Pulmonary artery stimulation ablation catheter and ablation system

Abstract

The invention provides a pulmonary artery stimulation ablation catheter and an ablation system. The pulmonary artery stimulation ablation catheter comprises a catheter body; the electrode device is arranged at the far end of the catheter body, the electrode device can be contracted and expanded and is configured to be of an annular structure or a cage-shaped structure allowing blood flow to pass through, the electrode device comprises an electrode mounting pipe section and a plurality of electrode sets arranged on the electrode mounting pipe section, and the electrode sets are sequentially arranged in the circumferential direction of the electrode device; each electrode group comprises an ablation electrode and a stimulation electrode which are arranged along the axial direction of the electrode mounting pipe section, and the stimulation electrode and the ablation electrode are ring electrodes; and the ring control device is connected with the electrode device and is used for adjusting the radial size of the electrode device. Therefore, when the pulmonary arterial hypertension is treated, the device can meet the requirements of different individuals, surgery is carried out at a more accurate sympathetic nerve position through the combination of stimulation and ablation, and the treatment effect is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a pulmonary artery stimulation ablation catheter and an ablation system. Background Art

[0002] Pulmonary hypertension (PH) is a major category of chronic pulmonary vascular diseases, which is characterized by common occurrence, serious harm, complex diagnosis and treatment, and high mortality. There are many causes of pulmonary hypertension, and the causes of some classifications are still unclear. However, many existing studies have shown that the pathogenesis of primary pulmonary hypertension, namely arterial pulmonary hypertension (PAH), involves the autonomic nervous system, which is associated with increased activation of the sympathetic nervous system, decreased heart rate variability, and the presence of arrhythmias. The sympathetic nervous system controls a wide range of organs, including circulatory organs, respiratory organs, digestive organs, endocrine organs, urinary organs, reproductive organs, and eyeballs. In addition, it also has effects on sugar metabolism and skeletal muscles. The sympathetic nerves have an excitatory effect on cardiac activity, which can accelerate heart rate and heart force. For blood vessels, it mainly promotes the contraction of arterioles, thereby increasing peripheral resistance to blood flow and raising arterial blood pressure.

[0003] In the pathogenesis of PAH, chronic activation of pulmonary sympathetic nerves is considered to be one of the key factors and plays a key role in the maintenance of hypertension. Pulmonary artery denervation (PADN) can improve the hemodynamics and exercise capacity of PAH patients by inhibiting sympathetic nerve excitation, and is an emerging and effective treatment. Radiofrequency ablation, as a form of nerve ablation, applies high-frequency current to the blood vessels or tracheal walls at specific locations to generate tissue heat, selectively causing irreversible damage to some nerves, thereby achieving the effect of nerve ablation.

[0004] In this regard, there are some ablation catheters for treating pulmonary hypertension in the prior art. These ablation catheters have complex shapes and thick tube bodies, which result in large occupied volumes or inflexibility, making it difficult to fit the pulmonary artery walls of different individuals, affecting the subsequent monitoring of ablation sites and the effect of ablation treatment. There are also some ablation catheters that rely solely on angiography to locate the catheter. Not only do they not show changes in heart rate and blood pressure after stimulation, making it difficult to find the exact location to be ablated, but they are also prone to surgical side effects, such as damaging the phrenic nerve and causing serious consequences such as dyspnea. At the same time, they place extremely high demands on the operator, greatly increasing the difficulty of the operation. In addition, ablation catheters for pulmonary artery treatment are still relatively blind, and are not accurate enough in finding ablation targets, affecting the effect of ablation treatment.

[0005] It should be noted that the information disclosed in the background technology section of this application is only intended to deepen the understanding of the general background technology of this application, and should not be regarded as an admission or suggestion in any form that the information constitutes prior art already known to those skilled in the art. Summary of the invention

[0006] Based on this, it is necessary to provide a pulmonary artery stimulation ablation catheter and ablation system, aiming to solve the problem that the existing technology cannot cope with the physiological structures of different individuals and is not accurate enough in finding ablation targets.

[0007] In order to achieve the above object, the present invention provides a pulmonary artery stimulation ablation catheter, which comprises:

[0008] a catheter body;

[0009] An electrode device is arranged at the distal end of the catheter body, the electrode device can be contracted and expanded, and is configured as a ring structure or a cage structure that allows blood to flow through, the electrode device includes an electrode mounting tube segment and a plurality of electrode groups arranged on the electrode mounting tube segment, the plurality of electrode groups are arranged in sequence along the circumference of the electrode device, each of the electrode groups includes an ablation electrode and a stimulation electrode arranged along the axial direction of the electrode mounting tube segment, the stimulation electrode and the ablation electrode are both ring electrodes; and,

[0010] A control ring device connected to the electrode device, wherein the control ring device is used to adjust the radial dimension of the electrode device.

[0011] In one embodiment, the number of the ablation electrode in each of the electrode groups is one, and the number of the stimulation electrodes in each of the electrode groups is one or two. When the number of the stimulation electrodes in the electrode group is two, the ablation electrode is disposed between the two stimulation electrodes.

[0012] In one embodiment, when the number of the stimulation electrodes in the electrode group is two, the sizes of the two stimulation electrodes are the same or different, and the distances between the two stimulation electrodes and the ablation electrode are the same or different.

[0013] In one embodiment, the ablation electrode is a boss-type structure, which has a middle boss and a proximal platform and a distal platform located on both sides of the middle boss, the outer diameters of the proximal platform and the distal platform are both smaller than the outer diameter of the middle boss, and the length of the proximal platform is greater than the length of the distal platform.

[0014] In one embodiment, it also includes a bending control device and a bending control pull wire, the catheter body includes an adjustable bending section, the adjustable bending section is located at the proximal end of the electrode device, the proximal end of the electrode device is connected to the distal end of the adjustable bending section, the bending control pull wire is arranged in the catheter body, the distal end of the bending control pull wire is connected to the adjustable bending section, and the proximal end of the bending control pull wire is connected to the bending control device.

