A ring electrode pulse electric field ablation device

By setting up the control department on the duct, controlling the electrode ring rotation and the tract bending, the problem of low -rate efficiency of the existing ring electrode when the rotating electrode ring changes and the extension parts, realized efficient and good quality ablation, and reduced Smaller damage.

CN112914715BActive Publication Date: 2025-01-24SHAOXING MAYO XINCI MEDICAL TECH CO LTD
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Patent Information

Application Number
CN202011466493.X
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2020-12-14
Publication Date
2025-01-24
Estimated Expiration
2040-12-14

AI Technical Summary

Technical Problem

When the existing annular electrode changes the ablation site, the ablation efficiency of the rotating electrode ring is low and cannot be well connected with the original ablation line, which affects the ablation efficiency and quality and increases the damage range.

Method used

By arranging a control part on the catheter, the electrode ring is controlled to rotate along the center of the ring and the curvature of the end of the catheter is adjusted so that the electrode ring reaches a preset position for density mapping or pulsed electric field ablation.

Benefits of technology

The stable and continuous adjustment of the electrode ring is realized to ensure that the electrode ring accurately meets the preset position, improves the amount of ablation efficiency and quality, reduces the scope of damage, and supplements or enhances the ablation without controlling the catheter.

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Abstract

The present invention discloses a ring-shaped electrode pulse electric field ablation device. The present invention arranges a control unit on a catheter, and controls the electrode ring to rotate around its ring center and adjusts the curvature of the catheter end through the control unit, so as to achieve stable and continuous adjustment of the electrode ring, so that the electrode ring can accurately reach a preset position, thereby achieving efficient ablation treatment. That is, the present invention can adjust the posture and angle of the electrode ring by manipulating the control unit, so that the electrode ring is well connected with the original ablation line, improve the ablation efficiency and quality, and reduce the damage range. When the present invention changes the position of the electrode ring for supplementary ablation or enhanced ablation, it is not necessary to manipulate the catheter, but only needs to actively rotate the electrode ring in the existing posture to achieve the purpose of supplementary point ablation or reinforced ablation on the existing ablation line, thereby effectively solving the problem of low ablation efficiency of the existing ring electrode when the ablation site is changed by rotating the electrode ring.
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Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a ring-shaped electrode pulse electric field ablation device. Background Art

[0002] In the prior art, a ring electrode is usually used to establish a pulsed electric field to achieve electrophysiological ablation treatment of cardiovascular target structures, and because the ring electrode can discharge synchronously with a ring electrode array, it can achieve a higher ablation efficiency.

[0003] However, in practice, when the ablation site is changed by rotating the electrode ring, the existing ring electrode cannot be well connected with the original ablation line, which affects the ablation efficiency and quality and also increases the damage range to a certain extent. Summary of the invention

[0004] The invention provides a ring-shaped electrode pulse electric field ablation device to solve the problem of low ablation efficiency of the existing ring-shaped electrode when the electrode ring is rotated to change the ablation position.

[0005] In a first aspect, the present invention provides a ring-shaped electrode pulsed electric field ablation device, comprising: an electrode ring and a control unit;

[0006] The electrode ring is connected to a first end of a catheter, and the control unit is arranged on the catheter at the first end side;

[0007] The control unit controls the electrode ring to rotate along the center of the electrode ring, and adjusts the curvature of the catheter on the first end side through the control unit, so that the electrode ring reaches a preset position for density mapping or pulsed electric field ablation.

[0008] Optionally, the control unit further includes: a rotation control unit and a steering control unit;

[0009] The rotation control unit is used to control the electrode ring to rotate along the center of the electrode ring;

[0010] The steering control unit is used to control the curvature of the catheter on the first end side to reach a preset curvature.

[0011] Optionally, the rotation control unit is a rotation motor, and the rotation motor is controlled to control the electrode ring to rotate along the center of the electrode ring.

[0012] Optionally, the steering control unit is a micro universal shaft, and the curvature of the catheter on the first end side is controlled to reach a preset curvature by controlling the micro universal shaft.

[0013] Optionally, the steering control unit further comprises: a side compression spring, a traction guide wire and a traction motor;

[0014] The side compression spring is arranged between the rotation control unit and the traction motor, and the traction guide wire is also arranged between the rotation control unit and the traction motor;

[0015] The traction motor is controlled to tighten or loosen the traction guidewire, thereby controlling the compression direction and compression force of the side compression spring, and ultimately controlling the curvature of the catheter on the first end side to reach a preset curvature.

[0016] Optionally, the device further comprises: a catheter handle and a traction wire;

[0017] The first end of the traction wire is arranged at the top of the ring portion of the electrode ring, and the traction wire enters the ring portion from the traction wire outlet on the ring portion through the top of the ring portion, and extends along the ring portion, the connecting portion, and through the catheter to the catheter handle. The second end of the traction wire is connected to the catheter handle, and the catheter handle can control the bending diameter of the electrode ring through the traction wire.

