CN116115329A

CN116115329A - Interventional ablation device and medical interventional device

Info

Publication number: CN116115329A
Application number: CN202211716334.XA
Authority: CN
Inventors: 许书菡; 杨勇; 陶霖; 姚佳星; 张芳芳; 叶萍
Original assignee: Ronghe Medical Technology Zhejiang Co ltd
Current assignee: Ronghe Medical Technology Zhejiang Co ltd
Priority date: 2022-12-29
Filing date: 2022-12-29
Publication date: 2023-05-16

Abstract

The invention discloses an interventional ablation device and a medical interventional device, which comprise a guiding inner shaft, a fixing sleeve, an ablation assembly and a control tube assembly, wherein the ablation assembly comprises at least one reticular flexible electrode; two ends of the flexible electrode are fixedly connected with the guiding inner shaft and/or the control tube through the fixed sleeve; the at least one control tube is sleeved outside the guide inner shaft and can move along the guide inner shaft to drive the flexible electrode to expand or contract; internal tooth structures are arranged at two ends of the sleeve body of the fixed sleeve along the circumferential direction, and the internal tooth structures at the two ends are obliquely arranged from the end face of the sleeve body to the inner side of the end face. By adopting the interventional ablation device, more narrow bronchial branches can be uniformly attached to focus tissues, and the accuracy, efficiency, treatment effect and treatment safety of the operation are improved.

Description

Interventional ablation device and medical interventional device

Technical Field

The invention relates to the technical field of medical equipment, in particular to an interventional ablation device and a medical interventional device.

Background

In the existing treatment of pulmonary branch diseases, firstly, goblet cells and mucous glands in epithelial cells are eliminated by ablation energy, so that mucous secretion in bronchial cavities is reduced. And secondly, directly killing the ineffective ciliated pseudo-multi-layer cells by using ablation energy. Since cilia in the trachea is an important tool for assisting the expectoration of the mucus in the trachea, the accumulation of the mucus in the trachea can be finally blocked and inflamed, and after epithelial cells are killed, the epithelial cells can grow new cells quickly and restart working because of the strong regeneration capacity of the epithelial cells.

Existing interventional ablation devices can reach up to the fourth level of the bronchi, and generally where the bronchi are most prone to inflammation is in the more stenosed bronchi, can reach the 12 th level or beyond the 12 th level of the bronchial branch. The existing interventional ablation device is large in size, poor in connection reliability, incapable of reaching a narrower bronchus branch and incapable of being well attached to focus tissues, and greatly influences the accuracy, efficiency and treatment effect of an operation.

Disclosure of Invention

In order to solve the problems that the interventional ablation device in the prior art has larger volume and poor connection reliability, can not accurately reach even and close bronchus branches and focus tissues, and affects the accuracy, efficiency and treatment effect of the operation.

The application provides an interventional ablation device, which comprises a guiding inner shaft, a fixing sleeve, an ablation assembly and a control tube assembly, wherein the ablation assembly comprises at least one flexible electrode, at least one flexible electrode is net-shaped, the control tube assembly comprises at least one control tube, and the guiding inner shaft is electrically connected with the flexible electrode and ablation equipment respectively;

at least one flexible electrode is sequentially arranged along the guiding inner shaft, and two ends of the flexible electrode are fixedly connected with the guiding inner shaft and/or the control tube through the fixing sleeve; at least one control tube is sleeved outside the guiding inner shaft, and at least one control tube can move along the guiding inner shaft to drive the flexible electrode to expand or contract;

internal tooth structures are arranged at two ends of the sleeve body of the fixed sleeve along the circumferential direction, and the internal tooth structures at two ends are obliquely arranged from the end face of the sleeve body to the inner side of the end face.

Further preferably, the ablation assembly comprises a flexible electrode, the control tube assembly comprises a control tube, the distal end of the flexible electrode is fixedly connected with the distal end of the guiding inner shaft through the fixing sleeve, the proximal end of the flexible electrode is fixedly connected with the outer wall of the control tube through the fixing sleeve, and the distal end of the control tube is arranged at intervals with the distal end of the guiding inner shaft.

Further preferably, the ablation assembly comprises a first flexible electrode and a second flexible electrode, the control tube assembly comprises a first control tube and a second control tube, and the first control tube and the second control tube are sleeved outside the guiding inner shaft in sequence from inside to outside;

the distal end of the first flexible electrode is fixedly connected with the distal end of the guiding inner shaft through the fixing sleeve, the proximal end of the first flexible electrode is fixedly connected with the outer wall of the first control tube through the fixing sleeve, and the distal end of the first control tube is arranged at intervals with the distal end of the first flexible electrode;

the distal end of the second flexible electrode is fixedly connected with the outer wall of the first control tube through the fixing sleeve, the outer wall is a certain distance away from the distal end of the first control tube, the proximal end of the second flexible electrode is fixedly connected with the outer wall of the second control tube through the fixing sleeve, and the distal end of the second control tube is arranged at intervals with the distal end of the second flexible electrode.

Further preferably, at least one of the flexible electrodes can be configured as a monopolar electrode or a bipolar electrode.

Further preferably, a plurality of said flexible electrodes arranged in sequence along said guiding inner shaft increases in sequence in the distal to proximal direction of the guiding inner shaft.

