Ablation catheter for human body
By designing an ablation catheter with an expandable ablation electrode and a control handle, the problems of complex operation of pulse electric field ablation technology and high control of consumables are solved, and the rapid and safe ablation operation is achieved, and suitable for use with robot devices, reducing personnel Cost and surgical risks.
Patent Information
- Application Number
- CN202411220710.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-09-02
- Publication Date
- 2024-12-10
AI Technical Summary
The existing pulse electric field ablation technology requires a single-handed mirror during surgical operations. It is complex in operation and has high consumable handling, resulting in increased surgical duration and the possibility of operation errors. It cannot be quickly and efficiently used with robot devices, increasing personnel costs and Patient risk.
Ablation catheter for the human body is designed, including an expandable ablation electrode and a control handle, which can achieve rapid expansion and contraction of the ablation electrode through the transmission assembly and limiting structure, and combines a locking mechanism and reset mechanism to facilitate one-hand operation and Improve operational safety.
By quickly moving the ablation electrode, the operation time and complexity are reduced, the risk of operation errors is reduced, and the operation safety and efficiency is improved. It is suitable for use with robot devices and reduces personnel costs.
Smart Images

Figure CN119097409A_ABST
Abstract
Description
Technical Field
[0001] The present invention belongs to the technical field of medical device ablation, and in particular relates to an ablation catheter for human body. Background Art
[0002] The prior art has adopted a variety of energy delivery methods in the treatment of human diseases, including radiofrequency, microwave, high-intensity focused ultrasound (HIFU) and pulsed electric fields (PEF).
[0003] Drug treatment mainly includes inhalation of salbutamol sulfate aerosol and salmeterol fluticasone powder inhalation to dilate the trachea, thereby relieving the symptoms of airway diseases; however, drug treatment can only increase airway oxygen uptake and have a relieving effect, but cannot cure the disease.
[0004] The main surgical treatment methods include bullectomy, lung volume reduction surgery and other surgical operations. The disadvantage is that surgical operations cause great damage to patients and may lead to the failure of some lung functions. The main surgical treatment methods are interventional ablation treatments, such as radiofrequency ablation and pulsed electric field ablation. Radiofrequency ablation uses radiofrequency energy to generate thermal energy at the distal end of the catheter, and ablates the tissue by contacting the lesion. However, this ablation based on heat conduction has certain limitations. Heat contact will destroy most of the tissues and cells in the treatment area and will damage healthy cells. In addition, the airway is close to the heart, and excessive heat energy ablation may cause damage to nearby cardiovascular and nerves. The principle of pulsed electric field ablation is to use extremely short high-voltage pulses to act on the phospholipid bilayer of the cell membrane, forming irreversible electroporation on the cell membrane, thereby causing cell apoptosis and achieving the purpose of ablation.
[0005] Pulsed electric field is a non-thermal energy ablation, which causes less damage to healthy tissues. In addition, pulsed electric field ablation is also selective for cells and tissues. Pulsed electric field ablation has a threshold, and can selectively ablate diseased tissues during the ablation process. It is a safe and effective airway ablation treatment method.
[0006] Existing pulse ablation usually requires a single-handed hand mirror, which places higher requirements on the one-handed controllability of consumables. Existing methods mostly include turning the wheel with one hand, pushing the slider with one hand, pushing or pulling back with both hands, etc. At present, manual control of electrode opening and recovery is often used, which cannot be used quickly and efficiently with other new devices (such as robots, etc.). When using a robot to operate the dashboard, it is still necessary to operate the consumables to open and recover. For some surgeries, such as bronchial rheoplasty, the release and recovery actions of consumables are repeated up to 170 times for each operation. The dashboard and consumables increase the duration and complexity of the operation and are prone to operational errors. The use of two people operating at the same time increases personnel costs and may result in damage to the patient due to failure to recover during movement. Summary of the invention
[0007] The present invention provides an ablation catheter for human body, which solves the technical problems existing in the above technical background and facilitates the operation of ablation surgery by surgical personnel.
[0008] In order to achieve the above technical purpose, the present invention adopts the following technical solution:
[0009] An ablation catheter for a human body, comprising:
[0010] The delivery sheath tube has guiding properties and is provided with a first through passage;
[0011] A traction wire is movably arranged in the first channel of the delivery sheath tube, and the traction wire can move axially relative to the delivery sheath tube;
[0012] At least one ablation electrode is an expandable structure that can be configured with ablation energy, the ablation electrode is disposed at the distal end of the delivery sheath, the ablation electrode has a first end and a second end, the first end of the ablation electrode is connected to one end of the traction wire, and the second end of the ablation electrode is connected to the distal end of the delivery sheath;
[0013] The control handle comprises a housing, a transmission assembly and a handle, wherein the housing is provided with a handle, the handle is rotatably arranged on the housing, the transmission assembly is arranged in the housing, the end of the traction wire close to the control handle is connected to the handle through the transmission assembly, and the proximal end of the delivery sheath is connected to the housing;
[0014] The transmission assembly includes a first fixed rack, a first movable gear and the first movable rack. The first fixed rack is fixedly arranged on the shell. The first movable gear is movably arranged relative to the shell and is movably connected to one end of the handle. The first movable rack is movably arranged relative to the shell. The first movable rack can make reciprocating linear movements relative to the shell. The first movable gear is respectively meshed with the first fixed rack and the first movable rack.