[0015] In one embodiment, the electrode device is an annular structure, the electrode tube segment is shaped into a non-closed annular ring, a shaping wire is provided inside the annular ring, the distal end of the shaping wire extends to and is connected to the distal end of the annular ring, the proximal end of the shaping wire extends to and is connected to the proximal end of the annular ring, and the distal end of the bending control wire is connected to the proximal end of the shaping wire through an intermediate tube.

[0016] In one embodiment, the ring control device includes a ring control operating part and a ring control pull wire, the ring control pull wire is passed through the catheter body and the annular ring, the distal end of the ring control pull wire is connected to the distal end of the shaping wire, and the proximal end of the ring control pull wire is connected to the ring control operating part, and the ring control operating part is movably disposed at the proximal end of the catheter body.

[0017] In one embodiment, a magnetic positioning sensor is sleeved on the outer surface of the catheter body, and the magnetic positioning sensor is arranged along the axial direction of the catheter body.

[0018] In one embodiment, the electrode installation pipe segment is composed of a plurality of branch pipe segments, and the plurality of branch pipe segments are distributed along the circumference of the electrode device, and each branch pipe segment is provided with an electrode group.

[0019] In one embodiment, the circle control device includes a circle control operating part and a circle control rod, the circle control operating part is movably disposed at the proximal end of the catheter body, the circle control rod is movably passed through the catheter body, the distal ends of all the branch pipe segments are connected to the distal end of the circle control rod extending out of the distal end of the catheter body, the proximal end of the circle control rod is connected to the circle control operating part, and the proximal ends of all the branch pipe segments are connected to the distal end of the catheter body.

[0020] In one embodiment, at least three of the branch pipe segments are provided with magnetic positioning sensors, and the magnetic positioning sensors are sleeved on the outer surfaces of the branch pipe segments.

[0021] In one embodiment, each of the branch pipe segments includes a fixed region and deformation regions located on both sides of the fixed region, and the electrode group is disposed in the fixed region.

[0022] In one embodiment, a rigid shaping wire is provided in the fixing region, and a deformable shaping wire is provided in the deformation region.

[0023] In one embodiment, the radial dimension of the electrode device is 20 mm to 40 mm.

[0024] In one embodiment, a saline tube is further included. The saline tube is inserted into the catheter body and the electrode mounting tube section and is used to provide physiological saline to the ablation electrode. The ablation electrode is provided with a plurality of saline holes.

[0025] Based on the same inventive concept, the present invention also provides an ablation system, which includes a stimulation ablation body and any one of the pulmonary artery stimulation ablation catheters, wherein the stimulation ablation body is electrically connected to the pulmonary artery stimulation ablation catheter and is used to provide energy for stimulation and ablation to the pulmonary artery stimulation ablation catheter, and is used to determine the position of the sympathetic nerve based on the signal fed back by the stimulation electrode.

[0026] As mentioned above, in the pulmonary artery stimulation ablation catheter and ablation system provided by the present invention, on the one hand, the electrode device is configured as a ring structure or a cage structure that allows blood flow to pass through, so that the blood flow will not be completely blocked, thereby improving the safety of the operation. On the other hand, the electrode device limits a plurality of electrode groups, each electrode group includes a stimulation electrode and an ablation electrode, so that the pulmonary artery stimulation ablation catheter has both stimulation and ablation functions, and then the stimulation electrode discharge can be used to electrically stimulate the target area, and the position of the sympathetic nerves can be accurately found, and then ablation can be performed at a more precise sympathetic nerve position, thereby improving the treatment effect and avoiding problems such as poor treatment effect caused by blind ablation. Furthermore, the control circle device is connected to the electrode device, and can be used to adjust the radial size of the electrode device (i.e., the length in the diameter direction), so that the catheter can adapt to the needs of different individuals, and can also ensure that the electrode device is more closely attached to the blood vessel wall, making the stimulation and ablation process safer and more effective. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Those skilled in the art will appreciate that the accompanying drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention.

[0028] Figure 1 is a schematic structural diagram of a pulmonary artery stimulation ablation catheter according to an embodiment of the present invention, wherein the electrode device is a ring-shaped structure;

[0029] Figure 2 yes Figure 1 Schematic cross-sectional view of the middle pulmonary artery stimulation ablation catheter at the α-α position;

[0030] Figure 3 It corresponds to Figure 2Installation diagram of each accessory;

[0031] Figure 4 yes Figure 1 Schematic cross-sectional view of the middle pulmonary artery stimulation ablation catheter at the β-β position;

[0032] Figure 5 It corresponds to Figure 4 Installation diagram of each accessory;

[0033] Figure 6 is a schematic structural diagram of an electrode group according to an embodiment of the present invention;

[0034] Figure 7 is a schematic structural diagram of an electrode group according to another embodiment of the present invention;

[0035] Figure 8 is a schematic structural diagram of an ablation electrode according to an embodiment of the present invention;

[0036] Fig. 9 is a schematic structural diagram of an electrode device according to another embodiment of the present invention, wherein the electrode device is a cage-like structure;

[0037] Fig.10 For the corresponding Fig. 9 A top view of the middle electrode device;

[0038] Fig.11 for Fig. 9 Schematic diagram of the state changes of the middle electrode device.

[0039] The reference numerals in the accompanying drawings are described as follows;

[0040] 1-soft head; 2-ablation electrode; 201-distal platform; 203-proximal platform; 202-saline hole; 3-stimulation electrode; 4-electrode device; 41-electrode mounting pipe section; 42-electrode group; 43-branch pipe section; 5-adjustable bending section; 6-magnetic positioning sensor; 7-control circle operating part; 8-bending control device; 9-saline tube; 10-first cavity; 11-second cavity; 12, 20-third cavity; 13-fourth cavity; 14-shaping wire; 15-control circle pull wire; 16-temperature measuring wire; 17-electrode wire; 18-bending control pull wire; 19-magnetic positioning wire; 22-control circle pull rod; 23-fixing area; 24-deformation area; 101-handle. DETAILED DESCRIPTION

[0041] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the specific embodiments of the present invention are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present invention, so the present invention is not limited by the specific embodiments disclosed below.

