An ablation catheter applicable to ablation in human body cavities

Abstract

The present invention belongs to the technical field of energy ablation in human body cavities, and provides an ablation catheter suitable for ablation in human body cavities, comprising: a guiding delivery catheter provided with a first channel penetrating through both ends; an ablation electrode disposed at the distal end of the delivery catheter, which is a hollow structure, one end of the ablation electrode is connected to the delivery catheter, wherein the ablation electrode can be expanded and maintained in an expanded state; a control wire movably inserted into the first channel of the delivery catheter, both ends of the control wire respectively extend out of both ends of the delivery catheter, one end of the control wire is connected to the second end of the ablation electrode; a control handle connected to the proximal end of the delivery catheter, a moving component is provided in the control handle, the other end of the control wire is connected to the moving component, and the moving component drives the control wire to move relative to the delivery catheter, so that the two ends of the ablation electrode approach each other, enabling the ablation electrode to expand. By providing an expandable ablation electrode in this application, precise abutment between the ablation electrode and the lesion site of different-diameter cavities is achieved.

Description

Technical Field

[0001] The invention belongs to the technical field of energy ablation of human cavity, and in particular to an ablation catheter suitable for ablation of human cavity. Background Art

[0002] At present, the main treatments for airway diseases are drug therapy and surgical treatment. Drug therapy mainly involves inhaling drugs such as salbutamol sulfate aerosol and salmeterol fluticasone powder inhalation to dilate the trachea, thereby relieving the symptoms of airway diseases. However, drug therapy can only increase airway oxygen uptake and have a relieving effect, but cannot cure the disease.

[0003] The main surgical treatment methods include bullectomy, lung volume reduction surgery and other surgical operations. The disadvantage is that surgical operations cause great damage to patients and may lead to the failure of some lung functions. The main surgical treatment methods are interventional ablation treatments, such as radiofrequency ablation, pulsed electric field ablation and microwave ablation. Radiofrequency ablation uses radiofrequency energy to generate thermal energy at the distal end of the catheter and ablate the tissue by contacting the lesion. Pulsed electric field (PEF) ablation technology applies instantaneous high voltage to the target location and generates a local high-voltage electric field of several hundred volts per centimeter. The local high-voltage electric field is higher than the threshold, so it can destroy the structure of the site to be ablated, and this damage is irreversible. At the same time, pulsed electric field ablation also has cell and tissue selectivity. Pulsed electric field ablation has a threshold, and can selectively ablate the lesion tissue during the ablation process. It is a safe and effective airway ablation treatment method. Summary of the invention

[0004] The present invention provides an ablation catheter suitable for ablation of human cavities. With the assistance of an endoscope working channel, the ablation electrode is accurately delivered to a target position by controlling a delivery catheter through a control handle, and the ablation electrode is expanded and supported at the same time, so that the ablation electrode is completely fitted to the airway and releases a pulsed electric field, thereby improving the accuracy and efficiency of ablation.

[0005] In order to achieve the above object, the present invention adopts the following technical solution:

[0006] An ablation catheter suitable for ablation of a human cavity, comprising:

[0007] A delivery catheter is provided with a first channel running through both ends, the delivery catheter is provided with a proximal end and a distal end, and the delivery catheter has a guiding function;

[0008] an ablation electrode, disposed at the distal end of the delivery catheter, the ablation electrode being a hollow structure having a first end and a second end, the first end of the ablation electrode being connected to the distal end of the delivery catheter, wherein the ablation electrode can expand and maintain an expanded state;

[0009] A control wire is movably inserted into the first channel of the delivery catheter, two ends of the control wire extend out of the proximal end of the delivery catheter and the distal end of the delivery catheter respectively, and one end of the control wire is connected to the second end of the ablation electrode;

[0010] A control handle, comprising a shell and a handle movably arranged relative to the shell, the shell being connected to the proximal end of the delivery catheter, a moving assembly being arranged inside the control handle, the moving assembly comprising a translation slider and a swing link, the swing link being rotatably arranged inside the shell, the translation slider being able to make reciprocating linear movements relative to the shell, the other end of the control wire being connected to the translation slider, one end of the swing link being movably connected to the handle, wherein a rotation point of the swing link is located between connection points of the swing link with the handle and the translation slider respectively, and the rotation point is arranged close to one side of the handle;

[0011] It also includes a range extender component, which includes a first fixed rack, a first movable rack and a first gear. The first fixed rack is arranged on the shell, the first movable rack is arranged on the translation slider, a first connecting shaft is provided on the first gear, and the first gear is respectively meshed with the first fixed rack and the first movable rack, and the other end of the swing connecting rod is movably connected to the first connecting shaft.

[0012] In some embodiments, the second end of the ablation electrode is provided with a guide tip, and the guide tip is provided with a smooth guide structure.

[0013] In some embodiments, the delivery catheter includes an outer layer, a middle layer and an inner layer, the outer layer is composed of a first section, a second section and a third section, the first section is arranged close to the control handle side, the third section is arranged close to the ablation electrode side, and the second section is arranged between the first section and the third section, wherein the hardness of the first section is greater than that of the second section, and the hardness of the second section is greater than that of the third section.

[0014] In some embodiments, the middle layer is a braided layer and / or a coiled spring, wherein the braiding density of the proximal end of the braided layer is less than the braiding density of the distal end of the braided layer, and the pitch range of the coiled spring is 1 mm-5 mm.

[0015] In some embodiments, the inner layer of the delivery catheter is made of a material with low friction resistance.

[0016] In some embodiments, it also includes a first wire disposed in the delivery catheter, an insulating sleeve is provided outside the first wire, one end of the first wire is connected to an external energy generator, and the other end of the first wire is connected to the ablation electrode.

[0017] In some embodiments, the ablation electrode is a basket weaving structure. When the ablation electrode with the basket weaving structure is in an expanded state, the middle outer diameter of the ablation electrode is large, and the outer diameters of both ends of the ablation electrode are small.

[0018] In some embodiments, the first end of the ablation electrode is provided with a first electrode ring, and the second end of the ablation electrode is provided with a second electrode ring, the first electrode ring wraps and fixes the first end of the ablation electrode, and the second electrode ring wraps and fixes the second end of the ablation electrode.