[0018] Optionally, a control panel is provided on the catheter handle;

[0019] The traction wire is controlled by the control panel, thereby controlling the bending diameter of the electrode ring.

[0020] Optionally, the traction line outlet is arranged at a position where the top of the ring portion corresponds to the body of the ring portion when the ring portion is fully closed.

[0021] Optionally, the ring portion of the electrode ring is further provided with: an ablation electrode, a ring electrode pair, a positioning sensor and a temperature sensor;

[0022] The ablation electrode is used for performing ablation treatment;

[0023] The annular electrode pair is used to detect the potential information of its current position and send the detected potential information to the control terminal;

[0024] The temperature sensor is arranged on the ablation electrode, and is used to detect the temperature information of the ablation electrode and send the detected temperature information to the control terminal;

[0025] The positioning sensor is used to detect its current location information in real time and send the detected location information to the control terminal;

[0026] The ablation electrodes, the annular electrode pairs and the positioning sensors are of the same number, and the ablation electrodes, the annular electrode pairs and the positioning sensors are alternately arranged in sequence and are evenly distributed on the ring portion.

[0027] Optionally, the control terminal is used to display the received potential information, temperature information and position information in real time, and to control the rotation control unit, the steering control unit and the ablation electrode in real time according to the potential information, the temperature information and the position information.

[0028] The beneficial effects of the present invention are as follows:

[0029] The ring-shaped electrode pulse electric field ablation device provided by the present invention achieves stable and continuous adjustment of the electrode ring by arranging a control unit on the catheter, and controlling the electrode ring to rotate around its ring center and adjusting the curvature of the catheter end through the control unit, so as to enable the electrode ring to accurately reach a preset position, thereby achieving efficient ablation treatment. That is, the present invention can adjust the posture and angle of the electrode ring by manipulating the control unit, so that the electrode ring is well connected with the original ablation line, improve the ablation efficiency and quality, and reduce the damage range. When the present invention changes the position of the electrode ring for supplementary ablation or enhanced ablation, it does not need to manipulate the catheter, but only needs to actively rotate the electrode ring in the existing posture to achieve the purpose of supplementary point ablation or reinforced ablation on the existing ablation line, thereby effectively solving the problem of low ablation efficiency of the existing ring electrode when the electrode ring is rotated to change the ablation site.

[0030] The above description is only an overview of the technical solution of the present invention. In order to more clearly understand the technical means of the present invention, it can be implemented according to the contents of the specification. In order to make the above and other purposes, features and advantages of the present invention more obvious and easy to understand, the specific implementation methods of the present invention are listed below. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Various other advantages and benefits will become apparent to those of ordinary skill in the art by reading the detailed description of the preferred embodiments below. The accompanying drawings are only for the purpose of illustrating the preferred embodiments and are not to be considered as limiting the present invention. Moreover, the same reference symbols are used throughout the accompanying drawings to represent the same components. In the accompanying drawings:

[0032] Figure 1 It is a schematic structural diagram of a ring electrode pulse electric field ablation device provided by an embodiment of the present invention;

[0033] Figure 2 It is a schematic diagram of the setting position of the ring electrode pulse electric field ablation device provided by an embodiment of the present invention;

[0034] Figure 3 It is a schematic diagram of the overall structure of the ring electrode pulse electric field ablation device provided by an embodiment of the present invention;

[0035] Figure 4 is a schematic diagram of a structure in which an electrode ring is completely closed according to an embodiment of the present invention;

[0036] Figure 5 is a schematic diagram of a partially closed structure of an electrode ring provided by an embodiment of the present invention;

[0037] Figure 6 is a schematic structural diagram of an electrode ring fully stretched according to an embodiment of the present invention;

[0038] Figure 7 It is a schematic diagram of the overall structure of a ring-shaped electrode pulse electric field ablation catheter provided by an embodiment of the present invention;

[0039] Figure 8 It is a schematic diagram of the overall structure of another ring-shaped electrode pulse electric field ablation catheter provided by an embodiment of the present invention;

[0040] Fig. 9 It is a schematic diagram of the overall structure of another ring-shaped electrode pulse electric field ablation catheter provided by an embodiment of the present invention;

[0041] Marking description: 1 distal fixing point of the first traction line, 2 outlet of the first traction line, 3 mapping and ablation electrode, 4 catheter, 5 attachment point of the second traction line, 6 first traction line, 7 guide sleeve, 8 slide handle, 9 traction line sliding point, 10 guide handle, 11 handle socket, 12 tail wire plug, 13 tail wire connector, 14 tail wire, 15 electrode ring operation panel connector, 16 slide handle slot, 17 control part, 18 ring part of the electrode ring, 19 connecting part of the electrode ring, 20 electrode ring, 21 guide sheath, 22 second traction line, 23 sheath, A first position marker, B second position marker, C third position marker and D fourth position marker, 171 rotary motor, 172 traction guide wire, 173 traction motor, 174 side compression spring. DETAILED DESCRIPTION

