Ablation catheter suitable for ablation of human body cavity

Abstract

The utility model belongs to the technical field of human body cavity energy ablation, and provides an ablation catheter suitable for human body cavity ablation, which comprises a delivery catheter with guidance quality and a first channel communicated with two ends of the delivery catheter; the ablation electrode is arranged at the far end of the conveying catheter and is of a hollow structure, one end of the ablation electrode is connected with the conveying catheter, and the ablation electrode can expand and maintain the expansion state; the control wire is movably inserted into the first channel of the conveying catheter, the two ends of the control wire extend out of the two ends of the conveying catheter respectively, and one end of the control wire is connected with the second end of the ablation electrode; the control handle is connected with the near end of the conveying catheter, a moving assembly is arranged in the control handle, the other end of the control wire is connected with the moving assembly, and the control wire is driven by the moving assembly to move relative to the conveying catheter, so that the two ends of the ablation electrode are close to each other, and the ablation electrode is expanded. By arranging the expandable ablation electrode, the ablation electrode can be accurately attached to diseased regions of cavities with different diameters.

Description

Technical Field

[0001] The utility model belongs to the technical field of energy ablation in human body cavities, and particularly relates to an ablation catheter suitable for ablation in human body cavities. Background Art

[0002] At present, the treatment methods for airway diseases are mainly drug treatment and surgical treatment. Among them, drug treatment mainly involves inhaling drugs such as salbutamol sulfate aerosol and salmeterol fluticasone powder inhaler to dilate the trachea, thereby relieving the symptoms of airway diseases. However, drug treatment can only increase airway oxygen inhalation and play a relieving role, and cannot cure the diseases.

[0003] The surgical treatment methods mainly include surgical operations such as bullae resection and lung volume reduction surgery. Its disadvantage is that the surgical operation causes great damage to the patient and may lead to the failure of some lung functions. The surgical treatment methods mainly also include interventional ablation treatment, such as radiofrequency ablation and pulsed electric field ablation. Radiofrequency ablation generates thermal energy at the distal end of the catheter with radiofrequency energy and ablates tissues by contacting the lesion site. The pulsed electric field (PEF) ablation technology applies an instantaneous high voltage to the target position 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 that the structure of the part to be ablated can be destroyed, and this destruction is irreversible. At the same time, pulsed electric field ablation also has selectivity for cells and tissues. Pulsed electric field ablation has a threshold and can selectively ablate diseased tissues during the ablation process, which is a safe and effective airway ablation treatment method. Summary of the Utility Model

[0004] The utility model provides an ablation catheter suitable for ablation in human body cavities. With the assistance of the working channel of the endoscope, the delivery catheter accurately delivers the ablation electrode to the target position through the control handle, and at the same time expands and supports the ablation electrode, so that the ablation electrode completely fits the airway and releases a pulsed electric field, improving the accuracy and efficiency of ablation.

[0005] In order to achieve the above object, the utility model adopts the following technical scheme:

[0006] An ablation catheter suitable for ablation in human body cavities, comprising:

[0007] A delivery catheter provided with a first channel penetrating through both ends. The delivery catheter has a proximal end and a distal end, and the delivery catheter has directivity;

[0008] An ablation electrode disposed at the distal end of the delivery catheter. The ablation electrode is a hollow structure and has a first end and a second end. The first end of the ablation electrode is connected to the distal end of the delivery catheter. Among them, the ablation electrode can be expanded and maintained in the expanded state;

[0009] A control wire is movably inserted through a first channel of the delivery catheter. Both ends of the control wire extend out of the proximal end and the distal end of the delivery catheter respectively. One end of the control wire is connected to a second end of the ablation electrode.

[0010] In some embodiments, a guiding tip is provided at the second end of the ablation electrode, and a smooth guiding structure is provided on the guiding tip.

[0011] In some embodiments, the delivery catheter includes an outer layer, an intermediate 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 disposed near the control handle side, the third section is disposed near the ablation electrode side, and the second section is disposed between the first section and the third section. Among them, 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.

[0012] In some embodiments, the intermediate layer is a braided layer and / or a coil spring. Among them, the braiding density at the proximal end of the braided layer is less than the braiding density at the distal end of the braided layer, and the pitch range of the coil spring is 1 mm - 5 mm.

