitability for smaller renal artery branches.

Disclosure of Invention

The invention provides a renal artery ablation system, which can smoothly enter a thinner renal artery branch from a renal artery trunk, can perform accurate positioning and then perform electrical stimulation ablation, and can also evaluate an ablation result in time after ablation, aiming at the problems that the existing minimally invasive ablation for cutting off renal sympathetic nerves has poor positioning accuracy of an ablation target point, can not evaluate an ablation curative effect immediately, is difficult to reach the thinner renal artery branch, and radio frequency current ablation causes renal artery thrombosis, spasm, perforation risk and the like; the electric stimulation is used for treating by using an electric field formed by high-voltage electric pulses, and no pressure requirement is imposed on the electrode; the electric field therapy is non-thermal tissue ablation, the tissue bracket structure cannot be damaged, the blood flow heat sink effect cannot be influenced, local thrombus cannot be ablated, vasospasm cannot be induced, and the electric field therapy has the specificity of resistance ablation of blood vessels and nerve tissues.

The technical scheme adopted by the invention for solving the technical problem is as follows: the utility model provides a renal artery ablation system, includes ablation device and voltage pulse device, ablation device includes the ablation electrode of near-end handle, distal end and connects the pipe on the handle, and the handle is connected to the pipe near-end, and ablation electrode locates the distal end inboard and the mobile pipe that stretches out or retracts of pipe, establishes the actuating mechanism that can drive the crooked and promotion ablation electrode activity of pipe distal end on the handle, and voltage pulse device passes through the handle and is connected with ablation electrode electricity, characterized by ablation electrode is many pairs of electrode ring that sets up on the tubule of an accessible handle accuse bend, the tubule is worn to locate in the pipe, many pairs of electrode ring distribute from its length direction of tip backward on the tubule, and every pair electrode ring includes adjacent an anodal electrode ring and a negative pole electrode ring, anodal electrode ring and negative pole electrode ring set up from the tip backward along its length direction in turn on the tubule, the renal artery ablation system further comprises an electrical stimulation mapping recorder, an electrophysiological recorder and an electrophysiological stimulator, wherein the output of the electrical stimulation mapping recorder is connected with the electrophysiological recorder, the electrophysiological recorder is in bidirectional transmission connection with the electrophysiological stimulator, the output of the electrophysiological stimulator is connected with a handle and is electrically connected with the ablation electrode through the handle, and the handle can be switched to connect with a voltage pulse device or the electrophysiological stimulator. The ablation electrode used in the invention is a bendable single thin tube which can stretch and move relative to the far end of the catheter, because the thin tube is a single tube, the thin tube and the catheter sleeved outside the thin tube can be made into a thinner size, so that the thin renal artery branches can be smoothly entered from the main renal artery, the head end of the catheter can enter the primary, secondary and tertiary lumens of the renal artery, then the thin tube extends out of the catheter, a plurality of pairs of electrodes arranged on the thin tube carry out discharge ablation, each pair of electrode rings comprises an anode electrode ring and a cathode electrode ring, the energy stimulating renal nerves is limited between the anode and the cathode of each pair of electrodes, the corresponding ablation points are limited between the anode and the cathode of each pair of electrodes, the ablation points corresponding to each pair of electrodes are discontinuous, no heat is generated, the nearby tissue structure can not be damaged, and the risks of over ablation and thrombus, spasm and stenosis of the renal artery vessel are avoided; the voltage pulse device is used for providing high-voltage electric pulses for each pair of electrodes on the ablation electrode, the electric field formed by the discharge of the high-voltage electric pulses is used for influencing and covering peripheral tissues, no pressure requirement exists for the sticking of the ablation electrode and the renal artery, the electric field treatment is non-thermal tissue ablation, the tissue stent structure cannot be damaged, the influence of the heat sink effect of blood flow cannot be caused, ablation local thrombus and induced vasospasm cannot be generated, and the resistance ablation device has the specificity of blood vessel and nerve tissue ablation. The handle can switch to select to connect voltage pulse device or electrophysiological stimulation appearance electrically in the work, melt before at every turn and all use the accurate demarcation of electrostimulation to melt the target spot and then melt, the electrophysiological stimulation appearance is connected earlier to the during operation handle, come accurate positioning out through the electro photoluminescence and wait the target spot that melts, it is specifically accurate positioning and discernment blood vessel wall in or adventitia epicondyle, then switch to the voltage pulse device of electricity connection from electrophysiological stimulation appearance, it melts to do the discharge, switch back the electric connection electrophysiological stimulation appearance again after melting, the result ability is melted in the immediate evaluation. The electrophysiology recorder sends the signal of mapping usefulness for the electrophysiology stimulator through the electrophysiology recorder, the electrophysiology stimulator sends the signal of telecommunication of mapping usefulness for melting electrode, do the electro photoluminescence through the electrode pair on melting electrode, the accurate mapping needs the position of high-voltage electric pulse treatment, the feedback signal that gathers after the electrode that melts carries out the electro photoluminescence simultaneously also can be transmitted back to the electrophysiology recorder through the electrophysiology stimulator, the electrophysiology recorder here can adopt common electrocardiograph recorder, the doctor judges the accurate position of location waiting to melt through observing the demonstration condition on the electrophysiology recorder, wherein electro photoluminescence mapping recorder and electrophysiology stimulator are prior art. In addition, after the position is mapped and positioned during ablation, the catheter is slightly rotated by an angle, the voltage pulse device is continuously used for providing high-voltage electric pulses for continuous ablation, an X-ray machine is not required to be started in the process, the adverse effect of X-rays on patients and doctors is reduced, the ablation time can be further shortened and the use of X-rays is reduced in the continuous ablation, the ablation curative effect is better, and the catheter is rotated by operating the handle in the process. Research shows that because sympathetic excitable nerves with obvious rising reaction of renal artery electrical stimulation blood pressure are dominant, ablation of the sites is theoretically more beneficial to blood pressure reduction, and the parasympathetic nerves of the sites without rising reaction of renal artery electrical stimulation blood pressure are higher in proportion and should be avoided or forbidden in the ablation process, so that stimulation of the renal artery nerves can help to identify the autonomic nerve distribution characteristics of the renal artery nerves, help to select ablation sites of the renal artery, and improve the blood pressure reduction effect of subsequent renal artery ablation.

