CN115778518A

CN115778518A - Device assembly for treating chronic obstructive pulmonary disease

Info

Publication number: CN115778518A
Application number: CN202211432985.6A
Authority: CN
Inventors: 郭剑; 费天一; 徐涛
Original assignee: Zhouling Shanghai Medical Instrument Co ltd
Current assignee: Zhouling Shanghai Medical Instrument Co ltd
Priority date: 2022-11-16
Filing date: 2022-11-16
Publication date: 2023-03-14

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to a device assembly for treating chronic obstructive pulmonary disease. A device assembly for treating chronic obstructive pulmonary disease comprises a pulse high-voltage device, a catheter handle and an electrode catheter which are connected in sequence, wherein the pulse high-voltage device comprises a circuit board, and a low-voltage section and a high-voltage section which are electrically connected with 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 at a preset distance; the pulse high voltage device further includes: the first glue filling layer is coated on the outer side of the high-pressure section; and the first shielding layer is coated outside the first glue filling layer. According to the invention, the high-voltage section of the pulse high-voltage equipment is independently filled with glue and matched with the first shielding layer, so that the high-voltage section is effectively prevented from being discharged to the outside to cause breakdown phenomenon, and the equipment is prevented from being damaged.

Description

Device assembly for treating chronic obstructive pulmonary disease

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a device assembly for treating chronic obstructive pulmonary disease.

Background

Chronic Obstructive Pulmonary Disease (COPD) refers to a chronic lung disease that results in a limitation of airflow in the lungs. COPD is progressive and irreversible; the external stimulation causes proliferation of partial cells in the lung trachea, the proliferated cells secrete more mucus to discharge external stimuli through the mucus, and the excessive cell proliferation and the generated excessive mucus further reduce the size of the lung trachea channel, so that the dyspnea is further aggravated.

Pulse Field Ablation (PFA) is a technique of using high voltage discharge to cause irreversible electroporation of cells, which can directly act on cells to cause apoptosis, thereby achieving the therapeutic goal. The irreversible electroporation ablation technology used for the pulse field ablation is a non-heating ablation technology, can selectively puncture cells by adjusting the voltage, does not influence peripheral tissues, and does not cause the phenomenon of tissue scabbing in the operation process and after the operation, thereby not influencing the normal functions of the lung trachea. In addition, the mechanism of cell death due to irreversible electroporation is apoptosis, not necrosis. The apoptosis has the advantages that apoptotic cells are eliminated through immune intervention, phagocytes simultaneously eliminate apoptotic cells as the death process of normal cells so as to promote the regeneration and repair of normal tissues, and therefore, a treatment area can be replaced by the normal cells in a short time after irreversible electroporation treatment so as to recover the original functions.

The existing treatment means is that an ablation catheter is connected with an energy generator, and energy is transmitted to an ablation electrode to ablate a focus. Because the pulse field ablation is a technology of generating irreversible electroporation by using high-voltage discharge, the control of the high-voltage pulse discharge of the pulse equipment is particularly important, and the pulse discharge generally adopts a method of controlling the high voltage by using low voltage. However, in practical situations, the voltage of the low voltage section is far lower than the voltage of the high voltage section, so that the high voltage section is likely to affect the low voltage section, and even when the high voltage section and the low voltage section are integrated on the same circuit board, a breakdown phenomenon occurs, so that the low voltage section cannot work. Meanwhile, in the prior art, the single-electrode ablation structure is mostly a basket type braided structure, and is attached to the tracheal wall through expansion or contraction, but because the two ends of the basket structure are respectively fixed on the central rod and the sleeve, the central rod and the sleeve can easily rotate relatively during actual operation, so that the ablation electrode of the basket structure is twisted, the basket can not be expanded to a preset diameter, and the ablation is incomplete or the operation fails.

Disclosure of Invention

The invention aims to solve the technical problem that in a high-voltage pulse device for providing high-voltage pulses for an electrode catheter for ablation, the high-voltage section easily influences the low-voltage section, even generates a breakdown phenomenon, and the low-voltage section cannot work, and aims to provide a device assembly for treating chronic obstructive pulmonary disease.

A 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, wherein the pulse high-voltage device comprises a circuit board, and a low-voltage section and a high-voltage section which are electrically connected with 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 at intervals of a preset distance;

the pulse high voltage equipment further comprises:

the first glue filling layer is coated on the outer side of the high-pressure section;

and the first shielding layer is coated on the outer side of the first glue filling layer.

Preferably, the pulse high voltage equipment further comprises:

and the ground wire is arranged on the circuit board outside the first adhesive filling layer, is laid around the high-voltage section for at least one circle, and is connected with a ground point at one end, and the ground point is positioned at the edge of the circuit board.

As preferred scheme, the last mounting groove of having seted up of circuit board, the mounting groove includes:

the closed ring groove is formed around the outer side of the first glue filling layer;

the lead groove is communicated with the closed ring groove and the grounding point;

the ground wire is laid in the mounting groove.

Preferably, the ground wire is located on the inner side of the first shielding layer, and the distance between the orthographic projection position of the side wall of the first shielding layer on the circuit board and the ground wire is not more than 5mm.

Preferably, the first shielding layer is in contact with the ground line, so that the first shielding layer is in communication with the ground point.

Preferably, the output end of the high-voltage section is connected with a row of high-voltage connectors, and the high-voltage connectors are electrically connected with the electrode catheter through the catheter handle.

Preferably, the low-voltage section comprises a main control CPU for controlling the action coordination among the devices in the pulse high-voltage equipment, and a driving chip for amplifying the input weak current signal.

Preferably, the low-voltage section and the high-voltage section are electrically connected through a photocoupler.

