CN117257438A - Dual-energy mapping ablation catheter - Google Patents

Dual-energy mapping ablation catheter Download PDF

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Publication number
CN117257438A
CN117257438A CN202311555594.8A CN202311555594A CN117257438A CN 117257438 A CN117257438 A CN 117257438A CN 202311555594 A CN202311555594 A CN 202311555594A CN 117257438 A CN117257438 A CN 117257438A
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China
Prior art keywords
electrode
catheter
basket
ablation
annular
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CN202311555594.8A
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CN117257438B (en
Inventor
卢才义
陈越猛
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Mayo Xinci Hangzhou Medical Technology Co ltd
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Mayo Xinci Hangzhou Medical Technology Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • A61B18/1206Generators therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345Vascular system
    • A61B2018/00351Heart
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577Ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • A61B18/14Probes or electrodes therefor
    • A61B2018/1405Electrodes having a specific shape
    • A61B2018/1407Loop
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • A61B18/14Probes or electrodes therefor
    • A61B2018/1467Probes or electrodes therefor using more than two electrodes on a single probe

Abstract

The invention provides a dual-energy mapping ablation catheter, which comprises: the catheter comprises a catheter body, a basket electrode and an annular electrode, wherein the basket electrode is arranged at the end part of the catheter body, the basket electrode is in a retracted state and an expanded state, the catheter body is provided with a catheter outlet, and the axial position of the catheter outlet on the catheter body is positioned at the rear end of the basket electrode. The annular electrode is accommodated in the catheter body and can extend out from the catheter outlet to be in annular expansion, and comprises an annular body and a plurality of first ablation electrodes which are arranged on the annular body at intervals, wherein the first ablation electrodes are perpendicular to the annular body and extend in a bending mode towards the direction of the basket-shaped electrode. The dual-energy mapping ablation catheter can be accommodated in the catheter body, so that the operation of the ablation catheter in the body is facilitated. Moreover, the first ablation electrode on the annular body is arranged in a structure form of bending and extending perpendicular to the annular body, so that the ablation effect can be improved by adapting to the vestibular intima surface of an irregular pulmonary vein.

Description

Dual-energy mapping ablation catheter
Technical Field
The invention relates to the technical field of ablation catheters, in particular to a dual-energy mapping ablation catheter.
Background
Clinically, the basic procedure for catheter ablation treatment of atrial fibrillation is to electrically isolate the vestibular region of the 4 pulmonary vein openings in the left atrium. The methods commonly used at present are as follows: catheter radio frequency ablation, catheter cryoballoon ablation, catheter ultrasound balloon ablation, catheter pulsed electric field ablation.
The shape, number and distribution of the electrodes at the catheter tip are also significantly different due to the different ablation energies employed. The catheter radio frequency ablation generally adopts a columnar electrode with the outer diameter of 8F, spot ablation is carried out in a monopolar mode, and an electrical loop is formed by a sheet-shaped reference electrode positioned on the skin of the body surface of a patient; the ablation method is characterized by being suitable for the ablation of almost all arrhythmia focuses, and not only can form ablation points and ablation surfaces, but also can be combined into various types of ablation lines through a single ablation point; the disadvantage is the low ablation efficiency and the non-selective damage to the lesion and surrounding tissue.
Catheter cryoballoon ablation generally adopts a shuttle-shaped balloon, and irreversible cryodamage can be caused to the opening part of a target blood vessel contacted with the middle part of the balloon by filling and recovering cryogen into the balloon; the ablation mode has the advantages that the ablation efficiency is high, and the accuracy of positioning can be checked by trial ablation; the balloon with the fixed outer diameter is difficult to adapt to different pulmonary vein diameters of different patients, continuous X-ray perspective guidance is needed, point-shaped ablation mode point supplement is needed when ablation leakage points occur, and operation cost is increased.
The catheter ultrasonic balloon ablation technology has the advantages of simple and convenient use and operation, but has the defect that the ultrasonic energy transmitted by the catheter is difficult to cause transmural injury of the vestibular part of the pulmonary vein, the recurrence rate of postoperative atrial fibrillation is relatively high, and the catheter ultrasonic balloon ablation technology is rarely used for clinic at present.
The ablation mode of catheter pulse electric field ablation is equivalent to that of a catheter ablation technology adopting columnar ablation electrodes and radio frequency energy, combined damage to an ablation surface and an ablation line can be realized by forming ablation points, and sheet-shaped or linear ablation can be performed by sequential or matrix electrodes of a special-shaped catheter. The pulsed electric field ablation technology has the advantages of strong tissue selectivity and high ablation efficiency; the defect is that the pain of the patient is obvious when discharging, the existing multipolar catheter is difficult to be coaxial with the pulmonary vein well and realize continuous and stable tissue contact, the ablation electrode is difficult to be attached to the tissue well at the same time, repeated position changing and repeated ablation are needed, and the operation efficiency and the long-term effect are affected.
Disclosure of Invention
The invention provides a dual-energy mapping ablation catheter, which aims to solve the technical problem of how to optimally design the ablation catheter.
A dual energy mapping ablation catheter according to an embodiment of the invention includes:
a catheter body provided with a catheter outlet;
the basket electrode is arranged at the end part of the catheter body and is provided with a retracted state and an expanded state, and the axial position of the catheter outlet on the catheter body is positioned at the rear end of the basket electrode;
the annular electrode is accommodated in the catheter body and can extend out of the catheter outlet to be in annular expansion, the annular electrode comprises an annular body and a plurality of first ablation electrodes arranged on the annular body at intervals, and when the annular electrode is in an annular expansion state, the plurality of first ablation electrodes are perpendicular to the annular body and extend in a bending mode towards the direction of the basket electrode.