[0013] In some embodiments, the inner layer of the delivery catheter is made of a material with low frictional resistance.

[0014] In some embodiments, it further 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.

[0015] In some embodiments, the ablation electrode is a basket weaving structure. When the ablation electrode in the basket weaving structure is in the expanded state, the middle outer diameter of the ablation electrode is large, and the outer diameters at both ends of the ablation electrode are small.

[0016] In some embodiments, 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.

[0017] 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.

[0018] In some embodiments, when the ablation electrode is in the closed state, the outer diameter of the contour of the ablation electrode ranges from 0.5 mm to 4 mm. When the ablation electrode is in the open state, the outer diameter of the contour of the ablation electrode ranges from 1 mm to 60 mm.

[0019] In some embodiments, the ablation electrode of the basket weaving structure is made of a metal material with high elasticity and low resistance.

[0020] In some embodiments, the basket weaving structure of the ablation electrode adopts a weaving method of 1 over 1, 1 over 2 or 2 over 2.

[0021] In some embodiments, the weaving density of the ablation electrode is 5 - 60.

[0022] In some embodiments, the ablation electrode is polished.

[0023] In some embodiments, the surface of the delivery catheter is provided with identification scales, and the identification scales are arranged from the distal end to the proximal end of the delivery catheter.

[0024] In some embodiments, it further includes a control handle, which has a housing, a grip fixedly connected to the housing, and a handle rotatably arranged relative to the grip. The housing is connected to the proximal end of the delivery catheter. A moving component is arranged in the housing. The other end of the control wire is connected to the moving component. The moving component includes a translation slider and a swing link. The swing link is rotatably arranged in the housing. A first limiting groove is arranged on the housing. The translation slider is slidably arranged in the first limiting groove. One end of the swing link is movably connected to the translation slider, and the other end of the swing link is movably connected to the handle. Wherein, the rotation point of the swing link is located between the connection points of the swing link with the handle and the translation slider respectively.

[0025] In some embodiments, a first kidney-shaped hole is arranged on the swing link, and a corresponding first round hole is arranged on the translation slider; or,

[0026] A first round hole is arranged on the swing link, and a corresponding first kidney-shaped hole is arranged on the translation slider; wherein, the swing link and the translation slider are movably connected by a first connecting shaft passing through the first kidney-shaped hole and the first round hole, and the first connecting shaft is adapted to the first round hole.

[0027] In some embodiments, a second kidney-shaped hole is arranged on the swing link, and a corresponding second round hole is arranged on the handle; wherein, the swing link and the handle are movably connected by a second connecting shaft passing through the second kidney-shaped hole and the second round hole, and the second connecting shaft is adapted to the second round hole.

[0028] In some embodiments, a second limiting groove adapted to the first connecting shaft is arranged on the housing, and both ends of the first connecting shaft are slidably arranged in the second limiting groove, wherein, the second limiting groove is arranged parallel to the first limiting groove.

[0029] In some embodiments, a locking mechanism is further included. The locking mechanism includes a locking ratchet provided on the swing link and a pawl rotatably provided on the housing. Among them, a plurality of locking grooves adapted to the pawl are provided on the locking ratchet.

[0030] In some embodiments, an opening and closing mark of the ablation electrode is further provided on the control handle, and the opening and closing size of the ablation electrode is fed back through the opening and closing mark.

[0031] 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.

[0032] In some embodiments, a range extension assembly is further included. The range extension assembly includes a first fixed rack, a first moving rack and a first gear. The first fixed rack is provided on the housing, the first moving rack is provided on the translation slider, the first gear is connected to the first connecting shaft, and the first gear meshes with the first fixed rack and the first moving rack respectively.

[0033] 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 in signal connection with the mechanical tester.

[0034] Compared with the prior art, the beneficial effects brought by the present invention are as follows:

[0035] In this application, by providing an expandable ablation electrode, the ablation electrode is transported to the target position in a complex airway through a delivery catheter with good directivity, and then the ablation electrode is controlled to expand and adhere to the airway surface through the control handle, so that the outer diameter of the expanded contour of the ablation electrode adapts to various different sizes of cavities, realizing precise and efficient ablation. In addition, the delivery catheter is arranged in layers and segments, so that the ablation catheter can extend into a relatively curved human cavity for ablation. At the same time, a range extension assembly is provided on the control handle, which can drive the control wire to move a large stroke within a limited stroke, so that the ablation electrode with a basket weaving structure can expand to a larger outer diameter contour, improving the applicable places of the ablation catheter.

