CN115444541A - Sympathetic nerve ablation catheter and system - Google Patents

Sympathetic nerve ablation catheter and system Download PDF

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Publication number
CN115444541A
CN115444541A CN202211295348.9A CN202211295348A CN115444541A CN 115444541 A CN115444541 A CN 115444541A CN 202211295348 A CN202211295348 A CN 202211295348A CN 115444541 A CN115444541 A CN 115444541A
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China
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ablation
balloon
catheter
tube
ablation catheter
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CN202211295348.9A
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Chinese (zh)
Inventor
周波
颜志平
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Zhongshan Hospital Fudan University
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Zhongshan Hospital Fudan University
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Priority to CN202211295348.9A priority Critical patent/CN115444541A/en
Publication of CN115444541A publication Critical patent/CN115444541A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053Mechanical features of the instrument of device
    • A61B2018/00214Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/0022Balloons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345Vascular system
    • A61B2018/00404Blood vessels other than those in or around the heart
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00434Neural system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00529Liver
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577Ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00696Controlled or regulated parameters
    • A61B2018/00714Temperature
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • A61B2018/00791Temperature
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0212Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques using an instrument inserted into a body lumen, e.g. catheter

Abstract

The application discloses a sympathetic nerve ablation catheter and a sympathetic nerve ablation system, the ablation catheter comprises a handle, a balloon, a catheter connected between the handle and the balloon and a plurality of ablation units arranged on the balloon, the ablation units are distributed along the circumferential direction of the balloon, each ablation unit comprises a flexible circuit connected with the balloon and an ablation electrode arranged on the flexible circuit, and the ablation electrode is exposed out of the outer wall surface of the balloon to be in contact with an ablation part; the pipe include the outer tube and nest in inner tube in the outer tube, be equipped with the inlet channel of coolant liquid between inner tube and the outer tube, inlet channel with the sacculus is linked together for the coolant liquid can inject into to melt the position cooling to in the sacculus, avoid organizing the carbonization and form the thrombus, make simultaneously through the deformation of sacculus melt the electrode and can paste with melting the position all-round and lean on, can adapt to blood vessel size better, avoid local production incomplete ablation.

Description

Sympathetic nerve ablation catheter and system
Technical Field
The application relates to the technical field of medical instruments, in particular to a sympathetic nerve ablation catheter and a sympathetic nerve ablation system.
Background
With the development of society and the improvement of living standard, the incidence rate of diabetes is higher and the onset age is lower, and the diabetes becomes one of serious diseases harmful to human health. Among them, type 2 diabetes belongs to a chronic progressive metabolic disease characterized by excessive glucose production and elevated blood glucose levels.
Studies have shown that the liver, which regulates and produces glucose, may be a key factor in the development and progression of type 2 diabetes, and in particular may be the result of sympathetic hyperactivity. Therefore, the sympathetic nerves are removed through the ablation instrument, the output of the liver to glucose can be reduced, and then the blood glucose concentration is controlled, so that the purpose of treating type 2 diabetes is achieved. However, ablation instruments on the market are designed for renal artery ablation, and most of the existing products adopt an electrode or catheter form, adopt a self-expansion mode of a built-in nickel-titanium wire or a woven basket, enter a blood vessel, and have poor attaching effect. Based on histological studies, most of the sympathetic nerves are discretely distributed at 0.5-6mm from the intima of the artery. If no good electrode is attached, the ablation region can not be guaranteed to reach the depth meeting the sympathetic nerve ablation region, so that the nerve ablation can not be effectively carried out, and the risk that the part can not be completely ablated or excessively ablated exists.
Disclosure of Invention
In view of this, the present application provides a sympathetic denervation ablation catheter and a sympathetic denervation ablation system, which can form a good adhesion with the common hepatic artery blood vessel to ensure an ablation effect.
