CN105078569B - Sympathetic nerve mapping ablating device and system - Google Patents

Abstract

The invention provides a sympathetic nerve mapping and ablation device and system. The device includes a guiding catheter, a mapping ablation tube and a handle part. The guiding catheter is a hollow tube with openings at both ends, which is sheathed outside the mapping ablation tube; It has a spiral structure, and a plurality of electrodes that can map and ablate the sympathetic nerves are arranged on the front surface of the mapping ablation tube, and each electrode has a mapping wire that is connected to the detector and the energy generator and The ablation guide wire; the handle part is connected with the guide catheter, and it has a component that can control the mapping ablation tube to protrude from the opening of the head end of the guide catheter or withdraw from the guide catheter. The device of the present invention can accurately map and ablate sympathetic nerve innervation points from the arterial adventitia during surgery, realize targeted detection and ablation of sympathetic nerves related to the disease, and avoid vascular damage and treatment resulting complications.

Description

Sympathetic nerve mapping and ablation device and system

technical field

The invention relates to a medical device, in particular to a sympathetic nerve mapping and ablation device and system.

Background technique

Hypertension is a global public disease with high incidence and great harm. It is the main risk factor for stroke, coronary heart disease, heart failure, vascular disease and renal failure, and it is also increasingly causing public health problems. concerns. In particular, resistant hypertension is a malignant disease with a high fatality rate without effective drug treatment, and its patients need to take a variety of antihypertensive drugs with different mechanisms of action to control systolic and diastolic blood pressure. To a certain extent, it increases the economic burden of patients, and also increases the adverse reactions of drugs to a certain extent. Therefore, a new treatment method is needed for the treatment of hypertension, especially resistant hypertension.

Medical research has proved that the origin of many diseases can be attributed to the excessive excitation of the human sympathetic nerve. For example, the kidney is mainly controlled by the sympathetic nerve and the postganglionic neurons of the reticular nerve. The sympathetic nerve passes through the renal circulation, the urinary function of the kidney and The endocrine function of the kidneys regulates the rotation of water and electrolytes, which plays an important role in regulating blood pressure. As the relationship between sympathetic nerves and hypertension is gradually recognized, sympathetic denervation is therefore also regarded as an effective method for the treatment of hypertension. However, blind ablation and removal of sympathetic nerves without screening often leads to complications such as bowel dysfunction, orthostatic hypotension, bladder function and sexual dysfunction in patients undergoing surgery. The era has been completely eliminated.

With the development of minimally invasive surgery technology, transcatheter intervention of renal sympathetic nerve treatment of hypertension is a new device treatment method that has emerged in the world medical field since 2009. This method has subverted all previous hypertension treatments. Traditionally, the safety and effectiveness of its treatment have been confirmed by multiple clinical studies. At present, Medtronic's device (Simplicity ^TM ) is the only FDA-approved commercial product and is used in clinical treatment. Its treatment principle is to insert the ablation catheter into the left and right renal arteries through the femoral artery to release radiofrequency energy. Paste on the intima of the renal artery, release radiofrequency energy to ablate 6 to 8 points, and destroy the sympathetic nerve endings on the wall of the renal artery with high temperature, so as to reduce the excitability of the sympathetic nerve, reduce the secretion of catecholamines in the kidney and increase the renal blood flow. The purpose is to treat some diseases related to sympathetic nervous overexcitation, which include diabetes, renal failure, arrhythmia and sleep disorders in addition to high blood pressure.

The above-mentioned interventional treatment method in the renal blood vessels avoids the trauma of open surgery, but the current clinical treatment results still cannot meet the needs, and there are two main shortcomings: 1. The existing device does not mark the sympathetic nervous system around the renal artery. Therefore, it is impossible to confirm which/which site ablation effect is better, or more symptomatic, so it uses multi-point pull-net ablation, usually multi-point ablation (6-8 points) in the blood vessel, in order to hope It can cover effective sites, but it will cause more punctate damage to the intima of the renal artery; 2. The ablation electrode of the existing device performs ablation in the vessel cavity, and the radiofrequency energy must pass through the vessel wall to reach the adventitia to ablate the vessel The sympathetic nerve endings on the wall and the adventitia of the blood vessels, so greater energy must be used. However, large or excessive radiofrequency energy will cause damage to blood vessels, especially the damage to the intima of the blood vessels, and postoperative complications are inevitable. The treatment effect is greatly affected. Based on the above characteristics and problems, there have been some reports of treatment-related complications and contraindications since this treatment method was launched, such as the recurrence of hypertension caused by scarred renal artery stenosis after multi-point ablation of the renal artery intima, Renal artery perforation, renal artery dissection aneurysm, etc. caused by excessive energy of the ablation catheter at a single point Patients with block or congenital malformation of the renal artery.