[0015] In some embodiments, a first limiting structure is provided between the first movable rack and the shell, and the first limiting structure includes a first limiting groove provided on the shell and a first limiting boss provided on the first movable rack, or a first limiting boss provided on the shell and a first limiting groove provided on the first movable rack, and the first limiting boss is movably engaged in the first limiting groove so that the first movable rack can make reciprocating linear movements in the shell.
[0016] In some embodiments, a second limiting structure is also provided on the shell, and the second limiting structure includes a second limiting groove arranged on the shell and a second limiting shaft arranged on the first moving gear, and the second limiting shaft is movably engaged in the second limiting groove, and the second limiting shaft can make reciprocating linear movements in the second limiting groove.
[0017] In some embodiments, the handle is rotatably arranged relative to the shell through a hole-axis structure, a first rotation point is arranged between the handle and the shell, a first connecting bracket is arranged on the side of the handle close to the first rotation point, a third limiting groove adapted to the second limiting rotating shaft is arranged on the first connecting bracket, and one end of the second limiting rotating shaft passes through the third limiting groove and is rotatably connected to the shell.
[0018] In some embodiments, there are two second limiting grooves symmetrically arranged in the housing, and two ends of the second limiting rotating shaft are respectively and movably inserted in the second limiting grooves.
[0019] In some embodiments, the first connecting bracket abuts against the first movable rack, so that the first movable rack can move back and forth linearly along the first limiting groove.
[0020] In some embodiments, when the first movable rack moves along the first limiting groove, the contact surface between the first connecting bracket and the first movable rack is a planar structure.
[0021] In some embodiments, a first clearance space is provided on a side of the handle close to the first limiting groove, so that the first movable rack can perform reciprocating linear movement along the first limiting groove.
[0022] In some embodiments, a first fixing groove is provided on the first movable rack, and an axial direction of the first fixing groove is consistent with a moving path of the first movable rack.
[0023] In some embodiments, the control handle is further provided with a reset mechanism, and the reset mechanism is used for resetting the handle.
[0024] In some embodiments, a locking mechanism is further included, wherein the locking mechanism is used to fix the position of the handle so that the ablation electrode maintains a current expansion state at the lesion site and performs ablation.
[0025] In some embodiments, the locking mechanism includes a locking spring with elastic deformation and a locking slider, a locking slide groove adapted to the locking slider is provided on the housing, the locking slider is slidably arranged in the locking slide groove, the locking spring is connected to the locking slider, and one end of the locking spring passes through the housing and can abut against the first movable rack;
[0026] When the locking spring piece is in contact with the first movable rack, the first movable rack can only move toward one side of the handle; when the locking spring piece is separated from the first movable rack, the first movable rack moves back and forth in a straight line.
[0027] In some embodiments, a first angle is provided between the locking spring piece and the moving trajectory of the first moving rack. When the locking spring piece abuts against the first moving rack, the first moving rack can only move toward one side of the handle. When the handle drives the first moving rack to move and expand the ablation electrode, one end of the locking spring piece can move from one tooth surface of the first moving rack to the other tooth surface and abut against it.
[0028] In some embodiments, when the number of ablation electrodes is greater than or equal to 2, a first connector is provided between two adjacent ablation electrodes, the first connector is movably mounted on the traction wire, and one end of the two adjacent ablation electrodes is respectively fixed to two ends of the first connector.
[0029] In some embodiments, the first connector and the two ablation electrodes connected to the first connector at both ends are integrally constructed, the first connector is made of conductive material, a first wire for energy transmission is arranged in the first channel, and one end of the first wire is connected to one of the ablation electrodes or the first connector, so that the multiple ablation electrodes are a monopolar ablation structure.
[0030] In some embodiments, the first connecting member is made of insulating material, and any two of the multiple ablation electrodes can be connected to the positive wire and the negative wire respectively to form a bipolar ablation structure, or at least one of the multiple ablation electrodes can be powered on and connected to the positive wire alone to form a monopolar ablation structure.
[0031] In some embodiments, a scale mark is provided on a side of the delivery sheath tube close to the ablation electrode, and the scale mark is evenly distributed from the distal end to the proximal end of the delivery sheath tube.
[0032] In some embodiments, a guide tip is provided at one end of the traction wire close to the ablation electrode, one end of the ablation electrode is fixed to the guide tip, wherein a smooth guide structure is provided at one end of the guide tip away from the ablation electrode.
[0033] In some embodiments, the ablation electrode is a basket weave structure.
[0034] In some embodiments, when the initial outer diameter range of the ablation electrode is 0.1-2 mm, the outer diameter of the ablation electrode can be expanded to or 2.1-60 mm; when the initial outer diameter of the ablation electrode is 0.1-3.2 mm, the outer diameter of the ablation electrode can be expanded to 3.3-60 mm; when the initial outer diameter of the ablation electrode is 0.1-4.2 mm, the outer diameter of the ablation electrode can be expanded to 4.3-60 mm.