Further preferably, a limiting structure is arranged in the flexible electrode, and the limiting structure and the distal end of the control tube are arranged at intervals.

Further preferably, the tooth form of the internal tooth structure is a wave tooth, a triangle tooth, a flat tooth or a trapezoid tooth.

Further preferably, an information acquisition element is arranged between the internal tooth structures at two ends of the fixed sleeve, and the information acquisition element is used for acquiring the intervention position information of the flexible electrode in the target intervention area.

Further preferably, the flexible electrode includes a plurality of electrode wires, and the plurality of electrode wires are cross-woven into the mesh-like flexible electrode.

Further preferably, the axial section of the flexible electrode after expansion is elliptical, spindle-shaped, polygonal or umbrella-shaped.

Further preferably, an insulating layer is provided on the outer side of the flexible electrode.

Further preferably, the steering device comprises a control handle, wherein a channel for the guiding inner shaft and the control tube assembly to pass through is arranged in the control handle.

Further preferably, the control handle is provided with a control assembly, the control assembly is slidably or rotatably connected with the control handle, and the control assembly is used for controlling at least one control tube to move.

The application also provides a medical intervention device comprising an inner core tube, a control outer tube, an electrode guide wire and the flexible electrode of any one of claims, wherein the electrode guide wire is detachably penetrated in the inner core tube, and the control outer tube is sleeved outside the inner core tube;

the distal end of the flexible electrode is fixedly connected with the distal end of the inner core tube, the proximal end of the flexible electrode is fixedly connected with the outer wall of the control outer tube, and the control outer tube can move along the inner core tube to drive the flexible electrode to expand or contract.

Further preferably, the inner core tube is a through tube, and the distal end of the electrode guide wire can pass through the distal end of the inner core tube to be in contact with lesion tissue of an object to be ablated.

Further preferably, both the electrode wire and the flexible electrode are electrically connected to an ablation device.

Further preferably, the flexible electrode includes a plurality of electrode wires, and a plurality of the electrode wires are cross-woven into a mesh shape.

Further preferably, the distal ends of a plurality of the electrode wires are fixedly connected with the outer wall of the distal end of the inner core tube.

The embodiment of the invention has the following beneficial effects:

the application ablation assembly comprises at least one flexible electrode, wherein the flexible electrode is of a reticular structure which can be expanded and contracted, the structure is compact, the support performance is good, the energy distribution is uniform, the lamination area of the reticular flexible electrode and pathological tissues is larger, and the ablation is more uniform. The two ends of the flexible electrode are fixed through the fixing sleeve with the internal tooth structure, so that the coaxiality is improved, the coaxial problem caused by bending torsion after the distal end of the flexible electrode is fixed with the guiding inner shaft is greatly reduced, the connection is reliable, the problems of falling and cracking of the distal end of the flexible electrode in the operation process can be effectively avoided, the reliability of the interventional ablation device is improved, and the treatment time is shortened.

The electrode guide wire is detachably arranged in the inner core tube of the medical intervention device in a penetrating mode, when lesion tissues are in narrower trachea, the electrode guide wire can be conveyed into thinner bronchus through the inner core tube to reach the lesion tissues, and therefore ablation treatment is conducted on the narrower region.

Drawings

In order to more clearly illustrate the technical solution of the present invention, the following description will make a brief introduction to the drawings used in the description of the embodiments or the prior art. It is evident that the drawings in the following description are only some embodiments of the present invention and that other drawings may be obtained from these drawings without inventive effort for a person of ordinary skill in the art.

FIG. 1 is a schematic illustration of an interventional ablation device in accordance with an embodiment of the present invention;

FIG. 2 is a schematic view of a flexible electrode with a spacing structure according to an embodiment of the present invention;

FIG. 3 is a schematic illustration of an interventional ablation device including two flexible electrodes and two steering tubes in accordance with an embodiment of the present invention;

FIG. 4 is a schematic structural view of an ablation assembly including a plurality of flexible electrodes in accordance with an embodiment of the invention;

FIG. 5 is a cross-sectional view of a control handle according to an embodiment of the present invention;

FIG. 6 is a schematic structural view of a retaining sleeve according to an embodiment of the present invention;

FIG. 7 is a schematic diagram of the structure of one implementation of the flexible electrode of the present invention;

FIG. 8 is a schematic view of the structure of another implementation of the flexible electrode of the present invention;

FIG. 9 is a schematic view of the structure of another implementation of the flexible electrode of the present invention;

FIG. 10 is a schematic illustration of a medical intervention device according to an embodiment of the invention;

FIG. 11 is a cross-sectional view of the inner core tube, the outer steering tube and the electrode wire of the medical intervention device of an embodiment of the invention;

fig. 12 is a schematic view showing a state in which the medical intervention device is inserted into the trachea according to the embodiment of the present invention.

Wherein, the reference numerals in the figures correspond to: 1-guiding inner shaft, 2-fixed sleeve, 21-internal tooth structure, 3-flexible electrode, 30-limit structure, 31-first flexible electrode, 32-second flexible electrode, 4-control tube, 41-first control tube, 42-second control tube, 5-information acquisition element, 6-control handle, 61-channel, 62-fixed bayonet, 63-sealing ring, 7-control assembly, 100-inner core tube, 101-control outer tube, 102-electrode guide wire, 103-fixing piece, 104-operation handle, 105-control piece.