Therefore, it is of great significance for the clinical treatment and application of related diseases to explore more scientific minimally invasive techniques to achieve ablation of the target sympathetic nerve and minimize the side effects and complications of treatment.

Contents of the invention

The present invention provides a sympathetic nerve mapping and ablation device, which can accurately map and ablate sympathetic nerve dominance points from the arterial adventitia during operation, so as to achieve more accurate point ablation, which is not only beneficial to improve the treatment effect, but also can maximize the Minimally avoid vascular damage and complications caused by ablation therapy.

The present invention also provides a sympathetic nerve mapping and ablation system, the electrodes of which can realize the functions of mapping and ablation at the same time, and the system has multiple electrodes at the same time, and multiple electrodes are in place at the same time, thus not only avoiding the need for multiple operations of a single electrode The positioning is difficult, and the displacement caused by the replacement of electrodes is avoided; the system uses a detector to detect the sympathetic nerves related to the disease, and according to the detection results, the sympathetic nerves that need to be ablated are targetedly ablated. The ablation effect can be judged by mapping, which is more convenient in practical applications.

A sympathetic nerve mapping and ablation device provided by the present invention includes a guide catheter, a mapping ablation tube and a handle,

The guide catheter is a hollow tube with openings at both ends, which is sheathed outside the mapping ablation tube;

The front section of the mapping ablation tube can protrude from the opening of the head end of the guiding catheter to form a helical structure, and a plurality of tubes that can map and ablate sympathetic nerves are arranged on the surface of the front section of the mapping ablation tube. electrodes, and each electrode has a mapping wire and an ablation wire respectively connected to the detector and the energy generator;

The handle part is connected with the guide catheter, and has a component capable of controlling the mapping and ablation tube to protrude from the head end opening of the guide catheter or withdraw from the guide catheter.

According to the sympathetic nerve mapping and ablation device provided by the present invention, the mapping and ablation tube is made of medical polymer material, its two ends are open and pre-shaped into a spiral structure, and the mapping and ablation tube is pierced with A guide wire, the guide wire can make the mapping ablation tube substantially straight, and when the mapping ablation tube protrudes from the opening of the head end of the guide catheter, its protruding part can be caused by the The guide wire is at least partially drawn out from the tail end of the mapping ablation tube to form a helical structure.

Further, the material of the guide wire is a medical metal material or a medical alloy material.

The present invention also provides a sympathetic nerve mapping and ablation system, including any one of the above-mentioned sympathetic nerve mapping and ablation devices, a detector and an energy generator, wherein the multiple electrodes of the mapping ablation tube pass through the mapping wire and ablation wires are respectively connected to the detector and the energy generator.

The present invention also provides a method for arterial sympathetic nerve mapping and ablation using any of the above devices or systems, comprising the following steps:

1) using the head end of the guiding catheter to separate the arteries;

2) using the part of the handle part to make the mapping ablation tube protrude from the head end opening of the guide catheter or retract the guide catheter, so as to perform multi-point or single-point mapping and monitoring of the arterial sympathetic nerve; ablation.

The implementation of the scheme of the present invention has at least the following advantages:

1. The mapping and ablation device of the present invention changes the traditional method of interventional therapy through the blood vessel. It uses the adventitia of the blood vessel to map and ablate the innervated point of the sympathetic nerve, so that there is no need to transmit large energy to the outside of the blood vessel through the inside of the blood vessel The membrane can realize the targeted detection and ablation of the sympathetic nerves related to the disease, and the energy required is less than ablation from the intima, so the damage to the blood vessels is small, and the damage to the blood vessels and the damage caused by the ablation treatment can be avoided to the greatest extent. complication.

2. The mapping and ablation device of the present invention has a plurality of electrodes that can simultaneously realize the mapping function and the ablation function, and it can perform mapping and ablation on multiple sites of the sympathetic nerve separately or simultaneously, not only the required sites are compared with the current Some multi-point pull-net ablation methods have few methods, and the ablation energy can be gradually increased from small to large, so as to achieve precise positioning and ablation with appropriate energy, and the accuracy and efficiency of ablation are improved; in addition, after ablation, it can also Judging the ablation effect by the mapping function of the electrode is beneficial to avoid defects such as incomplete ablation, thereby improving the curative effect of the treatment.

3. Under the guidance of the mapping results, the mapping and ablation device of the present invention can ensure that the ablation site is the site dominated by the sympathetic nerve endings, and avoid various disadvantages caused by blind ablation through selective denervation; in addition It uses smaller energy for multiple repeated ablation, thereby avoiding blood vessel damage caused by high ablation energy.

