Device assembly for the treatment of chronic obstructive pulmonary disease

Abstract

The application belongs to the technical field of medical devices, and particularly relates to a device assembly for treating chronic obstructive pulmonary disease. The device assembly for treating chronic obstructive pulmonary disease comprises a pulse high-voltage device, a catheter handle and an electrode catheter which are sequentially connected. The pulse high-voltage device comprises a circuit board, and a low-voltage section and a high-voltage section which are electrically connected to each other are arranged on the circuit board. The low-voltage section and the high-voltage section are arranged at two ends of the circuit board with a preset distance. The pulse high-voltage device further comprises a first glue filling layer which is wrapped outside the high-voltage section, and a first shielding layer which is wrapped outside the first glue filling layer. The high-voltage section of the pulse high-voltage device is independently filled with glue, and the first shielding layer is used to effectively prevent the high-voltage section from being broken down due to discharge to the outside, thereby preventing the device from being damaged.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a device assembly for the treatment of chronic obstructive pulmonary disease. Background Technology

[0002] Chronic obstructive pulmonary disease (COPD) is a chronic lung disease that causes airflow limitation in the lungs. COPD is progressive and irreversible; it is mainly caused by the proliferation of some cells in the trachea due to external stimuli. The proliferating cells secrete more mucus in order to expel external stimuli through the mucus. However, excessive cell proliferation and excessive mucus production further reduce the size of the trachea, thus exacerbating breathing difficulties.

[0003] Pulse field ablation (PFA) is a technique that uses high-voltage discharge to induce irreversible electroporation in cells. It directly targets cells, inducing apoptosis and thus achieving therapeutic effects. The irreversible electroporation technique used in PFA is a non-thermal ablation technique. By adjusting the voltage, it selectively breaks down cells without affecting surrounding tissues. Furthermore, no tissue crusting occurs during or after the procedure, thus preserving the normal function of the lungs and trachea. Additionally, the cell death mechanism induced by irreversible electroporation is apoptosis, not necrosis. The advantage of apoptosis is that it is cleared by immune intervention, while phagocytic cells eliminate apoptotic cells as part of the normal cell death process, promoting the regeneration and repair of normal tissues. Therefore, after irreversible electroporation treatment, the treated area can be quickly replaced by normal cells, restoring its original function.

[0004] Current treatment methods all involve connecting an ablation catheter to an energy generator, delivering energy to the ablation electrode to ablate the lesion. Since pulsed field ablation utilizes irreversible electroporation through high-voltage discharge, the control of the high-voltage pulse discharge in the pulsed device is crucial. Generally, a low-voltage control method is used to manage the high-voltage discharge. However, in practice, because the voltage of the low-voltage segment is much lower than that of the high-voltage segment, the high-voltage segment can easily affect the low-voltage segment. Even when the high-voltage and low-voltage segments are integrated on the same circuit board, breakdown can occur, rendering the low-voltage segment inoperable. Furthermore, in existing technologies, single-electrode ablation structures are often basket-type braided structures that achieve contact with the tracheal wall through expansion or contraction. However, because the two ends of the basket structure are fixed to a central rod and a cannula respectively, relative rotation can easily occur between the central rod and the cannula during actual operation. This can cause the ablation electrode of the basket structure to twist, preventing the basket from expanding to the predetermined diameter, resulting in incomplete ablation or surgical failure. Summary of the Invention

[0005] This invention addresses the technical problem in high-voltage pulse devices that provide high-voltage pulses to ablation electrode catheters, where the high-voltage section can easily affect the low-voltage section, or even cause breakdown, rendering the low-voltage section inoperable. The aim is to provide a device assembly for the treatment of chronic obstructive pulmonary disease.

[0006] A device assembly for the treatment of chronic obstructive pulmonary disease includes a pulsed high-voltage device, a catheter handle, and an electrode catheter connected in sequence. The pulsed high-voltage device includes a circuit board on which a low-voltage section and a high-voltage section are electrically connected to each other.

[0007] The low-voltage section and the high-voltage section are arranged at opposite ends of the circuit board at a predetermined distance.

[0008] The pulsed high-voltage device also includes:

[0009] A first potting layer covers the outside of the high-voltage section;

[0010] A first shielding layer is wrapped around the outside of the first potting layer.

[0011] As a preferred embodiment, the pulsed high-voltage device further includes:

[0012] A ground wire is installed on the circuit board outside the first potting layer, and is laid around the high voltage section at least once. One end of the ground wire is connected to a grounding point located at the edge of the circuit board.

[0013] As a preferred embodiment, the circuit board has a mounting slot, the mounting slot comprising:

[0014] A closed-loop groove is formed around the outer side of the first potting layer;

[0015] A lead-in slot connects the closed-loop slot and the grounding point;

[0016] The ground wire is laid in the mounting groove.

[0017] As a preferred embodiment, the ground wire is located inside the first shielding layer, and the distance between the orthographic projection of the sidewall of the first shielding layer on the circuit board and the ground wire does not exceed 5mm.

[0018] As a preferred embodiment, the first shielding layer is in contact with the ground wire, thereby connecting the first shielding layer with the grounding point.

[0019] As a preferred embodiment, the output end of the high-voltage section is connected to a row of high-voltage connectors, which are electrically connected to the electrode conduit via the conduit handle.

[0020] As a preferred embodiment, the low-voltage section includes a main control CPU for controlling the coordination of actions between various devices in the pulse high-voltage equipment and a driver chip for amplifying the input weak electrical signal.

[0021] As a preferred embodiment, the low-voltage section and the high-voltage section are electrically connected via an optocoupler.

[0022] As a preferred embodiment, the pulsed high-voltage device further includes:

[0023] A segmented isolation groove runs through the circuit board and is disposed on the circuit board between the low-voltage section and the high-voltage section, the isolation groove dividing the circuit board into two regions: a low-voltage side and a high-voltage side;

[0024] A second potting layer covers all components on both sides of the circuit board except for the high-voltage connector and the grounding point through the isolation groove.

