Self-expanding pulse energizing device
By designing a self-expanding pulse energization device, the combination of multi-cavity parts, shape memory parts and electrode parts is used to solve the problems of complex structure and high processing difficulty of PFA catheter, achieving efficient and selective tissue ablation, and improving reproductivity.
Patent Information
- Application Number
- CN202421162480.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-05-27
- Publication Date
- 2025-04-18
- Estimated Expiration
- 2034-05-27
Smart Images
Figure CN222765241U_ABST
Abstract
Description
Technical Field
[0001] The utility model belongs to the technical field of medical equipment, and particularly relates to a self-expanding pulse electrification device. Background Art
[0002] Atrial fibrillation is the most common arrhythmia, which may lead to stroke, cardiomyopathy, and even death in severe cases. The incidence of atrial fibrillation increases with age, and percutaneous catheter ablation is the first-line treatment for atrial fibrillation and has been widely recognized. The purpose of ablation is to destroy the potential arrhythmic myocardial tissue, prevent the propagation of abnormal electrical signals, or destroy the conduction of abnormal electrical signals in cardiac tissue.
[0003] Pulsed field ablation (PFA) is a new type of tissue ablation method based on high-voltage pulse energy that has emerged in recent years. It mainly uses the principle of irreversible electroporation (IRE) to act on cells through high-voltage pulse electric fields, causing irreversible perforation of the cell membrane, thereby gradually causing cell necrosis and ultimately achieving the purpose of tissue ablation. Due to the different damage thresholds of tissue electrical properties and cells to high-voltage pulse energy, PFA has good tissue selectivity. For example, myocardial tissue is more sensitive to high-voltage pulse electric fields, while neural tissue has a higher tolerance to pulse electric fields. Therefore, by reasonably selecting the intensity of high-voltage pulse electric fields, selective tissue ablation can be achieved, such as tissue ablation near nerves and blood vessels. In addition to the above-mentioned tissue selectivity, PFA is generally considered to be a non-thermal ablation technology, that is, the ablation process does not generate any heat or tissue temperature rise, which can eliminate the heat sink effect existing in traditional ablation methods such as radiofrequency, microwave, and cryoablation. Therefore, PFA is considered to have strong advantages in ablation of temperature-sensitive tissues (such as tissues near the gallbladder, bile duct, esophagus, etc.). Especially when performing ablation for atrial fibrillation, PFA has the advantages of short ablation time and can protect tissues such as the treatment area or blood vessels.
[0004] When performing PFA ablation for atrial fibrillation, it is necessary to quickly ablate the circumferential pulmonary veins and ensure that the catheter electrodes are close to each other, so the design of the PFA catheter is crucial. However, the existing PFA catheter has a complex structure and is difficult to produce and process, which increases the difficulty of PFA catheter production. Utility Model Content
[0005] In view of this, the utility model provides a self-expanding pulse current supply device to solve the problems of complex structure and high difficulty in processing and manufacturing of the self-expanding pulse current supply device.
[0006] To solve the above problems, the technical solution of the utility model is achieved as follows:
[0007] A self-expanding pulse current-carrying device comprises: a multi-cavity member having a central cavity and a plurality of peripheral cavities surrounding the central cavity, wherein the peripheral cavities and the central cavity extend axially and are not interconnected, the thickness of the multi-cavity member is greater than a preset value, the portion of the multi-cavity member between the axial proximal end and the axial distal end is cut axially into a plurality of sub-tube portions separated circumferentially, each of the sub-tube portions having one peripheral cavity inside, and each of the sub-tube portions being provided with a through hole connected to the peripheral cavity; a shape memory member arranged in each of the sub-tube portions, the shape memory member having a predetermined shape to drive each of the sub-tube portions to protrude outward in a curved shape; an electrode member sleeved on each of the sub-tube portions to pass a pulse current when the sub-tube portions protrude outward in a curved shape.
[0008] In some embodiments, the shape memory component is disposed in a surrounding cavity of the sub-tube portion, and one end of the shape memory component is connected to a distal end of the multi-cavity component.