4. The system of the present invention is simple in structure and easy to operate. It can control the state of the mapping ablation tube according to needs, thereby realizing single-point or multi-point mapping and ablation. It has a wide range of clinical applications, such as being applicable to the abdomen, In conventional surgery such as urology and direct vision surgery, it can be achieved without a large surgical incision, so it can be applied to minimally invasive surgery.

Description of drawings

1 is a schematic structural diagram of a sympathetic nerve mapping and ablation system according to Embodiment 1 of the present invention;

Fig. 2 is a cross-sectional view of the sympathetic nerve mapping and ablation device according to Embodiment 1 of the present invention;

3 is a schematic structural view of the head end of the sympathetic nerve mapping and ablation device according to Embodiment 1 of the present invention;

4 is a cross-sectional view of the head end of the sympathetic nerve mapping and ablation device according to Embodiment 1 of the present invention;

Fig. 5 is a front view of the sympathetic nerve mapping and ablation device in use according to Embodiment 1 of the present invention;

Fig. 6 is a left view of the sympathetic nerve mapping and ablation device according to Embodiment 1 of the present invention in use.

detailed description

In order to make the purpose, technical solutions and advantages of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention , but not all examples. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the protection scope of the present invention.

The sympathetic nerve mapping and ablation device of the present invention includes a guiding catheter, a mapping and ablation tube and a handle part, and the guiding catheter is a hollow tube with openings at both ends, which is sleeved outside the mapping and ablation tube; the front section of the mapping and ablation tube can Protruding from the opening of the head end of the guide catheter, it has a spiral structure. On the front surface of the mapping ablation tube, there are multiple electrodes that can map and ablate the sympathetic nerve, and each electrode has a connection with the detector and The mapping guide wire and the ablation guide wire of the energy generator; the handle part is connected with the guide catheter, and it has a component that can control the mapping ablation tube to protrude from the head end opening of the guide catheter or retreat into the guide catheter.

In the present invention, "mapping" refers to the detection of one or more physiological and clinical indicators of sympathetic nerves, and it can be judged whether it is necessary to ablate the sympathetic nerves at the mapping site through the detection results; "ablation" refers to The purpose is to use energy to damage and remove the sympathetic nerve at the site to be ablated, that is, the mapping site with a positive mapping result; "head end" refers to the front end in the forward direction when using the sympathetic nerve mapping ablation device The "front section"/"front end" refers to the section/end close to the head end of the guide catheter, and the "rear section"/"tail end" refers to the section/end away from the head end of the guide catheter.

Furthermore, the sympathetic nerve mapping and ablation device of the present invention can perform single-point or multi-point mapping and ablation of the sympathetic nerve. Specifically, when the mapping ablation tube protrudes from the opening of the head end of the guiding catheter, the protruding part of the mapping ablation tube forms a spiral structure with multiple electrodes distributed, so as to perform multi-point mapping and ablation of the sympathetic nerve; When the measuring ablation tube extends out of the guiding catheter from the opening at the head end, the electrode at the head end of the mapping ablation tube is exposed from the guiding catheter through the opening at the head end, so as to perform single-point mapping and ablation of the sympathetic nerve.

The tip end of the guide catheter should have a shape that facilitates entry into the surgical incision and separation of the soft tissue surrounding the sympathetic nerve, for example it may be flat. The tip can be as small as possible, and the guide catheter should have a certain length to be used in minimally invasive procedures. The guide catheter can be made of polymer materials or metal materials, such as polyether block amide, polyimide, thermoplastic polyacid, stainless steel, aluminum alloy, titanium alloy, etc.

The mapping ablation tube should be able to generate deformation. It can be basically linear so that it can be placed in the guide catheter, and it can also be helical in shape so as to realize the winding of arteries. For example, it can be made of memory alloy. It can also be made of medical polymer material pre-shaped into a helical structure. In a specific embodiment of the present invention, the mapping ablation tube is made of medical polymer materials, and its two ends are opened and pre-shaped into a spiral structure. A guide wire is threaded in the mapping ablation tube, and the guide wire can make the marker The measuring ablation tube is basically linear, and when the mapping ablation tube protrudes from the head opening of the guide catheter, its protruding part can be in a helical structure because the guide wire is pulled out at least partly from the tail end of the mapping ablation tube .

The medical polymer material used to make the marking ablation tube should be flexible, such as polyvinyl chloride, natural rubber, polyethylene, polyamide, polypropylene, polystyrene, silicone rubber, polyester, polytetrafluoroethylene, poly Methyl methacrylate and polyurethane, among others, polytetrafluoroethylene is preferred. Moreover, the helical inner diameter of the helical structure formed by the mapping ablation tube may be equal to or smaller than the outer diameter of the target blood vessel, preferably smaller, so as to form a close and stable contact with the target blood vessel.