[0019] In some embodiments, the first electrode ring and / or the second electrode ring is made of a conductive material, and one end of the first wire is electrically connected to the first electrode ring or the second electrode ring.

[0020] In some embodiments, when the ablation electrode is in a closed state, the outer diameter of the ablation electrode is in a range of 0.5 mm to 4 mm, and when the ablation electrode is in an open state, the outer diameter of the ablation electrode is in a range of 1 mm to 60 mm.

[0021] In some embodiments, the ablation electrode with the basket weaving structure is made of a metal material with high elasticity and low resistance.

[0022] In some embodiments, the basket weaving structure of the ablation electrode adopts a 1-on-1, 1-on-2 or 2-on-2 weaving method.

[0023] In some embodiments, the braiding density of the ablation electrode is 5-60.

[0024] In some embodiments, the ablation electrode is polished.

[0025] In some embodiments, the surface of the delivery catheter is provided with marking scales, and the marking scales are arranged from the distal end to the proximal end of the delivery catheter.

[0026] In some embodiments, a first limiting groove is provided on the housing, and the translation slider is slidably disposed in the first limiting groove.

[0027] In some embodiments, a first limiting groove is provided on the housing, and the translation slider is slidably disposed in the first limiting groove.

[0028] In some embodiments, the swing link is provided with a first waist-shaped hole, and the translation slider is provided with a corresponding first round hole; or,

[0029] The swing link is provided with a first circular hole, and the translation slider is provided with a corresponding first waist-shaped hole; wherein the swing link and the translation slider are movably connected via a first connecting shaft passing through the first waist-shaped hole and the first circular hole, and the first connecting shaft is adapted to the first circular hole.

[0030] In some embodiments, the swing link is provided with a second waist-shaped hole, and the handle is provided with a corresponding second circular hole; wherein the swing link and the handle are movably connected via a second connecting shaft passing through the second waist-shaped hole and the second circular hole, and the second connecting shaft and the second circular hole are adapted to each other.

[0031] In some embodiments, a second limiting groove adapted to the first connecting shaft is provided on the shell, and both ends of the first connecting shaft can be slidably disposed in the second limiting groove, wherein the second limiting groove is arranged parallel to the first limiting groove.

[0032] In some embodiments, a locking mechanism is further included, wherein the locking mechanism includes a locking ratchet disposed on the swing link and a pawl rotatably disposed on the housing, wherein the locking ratchet is provided with a plurality of locking grooves adapted to the pawl.

[0033] In some embodiments, the control handle is further provided with an opening and closing mark of the ablation electrode, and the opening and closing mark is used to provide feedback on the opening and closing size of the ablation electrode.

[0034] In some embodiments, a return spring is further included, one end of the return spring is connected to the housing of the control handle, and the other end of the return spring is connected to the handle.

[0035] In some embodiments, a pressure sensor is provided on the ablation electrode, a mechanical tester is provided on the control handle, and the pressure sensor is signal-connected to the mechanical tester.

[0036] Compared with the prior art, the present invention has the following beneficial effects:

[0037] The present application provides an expandable ablation electrode, and delivers the ablation electrode to the target position in a complex airway through a delivery catheter with good guidance, and then controls the ablation electrode to expand and abut against the airway surface through a control handle, so that the outer diameter of the expanded contour of the ablation electrode is adaptive to cavities of various sizes, thereby achieving accurate and efficient ablation. In addition, the delivery catheter is layered and segmented, so that the ablation catheter can be inserted into a relatively curved human cavity for ablation. At the same time, the control handle is provided with an extended-range component, which can drive the control wire to move a larger stroke within a limited stroke, so that the ablation electrode with a basket weaving structure can expand to a larger outer diameter contour, thereby improving the adaptability of the ablation catheter.

[0038] Additional aspects and advantages of the present application will be partially given in the following description, which will become apparent from the following description, or will be understood through the practice of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 It is a stereoscopic diagram of an ablation electrode of an ablation catheter suitable for ablation of a human cavity of the present invention in an initial state;

[0040] Figure 2 It is a stereoscopic diagram of an ablation electrode of an ablation catheter suitable for ablation of a human cavity of the present invention in an expanded state;

[0041] Figure 3 for Figure 2 Enlarged view of point C in the middle;

[0042] Figure 4 for Figure 1 Enlarged view of point A in the middle;

[0043] Figure 5 It is a structural schematic diagram of a delivery catheter of an ablation catheter suitable for ablation of a human cavity of the present invention;

[0044] Figure 6 for Figure 1 The enlarged view of point B in the middle;

[0045] Figure 7 It is a cross-sectional view of a delivery catheter of an ablation catheter suitable for ablation of a human cavity according to the present invention;

[0046] Figure 8 for Figure 7 A schematic diagram of a first conductor is provided;

[0047] Fig. 9 This is a schematic diagram of the internal structure of a control handle of an ablation catheter suitable for ablation of a human cavity according to the present invention;

[0048] Fig.10 for Fig. 9 Schematic diagram of the internal structure of the middle handle;

[0049] Fig.11 It is a structural schematic diagram of a range-extending mechanism of a control handle of an ablation catheter suitable for ablation of a human cavity according to the present invention;

[0050] Fig.12 It is a three-dimensional structural diagram of a translation slider of an ablation catheter suitable for ablation of a human cavity according to the present invention;

[0051] Fig.13 It is a three-dimensional structural diagram of a swing connecting rod of an ablation catheter suitable for ablation of a human cavity according to the present invention;

[0052] Fig.14 It is a schematic diagram of a first form of an opening and closing mark of a handle shell of an ablation catheter suitable for ablation of a human cavity of the present invention;

[0053] Fig.15 It is a schematic diagram of a second form of the opening and closing mark of the handle shell of an ablation catheter suitable for ablation of a human cavity according to the present invention;

[0054] Fig.16 It is a stereoscopic diagram of a locking mechanism of a pulsed electric field ablation catheter for airway ablation of the present invention;

[0055] Fig.17 The present invention is a front view of a locking mechanism of a pulsed electric field ablation catheter for airway ablation. DETAILED DESCRIPTION

[0056] The present application is further described in detail below in conjunction with specific drawings. In the description of this embodiment, unless otherwise specified, the terms "left", "right", etc. indicate directions or positional relationships based on the directions or positional relationships shown in the drawings, which are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the present application must have a specific direction, be constructed and operated in a specific direction, and therefore cannot be understood as limiting the present application.

