CN112914715B - A ring electrode pulse electric field ablation device - Google Patents
A ring electrode pulse electric field ablation device Download PDFInfo
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- CN112914715B CN112914715B CN202011466493.XA CN202011466493A CN112914715B CN 112914715 B CN112914715 B CN 112914715B CN 202011466493 A CN202011466493 A CN 202011466493A CN 112914715 B CN112914715 B CN 112914715B
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- 238000002679 ablation Methods 0.000 title claims abstract description 115
- 230000005684 electric field Effects 0.000 title claims abstract description 21
- 238000005452 bending Methods 0.000 claims abstract description 24
- 238000011298 ablation treatment Methods 0.000 claims abstract description 9
- 230000006835 compression Effects 0.000 claims description 20
- 238000007906 compression Methods 0.000 claims description 20
- 238000013507 mapping Methods 0.000 claims description 9
- 230000008859 change Effects 0.000 abstract description 6
- 230000002787 reinforcement Effects 0.000 abstract description 3
- 230000001276 controlling effect Effects 0.000 abstract 2
- 230000001105 regulatory effect Effects 0.000 abstract 2
- 210000003492 pulmonary vein Anatomy 0.000 description 17
- 238000010586 diagram Methods 0.000 description 5
- 230000008901 benefit Effects 0.000 description 3
- 210000004204 blood vessel Anatomy 0.000 description 3
- 239000000463 material Substances 0.000 description 2
- 229910000831 Steel Inorganic materials 0.000 description 1
- 238000007792 addition Methods 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 230000002526 effect on cardiovascular system Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000011810 insulating material Substances 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 230000003014 reinforcing effect Effects 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 230000009295 sperm incapacitation Effects 0.000 description 1
- 239000010959 steel Substances 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
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- A—HUMAN NECESSITIES
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- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00053—Mechanical features of the instrument of device
- A61B2018/00184—Moving parts
- A61B2018/00202—Moving parts rotating
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- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00345—Vascular system
- A61B2018/00351—Heart
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00595—Cauterization
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00773—Sensed parameters
- A61B2018/00791—Temperature
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B2018/1405—Electrodes having a specific shape
- A61B2018/1407—Loop
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B2018/1465—Deformable electrodes
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Abstract
The invention discloses a ring electrode pulse electric field ablation device, which is characterized in that a control part is arranged on a catheter, the control part is used for controlling an electrode ring to rotate around the ring center of the catheter, and the bending degree of the end part of the catheter is regulated, so that the electrode ring can be regulated stably and continuously, the electrode ring can accurately reach a preset position, and the ablation treatment can be realized efficiently, namely, the invention can regulate the posture and the angle of the electrode ring by controlling the control part, the electrode ring is well connected with the original ablation line, the ablation efficiency and quality are improved, and the damage range is reduced, so that when the position of the electrode ring is changed to perform supplementary ablation or enhanced ablation, the catheter does not need to be controlled, and the purpose of point-supplementing ablation or reinforcement ablation on the existing ablation line can be achieved only by actively rotating the electrode ring in the existing posture, thereby effectively solving the problem of low ablation efficiency of the existing annular electrode when the electrode ring is rotated to change the ablation part.
Description
Technical Field
The invention relates to the technical field of medical equipment, in particular to an annular electrode pulse electric field ablation device.
Background
In the prior art, a ring electrode is generally used for establishing a pulse electric field so as to realize electrophysiological ablation treatment on a cardiovascular target structure, and the ring electrode can synchronously discharge in a ring electrode array, so that higher ablation efficiency can be obtained.
However, in practice, when the rotating electrode ring changes the ablation part, the existing annular electrode cannot be well connected with the original ablation line, so that the ablation efficiency and quality are affected, and the damage range is increased to a certain extent.
Disclosure of Invention
The invention provides an annular electrode pulse electric field ablation device, which aims to solve the problem that the existing annular electrode has low ablation efficiency when an electrode ring is rotated to change an ablation part.
In a first aspect, the invention provides a ring-shaped electrode pulse electric field ablation device, comprising an electrode ring and a control part;
The electrode ring is connected with a first end of a catheter, and the control part is arranged on the catheter at the first end side;
The control part is used for controlling the electrode ring to rotate along the ring center of the electrode ring, and the bending degree of the catheter at the first end part side is adjusted by the control part, so that the electrode ring reaches a preset position to perform density mapping or pulse electric field ablation.