The guide wire should have certain rigidity and elasticity, and it should be able to resist the elasticity of the mapping ablation tube, so that the pre-shaped mapping ablation tube is placed in the guide catheter in a substantially straight shape. When the mapping ablation tube protrudes from the opening of the head end of the guide catheter, after pulling out at least part of the guide wire from the tail end of the mapping ablation tube, the mapping ablation tube will form a helical structure under the action of its own elasticity, thereby forming a helical structure on the target blood vessel. Winding; and when the mapping and ablation is completed, re-insert the guide wire into the mapping ablation tube, so that the helical diameter of the mapping ablation tube is enlarged to release the winding of the target blood vessel, and it is basically straight and set again in the guide catheter. The material of the guide wire can be a medical metal material or a medical alloy material, such as stainless steel, cobalt-based alloy, titanium-based alloy, and the like.

The electrodes should deliver electrical stimulation to map the sympathetic nerves and radiofrequency energy to ablate the sympathetic nerves. When the mapping ablation tube protrudes from the opening at the head end of the guide catheter to form a helical structure, the area where multiple electrodes are arranged should be located at least in the inner ring of the helical structure. For example, the electrodes may be ring-shaped and sheathed on the mapping ablation tube at intervals.

The electrodes can be made of metallic materials such as platinum, platinum-iridium alloys, gold, silver, and the like. The present invention does not specifically limit the number of electrodes, as long as the number does not affect the preparation and use of the device of the present invention, the number of electrodes may be, for example, 2-8. Moreover, each electrode can have an independent number, which can correspond to the number on the detector and the energy generator, so that the corresponding electrodes can be controlled by the detector and the energy generator to accurately detect and monitor the sympathetic nerve at the corresponding position. ablation. The energy generator may be a radio frequency generator.

The handle part should have a shape that is convenient for the operator to hold, and it can be made of polymer materials, such as polyoxymethylene, acrylonitrile-butadiene-styrene copolymer, polycarbonate, polyamide, polymethyl methacrylate, etc. . The part on the handle part that can control the mapping ablation tube to protrude from the opening of the head end of the guide catheter or retract the guide catheter can be conventionally set according to common knowledge in the field, for example, it can be a push-pull mechanism, specifically it can be set at the tail end of the handle part and The push-pull rod connected to the end of the mapping ablation tube can move the mapping ablation tube in the axial direction by pushing or stretching the push-pull rod, or a cavity can be opened on the surface of the handle part and the cavity can be set in conjunction with the mapping ablation The push rod that is fixedly connected to the tube; it can also be a clamping mechanism. Specifically, a component capable of clamping the mapping ablation tube can be set in the above cavity, for example, a protrusion can be set on the mapping ablation tube, and the A concave part matching the protruding part is provided on the component; it may also be a stopper mechanism, specifically, a stopper or the like that blocks the above-mentioned protruding part may be provided in the above-mentioned cavity.

The device of the present invention can be used for mapping and ablation of sympathetic nerves, especially renal artery sympathetic nerves. It realizes the winding of arteries and blood vessels through the mapping and ablation tubes in a spiral structure, so that it can be used in minimally invasive surgery and direct ablation. In visual surgery, the sympathetic innervation points are precisely mapped and ablated from the adventitia of the artery, and there is no need to transmit large energy to the adventitia of the vessel wall through the interior of the artery, so the intimal injury of the vessel can be avoided to the greatest extent. The plurality of electrodes provided on the device of the present invention are respectively connected to the detector and the energy generator correspondingly, so that multiple sites on the sympathetic nerve can be accurately detected and ablated separately or simultaneously, thereby avoiding the problems caused by blind ablation. disadvantages and harm. In addition, because the device also has a mapping function, it can use smaller energy for repeated ablation, thereby avoiding blood vessel damage and other complications caused by high ablation energy.

In a specific embodiment of the present invention, the handle part may include a handle cover and a propulsion part, the handle cover is provided with a through hole and communicates with the tail end of the guide catheter, and the rear section of the mapping ablation tube enters the through hole through the tail end of the guide catheter , and the guide wire in the mapping ablation tube protrudes from the end of the through hole; a first cavity communicating with the through hole is provided on the surface of the handle cover, and the propulsion part is arranged in the first cavity, which can control the mapping The ablation tube is moved axially to extend or retract the guide catheter from the tip opening of the guide catheter. Wherein, the through hole may be an axial through hole, and the propelling part may be the above-mentioned push rod, clamping mechanism or stop mechanism.

Further, the propulsion part may include a moving part and a driving part that are engaged with each other, and at least part of the driving part protrudes from the first cavity; the moving part is sleeved outside the mapping ablation tube, and it can The lower drives the mapping ablation tube to move axially. For example, a chute may be provided on the inner surface of the moving part and end faces may be formed at both ends of the moving part, and one or more end faces formed between the two ends of the moving part may be provided on the mapping ablation tube. The protrusions in contact, the protrusions can move in the axial direction in the sliding groove.