[0009] In some embodiments, each of the electrode members is connected to an insulated electrical lead disposed in the surrounding cavity, and the length of the sub-tube portion is 30 mm-80 mm.
[0010] In some embodiments, the insulated electrical lead includes a conductive core and an insulating layer, the conductive core is connected to the electrode member, the insulating layer is provided with multiple layers, each of the insulating layers is successively sleeved on the conductive core and extends along the length direction of the conductive core; wherein each of the insulating layers is coaxially arranged with the conductive core.
[0011] In some embodiments, a woven layer is provided in the multi-cavity member, and the woven layer extends from the proximal end toward the direction close to the sub-tube portion and does not extend into the sub-tube portion area; wherein, in the radial direction, the woven layer is provided on the outer side of each of the surrounding cavities.
[0012] In some embodiments, the braided layer is disposed around the circumference of the multi-cavity member, and each of the surrounding cavities is located in the area surrounded by the braided layer.
[0013] In some embodiments, perpendicular to the length direction of the multi-cavity member, the cross-sectional shapes of the surrounding cavities are at least partially the same; wherein the inner wall surface of the surrounding cavity is a smooth curved surface.
[0014] In some embodiments, the electrode member is formed with a receiving hole for inserting the sub-tube portion; wherein a pressure equalizing structure is provided on the discharge side of the electrode member; or a pressure equalizing ring is connected to the discharge side of the electrode member, and a pressure equalizing structure is provided on the pressure equalizing ring.
[0015] In some embodiments, perpendicular to the length direction of the sub-tube portion, at least the cross-sectional shape of the accommodating hole is the same as the shape of the outer edge of the cross-sectional shape of the sub-tube portion, and the electrode member is attached to the outer wall of the sub-tube portion.
[0016] In some embodiments, perpendicular to the length direction of the sub-tube portion, the shape of the outer edge of the cross section of the electrode member is the same as the shape of the outer edge of the cross section of the sub-tube portion.
[0017] In some embodiments, a positioning sensor for positioning is disposed in at least any one of the sub-tube portions, and the positioning sensor is close to the proximal end of the multi-lumen member.
[0018] The embodiment of the utility model provides a self-expanding pulse energizing device, including a multi-cavity part, a shape memory part and an electrode part. The multi-cavity part has a central cavity and a plurality of peripheral cavities surrounding the central cavity. A plurality of sub-tubes separated in the circumferential direction are formed by axially cutting the part between the proximal end and the distal end of the multi-cavity part. Each sub-tube has a peripheral cavity inside, and an electrode part is arranged in each sub-tube. At the same time, a shape memory part is arranged in each sub-tube, so that each sub-tube can be driven to protrude outward in a curved shape, and a pulse current is passed to the electrode part when the sub-tube is protruding outward in a curved shape, so as to achieve discharge and achieve the purpose of tissue ablation. The embodiment of the utility model is provided with a multi-cavity part, and is directly processed on the basis of the multi-cavity part, without too many other complex structural designs, and has a simple structure. Moreover, by providing a shape memory part, each sub-tube is automatically deformed into a preset shape, and the design is ingenious; and the processing and production are realized by cutting, and the processing method and process are relatively simple, and the requirements are relatively low. At the same time, it can also be reproduced repeatedly, which well meets the requirements for the reproducibility of the self-expanding pulse energizing device. BRIEF DESCRIPTION OF THE DRAWINGS
[0019] Figure 1 This is a structural schematic diagram of a self-expanding pulse energizing device provided by an embodiment of the utility model;
[0020] Figure 2 It is a schematic diagram of the structure of the shape memory element provided by the embodiment of the utility model;
[0021] Figure 3 It is a cross-sectional schematic diagram of a multi-cavity member provided by an embodiment of the utility model;
[0022] Figure 4 It is a cross-sectional schematic diagram of an insulated electric lead provided by an embodiment of the utility model;
[0023] Figure 5 It is a cross-sectional schematic diagram of an electrode member provided in an embodiment of the utility model;
[0024] Figure 6It is a schematic diagram of a voltage-equalizing structure provided on an electrode member provided in an embodiment of the utility model;
[0025] Figure 7 It is a schematic diagram of an electrode member provided by an embodiment of the utility model having a pressure equalizing ring arranged thereon.