According to the dual-energy mapping ablation catheter disclosed by the embodiment of the invention, the annular electrode can be accommodated into the catheter body, and the basket electrode can also be switched into a retracted state so as to facilitate the operation of the ablation catheter in a body. Moreover, the first ablation electrode on the annular body is perpendicular to the annular body and extends towards the basket-shaped electrode in a bending mode, so that the first ablation electrode on the annular body can adapt to the vestibular intima surface of an irregular pulmonary vein, and the ablation effect is improved.
According to some embodiments of the invention, the annular electrode has an outer diameter that is adjustable in both the annular expanded state and the basket electrode has an outer diameter that is greater in the maximum annular expanded state than in the maximum expanded state.
In some embodiments of the invention, the basket electrode comprises:
a distal end fixing ring fixed on the catheter body as a fulcrum for switching the basket-shaped electrode state;
the shape memory basket bone comprises a plurality of basket bones, a plurality of second ablation electrodes are arranged on the basket bones, the initial preformed state of each basket bone is semicircular, and one ends of the plurality of basket bones are connected with a far-end fixing ring;
the proximal end fixing ring is slidably arranged on the catheter body, and the other ends of the basket bones are connected with the proximal end fixing ring;
the traction steel wire is connected with the proximal end fixing ring and used for adjusting the basket bones between the straight line and the semicircle so as to realize the switching control of the basket-shaped electrode between the contracted state and the expanded state.
According to some embodiments of the invention, a plurality of mapping electrodes are arranged on the basket bones at intervals, and the mapping electrodes of the basket bones jointly form an electrode matrix for non-contact mapping.
In some embodiments of the invention, auxiliary reference electrodes are provided on the annular body on both sides of each first ablation electrode.
According to some embodiments of the invention, the axial front end of the basket electrode is provided with a columnar ablation electrode having a radiofrequency ablation mode and a pulsed electric field ablation mode.
In some embodiments of the invention, the columnar ablation electrode is provided with a plurality of irrigation micropores, the diameter of the irrigation micropores being no greater than 0.1mm.
According to some embodiments of the invention, a pressure deformation sensing device is arranged between the columnar ablation electrode and the basket electrode, and the pressure deformation sensing device comprises:
a deformation spring, one end of which is connected with the bottom of the columnar ablation electrode in an insulating way,
the piezoelectric crystal is connected with the other end of the deformation spring in an insulating way;
and the signal wire is connected with the piezoelectric crystal.
In some embodiments of the present invention, the catheter wall thickness outside the pressure deformation sensing device is no greater than 0.1mm, using an ultra-thin flexible material with low damping characteristics.
According to some embodiments of the invention, an operating handle is arranged at one end of the catheter body far away from the basket electrode, the operating handle is provided with a catheter head end double-bend adjusting knob, a basket electrode outer diameter adjusting knob and an annular electrode advancing and retreating hole, and an annular electrode diameter adjusting knob is arranged close to the operating handle.
Drawings
FIG. 1 is a schematic structural view of a dual energy mapping ablation catheter in accordance with an embodiment of the invention, wherein basket electrodes and ring electrodes are in a retracted state;
FIG. 2 is a schematic structural view of a dual energy mapping ablation catheter in accordance with an embodiment of the invention, wherein basket electrodes and ring electrodes are in a deployed state;
FIG. 3 is a schematic view of a head end configuration of a dual energy mapping ablation catheter in accordance with an embodiment of the invention, wherein basket electrodes and ring electrodes are in a retracted state;
FIG. 4 is a schematic view of a head end configuration of a dual energy mapping ablation catheter in accordance with an embodiment of the invention, wherein basket electrodes and ring electrodes are in a deployed state;
FIG. 5 is a schematic view of a head end configuration of a dual energy mapping ablation catheter in accordance with an embodiment of the invention, wherein basket electrodes and ring electrodes are in a deployed state;
FIG. 6 is a partial schematic view of a head end of a dual energy mapping ablation catheter in accordance with an embodiment of the invention;
FIG. 7 is a schematic cross-sectional view of a dual energy mapping ablation catheter in accordance with an embodiment of the invention;
fig. 8 is a schematic view of the operating handle of a dual energy mapping ablation catheter in accordance with an embodiment of the invention.
Reference numerals:
the catheter 100 is ablated,
the catheter body 10, the catheter outlet 101, the protective sleeve 120, the annular electrode channel tube 102, the catheter head end bending traction wire and the channel 103 thereof, the basket electrode stretching traction wire and the channel 104 thereof, the columnar ablation electrode perfusion tube 105,
basket electrode 20, distal fixation ring 210, basket bone 220, proximal fixation ring 230, traction wire 240, second ablation electrode 250,
the ring electrode 30, the ring body 300, the tube 301, the first ablation electrode 310, the auxiliary reference electrode 320, the signal wire 330, the ring electrode diameter adjusting guide wire and the channel 340 thereof, the second positioning chip 350,
columnar ablation electrode 40, irrigation microwells 410, temperature sensor 420, first positioning chip 430,
pressure deformation sensing device 50, deformation spring 510, piezoelectric crystal 520, signal wire 530,
operating handle 60, catheter tip double bend adjustment knob 610, basket electrode outside diameter adjustment knob 620, ring electrode diameter adjustment knob 630, ring electrode channel flush tube 640, basket electrode irrigation interface 650, basket electrode tail 651, ring electrode catheter tail 661, ring electrode irrigation interface 662,
distal reference electrode 70, proximal reference electrode 80, visualization electrode 90.
Detailed Description
In order to further describe the technical means and effects adopted by the present invention for achieving the intended purpose, the following detailed description of the present invention is given with reference to the accompanying drawings and preferred embodiments.