[0025] As a preferred embodiment, the isolation groove is a through groove that connects the upper and lower parts, and preferably the isolation groove is a segmented through groove, so that the circuit boards on the low-voltage side and the high-voltage side have a connection section.

[0026] As a preferred embodiment, both the first potting layer and the second potting layer are made of polymer insulating materials.

[0027] As a preferred embodiment, the circuit board is preferably a relay board.

[0028] As a preferred embodiment, the catheter handle has a handle housing, and a pulse connection portion is provided at the proximal end of the handle housing. The pulse connection portion is electrically connected to the output end of the high-voltage section via a wire.

[0029] The electrode conduit has electrodes and a central core rod electrically connected to the electrodes. The proximal end of the central core rod is disposed inside the handle housing and electrically connected to the pulse connection part.

[0030] As a preferred embodiment, the electrode adopts a woven basket structure, the woven basket structure has a hollow cavity, and the central core rod passes through the hollow cavity of the woven basket structure to connect the proximal end and the distal end of the basket structure;

[0031] The electrode conduit also includes:

[0032] A set of pipes;

[0033] A distal fixing component is provided to fix the distal end of the woven basket structure and the distal end of the central core rod.

[0034] A proximal fixing assembly secures the proximal end of the braided basket structure to the distal end of the sleeve;

[0035] The sleeve and the proximal fixing assembly are axially movable relative to the central core rod, and the proximal fixing assembly restricts the rotation of the sleeve relative to the central core rod so that the braided basket structure can contract or expand to a predetermined state.

[0036] As a preferred embodiment, the remote fixation component includes:

[0037] A raised ring is fixed internally to the distal end of the central core rod;

[0038] A fixing cap, with an open near end, is fitted over the protruding ring, and the fixing cap and the protruding ring engage the far end of the woven basket structure.

[0039] As a preferred embodiment, the fixing cap is provided with a plurality of guide grooves evenly arranged circumferentially, and the length direction of the guide grooves is axial.

[0040] The distal ends of the woven basket structure are evenly arranged within several of the guide grooves.

[0041] As a preferred embodiment, the depth of the guide groove is less than the diameter of the braided wires in the braided basket structure.

[0042] As a preferred embodiment, the proximal fixation assembly includes:

[0043] An inner fixing ring is sleeved outside the central core rod and can move along the axial direction of the central core rod;

[0044] An outer fixing ring is sleeved outside the inner fixing ring, and the outer fixing ring and the inner fixing ring are engaged with the proximal end of the woven basket structure;

[0045] The sleeve includes:

[0046] An outer tube, the distal end of which is fitted around the outer periphery of the outer fixing ring and fixed thereto.

[0047] As a preferred embodiment, the inner diameter of the inner fixing ring is equal to the diameter of the central core rod by 1.1-1.3.

[0048] As a preferred embodiment, the inner diameter of the outer tube is 0.9-1.0 times the outer diameter of the outer fixing ring.

[0049] As a preferred embodiment, the sleeve further includes:

[0050] An inner tube is disposed inside the outer tube and sleeved outside the central core rod, with the distal end of the inner tube abutting the proximal end of the outer fixing ring.

[0051] As a preferred embodiment, the outer diameter of the inner tube is the same as the outer diameter of the outer fixing ring.

[0052] As a preferred embodiment, the outer tube is a nylon elastic tube made of PEBAX (modified nylon) material.

[0053] As a preferred embodiment, the central core rod is a solid structure and is made of nickel-titanium alloy.

[0054] As a preferred embodiment, the core rod is a conductor, and the distal end and / or proximal end of the braided basket structure are electrically connected to the core rod so that the pulse ablation energy can be transferred to the braided basket structure.

[0055] As a preferred embodiment, the central core rod is a conductor, and at least one of the protruding ring and the inner fixing ring is a conductor.

[0056] As a preferred embodiment, the diameter of the central core rod is 0.4mm-0.8mm, preferably 0.5mm or 0.6mm.

[0057] As a preferred embodiment, the woven basket structure has an expanded state, and in the expanded state, it comprises, from the distal end to the proximal end, integrally connected components:

[0058] A first converging segment, the distal end of which is fixed to the distal end fixing component, and a hollow frustum-like structure with a proximal end diameter larger than the distal end diameter;

[0059] A hollow cylindrical segment;

[0060] A second converging segment, the proximal end of which is fixed to the proximal end fixing component, and the distal end having a diameter larger than the proximal end diameter, is a hollow frustum-like structure;

[0061] The openings of the first and second converging segments are arranged opposite to each other and both face the hollow cylindrical segment.

[0062] As a preferred embodiment, the axial length of the first converging segment is greater than the axial length of the second converging segment. The axial length of the first converging segment: the axial length of the hollow cylindrical segment = 1:1-3, preferably 1:1.2-2.5, such as 1:1.5, 1:1.8 or 1:2.2, etc.

[0063] As a preferred embodiment, the axial length of the woven basket structure is: the diameter of the hollow cylindrical section = 1.05-1.8, preferably 1.1-1.6, such as 1.2, 1.3, 1.5 or 1.7, etc.

[0064] As a preferred embodiment, the woven basket structure is a mesh basket structure formed by weaving woven yarns;

[0065] When the diameter of the hollow cylindrical section is 15mm-22mm, the mesh density (PPI) of the woven basket structure is 20-28, preferably 22-26, such as 23, 24 or 25, etc.

[0066] As a preferred embodiment, the woven basket structure has two sets of weaving groups, each set of weaving groups having a plurality of weaving threads;

[0067] The braided threads in the two braided groups are cross-woven to form a rhomboid mesh with a rhomboid structure.

[0068] As a preferred embodiment, two different sets of braided filaments intersect to form a braiding intersection, and the position of a single braided filament alternates between its two adjacent braiding intersections.