[0026] Description of reference numerals:
[0027] 1. Self-expanding pulse energizing device; 11. Multi-cavity component; 111. Central cavity; 112. Peripheral cavity; 113. Sub-tube; 114. Braided layer; 12. Shape memory component; 13. Electrode component; 131. Accommodating hole; 132. Voltage-equalizing structure; 133. Voltage-equalizing ring; 14. Insulated electric lead; 141. Conductive core; 142. Insulating layer. DETAILED DESCRIPTION
[0028] In order to make the purpose, technical solution and advantages of the utility model more clear, the utility model is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described here are only used to explain the utility model and are not used to limit the utility model.
[0029] The various specific technical features described in the specific embodiments can be combined in any suitable manner without contradiction, for example, different embodiments and technical solutions can be formed by combining different specific technical features. In order to avoid unnecessary repetition, the various possible combinations of the specific technical features in the utility model will not be described separately.
[0030] In the following description, the terms "first\second\..." are only used to distinguish different objects, and do not mean that the objects have the same or related points. It should be understood that the directions "above", "below", "outside" and "inside" are all directions in normal use, and the directions "left" and "right" refer to the left and right directions shown in the corresponding schematic diagrams, which may or may not be the left and right directions in normal use.
[0031] It should be noted that the terms "comprises", "includes" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also includes other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, an element defined by the sentence "comprises a ..." does not exclude the presence of other identical elements in the process, method, article or device including the element. "Multiple" means greater than or equal to two.
[0032] The utility model embodiment provides a self-expanding pulse energizing device, which is usually connected to a control device and a high-voltage pulse generator. By inserting one end of the self-expanding pulse energizing device into a blood vessel and operating the control device (such as an operating handle) to enable the self-expanding pulse energizing device to move along the blood vessel to the tissue to be treated, and after the self-expanding pulse energizing device is delivered to the position, the high-voltage pulse generator generates a high-voltage, high-frequency pulse voltage and transmits it to the self-expanding pulse energizing device, thereby establishing a high-intensity electric field at the tissue to be treated, forming an area with a high current density, and the high-voltage pulse electric field acts on cells to cause irreversible perforation of the cell membrane, thereby causing the cells to gradually necrotize, and ultimately achieving the purpose of tissue ablation.
[0033] The term "electroporation" herein refers to the application of an electric field to a cell membrane to change the permeability of the cell membrane to the extracellular environment. The term "irreversible electroporation" herein refers to the application of an electric field to a cell membrane to permanently change the permeability of the cell membrane to the extracellular environment. For example, cells subjected to irreversible electroporation can be observed to have one or more pores formed in their cell membranes, which remain after the electric field is removed. The term "proximal end" herein refers to the end of the self-expanding pulsed energization device close to the operator, or the end connected to the operation; "distal end" refers to the end of the self-expanding pulsed energization device inserted into the blood vessel, or the end close to the tissue to be treated.
[0034] like Figures 1 to 3As shown, a self-expanding pulse current supply device 1 provided by an embodiment of the utility model comprises a multi-chamber member 11, a shape memory member 12 and an electrode member 13. The multi-chamber member 11 is generally a tubular material with a circular axial cross-section, and has a central cavity 111 and a plurality of peripheral cavities 112 surrounding the central cavity 111 inside, each peripheral cavity 112 and the central cavity 111 extend axially and are not interconnected. The thickness of the multi-chamber member 11 is greater than a preset value, and the specific thickness is suitable to meet the reliable arrangement of the central cavity 111 and each peripheral cavity 112, and does not cause the overall diameter to be too large and not conducive to intravascular delivery. The portion between the proximal end and the distal end of the multi-chamber member 11 in the axial direction is cut axially into a plurality of sub-tubes 113 separated in the circumferential direction, each sub-tube 113 has a peripheral cavity 112 inside, and the distal end can move axially to drive each sub-tube 113 to switch between two shapes of extending in a straight line and protruding outward in a curved shape. Specifically, each sub-tube 113 has elastic deformation performance, can bend under the action of external force, and after the external force disappears, it can automatically return to the initial state or substantially the initial state under the action of the elastic deformation force of each sub-tube 113. Usually, the multi-chamber member 11 is made of a polymer material that meets the medical use standards, such as Pebax (thermoplastic nylon elastomer) and PA (polyamide) polymer materials, which have high strength, good anti-fracture and elastic properties. The multi-chamber member 11 can be formed into different positions with different hardnesses by a gradual transition, such as gradually decreasing the hardness from the distal end to the proximal end, so that the distal end has better insertion performance, which is conducive to guiding movement in the blood vessel, and the hardness close to the proximal end gradually decreases, which is convenient for bending. The hardness of the middle area of the multi-chamber member 11 is moderate to ensure the overall strength and pushability. Of course, the hardness of the multi-chamber member 11 can also be set to other forms according to the use requirements, such as making the hardness of a local place larger or lower, etc., with good design flexibility.