At present, in most of arrhythmia treatment centers at home and abroad, multipolar catheters adopting a pulse electric field as ablation energy mainly comprise: basket multipolar electrode catheters and annular multipolar electrode catheters. The operation process and advantages and disadvantages are as follows:
basket multipolar electrode catheter:
the operation process comprises the following steps: a1, delivering a basket electrode to a pulmonary vein opening under the guidance of a pulmonary vein guide wire; a2, adjusting the outer diameter of the basket to adapt to the size of the vestibule of the pulmonary vein; a3, judging the contact quality of the electrode and the tissue through the vestibular potential; a4, synchronizing multipolar discharge in different electrode combination modes; a5, when the tissue ablation ring has an ablation leakage point, the position of the basket electrode is adjusted and then the discharge is carried out again until the pulmonary vein electrical isolation is realized.
The advantages are that: 1. the ablation efficiency is high; 2. the size of the pulmonary vein opening of different individuals can be adapted by changing the outer diameter of the basket; 3. multiple electrode combinations discharge modes.
Disadvantages: 1. the ablation site is the pulmonary vein opening, not the actual pulmonary vein vestibule; 2. variations in catheter coaxiality will cause the ablation zone to deviate from the pulmonary vein opening and even into the pulmonary vein; 3. the relative position relation between all ablation electrodes and the pulmonary vein opening cannot be accurately judged through the change of the outer diameter of the basket; 4. when the morphology of the vestibule of the pulmonary vein is irregular, it cannot be guaranteed that all electrodes can be well attached to and kept on a preset ablating loop; 5. the parts outside the pulmonary vein opening cannot be ablated; 6. the three-dimensional modeling and high-density mapping functions are not provided; 7. adjusting the guide wire to enter different pulmonary veins requires perspective guidance, and increases the risk of radiation injury; 8. when a leakage point which is difficult to ablate appears on an endocardial ablation loop, remedial ablation cannot be performed in a punctiform ablation mode; 9. the flexible electrode does not have perfusion function, and has the risks of micro thrombus, micro air embolism, high ablation impedance and the like.
Annular multipolar electrode catheter:
the operation process is as follows: b1, delivering the annular electrode to the pulmonary vein opening under the guidance of the pulmonary vein guide wire; b2, adjusting the outer diameter of the electrode ring to adapt to the size of the vestibule of the pulmonary vein; b3, properly advancing the electrode ring to increase the contact quality between the electrode and the tissue; b4, forming a bipolar mode synchronous multipolar discharge by two adjacent electrodes; and B5, when an ablation leakage point exists in the tissue ablation ring, discharging again after adjusting the position of the electrode ring until the pulmonary vein electrical isolation is realized.
The advantages are that: 1. the ablation efficiency is high; 2. the size of the pulmonary vein opening of different individuals can be adapted by changing the outer diameter of the electrode ring; 3. adjacent electrode pairs have multiple combined discharge modes.
Disadvantages: 1. because the inner membranous surface of the vestibule part of the pulmonary vein is irregular and uneven, it is difficult to ensure that all electrodes on the electrode ring can reach good contact and stable adhesion with tissues at the same time; 2. because the coaxiality of the guide wire in the pulmonary vein is greatly changed, the coaxiality quality of the electrode ring at the vestibular part of the pulmonary vein is difficult to ensure; 3. when the outer diameter of the electrode ring is changed, the situation that all electrodes on the electrode ring are approximately equidistant from the axis of the pulmonary vein opening is not ensured, and poor electrode adhesion is easily caused; 4. the parts outside the pulmonary vein opening cannot be ablated; 5. the three-dimensional modeling and high-density mapping functions are not provided; 6. adjusting the guide wire to enter different pulmonary veins requires perspective guidance, and increases the risk of radiation injury; 7. when a leakage point which is difficult to ablate appears on the endocardium ablation loop, remedial ablation can not be performed in a punctiform ablation mode.
In addition, there is also a related art that employs a combination of a ring electrode and a basket electrode, such as an ablation catheter for arrhythmia treatment disclosed in the CN213963615U patent, in which the treatment effect is improved by combining the ring electrode and the basket electrode.
However, in the above-mentioned scheme, the annular catheter is disposed at the forefront end of the ablation catheter, which affects the convenience of the operation of the ablation catheter. In addition, the electrode on the annular catheter is arranged on the surface of the annular catheter, so that the irregular vestibular intima surface of the pulmonary vein cannot be effectively attached, and the ablation effect is affected.
To solve the above problems, the present invention proposes a dual-energy mapping ablation catheter 100.
As shown in fig. 1-5, a dual energy mapping ablation catheter 100 according to an embodiment of the invention includes: catheter body 10, basket electrode 20, and ring electrode 30.
Wherein the catheter body 10 is provided with a catheter outlet 101; basket electrode 20 is disposed at the end of catheter body 10, basket electrode 20 having a retracted state and an extended state. As shown in fig. 3, when the basket electrode 20 is in the retracted state, the basket electrode 20 is entirely linear; as shown in fig. 4 and 5, when the basket electrode 20 is in the expanded state, the basket electrode 20 is expanded in a net shape.
The axial position of the catheter outlet 101 on the catheter body 10 is at the rear end of the basket electrode 20. That is, basket electrode 20 is disposed near the front end, and catheter outlet 101 is located at the rear end of basket electrode 20.
The ring electrode 30 is housed in the catheter body 10 and can be extended out of the catheter outlet 101 in a ring shape. As shown in fig. 3, the ring electrode 30 may be received within the catheter body 10 to facilitate in vivo manipulation of the ablation catheter 100; as shown in fig. 4 and 5, the ring electrode 30 may also extend out of the catheter outlet 101 in a ring-like deployment.