In one aspect, the application provides a sympathetic nerve ablation catheter, which comprises a handle, a balloon, a catheter connected between the handle and the balloon, and a plurality of ablation units arranged on the balloon, wherein the ablation units are arranged along the circumferential direction of the balloon, each ablation unit comprises a flexible circuit connected with the balloon and an ablation electrode arranged on the flexible circuit, and the ablation electrode exposes out of the outer wall surface of the balloon to be in contact with an ablation part; the pipe include the outer tube with nest in inner tube in the outer tube, be equipped with the feed channel of coolant liquid between inner tube and the outer tube, feed channel with the sacculus is linked together for the coolant liquid can inject into to melt the position cooling in the sacculus.
In another aspect, the present application provides a sympathetic nerve ablation system, which comprises an ablation instrument, a cooling device and the sympathetic nerve ablation catheter, wherein the ablation instrument is electrically connected with the ablation unit, and the cooling device is butted with the liquid inlet channel.
The sympathetic nerve ablation removing catheter and the sympathetic nerve ablation removing system enable the ablation electrode to be attached to an ablation part in an all-around mode through deformation of the balloon, the size of a blood vessel can be better adapted, and incomplete ablation is avoided being generated locally; meanwhile, cooling liquid is injected to cool the ablation part in the ablation process, so that the tissue is prevented from carbonizing to form thrombus to form secondary damage to an operation object, the ablation effect is comprehensively improved, and the method is particularly suitable for sympathetic nerve ablation of hepatic common artery blood vessels and the like.
Drawings
In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings needed to be used in the description of the embodiments or the prior art will be briefly introduced below, and it is obvious that the drawings in the following description are some embodiments of the present application, and for those skilled in the art, other drawings can be obtained according to these drawings without inventive exercise.
FIG. 1 is a block diagram of a sympatholytic ablation system according to an embodiment of the present application.
Fig. 2 is a schematic view of a parasympathetic ablation catheter of an embodiment of the present application.
Fig. 3 is an enlarged view of a portion of the ablation catheter shown in fig. 2.
Fig. 4 is a cross-sectional view of fig. 3.
Fig. 5 is a plan view of an ablation unit of the ablation catheter of fig. 2.
Fig. 6 is a schematic view of the ablation catheter of fig. 2 in use.
Fig. 7 is a temperature profile of the ablation site of the ablation catheter of fig. 2 in use, without the cooling fluid.
Fig. 8 is a temperature profile of an ablation site of the ablation catheter of fig. 2 in use with a cooling fluid.
Fig. 9 is a schematic structural view of an ablation catheter in accordance with a second embodiment of the present application.
Fig. 10 is a schematic view of the internal structure of the ablation catheter shown in fig. 9.
Fig. 11 is a schematic structural view of an ablation catheter in accordance with a third embodiment of the present application.
Fig. 12 is a schematic view of the internal structure of the ablation catheter of fig. 11.
Fig. 13 is a schematic view of an access tube of the ablation catheter of fig. 11.
Fig. 14 is a schematic structural view of an ablation catheter according to a fourth embodiment of the present application.
Fig. 15 is a schematic structural view of an ablation catheter according to a fifth embodiment of the present application.
Fig. 16 is a schematic structural view of an ablation catheter according to a sixth embodiment of the present application.
Fig. 17 is a schematic structural view of an ablation catheter according to a seventh embodiment of the present application.
Fig. 18 is a schematic view of the ablation catheter of fig. 17 in use.
Fig. 19 is a schematic view of a branch ablation catheter of the ablation catheter of fig. 17.
Fig. 20 is an exploded view of the branch ablation catheter of fig. 19.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are some embodiments of the present application, but not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.
The first embodiment is as follows:
the application provides a remove sympathetic nerve and melt pipe and system, preferentially be applied to the sympathetic nerve of hepatic artery and melt, reduce the output of liver to glucose, and then reach the purpose of treatment type 2 diabetes.