Optionally, the control part further includes a rotation control unit and a steering control unit;
the rotation control unit is used for controlling the electrode ring to rotate along the ring center of the electrode ring;
the steering control unit is used for controlling the bending degree of the guide pipe at the first end part side to reach a preset bending degree.
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.
Optionally, the steering control unit is a miniature universal rotating shaft, and the curvature of the catheter at the first end side is controlled to reach a preset curvature by controlling the miniature universal rotating shaft.
Optionally, the steering control unit further comprises a side compression spring, a traction 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;
And the traction motor is controlled to tighten or loosen the traction guide wire so as to control the compression direction and the compression force of the side compression spring, and finally, the bending degree of the catheter at the first end part side is controlled to reach the preset bending degree.
Optionally, the device further comprises a catheter handle and a pull wire;
The first end of the traction wire is arranged at the top end of the ring part of the electrode ring, the traction wire enters the ring part from the traction wire outlet on the ring part through the top end of the ring part, and extends to the catheter handle through the catheter along the ring part and the connecting part, the second end of the traction wire is connected with the catheter handle, and the catheter handle can control the bending diameter of the electrode ring through the traction wire.
Optionally, a control panel is arranged on the catheter handle;
the control panel is used for controlling the traction wire, so that the bending diameter of the electrode ring is controlled.
Optionally, the traction wire outlet is provided at a position where the top end of the ring portion corresponds to the ring portion body when the ring portion is fully closed.
Optionally, an ablation electrode, an annular electrode pair, a positioning sensor and a temperature sensor are also arranged on the ring part of the electrode ring;
the ablation electrode is used for performing ablation treatment;
The annular electrode pair is used for detecting potential information of the current position of the annular electrode pair and sending the detected potential information to the control terminal;
The temperature sensor is arranged on the ablation electrode and is used for detecting temperature information of the ablation electrode and sending the detected temperature information to the control terminal;
The positioning sensor is used for detecting the current position information of the positioning sensor in real time and sending the detected position information to the control terminal;
The ablation electrode, the annular electrode pair and the positioning sensor are the same in number, and the ablation electrode, the annular electrode pair and the positioning sensor are alternately arranged in sequence at intervals and uniformly distributed on the annular part.
Optionally, the control terminal is configured to display the received potential information, the received temperature information, and the received position information in real time, and simultaneously perform real-time control on the rotation control unit, the steering control unit, and the ablation electrode according to the potential information, the received temperature information, and the received position information.
The invention has the following beneficial effects:
According to the annular electrode pulse electric field ablation device provided by the invention, the control part is arranged on the catheter, the electrode ring is controlled to rotate around the ring center of the catheter through the control part, and the bending degree of the end part of the catheter is adjusted, so that the electrode ring can be stably and continuously adjusted, and accurately reach the preset position, and therefore, the efficient ablation treatment is realized, namely, the electrode ring posture and the angle can be adjusted through controlling the control part, so that the electrode ring is well connected with the original ablation line, the ablation efficiency and the quality are improved, the damage range is reduced, and the invention can achieve the aim of compensating point ablation or reinforcing ablation on the existing ablation line without controlling the catheter when changing the position of the electrode ring, so that the problem of low ablation efficiency when the existing annular electrode rotates the ablation part is effectively solved.
The foregoing description is only an overview of the present invention, and is intended to be implemented in accordance with the teachings of the present invention in order that the same may be more clearly understood and to make the same and other objects, features and advantages of the present invention more readily apparent.