[0069] As a preferred embodiment, each group of the braided group has 16 to 20 braided threads.

[0070] As a preferred embodiment, the two interior angles of the rhomboid mesh along the axial direction are 45°-75°.

[0071] As a preferred embodiment, the diameter of the braided yarn is 0.05mm-0.15mm, preferably 0.07mm-0.12mm, such as 0.08mm, 0.09mm, 0.10mm or 0.11mm, etc.

[0072] As a preferred embodiment, the braided wire is a nickel-titanium alloy, and the braided wire is a conductive braided wire with no oxide layer on its surface.

[0073] As a preferred embodiment, the woven basket structure has a folded state. In the folded state, the middle part of the woven basket structure is recessed towards the central core rod, and the inner wall of the woven basket structure is at a predetermined distance from the central core rod.

[0074] The positive and progressive effects of the present invention are as follows: The device assembly for the treatment of chronic obstructive pulmonary disease of the present invention has the following beneficial effects:

[0075] 1. A pulsed high-voltage device is used to provide high-voltage pulses to electrode conduits. This device can control the discharge of multiple connected electrode conduits. Due to the selective discharge of some electrodes, when some electrodes are not discharging, the special characteristics of the high-voltage pulse energy (high voltage, multiple frequency components) can easily cause strong interference to other non-discharging electrodes, even leading to their damage. This invention addresses this by independently potting the high-voltage section of the pulsed high-voltage device, combined with a first shielding layer, effectively preventing breakdown caused by external discharge and thus preventing equipment damage.

[0076] 2. Since the high-voltage section will generate mutual inductance with the first shielding layer when the voltage changes, by setting a ground wire, the induced current on the first shielding layer can be discharged through the ground wire to avoid mutual inductance between internal components and prevent interference to the low-voltage section and other components on the circuit board, thus affecting the normal operation of the equipment.

[0077] 3. To avoid direct electrical signal exchange between the high-voltage and low-voltage sections, an optocoupler is installed between them. The low-voltage section controls the high-voltage section through the optocoupler, converting the direct AC electrical signal into an electro-optical-electric signal for transmission. This avoids direct electrical signal exchange between the two sections, resulting in strong anti-interference capability, electrical isolation, and effectively reducing the impact of the high-voltage section on the low-voltage section, thus improving the stability of the device.

[0078] 4. The high-voltage section and the low-voltage section are separated by an isolation groove, and glue is poured into the isolation groove. By setting a second glue layer, the entire circuit board is covered and insulated, which further improves the insulation performance between the high-voltage section and the low-voltage section, and effectively prevents the high-voltage section from discharging to the outside and causing breakdown.

[0079] 5. The isolation groove is not a completely continuous piece, but is divided into several small sections, which strengthens the circuit board itself.

[0080] 6. The electrode catheter uses the distal and proximal fixation components to fix the braided basket structure and the central core rod. The presence of the proximal fixation component restricts the rotation of the cannula, preventing it from easily rotating relative to the central core rod and allowing it to move only in its axial direction. Therefore, the braided basket structure will not twist. After being released, the braided basket structure can stably expand to the preset diameter, further improving the stability of pulsed field ablation COPD surgery.

[0081] 7. The guide groove inside the fixing cap serves to guide the braided yarns, preventing uneven distribution of the yarns during the winding process from affecting the mesh size and uniformity of the woven basket structure. The depth of the guide groove is less than the diameter of the braided yarns to increase the friction between the yarns and the raised rings, thereby improving the stability of the woven basket structure.

[0082] 8. An inner tube is installed inside the outer tube. This serves two purposes: firstly, to fill the large gap between the outer tube and the central core rod caused by the inner and outer fixing rings, ensuring the central core rod maintains its centering during movement and preventing bending; secondly, the inner tube supports the outer tube, reducing excessive local stress caused by the interference fit between the outer fixing ring and the outer tube, thus preventing damage to the outer tube during use due to excessive local stress. Simultaneously, the inner tube's filling ensures that the central core rod can only move axially relative to the outer tube, further restricting the rotation of the outer tube and making the entire structure more stable.

[0083] 9. The woven basket structure, as a single electrode, can be electrically connected to the woven basket structure directly through the core rod itself, or indirectly through the raised ring or the inner fixing ring.

[0084] 10. The woven basket structure has a mesh structure with both ends converging and the middle part being a hollow cylinder in the expanded state. The converging sections at both ends can maintain a fixed state with the distal and proximal fixation components, and the hollow cylinder in the middle has the characteristic of a large ablation area, resulting in good COPD ablation effect of pulse field.

[0085] 11. The design of the size, mesh density, number of braided filaments, braiding method, and concave state when the braided basket structure is closed allows the braided basket structure to achieve good closure and expand to the preset size after release, without affecting the pulse field ablation COPD surgery.

[0086] 12. The surface of the nickel-titanium braided wire does not contain an oxide layer. That is, in the nickel-titanium alloy, Ni and Ti exist in an atomic state, which can greatly improve the electrical conductivity of the braided basket structure and promote the electroporation effect of tissue cells. Attached Figure Description

[0087] Figure 1 This is a schematic diagram of an overall structure of the present invention;

[0088] Figure 2(a) is a perspective view of a circuit board in the pulse high voltage device of the present invention;

[0089] Figure 2(b) is a schematic diagram of the structure in Figure 2(a) excluding the second potting layer;

[0090] Figure 2(c) is a schematic diagram of the structure in Figure 2(b) excluding the first shielding layer;

[0091] Figure 2(d) is a schematic diagram of the structure in Figure 2(c) excluding the first potting layer and the optocoupler;

[0092] Figure 3(a) is a top view of the circuit board in the pulse high voltage device of the present invention;

[0093] Figure 3(b) is the AA cross-sectional view of Figure 3(a);

[0094] Figure 3(c) is a magnified view of part B in Figure 3(b);

[0095] Figure 3(d) is a cross-sectional view of the high-voltage side of the circuit board.