Fig. 1 illustrates an exemplary embodiment of a sympatholytic ablation system 200 (hereinafter referred to as an ablation system) of the present application, the ablation system 200 including a sympatholytic ablation catheter 100 (hereinafter referred to as an ablation catheter), an ablation instrument 120, a cooling device 140, and the like. In operation of the ablation system 200, as shown in fig. 6, the ablation catheter 100 is inserted into a blood vessel at a location where sympathetic nerve ablation is desired, with the ablation elements 40 in close proximity to the vessel wall; the ablator 120, preferably a radio frequency ablator, provides a radio frequency current to the ablation unit 40 causing sympathetic nerves on the vessel wall to necrotize under the effect of the biological thermal effect; the cooling device 140 is used for injecting cooling liquid, such as water, normal saline, dextran, glucose and the like, into the ablation catheter 100, so as to cool the contact surface of the ablation unit 40 and the vessel wall, reduce or even avoid tissue carbonization, avoid thrombus, and improve the safety of sympathetic nerve ablation.
As shown in fig. 2, in a particular embodiment, the ablation catheter 100 includes a handle 10, a catheter 20, a balloon 30, and an ablation unit 40. The catheter 20 is an elongated tube, the handle 10 is connected to a proximal end (i.e., an end close to the operator) of the catheter 20, the balloon 30 is disposed at a distal end (i.e., an end close to the operator) of the catheter 20, and the ablation unit 40 is disposed on an outer wall surface of the balloon 30. As shown in fig. 4, the catheter 20 is a double-layered structure including an outer tube 22 and an inner tube 24 nested in the outer tube 22. A first channel 25 is formed in the inner tube 24 and can be used as a working channel for a medical guide wire; the outer tube 22 has an inner diameter slightly larger than the outer diameter of the inner tube 24 and is spaced radially apart to form a second passage 23 which serves as a coolant delivery passage. Preferably, the outer tube 22 includes an outer tube inner layer 22a and an outer tube outer layer 22b, which are spaced apart from each other, and a third channel 21 is formed between the outer tube inner layer 22a and the outer tube outer layer 22b, which can be used as an electrical connection channel for the ablation unit 40.
Referring to fig. 3 and 4, balloon 30 is preferably made of an elastic material such as silicone, natural rubber, PU, PEBAX, PA, etc., which can expand or contract as desired. For example, during insertion of the balloon 30 into the portion of the blood vessel to be ablated, the balloon 30 may be slightly deflated to have an outer diameter slightly smaller than the inner diameter of the blood vessel, such that the balloon 30 may be moved smoothly within the blood vessel to adjust the position thereof to align with the portion to be ablated; after the balloon 30 is aligned with the site to be ablated, the balloon 30 can be slightly inflated to an outer diameter slightly larger than the inner diameter of the blood vessel, so that the ablation unit 40 on the balloon 30 can be tightly attached to the blood vessel wall, and the ablation operation effect is ensured. The ablation catheter 100 of the present application utilizes the elasticity of the balloon 30 itself, so that the balloon can have different outer diameters in different procedures of the ablation operation, and can be smoothly inserted into the portion to be ablated and tightly attached to the portion to be ablated.
In addition, the diameters of the blood vessels at different positions of the ablation object are different, and the diameters of the blood vessels at the same positions of the different ablation objects also have certain difference, so that the ablation catheter 100 can effectively compensate the difference of the diameters of the blood vessels by using the elasticity of the balloon 30, and the ablation catheter 100 and the ablation system 200 can be suitable for different blood vessels of different operation objects and can achieve a tight attaching effect. For example, the common hepatic artery vessels are larger in diameter than the renal artery vessels. When a catheter designed for renal artery vessel ablation in the prior art is applied to hepatic artery vessel ablation, the catheter cannot be attached to the whole blood vessel wall, so that partial ablation is incomplete and the expected treatment effect cannot be achieved; the ablation catheter 100 of the present application can be perfectly applied to the ablation operation of the common hepatic artery blood vessel by the inflation of the balloon 30 thereof.