[0057] like Figure 1-4 As shown, an ablation catheter suitable for ablation of a human cavity provided by the present invention mainly comprises a delivery catheter 1 , an ablation electrode 3 , a control wire 4 and a control handle 2 .

[0058] Specifically, Figure 7 As shown, the delivery catheter 1 is provided with a first channel 17 penetrating through both ends thereof, and the delivery catheter 1 includes a proximal end and a distal end, wherein the delivery catheter 1 has good guiding performance, so that the delivery catheter 1 can deliver the ablation electrode 3 to the target position in a complex and curved human cavity;

[0059] The ablation electrode 3 is arranged at the distal end of the delivery catheter 1, wherein the ablation electrode 3 is a hollow structure, and the ablation electrode 3 has a first end and a second end, and the first end of the ablation electrode 3 is connected to the distal end of the delivery catheter 1. It should be particularly pointed out that the ablation electrode 3 can be expanded and can maintain the expanded state so that the ablation electrode 3 can fit the human body cavity; the control wire 4 is movably arranged in the first channel 17 of the delivery catheter 1, and both ends of the control wire 4 extend out of the distal end and the proximal end of the delivery catheter 1, and one end of the control wire 4 is connected to the second end of the ablation electrode 3, and the control wire 4 moves relative to the delivery catheter 1 in the first channel 17, thereby driving the second end of the ablation electrode 3 to move closer to the first end of the ablation electrode 3 for expansion;

[0060] The control handle 2 is fixedly connected to the proximal end of the delivery catheter 1. A first cavity for installing parts is provided in the control handle 2. A moving component is provided in the control handle 2. The other end of the control wire 4 is connected to the moving component. By driving the moving component to move in the control handle 2, the control wire 4 connected to the moving component is driven to move axially relative to the delivery catheter 1, so that the control wire 4 drives the second end of the ablation electrode 3 to move closer to the first end, thereby realizing the expansion of the ablation electrode 3.

[0061] In the present application, the ablation electrode 3 is set to an expandable structure, and the ablation electrode 3 is delivered to the lesion in the human body cavity, such as tumor tissue in the human body cavity or vegetation of chronic obstructive pulmonary disease, through a delivery catheter 1 with good guidance. By expanding the ablation electrode 3 and bringing it into contact with the target tissue, the appropriate pulse energy is selectively released to form a pulse electric field, and the target tissue in contact with the ablation electrode 3 is accurately ablated, and ablation operations of smaller human cavities can be achieved, thereby improving the accuracy and ablation efficiency of the operator's surgery and the application of human cavity scenes of different sizes, while avoiding accidental injury to healthy tissues. It is understandable that the human body cavity referred to in the present application includes but is not limited to natural cavities such as the human airway, blood vessels, intestines, and esophagus. The ablation catheter of the present application is not limited to the application of pulse ablation energy, but can also be used to achieve ablation treatment of lesions through microwave energy through the ablation catheter in this embodiment.

[0062] In one embodiment, Figure 5 As shown, a guide tip 33 is provided at the second end of the ablation electrode 3, and a smooth guide structure is provided on the guide tip 33. Specifically, the guide tip 33 has a certain length, and the guide tip 33 is fixedly connected to the second end of the ablation electrode 3. Specifically, the ablation electrode 3 can be fixed to the guide tip 33 by hot-melt connection, glue bonding or laser welding. Further, when the ablation electrode 3 is preferably a basket weaving structure, since there are multiple electrode wire heads at both ends of the basket weaving structure, the guide tip 33 can gather and fix the electrode wire heads. At the same time, the control wire 4 is connected to the guide tip 33, which can drive the guide tip 33 to squeeze the ablation electrode 3 for expansion. A smooth guide structure is provided at the end of the guide tip 33 away from the ablation electrode 3, such as Figure 3 As shown, the smooth guide structure is a rounded hemispherical shape, which can effectively reduce the damage of the ablation catheter to the airway during the process of introducing the delivery catheter 1 into the airway. Optionally, the smooth guide structure can also be a curved surface or a combination of an inclined surface and a curved surface. Further, the guide tip 33 is made of block polyetheramide resin, polyurethane rubber or silicone.

[0063] In one embodiment, in order to ensure that the delivery catheter 1 has good pushing and guiding performance and can be smoothly pushed in the working channel of the endoscope, Figure 7As shown, the delivery catheter 1 includes an outer layer 11, an intermediate layer 12 and an inner layer 13, wherein Figure 5 As shown, the first section 16 of the outer layer 11 is made of a polymer material with good biocompatibility, and the hardness of the first section 16 of the outer layer 11 is greater than the hardness of the second section 15, and the hardness of the second section 15 of the outer layer 11 is greater than the hardness of the third section 14. Since the first section 16 of the outer layer 11 needs to be made of a high-hardness material to ensure the pushing performance of the delivery catheter 1, its material can be a polymer material such as PA6, PA12, Pebax, HDPE and polyamide, so that the delivery catheter 1 can be smoothly pushed in the working channel of the endoscope, and it is not easy to cause the occurrence of adverse conditions such as catheter bending, catheter plastic deformation, and catheter breakage. Since the second section 15 and the third section 14 of the delivery catheter 1 need to be flexible, the hardness is relatively low. The second section 15 and the third section 14 of the outer layer 11 can be made of a polymer material with medium strength, not easy to break and good biocompatibility, which can be PE, TPU, TPE, Pebax, etc.