Detailed Description

The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

In the description of the present invention, it should be understood that the directions or positional relationships indicated by the terms "upper", "lower", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, are merely for convenience of description and simplification of the description, and do not indicate or imply that the apparatus or element in question must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as limiting the present invention. The terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may include one or more of the feature, either explicitly or implicitly.

In addition, in the present invention, unless explicitly stated and limited otherwise, the terms "mounted," "connected," and the like should be construed broadly, and may be fixedly connected, detachably connected, or integrally connected, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.

The application provides an energy delivery intervention device, specifically including intervention ablation device and medical intervention device for accurate entering tumor, lumen, target intervention region such as organ form better subsides with pathological change tissue to be connected with ablation equipment, carry and apply the ablation energy that ablation equipment generated to pathological change tissue, realize ablation treatment, do not damage normal tissue around again.

As shown in fig. 1-9, the interventional ablation device comprises a guiding inner shaft 1, a fixing sleeve 2, an ablation assembly and a control tube assembly, wherein the ablation assembly comprises at least one flexible electrode 3, the at least one flexible electrode is net-shaped, the control tube assembly 4 comprises at least one control tube 4, and the guiding inner shaft 1 is respectively electrically connected with the flexible electrode 3 and an ablation device;

at least one flexible electrode 3 is sequentially arranged along the guiding inner shaft 1, and two ends of the flexible electrode 3 are fixedly connected with the guiding inner shaft 1 and/or the control tube 4 through the fixed sleeve 2; at least one control tube 4 is sleeved outside the guide inner shaft 1, and the at least one control tube 4 can move along the guide inner shaft 1 to drive the flexible electrode 3 to expand or contract;

the sleeve body of the fixed sleeve 2 is provided with an internal tooth structure 21 at both ends along the circumferential direction, and the internal tooth structures 21 at both ends are obliquely arranged from the end face of the sleeve body to the inner side of the end face.

In particular, the guiding inner shaft 1 is used for connection with an ablation device and for delivering ablation energy to the flexible electrode 3. In some possible embodiments, the guiding inner shaft 1 may be an electrode wire connected with the flexible electrode 3, the electrode wire may be single-stranded or multi-stranded, the wire diameter may be 0.05mm-1mm, and the electrode wire is made of a conductive metal material. In other possible embodiments, the guiding inner shaft 1 may be a tubular structure such as a spring tube, a hypotube or a hypotube spiral, and the electrode wires are threaded into the guiding inner shaft and electrically connected to the flexible electrode 3 and the ablation device, respectively. In some embodiments, the outer layer of the guiding inner shaft 1 is provided with a polytetrafluoroethylene coating or is uncoated.

Specifically, in some possible embodiments, the ablation assembly comprises a flexible electrode 3, the steering tube assembly comprises a steering tube 4, the distal end of the flexible electrode 3 is fixedly connected with the distal end of the guiding inner shaft 1 through the fixing sleeve 2, the proximal end of the flexible electrode 3 is fixedly connected with the outer wall of the steering tube 4 through the fixing sleeve 2, and the distal end of the steering tube 4 is arranged at a distance from the distal end of the guiding inner shaft 1. In some possible embodiments, as shown in fig. 3, the ablation assembly comprises a first flexible electrode 31 and a second flexible electrode 32, the steering tube assembly comprises a first steering tube 41 and a second steering tube 42, and the first steering tube 41 and the second steering tube 42 are sleeved outside the guiding inner shaft 1 from inside to outside in sequence; the distal end of the first flexible electrode 31 is fixedly connected with the distal end of the guiding inner shaft 1 through the fixing sleeve 2, the proximal end of the first flexible electrode 31 is fixedly connected with the distal end of the first control tube 41 through the fixing sleeve 2, and the distal end of the first control tube 41 is arranged at intervals with the distal end of the first flexible electrode 31; the distal end of the second flexible electrode 32 is fixedly connected with the outer wall of the first control tube 41 through the fixing sleeve 2, the outer wall is changed to be a certain distance away from the distal end of the first control tube 41, the proximal end of the second flexible electrode 32 is fixedly connected with the outer wall of the second control tube 42 through the fixing sleeve 2, and the distal end of the second control tube 42 is arranged at intervals with the distal end of the second flexible electrode 32. In other possible embodiments, as shown in fig. 4, the ablation assembly includes a plurality of flexible electrodes 3, the maximum distance that the plurality of flexible electrodes 3 can expand is the same. In other possible embodiments, as shown in fig. 9, the maximum expandable distance of the plurality of flexible electrodes 3 sequentially disposed along the guiding inner shaft 1 increases sequentially along the direction from the distal end to the proximal end of the guiding inner shaft 1, so that the flexible electrodes 3 with different diameters can be controlled to expand to adapt to the air pipes with different inner diameter sizes by manipulating the pipe assembly according to the change of the inner diameter of the air pipes. In particular, the at least one flexible electrode 3 can be configured as a monopolar electrode or as a bipolar electrode. In some possible embodiments, at least one flexible electrode 3 releases a monopolar pulse, the target subject's body surface is attached with a negative plate, and a circuit is formed in the body by combining the negative plate with the product, so that the pulse energy acts on the treatment area. In other possible embodiments, the different flexible electrodes 3 form positive and negative poles in the target body, and the positive and negative energy is transferred, so that the positive and negative poles and the energy range within the two poles form a closed loop treatment area. The circuit conduction of the flexible electrodes 3 at the two ends is controlled, so that a larger range of ablation area can be obtained, the circuit conduction of the two adjacent flexible electrodes 3 is controlled, the ablation range can be controlled between the two adjacent flexible electrodes 3, the treatment range is more accurate, and the stimulation response is smaller.