Drawings
Various other advantages and benefits will become apparent to those of ordinary skill in the art upon reading the following detailed description of the preferred embodiments. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the invention. Also, like reference numerals are used to designate like parts throughout the figures. In the drawings:
fig. 1 is a schematic structural diagram of an annular electrode pulse electric field ablation device according to an embodiment of the present invention;
FIG. 2 is a schematic diagram of a placement position of an annular electrode pulsed electric field ablation device according to an embodiment of the present invention;
FIG. 3 is a schematic diagram of the overall structure of a ring-shaped electrode pulsed electric field ablation device according to an embodiment of the present invention;
FIG. 4 is a schematic view of a fully closed electrode ring according to an embodiment of the present invention;
FIG. 5 is a schematic view of a partially closed electrode ring structure according to an embodiment of the present invention;
FIG. 6 is a schematic view of a fully straightened configuration of an electrode ring according to an embodiment of the present invention;
FIG. 7 is a schematic view showing the overall structure of a ring electrode pulsed electric field ablation catheter according to an embodiment of the present invention;
FIG. 8 is a schematic diagram of the overall structure of another ring electrode pulsed electric field ablation catheter provided by an embodiment of the present invention;
FIG. 9 is a schematic diagram of the overall structure of a still another ring electrode pulsed electric field ablation catheter provided by an embodiment of the present invention;
The identification instructions comprise a first traction wire distal end fixing point, a second traction wire outlet, a third mapping and ablation electrode, a catheter 4, a second traction wire attachment point 5, a first traction wire 6, a guide sleeve 7, a sliding handle 8, a traction wire sliding point 9, a guide handle 10, a handle jack 11, a tail wire plug 12, a tail wire connector 13, a tail wire 14, an electrode ring operating board connector 15, a sliding handle sliding groove 16, a control part 17, an electrode ring part 18, an electrode ring 19 connecting part 20, an electrode ring 21, a guide sheath tube 22, a second traction wire 23, a sheath tube A first position identification, a second position identification, a third position identification C and a fourth position identification D, and a 171 rotation motor, a 172 traction guide wire 173 traction motor and a 174 side compression spring.
Detailed Description
Aiming at the problem that the existing annular electrode has low ablation efficiency when the electrode ring is rotated to change the ablation part, the gesture and angle of the electrode ring are adjusted through controlling the control part, so that the electrode ring is well connected with the original ablation line, the ablation efficiency and quality are improved, and the damage range is reduced. The present invention will be described in further detail with reference to the accompanying drawings and examples. It should be understood that the particular embodiments described herein are illustrative only and not limiting of the invention.
In general, the main defects of the existing annular electrode catheter are that 1, the diameter of an electrode ring cannot be adjusted and cannot adapt to pulmonary vein openings with different diameters of the same patient, and cannot adapt to different patients with different pulmonary vein opening diameters, 2, the electrode ring is of an open-loop structure and can only rotate clockwise, and is easy to cause tissue hooking or damage when rotating reversely, 3, after the electrode ring reaches a pulmonary vein opening, the diameter of the electrode ring cannot be adjusted to adapt to a preset ablation line and the contact degree or distance between an ablation electrode and the inner wall of the pulmonary vein, 4, when the electrode ring and the pulmonary vein opening form an angle, the electrode ring cannot be actively adjusted to an optimal ablation position, 5, when the ablation part is changed by rotating the electrode ring, the electrode ring cannot be well connected with the original ablation line, the ablation efficiency and quality are affected, and the damage range is increased.
In view of the above problems, an embodiment of the present invention provides an annular electrode pulse electric field ablation apparatus, referring to fig. 1 to 3, which includes an electrode ring 20 and a control part 17 for controlling the electrode ring 20;
The electrode ring 20 is connected with the first end of the catheter 4, the control part 17 is arranged on the catheter 4 at the first end side, the control part 17 controls the electrode ring 20 to rotate along the center of the electrode ring 20, and the control part 17 adjusts the bending degree of the catheter 4 at the first end side, so that the electrode ring 20 reaches a preset position to perform density mapping or pulse electric field ablation.
It should be noted that, in the embodiment of the present invention, the first end of the catheter 4 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 guiding sleeve.
In particular, the control portion 17 in the embodiment of the present invention is disposed at one end of the catheter 4 and connected to the connection portion 19 of the electrode ring 20, and then the control portion 17 controls the rotation of the electrode ring 20 by controlling the connection portion 19, and the control portion 17 controls the pitch angle of the electrode ring 20 by steering control unit.
In order to more clearly describe the electrode ring 20 according to the embodiment of the present invention, a portion of the electrode ring 20 that can be bent into a ring shape is hereinafter referred to as a ring portion 18, and the electrode ring 20 connected to one end of the catheter 4 is referred to as a connecting portion 19.
In general, the annular electrode pulse electric field ablation device provided by the embodiment of the invention is characterized in that the control part 17 is arranged on the guide tube 4, the control part 17 controls the electrode ring 20 to rotate along the ring center of the electrode ring 20, and the control part 17 adjusts the bending degree of the guide tube 4 at the first end part side to realize stable and continuous adjustment of the electrode ring 20, so that the electrode ring 20 can accurately reach a preset position, in other words, the ablation treatment is realized effectively, in other words, when the electrode ring 20 is rotated to change the ablation position, the gesture and angle of the electrode ring 20 can be adjusted through the control part 17, so that the electrode ring 20 is well connected with the original ablation line, thereby improving the ablation efficiency and quality, reducing the damage range, and meanwhile, when the electrode ring 20 is changed to perform supplementary ablation or reinforced ablation, the guide tube 4 is not required to be controlled, and the purpose of point ablation or reinforcement ablation on the existing annular electrode ring 20 can be realized only by actively rotating the electrode ring 20 under the existing gesture, so that the problem of low ablation efficiency when the electrode ring 20 is rotated is effectively solved.