Preferably, the pulse high voltage device further comprises:

the segmented isolation groove penetrates through the circuit board and is arranged on the circuit board between the low-voltage segment and the high-voltage segment, and the isolation groove divides the circuit board into two areas, namely a low-voltage side area and a high-voltage side area;

and the second glue filling layer coats all components on the two sides of the circuit board except the high-voltage connector and the grounding point through the isolation groove.

Preferably, the isolation groove is a through groove which is communicated with the upper part and the lower part, and preferably, the isolation groove is a sectional through groove, so that the circuit boards on the low-pressure side and the high-pressure side are provided with connecting sections.

Preferably, the first glue filling layer and the second glue filling layer are made of high polymer insulating materials.

Preferably, the circuit board is a relay board.

Preferably, the catheter handle is provided with a handle shell, the proximal end of the handle shell is provided with a pulse connecting part, and the pulse connecting part is electrically connected with the output end of the high-voltage section through a lead;

the electrode catheter is provided with an electrode and a middle core rod electrically connected with the electrode, and the near end of the middle core rod is arranged in the handle shell and electrically connected with the pulse connecting part.

As a preferred scheme, the electrode adopts a woven basket structure, the woven basket structure is provided with a hollow cavity, and the central core rod penetrates through the hollow cavity of the woven basket structure to be connected with the near end and the far end of the basket woven structure;

the electrode catheter further includes:

a sleeve;

a distal fixation assembly securing a distal end of the woven basket structure and a distal end of the mandrel;

a proximal end securing assembly securing a proximal end of the braided basket structure to a distal end of the cannula;

the sleeve and the proximal fixation assembly are axially movable relative to the central core rod, and the proximal fixation assembly limits rotation of the sleeve relative to the central core rod to collapse or expand the braided basket structure to a predetermined state.

Preferably, the distal fixation assembly comprises:

the inner part of the convex ring is fixed with the far end of the central core rod;

a locking cap, the end face of nearing is the opening, the cover is established outside the protruding ring, the locking cap with joint between the protruding ring weave the distal end of basket structure.

As a preferred scheme, a plurality of guide grooves are uniformly arranged in the fixing cap along the circumferential direction, and the length direction of each guide groove is axial;

the far end of the weaving basket structure is uniformly arranged in the guide grooves.

Preferably, the depth of the guide groove is smaller than the diameter of the weaving wire of the weaving basket structure.

Preferably, the proximal fixation assembly comprises:

the inner fixing ring is sleeved outside the central core rod and can axially move along the central core rod;

the outer fixing ring is sleeved outside the inner fixing ring, and the near end of the woven basket structure is clamped between the outer fixing ring and the inner fixing ring;

the bushing includes:

the far end of the outer tube is sleeved on the periphery of the outer fixing ring and fixed with the outer fixing ring.

Preferably, the inner diameter of the inner fixing ring is: the diameter of the central core rod =1.1-1.3.

Preferably, the inner diameter of the outer tube is: the outer diameter of the outer fixing ring =0.9-1.0.

Preferably, the bushing further comprises:

the inner tube is arranged in the outer tube and sleeved outside the middle core rod, and the far end of the inner tube is abutted against the near end of the outer fixing ring.

Preferably, the outer diameter of the inner tube is the same as the outer diameter of the outer fixing ring.

Preferably, the outer tube is a nylon elastic tube made of PEBAX (modified nylon).

Preferably, the central core rod is of a solid structure and is made of nickel-titanium alloy.

Preferably, the central core rod is a conductor, and the distal end of the woven basket structure and/or the proximal end of the woven basket structure are in conduction connection with the central core rod, so that the pulse ablation energy can be transmitted to the woven basket structure.

Preferably, the central core bar is a conductor, and at least one of the protrusion ring and the inner fixing ring is a conductor.

Preferably, the diameter of the central core is 0.4mm to 0.8mm, preferably 0.5mm or 0.6mm.

Preferably, the woven basket structure has an expanded state comprising, in order from the distal end to the proximal end, integrally connected:

the first bundling section has a far end fixed with the far end fixing component and a near end diameter larger than that of the far end and is of a hollow circular truncated cone structure;

a hollow cylindrical section;

the second bundling section is fixed with the near end fixing component at the near end, and the diameter of the far end of the second bundling section is larger than that of the near end of the second bundling section;

the opening of the first beam-receiving section and the opening of the second beam-receiving section are oppositely arranged and face the hollow cylindrical body section.

Preferably, the axial length of the first bundling section is greater than the axial length of the second bundling section, and the axial length of the first bundling section is: the axial length of the hollow cylinder section =1:1-3, preferably 1:1.2-2.5, such as 1:1.5, 1:1.8 or 1:2.2, and so on.

Preferably, the axial length of the woven basket structure is: the hollow cylinder section has a diameter =1.05-1.8, preferably 1.1-1.6, such as 1.2, 1.3, 1.5 or 1.7, etc.

As a preferred scheme, the woven basket structure is a basket structure with meshes formed by weaving woven wires;

when the diameter of the hollow cylinder section is 15mm-22mm, the mesh density PPI of the woven mesh basket structure is 20-28, preferably 22-26, such as 23, 24 or 25, etc.

Preferably, the woven basket structure is provided with two groups of weaving groups, and each group of weaving groups is provided with a plurality of weaving wires;

and weaving wires in the two weaving groups are crossed and woven to form diamond-shaped meshes with diamond structures.

Preferably, the two different groups of knitting yarns intersect to form a knitting intersection point, and the single knitting yarn is alternately arranged up and down at the position of the two adjacent knitting intersection points.

Preferably, each group of knitting groups has 16 to 20 knitting filaments.

Preferably, two internal angles of the rhombic meshes in the axial direction are 45-75 degrees.