In some possible embodiments, the ablation assembly comprises one flexible electrode 3, the flexible electrode 3 being electrically connected to a connection port in the ablation device by a plurality of electrode wires, the connection port comprising one negative electrode port and 7 positive electrode ports. The negative electrode port is used for connecting a negative electrode plate attached to the body surface of the target object, the other 7 positive electrode ports are respectively connected with different electrode wires, and the electrode wires are connected with the flexible electrode 3. For example, a first electrode wire is connected to the first port, a second electrode wire is connected to the second port, a third electrode wire is connected to the third port, a fourth electrode wire is connected to the fourth port, a fifth electrode wire is connected to the fifth port, a sixth electrode wire is connected to the sixth port, and a seventh electrode wire is connected to the seventh port. Each electrode connection port can be independently controlled through user setting, and the on-off of the circuit is controlled according to the ablation area and range.

In some embodiments, the flexible electrode 3 comprises a plurality of electrode wires that are cross-woven into a mesh-like flexible electrode 3. Preferably, the electrode wire may be a conductive metal wire, and the material of the metal wire may be stainless steel, nickel-titanium alloy, cobalt-chromium alloy, or other materials with good conductive properties. The longitudinal section of the wire may be oval, circular or polygonal, so that the braided flexible electrode 3 may more fully conform to the diseased tissue. The reticular flexible electrode 3 is easy to change shape, can be expanded and contracted, has higher grid compactness, tensile property and structural stability, can be better attached to pathological tissues, has larger and more uniform attaching area and has better treatment effect.

In particular, as shown in fig. 7-9, the axial cross-section of the flexible electrode 3 after expansion may be elliptical, spindle-shaped, polygonal or umbrella-shaped. When the proximal end of the flexible electrode 3 is far from the distal end of the flexible electrode 3, the flexible electrode 3 collapses into a cylinder coaxial with the guiding inner shaft 1 to facilitate movement within the narrow channel; when the proximal end of the flexible electrode 3 is driven to move towards the direction close to the distal end by the control tube, the flexible electrode 3 can be expanded into a net-shaped body with an elliptical, spindle-shaped, polygonal or umbrella-shaped axial section, so that the attaching area of the flexible electrode with bronchi with different inner diameters and pathological tissues with special shapes is increased. In some possible embodiments, a plurality of flexible electrodes 3 are sequentially arranged along the guiding inner shaft 1 and can be expanded into cylinders, the diameters of the plurality of cylinders sequentially increase along the direction from the distal end to the proximal end of the guiding inner shaft 1, and the flexible electrodes 3 with different diameters can be controlled to be opened according to the diameters of the entering air pipes. When the trachea is particularly tiny, only the flexible electrode 3 with the smallest diameter at the most distal end can be controlled to be unfolded, and the cylindrical structure is more suitable for the trachea with smooth paths.

Specifically, as shown in fig. 2, a limiting structure 30 is disposed in the flexible electrode 3, and the limiting structure 30 is spaced from the distal end of the control tube 4. In some possible embodiments, the limiting structure may be a limiting tube disposed in the flexible electrode 3, where the limiting tube is spaced from the distal end of the control tube 4, and when the distal end of the control tube 4 abuts against the limiting tube, the flexible electrode 3 is stretched to the maximum. In some possible embodiments, when the interference between the limiting structure and the distal end of the control tube 4 is located at the middle position when the flexible electrode 3 is opened to the maximum, the whole flexible electrode 3 is more stable, and the fitting degree with the trachea is better. The maximum radial opening distance of the flexible electrode 3 can be adjusted by adjusting the length of the limiting tube. In some possible embodiments, the direction of deployment of the flexible electrode 3 may be limited by the limiting structure 30 when the flexible electrode 3 is deployed. Under normal circumstances, when limit structure 30 is close to the distal end of flexible electrode 3, flexible electrode 3 can open to umbrella form, and open the opening direction and also can be at the distal end to make in the short trachea, flexible electrode 3 can increase with the tracheal laminating area through this kind of expansion mode, and this kind of umbrella form structure also can conform to narrow and small trachea simultaneously, can not lead to because of radial holding power is too big and open the range too big and damage the tracheal inner wall because of flexible electrode 3.

Specifically, the fixing sleeve 2 is used to fix the end of the flexible electrode 3. As shown in fig. 6, the tooth form of the internal tooth structure 21 of the stationary sleeve 2 may preferably be wave teeth, triangular teeth, flat teeth or trapezoidal teeth. The mesh-shaped flexible electrode 3 can be better fixed by the internal tooth structure 21, the openings at two ends of the tube body of the fixed sleeve 2 are reduced by the arrangement of the internal tooth structure 21, the coaxiality is improved, and the coaxiality problem caused by bending torsion of the distal end of the flexible electrode 3 after the distal end of the flexible electrode is fixed with the guide inner shaft 1 is greatly reduced. In some possible embodiments, an information acquisition element 5 is arranged between the internal tooth structures 21 at both ends of the fixed sleeve 2, and the information acquisition element 5 is used for acquiring the intervention position information of the flexible electrode 3 in the target intervention region. The information acquisition element 5 is arranged inside the fixed sleeve 2, so that the space occupied by the information acquisition element 5 in installation can be greatly reduced. According to the flexible electrode fixing device, the two ends of the flexible electrode 3 are fixed through the fixing sleeve 2, so that the coaxiality and the connection reliability of the two ends of the flexible electrode 3 are improved, the flexible electrode 3 is prevented from falling off in the operation process, the reliability of an interventional device is improved, the treatment time is shortened, and a placement space can be reserved for the information acquisition element 5.