As shown in fig. 4 and 5, the ring electrode 30 includes a ring body 300 and a plurality of first ablation electrodes 310 provided on the ring body 300 at intervals, and when the ring electrode 30 is in a ring-shaped deployed state, the plurality of first ablation electrodes 310 are perpendicular to the ring body 300 and are bent and extended toward the basket electrode 20. As shown in fig. 4 and 5, a plurality of first ablation electrodes 310 are perpendicularly protruded from the surface of the ring-shaped body 300 and are fully extended toward the front end.
According to the dual energy mapping ablation catheter 100 of the embodiment of the invention, the ring electrode 30 can be received into the catheter body 10, and the basket electrode 20 can also be switched to a retracted state to facilitate operation of the ablation catheter 100 in the body. Moreover, the first ablation electrode 310 on the annular body 300 is arranged to be perpendicular to the annular body 300 and is bent and extended towards the basket electrode 20, so that the first ablation electrode 310 on the annular body 300 can adapt to the irregular vestibular intima surface of the pulmonary vein, and the ablation effect is improved.
According to some embodiments of the present invention, the outer diameter of the ring electrode 30 when deployed annularly and the outer diameter of the basket electrode 20 when deployed are both adjustable, and the outer diameter of the ring electrode 30 in its maximum annular deployed state is greater than the outer diameter of the basket electrode 20 in its maximum deployed state.
The ring electrode 30 of the present invention is disposed behind the basket electrode 20, and the maximum outer diameter of the basket electrode 20 disposed in front is smaller than the maximum outer diameter of the ring electrode 30 disposed behind, so that the ablation catheter 100 can be moved conveniently, the basket electrode 20 disposed in front can be inserted into a relatively smaller pulmonary vein space and supported and fixed by the ring electrode 30 disposed behind, and the basket electrode 20 disposed in the entrance of the pulmonary vein opening can ensure coaxial abutment of the ring electrode 20 and the vestibule of the pulmonary vein, thereby improving the stability and reliability of the ablation operation.
In some embodiments of the present invention, as shown in fig. 3-5, basket electrode 20 comprises: a distal fixation ring 210, a shape memory basket bone, a proximal fixation ring 230, and a traction wire 240.
Wherein, the distal end fixing ring 210 is fixed on the catheter body 10 and used as a fulcrum for switching the state of the basket electrode 20; the shape memory basket bone comprises a plurality of basket bones 220, a plurality of second ablation electrodes 250 are arranged on the basket bones 220, the initial preformed state of each basket bone 220 is semicircular, and one ends of the plurality of basket bones 220 are connected with the distal fixing ring 210; the proximal end fixing ring 230 is slidably arranged on the catheter body 10, and the other ends of the basket bones 220 are connected to the proximal end fixing ring 230; a traction wire 240 is connected to the proximal fixation ring 230 for adjustment of the plurality of basket bones 220 between straight and semi-circular shapes to effect switching control of the basket electrode 20 between the contracted and expanded states.
According to some embodiments of the present invention, a plurality of mapping electrodes are disposed on the basket bone 20 at intervals, and the mapping electrodes of the plurality of basket bones together form an electrode matrix for performing non-contact mapping.
The basket electrode 20 of the present invention has the following functions: 1. freely adjusting the outer diameter of the basket so as to adapt to pulmonary veins with different inner diameters of different individuals; 2. the basket-like structure entering the pulmonary vein opening can ensure that the annular electrode 30 is coaxially abutted with the vestibule of the pulmonary vein; 3. the potential change inside the pulmonary veins can be continuously monitored during the ablation process; 4. three-dimensional modeling can be independently completed; 5. high-density mapping of ectopic foci can be independently completed; 6. the non-contact mapping can be accomplished alone or in combination with the ring electrode 30.
In some embodiments of the present invention, as shown in fig. 5, auxiliary reference electrodes 320 are provided on both sides of each of the first ablation electrodes 310 on the ring-shaped body 300.
The ring electrode 30 of the present invention has the following functions:
1. the synchronous discharge ablation of the pulse electric field and multiple electrodes can be realized through the electrode ring;
2. a variety of non-contact mapping can be accomplished alone or in conjunction with basket electrode 20;
3. can be fully retracted into the catheter body 10 to function as a catheter tip columnar ablation electrode 40 and/or basket electrode 20;
4. the outer diameter of the electrode ring can be freely adjusted so as to adapt to the size and shape of the vestibule of the pulmonary veins of different individuals;
5. the first ablation electrode 310 in an orthogonal bending mode which is 3mm higher than the plane of the electrode ring is designed at the position of the annular electrode 30 which is abutted against the tissue, so as to overcome the convex-concave unevenness of the tissue of the vestibular inner membrane surface of the pulmonary vein and realize the synchronous and stable abutting of multiple electrodes;
6. the annular electrode 30 can be sent to a position beyond the head end columnar electrode, which is beneficial to selectively ablating the junction of the upper and lower pulmonary veins and realizing the isolation of the large rings of the double pulmonary veins;
7. each annular electrode 30 is designed with a saline perfusion micropore, which is beneficial to preventing micro thrombosis, eliminating micro bubbles and reducing the ablation impedance of a pulse electric field;
8. each ring electrode 30 is designed with a first ablation electrode 310 and an auxiliary reference electrode 320, which are capable of ablating in three modes at the same location: a first ablation electrode auxiliary reference electrode clockwise sequence, a first ablation electrode-reference electrode anticlockwise sequence, a first ablation electrode-first ablation electrode sequence;
9. the non-contact mapping can be accomplished alone or in combination with basket electrode 20.
According to some embodiments of the present invention, the axially forward end of basket electrode 20 is provided with a cylindrical ablation electrode 40, the cylindrical ablation electrode 40 having a radiofrequency ablation mode and a pulsed electric field ablation mode.