Preferably, the filament diameter of the weaving filament is 0.05mm to 0.15mm, preferably 0.07mm to 0.12mm, such as 0.08mm, 0.09mm, 0.10mm or 0.11mm, etc.

Preferably, the braided wire is nickel-titanium alloy, and the braided wire is a conductive braided wire without an oxide layer on the surface.

Preferably, 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 side, and the inner wall of the woven basket structure has a preset distance from the central core rod.

The positive progress effects of the invention are as follows: the device assembly for treating chronic obstructive pulmonary disease has the following beneficial effects:

1. the pulse high-voltage equipment is used for providing high-voltage pulses for the electrode guide pipes, the pulse high-voltage equipment can control the discharge of the electrode guide pipes connected with the pulse high-voltage equipment, and due to the fact that partial electrodes are in selective discharge, when partial electrodes are not discharged, due to the particularity of high-voltage pulse energy (high voltage and various frequency components), strong interference is easily generated on other electrodes which are not discharged, and even the electrodes are damaged. According to the invention, the high-voltage section of the pulse high-voltage equipment is independently filled with glue and matched with the first shielding layer, so that the high-voltage section is effectively prevented from being discharged to the outside to cause breakdown phenomenon, and the equipment is prevented from being damaged.

2. Because the high-voltage section can generate mutual inductance with the first shielding layer when the voltage changes, induced current on the first shielding layer is led out through the ground wire by arranging the ground wire, the mutual inductance phenomenon generated by an internal self element is avoided, and the normal operation of equipment is prevented from being influenced by the interference of the low-voltage section and other components on the circuit board.

3. In order to avoid direct electrical signal communication between the high-voltage section and the low-voltage section, a photoelectric coupler is arranged between the high-voltage section and the low-voltage section, the low-voltage section controls the high-voltage section through the photoelectric coupler, the direct alternating electrical signal is converted into electricity-light-electricity to carry out signal transmission, the direct alternating of the electrical signal between the high-voltage section and the low-voltage section is avoided, the anti-interference capacity is high, electrical isolation is realized, the influence of the high-voltage section on the low-voltage section is effectively reduced, and the stability of the device is improved.

4. Separate high-voltage section and low-voltage section through the isolation tank, simultaneously again at the isolation tank encapsulating, through setting up the second encapsulating layer, carry out the cladding with whole circuit board and insulate, further promoted the insulating properties between high-voltage section and the low-voltage section, and effectively prevent that the high-voltage section from discharging to the external world and producing the breakdown phenomenon.

5. The isolation groove is not completely communicated with the circuit board in a whole, but is divided into a plurality of small sections, so that the strength of the circuit board is enhanced.

6. The electrode catheter fixes the woven basket structure and the middle core rod through the synergistic effect of the far-end fixing component and the near-end fixing component, the rotation of the sleeve is limited by the near-end fixing component, the sleeve cannot easily rotate relative to the middle core rod and only moves in the axial direction of the sleeve, so that the woven basket structure cannot be twisted, the woven basket structure can stably expand to a preset diameter after being released, and the stability of a pulse field ablation COPD operation is further improved.

7. The guide groove in the fixing cap can play a role in guiding the weaving wires, and the mesh size and uniformity of the weaving basket structure are prevented from being influenced by uneven distribution of the weaving wires in the bundling process. The depth of the guide groove is smaller than the diameter of the weaving wire, so that the friction force between the weaving wire and the protruding ring is increased, and the stability of the fixation of the weaving basket structure is improved.

8. The inner tube is arranged in the outer tube, so that on one hand, in order to fill a large gap between the outer tube and the middle core rod, which is generated by the inner and outer fixing rings, the middle core rod always keeps the centrality in the movement process, and the bending phenomenon is avoided; on the other hand, the inner tube is used for supporting the outer tube, so that the phenomenon of overlarge local stress caused by interference fit between the outer fixing ring and the outer tube is reduced, and the problem that the outer tube is damaged due to overlarge local stress in the use process of the outer tube is solved. Meanwhile, the inner tube is filled to enable the middle core rod to only move axially relative to the outer tube, so that the rotation of the outer tube is further limited, and the whole structure is more stable.

9. The woven basket structure is used as a single electrode, and the electric connection of the woven basket structure can be directly electrically connected with the woven basket structure through the central core rod and can also be indirectly supplied with power through the convex ring or the inner fixing ring.

10. The mesh structure with the two ends contracted and the middle part hollow cylinder is adopted in the expansion state of the weaving basket structure, the two end contracted sections can be better kept in a fixed state with the far-end fixing component and the near-end fixing component, the hollow cylinder in the middle part has the characteristic of larger ablation area, and the pulse field ablation effect on COPD is good.

11. The size, mesh density, the number of braided wires, the braiding mode or the sinking state during furling of the braided basket structure are designed, so that the braided basket structure can be well bundled, can be expanded to a preset size after being released, and does not influence the pulse field ablation COPD operation.

12. The surface of the nickel-titanium woven wire does not contain an oxide layer, namely Ni and Ti exist in an atomic state in the nickel-titanium alloy, so that the conductivity of the woven basket structure can be greatly improved, and the electroporation effect of tissue cells is promoted.

Drawings

FIG. 1 is a schematic view of an overall structure of the present invention;

fig. 2 (a) is a perspective view of a circuit board in the impulse high voltage device according to the present invention;

FIG. 2 (b) is a schematic structural diagram of FIG. 2 (a) except for a second potting layer;

FIG. 2 (c) is a schematic structural view of FIG. 2 (b) except for the first shielding layer;

fig. 2 (d) is a schematic structural view of fig. 2 (c) except for the first adhesive filling layer and the photocoupler;

fig. 3 (a) is a top view of the circuit board in the impulse high voltage device according to the invention;

FIG. 3 (b) isbase:Sub>A cross-sectional view A-A of FIG. 3 (base:Sub>A);

FIG. 3 (c) is a partial enlarged view at B in FIG. 3 (B);

fig. 3 (d) is a cross-sectional view of the high voltage side of the circuit board.