[0042] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as limiting the present invention.

[0043] In addition, the terms "first", "second", "third", and "fourth" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Thus, a feature defined as "first", "second", "third", and "fourth" may explicitly or implicitly include at least one of the features. In the description of the present invention, the meaning of "multiple" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0044] In the present invention, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0045] In the present invention, unless otherwise clearly specified and limited, a first feature being "above" or "below" a second feature may mean that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediate medium. Moreover, a first feature being "above", "above" or "above" a second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. A first feature being "below", "below" or "below" a second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0046] It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be a central element. When an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. The terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used herein are for illustrative purposes only and are not intended to be the only implementation method.

[0047] The "proximal end" mentioned in this application document generally refers to the end close to the operator, and the "distal end" is the end opposite to the "proximal end", that is, the end far away from the operator. In addition, the term "axial" refers to the direction of the central axis, the "radial" is the direction perpendicular to the central axis, and the "circumferential" is the direction around the central axis.

[0048] Embodiment 1

[0049] like Figure 1 As shown, an embodiment of the present invention provides a pulmonary artery stimulation ablation catheter, which includes a catheter body and an electrode device 4. The electrode device 4 is arranged at the distal end of the catheter body. The electrode device 4 can be contracted and expanded; the radial dimension of the electrode device 4 is small when contracted, which is convenient for transportation and entry into smaller blood vessels; when the electrode device 4 is expanded, the radial dimension becomes larger, which is convenient for fitting the blood vessel wall. After the electrode device 4 is expanded, while supporting and positioning, it can also stimulate and ablate the sympathetic nerves through its own electrodes. The electrode device 4 is also configured as a structure that allows blood flow to pass through, so that the blood flow will not be completely blocked, thereby ensuring the safety of the operation.

[0050] For example, according to Figure 1 In the described embodiment, the electrode device 4 is configured as a ring structure that allows blood to flow through. Specifically, the electrode mounting tube section 41 in the electrode device 4 is formed into a non-closed annular ring, and the annular ring can be integrally formed with the catheter body. Figure 3As shown, a shaping wire 14 is provided inside the annular ring, the distal end of the shaping wire 14 extends to and is connected to the distal end of the annular ring, and the proximal end of the shaping wire 14 extends to and is connected to the proximal end of the annular ring. The shaping wire 14 is preferably a shape memory alloy wire, such as a shape memory material such as nickel-titanium alloy, stainless steel, titanium, etc.

[0051] The radial dimension of the electrode device 4 can be adjusted according to the width of the pulmonary artery of the individual to which it is applied, so that the electrode device 4 is closely and safely attached to the blood vessel wall. Preferably, the radial dimension of the electrode device 4 is 20 mm to 40 mm; when the size of the electrode device 4 is adjusted according to the radial dimension, the catheter can be applied to the pulmonary artery of different individuals to meet the treatment needs of different individuals.

[0052] Continue to refer to Figure 1 The catheter body includes an adjustable curved section 5. The adjustable curved section 5 is located at the proximal end of the electrode device 4. The proximal end of the electrode device 4 is connected to the distal end of the adjustable curved section 5. Figure 5 As shown, a bending control wire 18 is provided in the catheter body. The distal end of the bending control wire 18 is connected to the adjustable bending section 5, and the proximal end of the bending control wire 18 is connected to the bending control device 8. By operating the bending control device 8, the bending control wire 18 can be pulled to make the bending control wire 18 drive the adjustable bending section 5 to bend. The adjustable bending section 5 can be bent in multiple directions, and is not limited to bending in the same plane.

[0053] The distal end of the bending control wire 18 is also connected to the proximal end of the shaping wire 14, and the two are directly or indirectly connected. In view of the fact that the bending control wire 18 is harder and thicker than the shaping wire 14, if the two are directly connected, it is not easy to ensure the connection strength. For this reason, the bending control wire 18 and the shaping wire 14 can be connected by an intermediate tube, one end of the intermediate tube along the axial direction is connected to the shaping wire 14, and the other end of the intermediate tube along the axial direction is connected to the bending control wire 18, so that the connection strength between the bending control wire 18 and the shaping wire 14 can be strengthened. The intermediate tube can be a two-section tube.

[0054] like Figure 1 As shown, the pulmonary artery stimulation ablation catheter may further include a handle 101, and the bending control device 8 may be movably disposed on the handle 101. For example, the bending control device 8 includes a knob or a push knob, and the proximal end of the bending control wire 18 may be fixed on the knob or the push knob.

[0055] Furthermore, the radial size of the electrode device 4 is adjustable, so as to be able to adapt to the needs of different individuals. To this end, the pulmonary artery stimulation ablation catheter also includes a control ring device connected to the electrode device 4, which is used to adjust the radial size of the electrode device 4 so that the radial size of the electrode device 4 can be adjusted to a certain suitable size, ensuring that the electrode device 4 is closely attached to the blood vessel wall, making the stimulation and ablation process safer and more effective.

[0056] The structure of the control ring device can be flexibly set according to the structure of the electrode device 4, as long as the control ring device can act on the electrode device 4, so that the electrode device 4 is expanded or contracted under the action of the control ring device.

[0057] like Figure 1 , Figure 3 and Figure 5 As shown, in an illustrative embodiment, the ring control device includes a ring control operating part 7 and a ring control pull wire 15, and the ring control pull wire 15 is inserted into the catheter body and the annular ring. During assembly, the distal end of the ring control pull wire 15 is connected to the distal end of the shaping wire 14, and the proximal end of the ring control pull wire 15 is connected to the ring control operating part 7, and the ring control operating part 7 is movably arranged at the proximal end of the catheter body. By operating the ring control operating part 7, the ring control pull wire 15 can be pulled, and then the ring control pull wire 15 acts on the annular ring to adjust the size of the annular ring. For example, the ring control operating part 7 includes a ring control knob, which is rotatably arranged at the proximal end of the catheter body, and the proximal end of the ring control pull wire 15 can be fixed on the ring control knob.