[0035] Compared with the prior art, the present invention has the following beneficial effects:
[0036] By setting the control handle into a handle structure, it is convenient for the surgeon to operate flexibly with one hand, a first movable gear is set at one end of the handle, and a first fixed rack and a first movable rack are set inside the handle, wherein the first movable gear is movably set at one end of the handle, and the first movable gear and the first fixed rack and the first movable rack are all meshed, and the first movable rack is fixedly connected to the traction wire. When the handle drives the first movable gear to move along the first fixed rack, the first movable rack moves with a stroke twice that of the first movable gear, thereby realizing the rapid movement of the traction wire, so that the ablation electrode can expand or contract rapidly, avoiding damage to the human body caused by untimely contraction.
[0037] Additional aspects and advantages of the present application will be partially given in the following description, which will become apparent from the following description, or will be understood through the practice of the present application. BRIEF DESCRIPTION OF THE DRAWINGS
[0038] Figure 1 A stereoscopic diagram of an ablation catheter for use in a human body according to the present invention;
[0039] Figure 2 It is an enlarged structural diagram of an ablation electrode of an ablation catheter for human body of the present invention;
[0040] Figure 3 It is a stereoscopic diagram of the internal transmission structure of a control handle of an ablation catheter for human body of the present invention;
[0041] Figure 4 for Figure 3 The main view in ;
[0042] Figure 5 for Figure 4 Sectional view at AA in the middle;
[0043] Figure 6 A three-dimensional diagram of a first movable rack of an ablation catheter for human body according to the present invention;
[0044] Figure 7 A three-dimensional diagram of a handle of an ablation catheter for human body according to the present invention;
[0045] Figure 8 It is a schematic structural diagram of a plurality of ablation electrodes of an ablation catheter for human body according to the present invention;
[0046] Fig. 9 It is a schematic diagram of a locking mechanism of an ablation catheter for a human body according to the present invention;
[0047] Fig.10 for Fig. 9 The enlarged view of point B in the middle;
[0048] Fig.11 The present invention is a first embodiment of a resetting mechanism for an ablation catheter for a human body;
[0049] Fig.12 The present invention is a second embodiment of a resetting mechanism for an ablation catheter for a human body;
[0050] Fig.13 It is a structural schematic diagram of an ablation catheter for human body applied to an endoscope of the present invention;
[0051] Fig.14 A schematic diagram of scale markings of an ablation catheter for human body according to the present invention;
[0052] Fig.15 This is the third embodiment of the resetting mechanism of an ablation catheter for human body according to the present invention. DETAILED DESCRIPTION
[0053] The present application is further described in detail below in conjunction with specific drawings. In the description of this embodiment, unless otherwise specified, the terms "left", "right", etc. indicate directions or positional relationships based on the directions or positional relationships shown in the drawings, which are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the present application must have a specific direction, be constructed and operated in a specific direction, and therefore cannot be understood as limiting the present application.
[0054] In one embodiment, Figure 1-2 As shown, an ablation catheter for human body provided by the present invention mainly comprises a delivery sheath 200, a traction wire 300, an ablation electrode 201 and a control handle 100;
[0055] The delivery sheath 200 is provided with a first channel and has certain guiding properties and flexibility to adapt to various bends of the human body. Specifically, in the present embodiment, the delivery sheath 200 is composed of a multi-layer composite material, the outer layer is composed of a polymer material with good biocompatibility, and has multiple hardness levels. The proximal end near the control handle has good pushing properties and high hardness, and may be PA6, PA12, segmented polyamide or other polymer materials, and the distal end near the ablation electrode 201 has flexibility and low hardness, and may be segmented polyamide, polyamide or other polymer materials.
[0056] The middle layer is composed of a metal wire reinforcement layer, which can be a braided layer, a coil layer or a combination thereof. Furthermore, the braided layer has different braiding densities, and a low-density braiding is used near the proximal end of the control handle to enhance the push, and a high-density braiding is used near the distal end of the ablation electrode to enhance the flexibility. The material of the middle layer can be sus304, sus316, Ni-Ti, etc.
[0057] Furthermore, the inner layer is composed of a polymer material with good lubricity and low friction resistance to reduce the resistance of the traction wire when it moves in the first channel of the delivery sheath. Optionally, the inner layer material can be HDPE, PTFE, FEP or other polymer materials with low friction coefficient.
[0058] Furthermore, an insulating layer is provided on the delivery sheath 200. By providing the insulating layer, when the ablation energy is transmitted from the power connector to the ablation electrode, current leakage and ablation energy loss can be prevented in the delivery sheath 200. The ablation energy is only released at the ablation electrode 201, avoiding ablation energy loss and achieving the purpose of precise ablation.
[0059] The traction wire 300 is movably arranged in the first channel of the delivery sheath tube 200 and can perform axial reciprocating movement in the first channel;
[0060] The ablation electrode 201 is arranged at the distal end of the delivery sheath 200. The ablation electrode 201 is an expandable structure, which is adaptively matched and fitted with the human body. In this embodiment, the human body includes but is not limited to the airway, intestines or blood vessels, etc. The ablation electrode 201 can be configured with ablation energy. In this embodiment, the distal end of the delivery sheath 200 is the end away from the control handle 100. The ablation electrode 201 is provided with a first end and a second end. The first end of the ablation electrode 201 is connected to one end of the traction wire 300, and the second end of the ablation electrode 201 is connected to the distal end of the delivery sheath 200. The traction wire 300 drives the first end of the ablation electrode 201 close to the second end, thereby realizing the expansion of the ablation electrode 201, so that the ablation electrode 201 is close to the inner wall of the human body;
[0061] The control handle 100 includes a housing, a transmission assembly and a handle 102. A grip 101 is provided on the housing for the surgeon to hold and operate. The handle 102 is rotatably provided on the housing. When the surgeon holds the grip 101 with one hand, the surgeon can control the grip 102 to rotate toward the side of the grip 101 by fingers.