[0096] Figure 4 for Figure 1 Partial schematic diagram;

[0097] Figure 5(a) is a schematic diagram of one structure of the electrode conduit of the present invention;

[0098] Figure 5(b) is an internal sectional view of Figure 5(a);

[0099] Figure 5(c) is a magnified view of point C in Figure 5(b);

[0100] Figure 5(d) is a magnified view of point D in Figure 5(b);

[0101] Figure 6 This diagram illustrates the connection relationships between the woven basket structure, the central core rod, and the distal fixing assembly of the present invention.

[0102] Figure 7 This is a schematic diagram of one structure of the fixing cap of the present invention;

[0103] Figure 8 This invention provides a weaving method for the woven basket structure.

[0104] Figure 9 This is a diagram showing one state of the woven basket structure of the present invention during the winding process. Detailed Implementation

[0105] To make the technical means, creative features, objectives and effects of this invention easier to understand, the invention will be further described below with reference to specific illustrations.

[0106] In this invention, when describing a device assembly for the treatment of chronic obstructive pulmonary disease, the terms "distal," "proximal," "distal segment," and "proximal segment" are used as directional terms, which are common terms in the field of interventional medical devices. "Distal" and "distal segment" refer to the end or segment away from the operator during surgery, while "proximal" and "proximal segment" refer to the end or segment closer to the operator during surgery. "Axial" refers to a direction parallel to the line connecting the distal and proximal centers of the medical device; "radial" refers to a direction perpendicular to the aforementioned "axial" direction.

[0107] Reference Figure 1 and Figure 4 A device assembly for the treatment of chronic obstructive pulmonary disease includes, from distal to proximal, an electrode catheter 100, a catheter handle 200, and a pulsed high-voltage device 300 connected in sequence.

[0108] The proximal end of the catheter handle 200 is electrically connected to the pulsed high-voltage device 300, which provides high-voltage pulses to the catheter handle 200. The distal end of the catheter handle 200 is connected to the electrode catheter 100. The catheter handle 200 moves the electrode catheter 100 proximally or distally, and supplies power to the electrode catheter 100, thereby enabling the pulsed high-voltage device 300 to release positive and negative high-voltage pulse energy for ablation through the electrode catheter 100. The catheter handle 200 can be any handle in the prior art that can move the electrode catheter 100 and supply power to it, and will not be described in detail here.

[0109] Reference Figures 2(a) to 3(d) The pulse high voltage device 300 includes a circuit board 310, a low voltage section 320, a high voltage section 330, a first potting layer 340, and a first shielding layer 350.

[0110] The circuit board 310 is preferably a relay board, and more preferably a high-voltage relay board resistant to breakdown. A low-voltage section 320 and a high-voltage section 330, electrically connected to each other, are provided on the circuit board 310. The low-voltage section 320 and the high-voltage section 330 are positioned at opposite ends of the circuit board 310 at a predetermined distance. As shown in Figure 2(d), the low-voltage section 320 and the high-voltage section 330 are respectively positioned on the front and rear sides of the circuit board 310, separated by a certain distance. Referring to Figure 2(c), a first potting layer 340 covers the outside of the high-voltage section 330. Referring to Figure 2(b), a first shielding layer 350 covers the outside of the first potting layer 340.

[0111] The pulsed high-voltage device is used to provide high-voltage pulses to electrode conduits. It can control the discharge of multiple electrode conduits connected to it. However, due to the selective discharge of some electrodes, when some electrodes are not discharging, the special characteristics of the high-voltage pulse energy (high voltage, multiple frequency components) can easily cause strong interference to other non-discharging electrodes, even leading to their damage. This invention sets a preset distance between the low-voltage section 320 and the high-voltage section 330, and forms a first potting layer 340 by independently potting the high-voltage section 330 of the pulsed high-voltage device. Combined with the first shielding layer 350, this effectively prevents the high-voltage section 330 from undergoing breakdown due to external discharge, thus preventing equipment damage.

[0112] In some embodiments, the pulse high-voltage device 300 further includes a ground wire 360, which is disposed on the circuit board 310 outside the first potting layer 340. The ground wire 360 ​​is laid around the high-voltage section 330 at least once, and one end of the ground wire 360 ​​is connected to a grounding point 361, which is located at the edge of the circuit board 310. Since the high-voltage section 330 will generate mutual inductance with the first shielding layer 350 when the voltage changes, by setting the ground wire 360, the induced current on the first shielding layer 350 is conducted out through the ground wire 360, avoiding mutual inductance among internal components and preventing interference to the low-voltage section 320 and other components on the circuit board 310, thus affecting the normal operation of the device.

[0113] In some embodiments, a mounting groove is formed on the circuit board 310. The mounting groove includes a closed-loop groove and a lead wire groove. The closed-loop groove is formed around the outside of the first potting layer 340, and the lead wire groove connects the closed-loop groove and the grounding point 361. The ground wire 360 ​​is laid in the mounting groove. When laying the ground wire 360, after the closed-loop groove is laid around the high-voltage section 330 at least once, one end of the ground wire 360 ​​is laid along the lead wire groove to the grounding point 361. As shown in FIG2(d), the cross-section of the closed-loop groove is a rectangular frame structure, and the cross-section of the lead wire groove is an L-shaped structure. One end of the lead wire groove connects to any point in the closed-loop groove, and the other end of the lead wire groove connects to the grounding point 361.

[0114] In some embodiments, the ground wire 360 ​​is located inside the first shielding layer 350, and the distance between the sidewall of the first shielding layer 350 projected onto the circuit board 310 and the ground wire 360 ​​does not exceed 5 mm. As shown in FIG3(d), with the circuit board 310 as the projection plane, the distance between the sidewall of the first shielding layer 350 and the ground wire 360 ​​from a top view is no more than 5 mm. The smaller the distance between the two, the better the shielding effect. Therefore, preferably, as shown in FIG3(b), the first shielding layer 350 is in contact with the ground wire 360, so that the first shielding layer 350 is connected to the grounding point 361.