[0058] The bending control device 8 and the ring control operating part 7 are suitable to be arranged at a certain distance to prevent mutual influence and interference, and are easier to implement and more convenient to use from a process point of view. As in this embodiment, the ring control operating part 7 is arranged at the far end (i.e., the front end) of the bending control device 8, and the two are kept at a distance. At the same time, the ring control wire 15 and the bending control wire 18 are also arranged in different cavities to separate the two.

[0059] Continue to refer to Figure 1 The electrode device 4 includes an electrode mounting tube section 41 and a plurality of electrode groups 42 disposed on the electrode mounting tube section 41. The plurality of electrode groups 42 are sequentially disposed along the circumference of the electrode device 4. Each electrode group 42 includes an ablation electrode 2 and a stimulation electrode 3 arranged along the axial direction of the electrode mounting tube section 41. Specifically, with respect to the annular ring, the circumferential direction of the electrode device 4 is the circumferential direction of the annular ring, and the axial direction of the electrode mounting tube section 41 is the length extension direction of the annular ring.

[0060] The ablation electrodes 2 and stimulation electrodes 3 in each electrode group 42 do not overlap each other. A safe distance is maintained between the ablation electrodes 2 and the stimulation electrodes 3, for example, a distance of 1 mm to 2 mm. Both the ablation electrodes 2 and the stimulation electrodes 3 are ring electrodes, which are directly sleeved on the outer surface of the electrode mounting tube section 41. The stimulation electrode 3 is used to discharge and stimulate the target area to extract nerve signals, and then determine the position of the nerve to be ablated (i.e., the ablation target point). The ablation electrode 2 is also used to discharge to ablate the position of the sympathetic nerves. The stimulation electrode 3 and the ablation electrode 2 discharge separately. In actual operation, a back pole plate can be placed under the patient's body; during electrical stimulation, the stimulation electrode 3 and the back pole plate form a loop to implement discharge stimulation to the target area; during ablation, the ablation electrode 2 forms a loop with the back pole plate to implement discharge ablation at the position of the sympathetic nerves. In this way, by using a combination of the stimulation electrode 3 and the ablation electrode 2, the pulmonary artery stimulation ablation catheter has both stimulation and ablation functions, and when searching for ablation targets, the stimulation electrodes 3 in each electrode group 42 can be used to accurately search for ablation targets in the entire circumference of the blood vessel, avoiding blindness, and making it easier for the surgeon to more accurately determine the position of the sympathetic nerves before performing ablation, thereby ensuring the ablation treatment effect and avoiding problems such as poor treatment effects caused by blind ablation.

[0061] The present application does not limit the number of electrode groups 42. The number of electrode groups 42 is usually determined according to the structure of the electrode device 4 and the size of the ablation site. Figure 1 For the described annular ring, the number of electrode groups 42 can be 7 to 10; in this way, the electrode device 4 can accurately locate the position of the sympathetic nerves, and effectively stimulate and ablate the sympathetic nerves. At the same time, the annular ring can also support the positioning with sufficient points to reduce the movement of the catheter.

[0062] like Figure 6 and Figure 7 As shown, the stimulation electrode 3 is a relatively short metal ring, and the ablation electrode 2 is a boss-type structure with a high middle and low ends. The materials of the stimulation electrode 3 and the ablation electrode 2 are not limited, for example, they are made of metal materials such as stainless steel, platinum-iridium alloy, gold, and nickel alloy. The length of the stimulation electrode 3 is preferably about 1 mm, and the length of the ablation electrode 2 is generally about 3 mm, but it is not limited to this.

[0063] Figure 6 What is described is a structural form of an electrode group 42, wherein the electrode group 42 uses a stimulation electrode 3 and an ablation electrode 2, which can achieve the correspondence between the stimulation area and the ablation area. This structural design can meet basic stimulation and ablation requirements and save materials.

[0064] Figure 7What is described is another structural form of the electrode group. In this case, the electrode group 42 uses two stimulation electrodes 3 and one ablation electrode 2, and the ablation electrode 2 is located between the two stimulation electrodes 3. This structural design is more conducive to nerve positioning during surgery, and there is no need to add more stimulation electrodes 3. In more detail, the stimulation area stimulated by the two stimulation electrodes 3 corresponds well to the ablation area ablated by one ablation electrode 2. Therefore, there will be no obvious ablation weak area, so that the actual ablation point covers the actual stimulation area, thereby achieving precise ablation and improving the effectiveness and safety of ablation. Moreover, when the catheter stimulates the ablation target, the ablation of the same point can be completed by discharging the corresponding ablation electrode 2 without moving the entire catheter, which can avoid the operation of repositioning due to the movement of the catheter. In this way, while ensuring precise ablation, it also simplifies the surgical operation and reduces the difficulty of the surgical operation. However, no matter what combination is used, the stimulation electrode 3 is first used to electrically stimulate the target area to explore the ablation target, and after ablation, the ablation target can be evaluated by electrical stimulation.

[0065] according to Figure 7 In the described embodiment, the sizes of the two stimulation electrodes 3 may be the same or different. Preferably, the sizes of the two stimulation electrodes 3 are the same, and the same size includes the same length and diameter. In addition, the spacing between the ablation electrode 2 and the two adjacent stimulation electrodes 3 may be the same or different, and preferably, the spacing between the two stimulation electrodes 3 and the ablation electrode 2 is the same.

[0066] Return to reference Figure 1 The distal end of the electrode device 4 is usually provided with a soft tip 1, which can reduce damage to tissues and blood vessels. The soft tip 1 is an injection molded part made of common soft polymer materials such as Pebax or PU, which is embedded in the farthest end of the entire catheter body, not only forming a non-damaged end, but also used to seal the distal end of the electrode device 4.