[0036] The additional aspects and advantages of this application will be partially given in the following description, and these will become obvious from the following description, or will be understood through the practice of this application. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1 A perspective view of the ablation electrode of an ablation catheter suitable for ablation of human cavities in an initial state according to the present invention;

[0038] Figure 2 Stereogram of the ablation electrode of an ablation catheter for human body cavity ablation according to the present utility model in an expanded state;

[0039] Figure 3 It is Figure 2 Enlarged view at C in

[0040] Figure 4 It is Figure 1 Enlarged view at A in

[0041] Figure 5 Structural schematic diagram of the delivery catheter of an ablation catheter for human body cavity ablation according to the present utility model;

[0042] Figure 6 It is Figure 1 Enlarged view at B in

[0043] Figure 7 Cross-sectional view of the delivery catheter of an ablation catheter for human body cavity ablation according to the present utility model;

[0044] Figure 8 It is Figure 7 Schematic diagram with the first wire provided in

[0045] Figure 9 Internal structural schematic diagram of the control handle of an ablation catheter for human body cavity ablation according to the present utility model;

[0046] Figure 10 It is Figure 9 Internal structural schematic diagram of the handle in

[0047] Figure 11 Structural schematic diagram of the range extension mechanism of the control handle of an ablation catheter for human body cavity ablation according to the present utility model;

[0048] Figure 12 Stereogram of the translation slider of an ablation catheter for human body cavity ablation according to the present utility model;

[0049] Figure 13 Stereogram of the swing link of an ablation catheter for human body cavity ablation according to the present utility model;

[0050] Figure 14 Schematic diagram of the first form of the opening and closing mark of the handle housing of an ablation catheter for human body cavity ablation according to the present utility model;

[0051] Figure 15 Schematic diagram of the second form of the opening and closing mark of the handle housing of an ablation catheter for human body cavity ablation according to the present utility model;

[0052] Figure 16 Stereogram of a locking mechanism of an ablation catheter suitable for ablation in a human body cavity according to the present utility model;

[0053] Figure 17 Front view of a locking mechanism of an ablation catheter suitable for ablation in a human body cavity according to the present utility model. Specific embodiments

[0054] The following further describes the present application in detail with reference to specific drawings. In the description of this embodiment, unless otherwise specified, the orientation or positional relationship indicated by terms such as "left" and "right" is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the present application must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation to the present application.

[0055] As Figures 1-4 shown, an ablation catheter suitable for ablation in a human body cavity provided by the present utility model mainly includes a delivery catheter 1, an ablation electrode 3, a control wire 4, and a control handle 2.

[0056] Specifically, as Figure 7 shown, the delivery catheter 1 is provided with a first channel 17 that penetrates both ends of itself. The delivery catheter 1 includes a proximal end and a distal end. Among them, the delivery catheter 1 has good directivity, so that the delivery catheter 1 can deliver the ablation electrode 3 to the target position in a complexly curved human body cavity;

[0057] The ablation electrode 3 is arranged at the distal end of the delivery catheter 1. Among them, the ablation electrode 3 is a hollow structure. The ablation electrode 3 has a first end and a second end. The first end of the ablation electrode 3 is connected to the distal end of the delivery catheter 1. It should be particularly noted that the ablation electrode 3 can be expanded and can maintain the expanded state, so that the ablation electrode 3 fits with the human body cavity; the control wire 4 movably penetrates through the first channel 17 of the delivery catheter 1. Both ends of the control wire 4 extend out of the distal end and the proximal end of the delivery catheter 1. One end of the control wire 4 is connected to the second end of the ablation electrode 3. By moving the control wire 4 relative to the delivery catheter 1 in the first channel 17, the second end of the ablation electrode 3 is driven to approach the first end of the ablation electrode 3 for expansion;

[0058] The control handle 2 is fixedly connected to the proximal end of the delivery catheter 1. A first cavity for component installation 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 axially move relative to the delivery catheter 1, so that the control wire 4 drives the second end of the ablation electrode 3 to approach the first end, thereby realizing the expansion of the ablation electrode 3.

