Pulse ablation catheter

Abstract

The invention provides a pulse ablation catheter. The pulse ablation catheter comprises a traction piece, a mesh basket, a limiting ring, an inner catheter body, a front fixing end and a rear fixing end. The mesh basket is arranged outside the traction piece in a sleeving mode, the limiting ring is located at the far end of the mesh basket and fixedly arranged outside the traction piece in a sleeving mode, and the front fixing end is arranged at the far end of the mesh basket in a sleeving mode; the inner pipe body extends into the net basket from the near end of the net basket, the inner pipe body is arranged outside the traction piece in a sleeving mode and can move relative to the traction piece in the axial direction, and the rear fixing end is arranged outside the inner pipe body in a sleeving mode and used for fixedly connecting the near end of the net basket with the inner pipe body; the rear fixing end is arranged outside the inner pipe body in a sleeving mode, a gap is formed between the rear fixing end and the inner pipe body, a supporting ring located in the gap is arranged on the peripheral face of the inner pipe body, and the near end of the net basket is fixedly connected with the peripheral face of the supporting ring. According to the pulse ablation catheter, the near end and the far end of the mesh basket can have good supporting performance, the middle of the mesh basket has good flexibility, meanwhile, the smoothness of axial movement of the traction piece in the turning process of the mesh basket is improved, and pushing of the mesh basket is facilitated.

Description

Technical Field

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

[0002] The characteristic pathological changes of COPD exist in the airways, lung parenchyma and pulmonary blood vessels. In the central airways, there are inflammatory cell infiltration, epithelial damage, enlargement of mucus-secreting glands and increase in goblet cells, which increase mucus secretion. The main pathophysiological changes of COPD include airflow limitation, gas trapping and abnormal gas exchange. It may be accompanied by mucus hypersecretion, air epithelial ciliary dysfunction, systemic adverse effects, etc. In severe cases, pulmonary hypertension, chronic cor pulmonale and respiratory failure may occur. COPD patients often have multiple systemic complications at the same time, which are related to the severity of the disease.

[0003] Pulsed electric field ablation technology is a technology that generates a high-voltage pulsed electric field with a pulse width of milliseconds, microseconds or even nanoseconds, and releases extremely high energy in a short time to cause irreversible electroporation of cells. It can directly act on cells, causing cell apoptosis to achieve the purpose of treatment. As a non-thermal ablation technology, pulsed electric field ablation technology can selectively treat lung inflammatory cells without causing damage to other non-targeted cell tissues by adjusting parameters such as pulse voltage, pulse width, number of discharges, pulse waveform, and pulse train due to different electroporation thresholds of different cells. The mechanism of cell death caused by irreversible electroporation is apoptosis, not necrosis. The advantage of cell apoptosis is that apoptotic cells are cleared through immune intervention, while phagocytic cells clear apoptotic cells as a normal cell death process, thereby promoting the regeneration and repair of normal tissues. Therefore, after irreversible electroporation treatment, the treatment area can be replaced by normal cells in a short time to restore the original function. However, in the existing pulsed electric field ablation catheter, the support of the two ends of the basket is poor. Summary of the invention

[0004] The object of the present invention is to provide a pulse ablation catheter, which can make the proximal and distal ends of the basket have good support, the middle part of the basket has good flexibility, and at the same time increase the smoothness of the axial movement of the pulling member of the basket during the cornering process, thereby ensuring that the ablation catheter has good pushing performance.

[0005] To achieve the above object, the present invention provides the following technical solutions:

[0006] The present invention provides a pulse ablation catheter, comprising a pulling member, a mesh basket, a limiting ring, an inner tube body, a front fixing end and a rear fixing end;

[0007] The net basket is sleeved on the outside of the pulling member, the limiting ring is located at the distal end of the net basket and is fixedly sleeved on the outside of the pulling member, and the front fixed end is sleeved on the distal end of the net basket to fix the distal end of the net basket and the end of the pulling member protruding from the limiting ring along the axial direction;

[0008] The inner tube body extends from the proximal end of the net basket into the net basket, the inner tube body is sleeved on the outside of the pulling member and can move relative to the pulling member in the axial direction, and the rear fixed end is sleeved on the outside of the inner tube body to fix the proximal end of the net basket to the inner tube body;

[0009] The rear fixed end is sleeved on the outside of the inner tube body and has a gap between the rear fixed end and the inner tube body. The outer peripheral surface of the inner tube body has a support ring located in the gap. The proximal end of the basket is fixedly connected to the outer peripheral surface of the support ring.

[0010] Furthermore, the pulling member comprises a core shaft and an insulating sleeve, the outer surface of the core shaft has an insulating coating, and the insulating sleeve is fixedly sleeved on the outside of the core shaft;

[0011] The limiting ring is fixedly sleeved on the outside of the insulating sleeve, and the inner tube body is sleeved on the outside of the insulating sleeve and can move relative to the insulating sleeve along the axial direction.

[0012] Furthermore, the outer diameter of the core shaft is 0.1-1.5 mm, and / or the inner diameter of the insulating sleeve is 1.1-1.2 times the outer diameter of the core shaft, and / or the single-side wall thickness of the insulating sleeve is 0.02-0.4 mm, and / or the inner diameter of the limit ring is 1.1-1.2 times the outer diameter of the insulating sleeve, and / or the inner diameter of the inner tube body is 1.1-1.2 times the outer diameter of the insulating sleeve.