In a specific implementation, the control portion 17 of the embodiment of the present invention further includes a rotation control unit and a steering control unit, where the rotation control unit is configured to control the electrode ring 20 to rotate along the ring center of the electrode ring 20, and the steering control unit is configured to control the curvature of the catheter 4 at the first end portion side to reach a preset curvature.
That is, in the embodiment of the present invention, a rotation control unit and a steering control unit are provided on the first end portion of the catheter 4, and the rotation of the electrode ring 20 around the center of the ring and the bending of the head end of the catheter 4 are controlled by the rotation control unit and the steering control unit, respectively.
Further, in the embodiment of the present invention, the rotation control unit is a rotation motor 171, and the rotation of the electrode ring 20 along the center of the electrode ring 20 is controlled by controlling the rotation motor 171.
Specifically, the rotary motor 171 described in the embodiment of the present invention is movably connected to the connection portion 19 of the electrode ring 20, and the electrode ring 20 can be controlled to rotate around its center by the connection portion 19.
As a preferred embodiment of the present invention, the steering control unit in the embodiment of the present invention is a micro universal shaft, and the curvature of the catheter 4 at the first end side is controlled to reach a preset curvature by controlling the micro universal shaft.
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 to adjust the bending degree of the end of the catheter 4 by the universal shaft, and finally enable the electrode ring 20 to accurately reach a preset position, thereby achieving the purpose of efficiently performing the ablation treatment.
The material and model of the micro universal shaft may be set arbitrarily by those skilled in the art according to actual needs, and if the universal shaft is provided to adjust the bending degree of the end of the catheter 4, a through hole needs to be provided in the center of the universal shaft to allow various traction wires and the traction guide wire 172 to pass through the catheter, however, in practice, those skilled in the art may pass through the catheter by other means, such as traction wires, and the invention is not limited thereto.
In addition, the embodiment of the present invention provides another implementation manner, namely, the steering control unit is configured to include a side compression spring 174, a traction wire 172 and a traction motor 173;
The side compression spring 174 is arranged between the rotation control unit and the traction motor 173, and the traction guide wire 172 is also arranged between the rotation control unit and the traction motor 173;
by controlling the traction motor 173 to tighten or loosen the traction guide wire 172, the compression direction and the compression force of the side compression spring 174 are controlled, and finally the bending of the catheter 4 on the first end side is controlled to reach a preset bending.
In particular, in the embodiment of the present invention, a traction wire 172 is disposed between the rotation control unit and the traction motor 173, and the traction wire 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 at the first end reaches the preset curvature, and finally the electrode ring 20 can accurately reach the preset position, thereby realizing efficient ablation treatment.
As can be seen from the above description, the embodiment of the present invention is provided with the control portion 17, and the diameter of the electrode ring 20 is actively adjusted by the control portion 17, so that the catheter 4 with the same model is adapted to different pulmonary vein ports of the same patient and different patients with different pulmonary vein port diameters to the maximum extent. In addition, the electrode ring 20 in the embodiment of the invention is of a closed-loop structure, can rotate clockwise and anticlockwise bidirectionally, is simple, flexible and safe to operate, can fully adapt to a preset ablation line by adjusting the diameter of the electrode ring 20 after the electrode ring 20 reaches a pulmonary vein opening, can finely adjust the contact degree or distance between an ablation electrode and the inner wall of the pulmonary vein, can actively adjust the angulation state of the electrode ring 20 to reach and maintain an optimal ablation position when the electrode ring 20 is angulated with the pulmonary vein opening, can well adapt to the original ablation line by adjusting the posture and angle of the electrode ring 20 when the electrode ring 20 is rotated to change the ablation position, can improve the ablation efficiency and quality, can reduce the damage range, can achieve the purposes of point-complementing ablation or reinforcement on the existing ablation line by actively rotating the electrode ring 20 only when the electrode ring 20 is changed to have the incapacitation and the telescopic guide wire of the electrode ring 20 is not retracted, and can be removed by loosening and cutting off the electrode ring 20 when the closed electrode ring 20 is in the embedded or hung tissue structure.