[0035] In some embodiments, Figures 1 to 3As shown, the shape memory element 12 is arranged in each sub-tube 113, and the shape memory element 12 is provided with a predetermined shape to drive each sub-tube 113 to protrude outward in a curved shape. Specifically, the shape memory element 12 is arranged at any position of the sub-tube 113, and is extended along the length direction of the sub-tube 113, such as being embedded in the entity part of the sub-tube 113, or being penetrated in the surrounding cavity 112 inside the sub-tube 113, and the position is fixed. The shape memory element 12 is a special metal material that can restore its original macroscopic shape in another temperature range after plastic deformation in a certain temperature range, such as nickel-titanium memory alloy or copper-based memory alloy. In addition, a PTFE (polytetrafluoroethylene) or PI (polyimide) coating can also be provided on the shape memory element 12 to improve the durability of the shape memory element 12 and enable the shape memory element 12 to have a higher insulation safety to meet the requirements of medical use. The shape memory element 12 is pre-formed into a curved shape by thermoplasticity, and then transformed into a straight shape by external force and arranged in the sub-tube 113, so that after the shape memory element 12 is released from the external force shape constraint, it can automatically restore to the predetermined shape, and then the sub-tube 113 can protrude outward in a curved shape. The electrode member 13 is sleeved on each sub-tube 113 to pass a pulse current when the sub-tube 113 protrudes outward in a curved shape. That is, ablation treatment of tissue is performed when each sub-tube 113 protrudes outward in a curved shape. Therefore, in this state, the electrode member 13 arranged on each sub-tube 113 discharges to achieve the therapeutic purpose of annular ablation of tissue.
[0036] In some embodiments, due to the high-voltage, high-frequency nanosecond pulse, the electrode 13 is easily in contact with the blood and generates a certain amount of heat, which increases the surface temperature of the electrode 13 and triggers the coagulation mechanism of the blood around the electrode 13, resulting in scabs on the surface of the electrode 13, and the scabs will further increase the contact resistance between the electrode and the blood, thus forming a vicious circle. In the embodiment of the utility model, a through hole (not shown in the figure) connected to the surrounding cavity 112 is opened on each sub-tube 113, and the through hole is arranged adjacent to the electrode 13. By pouring saline into each surrounding cavity 112, and then making the poured saline flow out from the corresponding through holes, the saline flowing out from the vicinity of the electrode 13 can not only improve the surrounding conductivity, but also play a role in continuously cooling the electrode 13, thereby achieving the purpose of cooling the electrode 13 and preventing scabs.