FIG. 4 is a partial schematic view of FIG. 1;

FIG. 5 (a) is a schematic view showing a structure of an electrode catheter according to the present invention;

FIG. 5 (b) is an internal cross-sectional view of FIG. 5 (a);

FIG. 5 (C) is a partial enlarged view at C in FIG. 5 (b);

FIG. 5 (D) is a partial enlarged view at D in FIG. 5 (b);

FIG. 6 is a drawing of the connection between the woven basket structure, the central core rod and the distal anchor assembly of the present invention;

FIG. 7 is a schematic view of a locking cap according to the present invention;

FIG. 8 shows a weave pattern of the woven basket structure of the present invention;

fig. 9 is a state view of the woven basket structure of the present invention in a contracted state.

Detailed Description

In order to make the technical means, the creation characteristics, the achievement purposes and the effects of the invention easy to understand, the invention is further described with the specific drawings.

In the present invention, when describing a device assembly for chronic obstructive pulmonary disease treatment, "distal", "proximal", "distal", and "proximal" are used as terms of orientation that are conventional in the art of interventional medical devices, wherein "distal" and "distal" refer to the end or segment that is distal from the operator during a procedure, and "proximal" refer to the end or segment that is proximal to the operator during the procedure. "axial" refers to a direction parallel to the line joining the center of the distal end and the center of the proximal end of the medical device; "radial" refers to a direction perpendicular to the "axial" direction described above.

Referring to fig. 1 and 4, an apparatus assembly for the treatment of chronic obstructive pulmonary disease includes, from the distal end to the proximal end, an electrode catheter 100, a catheter handle 200, and a pulsed high voltage device 300, which are connected in this order.

The proximal end of the catheter handle 200 is electrically connected to a pulse high voltage device 300, and the pulse high voltage device 300 provides high voltage pulses to the catheter handle 200. The distal end of the catheter handle 200 is connected with the electrode catheter 100, the catheter handle 200 drives the electrode catheter 100 to move towards the proximal end or the distal end, and the catheter handle 200 supplies power to the electrode catheter 100, so that the purpose that the pulse high-voltage device 300 releases positive and negative high-voltage pulse energy through the electrode catheter 100 to perform ablation is achieved. The catheter handle 200 may be any handle that can move the electrode catheter 100 and supply power to the electrode catheter 100, which is known in the art and will not be described in detail herein.

Referring to fig. 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 shield layer 350.

The circuit board 310 is preferably a relay board, more preferably a high voltage relay board that is resistant to breakdown. A low voltage stage 320 and a high voltage stage 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 disposed at both ends of the circuit board 310 at a predetermined distance. As shown in fig. 2 (d), the low voltage section 320 and the high voltage section 330 are disposed at the front side and the rear side of the circuit board 310, respectively, with a certain distance therebetween. Referring to fig. 2 (c), the first potting layer 340 is coated outside the high pressure section 330. Referring to fig. 2 (b), the first shielding layer 350 is coated outside the first encapsulating layer 340.

The pulse high-voltage equipment is used for providing high-voltage pulses for the electrode guide pipes, the pulse high-voltage equipment can control the discharge of the electrode guide pipes connected with the pulse high-voltage equipment, and due to the fact that partial electrodes are in selective discharge, when partial electrodes are not discharged, due to the particularity of high-voltage pulse energy (high voltage and various frequency components), strong interference is easily generated on other electrodes which are not discharged, and even the electrodes are damaged. According to the invention, the low-voltage section 320 and the high-voltage section 330 are arranged at a preset distance, the high-voltage section 330 of the pulse high-voltage equipment is independently subjected to glue filling treatment to form the first glue filling layer 340, and the first glue filling layer 350 is matched, so that the breakdown phenomenon of the high-voltage section 330 caused by external discharge is effectively prevented, and the equipment is damaged.

In some embodiments, the pulsed high voltage device 300 further comprises a ground line 360, the ground line 360 is disposed on the circuit board 310 outside the first potting layer 340, the ground line 360 is laid around the high voltage section 330 for at least one turn, one end of the ground line 360 is connected to a grounding point 361, and the grounding point 361 is located at the edge of the circuit board 310. Because the high-voltage section 330 and the first shielding layer 350 generate mutual inductance when the voltage changes, induced currents on the first shielding layer 350 are led out through the ground wire 360 by arranging the ground wire 360, the mutual inductance phenomenon generated by internal self elements is avoided, and the influence on the normal operation of equipment caused by the interference of the low-voltage section 320 and other components on the circuit board 310 is avoided.

In some embodiments, the circuit board 310 has a mounting groove, which includes a closed-loop groove and a lead groove, the closed-loop groove is formed around the outer side of the first adhesive-filling layer 340, and the lead groove connects the closed-loop groove and the ground point 361. Ground wire 360 is laid in the mounting groove. Ground 360 may be routed around high voltage segment 330 for at least one turn during routing, and one end of ground 360 may be routed along a lead slot to ground 361. As shown in fig. 2 (d), the cross section of the closed loop groove is a rectangular frame structure, the cross section of the lead groove is an L-shaped structure, one end of the lead groove is communicated with any position of the closed loop groove, and the other end of the lead groove is communicated with the grounding point 361.