In particular, 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, and has a distance of about 2mm or more, and the main function of bi-directionally rotating the electrode ring 20. A central lumen for various wires passing through the head end of the electrode ring 20 is provided in the long axis direction of the rotation motor 171.
In the embodiment, a sealing structure is provided at a position of the rotation shaft of the rotation motor 171 to prevent foreign matters from entering the rotation motor 171 and affecting the normal operation of the rotation motor 171;
The electrode ring 20 rotation function in the embodiment of the present invention is mainly used for 1) changing the ablation site. 2) The contact or distance of the electrode with the tissue is adjusted. 3) The electrode ring 20, which is to be changed in posture, is partially in the direction of adjustment of the angle turning means.
In addition, the steering control unit in the embodiment of the present invention is located at the proximal end of the rotation motor 171 of the electrode ring 20, so that the control of the electrode ring 20 can be completed, and the specific location can be arbitrarily set by a person skilled in the art, which is not particularly limited in the present invention.
In particular, the steering control unit in the embodiment of the present invention may be a micro universal shaft, or may be a combination device composed of a side compression spring 174, a traction wire and a traction motor 173. The latter is used by 1) operating the rotation motor 171 of the electrode ring 20 to rotate the electrode ring 20 portion to be adjusted in angle or posture to the working direction of the turning device. 2) The traction motor 173 is operated to tighten the traction guide wire 172 positioned at one side of the corner spring, and the spring is compressed laterally to drive the electrode ring 20 to move toward the direction and degree of the preset posture adjustment.
As shown in fig. 4, 5 and 6, the grey rectangles in the figures are the mapping and ablation electrodes 3, the dots are the positioning electrodes, and it should be noted that the grey rectangles on the connection portions 19 are also the positioning electrodes.
As shown in fig. 4 to 6, in the embodiment of the present invention, the distal end fixing point 1 of the first traction wire is disposed at the top of the electrode ring 20, and the body of the electrode ring 20 is provided with the first traction wire outlet 2, and the first traction wire 6 enters the ring 18 from the traction wire outlet on the ring 18 through the top end of the ring 18, and extends along the ring 18 and 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.
Specifically, in the embodiment of the invention, the head end of the electrode ring 20 is provided with a first traction wire distal end fixing point 1, the first traction wire 6 can also be called a telescopic guide wire, the catheter 4 is pulled to stretch by the telescopic guide wire so as to increase or decrease the diameter of the electrode ring 20, and a telescopic guide wire outlet is arranged at a position 2-5cm away from the connecting part 19 at the proximal end of the electrode ring 20 and used for retracting and releasing the telescopic guide wire. By varying the length of the telescoping guidewire between the anchor point and the exit port, the tip of the catheter 4 can be pulled closer to the telescoping guidewire exit port, thereby changing the diameter of the electrode ring 20. The open-loop diameter range of the electrode ring 20 is the maximum open-loop diameter of the electrode ring 20 when the top end of the electrode ring 20 is fully sprung to restore the pre-set diameter. The minimum open diameter of the electrode ring 20 is obtained when the tip of the electrode ring 20 reaches the connecting portion 19, i.e., near the end of the electrode ring 20. The diameter range of the closed loop of the electrode ring 20 is the maximum closed loop diameter of the electrode ring 20 when the telescopic guide wire is tightened to bring the top end of the electrode ring into contact with the electrode ring end of the connecting part 19. The minimum closed loop diameter of the electrode loop 20 is achieved when the telescoping guidewire is tightened such that the tip of the electrode loop 20 is positioned at the exit of the telescoping guidewire. Emergency closed loop release, namely, when any part of the catheter 4 body is completely separated from the outside, the electrode ring 20 can be separated from the telescopic guide wire, namely, the first traction wire 6. At this point, the proximal end of the severed catheter 4 is withdrawn, and the electrode ring 20 may be withdrawn first, followed by withdrawal of the severed telescoping guidewire. The closed loop operation of the electrode ring 20 is suitable for three-dimensional modeling, high density mapping, access to the target pulmonary vein, matching the ostial ablation of the pulmonary vein to its diameter. The electrode ring 20 is adapted for use in matching pulmonary vein ostial ablations having diameters that exceed the diameter of the closed loop of the electrode ring 20.