In some embodiments, the information-gathering elements 5 may be disposed anywhere on the guiding inner shaft 1 or the ablation assembly, and the number of information-gathering elements 5 is not limited. The more the number of information acquisition elements 5, the more comprehensive the real-time positioning and presentation of the real-time variation of the interventional ablation device in the trachea, the different dimensions express the position of the product in the trachea.

Preferably, the information acquisition element 5 is provided at the distal end of the guiding inner shaft 1 and/or the ablation assembly. The information acquisition element 5 is used for acquiring the intervention position information of the ablation assembly in the target intervention region and transmitting the intervention position information to the navigation control device through a signal line. In some possible embodiments, the information acquisition element 5 may be a magnetic induction sensor that may acquire interventional position information of the ablation assembly in the target interventional region by means of a magnetic field; in other possible embodiments, the information acquisition element 5 may be an electric induction sensor that may acquire interventional position information of the ablation assembly in the target interventional region by means of an electric field. Preferably, the information acquisition element 5 comprises at least one five-degree-of-freedom magnetic positioning sensor or a six-degree-of-freedom magnetic positioning sensor.

In some embodiments, the outer side of the flexible electrode 3 is provided with an insulating layer for increasing the insulating properties of the flexible electrode 3.

In some embodiments, the steering tube 4 may be an extruded tube of PI (polyimide), PET (polyethylene terephthalate), pebax (block polyether amide resin), PTFE (polytetrafluoroethylene), or the like, or a PI/PTFE composite tube. The outer diameter of the handling tube 4 is preferably 0.5mm-5mm, the wall thickness of the handling tube 4 is preferably 0.025mm-0.5mm, and the length is preferably 40cm-80cm.

Specifically, as shown in fig. 5, the interventional ablation device further comprises a control handle 6, wherein a channel 61 is provided in the control handle 6 for passing the guiding inner shaft 1 and the steering tube assembly. The control handle 6 is a control handle of the interventional ablation device, the guiding inner shaft 1 and the signal wire of the interventional ablation device can be integrated into a whole, and the interventional ablation device passes out of the control handle 6, so that the structure is compact, and the redundancy that the signal wire is exposed is avoided. In some possible embodiments, the proximal end of the channel 61 is provided with a fixation bayonet 62, the fixation bayonet 62 being connected to the proximal end of the guiding inner shaft 1, the fixation bayonet 62 being used for fixation of the guiding inner shaft 1. A sealing ring 63 can be arranged on the inner side of the fixing bayonet 62, and the sealing ring 63 is used for improving the sealing performance and the electric conduction safety of the control handle 6. In some embodiments, the control handle 6 may be 3D printed or injection molded from a material such as plastic, nylon, or silicone.

Specifically, the control handle 6 is provided with a control assembly 7, the control assembly 7 is slidably or rotatably connected with the control handle 6, and the control assembly 7 is used for controlling the movement of at least one control tube 4. In some possible embodiments, one end of the steering assembly 7 is slidably or rotatably connected to the control handle 6, and the other end of the steering assembly 7 is fixedly connected to the proximal end of the steering tube 4. In some possible embodiments, one end of the control assembly 7 is configured as a slider slidingly connected to the outer wall of the control handle 6, and the other end of the control assembly 7 is configured as a plunger portion slidingly connected to the inner wall of the control handle 6, the plunger portion being fixedly connected to the proximal end of the control tube 4, and pushing the control assembly 7 can move the control tube 4. In other possible embodiments, the actuating assembly 7 can be configured as a rotary knob, the inner ring of which is screwed to the actuating tube 4, the actuating tube being axially movable by rotation of the rotary knob. The movement of the steering tube 4 relative to the guiding inner shaft 1 can be controlled by the steering assembly 7 to control the extent of the opening of the ablation assembly.

The application applies the steps of the interventional ablation device: the control handle 6 controls the guiding inner shaft 1 and the control tube assembly to send the ablation assembly in the contracted state into the trachea; when the ablation assembly reaches a target lesion tissue area, the opening degree of the flexible electrode 3 is controlled through the control assembly 7 according to the inner diameter of the trachea, so that the flexible electrode 3 is uniformly attached to the lesion tissue; the ablation energy is sent through an ablation device connected with the guiding inner shaft 1, and the flexible electrode 3 releases the ablation energy to perform ablation treatment on lesion tissues; the time and number of ablative treatments are controlled and manipulated for different types of lesions and different treatment regimens for different target areas, as well as the size and type of ablative energy delivered.