[0042] The embodiment of the present invention aims at the problem that the existing ring electrode has low ablation efficiency when the ablation site is changed by rotating the electrode ring. The electrode ring posture and angle are adjusted by manipulating the control unit so that the electrode ring is well connected with the original ablation line, thereby improving the ablation efficiency and quality and reducing the damage range. When the position of the electrode ring is changed for supplementary ablation or enhanced ablation, the present invention does not need to manipulate the catheter. It only needs to actively rotate the electrode ring in the existing posture to achieve the purpose of supplementary ablation or reinforced ablation on the existing ablation line. The present invention is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and do not limit the present invention.

[0043] In general, the main disadvantages of existing ring electrode catheters are: 1. The diameter of the electrode ring cannot be adjusted, and cannot adapt to pulmonary vein openings of different diameters in the same patient, nor can it adapt to different patients with different pulmonary vein opening diameters; 2. The electrode ring is an open-loop structure and can only rotate clockwise. When rotating in the opposite direction, it is easy to cause tissue hooking or damage; 3. After the electrode ring reaches the pulmonary vein opening, the diameter of the electrode ring cannot be adjusted to adapt to the predetermined ablation line and adjust the contact degree or distance between the ablation electrode and the inner wall of the pulmonary vein; 4. When the electrode ring is at an angle with the pulmonary vein opening, it cannot be actively adjusted to the optimal ablation position; 5. When the electrode ring is rotated to change the ablation site, it cannot be well connected with the original ablation line, which affects the ablation efficiency and quality and increases the range of damage.

[0044] In view of the above problems, an embodiment of the present invention provides a ring electrode pulse electric field ablation device, see Figure 1-Figure 3 , the device of the embodiment of the present invention comprises: an electrode ring 20 and a control unit 17 for controlling the electrode ring 20;

[0045] The electrode ring 20 is connected to the first end of the catheter 4, and the control unit 17 is arranged on the catheter 4 on the side of the first end; the electrode ring 20 is controlled by the control unit 17 to rotate along the center of the electrode ring 20, and the curvature of the catheter 4 on the side of the first end is adjusted by the control unit 17, so that the electrode ring 20 reaches a preset position for density mapping or pulsed electric field ablation.

[0046] It should be noted that the first end of the catheter 4 described in the embodiment of the present invention is the end of the catheter 4 connected to the electrode ring 20, and the other end of the catheter 4 is the end connected to the catheter handle through the guide sleeve.

[0047] In specific implementation, the control unit 17 in the embodiment of the present invention is arranged at one end of the catheter 4 and connected to the connecting part 19 of the electrode ring 20. Then the control unit 17 controls the rotation of the electrode ring 20 by controlling the connecting part 19, and the control unit 17 controls the pitch angle of the electrode ring 20 through the steering control unit.

[0048] In addition, in order to more clearly illustrate the electrode ring 20 according to the embodiment of the present invention, the portion of the electrode ring 20 that can be bent into a ring shape is hereinafter referred to as the ring portion 18 , and the electrode ring 20 at one end connected to the catheter 4 is referred to as the connecting portion 19 .

[0049] In general, the ring electrode pulse electric field ablation device provided by the embodiment of the present invention is to set a control unit 17 on the catheter 4, and control the electrode ring 20 to rotate along the center of the electrode ring 20 by the control unit 17, and adjust the curvature of the catheter 4 on the first end side by the control unit 17, so as to achieve stable and continuous adjustment of the electrode ring 20, so that the electrode ring 20 can accurately reach the preset position, thereby achieving efficient ablation treatment. In other words, the embodiment of the present invention is to adjust the posture and angle of the electrode ring 20 by the control unit 17 when the ablation site is changed by rotating the electrode ring 20, so that the electrode ring 20 is well connected with the original ablation line, thereby improving the ablation efficiency and quality, and reducing the damage range. At the same time, when the position of the electrode ring 20 is changed for supplementary ablation or enhanced ablation, the present invention does not need to control the catheter 4, but only needs to actively rotate the electrode ring 20 in the existing posture to achieve the purpose of supplementary ablation or reinforced ablation on the existing ablation line, thereby effectively solving the problem of low ablation efficiency of the existing ring electrode 20 when the ablation site is changed by rotating the electrode ring 20.

[0050] In specific implementation, the control unit 17 described in the embodiment of the present invention further includes: a rotation control unit and a steering control unit, wherein the rotation control unit is used to control the electrode ring 20 to rotate along the center of the electrode ring 20; the steering control unit is used to control the curvature of the catheter 4 on the first end side to reach a preset curvature.