[0064] The middle layer 12 is composed of a braided layer and / or a coiled spring, that is, the middle layer 12 is either composed of a full braided layer, or is composed of a full coiled spring, or is formed by a combination of a braided layer and a coiled spring. When the middle layer 12 adopts a braided layer, the proximal braiding density of the braided layer is less than the proximal braiding density of the proximal braided layer. The proximal braiding density is generally 30-60, and the distal braiding density is generally 70-110 for further enhancement, so as to ensure the proximal delivery strength of the delivery catheter 1 while also ensuring the flexibility of the distal end of the delivery catheter 1, and the delivery catheter 1 is not easy to collapse. The braided layer is formed by braiding metal wires with good elasticity, and round wires or flat wires such as SUS304, SUS316 or NITI can be used. The metal wire reinforcement layer can enhance the strength of the delivery catheter 1, and is not easy to plastically deform or break. At the same time, it enhances the flexibility, bending resistance, and torsion resistance of the delivery catheter 1. The delivery catheter 1 is not easy to bend and break, torsion break, and other unfavorable conditions during the curved airway pushing process, and has a smaller bending radius than a single polymer tube. When the braided layer is wound with a spring, the pitch of the spring is in the range of 1 mm to 5 mm.

[0065] Furthermore, the inner layer 13 is composed of a polymer material with good lubricity and low friction resistance. The resistance of the control wire 4 when it moves in the inner layer 13 of the delivery catheter 1 can be reduced, so that the control wire 4 can accurately control the opening and closing of the ablation electrode 3. The preferred material of the inner layer 13 can be HDPE, PTFE, FEP or other polymer materials with low friction coefficient. The thickness of the inner layer 13 is generally between 0.02-0.05mm.

[0066] Furthermore, the delivery catheter 1 is connected to the control handle 2 via a stress expansion tube 19, and the proximal end of the delivery catheter 1 is connected to the stress expansion tube 19 to prevent stress concentration in the connection transition section between the delivery catheter 1 and the control handle 2, thereby preventing the delivery catheter 1 from bending or breaking.

[0067] In one embodiment, in order to achieve the connection between the ablation electrode 3 and the external energy generator, the control handle is provided with a cable assembly 5, and the cable assembly 5 includes a power line 53, a first wire 51 and a power connector 52, such as Figure 8 and Fig.10 As shown, a first wire 51 is arranged in the delivery catheter 1, and an insulating sleeve is arranged on the first wire 51, so as to avoid the loss of ablation energy during the transmission process and realize that the ablation energy is released only on the ablation electrode 3. One end of the first wire 51 is connected to the ablation electrode 3, and the other end of the first wire 51 is connected to the power line 53, and the two are connected by welding. The power line 53 is coated with a thicker insulating sleeve, which can effectively avoid the wear and tear of the power line on the outside of the control handle 2. A power connector 52 is arranged at the other end of the power line 53. It should be particularly noted that the power line 53 and the first wire 51 are both Litz wires, which can effectively prevent the adhesion effect of the wires. Optionally, the control wire 4 may have conductive properties to replace the role of the first wire 51.

[0068] In one embodiment, in order to achieve better opening and closing of the ablation electrode 3 and to perfectly adhere to the inner wall of the human body cavity, the ablation electrode 3 adopts a basket weaving structure. In the expanded state, the ablation electrode 3 with the basket weaving structure presents a profile with a large outer diameter in the middle part and a small outer diameter at both ends, such as a teardrop shape, a spindle shape or a blade shape. The two ends of such shapes have strong support capabilities to ensure that the ablation electrode 3 with the basket weaving structure is straight. At the same time, the support capacity of the middle area is weak, so that the ablation electrode 3 has good compliance and can ensure a good adhesion effect. Optionally, the ablation electrode 3 can also be a plurality of through grooves parallel to its own axial direction on the elastic metal tubular structure of the hollow structure, so as to achieve the opening and closing of the ablation electrode 3.

[0069] Further, refer again to Figure 3 and Figure 4The first end of the ablation electrode 3 of the basket weaving structure is provided with a first electrode ring 32, and the second end of the ablation electrode 3 is provided with a second electrode ring 31. The first electrode ring 32 wraps and fixes the first end of the ablation electrode 3, and the second electrode ring 31 wraps and fixes the second end of the ablation electrode. By providing the first electrode ring 32 and the second electrode ring 31, the longitudinal length of the ablation electrode 3 of the basket weaving structure can be effectively limited, and the opening and closing size of the ablation electrode 3 can be further limited to between 1mm and 40mm. In addition, the first electrode ring 32 and the second electrode ring 31 are made of conductive material, and one end of the first wire 51 is electrically connected to the first electrode ring 32 or the second electrode ring 31, and the ablation energy is transmitted to the ablation electrode 3 through the first electrode ring 32 or the second electrode ring 31, thereby improving the conduction performance of the first wire 51 directly connected to the ablation electrode 3 and avoiding the occurrence of virtual connection or missing connection.

[0070] In one embodiment, when the ablation electrode 3 is in a closed state, the outer diameter of the ablation electrode 3 is in a range of 0.5 mm to 4 mm, and when the ablation electrode 3 is in an open state, the outer diameter of the ablation electrode 3 is in a range of 1 mm to 60 mm. Compared with the prior art which can only enter the thicker bronchus for treatment, the ablation catheter in this embodiment can enter the deeper bronchioles for ablation treatment.

[0071] In one embodiment, the ablation electrode 3 of the basket weaving structure is made of metal wire with low resistance and high elasticity, such as SUS304, SUS316L, cobalt-chromium alloy, nickel-titanium alloy, etc. By using such materials, the ablation energy loss is reduced, and plastic deformation is not easy to occur, and the effect of sticking to the target tissue is better. At the same time, the damage effect on the airway is small, and accurate and efficient treatment can be achieved.

[0072] In one embodiment, the ablation electrode 3 of the basket weaving structure adopts a 1-on-1, 1-on-2 or 2-on-2 weaving method. This weaving method can make the ablation electrode 3 of the basket weaving structure open and close evenly and circularly, and can more comprehensively cover the lesion cavity, so as to further enhance the treatment effect.

[0073] Furthermore, the weaving density (PPI) of the ablation electrode 3 of the basket weaving structure is preferably 5-60, (Picks Per Inch) the number of horizontal stripes per inch or the number of needle pitches. The ablation electrode 3 of this weaving density can provide good radial support when opened, so that the ablation electrode 3 fits tightly with the lesion cavity, improving the treatment effect. At the same time, this weaving density has a smaller outer diameter when closed, and can pass through the working channel of the endoscope to easily reach the lesion site.