[0013] Furthermore, the distal end of the core shaft has a fixing ring protruding from the limiting ring, and the basket is fixed to and electrically connected to the fixing ring under the action of the front fixing end.

[0014] Furthermore, the inner diameter of the fixing ring is 1.1-1.2 times the outer diameter of the mandrel, and the outer diameter of the fixing ring is D, D=(d*n) / 3.14-2d, wherein:

[0015] d is the diameter of the electrode wire in the mesh basket, and n is the number of strands woven in the mesh basket.

[0016] Furthermore, it also includes an outer tube body and a wire, the outer tube body is sleeved on the outside of the inner tube body, and the distal end of the outer tube body is the rear fixed end, the wire is passed between the outer tube body and the inner tube body, the distal end of the wire is wrapped around the outer ring of the proximal end of the basket and is electrically connected to the basket, and the wire is reserved with a buffer section along the axial direction to adapt to the movement of the inner tube body relative to the pulling member.

[0017] Furthermore, the outer diameter of the basket varies within a range of 3-22 mm when the inner tube moves relative to the pulling member.

[0018] Furthermore, the basket has a first area and second areas on both sides of the first area along the axial direction, the first area is a conductive area, and the conductivity of the second area is lower than that of the first area.

[0019] Furthermore, it also includes an operating handle, an outer handle and an electrical connector, one end of the operating handle extends into the outer handle and slides with the outer handle along the axial direction, the other end of the operating handle is fixedly connected to the inner tube body through the outer tube body, and the pulling piece passes through the operating handle and is connected to the outer handle through the electrical connector.

[0020] Furthermore, the operating handle is provided with a limiting groove, and the outer handle is provided with a limiting column extending into the limiting groove and slidingly cooperating with the limiting groove along the axial direction of the pulling member.

[0021] Furthermore, a damping member is provided between the operating handle and the outer handle.

[0022] Furthermore, the operating handle is provided with scales and / or color markings.

[0023] The pulse ablation catheter provided by the present invention can produce the following beneficial effects:

[0024] Compared with the prior art, firstly, the pulling member protrudes axially from the limiting ring, and can be fixed with the distal end of the net basket under the limiting of the front fixed end. Therefore, the limiting ring fixedly sleeved on the outside of the pulling member can support the pulling member. In addition, the inner tube body can extend into the net basket from the proximal end of the net basket, and can also support the pulling member, so that the proximal and distal ends of the net basket have better support. The part of the pulling member axially located between the limiting ring and the inner tube body can ensure that the middle part of the net basket has better flexibility, which is beneficial to the pushing of the net basket. At the same time, the distance between the rear end of the limiting ring and the front end of the inner tube body limits the expansion degree of the net basket.

[0025] Secondly, a support ring is provided in the gap between the rear fixed end and the inner tube body. The support ring is radially fixed between the proximal end of the basket and the inner tube body, which can increase the smoothness of the axial movement of the pulling member of the basket during the bending process and ensure that the ablation catheter has better pushing performance. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0027] Figure 1 A front view of a pulse ablation catheter provided in Embodiment 1 of the present invention;

[0028] Figure 2 A partial front view of a pulse ablation catheter provided in the first embodiment of the present invention when the basket is in an expanded state;

[0029] Figure 3 A partial cross-sectional view of a pulse ablation catheter provided in the first embodiment of the present invention when the basket is in an expanded state;

[0030] Figure 4 A cross-sectional view of the proximal end of a basket provided in Embodiment 1 of the present invention;

[0031] Figure 5 for Figure 1 A partial cross-sectional view of the part;

[0032] Figure 6 A schematic diagram of a mandrel provided in Embodiment 1 of the present invention;

[0033] Figure 7 A cross-sectional view of the far end of a basket provided in Embodiment 1 of the present invention;

[0034] Figure 8 A schematic diagram of the structure of the net basket provided in the first embodiment of the present invention when it is in a contracted state;

[0035] Fig. 9 A schematic diagram of the structure of the basket provided in the first embodiment of the present invention when it is in an expanded state;

[0036] Fig.10 A partial schematic diagram of the basket in the pulse ablation catheter provided in the first embodiment of the present invention before expansion in the bronchus;

[0037] Fig.11 A partial schematic diagram of the basket in the pulse ablation catheter provided in the first embodiment of the present invention after expansion in the bronchus;

[0038] Fig.12 It is a partial schematic diagram of the pulse ablation catheter provided in the first embodiment of the present invention after the basket in the large-bore bronchus is expanded;

[0039] Fig.13 A partial schematic diagram of the pulse ablation catheter provided in the first embodiment of the present invention after the basket in the small-bore bronchus is expanded;

[0040] Fig.14 A schematic diagram of a basket structure provided in Embodiment 1 of the present invention;

[0041] Fig.15 A schematic diagram of the three-dimensional structure of the elastic fixing ring provided in the first embodiment of the present invention;

[0042] Fig.16 A cross-sectional view of a pulse ablation catheter provided in Embodiment 1 of the present invention;

[0043] Fig.17 A partial cross-sectional view of a pulse ablation catheter provided in Embodiment 1 of the present invention;

[0044] Fig.18 A partial schematic diagram of the internal structure of a pulse ablation catheter provided in the second embodiment of the present invention Figure 1 ;

[0045] Fig.19 A partial schematic diagram of the internal structure of a pulse ablation catheter provided in the second embodiment of the present invention Figure 2 ;

[0046] Fig. 20 This is a cross-sectional view of the local structure of a pulse ablation catheter provided in the second embodiment of the present invention.