In some embodiments, the ground line 360 is located inside the first shielding layer 350, and a distance between an orthographic projection position of the sidewall of the first shielding layer 350 on the circuit board 310 and the ground line 360 is not more than 5mm. As shown in fig. 3 (d), the circuit board 310 is used as a projection plane, and the distance between the sidewall of the first shielding layer 350 and the ground line 360 is not more than 5mm in a plan view, and the smaller the distance between the sidewall and the ground line, the better the shielding effect. Therefore, preferably, as shown in fig. 3 (b), the first shielding layer 350 is in contact with the ground line 360, so that the first shielding layer 350 communicates with the ground point 361.

The first shielding layer 350 is tightly attached to the outer sidewall of the first encapsulating layer 340 to cover the first encapsulating layer 340, thereby isolating the high voltage section 330 from generating mutual inductance with external elements. However, since the high voltage segment 330 may generate a mutual inductance phenomenon with the first shielding layer 340 when the voltage changes, the first shielding layer 350 is connected to the ground point 361 to achieve grounding, so as to directly introduce the induced current into the ground, thereby preventing the internal elements from generating the mutual inductance phenomenon to affect the low voltage segment 320.

In some embodiments, referring to fig. 2 (a) -3 (b), an array of high voltage connectors 331 are connected to the output of the high voltage section 330, and the high voltage connectors 331 are electrically connected to the electrode catheter 100 via the catheter handle 200.

In some embodiments, the low voltage segment 320 includes a main control CPU for controlling the cooperation of actions among the devices in the pulsed high voltage device 300, and a driving chip for amplifying the input weak current signal.

In some embodiments, referring to fig. 2 (b), 2 (c), and 3 (b), the pulse high voltage device 300 further includes an opto-coupler 370 (photo-isolator), and the low voltage section 320 and the high voltage section 330 are electrically connected through the opto-coupler 370. In order to avoid direct electrical signal communication between the high voltage section 330 and the low voltage section 320, the photoelectric coupler 370 is arranged between the high voltage section 330 and the low voltage section 320, the low voltage section 320 controls the high voltage section 330 through the photoelectric coupler 370, the direct alternating electrical signal is converted into electricity-light-electricity for signal transmission, the direct communication between the two electrical signals is avoided, the anti-interference capability is strong, the electrical isolation is realized, the influence of the high voltage section 330 on the low voltage section 320 is effectively reduced, and the stability of the device is improved.

In some embodiments, referring to fig. 2 (a) to 3 (c), the pulsed high voltage device 300 further includes an isolation trench 380 and a second potting layer 390. An isolation groove 380 is provided on the circuit board 310 between the low voltage stage 320 and the high voltage stage 330, and the isolation groove 380 divides the circuit board 310 into two regions of a low voltage side and a high voltage side. The low pressure side is provided with low pressure section 320, and the high pressure side is provided with high pressure section 330, and the first encapsulating layer 340, first shielding layer 350, ground wire 360 and high-pressure joint 331 that high pressure section 330 is peripheral also all set up at the high pressure side. The row of photo-couplers 370 straddle the upper side of the isolation groove 380.

The isolation groove 380 may be a through groove communicated with the circuit board 310, that is, the circuit board 310 on the low-voltage side and the high-voltage side is not connected, and the two are connected by glue filling through the isolation groove 380. Preferably, as shown in fig. 2 (d), the isolation groove 380 is a segmented through groove that penetrates the circuit board 310 such that the low-and high-voltage side circuit boards 310 have connection segments. The isolation groove 380 is not completely through, but is divided into several small segments, which enhances the strength of the circuit board 310 itself.

The second glue filling layer 390 not only fills the glue isolation groove 380, but also coats all the components on both sides of the circuit board 310 except the high voltage connector 331 and the grounding point 361 through the isolation groove 380. As shown in fig. 2 (a), 3 (a) and 3 (b), the second potting layer 390 covers the entire circuit board 310 and exposes the high voltage connector 331 electrically connected to the catheter handle 200 and the ground point 361 for grounding. The periphery of the circuit board 310 may further be provided with fixing through holes for fixing the circuit board 310, and the fixing through holes are also exposed out of the second potting layer 390.

According to the invention, the high-voltage section 330 and the low-voltage section 320 are separated by the isolation groove 380, the isolation groove 380 is filled with glue, and the whole circuit board 310 is coated and insulated by arranging the second glue filling layer 390, so that the insulation performance between the high-voltage section 330 and the low-voltage section 320 is further improved, and the breakdown phenomenon caused by the discharge of the high-voltage section 330 to the outside is effectively prevented.

In some embodiments, the first encapsulating layer 340 and the second encapsulating layer 390 are both made of polymer insulating materials.

In some embodiments, the catheter handle 200 has a handle housing with a pulse connection at its proximal end that is electrically connected to the output of the high voltage section 330 by a wire. The electrode catheter 100 has an electrode, a central core rod 120 electrically connected to the electrode, and a proximal end of the central core rod 120 is disposed within the handle housing and electrically connected to the pulse connection. So that the purpose of the impulse high-voltage device 300 for releasing the positive and negative high-voltage impulse energy through the electrode catheter 100 for ablation is achieved.

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

The woven basket structure 110 has a hollow cavity communicating the distal and proximal ends through which the central core rod 120 passes to facilitate securing the distal and proximal ends thereof by distal and

proximal securing assemblies

130 and 140, respectively.

The distal end of the outer tube 151 is secured to the proximal fixation assembly 140. The outer tube 151 may be coupled to a catheter handle 200, and the catheter handle 200 may move, or rotate, the braided basket structure 110 distally or proximally through the outer tube 151.