[0059] In this application, the ablation electrode 3 is configured as an expandable structure. The ablation electrode 3 is delivered to the lesion in the human body cavity through a delivery catheter 1 with good guiding performance, such as tumor tissue in the human body cavity or neoplasm of airway chronic obstructive pulmonary disease. By expanding the ablation electrode 3 to abut against the target tissue, appropriate pulsed energy is selectively released to form a pulsed electric field, accurately ablating the target tissue abutted by the ablation electrode 3. Moreover, ablation operations in smaller human body cavities can be achieved, improving the accuracy and ablation efficiency of the operator's surgery and the application in human body cavity scenarios of different sizes. At the same time, accidental injury to healthy tissues can be avoided. It can be understood that the human body cavities referred to in this application include but are not limited to natural cavities such as the human airway, blood vessels, intestines, and esophagus. The ablation catheter of this application is not limited to the application of pulsed ablation energy, and ablation treatment of the lesion can also be achieved by microwave energy through the ablation catheter in this embodiment.

[0060] In one embodiment, as Figure 5 shown, a guiding tip 33 is provided at the second end of the ablation electrode 3, and a smooth guiding structure is provided on the guiding tip 33. Specifically, the guiding tip 33 has a certain length, and the guiding tip 33 is fixedly connected to the second end of the ablation electrode 3. Specifically, the ablation electrode 3 can be fixed on the guiding 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 guiding tip 33 can gather and fix the electrode wire heads. At the same time, the control wire 4 is connected to the guiding tip 33, which can drive the guiding tip 33 to squeeze the ablation electrode 3 to expand. A smooth guiding structure is provided at the end of the guiding tip 33 away from the ablation electrode 3. As Figure 3 shown, the smooth guiding 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 guiding structure can also be a combination of an arc surface or an inclined surface and an arc surface. Further, the guiding tip 33 is made of block polyether amide resin, polyurethane rubber, silica gel, etc.

[0061] In one embodiment, 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, as Figure 7 shown, the delivery catheter 1 includes an outer layer 11, an intermediate layer 12, and an inner layer 13, where, as Figure 5As shown, the first section 16 of the outer layer 11 is made of a polymer material with good biocompatibility. The hardness of the first section 16 of the outer layer 11 is greater than that of the second section 15, and the hardness of the second section 15 of the outer layer 11 is greater than that of the third section 14. Since the first section 16 of the outer layer 11 needs to use a high-hardness material to ensure the pushing performance of the delivery catheter 1, its material can be polymer materials such as PA6, PA12, Pebax, HDPE, and polyamide. Thus, the delivery catheter 1 can be smoothly pushed in the working channel of the endoscope, and it is not easy to occur such adverse conditions as catheter bending, plastic deformation of the catheter, and catheter fracture. Since the second section 15 and the third section 14 of the delivery catheter 1 need to have flexibility, their hardness is relatively low. The second section 15 and the third section 14 of the outer layer 11 can be made of polymer materials with medium strength, not easy to break, and good biocompatibility, such as PE, TPU, TPE, Pebax, etc.

[0062] The middle layer 12 is composed of a braided layer and / or a coil spring, that is, the middle layer 12 can be composed of a full braided layer, or entirely composed of a coil spring, or a combination of a braided layer and a coil spring. When the middle layer 12 adopts a braided layer, the proximal braiding density of the braided layer is less than the distal braiding density of the braided layer. The proximal braiding density is generally 30 - 60, and the distal braiding density is generally further enhanced at 70 - 110. While ensuring the proximal delivery strength of the delivery catheter 1, it can also ensure 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 it is not easy to occur plastic deformation or fracture. At the same time, it enhances the flexibility, bending resistance, and torsional resistance of the delivery catheter 1. The delivery catheter 1 is not easy to occur such adverse conditions as bending fracture and torsional fracture during the pushing process in the curved airway, and has a smaller bending radius compared to a single polymer pipe. When the middle layer 12 adopts a coil spring, the pitch range of the coil spring is 1 mm - 5 mm.

[0063] Furthermore, the inner layer 13 is composed of a polymer material with good lubricity and low frictional resistance. It can reduce the resistance when the control wire 4 moves in the inner layer 13 of the delivery catheter 1, thereby realizing the precise control of the opening and closing of the ablation electrode 3 by the control wire 4. The preferred material for the inner layer 13 can be HDPE, PTFE, FEP, or other polymer materials with low friction coefficients. The thickness of the inner layer 13 is generally between 0.02 - 0.05 mm.