The balloon 30 is of a cylindrical structure with two open ends as a whole, the ablation units 40 are preferably arranged along the circumferential direction of the outer wall surface of the balloon 30, and the ablation units 40 form an annular ablation zone as a whole, so that sympathetic nerves at all positions on the circumferential direction of the vessel wall attached with the ablation units can be ablated, and the occurrence of incomplete local ablation is further avoided. If 2-6 groups of ablation electrodes are arranged in parallel, spirally or alternatively arranged at a certain distance back and forth to form a single annular ablation band, or a plurality of single annular ablation bands are combined to form a multi-array annular ablation band, so that the ablation range is ensured to be enough to cover the whole vessel wall. Referring to fig. 5, each ablation unit 40 includes an ablation electrode 42, a temperature sensor 44, and a flexible circuit 46. The flexible circuit 46 is fixedly connected to the outer wall surface of the balloon 30 by means of heat melting, bonding and the like, and can generate corresponding deformation along with the expansion or contraction of the balloon 30, so that the stability and reliability of the connection of the ablation unit 40 are ensured. The ablation electrode 42 is a sheet-like structure, preferably made of conductive materials such as stainless steel, copper, platinum, gold, nickel-plated steel, magnesium, etc., and the conductive materials are plated with gold, gold-plating, etc., so that a pure copper, silver or gold layer is formed on the surface of the conductive materials, which can prevent the ablation electrode from adhering to tissues. Referring also to fig. 1, the flexible circuit 46 is attached to the ablation instrument 120 and electrically connected to the flexible circuit 46.
In the illustrated embodiment, the ablation electrodes 42 are distributed in a spiral shape along the circumferential direction of the balloon 30 and form at least two spiral turns, so that the contact between the ablation unit 40 and each position in the circumferential direction of the vessel wall can be effectively increased, and sympathetic nerves at each position of the vessel wall can be eliminated as much as possible. When the ablation electrode 42 is turned on, a large amount of heat is generated in the cell tissue in the vicinity thereof, so that sympathetic nerves are necrotized by high temperature. A temperature sensor 44 is located near the ablation electrode 42 to sense the temperature at the ablation site and feed back to the external programming system 160 via a circuit board in the handle. The program control system 160 controls the operation of the ablation instrument 120, the cooling device 140, etc. according to the temperature signal fed back by the temperature sensor 44, and provides a proper flow of cooling liquid to maintain the temperature of the ablation site within a proper range, for example, when the temperature of the ablation site is too high, the flow of the cooling liquid is increased and/or the output power of the ablation instrument 120 is reduced, so as to avoid carbonization of the tissue with too high temperature; when the temperature of the ablation part is too low, the flow of cooling liquid is reduced and/or the output power of the ablation instrument 120 is increased, so that incomplete ablation caused by too low temperature is avoided.
Fig. 7 is a graph showing the temperature profile of the ablation site of the ablation catheter 100 of the present embodiment in a use condition without injecting a cooling liquid; fig. 8 is a graph showing the temperature profile of an ablation site of the ablation catheter 100 of the present application in use with cooling fluid injection. As can be seen in fig. 7 and 8, the contact surface of the ablation site is at a temperature of about 80 ℃ in the presence of the cooling fluid; under the condition of no cooling liquid, the temperature is about 85 ℃, that is to say, the temperature of the contact surface is lower under the condition of cooling, thereby being beneficial to avoiding the carbonization of tissues and reducing the occurrence of thrombus. In addition, with cooling, the temperature inside the tissue at the ablation site is higher; moreover, compared with the situation without cooling, the tissue temperature is lost more quickly when cooling is performed, and in order to maintain the ablation temperature, the power output of the ablation instrument 120 is larger, the ablation range and depth are larger, and a better ablation effect can be generated.
In the illustrated embodiment, referring to fig. 3-5, the balloon 30 is provided with a plurality of through holes 32, the through holes 32 being disposed adjacent to the ablation electrodes 42, preferably with a 0.02-0.3mm diameter. The coolant flows into the balloon 30 through the second passage 23 between the inner tube 24 and the outer tube 22, and then flows out of the balloon 30 through the through holes 32 into the blood vessel. That is, in this embodiment, the second channel 23 serves as a liquid inlet channel for the cooling liquid, and the second through hole 32 of the balloon 30 serves as a liquid outlet channel for the cooling liquid. In the process that the cooling liquid flows through the balloon 30, the cooling liquid absorbs the heat of the ablation part to form a cooling effect on the contact surface of the ablation part; the cooling fluid then exits the balloon 30 into the blood circulation. In one embodiment, the cooling fluid may be a 0.9% sodium chloride solution.