The electrode ring 20 is provided with more than 2 ablation electrodes with equal distance, the length of a single electrode is more than 2mm, and the connecting part 19 of the electrode ring 20 is provided with more than 1 positioning electrode for marking the position of the electrode ring 20 and the serial number of the electrode ring 20.
The operation of the ring electrode pulse electric field ablation device according to the embodiment of the present invention will be described in detail with reference to fig. 7, 8 and 9:
Preparing the catheter 4, namely holding the guiding sheath tube 21 by one hand, withdrawing the catheter 4 by the other hand, and straightening the electrode ring 20 into the guiding sheath tube 21;
the electrode ring 20 is fed into the tail of the sheath 23. Under the protection of the guiding sheath tube 21, the head end of the guiding sheath tube 21 and the head end of the straightened electrode ring 20 are sent into the tail part of the sheath tube 23, and the electrode ring 20 is sent out of the head end of the sheath tube 23 according to the length and the position mark of the catheter 4, so that the prefabricated shape of the electrode ring 20 is restored;
three-dimensional modeling or mapping positioning, namely adjusting the electrode ring 20 to be in a minimum closed loop form, and finishing mapping modeling or accurate positioning of a target heart cavity and an ablation structure;
The pulse ablation electrode ring 20 is positioned by 1) operating a catheter handle to enable the electrode ring 20 in the minimum closed loop form to enter a target pulmonary vein opening, 2) advancing and retreating to adjust the depth of the electrode ring 20 entering the pulmonary vein opening to enable the outermost part of the electrode ring 20 to be positioned on a preset ablation line, 3) gradually increasing the diameter of the electrode ring 20 until the diameter of the electrode ring approaches to the diameter of the preset ablation ring of the pulmonary vein, 4) actively rotating the electrode ring 20 to enable the section of the electrode ring 20 to be adjusted in an angle to be positioned on the working surface of a rotating angle device of the electrode ring 20, 5) adjusting the pose of the electrode ring 20 under three-dimensional guidance until the whole electrode ring 20 is completely matched with the preset ablation line, and 6) gradually expanding the diameter of the electrode ring 20 until all electrodes of the electrode ring 20 completely contact the pulmonary vein inner wall of the preset ablation line or reach a satisfactory contact distance.
Further, as shown in fig. 4 to 6, a mapping and ablating electrode 3 is arranged on a ring portion 18 of an electrode ring 20, and specifically includes a plurality of ablating electrodes, a plurality of ring electrode pairs, a positioning sensor and a temperature sensor, wherein the plurality of ablating electrodes are used for performing ablating processing according to the ablating electrode of the control terminal, the plurality of ring electrode pairs are used for detecting potential information of a current position of the ablating electrode pairs and sending the detected potential information to the control terminal, the temperature sensor is arranged on the ablating electrode and used for detecting temperature information of the ablating electrode and sending the detected temperature information to the control terminal, and the plurality of positioning sensors are used for detecting the current position information of the ablating electrode in real time and sending the detected position information to the control terminal;
in a specific implementation, in the embodiment of the present invention, the number of the ring electrode pairs, the positioning sensor and the ablation electrode is the same, and the ablation electrode, the ring electrode pairs and the positioning sensor are sequentially and alternately arranged at intervals, and the ring electrode pairs, the positioning sensor and the ablation electrode are uniformly distributed on the ring portion 18.
The control terminal is used for displaying the received potential information, temperature information and position information in real time and simultaneously controlling the electrode ring 20 in real time according to the potential information, the temperature information and the position information.
It should be noted that, in the embodiment of the present invention, the control terminal may realize the real-time control of the electrode ring 20 through the control portion based on the received related information, and the operator may specifically control the electrode ring 20 through the control panel on the catheter handle, the diameter adjusting ring of the electrode ring 20, and the bent sliding handle 8 at the head of the catheter 4, so that the electrode ring 20 reaches the preset position for working.
In addition, in a specific embodiment, the control terminal according to the embodiment of the present invention may be various devices with display and calculation functions, such as a computer, and an operator may control each component through the control terminal. The specific program control software and wiring connections can be set arbitrarily by those skilled in the art, and this invention will not be described in detail.