[0047] Icons: 1-pull piece; 11-core shaft; 111-fixing ring; 12-insulating sleeve; 2-net basket; 21-first area; 22-second area; 23-elastic fixing ring; 24-first interval section; 25-second interval section; 3-limiting ring; 4-inner tube body; 41-support ring; 5-front fixed end; 6-outer tube body; 61-rear fixed end; 7-wire; 8-operating handle; 81-limiting groove; 82-stress relief tube; 83-O-ring; 9-outer handle; 91-limiting column; 92-rubber sealing ring; 10-electrical connector; 011-bronchus. DETAILED DESCRIPTION

[0048] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0049] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance.

[0050] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0051] The specific implementation of the present invention is described in detail below in conjunction with the accompanying drawings. It should be understood that the specific implementation described here is only used to illustrate and explain the present invention, and is not used to limit the present invention.

[0052] Embodiment 1 of the present invention provides a pulse ablation catheter, such as Figures 1 to 4 As shown, it includes a pulling member 1, a net basket 2, a limiting ring 3, an inner tube body 4, a front fixed end 5 and a rear fixed end 61;

[0053] The net basket 2 is sleeved on the outside of the pulling member 1, the limiting ring 3 is located at the distal end of the net basket 2 and is fixedly sleeved on the outside of the pulling member 1, and the front fixed end 5 is sleeved on the distal end of the net basket 2 to fix the distal end of the net basket 2 and the end of the pulling member 1 protruding from the limiting ring 3 along the axial direction;

[0054] The inner tube body 4 extends from the proximal end of the net basket 2 into the net basket 2, the inner tube body 4 is sleeved on the outside of the pulling member 1 and can move relative to the pulling member 1 along the axial direction, and the rear fixed end 61 is sleeved on the outside of the inner tube body 4 to fix the proximal end of the net basket 2 to the inner tube body 4;

[0055] The rear fixed end 61 is sleeved on the outside of the inner tube body 4 and has a gap between it and the inner tube body 4. The outer circumference of the inner tube body 4 has a support ring 41 located in the gap, and the proximal end of the basket 2 is fixedly connected to the outer circumference of the support ring 41.

[0056] The pulling member 1 protrudes axially from the limiting ring 3, and can achieve the fixation of the pulling member 1 and the far end of the basket 2 under the limiting position of the front fixed end 5. In addition, the inner tube body 4 can extend from the proximal end of the basket 2 into the basket 2, so that the proximal end of the basket has better support. The part of the pulling member 1 located axially between the limiting ring 3 and the inner tube body 4 can ensure that the middle part of the basket 2 has good flexibility, which is conducive to the pushing of the basket 2. At the same time, the distance between the rear end of the limiting ring 3 and the front end of the inner tube body 4 limits the expansion degree of the basket 2.

[0057] In the pulse ablation catheter provided in the above embodiment, the space surrounded by the basket 2 has not only one pulling member 1, but also an inner tube body 4 is provided at the proximal end of the pulling member 1 close to the basket 2, and a limiting ring 3 is provided at the distal end of the pulling member 1 close to the basket 2, which plays a role in supporting the two ends of the basket 2. At the same time, the middle part of the basket 2 maintains good flexibility, ensuring better operability.

[0058] In addition, since the inner tube body 4 is sleeved on the outside of the pulling member 1 and can move axially relative to the pulling member 1, the distance between the proximal end and the distal end of the basket 2 can be changed axially during the relative movement of the two, thereby changing the expansion degree of the basket 2 to adapt to bronchi with different inner diameters and to reach more distal and narrower airways, so that the ablation catheter provided in the above embodiment can be better applied to more complex lesions.

[0059] It is necessary or necessary to explain that the distal end is the end far away from the operating handle 8 of the pulse ablation catheter, and the proximal end is the end close to the operating handle 8 of the ablation catheter.

[0060] Finally, if Figure 4 As shown, if the support ring 41 is not configured, the maximum outer diameter of the rear fixed end 61 needs to be considered during the assembly process. During the assembly process, the inner tube body 4 is subjected to force, and its inner diameter will become relatively smaller, and the gap between the core shaft 11 and the inner tube body 4 will be reduced, affecting the smoothness of its operation; secondly, since the flexibility of the tube body at the rear fixed end 61 is deteriorated (the texture is harder), during the process of cooperating with the endoscope, when the bending angle of the endoscope is large and the bending radius is small, there is a force squeezing process at the rear fixed end 61, and the inner diameter of the inner tube body 4 will be relatively smaller due to squeezing, affecting its operating performance.