The propulsion part moves the moving part in the axial direction by rotating (rotating) the driving part, and when the moving part moves axially, its two end surfaces come into contact with the protruding part, so that the mapping ablation tube moves along the axial direction. Move, and then make the mapping ablation tube protrude from the opening of the head end of the guide catheter or retreat into the guide catheter. The present invention does not strictly limit the meshing, and the meshing only needs to satisfy the requirement that the moving part can move axially by rotating the driving part. The meshing can be the meshing between teeth, for example, the surfaces of the moving part and the driving part are respectively provided with mutually meshing teeth. , the engagement can also be the engagement between threads, for example, the moving part can be set as a hollow tubular structure with external threads, and the driving part can be set as an annular structure with internal threads, and the driving part can be sleeved outside the moving part, and By matching the internal thread and the external thread, the moving part is moved axially when the driving part is rotated. The propulsion part can make the device of the present invention conveniently perform operations related to mapping and ablation.

In a specific embodiment of the present invention, the handle part may also be provided with a direction control part capable of controlling the axial rotation of the mapping ablation tube, and a second cavity communicated with the through hole is also provided on the surface of the handle cover to control the direction. part is disposed in the second cavity. For example, the direction control part may include a fixed part and a rotating part. The rotating part has a through hole with a polygonal cross-sectional shape, which is sleeved outside the mapping ablation tube. Matching, so that when the mapping ablation tube protrudes from the head end opening of the guide catheter for a preset length, the mapping ablation tube can still be driven by the rotating part to rotate axially; at least part of the rotating part protrudes from the second cavity , a radial screw hole is opened on the handle cover, and the fixed part is screwed into the radial screw hole and resisted on the moving part.

Further, the polygon may be a regular polygon, such as a regular quadrilateral, a regular hexagon, a regular octagon, etc., preferably a regular hexagon. The direction control part sets the part of the mapping ablation tube to a polygonal cross-section and sets a matching rotating part so that the mapping ablation tube can move axially freely, which is beneficial to control the extension of the mapping ablation tube. The orientation of the helix in a helical structure.

A window can also be provided on the surface of the handle cover, and the window exposes the ablation tube for mapping. The viewing window can be used to measure the length of the mapping ablation tube protruding from the guide catheter, so that the actual operation of the operator is easier.

In the present invention, the positions of the first cavity, the second cavity and the window on the surface of the handle cover are not strictly limited. For example, the first cavity can be arranged at the rear end of the handle cover, and the second cavity can be arranged at the handle cover. At the front end of the sleeve, the viewing window may be disposed between the first cavity and the second cavity. Moreover, the first cavity, the second cavity and the viewing window may communicate with each other, or may be separated from each other.

The sympathetic nerve mapping and ablation system of the present invention includes any of the above-mentioned sympathetic nerve mapping and ablation devices, detectors and energy generators, wherein the multiple electrodes of the mapping ablation tube are respectively connected to the detector through the mapping wire and the ablation wire. Connect to a power generator.

When using the device or system of this embodiment for arterial sympathetic nerve mapping and ablation, firstly, the arterial blood vessel can be separated by using the head end of the guide catheter; secondly, the above-mentioned components of the handle part can be used to open the mapping ablation tube from the head end of the guide catheter Extend or retract the guide catheter for multi- or single-point mapping and ablation of the arterial sympathetic nerve.

Further, the driving part of the propulsion part can be manipulated so that the mapping ablation tube protrudes from the head end opening of the guide catheter; then at least part of the guide wire is drawn out from the tail end of the mapping ablation tube to protrude from the head end opening of the guide catheter The mapping ablation tube is in a helical structure, forming a winding around the target arterial vessel; and then releasing electrical stimulation through each electrode and transmitting the electrical stimulation information to the detector, while monitoring one or more physiological and clinical indicators at the stimulation site of each electrode, Energy is released through the electrodes corresponding to the sites with positive physiological and clinical indicators to ablate the positive sites. In addition, the fixed part and the rotating part of the direction control part can be manipulated to make the mapping ablation tube toward the target artery, and then the fixed part can be tightened.

Furthermore, after ablation, the electrodes corresponding to the positive parts can be used to release electrical stimulation, and at the same time monitor one or more physiological and clinical indicators of the corresponding positive parts, and release energy through the electrodes corresponding to the positive parts to ablate the positive parts until One or more physiological and clinical indicators at the positive site are negative.