[0051] That is, in the embodiment of the present invention, a rotation control unit and a steering control unit are arranged on the first end of the catheter 4, and the rotation control unit and the steering control unit are used to control the rotation of the electrode ring 20 around the ring center and the curvature of the catheter 4 head end respectively.

[0052] Furthermore, in an embodiment of the present invention, the rotation control unit is a rotation motor 171 , and the rotation motor 171 is controlled to control the electrode ring 20 to rotate along the center of the electrode ring 20 .

[0053] Specifically, the rotary motor 171 described in the embodiment of the present invention is movably connected to the connecting portion 19 of the electrode ring 20 , and can control the electrode ring 20 to rotate around its ring center through the connecting portion 19 .

[0054] As a preferred embodiment of the present invention, the steering control unit in the embodiment of the present invention is a micro universal shaft, which controls the curvature of the catheter 4 on the first end side to reach a preset curvature by controlling the micro universal shaft.

[0055] That is, a person skilled in the art can set a very small universal shaft at the end of the catheter 4, and send a control signal to the universal shaft so that the universal shaft can adjust the curvature of the end of the catheter 4, and finally enable the electrode ring 20 to accurately reach the preset position, thereby achieving the purpose of efficient ablation treatment.

[0056] As for the material and model of the micro universal shaft, those skilled in the art can arbitrarily set them according to actual needs. In addition, it should be noted that if a universal shaft is set to adjust the bending degree of the end of the catheter 4, a through hole needs to be set in the center of the universal shaft to allow various traction lines and traction guide wires 172 to pass through the catheter. Of course, in specific implementation, those skilled in the art can also pass the traction lines, etc. through the catheter through other methods, and the present invention does not make specific limitations on this.

[0057] In addition, the embodiment of the present invention also provides another implementation, that is, the steering control unit is configured to include: a side compression spring 174, a traction guide wire 172 and a traction motor 173;

[0058] The side compression spring 174 is provided between the rotation control unit and the traction motor 173 , and the traction guide wire 172 is also provided between the rotation control unit and the traction motor 173 ;

[0059] The traction motor 173 is controlled to tighten or loosen the traction guide wire 172 to control the compression direction and compression force of the side compression spring 174, and finally the curvature of the catheter 4 on the first end side is controlled to reach a preset curvature.

[0060] In specific implementation, in the embodiment of the present invention, a traction guidewire 172 is arranged between the rotation control unit and the traction motor 173, and the traction guidewire 172 is tightened or loosened by the traction motor 173 to adjust the compression direction and compression force of the side compression spring 174, so that the catheter 4 on the first end side reaches a preset curvature, and finally the electrode ring 20 can accurately reach the preset position, thereby realizing efficient ablation treatment.

[0061] It can be known from the above technical content that the embodiment of the present invention sets a control unit 17, and actively adjusts the diameter of the electrode ring 20 through the control unit 17, so as to maximize the adaptation of the same model of catheter 4 to pulmonary vein orifices of different diameters in the same patient and different patients with different pulmonary vein orifice diameters. In addition, the electrode ring 20 of the embodiment of the present invention is a closed-loop structure, which can rotate bidirectionally clockwise and counterclockwise, and is simple, flexible and safe to operate. When the electrode ring 20 reaches the opening of the pulmonary vein, the device of the embodiment of the present invention can adjust the diameter of the electrode ring 20 to fully adapt to the predetermined ablation line, and finely adjust the contact degree or distance between the ablation electrode and the inner wall of the pulmonary vein. When the electrode ring 20 is at an angle to the opening of the pulmonary vein, the angular state of the electrode ring 20 can also be actively adjusted to reach and maintain the optimal ablation position. When the ablation site is changed by rotating the electrode ring 20, the posture and angle of the electrode ring 20 can be adjusted to connect well with the original ablation line to improve the ablation efficiency and quality and reduce the scope of damage. When the position of the electrode ring 20 is changed for supplementary ablation or enhanced ablation, there is no need to control the catheter 4. It is only necessary to actively rotate the electrode ring 20 in the existing posture to achieve the purpose of supplementary ablation or reinforced ablation on the existing ablation line. When the closed electrode ring 20 is incarcerated or the hanging tissue structure cannot be withdrawn, the telescopic guide wire of the electrode ring 20 can be cut off externally to loosen and remove it.

[0062] In specific implementation, the rotation control unit in the embodiment of the present invention is a rotation motor 171, which is located near the end of the catheter 4 of the connection portion 19 of the electrode ring 20, with a distance of about 2 mm or more, and its main function is to bidirectionally rotate the electrode ring 20. A central lumen is provided in the long axis direction of the rotation motor 171, and the central lumen is used to pass various wires at the head end of the electrode ring 20.

[0063] It should be noted that, in a specific implementation, a sealing structure is provided at the rotating shaft of the rotating motor 171 to prevent foreign matter from entering the rotating motor 171 and affecting the normal operation of the rotating motor 171.