In the illustrated embodiment, the distal end of the flexible circuit 46 is secured to the balloon 30 and the proximal end extends outwardly relative to the balloon 30 and along the third passageway 21 between the outer tube inner layer 22a and the outer tube outer layer 22b of the outer tube 22 toward the handle 10. The ablation electrode 42 is attached to the flexible circuit 46 and protrudes outwards relative to the outer wall surface of the balloon 30, so that when the balloon 30 is expanded to be attached to the wall of the blood vessel, the ablation electrode 42 sinks into the wall of the blood vessel, the contact tightness between the ablation electrode 42 and the wall of the blood vessel can be further increased, and the ablation effect is further improved.
In the illustrated embodiment, the balloon 30 has a proximal end defining a first constriction and a distal end defining a second constriction. The end of the first constriction is connected to the distal end of the outer tube 22, and specifically, the first constriction and the flexible circuit 46 are sandwiched between the outer tube inner layer 22a and the outer tube outer layer 22b of the outer tube 22 and connected to each other by heat fusion, adhesion, or the like. The end of the second constriction is sleeved on a tip 34, the tip 34 is preferably a polymer elastomer, made of silicone, natural rubber, PU, PEBAX, PA, etc., and connected to the second constriction of the balloon 30 by heat melting, bonding, etc. The inner tube 24 has a length greater than the length of the outer tube 22, and its distal end passes through the balloon 30 and is embedded in the tip 34, both preferably connected by heat staking, adhesive bonding, or the like. A puncture hole 35 is centrally provided in the tip 34, the puncture hole 35 communicating with the first passage 25 of the inner tube 24, so that the distal end of the guide wire can project outwardly through the puncture hole 35 of the tip 34 into the blood vessel.
The balloon 30 is provided with a developing ring 36 at its first and second constrictions. The first channel 25 of the inner tube 24 serves not only as a working channel for the medical guidewire but also as an injection channel for contrast media, which is injected to flow into the blood vessel through the through-hole 32 of the tip 34. By visualizing the state of ring 36, it can be determined whether balloon 30 is occluding the vessel. Specifically, after the balloon 30 is adjusted to a predetermined position in a blood vessel, the balloon 30 is inflated to be tightly attached to the blood vessel wall, the contrast agent is injected and the flow of the contrast agent is observed, if only the developing ring 36 at the distal end of the balloon 30 is developed, it indicates that the contrast agent flowing out of the balloon 30 does not flow back, the balloon 30 is tightly attached to the blood vessel wall to seal the blood vessel, and then the ablation operation can be started; on the contrary, if the developing ring 36 at the proximal end of the balloon 30 is developed, it indicates that the developer flows back to the catheter side after flowing out of the balloon 30, and the balloon 30 is not adhered to the vessel wall, and at this time, the balloon 30 should be continuously enlarged until it is adhered to the vessel wall.
In some embodiments, as shown in FIG. 4, the inner tube 24 is further provided with a position sensor 26 at its distal end, the position sensor 26 being affixed to the wall of the inner tube 24 by adhesive, heat shrink, heat staking, etc. and being embedded within the balloon 30. The wires of the position sensor 26 extend through the second channel 23 between the inner tube 24 and the outer tube 22 towards the handle 10, connecting with an external programming system 160. That is, the second passage 23 may serve not only as a liquid inlet passage for the coolant but also as a connection passage for the wire of the position sensor 26. The position sensor 26 cooperates with the navigator 70 to positionally guide the balloon 30 so that it is aligned with the site to be ablated when the ablation catheter 100 is inserted into the blood vessel. In one embodiment, the navigator 70 preferably employs a 3D electromagnetic navigator, which in use generates an electromagnetic field at the 3D magnetic navigation pad 72 to precisely position and navigate the position sensor 26 within the magnetic field so that the balloon 30 can be accurately guided to the site to be ablated.