[0115] The first shielding layer 350 is closely attached to the outer wall of the first potting layer 340, covering the first potting layer 340 and isolating the high-voltage section 330 from external components. However, since the high-voltage section 330 will generate mutual inductance with the first shielding layer 340 when the voltage changes, grounding is achieved by connecting the first shielding layer 350 to the grounding point 361, directly conducting the induced current to the ground, and avoiding mutual inductance within the internal components that could affect the low-voltage section 320.

[0116] In some embodiments, refer to Figures 2(a) to 3(b) The output end of the high-voltage section 330 is connected to a row of high-voltage connectors 331, and the high-voltage connectors 331 are electrically connected to the electrode conduit 100 via the conduit handle 200.

[0117] In some embodiments, the low-voltage section 320 includes a main control CPU for controlling the coordination of actions between the devices in the pulse high-voltage device 300 and a driver chip for amplifying the input weak electrical signal.

[0118] In some embodiments, referring to Figures 2(b), 2(c), and 3(b), the pulsed high-voltage device 300 further includes an optocoupler 370 (opto-isolator), through which the low-voltage section 320 and the high-voltage section 330 are electrically connected. To prevent direct electrical signal exchange between the high-voltage section 330 and the low-voltage section 320, the optocoupler 370 is provided between them. The low-voltage section 320 controls the high-voltage section 330 through the optocoupler 370, converting the directly alternating electrical signal into an electro-optical-electric signal for transmission. This avoids direct electrical signal exchange between the two sections, resulting in strong anti-interference capability, electrical isolation, and effectively reducing the impact of the high-voltage section 330 on the low-voltage section 320, thereby improving the stability of the device.

[0119] In some embodiments, refer to Figures 2(a) to 3(c) The pulsed high-voltage device 300 also includes an isolation groove 380 and a second potting layer 390. The isolation groove 380 is disposed on the circuit board 310 between the low-voltage section 320 and the high-voltage section 330, dividing the circuit board 310 into two regions: a low-voltage side and a high-voltage side. The low-voltage side has the low-voltage section 320, and the high-voltage side has the high-voltage section 330. The first potting layer 340, the first shielding layer 350, the ground wire 360, and the high-voltage connector 331 surrounding the high-voltage section 330 are also disposed on the high-voltage side. A row of optocouplers 370 spans the upper side of the isolation groove 380.

[0120] The isolation groove 380 can be a through groove that connects and penetrates the circuit board 310, meaning that the circuit boards 310 on the low-voltage side and the high-voltage side are not connected, but are connected by potting compound through the isolation groove 380. Preferably, as shown in Figure 2(d), the isolation groove 380 is a segmented through groove that penetrates the circuit board 310, resulting in a connection section between the circuit boards 310 on the low-voltage side and the high-voltage side. The isolation groove 380 is not completely continuous, but is divided into several small segments, which strengthens the circuit board 310 itself.

[0121] The second potting layer 390 not only pots the isolation groove 380, but also covers all components on both sides of the circuit board 310 except for the high-voltage connector 331 and the grounding point 361 through the isolation groove 380. As shown in Figures 2(a), 3(a), and 3(b), while the second potting layer 390 covers the entire circuit board 310, it exposes the high-voltage connector 331, which is electrically connected to the conduit handle 200, and the grounding point 361, which is used for grounding. Fixing through holes for fixing the circuit board 310 can also be provided around the periphery of the circuit board 310, and these fixing through holes are also exposed in the second potting layer 390.

[0122] The present invention separates the high-voltage section 330 from the low-voltage section 320 through the isolation groove 380, and at the same time fills the isolation groove 380 with glue. By setting the second glue layer 390, the entire circuit board 310 is covered and insulated, which further improves the insulation performance between the high-voltage section 330 and the low-voltage section 320, and effectively prevents the high-voltage section 330 from discharging to the outside and causing breakdown.

[0123] In some embodiments, the first potting layer 340 and the second potting layer 390 are both polymer insulating materials.

[0124] In some embodiments, the catheter handle 200 has a handle housing, and a pulse connection portion is provided at the proximal end of the handle housing. The pulse connection portion is electrically connected to the output end of the high-voltage section 330 via a wire. The electrode catheter 100 has an electrode and a central core rod 120 electrically connected to the electrode. The proximal end of the central core rod 120 is disposed within the handle housing and electrically connected to the pulse connection portion. This enables the pulsed high-voltage device 300 to release positive and negative high-voltage pulse energy for ablation through the electrode catheter 100.

[0125] In some embodiments, referring to Figures 5(a) and 5(b), the electrode conduit 100 includes a braided basket structure 110, a central core rod 120, a distal fixation assembly 130, a proximal fixation assembly 140, and a sleeve, the sleeve including an outer tube 151.

[0126] The woven basket structure 110 has a hollow cavity connecting the distal and proximal ends, through which the central core rod 120 passes, so as to secure the distal and proximal ends of both by the distal fixing assembly 130 and the proximal fixing assembly 140, respectively.

[0127] The distal end of the outer tube 151 is fixed to the proximal end fixing assembly 140. The outer tube 151 can be connected to the catheter handle 200, which drives the braided basket structure 110 to move or rotate distally or proximally via the outer tube 151.

[0128] This invention utilizes the synergistic action of the distal fixation component 130 and the proximal fixation component 140 to fix both ends of the braided basket structure 110 and the central core rod 120. When the outer tube 151 rotates, the braided basket structure 110 rotates synchronously with it, preventing torsion. After release, the braided basket structure 110 stably expands to a preset diameter, further improving the stability of pulsed field ablation for COPD surgery. Optionally, as a further improvement, the inner fixation ring 141 of the proximal fixation component 140 and the central core rod 120 can be configured as a locking protrusion structure. For example, an axially extending locking protrusion or locking groove can be provided on the outer surface of the central core rod 120, and a corresponding axially extending locking groove or locking protrusion can be provided on the inner fixation ring 141, thereby restricting the rotation of the cannula relative to the central core rod 140. Alternatively, the central core rod 140 can be set to an irregular shape that is not circular, and a channel adapted to the external structure of the central core rod 140 can be provided inside the sleeve so that the outer tube can only move axially.