[0037] The self-expanding pulse current supply device 1 provided in the implementation of the utility model is provided with a multi-cavity member 11, a shape memory member 12 and an electrode member 13. The multi-cavity member 11 has a central cavity 111 and a plurality of peripheral cavities 112 surrounding the central cavity 111. The portion between the proximal end and the distal end of the multi-cavity member 11 is cut axially to form a plurality of sub-tubes 113 separated in the circumferential direction. Each sub-tube 113 has a peripheral cavity 112 inside, and an electrode member 13 is provided in each sub-tube 113. At the same time, a shape memory member 12 is provided in each sub-tube 113, so that under the action of the shape memory member 12, the sub-tube 113 can be automatically deformed into a curved shape protruding outward, and a pulse current is supplied to the electrode member 13 when the sub-tube 113 is in a curved shape protruding outward, so as to achieve discharge and achieve the purpose of tissue ablation. In the embodiment of the utility model, a multi-cavity member 11 is provided, and the multi-cavity member 11 is directly processed. The multi-cavity member 11 itself has a simple structure, and the structure can meet the use requirements, so there is no need for too many other complex structural designs. The structure is simple, and each sub-tube is automatically deformed into a preset shape by providing a shape memory member, which is cleverly designed. The processing and production are achieved by cutting, and the production process is relatively simple and has low requirements. At the same time, it can be reproduced repeatedly, which well meets the requirements for the reproducibility of the self-expanding pulse energizing device 1.
[0038] In some embodiments, Figure 1 As shown, the number of each sub-tube portion 113 formed by cutting the multi-cavity member 11 can be multiple, optionally 3-12, and the specific number can be set according to the actual use requirements. In this way, at the same position, each sub-tube portion 113 is oriented to different positions in the circumferential direction, so that discharge ablation can be performed on different parts of the tissue at the position in the circumferential direction, and there is no need to meet the treatment needs of different positions by rotating at the same position, thereby improving the convenience of treatment and reducing the discomfort of the patient during treatment. At the same time, each sub-tube portion 113 formed by cutting is relatively independent and has good deformation performance, thereby enhancing the fit between each sub-tube portion 113, which is conducive to reducing the overall outer diameter of the multi-cavity member 11, so that the overall outer diameter of the multi-cavity member 11 can be within 3.2 mm, thereby improving the passability in the blood vessel and being able to meet the use requirements of smaller blood vessels.
[0039] In some embodiments, Figure 1As shown, the number of electrode members 13 provided on each sub-tube portion 113 can be multiple, optionally 1-4, and the specific number can be set according to the actual use requirements. And along the axial direction of the multi-cavity member 11, the required electrode members 13 are arranged at intervals on each sub-tube portion 113. In this way, the discharge range of the electrode member 13 is increased in the axial direction, thereby increasing the treatable range. Specifically, the electrode member 13 provided on the sub-tube portion 113 can be inserted by the distal end and moved and adjusted to the set position on the sub-tube portion 113, or it can be formed by wrapping around the set position on the sub-tube portion 113.
[0040] Optionally, the shape memory member 12 is inserted into the surrounding cavity 112 of the sub-tube 113, and one end is connected to the distal end of the multi-cavity member 11, while the other end extends along the surrounding cavity 112 toward the proximal end of the multi-cavity member 11. In this arrangement, by connecting one end of the shape memory member 12 to the distal end of the multi-cavity member 11, the position of the shape memory member 12 in the surrounding cavity 112 is fixed, and when restoring the shape, the sub-tube 113 can be effectively driven to transform into a predetermined shape, and the shape finally transformed is the same as the predetermined shape, which can reliably meet the design requirements.
[0041] In some embodiments, Figure 1 and Figure 4 As shown, each electrode member 13 is connected to a surrounding cavity 112 (refer to Figure 3 ) is an insulated electric lead 14 in the electrode 13, and current is transmitted to the electrode 13 through the insulated electric lead 14. The effective diameter of the insulated electric lead 14 is not less than 0.12 mm, and the overall diameter does not exceed 0.25 mm. The insulation breakdown strength of the wire reaches more than 5kV, and the multi-layer insulation structure prevents electromagnetic interference during corona discharge, and can also prevent conduction and short circuit during saline injection. At the same time, the length of the sub-tube 113 is 30mm-80mm, so that the length of the sub-tube 113 is within a suitable range, and when it is bent, it can have a diameter size that meets the use requirements, avoiding too small a length to provide an effective working area or too long to reduce the overall structural strength.