[0062] The transmission assembly is disposed inside the housing, and one end of the handle 102 is connected to the traction wire 300 through the transmission assembly. Specifically, Figure 3-5 As shown, the transmission assembly includes a first fixed rack 105, a first movable rack 108 and a first movable gear 107. The first fixed rack 105 is fixedly arranged on the shell, and the first movable rack 108 is movably arranged relative to the shell and can make reciprocating linear movements. The first movable rack 108 and the first fixed rack 105 are relatively parallel to each other, and the first movable gear 106 is movably arranged at one end of the handle 102 and can rotate relative to the shell. At the same time, the first movable gear 107 is respectively meshed with the first fixed rack 105 and the first movable rack 108. By setting the first movable gear, the first fixed rack and the first movable rack, when the handle is rotated relative to the shell, it can drive the first movable gear 107 to move linearly along the first fixed rack 105. At the same time, the first movable gear 107 is engaged with the first movable rack 108, and can drive the first movable rack 108 to move with twice the stroke of the first movable gear 107, so that the handle 102 can quickly pull the wire 300 to move quickly when the rotation angle is small, so as to realize the first end and the second end of the ablation electrode 201 to move closer or farther away, thereby realizing the rapid expansion or contraction of the ablation electrode 201.
[0063] In one embodiment, Figure 3 and Figure 6 A first limiting structure is provided between the first movable rack 108 and the housing, and the first limiting structure is used for the first movable rack 108 to perform reciprocating linear movement relative to the housing. Specifically, the first limiting structure includes a first limiting groove 102 provided on the housing and a first limiting boss 1081 provided on the first movable rack 1081 and adapted to the first limiting groove 102. In this embodiment, the first limiting groove 102 is composed of two baffles, which are arranged in parallel and spaced apart. The thickness of the first limiting boss 1081 matches the space, and the first limiting boss 1081 is movably engaged in the first limiting groove 102, so that the first movable rack 108 performs reciprocating linear movement along the first limiting groove 102.
[0064] Optionally, the first limiting boss 1081 may be disposed on the housing, and the first limiting groove 102 may be disposed on the first movable rack 108, so that the first movable rack 108 can also reciprocate linearly relative to the housing. Further, the first movable rack 108 abuts against two baffles to prevent the first movable rack 108 from shaking.
[0065] In one embodiment, a second limiting structure is provided between the housing and the first movable gear 107, and the second limiting structure includes a second limiting groove 104 provided on the housing and a second limiting rotating shaft 106 provided on the first movable gear 107, the second limiting groove 104 is provided in parallel with the first limiting groove 102, the second limiting groove 104 is adapted to the outer diameter of the second limiting rotating shaft 106, and the second limiting groove 104 is provided with a certain length to meet the reciprocating linear movement of the first movable gear 107 along the first fixed rack 105, in this embodiment, both ends of the second limiting groove 104 are closed to prevent the second limiting rotating shaft 106 from exiting the second limiting groove 104, and the second limiting rotating shaft 106 and the first movable gear 107 can be connected in rotation or fixedly. In this embodiment, the second limiting grooves 104 are symmetrically provided, and the number is two, which are respectively provided on two relatively detachable housings, and the two ends of the second limiting rotating shaft 106 are respectively movably inserted in the second limiting grooves 104 to ensure that the first movable gear 107 can move back and forth linearly.
[0066] In one embodiment, Figure 3 and Figure 7 As shown, the handle 102 is rotatably arranged relative to the shell through a hole-axis structure, and a first rotation point 109 is provided between the handle and the shell. In this embodiment, a rotating shaft is provided on the handle 102, and a matching hole is provided on the shell. At the same time, the cooperation between the rotating shaft and the hole further limits the shaking of the handle 102, so that the handle 102 can only rotate relative to the shell, and its rotation trajectory is on a plane. A first connection bracket 1021 is provided on a side close to the first rotation point 109, wherein a certain angle is provided between the first connection bracket 1021 and the handle 102, so that the first connection bracket 1021 is provided toward the first fixed rack 105, and a third limiting groove 1022 is provided on the first connection bracket 1021, and the third limiting groove 1022 is provided along the length direction of the first connection bracket 1021, and the third limiting groove 1022 is adapted to the second limiting rotating shaft 106, and one end of the second limiting rotating shaft 106 passes through the third limiting groove 1022 and is movably inserted into the second limiting groove 104, wherein the third limiting groove 1022 is provided with a certain length to meet the yield compensation of the handle 102 driving the first moving gear 107 to perform reciprocating linear movement and avoid motion interference. In this embodiment, the length of the third limiting groove 1022 should meet the requirement that the ablation electrode 201 can be fully expanded.
[0067] Furthermore, in order to make the surgeon use less gripping force during the operation, the lever arm of the handle 102 is larger than the lever arm between the rotation center of the first movable gear 107 and the first rotation point 109 based on the first rotation point 109, thereby achieving a labor-saving effect.