In some embodiments of the present invention, as shown in fig. 3-5, the columnar ablation electrode 40 is provided with a plurality of irrigated micro-holes 410, the irrigated micro-holes 410 having a diameter of no greater than 0.1mm.
The columnar ablation electrode 40 of the present invention has the following functions: 1. the ablation energy can be freely switched between radio frequency ablation energy and pulse electric field ablation energy; 2. the lateral surface and the front surface of the electrode are provided with more than 50 evenly distributed perfusion micropores 410, which is beneficial to preventing micro thrombosis, eliminating micro bubbles, reducing the ablation impedance of a pulse electric field and preventing electrode eschar, bubbles and knocking during radio frequency ablation; 3. when the basket electrode 20 and the ring electrode 30 are completely recovered, the columnar ablation electrode 40 can be used as a conventional ablation catheter 100, and spot, sheet and linear ablations are independently completed.
According to some embodiments of the present invention, as shown in fig. 6, a pressure deformation sensing device 50 is provided between the columnar ablation electrode 40 and the basket electrode 20, and the pressure deformation sensing device 50 includes: deformation spring 510, piezoelectric crystal 520, and signal wire 530.
One end of the deformation spring 510 is connected with the bottom of the columnar ablation electrode 40 in an insulating manner, the piezoelectric crystal 520 is connected with the other end of the deformation spring 510 in an insulating manner, and the signal wire 530 is connected with the piezoelectric crystal 520.
The pressure deformation sensing device 50 disposed at the tip of the catheter transmits the pressure direction and the magnitude of the tip of the catheter to the piezoelectric crystal 520 through the flexible deformation spring 510, so that the pressure direction and the magnitude of the tip of the catheter can be indicated in a positive direction and a 120-degree axial direction.
In some embodiments of the present invention, the catheter wall thickness outside of the pressure deformation sensing device 50 is no greater than 0.1mm, using an ultra-thin flexible material with low damping characteristics.
According to some embodiments of the present invention, as shown in fig. 8, an operation handle 60 is provided at an end of the catheter body 10 remote from the basket electrode 20, the operation handle 60 is provided with a catheter head end double-bend adjustment knob 610, a basket electrode outer diameter adjustment knob 620, and an annular electrode advancing and retreating hole, and an annular electrode diameter adjustment knob 630 is provided near the operation handle 60. As shown in fig. 8, the tubular body 301 of the ring electrode 30 extends from the ring electrode advancing/retreating hole.
In summary, the dual-energy mapping ablation catheter 100 according to the present invention can be completed by using the same catheter: 1. three-dimensional modeling; 2. ectopic focus contact and non-contact high density mapping; 3. continuously monitoring pulmonary vein potential in the whole ablation process; 4. the ring electrode 30 is automatically coaxial with the pulmonary vein vestibule; 5. the orthogonal first ablation electrode 310 can be adaptively abutted with the vestibular ablation line; 6. synchronous ablation of a plurality of multipolar discharge modes of a pulsed electric field; 7. multipolar synchronous ablation is carried out on the junction of the upper pulmonary vein and the lower pulmonary vein, so that electrical isolation of the large rings of the double pulmonary veins is realized; 8. the free switching pulse electric field and the radio frequency dual energy complete point-shaped, sheet-shaped, linear and annular ablation.
The dual energy mapping ablation catheter 100 of the present invention is described in detail below in one specific embodiment with reference to the accompanying drawings. It is to be understood that the following description is exemplary only and is not to be taken as limiting the invention in any way.
The dual energy mapping ablation catheter 100 of the present invention has three non-contact mapping modes: 1. a reference electrode and basket electrode 20 matrix non-contact mapping pattern; 2. a reference electrode and ring electrode 30 non-contact mapping mode; 3. the reference electrode is associated with the basket electrode 20 and the ring electrode 30 in a non-contact mapping mode.
As shown in fig. 1-8, the dual energy mapping ablation catheter 100 of the present invention includes: the cylindrical ablation electrode 40, the distal reference electrode 70, the pressure deformation sensing device 50, the proximal reference electrode 80, the telescopic variable outer diameter multipolar basket electrode 20, the visualization electrode 90, the protective sleeve 120, the catheter head end double-bend adjusting knob 610, the operating handle 60, the basket electrode outer diameter adjusting knob 620, the annular electrode channel flushing pipe 640 and the joint, the cylindrical ablation electrode 40, the joint tail joint of the pressure deformation sensing device 50 and the basket electrode 20, the basket electrode pouring interface 650, the basket electrode tail 651, the cylindrical ablation electrode pouring pipe 105 and the joint, the adjustable outer diameter multipolar annular electrode 30, the annular electrode outer diameter adjusting knob 630, the annular electrode channel flushing pipe 640, the annular electrode catheter tail 661 and the joint, and the annular electrode pouring interface 662.
Specific structures, parameters and functional features of the above components are described below.
1. A columnar ablation electrode 40. Referring to fig. 1 and 6, the columnar ablation electrode 40 has an outer diameter 8F, a length of 3mm, a platinum iridium alloy, a double-layer hollow structure on the outer wall, 50 micropores penetrating through the side wall and the head end to the outside, a maximum perfusion flow of 100ml/min, and more than 2 temperature sensors 420 and more than 1 first positioning chips 430 arranged inside the columnar ablation electrode 40.
The bottom of the columnar ablation electrode 40 is connected with a signal wire, an infusion microtube and a deformation spring 510, and the bottom of the deformation spring 510 is connected with 3 piezoelectric crystals 520 distributed at 120 degrees, so that the pressure and the direction conducted by the columnar ablation electrode 40 and the deformation spring 510 can be sensed and displayed with 120-degree axial resolution.