As a further improvement and supplement to the above technical solution, the present invention adopts the following technical measures: the spacing distance between two adjacent pairs of electrode rings on the thin tube is 2-3 mm. The adjacent interval of each pair of electrode rings is 2-3 mm, so that the optimal electric field ablation effect can be achieved. In addition, the adjacent intervals of the positive electrode ring and the negative electrode ring of each pair of electrodes can also be set to be the same interval distance, so that the processing is convenient.

The catheter is a 4F catheter or a 5F catheter. Catheters are used which are clinically marked as 4F or 5F grade thick and thin in outer diameter so as to be capable of extending into the renal artery and its branches for ablation treatment, wherein 1F =0.33mm, and the size of the outer diameter of the catheter is conventionally denoted as F in the prior art of interventional therapy.

The thin tube is in transmission connection with the handle, and the thin tube can perform superimposed spiral motion of rotating around the axis of the catheter and translating along the axis of the catheter. The tubule all realizes the flexible displacement of relative pipe through helical motion at every turn, and the ablation electrode of locating on the tubule also does synchronous helical motion thereupon, and this helical motion is the handle and controls the stack that the tubule rotated around the pipe axis and followed two kinds of activities of pipe axial translation, and the tubule can be through the ablation target point of this kind of helical motion accurate positioning renal artery, fully melts the renal artery, promotes and melts the effect.

The voltage pulse device comprises a voltage pulse generator, a driving plate, a high-voltage power supply, an IGBT module and a high-voltage capacitor, wherein the output of the voltage pulse generator is connected with the driving plate and the high-voltage power supply, the output of the high-voltage power supply is connected with the high-voltage capacitor, the output of the high-voltage capacitor and the output of the driving plate are both connected with the IGBT module, and the output of the IGBT module is connected with a handle and is electrically connected with the ablation electrode through the handle.

The invention provides a renal artery ablation system, which can smoothly enter thinner renal artery branches from a renal artery trunk, can perform accurate ablation treatment by accurately positioning through electrical stimulation, and can evaluate an ablation result immediately after ablation; the electrical stimulation uses an electric field formed by high-voltage electric pulses for treatment, and has no pressure requirement on electrode attachment.

Drawings

FIG. 1: the invention is a system block diagram.

FIG. 2: the invention is a handle schematic diagram.

FIG. 3: the invention has the operation steps as shown.