In some embodiments, as shown in fig. 10-12, the present application provides a medical intervention device, which comprises an inner core tube 100, a control outer tube 101, an electrode guide wire 102 and the flexible electrode 3, wherein the electrode guide wire 102 is detachably penetrated in the inner core tube 100, and the control outer tube 101 is sleeved outside the inner core tube 100; the distal end of the flexible electrode 3 is fixedly connected with the distal end of the inner core tube 100, the proximal end of the flexible electrode 3 is fixedly connected with the outer wall of the outer control tube 101, and the outer control tube 101 can move along the inner core tube 100 to drive the flexible electrode 3 to expand or contract.

Specifically, the electrode wire 102 and the flexible electrode 3 are both electrically connected to the ablation device. In some embodiments, the inner core tube 100 may be a tubular structure such as a spring tube, a hypotube, or a hypotube spiral tube, and the electrode wire is disposed in the inner core tube 100, and the flexible electrode 3 is electrically connected to the ablation device through the electrode wire, so as to transmit ablation energy to the flexible electrode 3. The electrode wire can be single-stranded or multi-stranded, the wire diameter of the electrode wire can be 0.05mm-1mm, and the electrode wire is made of conductive metal materials. In some possible embodiments, when the flexible electrode 3 enters the trachea for ablation treatment, after the target lesion tissue is found, the flexible electrode 3 can be controlled to be opened according to the inner diameter size of the trachea by pushing the control outer tube 101, so as to be uniformly attached to the lesion tissue.

In some embodiments, the inner core tube 100 is a through-tube, and the distal end of the electrode wire 102 can be passed through the distal end of the inner core tube 100 to contact the diseased tissue. Preferably, the electrode guide wire can be a conductive metal wire, and the material of the metal wire can be preferably stainless steel, nickel-titanium alloy, cobalt-chromium alloy and other materials with good conductive performance. When performing ablation treatment on a narrower trachea, the electrode wire 102 may be threaded from the handle end and out the distal end of the inner core tube 100 to the target diseased tissue to perform ablation treatment on the diseased tissue.

Specifically, the flexible electrode 3 includes a plurality of electrode wires, and the plurality of electrode wires are cross-woven into a mesh. Preferably, the electrode wire may be a conductive metal wire, and the material of the metal wire may be stainless steel, nickel-titanium alloy, cobalt-chromium alloy, or other materials with good conductive properties. The longitudinal section of the wire may be oval, circular or polygonal, so that the braided flexible electrode 3 may more fully conform to the diseased tissue. The reticular flexible electrode 3 is easy to change shape, can be expanded and contracted, has higher grid compactness, tensile property and structural stability, can be better attached to pathological tissues, has larger and more uniform attaching area and has better treatment effect. The axial section of the flexible electrode 3 after expansion can be elliptic, spindle-shaped, polygonal or umbrella-shaped. When the proximal end of the flexible electrode 3 is far from the distal end of the flexible electrode 3, the flexible electrode 3 is contracted into a cylinder coaxial with the inner core tube 100 to facilitate movement within a narrow channel; when the proximal end of the flexible electrode 3 is driven to move in a direction approaching to the distal end by manipulating the outer tube 101, the flexible electrode 3 can be expanded into a net-shaped body with an elliptical, spindle-shaped, polygonal or umbrella-shaped axial section, so as to increase the fitting area with bronchi with different inner diameters and pathological tissues with special shapes.

In some embodiments, the electrode wires of the flexible electrode 3 are electrically connected with connection ports in the ablation device. For example, in some possible embodiments, the connection ports include one negative port and 7 positive ports. The negative electrode port is used for connecting a negative electrode plate attached to the body surface of the target object, one end of the electrode guide wire 102 is connected with the seventh port, and the other six positive electrode ports are respectively connected with different electrode wires. For example, a first electrode wire is connected to the first port, a second electrode wire is connected to the second port, a third electrode wire is connected to the third port, a fourth electrode wire is connected to the fourth port, a fifth electrode wire is connected to the fifth port, and a sixth electrode wire is connected to the sixth port. Each electrode connection port can be independently controlled through user setting, and the on-off of the circuit is controlled according to the ablation area and range.

In some embodiments, the flexible electrode 3 comprises a plurality of electrode wires that can be expanded into a lantern-like structure that can conform to different inner diameter bronchi and specially shaped diseased tissue.

Specifically, the distal ends of the plurality of electrode wires are fixedly connected to the outer wall of the distal end of the inner core tube 100. In some possible embodiments, the distal ends of the plurality of electrode wires may be fixedly attached to the outer wall of the distal end of the inner core tube 100 by welding, hot melt, or adhesive, or the like.