The diameter adjusting ring of the electrode ring 20 on the catheter handle of the embodiment of the invention is connected with the first traction wire 6 on the electrode ring 20, and the bent sliding handle 8 at the head of the catheter 4 is connected with the second traction wire 22 at the first end of the catheter 4, so that the diameter of the electrode ring 20 and the bending degree of the end of the catheter 4 are controlled through the diameter adjusting ring of the electrode ring 20 and the bent sliding handle 8 at the head of the catheter 4.
It should be noted that, in the embodiment of the present invention, a fixed heat insulating material ring is further disposed between the ring electrode pair and the ablation electrode, so as to avoid the interaction between the ring electrode pair and the ablation electrode.
In addition, the embodiment of the invention can display all the information detected by the electrode ring 20 in real time through the control terminal, and specifically control the operation through the control program of the control terminal based on various detection information received by the control terminal. Meanwhile, an operator can control the current actual operation process through the control of the catheter handle according to various control information displayed by the control terminal, so that a better control effect is finally achieved.
As shown in fig. 4 to 6, in the embodiment of the present invention, the number of the ring electrode pairs, the positioning sensor and the ablation electrode is 8, and the ring electrode pairs, the positioning sensor and the ablation electrode are uniformly distributed on the ring portion 18, and of course, those skilled in the art can also set the specific positions of the ring electrode pairs (hereinafter simply referred to as electrode pairs), the positioning sensor and the ablation electrode between the ring portion and the top end of the connecting end ring portion 18 of the connecting portion 19 according to actual needs.
According to the embodiment of the invention, the 8 ablation electrodes are arranged on the electrode ring 20, so that the ablation of the annular 8 points can be completed once, the ablation efficiency is improved, and meanwhile, the distance between ablation points can be precisely controlled through uniform annular distribution of the ablation electrodes, so that the probability of repeating or missing the ablation points is greatly reduced. In addition, the electrode ring 20 in the embodiment of the invention has larger diameter and certain opening tension in the open state, an operator can flexibly control the diameter of the electrode ring 20 by controlling the traction wire to realize the change of the diameter of the electrode ring 20 according to the requirement, so that the electrode ring 20 of the invention can adapt to blood vessels with different diameters, the contact quality of the electrode and the inner wall of the blood vessel is improved, and the invention also adds a radio frequency switch for controlling each electrode ring 20 at the handle end of the catheter, thereby realizing the flexible control of the number of single ablation electrodes and completing the independent punctiform ablation control of different blood vessel parts.
Furthermore, the catheter handle in the embodiment of the invention is also provided with a control panel, and any ablation electrode is controlled to be opened and closed through the control panel so as to meet the ablation requirements under different operation conditions.
Of course, the specific arrangement mode can be set by those skilled in the art according to actual needs, and the invention is not limited in particular, as long as the switching on and off of the ablation electrode can be realized.
Further, in practice, the device according to the embodiment of the present invention further comprises a first traction wire 6 and a second traction wire 22, the first traction wire 6 and the second traction wire 22 being passed through the guide sleeve 7 into the sliding handle chute 16 in the guide handle 10, and finally the first traction wire 6 and the second traction wire 22 being fixed to the traction wire sliding point 9 in the sliding handle chute 16;
The first end of the first traction wire 6 is arranged at the top end of the ring part 18, namely, the attachment point of the first traction wire 6 is the top end of the ring part 18, and the first traction wire 6 extends to the catheter handle through the catheter 4 along the ring part 18 and the connecting part 19 through the top end, so that the catheter handle can control the bending diameter of the electrode ring 20 through the first traction wire 6;
Specifically, the embodiment of the invention is based on the first traction wire 6 by the sliding handle 8 of the catheter 4 with the head bent on the catheter handle so as to control the bending diameter of the ring part 18;
The second pull wire 22 is arranged at a second pull wire attachment point 5 at a first end of the catheter 4, which is the end of the catheter 4 on the side connected to the connection 19, the second pull wire 22 extending through the catheter 4 up to the catheter handle, so that the catheter handle can control the bending of the first end of the catheter 4 by means of the second pull wire 22.
That is, the present embodiment is controlled by adjusting the diameter of the electrode ring 20 on the catheter handle based on the second pull wire 22 to control the curvature of the first end of the catheter 4.
In short, the embodiment of the invention can also control the diameter of the electrode ring 20 and the bending condition of the catheter 4 through two control pieces on the catheter handle respectively by different traction wires, so that the electrode ring 20 finally reaches a preset position and the ablation treatment is carried out on the position.