[0042] In some embodiments, Figure 4As shown, the insulated electric lead 14 includes a conductive core 141 and an insulating layer 142. The conductive core 141 is connected to the electrode member 13. The insulating layer 142 is provided with multiple layers. Each insulating layer 142 is sleeved on the conductive core 141 layer by layer, and extends along the length direction of the conductive core 141; wherein each insulating layer 142 is coaxially arranged with the conductive core 141. Specifically, the conductive core 141 may be optionally composed of a copper core with a diameter of not less than 0.12 mm. The copper ultra-fine wires constituting the copper core may be insulated by providing a PTFE (polytetrafluoroethylene) or PI (polyimide) coating to improve the insulation ability of the conductive core 141. In the embodiment of the utility model, each insulating layer 142 may be optionally provided with four layers. On the premise of meeting the overall insulation performance requirements, the overall size of the insulated electric lead 14 can be within the corresponding surrounding cavity 112 (refer to Figure 3 ) through.
[0043] Specifically, during the PFA (pulsed field ablation) operation, it is necessary to map the potential signal in the cardiac cavity to achieve immediate efficacy evaluation of electrophysiological examination and ablation treatment. Mapping is achieved by amplifying and collecting weak ECG signals, while ablation requires the release of high-voltage pulse energy through electrodes. In order to prevent high-voltage pulses from damaging the detection circuit of ECG signals. The utility model has separate leads for each electrode component 13, and the insulation between all electrode components 13 can reach more than 5kV, thereby integrating the mapping and ablation functions, and realizing the multiplexing of ablation and mapping functions through rapid switching inside the host.
[0044] In some embodiments, Figure 1 and Figure 3 As shown, a braided layer 114 is provided in the multi-chamber member 11, and the braided layer 114 extends from the proximal end toward the direction close to the sub-tube portion 113, and does not extend into the sub-tube portion 113 area; wherein, in the radial direction, a braided layer 114 is provided on the outside of each surrounding cavity 112. The braided layer 114 is provided to improve the torque transmission capacity of the multi-chamber member 11 so that the whole can move reliably in the blood vessel. The braided layer 114 can be a stainless steel braided mesh, which has high strength and suitable elastic bending deformation performance. The braided layer 114 is provided in the multi-chamber member 11 in such a way that it is not continuously provided in the circumferential direction, but is provided outside the position where each surrounding cavity 112 is located, and each braided layer 114 is not connected, so that it can not only enhance the strength of the surrounding cavity 112, but also improve the overall structural strength. In addition, since the distal end of the multi-cavity member 11 needs to be cut to form each sub-tube portion 113 , the braided layer does not extend into the sub-tube portion 113 area, thereby not affecting the cutting of the multi-cavity member 11 .
[0045] In some embodiments, Figure 3As shown, the braided layer 114 can also be arranged around the circumference of the multi-cavity member 11, and each surrounding cavity 112 is located in the area surrounded by the braided layer 114. In this way, in the circumference of the multi-cavity member 11, the same braided layer 114 surrounds the outer side of each sub-tube 113, which can provide protection for each sub-tube 113 at the same time to avoid accidental puncture.
[0046] In some embodiments, in order to adjust the hardness of the multi-cavity member 11 as needed, it can be achieved not only by adjusting the material forming the multi-cavity member 11, but also by adjusting the thickness or density of the braided layer, and the setting methods are various.
[0047] In some embodiments, perpendicular to the length direction of the multi-cavity member 11, the cross-sectional shapes of the surrounding cavities 112 are at least partially the same, that is, the cross-sectional shapes of the surrounding cavities 112 obtained in the same reference direction are at least partially the same. Since it is necessary to pass the insulated electric lead 14 through the surrounding cavity 112, such a setting does not require selectively passing the insulated electric lead 14 due to the different shapes of the surrounding cavity 112, thereby improving the convenience of installation. In addition, the inner wall surface of the surrounding cavity 112 is set as a smooth curved surface, and the friction resistance is small, which is conducive to improving the smoothness of the insulated electric lead 14 passing through. At the same time, it is also convenient for the flow of saline. Specifically, the inner wall surface of the surrounding cavity 112 is set as a smooth curved surface, which can be achieved by processing technology or by setting a PTFE (polytetrafluoroethylene) lining layer. Similarly, the inner wall surface of the central cavity 111 can also be provided with a PTFE (polytetrafluoroethylene) lining layer to improve the smoothness of the surface.