[0068] In one embodiment, in order to ensure the compactness of the structure and ensure that the first movable gear 107 only moves in a straight line, the first connecting bracket 1021 abuts against the side of the first movable rack 107, and then the other side of the first movable gear 107 abuts against the side of the second limiting groove 104, thereby ensuring that the first movable gear 107 moves in a straight line between the first connecting bracket 1021 and the second limiting groove 104. Optionally, the second limiting rotating shaft 106 can also be abutted against the inner wall of the second limiting groove 104 for limiting, which can also achieve the above effect.
[0069] Furthermore, if Figure 5 and Figure 7 As shown, in order to ensure that the first movable gear 107 can move smoothly, the contact surface between the first connecting bracket 1021 and the first movable rack 107 is a planar structure. In this embodiment, both are planar structures, which have a large contact area and a relatively stable support structure. Optionally, the first connecting bracket 1021 can also be set to an arc surface structure so as to be tangent to the first movable gear 107, which can also achieve the above effect.
[0070] In one embodiment, in order to make the first movable gear 107 move to meet the full expansion of the ablation electrode 201 and avoid motion interference, a first clearance space is provided on the side of the handle 102 close to the first limiting groove 102, so that the first movable rack 107 can move back and forth along the first limiting groove 102. In this embodiment, a plane clearance structure is provided on the handle 102, that is, Figure 7 As shown, it is coplanar with the side surface of the first connecting bracket 1021, thereby forming a clearance space.
[0071] In one embodiment, a first fixing groove 1082 is provided on the first movable rack 108 , and the first fixing groove is used for connecting and installing one end of the traction wire. The axial direction of the first axial groove 1082 is consistent with the moving direction of the first movable rack 108 .
[0072] In one embodiment, Fig.11 and 12 As shown, the control handle 100 is also provided with a reset mechanism, which is used to reset the handle 102. Specifically, in this embodiment, the reset mechanism is a reset spring 1023, one end of the reset spring 1023 is connected to the housing, and the other end of the reset spring 1023 is connected to the handle 102. Specifically, as Fig.11 As shown, one end of the return spring 1023 is connected to the handle 102 at the first connecting bracket 1021, and the other end of the return spring 1023 is connected to the shell. When the handle 102 rotates, the return spring 1023 is stretched. When the handle 102 is released, the return spring 1023 returns to its initial state, thereby resetting the handle 102.
[0073] Optionally, the return spring 1023 may also be arranged outside the housing, such as Fig.12 As shown, one end of the return spring 102 is connected to the handle 102, and the other end is connected to the grip 101. When the handle 102 rotates, the return spring 1023 is compressed. When the handle 102 is released, the return spring 1023 drives the handle 102 to return to its initial state.
[0074] Alternatively, if Fig.15 As shown, the reset mechanism can also be a compression spring 1024. In this embodiment, the compression spring 1024 is mounted on the shaft at the rotation point of the handle 102 and fixed. One end of the compression spring 1024 extends out to abut against the inner wall of the handle 102, and the other end of the compression spring 1024 extends out to abut against the inner wall of the grip 101. When the handle 102 approaches the grip 101, the compression spring 1024 undergoes elastic deformation and is compressed. When the handle 102 is released, the compression spring 1024 returns to its initial state, and the handle 102 is reset accordingly.
[0075] In one embodiment, in order to facilitate the operation of the surgeon, the ablation electrode 201 is expanded to a state and maintained, such as Fig. 9 and Fig.10 As shown, a locking mechanism 400 is also provided in the shell, and the locking mechanism 400 is used to fix the position of the handle 102, so as to maintain the expanded state of the ablation electrode 201, so that the surgeon does not need to hold the handle 102 during a long ablation time, and at the same time, it can also prevent the surgeon from causing inconsistent support state of the ablation electrode 201 due to inconsistent force, thereby affecting the ablation quality.
[0076] Furthermore, in this embodiment, the locking mechanism 400 includes a locking spring 402 with elastic deformation and a locking slider 401, a locking groove adapted to the locking slider 401 is provided on the shell, the locking slider 401 is slidably set in the locking groove, the locking spring 402 is connected to the locking slider 401, and one end passes through the shell to abut against the first moving rack 108.
[0077] Specifically, when locking is required, the surgeon moves the locking slider 401 to drive one end of the locking spring 402 to move into the tooth groove of the first movable gear 108 and abut against one of the tooth surfaces. A certain angle is set between the locking spring 402 and the moving trajectory of the first movable rack 108, such as Fig. 9As shown, the first movable rack 108 can only move toward one side of the handle 102, thereby effectively abutting the first movable rack 108. In this embodiment, the abutment effect is best when the axis of the locking spring piece 402 is perpendicular to the abutted tooth surface. When the first movable rack 108 moves to drive the ablation electrode 201 to expand, the locking spring piece 402 undergoes elastic deformation under the action of the first movable rack 108, so that one end of the locking spring piece 402 withdraws from the previous tooth groove. When the locking spring piece 402 moves to the next tooth groove, the locking spring piece 402 returns to its original state and abuts against the tooth surface of the next adjacent tooth, so that the first movable rack can only move in one direction, avoiding the first movable rack 108 from retreating when the surgeon does not apply grip force to the handle 102. When the operation is finished, the surgeon pushes the locking slider 401 to the initial position, and one end of the locking spring 402 is disengaged from the tooth groove of the first movable rack 108 . Under the action of the return spring 1023 , the ablation electrode 201 quickly shrinks to the initial state.