FIG. 4 is a schematic view of: the invention also discloses a working flow chart.

FIG. 5 is a schematic view of: the invention discloses a schematic diagram of an ablation electrode extending out of an electrode catheter.

FIG. 6: the ablation electrode of the invention enters the renal artery branch schematic diagram from the renal artery trunk.

In the figure: 1. the device comprises a catheter, a handle, a ablation electrode, an electrode ring, a positive electrode ring, a negative electrode ring, a tubule, a voltage pulse generator, a driving plate, a high-voltage power supply, an IGBT module, a high-voltage capacitor, a renal artery and a renal artery branch, wherein the electrode ring comprises 31, 311, the positive electrode ring, 312, the negative electrode ring, 4, the tubule, 5, the voltage stimulation and mapping recorder, 6, the electrophysiological recorder, 7, the electrophysiological stimulator, 8, the voltage pulse generator, 9, the driving plate, 10, the high-voltage power supply, 11, the IGBT module, 12, the high-voltage capacitor, 13, the renal artery and 14.

Detailed Description

The invention is further described with reference to the following description and embodiments in conjunction with the accompanying drawings.

As shown in fig. 1 to 5, a renal artery ablation system comprises an ablation device and a voltage pulse device, wherein the ablation device comprises a near-end handle 2, a far-end ablation electrode 3 and acatheter 1 connected to the handle 2, the near-end of thecatheter 1 is connected to the handle 2, theablation electrode 3 is arranged on the inner side of the far-end of thecatheter 1 and can movably extend out of or retract into thecatheter 1, thecatheter 1 uses 4F or 5F, thecatheter 1 is preferably 4F in the embodiment, a driving mechanism capable of driving the far-end of thecatheter 1 to bend and pushing theablation electrode 3 to move in a telescopic manner is arranged on the handle 2, the voltage pulse device is electrically connected with theablation electrode 3 through the handle 2, theablation electrode 3 is a plurality of pairs ofelectrode rings 31 arranged on a tubule which can be controlled to bend through the handle 2, thetubule 4 is arranged in thecatheter 1 in a penetrating manner, thetubule 4 is in transmission connection with the handle 2 and can rotate around the axis of thecatheter 1 and can be superimposed with the axial translation along the axis of thecatheter 1, the multiple pairs ofelectrode rings 31 are distributed on the tubule from the front end part to the back along the length direction thereof, each pair ofelectrode rings 31 comprises an adjacentpositive electrode ring 311 and an adjacentnegative electrode ring 312, in this embodiment, thepositive electrode rings 311 and thenegative electrode rings 312 are alternately arranged on the tubule from the front end part to the back along the length direction thereof, and the spacing distance between the two adjacent pairs ofelectrode rings 31 is 2-3 mm; the renal artery ablation system further comprises an electricalstimulation mapping recorder 5, an electrophysiological recorder 6 and an electrophysiological stimulator 7, wherein the output of the electricalstimulation mapping recorder 5 is connected with the electrophysiological recorder 6, the electrophysiological recorder 6 is in bidirectional transmission connection with the electrophysiological stimulator 7, the output of the electrophysiological stimulator 7 is connected with the handle 2 and is electrically connected with theablation electrode 3 through the handle 2, and the handle 2 can be switched and connected with a voltage pulse device or the electrophysiological stimulator 7; the voltage pulse device comprises a voltage pulse generator 8, adriving plate 9, a high-voltage power supply 10, anIGBT module 11 and a high-voltage capacitor, the voltage pulse generator 8 is connected with thedriving plate 9 and the high-voltage power supply 10 in an output mode, the high-voltage power supply 10 is connected with the high-voltage capacitor in an output mode, the high-voltage capacitor and thedriving plate 9 are both connected with theIGBT module 11 in an output mode, and theIGBT module 11 is connected with the handle 2 in an output mode and is electrically connected with theablation electrode 3 through the handle 2.