2. A distal reference electrode 70. As shown in fig. 1 and 3, the distal reference electrode 70 is a platinum iridium alloy ring electrode with a wall thickness of 0.1mm and a length of 2mm, is spaced apart from the columnar ablation electrode 40 by not more than 2mm, and is connected with a signal line on the inner side for recording unipolar potential and bipolar potential as a reference electrode of the columnar ablation electrode 40, respectively.
3. A pressure deformation sensing means 50. As shown in fig. 6, the pressure deformation sensing device 50 is composed of a deformation spring 510 of a head portion, a piezoelectric crystal 520 of a middle portion, and a signal wire 530 of a tail portion.
Wherein, the diameter of the deformation spring 510 is not more than 2.5mm, the length is not more than 10mm, the maximum deformation pressure is not less than 500g, the deformation sensitivity is not more than 0.1g, the head is connected with the bottom of the columnar ablation electrode 40 in an insulating manner, and the tail is connected with more than 3 piezoelectric crystals 520 distributed in equal angle.
The deformation sensitivity of the piezoelectric crystals 520 is not more than 0.1g, the maximum perceived pressure is not less than 500g, and each piezoelectric crystal 520 is respectively connected with a respective signal line.
The thickness of the catheter wall outside the pressure deformation sensing device 50 is not more than 0.1mm, and is made of ultrathin flexible materials with low damping characteristics, and the catheter body 10 is respectively connected to the bottom of the columnar ablation electrode 40 at the head end and the catheter body 10 at the tail end; the ultra-thin tube wall can not only furthest reduce the motion damping of the columnar ablation electrode 40 and the deformation spring 510 and protect the deformation sensitivity of the deformation spring 510, but also maintain the flexibility, continuity and integrity of the outer wall of the ablation catheter 100.
4. A proximal reference electrode 80. As shown in fig. 6, the proximal reference electrode 80 is a ring electrode, platinum-iridium alloy, with a wall thickness of 0.1mm and a length of 2mm, and is spaced apart from the columnar ablation electrode 40 by more than 5mm, and the inner side is connected with a signal wire, and the electrode pair formed by the distal fixing ring 210 of the basket electrode 20 adjacent to the electrode pair is used for recording monopolar potential and recording bipolar potential at the proximal end of the columnar ablation electrode 40.
5. Telescoping variable outer diameter multipolar basket electrode 20. As shown in fig. 2-5, basket electrode 20 is comprised of a distal fixation ring 210, a shape memory basket, a basket mapping electrode set, a proximal fixation ring 230, a traction wire 240, and a mapping electrode lead.
Wherein, the material of the distal fixing ring 210 is platinum iridium alloy, the length is not more than 5mm, the distance between the distal fixing ring and the proximal reference electrode 80 is not more than 2mm, and the inner side is connected with a signal wire. The device is mainly used for fixing the head ends of more than 6 memory basket bones, and is also fixed with the catheter body 10, and is used as a fulcrum for deformation and expansion of the basket-shaped electrode 20. Both unipolar potentials can be recorded, and bipolar potentials at the proximal end of the columnar ablation electrode 40 can be recorded in combination with the proximal reference electrode 80 to form an electrode pair.
The shape memory basket bone 220 is made of shape memory medical polyurethane material, the cross section of the shape memory basket bone is in a circular tube shape, more than 6 shape memory basket bones are arranged equidistantly; the outer diameter of the circular tube of the basket bone 220 is not more than 0.3mm, the length is not less than 10mm, and more than 3 annular electrode single electrodes are arranged equidistantly; the initial preformed state of the basket bones 220 is a semicircle having a radius of not less than 5mm, and the traction wire 240 adjusting the tail can adjust the size of the preformed semicircle between a straight line type and a semicircle, thereby freely changing the outer diameter of the basket electrode 20.
Basket mapping electrode set. More than 3 mapping electrodes are equidistantly arranged on a single basket bone 220, and all mapping electrodes of a plurality of basket bones 220 jointly form an electrode matrix; the electrode material is platinum iridium alloy, and the length is not more than 2mm; the length of the single electrode is not more than 2mm, and the inner side of the single electrode is connected with a wire; the electrode matrix in combination with the proximal visual reference electrode may enable non-contact mapping.
The length of the proximal end fixing ring 230 is not more than 5mm, and the proximal end fixing ring is used for fixing the tail ends of more than 6 memory basket bones 220, is not fixed with the catheter body 10, and can slide under the catheter body 10 under the basket bones 220; an outer diameter adjustment traction wire 240 of basket electrode 20 is connected to proximal fixation ring 230.
The head end of the traction steel wire 240 is connected with the proximal end fixing ring 230 of the basket electrode 20, and the tail end is connected with the basket electrode outer diameter adjusting knob 620 on the operating handle 60; the basket electrode 20 can be straightened by tightening the traction wire 240 by manipulating the basket electrode outer diameter adjustment knob 620 on the handle 60, and loosening the traction wire 240 to varying degrees can maintain the basket electrode 20 with different outer diameters to accommodate pulmonary veins of different inner diameters.
Basket mapping electrode mapping wires are connected to the inner side of the basket electrode 20 at the distal end and connected to the tail wire joint at the proximal end, and intensively run in the special microtubes of the wires of the catheter body 10.
6. The electrode 90 is visualized. As shown in fig. 1, the visual electrode 90 is a platinum iridium alloy annular electrode, the length is 2mm, and the inner side is connected with a wire; the number of the guide pipes is more than 2; the distance between the most far electrode and the annular electrode outlet is less than 5mm, and the electrode spacing is not less than 10mm; the device can be used for displaying the posture of the catheter head end on a three-dimensional image and can also be used as a reference electrode for non-contact mapping of the basket electrode 20 matrix.