The handle 10 is provided with a plurality of interfaces, such as a first interface 12, a second interface 14, a third interface 16, etc. in the illustrated embodiment, wherein the first interface 12 is in butt joint with the first channel 25 of the inner tube 24 for the penetration of the medical guide wire; the second port 14 interfaces with a second channel 23 between the inner tube 24 and the outer tube 22 for the injection of the cooling liquid; the third interface 16 is a cable interface for interfacing with the flexible circuit 46, the wires of the position sensor 26, etc. In some embodiments, the ablation system 200 further includes an electrophysiology monitor 180 for monitoring physiological parameters of the operation object during the ablation process, such as temperature, electrical impedance, etc., so that the operator can find and handle unexpected situations in the ablation operation process in time, and the safety of the ablation operation is further improved.
Example two:
fig. 9-10 illustrate a second embodiment of an ablation catheter 100 of the present application, which differs from the first embodiment primarily in the arrangement of the coolant channels. In this embodiment, a liquid inlet pipe 28 is disposed in the second channel 23 between the inner pipe 24 and the outer pipe 22, the liquid inlet pipe 28 is used as a liquid inlet channel for the cooling liquid, and the proximal end of the liquid inlet pipe is abutted to the handle 10, and the distal end of the liquid inlet pipe extends into the balloon 30. In this case, the part of the second channel 23 between the inner tube 24 and the outer tube 22 not occupied by the inlet tube 28 can be used as an outlet channel for the cooling liquid, and the balloon 30 can no longer be provided with through holes. In this manner, the cooling fluid is injected into the balloon 30 through the fluid inlet tube 28 and then exits the ablation catheter 100 through the portion of the second channel 23 not occupied by the fluid inlet tube 28, and the cooling fluid is pumped out of the ablation catheter 100 after flowing through the balloon 30 to cool the ablation site rather than into the blood circulation. Correspondingly, the handle 10 is provided with a liquid inlet interface and a liquid outlet interface which are respectively in butt joint with the liquid inlet channel and the liquid outlet channel.
Example three:
fig. 11-13 illustrate a third embodiment of the ablation catheter 100 of the present application, which differs from the second embodiment primarily by the fluid inlet tube 28. In this embodiment, the proximal end of the fluid inlet tube 28 is in abutment with the handle 10, and the distal end extends into the balloon 30 and is disposed helically around the distal end of the inner tube 24. A plurality of openings 29 are provided at intervals along the spiral direction of the liquid inlet pipe 28. Due to the spiral structure of the liquid inlet pipe 28, the directions of the openings 29 are different, so that cooling liquid can be sprayed out towards different positions of the balloon 30 through the openings 29, and a better cooling effect is formed on an ablation part. Preferably, each opening 29 is radially disposed corresponding to one of the ablation electrodes 42, so that the cooling liquid can be directly sprayed toward the position of the ablation electrode 42, and the cooling effect on the ablation part is further improved.
Example four:
fig. 14 shows a fourth embodiment of an ablation catheter 100 of the present application, which differs from the third embodiment mainly by the ablation unit 40. In this embodiment, the ablation electrodes 42 of the ablation unit 40 are comb-shaped structures, and the number of the ablation electrodes is 2 to 8, and the ablation electrodes are uniformly spaced along the circumferential direction of the balloon 30. Preferably, the temperature sensor 44 is integrated directly into the flexible circuit 46 by a printing process, maintaining overall compliance and maximizing electrode coverage and ensuring overall ablation of the vessel wall. The flexible circuit 46 is connected with the balloon 30 by means of hot melting, bonding and the like, and a press ring is designed at the far end of the balloon 30 to be sleeved with the flexible circuit 46 so as to prevent the flexible circuit from falling off.
Example five:
fig. 15 shows a fifth embodiment of the ablation catheter 100 of the present application, which differs from the first embodiment primarily by the balloon 30. In this embodiment, the balloon 30 has a double-layer structure including an inner balloon layer 30a and an outer balloon layer 30b. The flexible circuit 46 is sandwiched between the inner balloon layer 30a and the outer balloon layer 30 b; the ablation electrode 42 is exposed through the outer balloon layer 30b and can be directly abutted against the vessel wall; the temperature sensor 44 may be sandwiched between the inner balloon layer 30a and the outer balloon layer 30b or may be exposed as with the ablation electrode 42. By the double-layer design of the balloon 30, the ablation unit 40 can be better secured against falling off during use. In addition, the balloon 30 with a double-layer structure also has a better anti-explosion effect, so that damage in the expansion process is avoided, and the use safety is ensured.