[0067] The following is a further description of the usage of the pulmonary artery stimulation ablation catheter described in the embodiment of the present invention.

[0068] The pulmonary artery stimulation ablation catheter of the present invention can be inserted through the catheter sheath placed in the pulmonary artery, and finally the pulmonary artery stimulation ablation catheter is placed in a suitable position. After positioning, the outer side of the electrode device 4 contacts the blood vessel wall, and will not completely block the blood flow, thereby ensuring the safety of the operation. However, the present invention does not limit the surgical path of the catheter sheath. Generally, for PADN technology, it is accessed through the jugular (or femoral) vein, and the commonly used operation is the femoral vein access. The specific understanding can be referred to the prior art, and the present invention will not be described in detail.

[0069] by Figure 1The described annular ring (i.e., an example of the electrode device 4) is for illustration. In actual use, a catheter sheath of corresponding size is used to transport the pulmonary artery stimulation ablation catheter from outside the body to the target position inside the body. During the transportation process, the annular ring is received in the catheter sheath and stretched into a straight shape under the constraint of the catheter sheath. After the distal end of the pulmonary artery stimulation ablation catheter extends out of the catheter sheath, the annular ring can restore its shape with the help of the internal shaping wire 14. In this way, the pulmonary artery stimulation ablation catheter can be moved in complex structures such as veins, arteries, and heart in the body through the cooperation of the catheter sheath and the pulmonary artery stimulation ablation catheter until it reaches the target position in the body. After reaching the target position, the annular ring is closely attached to the pulmonary artery blood vessel wall. After reaching the target position, the stimulation electrode 2 can be used to electrically stimulate the blood vessel wall, and the sympathetic nerve position (i.e., ablation target) can be determined by corresponding heart rate, impedance and other change data. After the sympathetic nerve position to be ablated is selected according to the electrical stimulation, the ablation electrode 3 is used to ablate the selected sympathetic nerve position without moving the catheter. During the ablation process, physiological saline may also be delivered through the saline tube 9 to cool the body during the ablation process and avoid burning vascular tissue.

[0070] Reference Figure 1 As shown, in an exemplary embodiment, the pulmonary artery radiofrequency ablation catheter further includes a saline tube 9, which is arranged in the catheter body and the electrode installation tube section 41, and can provide physiological saline to the ablation electrode 2 on the electrode device 4. The physiological saline finally input can pass through the saline hole 202 on the ablation electrode 3 (see Figure 8 ) release. The proximal end of the saline tube 9 can be connected to a pump. The flow rate of the physiological saline can be regulated by the pump to ensure safety and effectiveness.

[0071] Reference Figure 8 As shown, the ablation electrode 2 is a boss-type structure, and the boss-type structure has a middle boss, and a plurality of saline holes 202 are arranged on the middle boss, and the saline holes 202 are connected to the saline tube 9. The middle boss can form a cavity inside (shown by the dotted line), so that the physiological saline flows slowly in the internal cavity, and the saline in the cavity flows out through the saline holes 202 to cool the perfusion surface. The number and distribution of the saline holes 202 can be set as required. Preferably, a plurality of saline holes 202 are evenly distributed on the middle boss, for example, 4 saline holes 202 can be set. After the physiological saline diffuses outward from the saline tube 9 through the saline holes 202 on the ablation electrode 2, it quickly fills the gap between the ablation electrode 2 and the catheter, and is sprayed out from the saline holes 202 to cool the active surface during ablation. Saline perfusion can reduce the damage to the blood vessel wall caused by ablation and increase the ablation depth, thereby improving the ablation effect.

[0072] The two sides of the middle boss of the ablation electrode 2 are the distal platform 201 and the proximal platform 203, and the proximal platform 203 is farther away from the distal end of the electrode device 4 than the distal platform 201. The outer diameters of the distal platform 201 and the proximal platform 203 are the same, and both are smaller than the outer diameter of the middle boss, thereby forming a step. The ablation electrode 2 is fixed to the electrode mounting tube segment 41 (such as adhesive fixation) through the distal platform 201 and the proximal platform 203, that is, the inner diameters of the distal platform 201 and the proximal platform 203 match the outer diameter of the electrode mounting tube segment 41. The inner diameter of the middle boss is larger than the outer diameter of the electrode mounting tube segment 41, so that a cavity is formed between the inner side of the middle boss and the outer surface of the electrode mounting tube segment 41. The length of the distal platform 201 and the length of the proximal platform 203 can be the same or different. Preferably, the length of the proximal platform 203 is greater than that of the distal platform 201. This makes it easier to weld the electrode wire 17, reduces the difficulty of the manufacturing process, and allows the electrode wire 17 to be welded more securely.

[0073] In order to monitor the ablation temperature, a temperature sensor (not shown) may be provided on the ablation electrode 2 to monitor the surface temperature of the ablation electrode 2. The temperature sensor is connected to the temperature measuring wire 16. The temperature measuring wire 16 extends through the catheter body and is connected to the stimulation ablation body outside the body. The stimulation ablation body can monitor the ablation temperature based on the temperature information fed back by the temperature sensor. In addition, all the electrode wires 17 extend through the catheter body and are connected to the stimulation ablation body outside the body, and the stimulation ablation body can output electrical stimulation energy (corresponding to pulse signals) to the stimulation electrode 3 and the ablation electrode 2. As can be understood by those skilled in the art, the stimulation ablation body may include any signal generator capable of outputting pulse waves and radio frequencies, such as a radio frequency instrument.