[0129] In some embodiments, refer to Figures 5(b), 5(c), and Figure 6 The distal fixing assembly 130 includes a protruding ring 131 and a fixing cap 132. The distal end of the central core rod 120 is inserted into the protruding ring 131, and the interior of the protruding ring 131 is fixed to the distal end of the central core rod 120. The proximal end face of the fixing cap 132 is open, and the fixing cap 132 is sleeved on the outside of the protruding ring 131, engaging the distal end of the woven basket structure 110 between the fixing cap 132 and the protruding ring 131. The distal end of the woven basket structure 110 is gathered by the engagement of the fixing cap 132 and the protruding ring 131.

[0130] In some embodiments, refer to Figure 7 The fixing cap 132 has several guide grooves 1321 evenly arranged circumferentially inside, with the length direction of the guide grooves 1321 being axial. The distal end of the woven basket structure 110 is evenly arranged within the several guide grooves 1321. The braided filaments gathered at the distal end of the woven basket structure 110 can be stacked single or multiple in the same guide groove 1321. When the number of braided filaments is small, it is preferable that a single braided filament is placed in a corresponding single guide groove 1321, and multiple braided filaments are independent of each other.

[0131] The guide groove 1321 inside the fixing cap 132 of the present invention can guide the braided yarn, so as to avoid the braided yarn from affecting the mesh size and uniformity of the braided basket structure 110 due to uneven distribution during the winding process.

[0132] In some embodiments, refer to Figure 6 The depth of the guide groove 1321 is less than the diameter of the braided wire of the braided basket structure 110. This increases the friction between the braided wire and the raised ring 131, thereby improving the stability of the braided basket structure 110.

[0133] In some embodiments, referring to Figures 5(b) and 5(d), the proximal fixation assembly 140 includes an inner fixation ring 141 and an outer fixation ring 142. The proximal end of the central core rod 120 passes through and is fixed to the inner fixation ring 141. The outer fixation ring 142 is sleeved over the inner fixation ring 141, and the proximal end of the woven basket structure 110 is engaged between the outer fixation ring 142 and the inner fixation ring 141. The present invention uses the outer fixation ring 142 and the inner fixation ring 141 to clamp the braided yarns gathered at the proximal end of the woven basket structure 110 between them. The inner fixation ring 141 is tightly fitted to the central core rod, preventing the inner fixation ring 141 from rotating with the outer tube 151 when the outer tube 151 and the central core rod 120 rotate relative to each other, thereby preventing the torsion of the woven basket structure 110.

[0134] In some embodiments, the central core rod 120 can be configured as an irregular cylindrical structure, or a prismatic or elliptical structure, etc., so that the inner fixing ring 141 can be adapted to fit around the outer periphery of the central core rod 120, thus preventing the inner fixing ring 141 from rotating with the outer tube 142. Optionally, the mating point between the inner fixing ring 141 and the central core rod 120 can be configured as a snap-fit ​​structure, with a protrusion or groove on the central core rod 120 and a corresponding groove or protrusion on the inner fixing ring 141 for engagement and limiting, thus preventing the inner fixing ring 141 from rotating along the axis of the central core rod 120.

[0135] In some embodiments, the inner diameter of the inner retaining ring 141 is 1.1-1.3 times the diameter of the central core rod 120. This allows the central core rod 120 to pass through the inner retaining ring 141 more smoothly.

[0136] In some embodiments, the inner diameter of the outer tube 151 is 0.9-1.0 mm from the outer diameter of the outer fixing ring 142, to achieve an interference fit fixation between the outer tube 151 and the outer fixing ring 142.

[0137] In some embodiments, the sleeve further includes an inner tube 152, which is disposed inside the outer tube 151 and sleeved around the central core rod 120. The distal end of the inner tube 152 abuts against the proximal end of the outer fixing ring 142. The inner tube 152 is located inside the outer tube 151 to fill the large gap between the outer tube 151 and the central core rod 120 caused by the inner and outer fixing rings 142, ensuring the central core rod 120 maintains its centering during movement and preventing bending. Furthermore, the inner tube supports the outer tube 151, reducing excessive local stress caused by the interference fit between the outer fixing ring 142 and the outer tube 151, thus preventing damage to the outer tube 151 during use. Simultaneously, the inner tube 152 fills the gap between the outer tube 151 and the central core rod 120, increasing the radial rotation resistance of the central core rod 120 and further restricting the rotation of the outer tube 151, making the entire structure more stable. Alternatively, the outer tube 151 can be configured as a stepped structure at the fixing point of the proximal fixing component 140, that is, the inner diameter of the outer tube 151 at the fixing point of the proximal fixing component 140 matches the outer diameter of the outer fixing ring 142, and the inner diameter of the outer tube 151 at the non-proximal fixing component 140 matches the shape of the central core rod 120. This structure can also restrict the rotation of the outer tube 151.

[0138] In some embodiments, the outer diameter of the inner tube 152 is the same as the outer diameter of the outer fixing ring 142.

[0139] In some embodiments, the outer tube 151 is made of PEBAX (modified nylon) material. This allows the outer tube 151 to have a certain degree of flexibility, facilitating its insertion into the target location within the body. The outer wall of the outer tube 151 should be smooth and burr-free to avoid damaging internal tissues.

[0140] In some embodiments, the core rod 120 is a solid structure, which can enhance its supporting strength. The core rod 120 is made of nickel-titanium alloy. The oxide layer on the surface of the core rod 120 may or may not be removed. When the core rod 120 acts as a conductor to supply power to the braided basket structure 110, the oxide layer on the surface of the core rod 120 is removed to improve conductivity.