According to the invention, the far-end fixing component 130 and the near-end fixing component 140 cooperate to fix the two ends of the woven basket structure 110 and the central rod 120, when the outer tube 151 rotates, the woven basket structure 110 synchronously rotates along with the outer tube 151, the woven basket structure 110 cannot be twisted, and after the woven basket structure 110 is released, the woven basket structure 110 can be stably expanded to a preset diameter, so that the stability of a pulse field ablation COPD operation is further improved. Optionally, as a further improvement of the present invention, the inner fixing ring 141 of the proximal end fixing assembly 140 and the central core rod 120 may be configured as a snap-in structure, for example, an axially extending snap-in boss or a snap-in groove is disposed on the outer surface of the central core rod 120, and a corresponding axially extending snap-in groove or a snap-in boss is disposed on the inner fixing ring 141, so as to limit the rotation of the cannula relative to the central core rod 140. It is also possible to provide the central core rod 140 with a non-regular shape other than a circle, and to provide a channel in the sleeve that is adapted to the outer shape of the central core rod 140, so that the outer tube is only axially displaceable.

In some embodiments, referring to fig. 5 (b), 5 (c), and 6, distal fixation assembly 130 includes a raised ring 131 and a fixation cap 132. The distal end of central core rod 120 is inserted into raised ring 131, and the interior of raised ring 131 is secured to the distal end of central core rod 120. The proximal end face of the fixing cap 132 is an opening, the fixing cap 132 is sleeved outside the protrusion ring 131, and the distal end of the woven basket structure 110 is clamped between the fixing cap 132 and the protrusion ring 131. The distal end of the braided basket structure 110 is captured by the socket of the locking cap 132 and raised ring 131.

In some embodiments, referring to fig. 7, a plurality of guide slots 1321 are uniformly arranged in the fixing cap 132 along the circumferential direction, and the length direction of the guide slots 1321 is axial. The distal ends of the woven basket structure 110 are uniformly arranged within the plurality of guide slots 1321. The weaving filaments bundled at the distal end of the woven basket structure 110 may be individually or in multiple stacked within the same guide slot 1321. When the number of the knitting yarns is small, it is preferable that a single knitting yarn is disposed in the corresponding single guide slot 1321 and a plurality of knitting yarns are independent from each other.

The guiding slot 1321 in the fixing cap 132 of the present invention can guide the weaving yarn, and prevent the uneven distribution of the weaving yarn from affecting the mesh size and uniformity of the woven basket structure 110 during the binding process.

In some embodiments, referring to fig. 6, the depth of the guide slots 1321 is less than the braided wire diameter of the braided basket structure 110. So as to increase the friction between the knitting yarn and the raised ring 131 and improve the stability of the fixing of the knitted basket structure 110.

In some embodiments, referring to fig. 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 center core rod 120 passes through the inner fixing ring 141 and is fixed with the inner fixing ring 141. The outer fixing ring 142 is sleeved outside the inner fixing ring 141, and the proximal end of the woven basket structure 110 is clamped between the outer fixing ring 142 and the inner fixing ring 141. The present invention sandwiches the proximally-constricted braided filaments of the braided basket structure 110 by the outer and inner retaining rings 142, 141. The inner fixing ring 141 is tightly fitted with the center core rod, so that when the outer tube 151 and the center core rod 120 are prevented from rotating relatively, the inner fixing ring 141 cannot rotate together with the outer tube, and the twisting of the woven basket structure 110 is avoided.

In some embodiments, the inner fixing ring 141 can be fittingly sleeved on the outer circumference of the central core rod 120 by disposing the central core rod 120 in an irregular cylindrical structure, or in a prism shape, or in an oval shape, or in other structures, and the inner fixing ring 141 can be prevented from rotating along with the outer tube 142. Optionally, the matching position of the inner fixing ring 141 and the middle core rod 120 may be set to be a clamping convex structure, a protrusion or a groove is arranged on the middle core rod 120, and a corresponding groove or protrusion is arranged on the inner fixing ring 141 to be clamped and clamped for limiting, so as to prevent the inner fixing ring 141 from rotating along the axis of the middle core rod 120.

In some embodiments, the inner diameter of the inner retaining ring 141: the diameter of the central core bar 120 =1.1-1.3. So that the central rod 120 can smoothly pass through the inner fixing ring 141.

In some embodiments, the inner diameter of the outer tube 151: the outer diameter of the outer fixing ring 142 =0.9-1.0. So as to realize the interference fit fixation of the outer tube 151 and the outer fixing ring 142.

In some embodiments, the cannula further includes an inner tube 152, the inner tube 152 is disposed within the outer tube 151 and sleeved outside the central core rod 120, and a distal end of the inner tube 152 abuts against a proximal end of the outer fixing ring 142. The inner tube 152 is arranged in the outer tube 151, so that on one hand, in order to fill a large gap between the outer tube 151 and the middle core rod 120, which is generated by the inner and outer fixing rings 142, the middle core rod 120 always keeps the centrality in the movement process, and the bending phenomenon is avoided; on the other hand, the inner tube is used for supporting the outer tube 151, so that the phenomenon of overlarge local stress caused by interference fit between the outer fixing ring 142 and the outer tube 151 is reduced, and the problem that the outer tube 151 is damaged due to overlarge local stress in the use process is solved. Meanwhile, the inner tube 152 is filled to reduce the gap between the outer tube 151 and the central core rod 120, so that the radial rotation resistance of the central core rod 120 is increased, the rotation of the outer tube 151 is further limited, and the whole structure is more stable. Alternatively, the outer tube 151 may be provided with a step structure at the fixing position of the proximal fixing assembly 140, that is, the inner diameter of the outer tube 151 at the fixing position of the proximal fixing assembly 140 matches the outer diameter 142 of the outer fixing ring, and the inner diameter of the outer tube 151 at the non-proximal fixing assembly 140 matches the outer shape of the central core rod 120, and such a structure may also limit the rotation of the outer tube 151.