[0074] It should also be recognized that after reaching the target position, in order to adapt to the physiological structure of different individuals, the electrode device 4 also has the functions of adjustable bending and variable diameter: on the one hand, the bending control wire 18 can be pulled by the bending control device 8 to control the bending of the adjustable bending section 5, and the adjustable bending section 5 can be deflected in the positive and negative directions in the same plane, and the deflection angle can reach -90° to 90°. In this way, the electrode device 4 can be better attached to the blood vessel wall at positions with complex physiological structures in the body (such as atria and ventricles) and at similar positions (such as the bifurcation of the left and right pulmonary arteries); on the other hand, the radial size of the electrode device 4 can be adjusted by pulling the control ring wire 15 through the control ring operating part 7 to make it adapt to the blood vessel size of different individuals, and also make the electrode device 4 more closely and safely attached.

[0075] In terms of positioning, the pulmonary artery stimulation ablation catheter of the present invention preferably uses a magnetic positioning sensor 6 for positioning to avoid contrast agent positioning during surgery. Figure 1In the described embodiment, the magnetic positioning sensor 6 is sleeved on the outer surface of the catheter body. Preferably, there are two magnetic positioning sensors 6, and both magnetic positioning sensors 6 are sleeved on the outer surface of the catheter body and arranged along the axial direction of the catheter body. All magnetic positioning sensors 6 are connected to the stimulation ablation body through the magnetic positioning wire 19 to transmit the sensing signal of the magnetic positioning sensor 6 to the stimulation ablation body. The stimulation ablation body can amplify, filter and other processing on the sensing signal of the magnetic positioning sensor 6 to obtain the position of the catheter. In this way, when the pulmonary artery stimulation ablation catheter moves and ablates, a three-dimensional model of the physiological structure in the patient's body can be provided by two magnetic positioning sensors 6, which is convenient for the surgical operator to more thoroughly understand the patient's internal condition and make the selection of the target position more accurate. Because the magnetic positioning sensor 6 is sleeved on the catheter body instead of being arranged inside the catheter body, it can avoid occupying too much space inside the catheter body and avoid increasing the catheter diameter.

[0076] The electrode installation tube section 41 and the catheter body are both multi-lumen tubes, and the number of lumens is set according to needs, such as a three-lumen tube, a four-lumen tube or more lumens, and the more suitable number of lumens is not more than four.

[0077] Reference Figure 2 and Figure 3 In one embodiment, the electrode installation tube section 41 is a four-lumen tube, which is defined as: a first cavity 10, a second cavity 11, a third cavity 12 and a fourth cavity 13, and these cavities are all sealed at the soft head 1, such as glue bonding sealing or heat welding sealing inside the soft head 1. Among them, the electrode wire 17 is arranged in the first cavity 10 of the electrode installation tube section 41, and a temperature measuring wire 16 can be further arranged; a saline tube 9 is arranged in the second cavity 11; a shaping wire 14 is arranged in the third cavity 12; and a control ring pull wire 15 is arranged in the fourth cavity 13. In this way, it is convenient to effectively integrate various functions on the annular ring, and basically there is no need to use a thicker tube and a more complex structure to prepare the annular ring. Compared with the prior art, the present invention can be implemented using a 6F catheter, so it can be thinner and smaller in size.

[0078] Reference Figure 4 and Figure 5 In one embodiment, the catheter body is also a four-lumen tube, which is also defined as: a first cavity 10, a second cavity 11, a third cavity 20 and a fourth cavity 13. The difference from the electrode installation tube section 41 is that the third cavity 20 of the catheter body is provided with a bending control wire 18 instead of a shaping wire 14.

[0079] Of course, the first cavity 10, the second cavity 11, the third cavity 12 and the fourth cavity 13 of the electrode installation tube section 41 are connected to the first cavity 10, the second cavity 11, the third cavity 20 and the fourth cavity 13 of the catheter body in a one-to-one correspondence. Further, at least part of the wires in the first cavity 10 are separated by a protective cover to prevent the wires from being entangled with each other. The protective cover can be made of soft tubing such as PI material.

[0080] Embodiment 2

[0081] The structure is basically similar to that of the first embodiment, except that the electrode device 4 of the second embodiment adopts a cage structure, gaps are formed between the branch pipe sections 43 of the cage structure to facilitate blood flow, the proximal and distal ends of the cage structure are sealed, and in addition, the control ring pull rod 22 replaces the control ring pull wire 15 to control the extension and contraction of the electrode device 4. It should be noted that the parts of the second embodiment that are the same as those of the first embodiment will not be described in detail, and the details can be referred to the first embodiment.

[0082] like Figures 9 to 11 As shown, the electrode mounting pipe segment 41 in the second embodiment is composed of a plurality of branch pipe segments 43, and the plurality of branch pipe segments 43 are distributed along the circumference of the electrode device 4. At this time, an electrode group 42 is provided on each branch pipe segment 43, and all branch pipe segments 43 extend along the axial direction of the catheter body. Further, the proximal ends of all branch pipe segments 43 are directly or indirectly connected to the catheter body, and the distal ends of all branch pipe segments 43 are connected to the distal ends of the control ring pull rod 22 in the control ring device. The proximal end of the control ring pull rod 22 is connected to the control ring operating part 7. By operating the control ring operating part 7, the control ring pull rod 22 is pushed or pulled, so that the control ring pull rod 22 acts on each branch pipe segment 43, so that each branch pipe segment 43 is synchronously extended or contracted. At this time, the radial size of the electrode device 4 is changed by adjusting the curvature of each branch pipe segment 43.

[0083] The number of branch pipe segments 43 is 4 or more. If saline perfusion is required, a maximum of 8 branch pipe segments 43 are provided, so as not to increase the pipe diameter and to have enough space to accommodate various accessories such as wires and saline tubes 9. If saline perfusion is not required, more branch pipe segments 43 may be provided. Preferably, the number of branch pipe segments 43 does not exceed 8. During saline perfusion, only one saline tube 9 is provided, and physiological saline is simultaneously delivered to all branch pipe segments 43 by one saline tube 9, so as to save materials and conduit space.

[0084] In this embodiment, each branch pipe segment 43 can be configured as a multi-lumen tube, such as a three-lumen tube or a four-lumen tube, and the structure and function are similar to the single electrode mounting pipe segment 41 in the first embodiment, and will not be described in detail.