[0061] In the above embodiment, a support ring 41 is provided in the gap between the rear fixed end 61 and the inner tube body 4. The support ring 41 is radially fixed between the proximal end of the basket 2 and the inner tube body 4. The support ring 41 increases the strength of the inner tube body 4, thereby increasing the smoothness of the axial movement of the pulling member 1 of the basket 2 during the bending process, thereby ensuring that the ablation catheter has better pushing performance.

[0062] Specifically, the support ring 41 is coaxially arranged with the inner tube body 4 and fixed to the inner tube body 4 by at least one method such as gluing, crimping, welding, etc. The support ring 41 is fixed to the proximal end of the basket 2, specifically by any method such as laser welding, gluing, etc.

[0063] In the first embodiment, the outer diameter of the limiting ring 3 is optionally matched with the outer diameter of the braided structure of the basket 2. The limiting ring 3 can ensure that the multiple braided wires of the basket 2 are evenly distributed circumferentially at the front fixed end 5, so the limiting ring 3 sleeved on the outside of the pulling member 1 can play a supporting role and bear force evenly, ensuring that the basket 2 does not eccentrically occur during the contraction process, and at the same time making the distal end of the basket 2 have better support.

[0064] In the first embodiment, optionally, the outer diameter of the support ring 41 matches the outer diameter of the braided structure of the basket 2. The support ring 41 can ensure that the multiple braided wires of the basket 2 are evenly distributed circumferentially at the rear fixed end 61. Therefore, the inner tube body 4 sleeved on the outside of the pulling member 1 can play a supporting role and bear force evenly, ensuring that the basket 2 does not eccentricity during the contraction process.

[0065] In this embodiment 1, optionally, as Figure 4 As shown, the pulse ablation catheter further includes an outer tube body 6 which is sleeved on the outside of the inner tube body 4 and fixedly connected to the inner tube body 4 , and the distal end of the outer tube body 6 is a rear fixed end 61 .

[0066] The inner tube body 4 and the outer tube body 6 can be fixed by glue or other similar fixing methods, so that the outer tube body 6 and the inner tube body 4 form a whole.

[0067] In this embodiment 1, optionally, as Figure 3 and Figure 5 As shown, the pulling member 1 includes a core shaft 11 and an insulating sleeve 12. The outer surface of the core shaft 11 has an insulating coating. The insulating sleeve 12 is fixedly sleeved on the outside of the core shaft 11. The limit ring 3 is fixedly sleeved on the outside of the insulating sleeve 12. The inner tube body 4 is sleeved on the outside of the insulating sleeve 12 and can move axially relative to the insulating sleeve 12.

[0068] In the above embodiment, the insulating sleeve 12 can play an insulating role to prevent the power of the core shaft 11 from being transmitted to the outside of the insulating sleeve 12, thereby ensuring the safety and stability of the electrical connection.

[0069] It should be noted that if Figure 1 and Figure 5 As shown, the length of a section of the area where the proximal end of the insulating sleeve 12 is inserted into the distal end of the inner tube body 4 is greater than the travel of the operating handle 8 to drive the basket 2 to slide, thereby preventing the core shaft 11 from directly contacting the proximal end of the basket 2 during the contraction process due to the insulating sleeve 12 being too short.

[0070] The core shaft 11 is made of conductive material, specifically nickel-titanium wire, the insulating coating is PTFE coating, and the insulating sleeve 12 is coaxially fixed to the core shaft 11 by glue or physical crimping.

[0071] In the first embodiment, optionally, the outer diameter of the core shaft 11 is 0.1-1.5 mm, and specifically may be 0.1 mm, 0.3 mm, 0.45 mm, 0.8 mm, 1.0 mm or 1.5 mm.

[0072] In the first embodiment, optionally, the material of the insulating sleeve 12 is preferably polyimide, and the inner diameter of the insulating sleeve 12 is 1.1-1.2 times the outer diameter of the core shaft 11, and specifically can be 1.1, 1.12, 1.15 or 1.2 times.

[0073] In the first embodiment, optionally, the single-side wall thickness of the insulating sleeve 12 is 0.02-0.4 mm, and specifically can be 0.02 mm, 0.05 mm, 0.1 mm, 0.2 mm, 0.3 mm or 0.4 mm.

[0074] In the first embodiment, optionally, the limiting ring 3 is coaxially arranged with the core shaft 11 , and the inner diameter of the limiting ring 3 is 1.1-1.2 times the outer diameter of the insulating sleeve 12 , and specifically can be 1.1, 1.12, 1.15 or 1.2 times.

[0075] In the first embodiment, optionally, the inner tube body 4 is coaxially arranged with the core shaft 11, and the inner tube body 4 is a composite braided tube, preferably made of PA12+SUS304 stainless steel, and the inner diameter of the inner tube body 4 is 1.1-1.2 times the outer diameter of the insulating sleeve 12, specifically 1.1, 1.12, 1.15 or 1.2 times.