Specifically, the interventional device further comprises a fixation member 103, the fixation member 103 being adapted to fix the proximal end of the flexible electrode 3. The sleeve body of the fixing member 103 is provided with internal tooth structures at both ends in the circumferential direction, and the internal tooth structures at both ends are inclined from the end face of the sleeve body to the inner side of the end face. The tooth form of the internal tooth structure can be wave teeth, triangular teeth, flat teeth or trapezoidal teeth. The mesh-shaped flexible electrode 3 can be better fixed by the internal tooth structure, and the openings at the two ends of the tube body of the fixing piece 103 are reduced by the arrangement of the internal tooth structure, so that the coaxiality is improved. In some possible embodiments, an information acquisition element is provided between the internal tooth structures at both ends of the fixing member 103, and is used for acquiring the intervention position information of the flexible electrode 3 in the target intervention area, and transmitting the intervention position information to the external navigation control device through a signal line. The information collecting element is arranged inside the fixing piece 103, so that the space occupied by the information collecting element 5 can be greatly reduced. According to the flexible electrode fixing device, the flexible electrode 3 is fixed through the fixing piece 103, so that the connection reliability of the flexible electrode 3 is improved, the flexible electrode 3 is prevented from falling off in the operation process, the reliability of an interventional device is improved, the treatment time is shortened, and a placement space can be reserved for the information acquisition element 5. In some embodiments, the information collecting elements 5 may be disposed at any position of the inner core tube 100 or the flexible electrode 3, and the number of the information collecting elements 5 is not limited. The more the number of information acquisition elements 5, the more comprehensive the real-time positioning and presentation of the real-time variation of the interventional device in the trachea, the different dimensions express the position of the product in the trachea.

In some embodiments, the steering outer tube 101 may be an extruded tube of PI, PET, pebax or PTFE, or a PI/PTFE composite tube. The outer diameter of the manipulation outer tube 101 is preferably 0.5mm-5mm, the wall thickness of the manipulation outer tube 101 is preferably 0.025mm-0.5mm, and the length is preferably 40cm-80cm.

Specifically, the interventional device further comprises an operation handle 104, and a channel for the inner core tube 100 and the operation outer tube 101 to pass through is arranged in the operation handle 104. The inner core tube 100, the electrode guide wire 102 and the signal wire of the interventional device can be integrated, and pass out of the operation handle 104, so that the structure is compact, and the redundancy that the signal wire is exposed outside is avoided. In some embodiments, the proximal end of the channel is provided with a securing bayonet, which is connected to the proximal end of the inner core tube 100, for securing the inner core tube 100. A sealing ring may be disposed on the inner side of the fixing bayonet, where the sealing ring is used to improve the tightness and electrical conductivity security of the operating handle 104. In some embodiments, the operating handle 104 may be 3D printed or injection molded from a material such as plastic, nylon, or silicone.

Specifically, an operation control 105 is disposed on the operation handle 104, the operation control 105 is slidably or rotatably connected to the operation handle 104, and the operation control 105 is used for controlling the outer tube 101 to move. In some possible embodiments, one end of the manipulation member 105 is slidably or rotatably connected to the manipulation handle 104, and the other end of the manipulation member 105 is fixedly connected to the proximal end of the manipulation outer tube 101. In some possible embodiments, one end of the manipulation member 105 is configured as a slider slidingly connected to the outer wall of the manipulation handle 104, and the other end of the manipulation member 105 is configured as a plunger portion slidingly connected to the inner wall of the manipulation handle 104, the plunger portion being fixedly connected to the proximal end of the manipulation outer tube 101. In other possible embodiments, the actuating element 105 can be configured as a rotary knob, the inner ring of which is screwed to the actuating handle 104, by means of which the actuating outer tube 101 can be moved axially. The movement of the outer tube 101 relative to the inner tube 100 can be controlled by the control 105 to control the extent of deployment of the expandable electrode 3.

The application applies the steps of the above interventional device: the inner core tube 100 is controlled by the operation handle 104, and the outer tube 101 is controlled to send the flexible electrode 3 in a contracted state into the trachea; when the flexible electrode 3 reaches the target lesion tissue area, the opening degree of the flexible electrode 3 is controlled by the control piece 105 according to the inner diameter of the trachea, so that the flexible electrode 3 is uniformly attached to the lesion tissue; when the pathological tissue is in a narrower trachea, the flexible electrode 3 is contracted to reach the smallest bronchus which can be reached, and then the electrode guide wire 102 is penetrated from the inner core tube 100 at the end of the operation handle 104 and is extended out from the distal end of the inner core tube 100 to be conveyed into the thinner bronchus to reach the pathological tissue; the ablation energy is sent through an ablation device electrically connected with the electrode guide wire 102 and the flexible electrode 3, and the electrode guide wire 102 and/or the flexible electrode 3 release the ablation energy to perform ablation treatment on lesion tissues; the time and number of ablative treatments are controlled and manipulated for different types of lesions and different treatment regimens for different target areas, as well as the size and type of ablative energy delivered.

While the foregoing description illustrates and describes the preferred embodiments of the present invention, as noted above, it is to be understood that the invention is not limited to the forms disclosed herein but is not to be construed as excluding other embodiments, and that various other combinations, modifications and environments are possible and may be made within the scope of the inventive concepts described herein, either by way of the foregoing teachings or by those of skill or knowledge of the relevant art. And that modifications and variations which do not depart from the spirit and scope of the invention are intended to be within the scope of the appended claims.

Claims

1. An interventional ablation device is characterized by comprising a guiding inner shaft (1), a fixing sleeve (2), an ablation assembly and a control tube assembly, wherein the ablation assembly comprises at least one flexible electrode (3), at least one flexible electrode (3) is net-shaped, the control tube assembly (4) comprises at least one control tube (4), and the guiding inner shaft (1) is electrically connected with the flexible electrode (3) and ablation equipment respectively;

at least one flexible electrode (3) is sequentially arranged along the guiding inner shaft (1), and two ends of the flexible electrode (3) are fixedly connected with the guiding inner shaft (1) and/or the control tube (4) through the fixing sleeve (2); at least one control tube (4) is sleeved outside the guide inner shaft (1), and at least one control tube (4) can move along the guide inner shaft (1) to drive the flexible electrode (3) to expand or contract;

internal tooth structures (21) are arranged at two ends of the sleeve body of the fixed sleeve (2) along the circumferential direction, and the internal tooth structures (21) at two ends are obliquely arranged from the end face of the sleeve body to the inner side of the end face.