[0064] Furthermore, the delivery catheter 1 is connected to the control handle 2 through a stress expansion tube 19. The proximal end of the delivery catheter 1 is connected to the stress expansion tube 19 to prevent stress concentration at the connection transition section between the delivery catheter 1 and the control handle 2, and avoid bending or breaking of the delivery catheter 1.

[0065] In one embodiment, in order to achieve the connection between the ablation electrode 3 and an external energy generator, a cable assembly 5 is provided on the control handle. The cable assembly 5 includes a power cord 53, a first wire 51, and a power connector 52. As Figure 8 and Figure 10 shown, the first wire 51 is disposed within the delivery catheter 1, and an insulating sleeve is provided on the first wire 51, thereby avoiding the loss of ablation energy during transmission and enabling the ablation energy to be 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 cord 53, and the connection between the two is made by welding. The power cord 53 is coated with a relatively thick insulating sleeve, which can effectively prevent the power cord outside the control handle 2 from being worn and cracked. The other end of the power cord 53 is provided with a power connector 52. It should be particularly noted that both the power cord 53 and the first wire 51 are Litz wires, which can effectively eliminate the skin effect of the wires. Optionally, the control wire 4 may have electrical conductivity to replace the function of the first wire 51.

[0066] In one embodiment, in order to enable the ablation electrode 3 to open and close better 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 of the basket weaving structure presents a profile with a larger outer diameter in the middle part and smaller outer diameters at both ends, such as a water droplet shape, a spindle shape, or a blade shape, etc. The two ends of such shapes have strong supporting capabilities, ensuring that the ablation electrode 3 of the basket weaving structure is straight. At the same time, the supporting capability in the middle region is weak, enabling the ablation electrode 3 to have good compliance and ensuring a good adhering effect. Optionally, the ablation electrode 3 may also be a hollow elastic metal tubular structure with a plurality of through grooves parallel to its own axial direction opened thereon, thereby realizing the opening and closing of the ablation electrode 3.

[0067] Further, referring again to Figure 3 and Figure 4 , a first electrode ring 32 is provided at the first end of the ablation electrode 3 of the basket weaving structure, and a second electrode ring 31 is provided at the second end of the ablation electrode 3. 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 3. 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 at the same time, the opening and closing size of the ablation electrode 3 can be further limited to be between 1 mm and 40 mm. In addition, the first electrode ring 32 and the second electrode ring 31 are made of a 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, transmitting the ablation energy to the ablation electrode 3 through the first electrode ring 32 or the second electrode ring 31, improving the conduction performance of the direct connection between the first wire 51 and the ablation electrode 3 and avoiding the occurrence of virtual connection or missed connection.

[0068] In one embodiment, when the ablation electrode 3 is in a closed state, the outer diameter of the contour of the ablation electrode 3 ranges from 0.5 mm to 4 mm, and when the ablation electrode 3 is in an open state, the outer diameter of the contour of the ablation electrode 3 ranges from 1 mm to 60 mm. Compared with the prior art which can only enter thicker bronchi for treatment, the ablation catheter in this embodiment can enter deeper bronchioles for ablation treatment.

[0069] In one embodiment, the ablation electrode 3 with a basket weaving structure is made of metal wires with low resistance and high elasticity, such as SUS304, SUS316L, cobalt-chromium alloy, nitinol alloy, etc. By using such materials, the ablation energy loss is reduced, and at the same time, plastic deformation is not likely to occur, and the effect of adhering to the target tissue is better. At the same time, the damage to the airway is smaller, and precise and efficient treatment can be achieved.

[0070] In one embodiment, the ablation electrode 3 with a basket weaving structure adopts a weaving method of 1 over 1, 1 over 2 or 2 over 2. Such a weaving method can make the ablation electrode 3 with a basket weaving structure open and close evenly and circularly, and can cover the diseased cavity more comprehensively, further improving the treatment effect.

[0071] Furthermore, the weaving density (PPI) of the ablation electrode 3 with a basket weaving structure is preferably 5 - 60. The ablation electrode 3 with such a weaving density can provide good radial support force when opened, making the ablation electrode 3 closely fit the diseased cavity, improving the treatment effect. At the same time, when closed, such a weaving density has a smaller outer diameter of the contour and can pass through the working channel of the endoscope, facilitating reaching the diseased site.