[0141] In some embodiments, the central core rod 120 is a conductor, and at least one of the following connections is made: the distal end of the braided basket structure 110 and the distal end of the central core rod 120; or the proximal end of the braided basket structure 110 and the proximal end of the central core rod 120. Specifically, the distal end of the braided basket structure 110 and the distal end of the central core rod 120 are connected; or the proximal end of the braided basket structure 110 and the proximal end of the central core rod 120 are connected; or both the distal end of the braided basket structure 110 and the proximal end of the central core rod 120 are connected. The connection can be secured with fasteners, such as by wrapping copper wire around the proximal end of the distal end fixing component 130 or the distal end of the proximal end fixing component 140 to achieve an electrical connection.

[0142] When the braided basket structure 110 described above is used as a single electrode, it is electrically connected to the braided basket structure 110 directly through the central core rod 120 itself to supply power.

[0143] The central core rod 120 and the outer tube 151, which pass through the inner fixing ring 141, are respectively connected to the conduit handle 200. The outer tube 151 is rotated by the conduit handle 200, and the central core rod 120 is powered by the conduit handle 200.

[0144] In some embodiments, the central core rod 120 is a conductor, and at least one of the protruding ring 131 and the inner fixing ring 141 is a conductor. That is, the protruding ring 131 is a conductor, or the inner fixing ring 141 is a conductor, or both the protruding ring 131 and the inner fixing ring 141 are conductors.

[0145] When the woven basket structure 110 described above is used as a single electrode, the central core rod 120 is indirectly powered through the protruding ring 131 or through the inner fixing ring 141.

[0146] The power supply method for the braided basket structure 110 is not limited to the above-mentioned direct or indirect power supply methods, as long as the power supply to the braided basket structure 110 can be provided through the conduit handle 200. For example, an axial power supply through hole is drilled in the core rod 120, and the wire passes through the power supply through hole from the conduit handle 200 and is connected to the braided basket structure 110. In this case, the core rod 120 is an insulator.

[0147] In some embodiments, the diameter of the central core rod is 0.5mm-0.8mm, preferably 0.6mm or 0.7mm.

[0148] In some embodiments, the woven basket structure 110 typically has an expanded state and a contracted state. Referring to Figures 5(a) and 5(b), the woven basket structure 110 of the present invention is in an expanded state. (Refer to...) Figure 9 The woven basket structure 110 of the present invention is in a folded state.

[0149] In some embodiments, referring to FIG5(a), in the expanded state, the woven basket structure 110 includes, from the distal end to the proximal end, an integrally connected first gathering segment 111, a hollow cylindrical segment 112, and a second gathering segment 113. The distal end of the first gathering segment 111 is fixed to the distal end fixing component 130, and the first gathering segment 111 adopts a hollow frustum-like structure with a proximal diameter larger than the distal diameter. The proximal end of the second gathering segment 113 is fixed to the proximal end fixing component 140, and the second gathering segment 113 adopts a hollow frustum-like structure with a distal diameter larger than the proximal diameter. The openings of the first gathering segment 111 and the second gathering segment 113 are arranged opposite to each other and both face the hollow cylindrical segment 112. The woven basket structure 110 of the present invention is a mesh structure with both ends constricted and the middle part being a hollow cylinder in the expanded state. The constricted sections at both ends can maintain a fixed state with the distal fixing component 130 and the proximal fixing component 140. The hollow cylinder in the middle has the characteristic of having a large ablation area, and the pulse field ablation effect of COPD is good.

[0150] In some embodiments, the axial length of the first converging segment 111 is greater than the axial length of the second converging segment 113. The axial length of the first converging segment 111: axial length of the hollow cylindrical segment 112 = 1:1-3, preferably 1:1.2-2.5, such as 1:1.5, 1:1.8 or 1:2.2, etc.

[0151] In some embodiments, the axial length of the woven basket structure 110 is: the diameter of the hollow cylindrical segment 112 = 1.05-1.8, preferably 1.1-1.6, such as 1.2, 1.3, 1.5 or 1.7, etc.

[0152] In some embodiments, the woven basket structure 110 is a mesh basket structure formed by weaving filaments. When the diameter of the hollow cylindrical segment 112 is 15mm-22mm, the mesh density (PPI) of the woven basket structure 110 is 20-28, preferably 22-26, such as 23, 24, or 25, etc. Here, mesh density (PPI) refers to the number of mesh openings per unit length (inch) during the production and weaving of the woven basket structure 110.

[0153] In some embodiments, refer to Figure 8 The woven basket structure 110 has two sets of weaving groups, each with a number of weaving threads. For example, each weaving group has 16-20 weaving threads. The weaving threads in the two sets of weaving groups are cross-woven to form a diamond-shaped mesh with a diamond structure. The two interior angles α of this diamond-shaped mesh along the axial direction are preferably 45°-75°. That is, the diamond-shaped mesh is easier to stretch axially than radially.

[0154] During weaving, adjacent weaving threads within a single weaving group are arranged basically parallel, with no weaving intersections. Any two weaving threads in two weaving groups are not parallel to each other, achieving the purpose of cross weaving.

[0155] For example, a single diamond mesh is formed by weaving adjacent braids a1 and a2 in one braiding group and adjacent braids b1 and b2 in another braiding group.

[0156] In some embodiments, the weaving method of the present invention adopts a one-press-one-weave method, that is, two different groups of weaving threads cross to form a weaving intersection, and the position of a single weaving thread alternates vertically between two adjacent weaving intersections. For example... Figure 8 As shown, taking braided yarn a1 as an example, it intersects with braided yarns b1 and b2 to form adjacent braiding intersections o1 and o2, respectively. If braided yarn a1 at intersection o1 is above braided yarn b1, then braided yarn a1 at intersection o2 is below braided yarn b2. Similarly, when braided yarn b1 is below at intersection o1, the braided yarn b1 at the other two adjacent braiding intersections formed by it is above.