2. An interventional ablation device according to claim 1, wherein the ablation assembly comprises a flexible electrode (3), the steering tube assembly comprises a steering tube (4), the distal end of the flexible electrode (3) is fixedly connected with the distal end of the guiding inner shaft (1) through the fixing sleeve (2), the proximal end of the flexible electrode (3) is fixedly connected with the outer wall of the steering tube (4) through the fixing sleeve (2), and the distal end of the steering tube (4) is arranged at a distance from the distal end of the guiding inner shaft (1).

3. An interventional ablation device according to claim 1, wherein the ablation assembly comprises a first flexible electrode (31) and a second flexible electrode (32), the steering tube assembly comprises a first steering tube (41) and a second steering tube (42), the first steering tube (41) and the second steering tube (42) are sleeved outside the guiding inner shaft (1) in sequence from inside to outside;

the distal end of the first flexible electrode (31) is fixedly connected with the distal end of the guiding inner shaft (1) through the fixing sleeve (2), the proximal end of the first flexible electrode (31) is fixedly connected with the outer wall of the first control tube (41) through the fixing sleeve (2), and the distal end of the first control tube (41) is arranged at intervals with the distal end of the first flexible electrode (31);

the distal end of the second flexible electrode (32) is fixedly connected with the outer wall of the first control tube (41) through the fixing sleeve (2), the outer wall is a certain distance away from the distal end of the first control tube (41), the proximal end of the second flexible electrode (32) is fixedly connected with the outer wall of the second control tube (42) through the fixing sleeve (2), and the distal end of the second control tube (42) is arranged at intervals with the distal end of the second flexible electrode (32).

4. An interventional ablation device according to claim 1, characterized in that at least one of the flexible electrodes (3) is configured as a monopolar electrode or a bipolar electrode.

5. An interventional ablation device according to claim 1, wherein a plurality of the maximum distances at which the flexible electrodes (3) are expandable, which are arranged sequentially along the guiding inner shaft (1), sequentially increase in the distal to proximal direction of the guiding inner shaft (1).

6. An interventional ablation device according to claim 1, characterized in that a limit structure (30) is arranged in the flexible electrode (3), the limit structure (30) being arranged at a distance from the distal end of the steering tube (4).

7. An interventional ablation device according to claim 1, characterized in that the tooth profile of the internal tooth structure (21) is wave, delta, flat or trapezoidal.

8. An interventional ablation device according to claim 7, characterized in that an information acquisition element (5) is arranged between the internal tooth structures (21) at both ends of the fixation sleeve (2), said information acquisition element being adapted to acquire interventional position information of the flexible electrode (3) in a target interventional region.

9. An interventional ablation device according to claim 1, wherein the flexible electrode (3) comprises a plurality of electrode wires, the plurality of electrode wires being cross-woven into the mesh-like flexible electrode (3).

10. An interventional ablation device according to claim 1, characterized in that the axial cross-section of the flexible electrode (3) after expansion is elliptical, spindle-shaped, polygonal or umbrella-shaped.

11. An interventional ablation device according to claim 1, characterized in that the outer side of the flexible electrode (3) is provided with an insulating layer.

12. An interventional ablation device according to claim 1, comprising a control handle (6), a channel (61) being provided in the control handle (6) for the guiding inner shaft (1) and the steering tube assembly to pass through.

13. An interventional ablation device according to claim 12, characterized in that a control handle (6) is provided with a steering assembly (7), said steering assembly (7) being in sliding or rotational connection with said control handle (6), said steering assembly (7) being adapted to control the movement of at least one of said steering tubes (4).

14. A medical intervention device, characterized by comprising an inner core tube (100), a manipulation outer tube (101), an electrode wire (102) and the flexible electrode (3) according to any of claims 1-13, wherein the electrode wire (102) is detachably arranged in the inner core tube (100) in a penetrating way, and the manipulation outer tube (101) is sleeved outside the inner core tube (100);

the distal end of the flexible electrode (3) is fixedly connected with the distal end of the inner core tube (100), the proximal end of the flexible electrode (3) is fixedly connected with the outer wall of the control outer tube (101), and the control outer tube (101) can move along the inner core tube (100) to drive the flexible electrode (3) to expand or contract.

15. The medical intervention device of claim 14, wherein the inner core tube (100) is a through tube, and the distal end of the electrode wire (102) is adapted to contact the diseased tissue through the distal end of the inner core tube (100).

16. A medical intervention device according to claim 15, wherein the electrode wire (102) and the flexible electrode (3) are both electrically connected to an ablation device.

17. A medical intervention device according to any of the claims 14, wherein the flexible electrode (3) comprises a plurality of electrode wires, a plurality of the electrode wires being cross-woven into a mesh.

18. The medical intervention device of claim 17, wherein distal ends of a plurality of the electrode wires are fixedly connected to an outer wall of the distal end of the inner core tube (100).