[0074] Furthermore, the ablation electrode 3 is polished. The ablation electrode that has been polished has a smaller high-frequency resistance, which can improve the transmission ability of the pulse electric field and promote the electroporation effect of cells.

[0075] In one embodiment, Figure 6 As shown, the surface of the delivery catheter 1 is provided with marking scales 18, which are provided from the distal end to the proximal end of the delivery catheter 1, and the numbers are increased or decreased in sequence. In this embodiment, the marking scales 18 are used in a sequentially increasing manner. By providing the marking scales 18, on the one hand, the operator can see the length of the delivery catheter 1 extending out of the working channel of the endoscope through the endoscope, thereby preventing the delivery catheter 1 from extending out of the working channel of the endoscope too long and causing damage to the human body cavity; on the other hand, the operator can also be reminded of the length of the delivery catheter 1 entering the endoscope, thereby achieving the purpose of precise treatment.

[0076] Furthermore, the marking scale 18 can be manufactured by thermo-rheological, printing or laser marking. Furthermore, the marking scale 18 can be a number, a graphic or a combination of the two, and the graphic can be a solid line full circle or a dotted line full circle or a combination of the two.

[0077] In one embodiment, Figure 1 He Ru Fig. 9 As shown, the control handle 2 includes a shell and a handle 22 movably arranged relative to the shell, and a grip 21 is arranged on the shell. The movement of the handle 22 relative to the shell drives the moving component connected to the handle 22 to move, and then the moving component drives the control wire 4 to move axially relative to the delivery catheter 1, and finally the expansion or closing of the ablation electrode 3 is realized.

[0078] Furthermore, if Fig. 9 and Fig.10 As shown, the moving assembly includes a translation slider 213 and a swing link 218, wherein the swing link 218 is rotatably arranged inside the housing, wherein a first limiting groove 211 is arranged on the housing, and a portion of the translation slider 213 is slidably arranged in the first limiting groove 211, one end of the swing link 218 is movably connected to the translation slider 213, and the other end of the swing link 218 is movably connected to the handle 22. It should be particularly pointed out that the rotation point of the swing link 218 rotatably arranged inside the housing is located between the swing link 218 and the handle 22 and the swing link 218 and the translation slider 213. Further, in order to make the control handle 2 control the control wire 4 more smoothly, the connection section where the control wire 4 passes through the proximal end of the delivery catheter 1 and the translation slider 213 is parallel to the sliding direction of the translation slider 213, and in this embodiment, both are in a horizontal collinear state.

[0079] Specifically, the first limiting groove 211 is horizontally arranged and consists of two clamping plates, wherein the portion of the translation slider 213 is adapted to the width of the first limiting groove 211, so that the translation slider 213 can perform horizontal linear reciprocating movement under the action of the first limiting groove 211. It should be pointed out that the housing is composed of a symmetrical first side shell and a second side shell, so the first limiting groove 211 is respectively located on the first side shell and the second side shell, and the positions correspond. The first side shell and the second side shell are detachably connected, and a clearance notch is set at the edge of the housing so that the handle 22 can rotate relative to the housing.

[0080] Furthermore, if Fig.10 , Fig.12 and Fig.13 As shown, a first waist-shaped hole 2182 is provided on the swing link 218, and a corresponding first circular hole 2133 is provided on the translation slider 213. The aperture of the first waist-shaped hole 2182 is the same as that of the first circular hole 2133. A first connecting shaft 214 is provided in the first circular hole 2133. The swing link 218 is movably connected to the first waist-shaped hole 2182 through the first connecting shaft 214 passing through the first circular hole 2133. By providing the first waist-shaped hole 2182, the swing link 218 can make way for the first connecting shaft 214 in its own axial direction, thereby driving the translation slider 213 to slide along the first limiting groove 211. As another variation of this embodiment, the first waist-shaped hole 2182 can be provided on the translation slider 213, and the first circular hole 2133 can be provided on the swing link 218, so that the first connecting shaft 214 can make way for the axial direction of the swing link 218. Optionally, the first waist-shaped hole 2182 may be configured as a round hole with a larger aperture to meet the need for making way for the first connecting shaft 214 to move.

[0081] Furthermore, a third circular hole 2183 is provided on the swing link 218, and a third rotating shaft 219 adapted to the third circle 2183 is provided on the shell, and the third circular hole 2183 is located between the first waist-shaped hole 2182 and the second waist-shaped hole 2184, so that the rotation point of the swing link 218 around the shell is between the movable connection point between the translation slider 213 and the swing connection 218 rod and the movable connection point between the swing link 218 and the handle 22, and the third rotating shaft 219 is arranged closer to the second waist-shaped hole 2184, so that the handle 22 can achieve a longer sliding distance of the translation slider 213 within a smaller swing angle range.

[0082] In one embodiment, a second waist-shaped hole 2184 is provided at one end of the swing link 218 close to the handle 22, and a corresponding second round hole is provided on the handle 22, wherein the handle 22 and the swing link 218 are movably connected via a second connecting shaft 217, the second connecting shaft 217 is adapted to the aperture of the second round hole, and the aperture of the second waist-shaped hole 2184 is the same as the aperture of the second round hole. Optionally, the second waist-shaped hole 2184 can also be set as a round hole with a larger aperture to meet the need for the second connecting shaft 217 to make way for the movement of the swing link.

[0083] In one embodiment, a second limiting groove 212 is provided on the inner wall of the shell, the width of the second limiting groove 212 is adapted to the outer diameter of the first connecting shaft 214, a part of the first connecting shaft 214 is inserted into the second limiting groove 212, and the first connecting shaft 214 can move relative to the second limiting groove 212; at the same time, the second limiting groove 212 is arranged in parallel with the first limiting groove 211, and in this embodiment, the first limiting groove 211 and the second limiting groove 212 are both arranged horizontally. Since the shell adopts a symmetrical first side shell and a second side shell. Therefore, the first side shell and the second side shell are both provided with a second limiting groove 212, and the positions correspond, and the two ends of the first connecting shaft 214 are respectively clamped in the two second limiting grooves 212. By setting the second limiting groove 212, it is further ensured that the translation slider 213 moves horizontally, and the translation slider 213 has more support points, and the structure of the moving component is more stable. Furthermore, the length of the second limiting groove 212 should meet the opening and closing requirements of the ablation electrode 3. That is, when the first connecting shaft 214 is located at the two end limit positions of the second limiting groove 212, the ablation electrode 3 should be in a closed or maximum expansion state. At the same time, the second limiting groove 212 is a closed structure, so as to limit the sliding direction of the first connecting shaft 214 when sliding, and avoid excessive expansion or excessive contraction of the ablation electrode 3.