In some embodiments, the outer diameter of the inner tube 152 is the same as the outer diameter of the outer retaining ring 142.

In some embodiments, the outer tube 151 is made of PEBAX (modified nylon) material. So that the outer tube 151 can have a certain degree of bending to facilitate entry into a target site in the body. The outer wall of the outer tube 151 should be smooth and burr-free to avoid damaging the internal tissues of the human body.

In some embodiments, the central core rod 120 is a solid structure, which can enhance the supporting strength of the central core rod 120. The central core rod 120 is made of nickel titanium alloy. The surface of the central rod 120 may or may not be oxidized. When the central core rod 120 is used as a conductor to supply power to the woven basket structure 110, the oxide layer is removed from the surface of the central core rod 120 to improve the conductivity.

In some embodiments, the central core 120 is a conductor, and the distal end of the braided basket structure 110 and the distal end of the central core 120 are interconnected at least one of the proximal end of the braided basket structure 110 and the proximal end of the central core 120. That is, the distal end of the braided basket structure 110 and the distal end of the central mandrel 120 are interconnected, or the proximal end of the braided basket structure 110 and the proximal end of the central mandrel 120 are interconnected, or the distal end of the braided basket structure 110 and the distal end of the central mandrel 120 are interconnected and the proximal end of the braided basket structure 110 and the proximal end of the central mandrel 120 are interconnected. The connection between the two can be fastened by a fastener, such as a copper wire, wound around the proximal side of the distal fixation assembly 130 or the distal side of the proximal fixation assembly 140 to achieve electrical connection.

When the woven basket structure 110 is used as a single electrode, the core rod 120 is directly electrically connected to the woven basket structure 110 for power supply.

The central core rod 120 and the outer tube 151 penetrating through the inner fixing ring 141 are respectively connected with the catheter handle 200, the outer tube 151 is driven to rotate by the catheter handle 200, and the catheter handle 200 supplies power to the central core rod 120.

In some embodiments, the center core rod 120 is a conductor and at least one of the raised ring 131 and the inner securing ring 141 is a conductor. That is, the raised ring 131 is a conductor, the inner fixing ring 141 is a conductor, or both the raised ring 131 and the inner fixing ring 141 are conductors.

When the woven basket structure 110 is used as a single electrode in the above manner, the middle core bar 120 is indirectly supplied with power through the protrusion ring 131 or through the inner fixing ring 141.

The manner of supplying power to the woven basket structure 110 is not limited to the above-described direct or indirect manner of supplying power, as long as power can be supplied to the woven basket structure 110 via the catheter handle 200. For example, an axial power supply through hole is dug in the central core rod 120, and the conducting wire is connected to the woven basket structure 110 after passing through the power supply through hole from the catheter handle 200, and the central core rod 120 is an insulator.

In some embodiments, the diameter of the central core is 0.5mm to 0.8mm, preferably 0.6mm or 0.7mm.

In some embodiments, the woven basket structure 110 generally has an expanded state and a collapsed state, and referring to fig. 5 (a) and 5 (b), the woven basket structure 110 of the present invention is in the expanded state. Referring to fig. 9, the woven basket structure 110 of the present invention is in a collapsed condition.

In some embodiments, referring to fig. 5 (a), in the expanded state, the woven basket structure 110 comprises, in order from the distal end to the proximal end, a first necked-in section 111, a hollow cylinder section 112, and a second necked-in section 113 that are integrally connected. The far end of the first beam-receiving section 111 is fixed to the far-end fixing component 130, and the first beam-receiving section 111 is of a hollow circular truncated cone structure with a near-end diameter larger than a far-end diameter. The proximal end of the second beam-receiving section 113 is fixed to the proximal end fixing assembly 140, and the second beam-receiving section 113 is of a hollow circular truncated cone structure with a distal end diameter larger than a proximal end diameter. The opening of the first beam-receiving section 111 and the opening of the second beam-receiving section 113 are oppositely arranged and both face the hollow cylindrical section 112. The woven basket structure 110 is a mesh structure with two ends being contracted and the middle being a hollow cylinder in the expansion state, the two end contracted sections can be well maintained in a fixed state with the far-end fixing component 130 and the near-end fixing component 140, the hollow cylinder in the middle has the characteristic of large ablation area, and the pulse field ablation effect on COPD is good.

In some embodiments, the axial length of the first beam-receiving section 111 is greater than the axial length of the second beam-receiving section 113, the axial length of the first beam-receiving section 111: axial length of hollow cylindrical section 112 =1:1-3, preferably 1:1.2-2.5, such as 1:1.5, 1:1.8 or 1:2.2, and so on.

In some embodiments, the axial length of the woven basket structure 110: the hollow cylinder section 112 has a diameter =1.05-1.8, preferably 1.1-1.6, such as 1.2, 1.3, 1.5 or 1.7, etc.

In some embodiments, the woven basket structure 110 is a mesh-meshed basket structure formed using woven wire weaving. When the diameter of the hollow cylinder section 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. Wherein the PPI is the number of openings per unit length (inch) of the woven basket structure 110 during production weaving.

In some embodiments, referring to fig. 8, the woven basket structure 110 has two sets of weaves, each set having a number of weave filaments. For example, each braid set has 16-20 braid filaments. The knitting filaments in the two knitting groups are crossed and knitted to form diamond meshes with diamond structures. The two internal angles alpha of the rhombic meshes along the axial direction are preferably 45-75 degrees. That is, the diamond mesh is more easily stretched axially than radially.

When weaving, adjacent weaving filaments in the single group of weaving group are basically arranged in parallel without weaving intersection points. Any two weaving yarns in the two weaving groups are not parallel to each other, so that the purpose of cross weaving is realized.