[0076] In the first embodiment, the far end of the basket 2 is powered, while the near end is not powered. Figures 3 to 6 As shown, the distal end of the core shaft 11 has a fixing ring 111 protruding from the distal end of the limiting ring 3. The basket 2 is fixed and electrically connected to the fixing ring 111 under the action of the front fixing end 5. The rear fixing end 61 fixes the proximal end of the basket 2 to the inner tube body 4. The pulling member 1 and the inner tube body 4 can generate relative movement in the axial direction. The distal end of the basket 2 is controlled by controlling the pulling member 1, or the proximal end of the basket 2 is moved by controlling the movement of the inner tube body 4, thereby controlling the expansion degree of the basket 2.

[0077] In the first embodiment, the inner diameter of the fixing ring 111 is 1.1-1.2 times the outer diameter of the core shaft 11 , and specifically can be 1.1, 1.12, 1.15 or 1.2 times.

[0078] In the first embodiment, the outer diameter of the fixing ring 111 is D, D=d*n / 3.14-2d, wherein: d is the diameter of the electrode wire in the basket 2, and n is the number of strands woven in the basket 2.

[0079] The above embodiment defines the relationship between the fixing ring 111, the diameter of the electrode wire and the number of weaving strands of the basket 2 to avoid overlapping of the electrode wires along the circumference of the fixing ring 111, and also to avoid excessive gaps between adjacent electrode wires along the circumference of the fixing ring 111, thereby reducing the circumferential size of the fixing ring as much as possible.

[0080] In the first embodiment, the fixing ring 111 and the distal end of the core shaft 11 are fixed and electrically connected by at least one of physical crimping, laser welding, etc.

[0081] During processing, the distal end of the mandrel 11 is initially connected to the fixing ring 111 by crimping to achieve fixation and electrical connection, and is sleeved with an insulating sleeve 12, which is inserted into the distal end of the mandrel 11 and covers the entire basket electrode segment. The insulating sleeve 12 is fixedly connected to the mandrel 11, and the insulating sleeve 12 has a certain insulation withstand voltage strength, which can prevent the mandrel 11 from being broken down by high voltage during surgery and generating an arc. The distal end of the basket 2 is fixedly connected to the distal end of the mandrel 11 and electrically connected, and the head of the basket 2 has a front fixed end 5, which is fixed by glue. An insulating limit ring 3 is coaxially arranged on the distal end of the net basket 2 and fixed to the core shaft 11. The inner tube body 4 is passed through the core shaft 11 and is coaxially arranged. The distal end of the inner tube body 4 is exposed at the proximal end of the net basket 2. The proximal end of the net basket 2 is fixed to the distal end of the outer tube body 6 by glue. The outer tube body 6 and the core shaft 11 can move axially to control the contraction and expansion of the net basket 2.

[0082] It should be noted that along the axial direction of the core shaft 11, the distal end of the insulating sleeve 12 and the distal end of the limiting ring 3 are both against the proximal end face of the fixing ring 111, the limiting ring 3 is wrapped around the outside of the insulating sleeve 12, and the outer diameter of the limiting ring 3 is not greater than the outer diameter of the fixing ring 111.

[0083] The above arrangement can prevent the limiting ring 3 from protruding out of the fixing ring 111 along the radial direction of the core shaft 11, thereby causing obstruction to the basket 2, which is beneficial to reducing the shrinkage size of the basket 2.

[0084] In this embodiment 1, optionally, as Figure 7 As shown, the distal end of the front fixing end 5 may be tapered, and the end portion may have a smooth transition.

[0085] The structure of the net basket 2 is described in detail below:

[0086] In this embodiment 1, optionally, as Figure 2 As shown, the basket 2 adopts a woven structure, which can be 12, 18, 24, 36, 48, 72 strands, preferably 24 strands, and the weaving method is one-on-one. The material of the basket 2 is preferably nickel-titanium wire, and the electrode wire of the basket 2 can be wire-shaped or strip-shaped, preferably wire-shaped. The diameter of the electrode wire can be 0.05-0.3mm, specifically 0.05mm, 0.1mm, 0.2mm or 0.3mm, preferably 0.12mm.

[0087] In the first embodiment, optionally, the basket 2 has a variable outer diameter, and the contraction and expansion of the basket 2 can be controlled by controlling the relative axial movement of the pulling member 1 and the inner tube body 4. The outer diameter of the basket 2 varies in the range of 3-22 mm when the inner tube body 4 moves relative to the pulling member 1, and can completely cover the bronchus levels 0-6, so as to achieve the purpose of pulsed electric field treatment of the narrower bronchi and the most prone to inflammation.

[0088] Existing pulsed electric field ablation catheters generally need to be used with bronchoscopes with instrument channels larger than 2.8 mm, and can only reach the 4th and 5th poles of the bronchus at most. However, the most prone areas of bronchi inflammation are generally in the narrower bronchi. Existing pulsed electric field ablation catheters are large in size, have poor connection reliability, poor bending flexibility, and cannot reach farther and narrower airways.

[0089] The pulse ablation catheter in the above embodiment is compatible with both a bronchoscope with a 2.8 mm (6.0 mm outer diameter) instrument channel and a bronchoscope with a 2.0 mm (4.0 mm outer diameter) instrument channel.

[0090] The electrode wires at the proximal end of the basket 2 are arranged in an orderly manner around the support ring 41, and the two adjacent electrode wires at the proximal end are fixed by laser welding, so that the force on the basket 2 is more uniform, ensuring that the basket 2 does not eccentrically occur during the contraction process, and at the same time making the distal end of the basket 2 have better support.