When the device works, as shown in figure 3, the device is used in the preparation working stage, similar to the conventional interventional operation, a sheath is implanted in the peripheral artery puncture of a patient, a guide wire is pushed to the renal artery opening along the guide wire, then the catheter is actively bent to push the catheter to a thinner 3-4-level renal artery branch as shown in figure 6, an ablation electrode and an electrophysiological stimulator are electrically connected through an operating handle, the ablation target is precisely calibrated by electrical stimulation and then ablated, the handle is in a state of being connected with the electrophysiological stimulator when the ablation target is calibrated, the target to be ablated is precisely positioned by electrical stimulation, the nerve plexus in the vessel wall or on the adventitia is precisely positioned and identified, after the ablation target is calibrated, the ablation electrode is switched to an electrical connection voltage pulse device from the electrical connection electrophysiological stimulator to perform discharge ablation, the electrical connection electrophysiological stimulator is switched back after each discharge ablation, and (6) evaluating the ablation result in real time. In the ablation process, when the ablation result is evaluated to be not expected, judging that the current ablation target point is not right, returning to the step of transmitting an electrical stimulation signal to an ablation electrode of the target position to reposition the target point; and when the range of the ablation result is evaluated to be expected, the new ablation target point is calibrated by electrical stimulation, namely other new ablation areas are searched, the next target is selected, otherwise, the new ablation target point is not required to be calibrated, namely, the ablation is finished when the new ablation target point is not calibrated, and the catheter is taken out of the body of the patient. The double-headed arrows in fig. 3 are used to indicate positive and negative feedback regulation. As shown in fig. 5, the ablation electrode can move relative to the catheter in a telescopic way along with the spiral movement of the thin tube, and smoothly enters the thinner renal artery branch from the main renal artery. In the continuous ablation process after the ablation target point is calibrated, the ablation electrode can be continuously switched to connect the voltage pulse device and the electrophysiological stimulation instrument so as to record electrophysiological data while ablating, and instantly judge the ablation effect.

Claims (5)

1. The utility model provides a renal artery ablation system, includes ablation device and voltage pulse device, ablation device includes near-end handle (2), distal end ablation electrode (3) and connects pipe (1) on handle (2), and handle (2) are connected to pipe (1) near-end, and ablation electrode (3) are located the distal end inboard of pipe (1) and mobile pipe (1) of stretching out or retracting, establish the actuating mechanism that can drive pipe (1) distal end bending and promote ablation electrode (3) concertina movement on handle (2), and voltage pulse device passes through handle (2) and is connected with ablation electrode (3) electricity, characterized by ablation electrode (3) are many pairs of electrode ring (31) that set up on the curved tubule of an accessible handle (2) accuse, tubule (4) are worn to locate in pipe (1), many pairs of electrode ring (31) distribute along its length direction backward from the front end on the tubule, each pair of electrode rings (31) comprises a positive electrode ring (311) and a negative electrode ring (312) which are adjacent to each other, the positive electrode rings (311) and the negative electrode rings (312) are alternately arranged on the tubule from the front end part to the back along the length direction of the tubule, the renal artery ablation system further comprises an electrical stimulation mapping recorder (5), an electrophysiological recorder (6) and an electrophysiological stimulator (7), the output of the electrical stimulation mapping recorder (5) is connected with the electrophysiological recorder (6), the electrophysiological recorder (6) is in bidirectional transmission connection with the electrophysiological stimulator (7), the output of the electrophysiological stimulator (7) is connected with the handle (2) and is electrically connected with the ablation electrode (3) through the handle (2), and the handle (2) can be connected with a voltage pulse device or the electrophysiological stimulator (7) in a switching mode.

2. The renal artery ablation system according to claim 1, wherein the spacing distance between two adjacent pairs of electrode rings (31) on the tubules is 2-3 mm.

3. The renal artery ablation system according to claim 1, wherein the catheter (1) is a 4F catheter or a 5F catheter.

4. The renal artery ablation system according to claim 1, wherein the tubule (4) is drivingly connected to the handle (2) and the tubule (4) is capable of a superimposed helical movement of rotation about the axis of the catheter (1) and translation along the axis of the catheter (1).

5. The renal artery ablation system according to any one of claims 1 to 4, wherein the voltage pulse device comprises a voltage pulse generator (8), a driving plate (9), a high-voltage power supply (10), an IGBT module (11) and a high-voltage capacitor (12), the output of the voltage pulse generator (8) is connected with the driving plate (9) and the high-voltage power supply (10), the output of the high-voltage power supply (10) is connected with the high-voltage capacitor (12), the output of each of the high-voltage capacitor (12) and the driving plate (9) is connected with the IGBT module (11), and the output of the IGBT module (11) is connected with the handle (2) and electrically connected with the ablation electrode (3) through the handle (2).

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