[0048] In some embodiments, Figures 5 to 7 As shown, the electrode member 13 is formed with a sub-tube 113 (refer to Figure 1) is inserted into the receiving hole 131, so that the electrode member 13 can be installed on the sub-tube portion 113. In addition, a voltage equalizing structure 132 is provided on the discharge side of the electrode member 13; or a voltage equalizing ring 133 is connected to the discharge side of the electrode member 13, and a voltage equalizing structure 132 is provided on the voltage equalizing ring 133. Specifically, since the voltage that the nanosecond self-expanding pulse energization device 1 needs to withstand is higher, when performing a pulse electric field ablation operation, the high-voltage pulse energy is released through the catheter electrode. When the high-voltage pulse is discharged, in order to prevent tip discharge or spark discharge, the electric field distribution is designed to be more uniform. In the embodiment of the utility model, a voltage equalizing structure 132 is provided on the discharge side of the electrode member 13 or a voltage equalizing ring 133 having the voltage equalizing structure 132 is provided, and the voltage equalizing structure 132 is a smooth arc surface. Under the action of the voltage equalizing structure 132, the discharge side of the electrode member 13 no longer has a sharp tip, so that the electric field distribution is more uniform, and serious power line distortion points are not formed at both ends of the electrode member 13, ensuring that the electrode member 13 does not generate spark discharge caused by the tip under a high-voltage nanosecond pulse with a voltage of up to 10kV, thereby improving the safety of use and service life.
[0049] In some embodiments, Figure 1 and Figure 5 As shown, perpendicular to the length direction of the sub-tube portion 113, at least the cross-sectional shape of the receiving hole 131 is the same as the shape of the outer edge of the cross-sectional shape of the sub-tube portion 113, and the electrode member 13 is attached to the outer wall of the sub-tube portion 113. In this way, after the electrode member 13 is installed on the sub-tube portion 113, it can be tightly attached to the outer surface of the sub-tube portion 113, which can not only reliably achieve discharge, but also has no local protrusions, which is conducive to reducing the overall radial size of the multi-cavity member 11. In addition, in this way, the shape of the outer edge of the cross-sectional shape of the electrode member 13 can be the same as the shape of the receiving hole 131, or it can be different, and can be set as needed.
[0050] In some embodiments, perpendicular to the length direction of the sub-tube 113, the shape of the cross-sectional outer edge of the electrode member 13 is the same as the shape of the cross-sectional outer edge of the sub-tube 113. This arrangement enables the cross-sectional shape of the multi-chamber member 11 as a whole perpendicular to the axial direction to be consistent, all of which are circular, with good overall aesthetics, and also facilitates delivery through the blood vessel.
[0051] In some embodiments, a positioning sensor (not shown) for positioning is provided in at least one of the sub-tubes 113, and the positioning sensor is close to the proximal end of the multi-chamber member 11. In this way, the sub-tube 113 can be positioned by the positioning sensor, so as to facilitate accurate treatment. Optionally, the positioning sensor is a magnetic positioning sensor, which has good positioning effect and is safe to use.
[0052] A self-expanding pulse energizing device 1 provided in the embodiment of the utility model is provided with a multi-cavity member 11, and is directly processed on the basis of the multi-cavity member 11, without too many other complex structural designs, so that the structure of the self-expanding pulse energizing device 1 is simpler, and the processing and production are realized by cutting. The production process is relatively simple and the requirements are relatively low, which well meets the requirements for the reproducibility of the self-expanding pulse energizing device 1. The shape memory member 12 is provided to automatically deform each sub-tube 113 into a preset shape, and the design is ingenious. The multi-layer insulation design of the insulating electrical lead 14 improves the insulation capacity between each electrode member 13, so that the insulation level of different electrode members 13 can meet the requirements of nanosecond pulse discharge with higher voltage and higher repetition frequency, and prevent the generation of corona discharge and interference electrical signals. The voltage-equalizing structure 132 design on the end face of the electrode member 13 makes the electric field distribution more uniform, effectively prevents the generation of spark discharge, and greatly reduces the heat generation during the discharge process. By making the electrode 13 and the sub-tube 113 fit each other, the overall outer diameter of the multi-cavity member 11 is effectively reduced, and the overall transportability and passability are improved. In addition, each electrode 13 is connected by a separate and mutually insulated insulated electrical lead 14, so that the time-sharing multiplexing of the electrode 13 is realized, so that during the PFA operation, ablation and mapping can be performed simultaneously based on the same electrode 13.