[0091] In this embodiment 1, optionally, as Figure 8 and Fig. 9 As shown, the basket 2 has a first area 21 and second areas 22 on both sides of the first area 21 along the axial direction. The first area 21 is a conductive area, and the conductivity of the second area 22 is weaker than that of the first area 21. The second area 22 can be a weakly conductive area or an insulating area.

[0092] Specifically, the surface of the electrode wire in the first region 21 does not contain an oxide layer, which can effectively improve the conductivity of the first region 21 and promote the electroporation effect of tissue cells. The surface insulation degree of the second region 22 is controlled by the oxide layer, and weak insulation or insulation effect is achieved by controlling the oxidation products and thickness of the oxide layer.

[0093] When the traditional basket 2 is released, since the entire basket 2 is an electrode, the electric field strength at both ends of the basket 2 is relatively large, resulting in uneven distribution of the electric field of the basket 2 electrodes, and arcing is likely to occur at both ends of the basket 2.

[0094] In the above embodiment, the second area 22 is added at both ends of the basket 2, which can make the electric field distribution of the first area 21 more uniform, the field strength more stable, the ablation range closer to the basket 2 and the bronchial wall area, and can also reduce the probability of muscle tremor during the operation.

[0095] like Fig.10 As shown, the basket 2 can reach a predetermined position through the bronchoscope instrument channel in a contracted state. Fig.11 As shown, the basket 2 can reach a predetermined position through the bronchoscope instrument channel in a contracted state, and through the expansion of the basket 2, it is tightly attached to the inner wall of the bronchus, and the second areas 22 at both ends of the basket 2 are not attached to the inner wall of the bronchus.

[0096] like Fig.12 As shown, for a bronchus 011 with a larger diameter, after the basket 2 is closely attached to the inner wall of the bronchus, the first area 21 in the middle is rectangular, and the second areas 22 at both ends of the basket 2 are not attached to the inner wall of the bronchus. The axial lengths of the first area 21 and the second area 22 are slightly shorter, and the radial dimension of the expanded basket 2 is larger; Fig.13 As shown, for the bronchus 011 with a smaller diameter, after the basket 2 is tightly attached to the inner wall of the bronchus, the first area 21 in the middle is rectangular, and the second areas 22 at both ends of the basket 2 are not attached to the inner wall of the bronchus. The axial lengths of the first area 21 and the second area 22 are slightly longer, and the radial dimension of the expanded basket 2 is smaller.

[0097] In summary, after the basket 2 is closely attached to the inner walls of bronchial tubes of different sizes, its first region 21 is rectangular, and the length of the first region 21 decreases as the aperture size of the inner wall of the bronchial tube increases. The second regions 22 at both ends of the basket 2 are not attached to the inner wall of the bronchial tube.

[0098] like Fig.14 and Fig.15 As shown, the far end of the basket 2 has a first interval segment 24 and a second interval segment 25, the electrode wires of the first interval segment 24 of the basket 2 are arranged side by side in order, the adjacent electrode wires of the first interval segment 24 are laser welded and electrically connected, the outer ring of the first interval segment 24 is coaxially set with an elastic fixing ring 23, the elastic fixing ring 23 is fixed to the first interval segment 24 by laser welding, and the second interval segment 25 is fixed and electrically connected by laser welding for the second time.

[0099] The elastic fixing ring 23 is made of metal, preferably the same material as the basket 2. The elastic fixing ring 23 can be processed by laser cutting the metal ring and has a certain elastic structure. Its inner diameter can vary within a certain range. It is used to fix the distal end of the basket 2, enhance the operational stability of the basket 2 and ensure the force consistency between the nickel-titanium wires of the basket 2.

[0100] In this embodiment 1, optionally, as Fig.16 and Fig.17 As shown, the pulse ablation catheter also includes an operating handle 8, an outer handle 9 and an electrical connector 10. One end of the operating handle 8 extends into the outer handle 9 and slides axially with the outer handle 9. The other end of the operating handle 8 is fixedly connected to the inner tube body 4 through the outer tube body 6. The pulling member 1 passes through the operating handle 8 and is connected to the outer handle 9 through the electrical connector 10.

[0101] When in use, the outer handle 9 can be held and the operating handle 8 can be slid relative to the outer handle 9, so that the inner tube 4 drives the proximal end of the basket 2 to slide relative to the pulling member 1, thereby changing the outer diameter of the basket 2.

[0102] Of course, in other embodiments, the expansion degree of the basket 2 can also be changed by controlling the distal movement of the basket 2 through the pulling member 1 .

[0103] Specifically, Fig.17 As shown, the operating handle 8 may be provided with a limit groove 81, and the outer handle 9 may be provided with a limit column 91 extending into the limit groove 81 and slidingly cooperating with the limit groove 81, so that the operating handle 8 can only move axially along the pulling member 1 and does not rotate circumferentially.

[0104] In the prior art, when the basket 2 is released or contracted, the inner tube 4 and the pulling member 1 may rotate relative to each other, causing the basket 2 to twist and prevent the basket 2 from expanding as expected, which may lead to failure of the operation.