In the method of the present invention, the physiological clinical indicators include one or more of blood pressure and heart rate. When each electrode is in place, release electrical stimulation (such as electric pulse) from each electrode to perform nerve stimulation, and monitor physiological and clinical indicators such as heart rate and blood pressure. When nerve stimulation to a certain part (site) does not cause obvious physiological When responding, this part is defined as a negative part; when the nerve stimulation to a certain part causes the heart rate and/or blood pressure to rise, this part is defined as a positive part; then, the ablation energy is released through the electrode corresponding to the positive part for ablation, In this way, the nerve endings in this part are damaged; after ablation, re-mapping is performed. If the positive reaction disappears, it means that the ablation of this part is successful. If the positive reaction still exists, ablation is performed again with the same energy or increased energy, and re-mapping after ablation , until the positive reaction disappears; after performing the above operations on all parts, re-mapping, if all parts are negative, the ablation is successful, and the treatment is over; if there are still positive parts, repeat the above operation until all parts have positive reactions Disappear, end treatment.

Example 1

As shown in FIGS. 1 and 2 , the sympathetic nerve mapping and ablation device of this embodiment includes a guide catheter 1 , a mapping and ablation tube 2 and a handle part 3 .

Combined with Fig. 3 and Fig. 4, the guide catheter 1 is a hollow tube with openings at both ends, which is sheathed outside the mapping ablation tube 2. The guide catheter 1 has a flat head end 11, and the front end of the head end 11 is tilted up. , and the guiding catheter 1 has a certain length.

Further referring to Fig. 5 and Fig. 6, the mapping ablation tube 2 is made of polytetrafluoroethylene, its two ends are open and pre-shaped into a helical structure (in a relaxed state), and a guiding guide is pierced in the mapping ablation tube 2. Wire 21, the guide wire 21 can make the mapping ablation tube 2 basically linear, and when the mapping ablation tube 2 protrudes from the head end opening of the guide catheter 1, its protruding part can be ablated from the mapping by the guide wire. The tail end of the tube 2 is extracted at least partially to form a helical structure. Moreover, the helical inner diameter of the helical structure can be smaller than the outer diameter of the target blood vessel, so as to form a tight and stable contact with the target blood vessel.

The guide wire 21 is made of stainless steel, which enables the pre-shaped mapping ablation tube 2 to be placed in the guide catheter 1 in a substantially straight shape. When the mapping ablation tube 2 protrudes from the opening of the head end of the guiding catheter 1, after pulling out at least part of the guide wire 21 from the tail end of the mapping ablation tube 2, the mapping ablation tube 2 will form a helical structure under the action of its own elasticity, In this way, the target blood vessel is entangled; and when the mapping and ablation are completed, the guide wire 21 is reinserted into the mapping ablation tube 2, so that the helical diameter of the mapping ablation tube 2 is enlarged, so as to release the entanglement of the target blood vessel, and It is substantially rectilinear again and placed in the guide catheter 1 .

Eight electrodes 22 capable of mapping and ablation the sympathetic nerve are arranged on the front surface of the mapping ablation tube 2, and each electrode 22 has a mapping wire and an ablation wire connected to the detector 4 and the energy generator 5 respectively 221 , the electrodes 22 are annular and sheathed on the mapping ablation tube 2 at intervals.

The handle part 3 includes a handle cover 31 and a propulsion part. The handle cover 31 has a through hole and communicates with the tail end of the guide catheter 1. The rear section of the mapping ablation tube 2 enters the through hole through the tail end of the guide catheter 1 and is The guide wire 21 in the ablation tube 2 protrudes from the end of the through hole; a first cavity 311 communicating with the through hole is provided on the surface of the handle cover 31 , and the propelling part is arranged in the first cavity 311 .

The propulsion part includes a moving part 32 and a driving part 33 that are engaged with each other, wherein the moving part 32 is a hollow tube with an external thread, and the driving part 33 is a ring with an internal thread. When the driving part 33 is sleeved on the moving part 32, The internal thread matches the external thread, so that the moving part 32 moves axially when the driving part 33 is rotated, and at least part of the driving part 33 protrudes from the first cavity 311, thereby facilitating the actual operation of the operator; the moving part 32 It is sleeved on the outside of the mapping ablation tube 2 , and driven by the driving part 31 , it can drive the mapping ablation tube 2 to move in the axial direction.

Further, the inner surface of the moving part 32 is provided with a sliding groove 321, and the two ends of the moving part 32 have end faces 322, and a mapping ablation tube 2 located between the end faces 322 at the two ends of the moving part 32 is provided with a The end surfaces 322 at both ends form contacting protrusions 23 , and the protrusions 23 can move axially in the slide groove 321 . The propulsion part moves the moving part 32 in the axial direction by rotating the driving part 33, and when the moving part 32 moves in the axial direction, its two end surfaces 322 come into contact with the protruding part 23, so that the mapping ablation tube 2 follows Axial movement is performed, and then the mapping ablation tube 2 is extended from the opening of the head end of the guide catheter 1 or withdrawn from the guide catheter.