[0072] Furthermore, the ablation electrode 3 is polished. The polished ablation electrode has a smaller high-frequency resistance, which can improve the transmission ability of the pulsed electric field and promote the electroporation effect of cells.

[0073] In one embodiment, as Figure 6 shown, identification scales 18 are provided on the surface of the delivery catheter 1. The identification scales 18 are arranged from the distal end to the proximal end of the delivery catheter 1, and the numbers increase or decrease in sequence. In this embodiment, the increasing sequence is adopted. By setting the identification 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, avoiding the length of the delivery catheter 1 extending out of the working channel of the endoscope being too long and damaging the human body cavity; on the other hand, it can also prompt the operator of the length of the delivery catheter 1 entering the endoscope, so as to achieve the purpose of precise treatment.

[0074] 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.

[0075] In one embodiment, Figure 1 He Ru Figure 9 As shown, the control handle 2 includes a shell and a handle 22 movably arranged relative to the shell, a grip 21 fixedly connected to the shell is arranged on the shell, and the proximal end of the delivery catheter 1 is connected to the shell. The movement of the handle 22 relative to the shell drives the moving component connected to the handle 22 to move, thereby enabling the moving component to drive the control wire 4 to move axially relative to the delivery catheter 1, and finally realizing the expansion or closing of the ablation electrode 3.

[0076] Furthermore, if Figure 9 and Figure 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.

[0077] 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.

[0078] Furthermore, if Figure 10 , Figure 12 and Figure 13As shown, a first kidney-shaped hole is provided on the swing link 218, and a corresponding first round hole 2133 is provided on the translation slider 213. The aperture of the first kidney-shaped hole 2182 is the same as that of the first round hole 2133. A first connecting shaft 214 adapted thereto is arranged in the first round hole 2133. The swing link 218 is movably connected through the first connecting shaft 214 passing through the first round hole 2133 and the first kidney-shaped hole 2182. By providing the first kidney-shaped hole 2182, the swing link 218 can perform a yielding movement of the first connecting shaft 214 in its own axial direction, so as to drive the translation slider 213 to slide along the first limiting groove 211. As another deformation mode of this embodiment, it may also be that a first kidney-shaped hole 2182 is provided on the translation slider 213 and a first round hole 2133 is provided on the swing link 218, and the yielding movement of the first connecting shaft 214 in the axial direction of the swing link 218 can also be realized. Optionally, the first kidney-shaped hole 2182 can also be set as a round hole with a larger aperture to meet the yielding requirement for the movement of the first connecting shaft 214.

[0079] Furthermore, a third round hole 2183 is provided on the swing link 218, and a third rotating shaft 219 adapted to the third round hole 2183 is provided on the housing. The third round hole 2183 is located between the first kidney-shaped hole 2182 and the second kidney-shaped hole 2184, so that the rotation point of the swing link 218 around the housing is between the movable connection point of the translation slider 213 and the swing link 218 and the movable connection point of the swing link 218 and the handle 22, and the third rotating shaft 219 is arranged closer to the second kidney-shaped hole 2184 side, so that the handle 22 can achieve a longer sliding distance of the translation slider 213 within a smaller swing angle range.

[0080] In one embodiment, a second kidney-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. The handle 22 and the swing link 218 are movably connected through 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 kidney-shaped hole 2184 is the same as that of the second round hole. Optionally, the second kidney-shaped hole 2184 can also be set as a round hole with a larger aperture to meet the yielding requirement for the movement of the second connecting shaft 217 on the swing link.

[0081] In one embodiment, a second limiting groove 212 is provided on the inner wall of the housing. 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 respect to the first limiting groove 211. In this embodiment, both the first limiting groove 211 and the second limiting groove 212 are horizontally arranged. Since the housing adopts a symmetrical first side shell and second side shell, second limiting grooves 212 are provided on both the first side shell and the second side shell, and the positions correspond to each other. Both ends of the first connecting shaft 214 are respectively clamped in the two second limiting grooves 212. By providing 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. Further, 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 at the two extreme 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 during sliding, and prevent the ablation electrode 3 from being over-expanded or over-contracted.