[0105] The sliding fit between the limiting groove 81 and the limiting column 91 can ensure that the inner tube 4 will not rotate relative to the core shaft 11, prevent the basket from twisting and deforming, and enable the basket 2 to expand as expected, which is conducive to the smooth progress of the operation.

[0106] The electrical connector 10 includes an electrode connector and an insulating heat shrink tube fixedly mounted on the outside of the electrode connector. The provision of the insulating heat shrink tube can reduce the probability of electric shock. The core shaft 11 can be fixed and electrically connected to the electrode connector by at least one method such as laser welding, soldering or physical crimping.

[0107] In this embodiment 1, optionally, as Fig.16As shown, the tail of the outer handle 9 has a rubber sealing ring 92. When the external cable is connected to the tail of the outer handle 9 and electrically connected, the damage to the patient or operator caused by liquids during surgery can be reduced.

[0108] In this embodiment 1, optionally, as Fig.16 As shown, a stress release tube 82 is provided at one end of the operating handle 8 away from the outer handle 9. The stress release tube 82 is sleeved on the outside of the outer tube body 6. The stress release tube 82 has a soft structure and can be made of soft materials such as rubber to prevent the outer tube body 6 from breaking during the operation.

[0109] In this embodiment 1, optionally, as Fig.17 As shown, a damping member is provided between the operating handle 8 and the outer handle 9. The damping member may be, but is not limited to, an O-ring 83. The operating handle 8 may achieve a damping push feeling with the outer handle 9 through the O-ring 83, thereby increasing the resistance between the operating handle 8 and the outer handle 9, and through the resistance, the basket 2 may be expanded to a certain extent and then positioned.

[0110] The provision of the O-ring 83 not only enables the operating handle 8 to slide relative to the outer handle 9, but also limits the operating handle 8 at any position to maintain the expanded state of the basket 2, which is convenient for the user to use.

[0111] In the first embodiment, optionally, the operating handle 8 is provided with scales and / or color markings, that is, the operating handle 8 may be provided with scales or color markings alone, or the operating handle 8 may be provided with scales and color markings at the same time.

[0112] The scale can be used to indicate the radial dimension of the expanded basket 2 when the operating handle 8 is pushed to this point, can also be used to indicate the pushing distance of the operating handle 8, and can also be used to indicate the inner diameter of the bronchus applicable when the operating handle 8 is pushed to this point, so that the user can control the basket 2 to a suitable size.

[0113] Of course, the usefulness of the data displayed by the scale is not limited to the above examples, and the user can adjust it according to actual needs.

[0114] The color marking may correspond to the basket 2 being suitable for different levels of bronchi, or the color marking may indicate whether the basket 2 is within the limit expansion range or the expansion size is still within the adjustable range, so that the user can control the basket 2 to a suitable size.

[0115] Of course, the usefulness of color identification is not limited to the above examples, and users can adjust it according to actual needs.

[0116] In the first embodiment, optionally, the outer surface of the operating handle 8 may have anti-slip stripes, which can increase the friction of the operating handle 8 .

[0117] According to the power-on status of the proximal end and the distal end of the basket 2, the following embodiment 2 can be further divided. The difference from the embodiment 1 is that in the embodiment 2, the proximal end of the basket 2 is powered, and the distal end is not powered. Figures 18 to 20 As shown, the pulse ablation catheter includes a wire 7, which is inserted between the outer tube body 6 and the inner tube body 4. The distal end of the wire 7 is wrapped around the outer ring of the proximal end of the basket 2 and is electrically connected to the basket 2. The wire 7 has a buffer section reserved along the axial direction to accommodate the movement of the inner tube body 4 relative to the pulling member 1.

[0118] The buffer section can prevent the wire 7 from being overstretched during the bending process of the pulsed electric field ablation catheter, thereby ensuring the electrical connection reliability of the basket 2.

[0119] During processing, the distal end of the mandrel 11 is initially connected and fixed to the fixing ring 111 by crimping, and an insulating sleeve 12 is inserted. The insulating sleeve 12 is inserted into the distal end of the mandrel 11 and covers the entire mesh basket electrode segment. The insulating sleeve 12 is fixedly connected to the mandrel 11, and the insulating sleeve 12 has a certain insulation withstand voltage strength, which can prevent the mandrel 11 from being broken down by high voltage during surgery and generating an arc. The head of the mesh basket 2 has a front fixed end 5, and the front fixed end 5 is fixed by glue. The distal end of the mesh basket 2 is coaxially provided with an insulating limit ring 3 and fixed with the mandrel 11, and the inner tube body 4 is inserted into the mandrel 11 and coaxially arranged, and the distal end of the inner tube body 4 is exposed at the proximal end of the mesh basket 2. The proximal end of the mesh basket 2 is fixed to the distal end of the outer tube body 6 by glue, and the outer tube body 6 and the mandrel 11 can move axially to control the contraction and expansion of the mesh basket 2. The proximal end of the basket 2 has an electrically connected wire 7, the head end of the wire 7 is wrapped and fixed with the proximal end of the basket 2 to achieve electrical connection, the wire 7 is inserted between the outer tube body 6 and the inner tube body 4, and the tail end of the wire 7 is connected to the electrode connector to achieve electrical conduction.