[0085] Further, according to Fig.11 The deformation of the cage structure can be understood by the explanation. Fig.11 As shown, the electrode device 4 has at least Fig.11 The electrode device 4 is shown in the A state, B state and C state; the A state is the contracted state, the electrode device 4 contracts radially and stretches axially; the B state is the intermediate stretching state, and has not yet been expanded to the maximum diameter; the C state is the maximum stretching state, the electrode device 4 is expanded to the maximum diameter and the axial direction is the shortest; the electrode device 4 can be transformed between these states. In this way, the electrode device 4 can be expanded and contracted under the action of the control ring device, and the shape of the electrode device 4 after expansion is roughly a spindle. Even if Fig.11 In the C state shown, when in the maximum stretching state, the electrode groups 42 on each branch tube segment 43 still maintain a state relative to the same axis, which is conducive to stimulating and ablating by sticking to the blood vessel wall.

[0086] The control ring pull rod 22 is a rod capable of bearing pressure, and is made of hard materials, such as common hard materials such as polyurethane or metal materials. When regulation is required, the catheter body is kept stationary, and the curvature of each branch pipe segment 43 can be adjusted by simply pulling the control ring pull rod 22. Another adapter tube can be set in the catheter body. The adapter tube is a shorter tube that directly connects the proximal ends of all branch pipe segments 43 to the adapter tube, and then fixes the adapter tube to the catheter body. The adapter tube is equivalent to a slider, which can be slidably sleeved on the control ring pull rod 22.

[0087] Furthermore, if Fig. 9 As shown, each branch pipe segment 43 includes a fixed area 23 and a deformation area 24 located on both sides of the fixed area 23. The deformation area 24 can be deformed under force to control the curvature of the branch pipe segment 43. A deformable shaping wire 14 can be arranged inside the deformation area 24, such as using a metal wire such as nickel-titanium alloy or stainless steel, so as to constrain the shape of the branch pipe segment 43 through the deformable shaping wire 14, and make the branch pipe segment 43 only bend centripetally after being stressed, that is, protrude outward. The fixed area 23 is deformed very little or basically not deformed after being stressed, and is always in the position of maximum diameter. A rigid shaping wire 14 can be arranged inside the fixed area 23, such as using a metal or other material that is not easily deformed, so that the fixed area 23 can keep its own shape unchanged or slightly deform when the branch pipe segment 43 is stressed. The electrode group 42 is arranged on the fixed area 23 to ensure that the electrode group 42 can be close to the blood vessel wall.

[0088] In the embodiment described in the figure, the number of branch segments 43 is 6, and an electrode group 42 is arranged on each branch segment 43, and the electrode group 42 is composed of an ablation electrode 2 and two stimulation electrodes 3. However, it should be understood that the number of branch segments 43 is not limited to 6, and the structure of the electrode group 42 on the branch segment 43 is not limited to this. The 6 branch segments 43 are distributed circumferentially around the axis of the entire catheter body. When viewed from the distal end to the proximal end along the axial direction, the electrode device 4 is hexagonal in shape, and the 6 branch segments 43 are basically symmetrically distributed. At this time, the entire catheter body is coaxial, which is different from Figure 1The electrode mounting tube section 41 on the middle ring coil is not coaxial with the catheter body.

[0089] Operation method: Fig.11 As shown, when the pulmonary artery stimulation ablation catheter is transported from outside the body to the ablation position through the catheter sheath, the electrode device 4 contracts to the A state; when reaching the target position, the electrode device 4 can be adjusted according to the width of the blood vessel until the electrode device 4 reaches the appropriate B state or C state to closely adhere to the blood vessel wall; even at the maximum diameter in the C state, due to the non-deformability of the fixed area 23, the electrode groups 42 on each branch pipe segment 43 still maintain a state relative to the same axis.

[0090] Furthermore, in this embodiment, at least three branch pipe segments 43 are also provided with magnetic positioning sensors 6, which are sleeved on the outer surface of the branch pipe segment 43, and only one magnetic positioning sensor 6 is provided on the corresponding branch pipe segment 43, so as to perform magnetic positioning. Such a magnetic positioning method can monitor the extension and contraction degree of the branch pipe segment 43, so as to accurately measure the width of the blood vessel where the electrode device 4 is located, so that the surgical operator can more accurately adjust the radial dimension of the electrode device 4 to ensure that the electrode device 4 can be closely attached to the blood vessel wall.

[0091] Finally, based on the same inventive concept, an embodiment of the present invention also provides an ablation system, which includes a stimulation ablation body and a pulmonary artery stimulation ablation catheter provided by any embodiment, wherein the stimulation ablation body is electrically connected to the pulmonary artery stimulation ablation catheter and is used to provide energy for stimulation and ablation to the pulmonary artery stimulation ablation catheter. The stimulation ablation body can integrate the functions of control and energy output. For example, the position of the sympathetic nerve can be determined according to the signal fed back by the stimulation electrode. As described above, the position of the sympathetic nerve can be determined by corresponding heart rate, impedance and other change data. It can also have a temperature monitoring function, and can monitor the ablation temperature according to the temperature data fed back by the temperature sensor. For the stimulation ablation body, those skilled in the art can know how to set the stimulation ablation body to achieve the corresponding functions and / or effects based on the disclosure of this application and the common knowledge in the field. Specifically, this application will not elaborate on it.

[0092] In summary, the present invention provides a multifunctional pulmonary artery stimulation ablation catheter that combines stimulation and ablation, so that the operator can perform surgery at a more precise sympathetic nerve location, avoid over-reliance on the operator's experience, and improve the accuracy of the surgery. The combination of stimulation and ablation also allows the operator to adapt to individual differences in surgical locations among different patients, avoiding problems such as poor treatment effects caused by blind ablation. In particular, when the electrode device adopts a spindle-shaped cage structure, the blood vessel width can be measured more accurately, thereby adjusting the radial size of the electrode device under more accurate measurement results, so that the electrode device can better adhere to the blood vessel wall, thereby improving the safety and effectiveness of the surgery.