[0084] In one embodiment, a locking mechanism 24 is further included, and the locking mechanism 24 includes a locking ratchet 241 fixedly disposed on the swing link 218 and a ratchet pawl 242 rotatably disposed on the housing. Fig.16 and Fig.17As shown, a plurality of locking grooves 2412 adapted to the pawl 242 are provided on the locking ratchet 241. Specifically, a plurality of first guide surfaces 2411 are provided on the locking groove 2412, and a corresponding second guide surface 2421 is provided on the pawl 242. When the swing link 218 rotates, in this embodiment, the swing link 218 rotates clockwise. According to the rotation angle of the swing link 218, the pawl 242 will be engaged with the first guide surface 2411 and the second guide surface 2421 to be inserted into the corresponding locking groove 2412. At this time, the pawl 242 is fixed, thereby achieving a locking state, preventing the ablation electrode 3 from automatically rebounding and collapsing, resulting in poor adhesion of the ablation electrode 3 of the basket weaving structure to the wall due to operator error or failure of the moving component during treatment, resulting in surgical failure.

[0085] When the swing link 218 needs to rotate counterclockwise, the pawl 242 needs to be disengaged from the locking groove 2412. The specific implementation method can be that the pawl 242 is disengaged from the locking groove 2412 vertically relative to the rotation direction of the locking ratchet 241, or the pawl 242 is rotated relative to the housing, and the knob connected to the pawl 242 is rotated clockwise to disengage the pawl 242 from the locking groove 2412 through the first guide surface 2411 and the second guide surface 2421. It can be understood that the number of locking grooves 2412 of the locking ratchet 241 should meet the adaptive adjustment of the outer diameter profiles of the ablation electrode 3 to adapt to the precise contact with cavities with different inner diameters.

[0086] Furthermore, after the ablation operation is completed, the ablation electrode 3 needs to be restored to its initial state and withdrawn. Fig.10As shown, a return spring 216 is also provided on the control handle 2, one end of the return spring 216 is connected to the housing of the control handle 2, and the other end of the return spring 216 is connected to the handle 22. Specifically, in this embodiment, in the initial position, the return spring 216 is in a natural state, and when the handle 22 approaches the grip 21, the return spring 216 is in a stretched state. At the same time, in combination with the locking mechanism 24, the position of the handle 22 relative to the grip 21 is fixed, so that the ablation electrode 3 of the basket weaving structure is in an expanded maintenance state. After the ablation operation is completed, the ablation electrode 3 needs to be restored to the initial state and withdrawn from the lesion cavity, so the pawl 242 of the locking mechanism 24 is disengaged from the locking groove 2412 of the locking ratchet 241. At this time, the return spring 216 is instantly restored to the initial natural state by its own elastic force in the stretched state, and the ablation electrode 3 is instantly restored from the expanded state to the initial closed state. The reset spring 216 can quickly respond and retract the ablation electrode 3 of the basket weaving structure, avoiding the airway damage caused by the slow recovery of the ablation electrode 3, the operator cannot judge the state of the ablation electrode 3, and the ablation electrode 3 in the open state is moved in advance. At the same time, the reset spring 216 provides the operator with a one-way operation to prevent the operator from operating the handle incorrectly, causing the ablation electrode 3 to open and close in the opposite direction, causing cavity damage. Optionally, the reset spring 216 can also be set on the outside of the shell, one end of the reset spring 216 is connected to the handle 22, and the other end is connected to the grip 21. In the initial state, the reset spring 216 is in a natural state. When the handle 22 approaches the grip 21, the reset spring 216 is squeezed. When the locking mechanism 24 is unlocked, the reset spring 216 will stretch to the initial natural length under its own elastic force, so that the expanded ablation electrode 3 is restored to a closed state.

[0087] Furthermore, in order to facilitate the operator to understand the state of the ablation electrode 3, an opening and closing mark is also provided on the control handle 2, and the operator can understand the opening and closing size of the ablation electrode 3 in the human body cavity through the opening and closing mark. This avoids moving the delivery catheter 1 when the ablation electrode 3 is in the expanded state, which may cause damage to the human body cavity. Specifically, the opening and closing mark can be in two forms, such as Fig.14 and 15As shown, the handle 22 is provided with an indication mark 221 of the opening and closing size of the ablation electrode 3. When the ablation electrode 3 is closed, the indication mark 221 of the ablation electrode 3 will be hidden inside the shell of the control handle 2. As the ablation electrode 3 is opened, the indication mark 221 on the handle 22 will gradually be exposed. The indication mark 221 of the ablation electrode 3 is divided into three gears: large, medium and small, corresponding to the opening and closing size of the ablation electrode 3. Further, it can also be set on the shell with an accurate opening and closing number 25, which is specifically notched on the shell, and the opening and closing number is set on the edge of the notch to correspond to the opening and closing size of the ablation electrode 3, wherein the translation slider 213 will be exposed in the notch, and in the initial position, the translation slider 213 will not be exposed. When the ablation electrode 3 is expanded, the translation slider 213 will be exposed in the notch, and the opening and closing number 25 corresponding to the exposed length is used to let the operator know the opening and closing size of the ablation electrode 3.