[0082] In one embodiment, a locking mechanism 24 is further included. The locking mechanism 24 includes a locking ratchet 241 fixedly arranged on the swing link 218 and a pawl 242 rotatably arranged on the housing, as Figure 16 and Figure 17 shown. A plurality of locking grooves 2412 adapted to the pawl 242 are provided on the locking ratchet 241. Specifically, a plurality of first guiding surfaces 2411 are provided on the locking groove 2412, and corresponding second guiding surfaces 2421 are provided on the pawl 242. When the swing link 218 rotates, in this embodiment, the rotation direction of the swing link 218 is clockwise. According to the rotation angle of the swing link 218, the pawl 242 will be clamped into the corresponding locking groove 2412 under the cooperation of the first guiding surface 2411 and the second guiding surface 2421. At this time, the pawl 242 is fixed, so as to achieve a locked state, preventing the ablation electrode 3 from automatically rebounding and collapsing, resulting in poor wall attachment of the ablation electrode 3 of the basket weaving structure due to operator error or failure of the moving component during the treatment process, causing surgical failure.

[0083] When it is necessary to swing the connecting rod 218 to rotate counterclockwise, at this time, the pawl 242 needs to be disengaged from the locking groove 2412. The specific implementation method can be that the pawl 242 disengages from the locking groove 2412 vertically with respect to the rotation direction of the locking ratchet 241, or the pawl 242 is rotationally arranged relative to the housing, and the knob connected to the pawl 242 is rotated clockwise. Through the first guiding surface 2411 and the second guiding surface 2421, the pawl 242 is disengaged from the locking groove 2412. 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 each ablation electrode 3 to adapt to the precise fitting of different inner diameter channels.

[0084] Furthermore, after the ablation surgery is completed, the ablation electrode 3 needs to be restored to its initial state for withdrawal, as Figure 10 shown. Therefore, 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, at the initial position, the return spring 216 is in a natural state. 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 surgery is completed, the ablation electrode 3 needs to be restored to its initial state and withdrawn from the lesion channel. Therefore, 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 instantaneously returns to its initial natural state under its own elastic force in the stretched state, and the ablation electrode 3 instantaneously returns from the expanded state to the initial closed state. The return spring 216 can quickly respond and retract the ablation electrode 3 of the basket weaving structure, avoiding airway damage caused by the slow recovery of the ablation electrode 3, which makes the operator unable to judge the state of the ablation electrode 3 and prematurely move the ablation electrode 3 in the open state. At the same time, the return spring 216 provides a unidirectional operation for the operator to prevent the operator from operating the handle incorrectly, resulting in the reverse opening and closing of the ablation electrode 3 and causing channel damage. Optionally, the return spring 216 can also be arranged outside the housing, with one end of the return spring 216 connected to the handle 22 and the other end connected to the grip 21. In the initial state, the return spring 216 is in a natural state. When the handle 22 approaches the grip 21, the return spring 216 is compressed. When the locking mechanism 24 is unlocked, the return spring 216 will extend to its initial natural length under its own elastic force, so that the expanded ablation electrode 3 is restored to the closed state.

[0085] Further, for the convenience of the operator to understand the state of the ablation electrode 3, an opening and closing mark is also provided on the control handle 2. 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, so as to avoid moving the delivery catheter 1 in the expanded state of the ablation electrode 3, which may cause damage to the human body cavity. Specifically, the opening and closing mark can be in two forms. For example, Figure 14 and 15 As shown, an indication mark 221 for the opening and closing size of the ablation electrode 3 is provided on the handle 22. When the ablation electrode 3 is closed, the indication mark 221 of the ablation electrode 3 will be hidden inside the housing of the control handle 2. As the ablation electrode 3 opens, the indication mark 221 on the handle 22 will gradually appear. 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 an accurate opening and closing number 25 set on the housing. Specifically, a slot is opened on the housing, and the opening and closing numbers are set on the edge of the slot to correspond to the opening and closing size of the ablation electrode 3. Among them, the translation slider 213 will be exposed in the slot. In the initial position, the translation slider 213 will not be exposed. When the ablation electrode 3 expands, the translation slider 213 will be exposed in the slot, and the opening and closing number 25 corresponding to the exposed length will enable the operator to know the opening and closing size of the ablation electrode 3.