[0093] The above description is only a description of the preferred embodiment of the present invention, and is not intended to limit the scope of the present invention. Any changes or modifications made by a person skilled in the art in the field of the present invention based on the above disclosure shall fall within the scope of protection of the technical solution of the present invention.

Claims

1. A pulmonary artery stimulation ablation catheter, characterized in that: include: a catheter body; An electrode device is arranged at the distal end of the catheter body, the electrode device can be contracted and expanded, and is configured as a ring structure or a cage structure that allows blood to flow through, the electrode device includes an electrode mounting tube segment and a plurality of electrode groups arranged on the electrode mounting tube segment, the plurality of electrode groups are arranged in sequence along the circumference of the electrode device, each of the electrode groups includes an ablation electrode and a stimulation electrode arranged along the axial direction of the electrode mounting tube segment, the stimulation electrode and the ablation electrode are both ring electrodes; and, A control ring device connected to the electrode device, wherein the control ring device is used to adjust the radial dimension of the electrode device.

2. The pulmonary artery stimulation ablation catheter according to claim 1, characterized in that: The number of the ablation electrode in each of the electrode groups is one, and the number of the stimulation electrodes in each of the electrode groups is one or two. When the number of the stimulation electrodes in the electrode group is two, the ablation electrode is arranged between the two stimulation electrodes.

3. The pulmonary artery stimulation ablation catheter according to claim 2, characterized in that: When the number of the stimulation electrodes in the electrode group is two, the sizes of the two stimulation electrodes are the same or different, and the distances between the two stimulation electrodes and the ablation electrode are the same or different.

4. The pulmonary artery stimulation ablation catheter according to claim 1, characterized in that: The ablation electrode is a boss-type structure having a middle boss and a proximal platform and a distal platform located on both sides of the middle boss. The outer diameters of the proximal platform and the distal platform are both smaller than the outer diameter of the middle boss, and the length of the proximal platform is greater than the length of the distal platform.

5. The pulmonary artery stimulation ablation catheter according to claim 1, characterized in that: It also includes a bending control device and a bending control pull wire. The catheter body includes an adjustable bending section, which is located at the proximal end of the electrode device. The proximal end of the electrode device is connected to the distal end of the adjustable bending section. The bending control pull wire is arranged in the catheter body, the distal end of the bending control pull wire is connected to the adjustable bending section, and the proximal end of the bending control pull wire is connected to the bending control device.

6. The pulmonary artery stimulation ablation catheter according to claim 5, characterized in that: The electrode device is an annular structure, the electrode tube segment is shaped into a non-closed annular ring, a shaping wire is provided inside the annular ring, the distal end of the shaping wire extends to and is connected to the distal end of the annular ring, the proximal end of the shaping wire extends to and is connected to the proximal end of the annular ring, and the distal end of the bending control wire is connected to the proximal end of the shaping wire through an intermediate tube.

7. The pulmonary artery stimulation ablation catheter according to claim 6, characterized in that: The ring control device includes a ring control operating part and a ring control pull wire. The ring control pull wire is passed through the catheter body and the annular ring. The distal end of the ring control pull wire is connected to the distal end of the shaping wire, and the proximal end of the ring control pull wire is connected to the ring control operating part. The ring control operating part is movably arranged at the proximal end of the catheter body.

8. The pulmonary artery stimulation ablation catheter according to claim 6, characterized in that: A magnetic positioning sensor is sleeved on the outer surface of the catheter body, and the magnetic positioning sensor is arranged along the axial direction of the catheter body.

9. The pulmonary artery stimulation ablation catheter according to claim 1, characterized in that: The electrode installation pipe section is composed of a plurality of branch pipe sections, and the plurality of branch pipe sections are distributed along the circumference of the electrode device, and each branch pipe section is provided with an electrode group.

10. The pulmonary artery stimulation ablation catheter according to claim 9, characterized in that: The circle control device includes a circle control operating part and a circle control rod. The circle control operating part can be movably arranged at the proximal end of the catheter body, and the circle control rod can be movably passed through the catheter body. The distal ends of all the branch pipe sections are connected to the distal end of the circle control rod extending out of the distal end of the catheter body, and the proximal end of the circle control rod is connected to the circle control operating part, and the proximal ends of all the branch pipe sections are connected to the distal end of the catheter body.

11. The pulmonary artery stimulation ablation catheter according to claim 9, characterized in that: At least three of the branch pipe sections are provided with magnetic positioning sensors, and the magnetic positioning sensors are sleeved on the outer surfaces of the branch pipe sections.

12. The pulmonary artery stimulation ablation catheter according to claim 9, characterized in that: Each of the branch pipe segments includes a fixed area and deformation areas located on both sides of the fixed area, and the electrode group is arranged in the fixed area.

13. The pulmonary artery stimulation ablation catheter according to claim 12, characterized in that: A rigid shaping wire is arranged in the fixing area, and a deformable shaping wire is arranged in the deformation area.

14. The pulmonary artery stimulation ablation catheter according to claim 1, characterized in that: The radial dimension of the electrode device is 20 mm to 40 mm.

15. The pulmonary artery stimulation ablation catheter according to claim 1, characterized in that: It also includes a saline tube, which is inserted into the catheter body and the electrode installation tube section and is used to provide physiological saline to the ablation electrode. The ablation electrode is provided with a plurality of saline holes.

16. An ablation system, characterized in that: It comprises a stimulation and ablation body and a pulmonary artery stimulation and ablation catheter as described in any one of claims 1 to 15, wherein the stimulation and ablation body is electrically connected to the pulmonary artery stimulation and ablation catheter and is used to provide energy for stimulation and ablation to the pulmonary artery stimulation and ablation catheter, and is used to determine the position of the sympathetic nerve according to the signal fed back by the stimulation electrode.

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