Example six:
fig. 16 shows a sixth embodiment of the ablation catheter 100 of the present application, in which the balloon 30 has a double-layered structure including an inner balloon layer 30a and an outer balloon layer 30b, similar to the fifth embodiment. Except that the flexible circuit 46 and the temperature sensor 44 of the ablation unit 40 are sandwiched between the inner balloon layer 30a and the outer balloon layer 30b, and the ablation electrode 42 is in the shape of a spike and is exposed by puncturing the outer balloon layer 30b of the balloon 30, so as to be in close contact with the blood vessel wall. Because the ablation electrode 42 is in a sharp-pointed shape, the ablation electrode can be inserted into the vessel wall to a certain depth, and the deep sympathetic nerve ablation is completed.
Example seven:
fig. 17 shows a seventh embodiment of the ablation catheter 100 of the present application, which differs from the first embodiment mainly in that it further includes a branch ablation catheter 50, and the distal end of the branch ablation catheter 50 is provided with a radio frequency electrode 52. As shown in fig. 18, in the use of the ablation catheter 100 of the present embodiment, the balloon 30 is inserted into the common hepatic artery for ablation, and the rf electrode 52 of the branch ablation catheter 50 is placed in a branch of the common hepatic artery, generally a branch having a diameter less than 2.5mm, so that the common hepatic artery and the branch can be ablated at the same time. Preferably, the outer diameter of the branch ablation catheter 50 should be smaller than the inner diameter of the first channel 25 (i.e., the working channel of the guidewire), and the branch ablation catheter 50 can reach the predetermined location of the branch vessel directly through the first channel 25.
As shown in fig. 19-20, the branched ablation catheter 50 includes a branched tube 54, a temperature sensor 56 disposed in the branched tube 54, a radio frequency electrode 52 disposed at a distal end of the branched tube 54, a connection plug connecting a proximal end and a tip of the branched tube 54, and the like. The branch pipe 54 is preferably made of an elastic polymer material such as PEBAX, PI, PA, PEEK, PU, or the like; the rf electrode 52 is made of gold, silver platinum, platinum or alloys thereof, which have good electrical conductivity. The rf electrode 52 may be a tip electrode, and is connected to the outer tube by bonding, welding, or the like; alternatively, the rf electrode 52 may be a ring electrode, and connected to the outer tube by ring-like clasping, bonding, welding, or the like. The temperature sensor 56 and the lead wires of the radio-frequency electrode 52 extend outwards through the branch pipe 54 and are electrically connected with other related devices
In some embodiments, a shaping wire 58 is further disposed in the branch tube 54, and the shaping wire 58 is preferably made of 316 stainless steel, 304 stainless steel, nitinol, or the like. The shaping wire 58 is shaped into a particular shape, such as a circular loop, a spiral, a curve. The lead of the radio-frequency electrode 52 and the shaping metal wire 58 are connected to the electrode by welding, on one hand, the branch pipe 54 can be supported to form a specific shape, and on the other hand, the welding strength of the shaping metal wire 58 and the radio-frequency electrode 52 is greater than that of the lead of the radio-frequency electrode 52, so that the radio-frequency electrode 52 can be prevented from falling off, and the risk that the radio-frequency electrode 52 falls off in the using process is avoided.
The ablation system and the ablation catheter adopt the elastic balloon as a carrier of the ablation electrode, the size of the blood vessel is adapted by utilizing the telescopic characteristic of the balloon, and a good sticking effect can be formed with the whole blood vessel wall, so that a good ablation effect can be realized on sympathetic nerves on the whole blood vessel wall, and the phenomenon of incomplete local ablation is effectively avoided; in addition, the cooling liquid channel is arranged to cool the ablation part, so that the surface temperature of the ablation part is effectively reduced, the internal temperature of the tissue is higher, the tissue carbonization is avoided, the ablation range can be deeper and wider, the ablation effect is further improved, and the safety of ablation operation is enhanced. The application can adapt to ablation operation of large-size blood vessels, is preferably applied to ablation operation of common hepatic artery blood vessels, and can be applied to ablation operation of other blood vessels, without being limited to a specific embodiment.