[0088] In one embodiment, in order to realize a larger opening and closing diameter of the ablation electrode 3 of the basket weave structure, the control handle 2 is relatively small in size, such as Fig.11 As shown, the range-extending assembly is also included in the housing, and the range-extending assembly includes a first fixed rack 2132, a first movable rack 2131, and a first gear 2181. The first fixed rack 2132 is fixedly arranged on the housing, the first movable rack 2131 is arranged on the translation slider 213, and can move synchronously with the translation slider 213, and the first gear 2181 is respectively meshed with the first fixed rack 2132 and the first movable rack 2131. In this embodiment, the first gear 2181 is rotatably arranged on the swing link 218 through the first connecting shaft 214. When the swing link 218 rotates clockwise, the first gear 2181 rolls along the first fixed rack 2132, and at the same time, the first movable rack 2131 meshed with the first gear 2181 drives the translation slider 213 to move linearly along the first limiting groove 211. By setting up an extended-range component, within the same swing angle of the swing link 218, the translation slider 213 moves twice the distance, so that the ablation electrode 3 is reset from the expanded state. On the contrary, if the swing link 218 rotates counterclockwise, the ablation electrode 3 slowly changes from the closed state to the expanded state. In this embodiment, the extended-range component satisfies the requirement that the ablation electrode 3 can achieve a larger profile expansion in a limited and smaller space, and the response is more sensitive. This structure can be adapted to the ablation electrode 3 with a larger diameter basket weave structure, and can treat larger diameter airways, esophagus, blood vessels or other larger diameter human body passages.

[0089] In one embodiment, again referring to Fig. 9, a mechanical tester 23 is also provided in the shell of the control handle 2, and a pressure sensor is provided on the ablation electrode 3, and the pressure sensor and the mechanical tester 23 are connected by signal. Specifically, when the ablation electrode 3 of the basket weaving structure is opened, it will be subjected to the squeezing force of the human body cavity, which is measured by the pressure sensor located on the ablation electrode 3 and fed back to the mechanical tester 23 located in the shell in a timely manner. When the squeezing force is zero, it means that the ablation electrode 3 is not attached to the inner wall of the human body cavity, and the ablation electrode 3 needs to be further opened by the control handle 22. When a smaller squeezing force is generated, it means that the ablation electrode 3 has been attached successfully and can be connected to the external energy generator to release the ablation energy; when the squeezing force measured by the mechanical tester 23 is too large, the mechanical tester 23 will alarm, for example, through sound or light alarm feedback, prompting the operator to appropriately reduce the squeezing force, so that the ablation electrode 3 is adjusted to a reasonable size and attached. Reduce the damage to the human body cavity caused by excessive expansion of the ablation electrode 3.

[0090] In one embodiment, the control handle 2 is provided with a thumb grip position according to the principle of ergonomics, that is, the handle 21 is provided with an arc structure that fits the thumb of a human hand; the opening and closing angle of the handle 22 and the longest length from the handle 22 to the handle 21 are in line with the holding method of normal adults (male and female), and the overall shape adopts a streamlined design, which is comfortable to hold; a round groove is provided on the top of the control handle 2 and a waistline is provided at the waist, which is simple but not monotonous; the overall texture adopts discharge texture, and the contact position between the fingers and the palm is provided with leather texture, providing a better grip and pressing feel; the overall shape refers to the dolphin bionic design, which is more vivid and dexterous.

[0091] In one embodiment, the present invention also provides an operation process of a pulsed electric field ablation catheter, which is as follows: Taking the airway of a human lung as an example,

[0092] The operator first introduces the endoscope into the patient's airway to find the lesion. The power connector 52 of the pulsed electric field ablation catheter is connected to the pulsed electric field generator; the pulsed electric field ablation catheter is introduced into the lesion in the patient's airway through the working channel of the endoscope, and the extension length of the ablation electrode 3 of the basket weaving structure is controlled according to the marking scale 18 on the catheter, so that the ablation electrode 3 accurately reaches the lesion site of the human airway. The operator holds the handle 21, presses the handle 22, and according to the opening and closing mark and the wall adhesion detection of the pressure sensor, cooperates with the observation of the endoscope output image, opens the ablation electrode 3 to the appropriate size and fits with the lesion airway. Control the pulsed electric field generator to release the pulse energy, and release the pulsed electric field at the ablation electrode 3 through the first wire 51 inside the catheter. The electric field acts on the lesion site, destroys the phospholipid bilayer of the lesion cells below the threshold, causes irreversible electroporation of the lesion cells, and protects the normal cells above the threshold to obtain a good treatment effect. After the pulse energy is released, the operator can push open the pawl 242 of the locking mechanism 24. Since the reset spring 216 will reset, the ablation electrode 3 will automatically return to the closed state in the expanded state. The operator can withdraw the pulse electric field ablation catheter into the endoscope to perform sputum suction in the airway. The ablation catheter can be withdrawn from the working channel of the endoscope, the ablation electrode 3 can be cleaned with saline, and then introduced into the next lesion for treatment. During the operation, a ventilator is used to supply oxygen to the patient, and an electrocardiogram detector is used to detect the patient's electrocardiogram data in real time.

[0093] The above is only a preferred embodiment of the present invention. It should be noted that a person skilled in the art can make several improvements and modifications without departing from the principle of the present invention. These improvements and modifications should also be considered as the protection scope of the present invention.

Claims

1. An ablation catheter suitable for ablation of a human cavity, characterized in that: include: A delivery catheter is provided with a first channel running through both ends, the delivery catheter is provided with a proximal end and a distal end, and the delivery catheter has a guiding function; an ablation electrode, disposed at the distal end of the delivery catheter, the ablation electrode being a hollow structure having a first end and a second end, the first end of the ablation electrode being connected to the distal end of the delivery catheter, wherein the ablation electrode can expand and maintain an expanded state; A control wire is movably inserted into the first channel of the delivery catheter, two ends of the control wire extend out of the proximal end of the delivery catheter and the distal end of the delivery catheter respectively, and one end of the control wire is connected to the second end of the ablation electrode; A control handle, comprising a shell and a handle movably arranged relative to the shell, the shell being connected to the proximal end of the delivery catheter, a moving assembly being arranged inside the control handle, the moving assembly comprising a translation slider and a swing link, the swing link being rotatably arranged inside the shell, the translation slider being able to make reciprocating linear movements relative to the shell, the other end of the control wire being connected to the translation slider, one end of the swing link being movably connected to the handle, wherein a rotation point of the swing link is located between connection points of the swing link with the handle and the translation slider respectively, and the rotation point is arranged close to one side of the handle; It also includes a range extender component, which includes a first fixed rack, a first movable rack and a first gear. The first fixed rack is arranged on the shell, the first movable rack is arranged on the translation slider, a first connecting shaft is provided on the first gear, and the first gear is respectively meshed with the first fixed rack and the first movable rack, and the other end of the swing connecting rod is movably connected to the first connecting shaft.