As shown in Figure 1, the sympathetic nerve mapping and ablation system of this embodiment includes the above-mentioned sympathetic nerve mapping and ablation device, a detector 4 and an energy generator 5, wherein the plurality of electrodes 22 of the mapping ablation tube 2 pass through the mapping The lead and the ablation lead 221 are respectively connected to the detector 4 and the energy generator 5 .

Further, each electrode 22 can have an independent number, and corresponds to the number on the detector 4 and the energy generator 5, thereby controlling the corresponding electrode 22 to the sympathetic nerve at the corresponding part through the detector 4 and the energy generator 5. Perform precise detection and ablation.

Using the device or system of this embodiment to perform arterial sympathetic nerve mapping and ablation, for example, renal artery sympathetic nerve, includes the following steps:

11. Use the head end 11 of the guide catheter 1 to separate the arterial vessel (renal artery);

12. Use the propulsion part of the handle to make the mapping ablation tube 2 protrude from the opening of the head end of the guide catheter 1 or retract the guide catheter 1, so as to perform multi-point or single-point mapping and ablation of the arterial sympathetic nerve; specifically including:

121. Manipulate the driving part 33 of the propulsion part, so that the mapping ablation tube 2 protrudes from the opening of the head end of the guiding catheter 1;

122. Pull out at least part of the guide wire 21 from the tail end of the mapping ablation tube 2 so that the mapping ablation tube 2 protruding from the opening of the head end of the guide catheter 1 has a spiral structure, forming a winding around the target artery;

123. Release electrical stimulation through each electrode 22, and simultaneously monitor one or more physiological clinical indicators caused by the stimulation of each electrode 22;

124. Use the energy generator 5 to make the electrodes corresponding to the parts with positive physiological and clinical indicators release energy, so as to ablate the positive parts;

125. Release electrical stimulation through the electrode 22 corresponding to the positive part, and simultaneously monitor one or more physiological clinical indicators caused by the stimulation of the corresponding positive part, wherein the physiological clinical indicators include blood pressure and heart rate;

126. Release energy through the electrode 22 corresponding to the positive part, and ablate the positive part until one or more physiological and clinical indicators caused by the stimulation of the positive part are negative.

The mapping and ablation device/system of this embodiment changes the traditional method of interventional therapy through blood vessels. It maps and ablates the sympathetic nerve innervation points in the adventitia of the blood vessels, so that there is no need to transmit large energy through the inside of the blood vessels to the The vascular adventitia can be used to detect and ablate the sympathetic nerves related to the disease in a targeted manner, so that blood vessel damage and complications caused by ablation therapy can be avoided to the greatest extent; and, by setting multiple The electrode 22 with the ablation function can not only map and ablate multiple sites of the sympathetic nerve separately or simultaneously, but also accurately locate the mapped ablation site, and ensure ablation under the guidance of the mapping results The site is the part dominated by the sympathetic nerve endings, through selective denervation, so as to avoid various disadvantages caused by blind ablation. The device/system can be applied to conventional surgery such as abdominal surgery and urology surgery and direct vision surgery, especially it can be realized without a large surgical incision, and can be preferably applied to minimally invasive surgery.

Example 2

As shown in FIG. 2 , in this embodiment, on the basis of Embodiment 1, a direction control part capable of controlling the rotation of the mapping ablation tube 2 in the axial direction is further provided in the first cavity 311 of the handle cover 31 . Specifically, the direction control part may include a fixed part 34 and a rotating part 35. The rotating part 35 is T-shaped and has a through hole with a regular hexagonal cross-section. 1, the mapping ablation tube 2 has at least a part of the area that can match the through hole of the rotating part 35, so that when the mapping ablation tube 2 protrudes from the opening of the head end of the guide catheter 1 for a preset length, the mapping The ablation tube 2 can still be driven by the rotating part 35 to rotate in the axial direction; the head end of the rotating part 35 protrudes from the first cavity 311, so as to facilitate the actual operation of the operator; a radial screw hole is provided on the handle cover 31 , the fixed part 34 is screwed into the radial screw hole and resisted on the moving part 35 . The direction control part can control the orientation of the helix when the mapping ablation tube 2 is stretched out to form a helical structure.

In this embodiment, the direction control part is arranged at the front end of the propulsion part, and a window (that is, the part where the direction control part and the propulsion part are not provided in the first cavity 311) can be formed between the direction control part and the propulsion part. The mapping ablation tube 2 is exposed, which can be used to observe and measure the length of the mapping ablation tube 2 protruding from the guide catheter 1, so that the actual operation of the operator is easier.