It should be noted that, in the embodiment of the present invention, the first traction wire 6 and the second traction wire 22 may be made of very thin steel wire materials. One end of the wire is disposed on the tip of the electrode ring 20 and the first end of the catheter 4, and the other end of the wire is disposed on a control member of the catheter handle, so that the electrode ring 20 and the catheter 4 are controlled by manipulating the control member.
In the embodiment of the invention, the tail of the guiding handle 10 is provided with the handle socket 11, and the tail is connected with the tail plug 12 and the tail connector 13 through the handle socket 11, so that the tail connection with the tail 14 is realized.
In addition, the tail of the guiding handle 10 of the embodiment of the invention is also provided with an electrode ring 20 operation plate joint 15, through which the control terminal realizes specific control of the electrode ring 20.
As shown in fig. 9, the device according to the embodiment of the present invention further includes a marking portion, which is disposed 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;
A first position mark a for marking the ring 18 to be changed from a ring shape to a straight shape, and the straight ring 18 completely enters the guide sheath;
A second position mark B for marking the complete entry of the ring portion 18 from the introducer sheath into the sheath tube 23;
a third position mark C for marking that the top end of the ring portion 18 is flush with the outlet end of the sheath 23;
A fourth position indicator D for indicating that the annular portion 18 is fully extended beyond the outlet end of the sheath 23 and is restored to the annular state.
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 guiding sheath 21 is 10.5 cm, the distance between the first position mark a and the end of the straightened electrode ring 20 is 10.5 cm, the distance between the second position mark B18 and the first position mark a is 10.5 cm, the distance between the second position mark B and the top of the straightened electrode ring 20 is 21 cm, the distance between the third position mark C and the top of the straightened electrode ring 20 is 85 cm, the distance between the fourth position mark D and the top of the straightened electrode ring 20 is 90.5 cm, and the distance between the fourth position mark D and the root of the electrode ring 20 is 85 cm.
In a word, the embodiment of the invention can adjust the posture and the angle of the electrode ring through controlling the control part, so that the electrode ring is well connected with the original ablation line, the ablation efficiency and the quality are improved, and the damage range is reduced.
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 accordingly the scope of the invention is not limited to the embodiments described above.
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| CN113995504B (en) * | 2021-10-22 | 2024-04-19 | 苏州中荟医疗科技有限公司 | Ablation device |
| CN114288013A (en) * | 2021-12-24 | 2022-04-08 | 杭州堃博生物科技有限公司 | Control method and device for radiofrequency ablation and radiofrequency ablation assembly |
| CN115024812A (en) * | 2022-01-27 | 2022-09-09 | 苏州心岭迈德医疗科技有限公司 | Ablation catheter with adjustable supporting rod and equipment |
| CN116115321A (en) * | 2022-12-30 | 2023-05-16 | 乐普医学电子仪器股份有限公司 | A pulsed electric field ablation catheter and ablation method thereof |
| CN117481789B (en) * | 2024-01-03 | 2024-04-02 | 梅奥心磁(杭州)医疗科技有限公司 | Double-energy multifunctional electrophysiology catheter |
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| US5242441A (en) * | 1992-02-24 | 1993-09-07 | Boaz Avitall | Deflectable catheter with rotatable tip electrode |
| US9308041B2 (en) * | 2010-12-22 | 2016-04-12 | Biosense Webster (Israel) Ltd. | Lasso catheter with rotating ultrasound transducer |
| US9220433B2 (en) * | 2011-06-30 | 2015-12-29 | Biosense Webster (Israel), Ltd. | Catheter with variable arcuate distal section |
| US10064678B2 (en) * | 2011-10-26 | 2018-09-04 | Medtronic Ablation Frontiers Llc | Semi-circular pulmonary vein ablation catheter |
| CN102579031B (en) * | 2012-01-19 | 2014-10-01 | 洪浪 | Right ventricular outflow tract mapping and angiographic catheter and preparation method of angiographic catheter |
| RU2593979C1 (en) * | 2012-08-24 | 2016-08-10 | Симап Медикал (Сучжоу), Лтд. | Device for mapping and removal of renal nerves, located in renal artery |
| CN210990694U (en) * | 2019-07-31 | 2020-07-14 | 江西同德药业发展有限公司 | Needle-shaped condensable and absorbable ablation electrode |
| CN111789587B (en) * | 2020-07-29 | 2024-02-09 | 绍兴梅奥心磁医疗科技有限公司 | Mapping catheter device and mapping method |
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