[0078] Furthermore, the end of the locking spring 402 that contacts the first moving rack 108 is a planar structure, and the planar structure is provided with a certain inclination angle, which is consistent with the inclination angle of the tooth surface abutted by the locking spring 402. On the one hand, it provides stable support by increasing the contact surface, and on the other hand, it can also facilitate the locking spring 402 to withdraw from the tooth groove of the first moving rack 108, thereby reducing the withdrawal resistance.
[0079] In one embodiment, Figure 8 As shown, in order to make the ablation range larger, a plurality of expandable ablation electrodes 201 are arranged at the distal end of the delivery sheath 200, when the number of ablation electrodes 201 is greater than 2. A first connecting member 102 is arranged between two adjacent ablation electrodes 201, and the first connecting member 102 is movably sleeved on the traction wire 300, and the two ends of the two adjacent ablation electrodes 201 are respectively connected to the two ends of the first connecting member 102. In this embodiment, the first connecting member 102 is set to a certain length, so that a certain distance is set between the two adjacent ablation electrodes 201.
[0080] Furthermore, the first connector 102 and the two ablation electrodes 201 connected to the two ends of the first connector 102 are integrally constructed, the first connector 102 is made of conductive material, a first wire for energy transmission is arranged in the first channel, one end of the first wire is connected to one of the ablation electrodes or the first connector, the other end of the first wire passes through the first channel and is connected to the control handle and the external energy generator, when the first wire 204 is connected to one of the ablation electrodes 201, multiple ablation electrodes 201 can be energized to form a monopolar ablation structure, increasing the ablation range to accommodate ablation of larger lesions. The monopolar ablation structure is that the positive pole of the energy generator is connected to the ablation electrode, the negative pole of the energy generator is connected to the negative plate, and the negative plate is fitted and fixed on the surface of human skin, thereby forming a monopolar ablation.
[0081] Furthermore, the first connector 102 can be made of insulating material. To expand the ablation range, any two of the multiple ablation electrodes 201 can be connected to the positive wire and the negative wire, so that a dual-electrode ablation structure is formed between the two ablation electrodes 201 connected to the positive wire and the negative wire. Since the current of the bipolar structure passes through the medium stably, the current density is stable, so that the output energy efficiency of the bipolar state is more stable. The bipolar structure is that one ablation electrode 201 is connected to the positive pole of the energy generator, and the other ablation electrode 201 is connected to the negative pole of the energy generator, both of which are located inside the human body. When the number of ablation electrodes 201 is greater than 2, the electrical connection of the ablation electrodes 201 is changed, and the distance between the energized ablation electrodes 201 is changed, thereby increasing the ablation range of the two ablation electrodes 201.
[0082] When multiple ablation electrodes 201 are connected to the positive lead wires, ablation of a single ablation electrode 201 can be achieved, and the ablation range can be reduced to adapt to ablation of smaller ablation lesions.
[0083] Furthermore, when there are multiple ablation electrodes 201, the ablation electrodes 201 are of different sizes. The ablation electrode 201 far from the distal end of the delivery sheath 200 has a small expansion range, while the ablation electrode 202 near the distal end of the delivery sheath 200 has a large expansion range, which has been adapted to the needs of different lesions.
[0084] In one embodiment, Figure 13-14 As shown, in order to facilitate the surgeon to confirm the position of the ablation catheter, the patient's lesion site is found with the assistance of the endoscope 500, the energy generator is connected to the ablation electrode 201, and after reaching the lesion site, the control handle 100 controls the ablation electrode 201 of the basket structure to open and fit the inner wall of the human body for ablation. Since the ablation catheter needs to be used under the working channel of the endoscope 500, a scale mark 205 is set at the distal end of the delivery sheath 200, and the scale mark 205 is evenly distributed from the distal end to the proximal end of the delivery sheath 200. When the ablation catheter extends out of the working forceps channel, the scale mark 205 will be exposed under the lens of the endoscope 500, and the surgeon can observe the scale mark 205 through the lens to determine the position of the ablation electrode 201, so that the ablation electrode 201 can accurately reach the lesion site and increase the success rate of the operation.
[0085] In one embodiment, a guide tip 301 is provided at one end of the traction wire 300 close to the ablation electrode 201, and one end of the ablation electrode 201 is fixed to the guide tip 301, wherein a smooth guide structure is provided at one end of the guide tip 301 away from the ablation electrode 201, and the smooth guide structure is a spherical surface or an arc surface. Specifically, the guide tip 301 and the ablation electrode 201 can be connected by hot melt, glue bonding, laser welding, etc. The guide tip 301 has a soft feature, which can effectively reduce damage to the human body during the process of introduction into the airway or other human body. Furthermore, the guide tip 301 is a polymer material, which can be composed of block polyetheramide resin, polyurethane rubber, silicone, etc. By providing a smooth guide structure, the damage to its inner wall can be effectively reduced during the process of introduction into the human body.
[0086] In one embodiment, the ablation electrode 201 is a basket weaving structure. Specifically, the ablation electrode 201 is prepared by weaving metal wires, and the ablation electrode 201 in this manner can be opened and closed in size, and has the characteristics of low resistance and low external tension, and can fully fit the lesion site while causing little damage to the airway, and can achieve good treatment effects after releasing the pulsed electric field.