When using the device or system of this embodiment to perform arterial sympathetic nerve mapping and ablation, after the mapping and ablation tube 2 protrudes from the head opening of the guide catheter 1 (that is, after step 121 of Embodiment 1), the direction control can be operated (that is, loosen the fixing part 34 and rotate the rotating part 35), make the mapping ablation tube 2 face the target artery, and after winding the target artery, tighten the fixing part 34, so as to perform precise positioning.

Finally, it should be noted that: the above embodiments are only used to illustrate the technical solutions of the present invention, rather than limiting them; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: It is still possible to modify the technical solutions described in the foregoing embodiments, or perform equivalent replacements for some or all of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the technical solutions of the various embodiments of the present invention. scope.

Claims (6)

1. A kind of 1. sympathetic nerve mapping ablating device, it is characterised in that including guiding catheter, mapping ablation is managed and handle portion,

   The guiding catheter is the hollow tube of both ends open, and it is outer that it is sheathed on the mapping ablation pipe；

   The leading portion of mapping ablation pipe can stretch out and structure in the shape of a spiral from the head end opening of the guiding catheter, in the mark The preceding section surface for surveying ablation pipe is laid with multiple electrodes that mapping and ablation can be carried out to sympathetic nerve, and each electrode has There are the mapping wire and ablation wire of connecting detection device respectively and power generator；

   The handle portion is connected with the guiding catheter, and it, which has, can control the mapping to melt head of the pipe from the guiding catheter End opening stretches out or retracted the part of the guiding catheter；

   The handle portion includes taper knob and promotion part,

   The taper knob offers through hole and connected with the tail end of the guiding catheter, described in the back segment warp of the mapping ablation pipe The tail end of guiding catheter enters in the through hole, and the seal wire in mapping ablation pipe stretches out from the through hole tail end；

   The first cavity connected with the through hole is provided with the taper knob surface, it is empty that the promotion part is arranged on described first In chamber, it can control the mapping ablation pipe to be axially moveable, so as to stretch out or retract from the head end opening of the guiding catheter The guiding catheter；

   The promotion part includes mutually forming the move portion and drive division of engagement, and at least part of the drive division is from described the One cavity stretches out；

   The move portion is set in outside the mapping ablation pipe, and it can drive the mapping under the driving of the drive division Ablation pipe is axially moveable；

   The handle portion is additionally provided with the direction controlling portion that the mapping ablation pipe can be controlled to axially rotate, in the taper knob table The second cavity connected with the through hole is additionally provided with face, the direction controlling portion is arranged in second cavity；

   The direction controlling portion includes fixed part and rotation section,

   The rotation section has the through hole that cross sectional shape is polygon, and it is set in outside the mapping ablation pipe, the mapping Ablation pipe at least there is subregion can match with the through hole of the rotation section, so that mapping ablation pipe draws from described When the head end opening of conduit stretches out preset length, the mapping ablation pipe is remained to be driven by the rotation section and turned vertically It is dynamic；At least part of the rotation section is stretched out from second cavity,

   Radial direction screw is offered on the taper knob, the fixed part is screwed onto in the radial direction screw and is butted on the shifting In dynamic portion；

   The form for exposing the mapping ablation pipe is offered on the taper knob surface.
2. 2. sympathetic nerve mapping ablating device according to claim 1, it is characterised in that the mapping melts pipe by medical High polymer material is made, and its both ends open and is shaped as helicoidal structure in advance, and seal wire is equipped with mapping ablation pipe, The seal wire can make the mapping ablation pipe substantially linearly, also, when the mapping melts pipe from the guiding catheter When head end opening is stretched out, its extension can be drawn to small part from mapping ablation pipe tail end because of the seal wire and be in spiral shell Revolve shape structure.
3. 3. sympathetic nerve mapping ablating device according to claim 1, it is characterised in that the material of the seal wire is medical Metal material or medical alloy material.
4. 4. sympathetic nerve mapping ablating device according to any one of claims 1 to 3, it is characterised in that when the mapping disappears Melt pipe from the head end opening of the guiding catheter stretch out and in the shape of a spiral structure when, the region for being laid with multiple electrodes is located at least in The inner ring of helicoidal structure.
5. 5. sympathetic nerve mapping ablating device according to claim 4, it is characterised in that the electrode it is annular in shape and Spacer is located on the mapping ablation pipe.
6. 6. a kind of sympathetic nerve mapping ablation system, it is characterised in that including any described sympathetic nerve marks of claim 1-5 Ablating device, detector and power generator are surveyed, wherein, the multiple electrodes of the mapping ablation pipe pass through mapping wire and ablation Wire is connected with the detector and the power generator respectively.