2. The ablation catheter suitable for ablation of a human cavity according to claim 1, characterized in that: The second end of the ablation electrode is provided with a guide tip, and the guide tip is provided with a smooth guide structure.

3. The ablation catheter suitable for ablation of a human cavity according to claim 1, characterized in that: The delivery catheter includes an outer layer, a middle layer and an inner layer, the outer layer is composed of a first section, a second section and a third section, the first section is arranged close to the control handle, the third section is arranged close to the ablation electrode, and the second section is arranged between the first section and the third section, wherein the hardness of the first section is greater than that of the second section, and the hardness of the second section is greater than that of the third section.

4. The ablation catheter suitable for ablation of a human cavity according to claim 3, characterized in that: The middle layer is a braided layer and / or a coiled spring, wherein the braiding density of the proximal end of the braided layer is less than the braiding density of the distal end of the braided layer, and the pitch range of the coiled spring is 1mm-5mm.

5. The ablation catheter suitable for ablation of a human cavity according to claim 3, characterized in that: The inner layer of the delivery conduit is made of a material with low friction resistance.

6. The ablation catheter suitable for ablation of a human cavity according to claim 1, characterized in that: It also includes a first wire arranged in the delivery catheter, an insulating sleeve is arranged outside the first wire, one end of the first wire is connected to an external energy generator, and the other end of the first wire is connected to the ablation electrode.

7. The ablation catheter suitable for ablation of a human cavity according to claim 6, characterized in that: The ablation electrode is a basket weaving structure. When the ablation electrode with the basket weaving structure is in an expanded state, the outer diameter in the middle of the ablation electrode is large, and the outer diameters at both ends of the ablation electrode are small.

8. The ablation catheter suitable for ablation of a human cavity according to claim 7, characterized in that: A first electrode ring is provided at the first end of the ablation electrode, and a second electrode ring is provided at the second end of the ablation electrode. The first electrode ring wraps and fixes the first end of the ablation electrode, and the second electrode ring wraps and fixes the second end of the ablation electrode.

9. The ablation catheter suitable for ablation of a human cavity according to claim 8, characterized in that: The first electrode ring and / or the second electrode ring are made of conductive material, and one end of the first wire is electrically connected to the first electrode ring or the second electrode ring.

10. The ablation catheter suitable for ablation of a human cavity according to claim 7, characterized in that: When the ablation electrode is in a closed state, the outer diameter of the ablation electrode is in a range of 0.5 mm to 4 mm. When the ablation electrode is in an open state, the outer diameter of the ablation electrode is in a range of 1 mm to 60 mm.

11. The ablation catheter suitable for ablation of a human cavity according to claim 7, characterized in that: The ablation electrode of the basket weaving structure is made of a metal material with high elasticity and low resistance.

12. The ablation catheter suitable for ablation of a human cavity according to claim 7, characterized in that: The basket weaving structure of the ablation electrode adopts a 1-on-1, 1-on-2 or 2-on-2 weaving method.

13. The ablation catheter suitable for ablation of a human cavity according to claim 7, characterized in that: The weaving density of the ablation electrode is 5-60.

14. The ablation catheter suitable for ablation of a human cavity according to claim 7, characterized in that: The ablation electrode is polished.

15. The ablation catheter suitable for ablation of a human cavity according to claim 1, characterized in that: The surface of the delivery catheter is provided with marking scales, and the marking scales are arranged from the distal end to the proximal end of the delivery catheter.

16. The ablation catheter suitable for ablation of a human cavity according to claim 1, characterized in that: The housing is provided with a first limiting groove, and the translation sliding block is slidably disposed in the first limiting groove.

17. The ablation catheter suitable for ablation of a human cavity according to claim 16, characterized in that: The swing link is provided with a first waist-shaped hole, and the translation slider is provided with a corresponding first round hole; or, The swing link is provided with a first circular hole, and the translation slider is provided with a corresponding first waist-shaped hole; wherein the swing link and the translation slider are movably connected by the first connecting shaft passing through the first waist-shaped hole and the first circular hole, and the first connecting shaft is adapted to the first circular hole.

18. The ablation catheter suitable for ablation of a human cavity according to claim 16, characterized in that: The swing link is provided with a second waist-shaped hole, and the handle is provided with a corresponding second round hole; the swing link and the handle are movably connected via a second connecting shaft passing through the second waist-shaped hole and the second round hole, and the second connecting shaft is adapted to the second round hole.

19. The ablation catheter suitable for ablation of a human cavity according to claim 17, characterized in that: The shell is provided with a second limiting groove adapted to the first connecting shaft, and both ends of the first connecting shaft can be slidably arranged in the second limiting groove, wherein the second limiting groove is arranged parallel to the first limiting groove.

20. The ablation catheter suitable for ablation of a human cavity according to claim 16, characterized in that: It also includes a locking mechanism, which includes a locking ratchet arranged on the swing link and a pawl rotatably arranged on the shell, wherein the locking ratchet is provided with a plurality of locking grooves adapted to the pawl.

21. The ablation catheter suitable for ablation of a human cavity according to claim 1, characterized in that: The control handle is also provided with an opening and closing mark of the ablation electrode, and the opening and closing mark is used to feedback the opening and closing size of the ablation electrode.

22. The ablation catheter suitable for ablation of a human cavity according to claim 20, characterized in that: It also includes a return spring, one end of which is connected to the housing of the control handle, and the other end of which is connected to the handle.

23. The ablation catheter suitable for ablation of a human cavity according to claim 1, characterized in that: The ablation electrode is provided with a pressure sensor, the control handle is provided with a mechanical tester, and the pressure sensor is connected to the mechanical tester by signal.

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