[0053] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the protection scope of the present invention.
Claims
1. A self-expanding pulse current device, characterized in that: include: A multi-cavity part, having a central cavity and a plurality of peripheral cavities surrounding the central cavity, each of the peripheral cavities and the central cavity extending in the axial direction and not connected to each other, the thickness of the multi-cavity part being greater than a preset value, the portion of the multi-cavity part between the axial proximal end and the distal end being cut in the axial direction into a plurality of sub-tube parts separated in the circumferential direction, each of the sub-tube parts having one of the peripheral cavities in the interior, and each of the sub-tube parts being provided with a through hole connected to the peripheral cavity; A shape memory member is disposed in each of the sub-tubes, and the shape memory member has a predetermined shape to drive each of the sub-tubes to protrude outwards in a curved shape; The electrode member is sleeved on each of the sub-tube parts and is used for passing a pulse current when the sub-tube parts protrude outwards in a curved state.
2. The self-expanding pulse current supply device according to claim 1, characterized in that: The shape memory component is disposed in the surrounding cavity of the sub-tube portion, and one end of the shape memory component is connected to the distal end of the multi-cavity component.
3. The self-expanding pulse current supply device according to claim 1, characterized in that: Each of the electrode members is connected to an insulated electric lead disposed in the surrounding cavity, and the length of the sub-tube portion is 30 mm-80 mm.
4. The self-expanding pulse current supply device according to claim 3, characterized in that: The insulated electrical lead includes a conductive core and an insulating layer, wherein the conductive core is connected to the electrode member, and the insulating layer is provided with multiple layers, each of which is successively sleeved on the conductive core and extends along the length direction of the conductive core; wherein each of the insulating layers is coaxially arranged with the conductive core.
5. The self-expanding pulse current supply device according to claim 1, characterized in that: A woven layer is arranged in the multi-cavity part, and the woven layer extends from the proximal end toward the direction close to the sub-tube part, and does not extend into the sub-tube part area; wherein, in the radial direction, the woven layer is arranged on the outer side of each of the surrounding cavities.
6. The self-expanding pulse current supply device according to claim 5, characterized in that: The braided layer is disposed around the circumference of the multi-cavity member, and each of the surrounding cavities is located in the area surrounded by the braided layer.
7. The self-expanding pulse current supply device according to claim 1, characterized in that: Vertically to the length direction of the multi-cavity member, the cross-sectional shapes of the surrounding cavities are at least partially the same; wherein the inner wall surface of the surrounding cavity is a smooth curved surface.
8. The self-expanding pulse current supply device according to any one of claims 1 to 7, characterized in that: The electrode member is formed with a receiving hole for inserting the sub-tube portion; wherein a voltage equalizing structure is provided on the discharge side of the electrode member; or a voltage equalizing ring is connected to the discharge side of the electrode member, and a voltage equalizing structure is provided on the voltage equalizing ring.
9. The self-expanding pulse current supply device according to claim 8, characterized in that: Perpendicular to the length direction of the sub-tube portion, at least the cross-sectional shape of the accommodating hole is the same as the shape of the cross-sectional outer edge of the sub-tube portion, and the electrode member is attached to the outer wall of the sub-tube portion.
10. The self-expanding pulse current supply device according to any one of claims 1 to 7, characterized in that: Perpendicular to the length direction of the sub-tube portion, the shape of the outer edge of the cross section of the electrode member is the same as the shape of the outer edge of the cross section of the sub-tube portion.
11. The self-expanding pulse current supply device according to any one of claims 1 to 7, characterized in that: A positioning sensor for positioning is arranged in at least any one of the sub-tube parts, and the positioning sensor is close to the proximal end of the multi-cavity member.