[0087] Furthermore, the braided wire of the ablation electrode 201 is made of a metal material with low resistance, good elasticity and not prone to plastic deformation, which may be SUS304, SUS316L, cobalt-chromium alloy, nickel-titanium alloy, etc.;
[0088] Furthermore, the ablation electrode 201 with a basket weaving structure can be in a teardrop shape, a spindle shape, a blade shape, etc. after expansion. This type of shape has a large outer diameter in the middle area and a small outer diameter in the two end areas. The two end areas have strong supporting force and the middle area has weak supporting force. The strong supporting force on both sides can ensure that the ablation electrode is straight, and the weak supporting force in the middle area has good compliance and can ensure a good wall-adhering effect.
[0089] Furthermore, the basket weaving structure of the ablation electrode 201 can be woven in a manner of 1-on-1, 1-on-2, 2-on-2 or other weaving manners. This weaving manner can make the ablation electrode 201 uniform and circularly open and close, and can fully cover the diseased airway to obtain a good treatment effect.
[0090] Furthermore, the weaving density PPI of the ablation electrode 201 with a basket weaving structure can be 5 to 60. This weaving density can provide good radial support when opened, can fit tightly with the airway, and obtain good treatment effects. At the same time, this weaving density has a smaller outer diameter when closed, and can pass through the working channel of the endoscope to easily reach the lesion site.
[0091] Furthermore, the ablation electrode 201 is polished to have a smaller high-frequency resistance, thereby improving the transmission capability of the pulse electric field and promoting the electroporation effect of cells.
[0092] Furthermore, electrode rings 202 are provided at both ends of the ablation electrode 201 with the basket weaving structure. The electrode rings 202 wrap the both ends of the ablation electrode 201 with the basket weaving structure to limit the longitudinal length of the ablation electrode 201 .
[0093] Furthermore, when the initial outer diameter range of the ablation electrode 201 is 0.1-2 mm, under the traction of the traction wire 300, the outer diameter of the ablation electrode 201 can be expanded to or 2.1-60 mm. For example, the outer diameter of the ablation electrode 201 in the initial state can be 0.4 mm, 0.6 mm, 1.0 mm or 1.5 mm, etc.; in the expanded state, the outer diameter of the ablation electrode 201 can be 3 mm, 5 mm, 20 mm or 50 mm, etc.
[0094] When the initial outer diameter of the ablation electrode 201 is 0.1-3.2 mm, the outer diameter of the ablation electrode 201 can be expanded to 3.3-60 mm. For example, in the initial state, the outer diameter of the ablation electrode 201 can be 0.3 mm, 3.0 mm, 1.2 mm or 1.8 mm, and in the expanded state, the outer diameter of the ablation electrode 201 can be expanded to different diameters such as 3.4 mm, 3.9 mm, 35 mm or 50 mm.
[0095] When the initial outer diameter of the ablation electrode 201 is 0.1-4.2 mm, the outer diameter of the ablation electrode 201 can be expanded to 4.3-60 mm. For example, the outer diameter of the ablation electrode 201 in the initial state can be 0.1 mm, 1.0 mm, 1.8 mm or 4.2 mm, and the outer diameter of the ablation electrode 201 after expansion can be different diameters such as 4.3 mm, 10 mm, 25 mm or 60 mm.
[0096] By setting the outer diameters of the ablation electrodes 201 in the initial state and the outer diameters in the expanded state, the sizes of the working channels of different endoscopes 500 can be matched, so that surgeons can flexibly apply them to suit lesions of various sizes in the human body, thereby increasing the scope of ablation treatment.
[0097] The above is only a preferred embodiment of the present invention. It should be noted that a person skilled in the art can make several improvements and modifications without departing from the principle of the present invention. These improvements and modifications should also be considered as the protection scope of the present invention.
Claims
1. An ablation catheter for use in a human body, It is characterized in that include: A delivery sheath tube, wherein the delivery sheath tube is provided with a first through passage; A traction wire is movably arranged in the first channel of the delivery sheath tube, and the traction wire can move axially relative to the delivery sheath tube; At least one ablation electrode is an expandable structure, the ablation electrode can be configured with ablation energy, the ablation electrode is disposed at the distal end of the delivery sheath, the ablation electrode has a first end and a second end, the first end of the ablation electrode is connected to one end of the traction wire, and the second end of the ablation electrode is connected to the distal end of the delivery sheath; The control handle comprises a shell, a transmission assembly and a handle, wherein the shell is provided with a handle, the handle is rotatably arranged on the shell, the transmission assembly is arranged in the shell, the end of the traction wire close to the control handle is connected to the handle through the transmission assembly, and the proximal end of the delivery sheath is connected to the shell; The transmission assembly includes a first fixed rack, a first movable gear and the first movable rack. The first fixed rack is fixedly arranged on the shell. The first movable gear is movably arranged relative to the shell and is movably connected to one end of the handle. The first movable rack is movably arranged relative to the shell. The first movable rack can make reciprocating linear movements relative to the shell. The first movable gear is respectively meshed with the first fixed rack and the first movable rack.
2. An ablation catheter for human body according to claim 1, It is characterized in that A first limiting structure is provided between the first movable rack and the shell, and the first limiting structure includes a first limiting groove provided on the shell and a first limiting boss provided on the first movable rack, or a first limiting boss provided on the shell and a first limiting groove provided on the first movable rack, and the first limiting boss is movably engaged in the first limiting groove so that the first movable rack can make reciprocating linear movements in the shell.