For example, the single diamond-shaped meshes are respectively formed by weaving adjacent weaving filaments a1 and a2 in one weaving group and adjacent weaving filaments b1 and b2 in the other weaving group.

In some embodiments, the knitting method of the present invention adopts a one-over-one knitting method, that is, two different groups of knitting yarns are crossed to form a knitting intersection point, and a single knitting yarn is alternately arranged up and down at the position of two adjacent knitting intersection points. As shown in fig. 8, taking the knitting yarn a1 as an example, it crosses the knitting yarn b1 and the knitting yarn b2 to form a knitting intersection o1 and a knitting intersection o2 adjacent to each other, and the knitting yarn a1 at the knitting intersection o1 is located above the knitting yarn b1, and the knitting yarn a1 at the knitting intersection o2 is located below the knitting yarn b 2. Similarly, when the knitting yarn b1 at the knitting intersection o1 is located below, the knitting yarn b1 at two other knitting intersections formed adjacent to the knitting intersection o1 is located above.

In some embodiments, the filaments of the braided filaments have a filament diameter of 0.05mm to 0.15mm, preferably 0.07mm to 0.12mm, such as 0.08mm, 0.09mm, 0.10mm, or 0.11mm, and the like.

In some embodiments, the braided wire is nitinol, and the braided wire is a conductive braided wire with a surface free of an oxide layer. The surface of the nickel-titanium woven wire does not contain an oxide layer, namely Ni and Ti exist in an atomic state in the nickel-titanium alloy, so that the conductivity of the woven basket structure can be greatly improved, and the electroporation effect of tissue cells is promoted.

In some embodiments, referring to fig. 9, in a collapsed state, a middle portion of the woven basket structure 110 is recessed toward the side of the central core rod 120, and an inner wall of the woven basket structure 110 has a predetermined distance from the central core rod 120. The woven basket structure 110 in the collapsed state is not in contact with the central core rod 120.

The foregoing shows and describes the general principles, essential features, and advantages of the invention. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, which are given by way of illustration of the principles of the present invention, but that various changes and modifications may be made without departing from the spirit and scope of the invention, and such changes and modifications are within the scope of the invention as claimed. The scope of the invention is defined by the appended claims and equivalents thereof.

Claims

1. A 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, wherein the pulse high-voltage device comprises a circuit board, and a low-voltage section and a high-voltage section which are electrically connected with each other are arranged on the circuit board;

the circuit board is characterized in that the low-voltage section and the high-voltage section are arranged at two ends of the circuit board at intervals of a preset distance;

the pulse high voltage device further comprises:

2. The apparatus assembly for chronic obstructive pulmonary disease treatment of claim 1, wherein the pulsed high voltage device further comprises:

and the ground wire is arranged on the circuit board outside the first adhesive filling layer, is laid around the high-voltage section for at least one circle, and is connected with the grounding point at one end, and the grounding point is positioned at the edge of the circuit board.

3. The device assembly for chronic obstructive pulmonary disease treatment of claim 2, wherein the circuit board has a mounting slot formed thereon, the mounting slot comprising:

the ground wire is laid in the mounting groove.

4. The device assembly for chronic obstructive pulmonary disease treatment of claim 2, wherein the ground line is located inside the first shield layer, and a distance between a orthographic projection position of a sidewall of the first shield layer on the circuit board and the ground line is not more than 5mm.

5. The device assembly for chronic obstructive pulmonary disease treatment of claim 4, wherein the first shield layer is in contact with the ground line such that the first shield layer is in communication with the ground point.

6. The device assembly for chronic obstructive pulmonary disease treatment of claim 1, wherein the low voltage section comprises a master CPU for controlling the motion coordination between the devices in the pulsed high voltage apparatus, a driving chip for amplifying the input weak current signal.

7. The device assembly for use in the treatment of chronic obstructive pulmonary disease of claim 1, wherein the low pressure section and the high pressure section are electrically connected by an opto-coupler.

8. The apparatus assembly for chronic obstructive pulmonary disease treatment of claim 1, wherein the pulsed high voltage device further comprises:

the segmented isolation groove penetrates through the circuit board and is arranged on the circuit board between the low-voltage section and the high-voltage section, and the isolation groove divides the circuit board into two areas, namely a low-voltage side area and a high-voltage side area;

and the second glue filling layer coats all components on two sides of the circuit board except the high-voltage connector and the grounding point through the isolation groove.

9. The device assembly for the treatment of chronic obstructive pulmonary disease of any one of claims 1 to 8, wherein the catheter handle has a handle housing, a proximal end of which is provided with a pulse connection part electrically connected to an output end of the high voltage section through a wire;

10. The device assembly for chronic obstructive pulmonary disease treatment of claim 9, wherein the electrode is in a woven basket structure having a hollow cavity, the central core rod connecting proximal and distal ends of the basket weave structure through the hollow cavity of the woven basket structure;

the electrode catheter further includes:

a sleeve;

11. The device assembly for chronic obstructive pulmonary disease treatment of claim 10, wherein the distal fixation assembly comprises:

the inner part of the convex ring is fixed with the far end of the middle core rod;

12. The device assembly for chronic obstructive pulmonary disease treatment of claim 10, wherein the proximal fixation assembly comprises:

the bushing includes:

13. The device assembly for chronic obstructive pulmonary disease treatment of claim 12, wherein the cannula further comprises:

14. The device assembly for chronic obstructive pulmonary disease treatment of claim 13, wherein the central core rod is a conductor, and the distal end of the woven basket structure and/or the proximal end of the woven basket structure are in conductive communication with the central core rod to enable pulse ablation energy to be delivered to the woven basket structure.