[0157] In some embodiments, the diameter of the braided yarn is 0.05mm-0.15mm, preferably 0.07mm-0.12mm, such as 0.08mm, 0.09mm, 0.10mm or 0.11mm, etc.

[0158] In some embodiments, the braided wire is a nickel-titanium alloy, and the braided wire is a conductive braided wire with no oxide layer on its surface. The nickel-titanium braided wire has no oxide layer on its surface; that is, in the nickel-titanium alloy, Ni and Ti exist in an atomic state, which can greatly improve the electrical conductivity of the braided basket structure and promote the electroporation effect of tissue cells.

[0159] In some embodiments, refer to Figure 9 In the folded state, the middle part of the woven basket structure 110 is recessed towards the central core rod 120, and the inner wall of the woven basket structure 110 is at a predetermined distance from the central core rod 120. The woven basket structure 110 and the central core rod 120 do not contact each other in the folded state.

[0160] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely illustrative of the principles of the invention. Various changes and modifications can be made to the invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the present invention as claimed. The scope of protection of this invention is defined by the appended claims and their equivalents.

Claims

1. A device assembly for treating chronic obstructive pulmonary disease, comprising a pulsed high-voltage device, a catheter handle, and an electrode catheter connected in sequence, wherein the pulsed high-voltage device includes a circuit board having a low-voltage section and a high-voltage section electrically connected to each other; Its features are, The low-voltage section and the high-voltage section are spaced at a preset distance at both ends of the circuit board, and the low-voltage section and the high-voltage section are electrically connected through an optocoupler; The pulsed high-voltage device also includes: A first potting layer covers the outside of the high-voltage section; A first shielding layer covers the outside of the first potting layer; Also includes: A ground wire is provided on the circuit board outside the first potting layer, and is laid around the high voltage section at least once. One end of the ground wire is connected to a grounding point, which is located at the edge of the circuit board. Also includes: A segmented isolation groove extends through the circuit board and is disposed on the circuit board between the low-voltage section and the high-voltage section, dividing the circuit board into two regions: a low-voltage side and a high-voltage side. A second potting layer, which covers all components on both sides of the circuit board except for the high-voltage connector and the grounding point through the isolation groove.

2. The device assembly for treating chronic obstructive pulmonary disease as described in claim 1, characterized in that, The circuit board has a mounting slot, the mounting slot comprising: A closed-loop groove is formed around the outer side of the first potting layer; A lead-in groove connects the closed-loop groove and the grounding point; The ground wire is laid in the mounting groove.

3. The device assembly for treating chronic obstructive pulmonary disease as described in claim 2, characterized in that, The ground wire is located inside the first shielding layer, and the distance between the orthographic projection of the sidewall of the first shielding layer on the circuit board and the ground wire does not exceed 5mm.

4. The device assembly for treating chronic obstructive pulmonary disease as described in claim 3, characterized in that, The first shielding layer is in contact with the ground wire, causing the first shielding layer to be connected to the grounding point.

5. The device assembly for treating chronic obstructive pulmonary disease as described in claim 1, characterized in that, The low-voltage section includes a main control CPU for controlling the coordination of actions between various devices in the pulse high-voltage equipment, and a driver chip for amplifying the input weak electrical signals.

6. The device assembly for treating chronic obstructive pulmonary disease as described in any one of claims 1 to 5, characterized in that, The catheter handle has a handle housing, and a pulse connection part is provided at the proximal end of the handle housing. The pulse connection part is electrically connected to the output end of the high-voltage section through a wire. The electrode conduit has electrodes and a central core rod electrically connected to the electrodes. The proximal end of the central core rod is disposed inside the handle housing and electrically connected to the pulse connection part.

7. The device assembly for treating chronic obstructive pulmonary disease as described in claim 6, characterized in that, The electrode adopts a woven basket structure, the woven basket structure has a hollow cavity, and the central core rod passes through the hollow cavity of the woven basket structure to connect the proximal end and the distal end of the basket structure; The electrode conduit also includes: A set of pipes; A distal fixing component is provided to fix the distal end of the woven basket structure and the distal end of the central core rod. A proximal fixing assembly secures the proximal end of the braided basket structure to the distal end of the sleeve; The sleeve and the proximal fixing assembly are axially movable relative to the central core rod, and the proximal fixing assembly restricts the rotation of the sleeve relative to the central core rod so that the braided basket structure can contract or expand to a predetermined state.

8. The device assembly for treating chronic obstructive pulmonary disease as described in claim 7, characterized in that, The remote fixation component includes: A raised ring is fixed internally to the distal end of the central core rod; A fixing cap, with an open near end, is fitted over the protruding ring, and the fixing cap and the protruding ring engage the far end of the woven basket structure.

9. The device assembly for treating chronic obstructive pulmonary disease as described in claim 7, characterized in that, The proximal fixation assembly includes: An inner fixing ring is sleeved outside the central core rod and can move along the axial direction of the central core rod; An outer fixing ring is sleeved outside the inner fixing ring, and the outer fixing ring and the inner fixing ring are engaged with the proximal end of the woven basket structure; The sleeve includes: An outer tube, the distal end of which is fitted around the outer periphery of the outer fixing ring and fixed thereto.

10. The device assembly for treating chronic obstructive pulmonary disease as described in claim 9, characterized in that, The sleeve also includes: An inner tube is disposed inside the outer tube and sleeved outside the central core rod, with the distal end of the inner tube abutting the proximal end of the outer fixing ring.

11. The device assembly for treating chronic obstructive pulmonary disease as described in claim 10, characterized in that, The central core rod is a conductor, and the distal end and / or proximal end of the braided basket structure are electrically connected to the central core rod so that the pulse ablation energy can be transmitted to the braided basket structure.

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