[0120] Of course, in other embodiments, both the proximal end and the distal end of the basket 2 may be powered.

[0121] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A pulse ablation catheter, characterized in that: It comprises a pulling piece (1), a net basket (2), a limiting ring (3), an inner tube body (4), a front fixing end (5) and a rear fixing end (61); The net basket (2) is sleeved on the outside of the pulling member (1), the limiting ring (3) is located at the distal end of the net basket (2) and is fixedly sleeved on the outside of the pulling member (1), and the front fixed end (5) is sleeved on the distal end of the net basket (2) to fix the distal end of the net basket (2) and the end of the pulling member (1) protruding axially from the limiting ring (3); The inner tube body (4) extends from the proximal end of the net basket (2) into the net basket (2), the inner tube body (4) is sleeved on the outside of the pulling member (1) and can move axially relative to the pulling member (1), and the rear fixed end (61) is sleeved on the outside of the inner tube body (4) for fixing the proximal end of the net basket (2) to the inner tube body (4); The rear fixed end (61) is sleeved on the outside of the inner tube body (4) and has a gap between it and the inner tube body (4); the outer peripheral surface of the inner tube body (4) has a support ring (41) located in the gap; the proximal end of the basket (2) is fixedly connected to the outer peripheral surface of the support ring (41).

2. The pulse ablation catheter according to claim 1, characterized in that: The pulling member (1) comprises a core shaft (11) and an insulating sleeve (12); the outer surface of the core shaft (11) has an insulating coating, and the insulating sleeve (12) is fixedly sleeved on the outside of the core shaft (11); The limiting ring (3) is fixedly sleeved on the outside of the insulating sleeve (12), and the inner tube body (4) is sleeved on the outside of the insulating sleeve (12) and can move axially relative to the insulating sleeve (12).

3. The pulse ablation catheter according to claim 2, characterized in that: The outer diameter of the core shaft (11) is 0.1-1.5 mm, and / or the inner diameter of the insulating sleeve (12) is 1.1-1.2 times the outer diameter of the core shaft (11), and / or the single-side wall thickness of the insulating sleeve (12) is 0.02-0.4 mm, and / or the inner diameter of the limiting ring (3) is 1.1-1.2 times the outer diameter of the insulating sleeve (12), and / or the inner diameter of the inner tube body (4) is 1.1-1.2 times the outer diameter of the insulating sleeve (12).

4. The pulse ablation catheter according to claim 2, characterized in that: The distal end of the core shaft (11) is provided with a fixing ring (111) protruding from the limiting ring (3), and the basket (2) is fixed and electrically connected to the fixing ring (111) under the action of the front fixing end (5).

5. The pulse ablation catheter according to claim 4, characterized in that: The inner diameter of the fixing ring (111) is 1.1-1.2 times the outer diameter of the core shaft (11), and the outer diameter of the fixing ring (111) is D, where D=(d*n) / 3.14-2d, wherein: d is the diameter of the electrode wire in the mesh basket (2), and n is the number of strands woven in the mesh basket (2).

6. The pulse ablation catheter according to claim 1, characterized in that: It also includes an outer tube body (6) and a wire (7), wherein the outer tube body (6) is sleeved on the outside of the inner tube body (4), and the distal end of the outer tube body (6) is the rear fixed end (61), and the wire (7) is passed between the outer tube body (6) and the inner tube body (4), and the distal end of the wire (7) is wound around the outer ring of the proximal end of the basket (2) and is electrically connected to the basket (2), and the wire (7) is reserved with a buffer section along the axial direction to adapt to the movement of the inner tube body (4) relative to the pulling member (1).

7. The pulse ablation catheter according to any one of claims 1 to 6, characterized in that: The outer diameter of the net basket (2) changes within a range of 3-22 mm when the inner tube (4) moves relative to the pulling member (1).

8. The pulse ablation catheter according to any one of claims 1 to 6, characterized in that: The mesh basket (2) has a first area (21) and second areas (22) located on both sides of the first area (21) along the axial direction; the first area (21) is a conductive area, and the conductive performance of the second area (22) is lower than that of the first area (21).

9. The pulse ablation catheter according to any one of claims 1 to 6, characterized in that: It also includes an operating handle (8), an outer handle (9) and an electrical connector (10), one end of the operating handle (8) extends into the outer handle (9) and slides with the outer handle (9) along the axial direction, the other end of the operating handle (8) is fixedly connected to the inner tube body (4) through the outer tube body (6), and the pulling member (1) passes through the operating handle (8) and is connected to the outer handle (9) through the electrical connector (10).

10. The pulse ablation catheter according to claim 9, characterized in that: The operating handle (8) is provided with a limiting groove (81), and the outer handle (9) is provided with a limiting column (91) extending into the limiting groove (81) and slidingly cooperating with the limiting groove (81) along the axial direction of the pulling member (1).

11. The pulse ablation catheter according to claim 9, characterized in that: A damping member is provided between the operating handle (8) and the outer handle (9).

12. The pulse ablation catheter according to claim 9, characterized in that: The operating handle (8) is provided with scales and / or color markings.

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