It should be noted that the present invention is not limited to the above-mentioned embodiments, and other changes and modifications can be made by those skilled in the art according to the spirit of the present invention, and these changes and modifications made according to the spirit of the present invention should be included in the scope of the present invention as claimed.

Claims (10)

1. A sympathetic nerve ablation catheter is characterized by comprising a handle, a balloon, a catheter connected between the handle and the balloon and a plurality of ablation units arranged on the balloon, wherein the ablation units are distributed along the circumferential direction of the balloon, each ablation unit comprises a flexible circuit connected with the balloon and an ablation electrode arranged on the flexible circuit, and the ablation electrode is exposed out of the outer wall surface of the balloon to be in contact with an ablation part; the catheter comprises an outer tube and an inner tube nested in the outer tube, a liquid inlet channel of cooling liquid is arranged between the inner tube and the outer tube, and the liquid inlet channel is communicated with the balloon, so that the cooling liquid can be injected into the balloon to cool an ablation part.
2. The parasympathetic ablation catheter of claim 1, wherein the ablation unit further includes a temperature sensor, the temperature sensor being electrically connected to the flexible circuit; the outer tube is bilayer structure, including outer tube inlayer and outer pipe layer, the flexible circuit passes through the passageway orientation between outer tube inlayer and the outer pipe layer the handle extends.
3. The denervation nerve ablation catheter according to claim 2, characterized in that said ablation electrode is convex with respect to the outer wall surface of said balloon, said ablation electrode being in the shape of a sheet, comb or spike.
4. The sympathetic denervation catheter of claim 2, wherein said balloon is a double-layered structure comprising an inner balloon layer and an outer balloon layer, said flexible circuit and temperature sensor being disposed between said inner and outer balloon layers, said ablation electrode exposing said outer balloon layer.
5. The parasympathetic ablation catheter of claim 1, wherein the balloon is provided with through holes as an outflow channel for the coolant to flow out of the balloon.
6. The sympathetic nerve ablation catheter according to claim 1, wherein a liquid inlet pipe is provided between the inner pipe and the outer pipe, the liquid inlet pipe serving as a liquid inlet channel for the cooling liquid; and the part of the channel between the inner pipe and the outer pipe except the liquid inlet pipe is used as a liquid outlet channel of the cooling liquid.
7. The sympathetic nerve ablation catheter of claim 6, wherein the distal end of the fluid inlet tube extends into the balloon and extends in a spiral shape, the fluid inlet tube being provided with a plurality of openings spaced along its spiral direction, the openings being oriented differently.
8. The denervating nerve ablation catheter according to any of claims 1-7, characterized in that a branch ablation catheter is further connected to the distal end of the balloon; the ablation catheter is used for sympathetic nerve ablation of common hepatic artery vessels, and the branch ablation catheter is used for sympathetic nerve ablation of branch vessels with the diameter smaller than 2.5 mm.
9. A denervation nerve ablation system, comprising an ablation instrument, a cooling device and a denervation nerve ablation catheter according to any of claims 1-8, the ablation instrument being electrically connected to the ablation unit, the cooling device interfacing with the fluid inlet channel.
10. The sympathetic denervation ablation system according to claim 9, further comprising an electromagnetic navigator, the distal end of the inner tube extending into the balloon and provided with a position sensor cooperating with the electromagnetic navigator to guide the balloon to an ablation site, the lead of the position sensor extending through a channel between the inner tube and the outer tube towards the handle.
CN202211295348.9A 2022-10-21 2022-10-21 Sympathetic nerve ablation catheter and system Pending CN115444541A (en)

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CN202211295348.9A CN115444541A (en) 2022-10-21 2022-10-21 Sympathetic nerve ablation catheter and system

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Application Number Priority Date Filing Date Title
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