7. And a protective sleeve 120. As shown in fig. 1, the protective sleeve 120 is positioned on the catheter body 10, is made of medical polyurethane material, has the length of not more than 60mm, the inner diameter of not less than 8F, and the thickness of the catheter wall of not more than 0.1mm, and can freely slide on the catheter body 10; for guiding and protecting the safe entry of the catheter head end into the sheath.
8. Referring to fig. 1 and 8, a catheter head double-bend adjusting knob 610 is located at the distal end of the operating handle 60 and is connected with a catheter head bending adjusting traction wire, the catheter head bending traction wire and a channel 103 thereof are as shown in fig. 7, and the control adjusting knob can realize the double-bend of the catheter head at different angles by tightening and loosening the traction wire.
9. Handle 60 is operated. As shown in fig. 1 and 8, the operating handle 60 is located at the tail of the catheter body 10 and has a length of not shorter than 50mm; the head end is connected with the catheter body 10, and the tail end is provided with a basket electrode outer diameter adjusting knob 620, an annular electrode advancing and retreating hole, a basket electrode infusion interface 650, an ablation electrode infusion joint, an annular electrode channel flushing pipeline 640, a joint, an electrode tail wire and a joint for holding and controlling the ablation catheter 100 by an operator. The annular electrode catheter tail 661 and annular electrode irrigation interface 662 are located at the rear end of the operating handle 60.
10. Basket electrode outer diameter adjustment knob 620. Referring to fig. 1 and 8, the basket electrode outer diameter adjusting knob 320 is located at the tail of the operating handle 60 and is connected to the tail end of the basket electrode outer diameter adjusting traction wire 240, the basket electrode telescopic traction wire and the channel 104 thereof are as shown in fig. 7, and the outer diameter of the matrix of the basket electrodes 20 can be freely adjusted by controlling the knob.
11. As shown in fig. 1 and 8, the ring-shaped electrode channel flushing pipe 640 and the joint are positioned at the tail part of the operating handle 60, are flexible medical plastic pipes, have the length not shorter than 50mm, and have medical plastic 3-way joints at the tail end.
12. As shown in FIG. 8, the joint tail joint of the columnar ablation electrode 40, the pressure deformation sensing device 50 and the basket electrode 20 is positioned at the tail of the operation handle 60, and the length is not less than 50mm.
13. As shown in fig. 8, the columnar ablation electrode perfusion tube and the joint are positioned at the tail part of the catheter control handle, have the length not smaller than 50mm, are provided with a buckle type joint and are used for being connected with a saline perfusion flow pump, and the maximum perfusion flow is not smaller than 50ml/min.
14. An adjustable outer diameter ring electrode 30. The outer diameter is not greater than 6F, the length is not shorter than the total length of the catheter body 10, and the medical polyurethane material, as shown in figure 7, runs inside the dedicated channel annular electrode channel tube 102. The self-adaptive attachment of the orthogonal electrode and the irregular vestibular intima surface can be realized in two ways: built-in shape memory semicircular orthogonal electrode catheters (fig. 4) and built-in shape memory spring-loaded orthogonal electrode catheters (fig. 5).
The following describes an example of a built-in shape memory semicircular orthogonal electrode catheter (fig. 4), its main structure and its uses include:
1. a shape memory electrode ring. The cross section of the catheter is of a circular tubular structure, and the outer diameter of the catheter is not more than 6F; the maximum diameter of the preformed memory ring is not more than 50mm and not less than 20mm; the different diameters of the annular electrode 30 can be changed and maintained by operating the annular electrode outer diameter adjusting knob 620 at the tail of the handle 60 so as to adapt to the different pulmonary vein vestibules; the handle of the catheter is advanced to the maximum extent, so that the plane of the electrode ring exceeds the head end of the columnar ablation electrode 40 by more than 2mm, and the electrode ring can be controlled to be singly attached to the joint parts of the upper pulmonary vein and the lower pulmonary vein; the handle of the catheter is retracted to the maximum extent that the catheter can be retracted into the catheter body 10 and the tip of the catheter held flush with the catheter outlet 101 at the distal end of the catheter.
2. Shape memory semicircular orthogonal electrodes. The number of the annular bodies 300 is not less than 6, and the annular bodies are distributed in sequence at equal intervals; in a preformed semicircular structure, the radius or the height is not less than 3mm and is perpendicular to the plane of the annular body 300; the electrode material platinum iridium alloy is an annular electrode, the inner side of the electrode material platinum iridium alloy is connected by a wire, the length of the electrode is not less than 5mm, and the surface of the electrode material platinum iridium alloy is provided with pouring micropores, and the number of the electrode material platinum iridium alloy is not less than 6; the distance between every two adjacent 2 orthogonal electrodes is not less than 5mm, and a reference electrode is arranged on each of the left side and the right side; after the annular electrode 30 is in stable contact with endocardial tissue, the annular electrode 30 is continuously advanced to increase the tissue attaching force, so that more semicircular orthogonal electrodes can be promoted to be more closely attached to the uneven vestibular part of the pulmonary vein.
3. The orthogonal ablation electrode perfuses the microwells. The diameter of the micropores is not more than 0.1mm, the micropores are uniformly opened on the surface of the orthogonal electrode, and the number of the micropores is not less than 6 and is the same as that of the honeycomb ducts of the electrode ring body.
4. Orthogonal ablation electrode leads. A special conduit which is positioned at the inner side of each orthogonal electrode and is clustered to run on the electrode ring body part.