[0064] The rotation function of the electrode ring 20 in the embodiment of the present invention is mainly used for: 1) changing the ablation site; 2) adjusting the contact or distance between the electrode and the tissue; 3) adjusting the portion of the electrode ring 20 to be changed in the adjustment direction of the corner device.

[0065] In addition, the steering control unit in the embodiment of the present invention is located at the proximal end of the rotating motor 171 of the electrode ring 20, so as to be able to complete the control of the electrode ring 20. The specific setting position can be arbitrarily set by those skilled in the art, and the present invention does not make any specific limitation on this.

[0066] In specific implementation, the steering control unit in the embodiment of the present invention can be a micro universal shaft, or a combined device consisting of a side compression spring 174, a pulling guide wire and a traction motor 173. The latter is used as follows: 1) operate the rotation motor 171 of the electrode ring 20 to rotate the portion of the electrode ring 20 to be adjusted in angle or posture to the working direction of the turning device. 2) operate the traction motor 173 to tighten the pulling guide wire 172 located on one side of the turning spring, and the spring is compressed laterally, driving the electrode ring 20 to move in the direction and degree of the predetermined posture adjustment.

[0067] like Figure 4 , Figure 5 and Figure 6 As shown, the grey rectangle in the figure is the mapping and ablation electrode 3, and the circle is the positioning electrode. It should be pointed out in particular that the grey rectangle on the connecting part 19 is also a positioning electrode.

[0068] like Figures 4 to 6 As shown, in the embodiment of the present invention, a first traction wire distal end fixing point 1 is provided at the top of the electrode ring 20, and a first traction wire outlet 2 is provided at the body of the electrode ring 20. The first traction wire 6 enters the ring portion 18 from the traction wire outlet on the ring portion 18 through the top of the ring portion 18, and extends along the ring portion 18, the connecting portion 19, through the catheter 4 to the catheter handle, so that the catheter handle can control the bending diameter of the electrode ring 20 through the traction wire.

[0069] Specifically, in the embodiment of the present invention, the head end of the electrode ring 20 has a first traction wire distal end fixed point 1, and the first traction wire 6 can also be called a telescopic guidewire, through which the catheter 4 is pulled to expand and contract to increase or decrease the diameter of the electrode ring 20; the electrode ring 20 proximal end is provided with a telescopic guidewire outlet at 2-5 cm from the connection part 19, which is used to retract and release the telescopic guidewire. By changing the length of the telescopic guidewire between the fixed point and the outlet, the head end of the catheter 4 can be pulled close to the telescopic guidewire outlet, thereby changing the diameter of the electrode ring 20. The open loop diameter range of the electrode ring 20: when the top of the electrode ring 20 is completely rebounded to restore the prefabricated diameter, it is the maximum open loop diameter of the electrode ring 20. When the top of the electrode ring 20 reaches the connection part 19, that is, near the end of the electrode ring 20, it is the minimum open loop diameter of the electrode ring 20. The closed loop diameter range of the electrode ring 20: when the telescopic guidewire is tightened so that the top of the electrode ring contacts the electrode ring end of the connection part 19, it is the maximum closed loop diameter of the electrode ring 20. When the telescopic guidewire is tightened so that the top of the electrode ring 20 is located at the exit of the telescopic guidewire, it is the minimum closed-loop diameter of the electrode ring 20. Emergency closed-loop release: When any part of the body of the catheter 4 is completely disconnected outside the body, the telescopic guidewire of the electrode ring 20, that is, the first traction wire 6 mentioned above, can be disconnected at the same time. At this time, withdraw the proximal end of the disconnected catheter 4, and the electrode ring 20 can be withdrawn first, and then the disconnected telescopic guidewire can be withdrawn. The closed-loop operation of the electrode ring 20 is applicable to: three-dimensional modeling, high-density mapping, entering the target pulmonary vein, and matching the ablation of the pulmonary vein orifice with a diameter that is compatible with it. The open-loop operation of the electrode 20 is applicable to: matching the ablation of the pulmonary vein orifice whose diameter exceeds the closed-loop diameter of the electrode ring 20.

[0070] More than two ablation electrodes are evenly spaced on the electrode ring 20 , and the length of a single electrode is more than 2 mm. More than one positioning electrode is installed on the connecting portion 19 of the electrode ring 20 to mark the position of the electrode ring 20 and the serial number of the electrode of the electrode ring 20 .