[0086] In one embodiment, to achieve a larger opening and closing diameter of the ablation electrode 3 with a basket weaving structure and a relatively small structure size of the control handle 2, as shown in Figure 11 As shown, a range extension component is further included in the housing. The range extension component includes a first fixed rack 2132, a first moving rack 2131, and a first gear 2181. The first fixed rack 2132 is fixedly arranged on the housing. The first moving rack 2131 is arranged on the translation slider 213 and can move synchronously with the translation slider 213. The first gear 2181 meshes with the first fixed rack 2132 and the first moving rack 2131 respectively. In this embodiment, the first gear 2181 is rotatably arranged on the swing link 218 through a first connecting shaft 214. When the swing link 218 rotates clockwise, the first gear 2181 rolls along the first fixed rack 2132. At the same time, the first moving rack 2131 meshing with the first gear 2181 drives the translation slider 213 to move linearly along the first limiting groove 211. By setting the range extension component, within the same angle of swing of the swing link 218, the translation slider 213 moves twice the distance, so that the ablation electrode 3 returns 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 range extension component satisfies the requirement that the ablation electrode 3 can achieve a larger contour expansion within a limited small space and is more sensitive in response. This structure can be adapted to the ablation electrode 3 with a larger diameter basket weaving structure and can treat airways, esophagi, blood vessels or other human channels with a larger diameter.

[0087] In one embodiment, again referring to Figure 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.

[0088] 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 leather texture is provided at the contact position between the fingers and the palm, providing a better grip and pressing feel; the overall shape refers to the dolphin bionic design, which is more vivid and dexterous.

[0089] In one embodiment, the utility model 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,

[0090] The operator first inserts the endoscope into the patient's airway to locate the lesion. Connect the power connector 52 of the pulsed electric field ablation catheter to the pulsed electric field generator to establish electrical conduction; insert the pulsed electric field ablation catheter through the working channel of the endoscope into the lesion in the patient's airway. According to the marking scale 18 on the catheter, control the extension length of the ablation electrode 3 of the basket weaving structure to accurately reach the lesion site in the human airway. The operator holds the grip 21 and presses the handle 22. According to the wall attachment detection of the opening / closing marking and the pressure sensor, and in cooperation with observing the output image of the endoscope, open the ablation electrode 3 to an appropriate size and fit it to the diseased airway. Control the pulsed electric field generator to release pulsed energy. Through the first wire 51 inside the catheter, release a pulsed electric field at the ablation electrode 3. The electric field acts on the lesion site, destroying the phospholipid bilayer of the lesional cells below the threshold, causing irreversible electroporation of the lesional cells, and protecting the normal cells above the threshold, thereby achieving a good treatment effect. After the pulsed energy is released, the operator can disengage the pawl 242 of the locking mechanism 24. Since the return spring 216 will return to its original position, the ablation electrode 3 will automatically return to the closed state in the expanded state. The operator can withdraw the pulsed electric field ablation catheter into the endoscope to aspirate the sputum in the airway. The ablation catheter can be withdrawn from the working channel of the endoscope, the ablation electrode 3 can be cleaned with normal 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 continuously detect the electrocardiogram data of the patient.

[0091] The above are only the preferred embodiments of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and refinements can be made. These improvements and refinements should also be regarded 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; It also includes a control handle, which has a shell, a grip fixedly connected to the shell, and a handle rotatably arranged relative to the grip, the shell is connected to the proximal end of the delivery catheter, a moving component is arranged in the shell, the moving component includes a translation slider and a swing connecting rod, the swing connecting rod is rotatably arranged in the shell, the translation slider can make reciprocating linear movements in the shell, the other end of the control wire is connected to the translation slider, one end of the swing connecting rod is movably connected to the translation slider, and the other end of the swing connecting rod is movably connected to the handle, wherein the rotation point of the swing connecting rod is located between the connection points of the swing connecting rod with the handle and the translation slider respectively, and the rotation point is arranged close to one side of the handle.

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 slider is slidably disposed in the first limiting groove so that the translation slider performs reciprocating linear movement.

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 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.

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 16, 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 19, characterized in that: 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, the first gear is connected to the first connecting shaft, and the first gear is respectively meshed with the first fixed rack and the first movable rack.

24. The ablation catheter suitable for ablation of a human cavity according to claim 16, 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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