3. An ablation catheter for human body according to claim 2, It is characterized in that The shell is also provided with a second limiting structure, which includes a second limiting groove arranged on the shell and a second limiting rotating shaft arranged on the first moving gear. The second limiting rotating shaft is movably engaged in the second limiting groove, and the second limiting rotating shaft can make reciprocating linear movements in the second limiting groove.
4. An ablation catheter for human body according to claim 3, It is characterized in that The handle is rotatably arranged relative to the shell through a hole-axis structure, a first rotation point is arranged between the handle and the shell, a first connecting bracket is arranged on the side of the handle close to the first rotation point, a third limiting groove adapted to the second limiting rotating shaft is arranged on the first connecting bracket, and one end of the second limiting rotating shaft passes through the third limiting groove and is rotatably connected to the shell.
5. An ablation catheter for human body according to claim 4, It is characterized in that There are two second limiting grooves which are symmetrically arranged in the housing, and two ends of the second limiting rotating shaft are respectively and movably inserted in the second limiting grooves.
6. An ablation catheter for human body according to claim 5, It is characterized in that The first connecting bracket abuts against the first movable rack, so that the first movable rack can move back and forth linearly along the first limiting groove.
7. An ablation catheter for human body according to claim 6, It is characterized in that When the first movable rack moves along the first limiting groove, the contact surface between the first connecting bracket and the first movable rack is a planar structure.
8. The ablation catheter for human body according to claim 6, It is characterized in that A first clearance space is arranged on one side of the handle close to the first limiting groove, so that the first movable rack can move back and forth linearly along the first limiting groove.
9. The ablation catheter for human body according to claim 1, It is characterized in that The first movable rack is provided with a first fixing groove, and the axial direction of the first fixing groove is consistent with the moving path of the first movable rack.
10. An ablation catheter for human body according to claim 1, It is characterized in that The control handle is also provided with a reset mechanism, and the reset mechanism is used for resetting the handle.
11. An ablation catheter for human body according to claim 1, It is characterized in that It also includes a locking mechanism, which is used to fix the position of the handle so that the ablation electrode maintains a current expansion state at the lesion site and performs ablation.
12. An ablation catheter for human body according to claim 11, It is characterized in that The locking mechanism comprises a locking spring sheet with elastic deformation and a locking slider. A locking slide groove adapted to the locking slider is provided on the housing. The locking slider is slidably arranged in the locking slide groove. The locking spring sheet is connected to the locking slider, and one end of the locking spring sheet passes through the housing and can abut against the first movable rack. When the locking spring piece is in contact with the first movable rack, the first movable rack can only move toward one side of the handle; when the locking spring piece is separated from the first movable rack, the first movable rack moves back and forth in a straight line.
13. An ablation catheter for human body according to claim 12, It is characterized in that A first angle is provided between the locking spring piece and the moving trajectory of the first moving rack. When the locking spring piece abuts against the first moving rack, the first moving rack can only move toward one side of the handle. When the handle drives the first moving rack to move and expand the ablation electrode, one end of the locking spring piece can move from one tooth surface of the first moving rack to the other tooth surface and abut against it.
14. An ablation catheter for human body according to claim 1, It is characterized in that When the number of the ablation electrodes is greater than or equal to 2, a first connector is provided between two adjacent ablation electrodes, the first connector is movably sleeved on the traction wire, and one end of the two adjacent ablation electrodes is fixed to two ends of the first connector respectively.
15. An ablation catheter for human body according to claim 14, It is characterized in that The first connecting member and the two ablation electrodes connected to the first connecting member at both ends are integrally constructed. The first connecting member is made of conductive material. A first wire for energy transmission is arranged in the first channel. One end of the first wire is connected to one of the ablation electrodes or the first connecting member so that the multiple ablation electrodes are a monopolar ablation structure.
16. An ablation catheter for human body according to claim 14, It is characterized in that The first connecting member is made of insulating material, and any two of the multiple ablation electrodes can be connected to the positive wire and the negative wire respectively to form a bipolar ablation structure, or at least one of the multiple ablation electrodes can be powered on and connected to the positive wire to form a monopolar ablation structure.
17. An ablation catheter for human body according to claim 1, It is characterized in that A scale mark is provided on one side of the delivery sheath tube close to the ablation electrode, and the scale mark is evenly distributed from the distal end to the proximal end of the delivery sheath tube.
18. The ablation catheter for human body according to claim 1, It is characterized in that A guide tip is arranged at one end of the traction wire close to the ablation electrode, one end of the ablation electrode is fixed to the guide tip, wherein a smooth guide structure is arranged at one end of the guide tip away from the ablation electrode.
19. The ablation catheter for human body according to claim 1, It is characterized in that The ablation electrode is a basket weaving structure.
20. The ablation catheter for human body according to claim 19, It is characterized in that When the initial outer diameter of the ablation electrode is in the range of 0.1-2mm, the outer diameter of the ablation electrode can be expanded to 2.1-60mm; when the initial outer diameter of the ablation electrode is 0.1-3.2mm, the outer diameter of the ablation electrode can be expanded to 3.3-60mm; when the initial outer diameter of the ablation electrode is 0.1-4.2mm, the outer diameter of the ablation electrode can be expanded to 4.3-60mm.
Citation Information
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