[0071] The following will be combined Figure 7 , Figure 8 and Fig. 9 The operation process of the ring electrode pulse electric field ablation device according to the embodiment of the present invention is described in detail:

[0072] Prepare the catheter 4: hold the guiding sheath 21 with one hand, withdraw the catheter 4 with the other hand, and straighten the electrode ring 20 into the guiding sheath 21;

[0073] The electrode ring 20 is sent into the tail of the sheath tube 23. Under the protection of the guide sheath tube 21, the head end of the guide sheath tube 21 together with the straightened head end of the electrode ring 20 is sent into the tail of the sheath tube 23, and according to the length and position mark of the catheter 4, the electrode ring 20 is sent out of the head end of the sheath tube 23 to restore the prefabricated shape of the electrode ring 20;

[0074] Three-dimensional modeling or mapping and positioning: adjusting the electrode ring 20 to a minimum closed loop shape to complete mapping and modeling or precise positioning of the target cardiac cavity and ablation structure;

[0075] Positioning of the pulse ablation electrode ring 20: 1) Operate the catheter handle to allow the electrode ring 20 in the smallest closed loop shape to enter the target pulmonary vein orifice; 2) Move forward and backward to adjust the depth of the electrode ring 20 entering the pulmonary vein orifice so that the outermost part of the electrode ring 20 is located on the preset ablation line; 3) Gradually increase the diameter of the electrode ring 20 until it approaches the diameter of the predetermined ablation ring of the pulmonary vein; 4) Actively rotate the electrode ring 20 so that the segment of the electrode ring 20 to be adjusted is located on the working surface of the electrode ring 20 rotation device; 5) Adjust the posture of the electrode ring 20 under three-dimensional guidance until the entire electrode ring 20 is completely consistent with the preset ablation line; 6) Gradually expand the diameter of the electrode ring 20 until all electrodes of the electrode ring 20 are in full contact with the inner wall of the pulmonary vein at the preset ablation line or a satisfactory contact distance is reached.

[0076] Furthermore, if Figure 4-Figure 6 As shown, in the embodiment of the present invention, the ring portion 18 of the electrode ring 20 is provided with a marking and ablation electrode 3, specifically including: an ablation electrode, an annular electrode pair, a positioning sensor and a temperature sensor; wherein, the ablation electrode is multiple and used to perform ablation processing according to the ablation electrode of the control terminal; the annular electrode pair is multiple and used to detect the potential information of its current position and send the detected potential information to the control terminal; the temperature sensor is arranged on the ablation electrode and used to detect the temperature information of the ablation electrode and send the detected temperature information to the control terminal; the positioning sensor is multiple and used to detect the current position information in real time and send the detected position information to the control terminal;

[0077] In a specific implementation, in an embodiment of the present invention, the number of the annular electrode pairs, the positioning sensors and the ablation electrodes is the same, and the ablation electrodes, the annular electrode pairs and the positioning sensors are alternately arranged in sequence, and the annular electrode pairs, the positioning sensors and the ablation electrodes are evenly distributed on the ring portion 18.

[0078] The control terminal is used to display the received potential information, temperature information and position information in real time, and to control the electrode ring 20 in real time according to the potential information, temperature information and position information.

[0079] It should be noted that, in the embodiment of the present invention, in addition to the real-time control of the electrode ring 20 by the control terminal based on the relevant information it receives through the control unit, the operator can also specifically control the electrode ring 20 through the control panel on the catheter handle, the diameter adjustment ring of the electrode ring 20 and the bent slide handle 8 at the head of the catheter 4, so that the electrode ring 20 reaches a preset position for operation.

[0080] In addition, in the specific implementation, the control terminal described in the embodiment of the present invention can be a computer or other device with display and computing functions, and the operator can control each component through the control terminal. The specific program control software and line connection can be set arbitrarily by those skilled in the art, and the present invention will not explain this in detail.

[0081] Among them, the diameter adjustment ring of the electrode ring 20 on the catheter handle of the embodiment of the present invention is connected to the first traction line 6 on the electrode ring 20, and the sliding handle 8 bent at the head of the catheter 4 is connected to the second traction line 22 at the first end of the catheter 4, so as to control the diameter of the electrode ring 20 and the curvature of the end of the catheter 4 through the diameter adjustment ring of the electrode ring 20 and the sliding handle 8 bent at the head of the catheter 4.

[0082] It should be noted that, in the embodiment of the present invention, a fixed heat-insulating material ring is further provided between the annular electrode pair and the ablation electrode to avoid mutual influence between the annular electrode pair and the ablation electrode.

[0083] In addition, the embodiment of the present invention can display all the information detected by the electrode ring 20 in real time through the control terminal, and based on the various detection information received, the control program of the control terminal can be used to specifically control the operation. At the same time, the operator can also control the catheter handle according to the various control information displayed by the control terminal to achieve overall control of the current actual operation process, so as to ultimately achieve a better control effect.

[0084] like Figure 4-Figure 6 As shown, in a specific implementation, the number of the annular electrode pairs, positioning sensors and ablation electrodes in the embodiment of the present invention are 8, and the annular electrode pairs, positioning sensors and ablation electrodes are evenly distributed on the ring portion 18. Of course, those skilled in the art can also arbitrarily set the specific positions of the annular electrode pairs (hereinafter referred to as electrode pairs), positioning sensors and ablation electrodes between the top of the ring portion 18 at the connecting end of the ring portion and the connecting portion 19 according to actual needs.