5. The orthogonal electrodes assist the reference electrode 320 right and left. The distance between the electrodes and the orthogonal electrode is not less than 2mm, the length of the platinum iridium alloy is not more than 2mm, and the inner side of the platinum iridium alloy is connected with a wire; respectively combined with the orthogonal electrodes, can realize 2 synchronous bipolar ablation modes clockwise and anticlockwise; the combination between adjacent orthogonal electrodes can realize the 3 rd synchronous bipolar ablation mode.
6. As shown in fig. 5. The second positioning cores 350 are located on the tube body of the ring electrode 30 and are distributed 180 degrees relatively, and are used for positioning the ring electrode 30 on the three-dimensional image.
7. The annular electrode 30 is made of medical polyurethane material, the outer diameter is not more than 6F, the head end is connected with a multipolar electrode ring, the tail end is connected with an operating handle 60, and the annular electrode is arranged in a special pipeline of the catheter body 10; the handle of the catheter can be retracted or the annular electrode 30 can be retracted completely or the distance between the annular electrode 30 and the matrix of the basket electrode 20 can be adjusted through the catheter body, and the abutting quality and force between the orthogonal electrode and the endocardial tissue of the vestibular region can be adjusted.
8. An annular electrode diameter adjustment knob 630 is located at the tail of the catheter, which can be manipulated to adjust the outer diameter of the tip electrode ring, an annular electrode diameter adjustment guidewire and its passageway 340 as shown in fig. 7.
9. The ring electrode 30 manipulates the handle (fig. 1, 4). The handle is positioned at the tail part of the catheter, and the handle can be advanced and retracted to control the electrode ring to freely enter and exit the catheter body 10 through the catheter outlet 101 at the head end of the catheter, adjust the distance between the electrode ring and the matrix of basket electrodes 20, enable the plane of the electrode ring to exceed the columnar ablation electrode 40 at the head end of the catheter, and improve the contact quality and pressure between the orthogonal electrode and the vestibular part of the pulmonary vein.
10. The tail connector of the ring electrode 30 and the orthogonal electrode irrigation connector are connected to the handle tail of the catheter in a joint tail for subsequent connection of the electrode tail and the saline irrigation extension tube.
The main structure and use of the built-in shape memory spring-type orthogonal electrode catheter (fig. 5) are similar to those of the built-in shape memory semicircular orthogonal electrode catheter (fig. 4), and are not repeated here.
While the invention has been described in connection with specific embodiments thereof, it is to be understood that these drawings are included in the spirit and scope of the invention, it is not to be limited thereto.

Claims (10)

1. A dual energy mapping ablation catheter, comprising:
a catheter body provided with a catheter outlet;
a basket electrode disposed at an end of the catheter body, the basket electrode having a retracted state and an extended state, an axial position of the catheter outlet on the catheter body being at a rear end of the basket electrode;
the annular electrode is contained in the catheter body and can extend out of the catheter outlet to be unfolded in an annular mode, and comprises an annular body and a plurality of first ablation electrodes arranged on the annular body at intervals.
2. The dual energy mapping ablation catheter of claim 1, wherein the outer diameter of the ring electrode when deployed and the outer diameter of the basket electrode when deployed are both adjustable, and the outer diameter of the ring electrode in its maximum ring deployed state is greater than the outer diameter of the basket electrode in its maximum deployed state.
3. The dual energy mapping ablation catheter of claim 1, wherein the basket electrode comprises:
a distal end fixing ring fixed on the catheter body as a fulcrum for switching the basket electrode state;
the shape memory basket bone comprises a plurality of basket bones, a plurality of second ablation electrodes are arranged on the basket bones, the initial preformed state of each basket bone is semicircular, and one ends of the plurality of basket bones are connected with the distal fixing ring;
the proximal end fixing ring is slidably arranged on the catheter body, and the other ends of the basket bones are connected with the proximal end fixing ring;
and the traction steel wire is connected with the proximal end fixing ring and used for adjusting the basket bones between a straight line and a semicircle so as to realize the switching control of the basket-shaped electrode between a contracted state and an expanded state.
4. The dual energy mapping ablation catheter of claim 3, wherein a plurality of mapping electrodes are spaced apart on the basket bone, the plurality of mapping electrodes of the basket bone together forming an electrode matrix for performing non-contact mapping.
5. The dual energy mapping ablation catheter of claim 1, wherein auxiliary reference electrodes are provided on the annular body on both sides of each of the first ablation electrodes.
6. The dual energy mapping ablation catheter of claim 1, wherein the axial forward end of the basket electrode is provided with a cylindrical ablation electrode having a radiofrequency ablation mode and a pulsed electric field ablation mode.
7. The dual energy mapping ablation catheter of claim 6, wherein the columnar ablation electrode is provided with a plurality of irrigated micro-holes, the irrigated micro-holes having a diameter no greater than 0.1mm.
8. The dual energy mapping ablation catheter of claim 6, wherein a pressure deformation sensing device is disposed between the columnar ablation electrode and the basket electrode, the pressure deformation sensing device comprising:
one end of the deformation spring is connected with the bottom of the columnar ablation electrode in an insulating way,
the piezoelectric crystal is connected with the other end of the deformation spring in an insulating way;
and the signal wire is connected with the piezoelectric crystal.
9. The dual energy mapping ablation catheter of claim 8, wherein the catheter wall thickness outside the pressure deformation sensing device is no greater than 0.1mm using an ultra-thin flexible material with low damping characteristics.
10. The dual energy mapping ablation catheter according to any of claims 1-9, wherein an end of the catheter body distal from the basket electrode is provided with an operating handle provided with a catheter head end dual bend adjustment knob, a basket electrode outer diameter adjustment knob, and an annular electrode advance and retreat hole, and an annular electrode diameter adjustment knob is provided adjacent to the operating handle.
CN202311555594.8A 2023-11-21 2023-11-21 Dual-energy mapping ablation catheter Active CN117257438B (en)

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