[0085] The embodiment of the present invention can complete the ablation of 8 points in a ring at a time by arranging 8 ablation electrodes on the electrode ring 20, thereby improving the ablation efficiency. At the same time, the embodiment of the present invention can precisely control the distance between the ablation points by evenly distributing the ablation electrodes in a ring shape, thereby greatly reducing the probability of repeated or missing ablation points. In addition, the electrode ring 20 of the embodiment of the present invention has a larger diameter and a certain open tension in the open state. The operator can control the traction line to change the diameter of the electrode ring 20 as needed, and flexibly control the diameter of the electrode ring 20, so that the electrode ring 20 of the present invention can adapt to blood vessels of different diameters, improve the contact quality between the electrode and the inner wall of the blood vessel, and the present invention also adds a radio frequency switch to control each electrode ring 20 at the end of the catheter handle, so as to flexibly control the number of ablation electrodes in a single time, thereby completing independent point ablation control of different blood vessel parts.

[0086] Furthermore, a control panel is provided on the catheter handle in the embodiment of the present invention, and the opening and closing of any ablation electrode is controlled by the control panel to meet the ablation requirements under different surgical conditions.

[0087] Of course, the specific configuration can be configured by those skilled in the art according to actual needs, and generally speaking, the ablation electrode can be opened and closed, and the present invention does not make any specific limitation on this.

[0088] Furthermore, in a specific implementation, the device described in the embodiment of the present invention further includes: a first traction line 6 and a second traction line 22, which are guided through the guide sleeve 7 to the slide handle slot 16 in the guide handle 10, and finally the first traction line 6 and the second traction line 22 are fixed to the traction line sliding point 9 in the slide handle slot 16;

[0089] The first end of the first traction wire 6 is arranged at the top of the ring portion 18, that is, the attachment point of the first traction wire 6 is the top of the ring portion 18, and the first traction wire 6 extends through the top along the ring portion 18, the connecting portion 19, through the catheter 4 to the catheter handle, so that the catheter handle can control the bending diameter of the electrode ring 20 through the first traction wire 6;

[0090] Specifically, in the embodiment of the present invention, the bending diameter of the ring portion 18 is controlled based on the first traction wire 6 by using the sliding handle 8 bent at the head of the catheter 4 on the catheter handle;

[0091] The second traction line 22 is arranged at the second traction line attachment point 5 of the first end of the catheter 4, and the first end is the end of the catheter 4 on the side connected to the connecting part 19. The second traction line 22 extends through the catheter 4 all the way to the catheter handle, so that the catheter handle can control the curvature of the first end of the catheter 4 through the second traction line 22.

[0092] That is, in the embodiment of the present invention, the diameter of the electrode ring 20 on the catheter handle is adjusted based on the second traction wire 22 to control the curvature of the first end of the catheter 4 .

[0093] In short, the embodiment of the present invention can also control the diameter of the electrode ring 20 and the bending of the catheter 4 through different traction lines through two control components on the catheter handle, so as to eventually make the electrode ring 20 reach a preset position and perform ablation treatment on the position.

[0094] It should be noted that, in the embodiment of the present invention, the first traction wire 6 and the second traction wire 22 can be made of very thin steel wire materials, etc. One end of the steel wire is set on the top of the electrode ring 20 and the first end of the catheter 4, and the other end of the steel wire is set on the control member of the catheter handle, so that the electrode ring 20 and the catheter 4 are controlled by manipulating the control member.

[0095] In specific implementation, in the embodiment of the present invention, a handle socket 11 is provided at the tail of the guide handle 10 , and the handle socket 11 is connected to the tail line plug 12 and the tail line connector 13 , thereby realizing connection with the tail line 14 .

[0096] In addition, the tail of the guide handle 10 of the embodiment of the present invention is also provided with an electrode ring 20 operating plate connector 15 , through which the control terminal can realize specific control of the electrode ring 20 .

[0097] like Fig. 9 As shown, the device according to the embodiment of the present invention further includes a marking portion, which is arranged on the catheter 4, and the marking portion further includes a first position mark A, a second position mark B, a third position mark C and a fourth position mark D;

[0098] The first position mark A is used to mark that the ring portion 18 changes from a ring shape to a straight shape, and the straight ring portion 18 completely enters the guide sheath;

[0099] The second position mark B is used to mark that the ring portion 18 has completely entered the sheath tube 23 from the guide sheath;

[0100] A third position mark C is used to mark that the top of the ring portion 18 is flush with the outlet end of the sheath tube 23;

[0101] The fourth position mark D is used to mark that the ring portion 18 is completely extended out of the outlet end of the sheath tube 23 and restored to a ring state.

[0102] For example: the length of the catheter 4 is 135 cm, the length of the sheath 23 is 85 cm, the circumference of the electrode ring 20 is 10 cm, the guide sheath 21 is 10.5 cm, the first position mark A is 10.5 cm away from the head end of the straightened electrode ring 20, the second position mark B18 is 10.5 cm away from the first position mark A, and is 21 cm away from the top of the straightened electrode ring 20, the third position mark C is 85 cm away from the top of the straightened electrode ring 20, and the fourth position mark D is 90.5 cm away from the top of the straightened electrode ring 20, and is 85 cm away from the root of the electrode ring 20. Of course, the above setting is only an example. In specific implementation, those skilled in the art can make any setting according to actual conditions, and the present invention does not make any specific limitation on this.

[0103] In summary, the embodiment of the present invention can adjust the posture and angle of the electrode ring by manipulating the control unit, so that the electrode ring can be well connected with the original ablation line, improve the ablation efficiency and quality, and reduce the damage range. In addition, when the position of the electrode ring is changed for supplementary ablation or enhanced ablation, the present invention does not need to manipulate the catheter, but only needs to actively rotate the electrode ring in the existing posture to achieve the purpose of supplementary ablation or reinforced ablation on the existing ablation line, thereby effectively solving the problem of low ablation efficiency of the existing ring electrode when the electrode ring is rotated to change the ablation site.

[0104] Although the preferred embodiments of the present invention have been disclosed for illustrative purposes, those skilled in the art will appreciate that various modifications, additions and substitutions are possible, and thus, the scope of the present invention should not be limited to the above embodiments.

Claims

1. A ring electrode pulse electric field ablation device, characterized in that: include: Electrode ring and control unit; The electrode ring is connected to a first end portion of the catheter, and the control unit is arranged on the catheter at the first end portion side; The control unit controls the electrode ring to rotate along the center of the electrode ring, and the control unit adjusts the curvature of the catheter on the first end side so that the electrode ring reaches a preset position for density mapping or pulsed electric field ablation; The control unit further comprises: a rotation control unit and a steering control unit; the rotation control unit is used to control the electrode ring to rotate along the center of the electrode ring; the steering control unit is used to control the curvature of the catheter on the first end side to reach a preset curvature; The rotation control unit is a rotation motor, which controls the electrode ring to rotate along the center of the electrode ring by controlling the rotation motor; The steering control unit is a micro universal shaft, which controls the curvature of the catheter on the first end side to reach a preset curvature by controlling the micro universal shaft; The steering control unit further comprises: a side compression spring, a traction guide wire and a traction motor; the side compression spring is arranged between the rotation control unit and the traction motor, and the traction guide wire is also arranged between the rotation control unit and the traction motor; the compression direction and compression force of the side compression spring are controlled by controlling the traction motor to tighten or loosen the traction guide wire, so as to finally control the curvature of the catheter on the first end side to reach a preset curvature; The device further comprises: a catheter handle and a traction wire; the first end of the traction wire is arranged at the top of the ring portion of the electrode ring, and the traction wire enters the ring portion from the traction wire outlet on the ring portion through the top of the ring portion, the portion of the electrode ring that can be bent into a ring shape is recorded as the ring portion, and the electrode ring connected to one end of the catheter is recorded as the connecting portion, along the ring portion, the connecting portion, through the catheter, and extends to the catheter handle, the second end of the traction wire is connected to the catheter handle, and the catheter handle can control the bending diameter of the electrode ring through the traction wire; The catheter handle is provided with a control panel; the traction wire is controlled by the control panel, thereby controlling the bending diameter of the electrode ring; The traction line outlet is arranged at a position where the top end of the ring portion corresponds to the body of the ring portion when the ring portion is fully closed.

2. The device according to claim 1, characterized in that The ring portion of the electrode ring is also provided with: an ablation electrode, a ring electrode pair, a positioning sensor and a temperature sensor; The ablation electrode is used for performing ablation treatment; The annular electrode pair is used to detect the potential information of its current position and send the detected potential information to the control terminal; The temperature sensor is arranged on the ablation electrode, and is used to detect the temperature information of the ablation electrode and send the detected temperature information to the control terminal; The positioning sensor is used to detect its current location information in real time and send the detected location information to the control terminal; The ablation electrodes, the annular electrode pairs and the positioning sensors are of the same number, and the ablation electrodes, the annular electrode pairs and the positioning sensors are alternately arranged in sequence and are evenly distributed on the ring portion.

3. The device according to claim 2, characterized in that The control terminal is used to display the received potential information, temperature information and position information in real time, and to control the rotation control unit, the steering control unit and the ablation electrode in real time according to the potential information, the temperature information and the position information.

Citation Information

Patent Citations

  • Annular electrode pulsed electric field ablation device

    CN216570185U