CN112618002A - Orthogonal electrode pulse electric field ablation catheter - Google Patents
Orthogonal electrode pulse electric field ablation catheterDownload PDFInfo
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- CN112618002A CN112618002ACN202011465641.6ACN202011465641ACN112618002ACN 112618002 ACN112618002 ACN 112618002ACN 202011465641 ACN202011465641 ACN 202011465641ACN 112618002 ACN112618002 ACN 112618002A
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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
- 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
- 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
- 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
- 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
- A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe
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Abstract
Description
Technical Field
The invention relates to the technical field of medical equipment, in particular to an orthogonal electrode pulsed electric field ablation catheter.
Background
The pulse electric field energy is adopted to cause irreversible perforation to the myocardial cell membrane, and the myocardial cell can lose the electrophysiological function under the condition of keeping the basic framework of the cell and the tissue, thereby achieving the purpose of treating arrhythmia. The animal experiments and preliminary clinical tests which are carried out at present adopt the traditional radio frequency ablation catheter to deliver and send a pulse electric field, thereby completing the irreversible perforation treatment of cell membranes of target tissue sites.
The technical means have the following disadvantages:
1) when the pulse electric field energy is delivered in a combined mode of the head end columnar electrode and the near end annular electrode of the traditional radio frequency catheter, the electric field energy is transmitted and attenuated to the periphery along the columnar electrode in a concentric circle mode, the energy cannot be completely delivered in a directional mode along the long axis direction of the myocardial cells and the myocardial beams, and the ablation efficiency is reduced.
2) When the pulsed electric field is repeatedly released to ablate at the same position, the same ablation mode, range and sequence are repeated each time, which is not beneficial to the homogeneity ablation effect.
3) When the combination mode of the head end columnar electrode and the proximal end annular electrode of the traditional radio frequency catheter is adopted to carry out mapping and positioning on the target point, the recorded bipolar potential cannot reflect the exciting conduction direction, all excitations at 180 degrees with each other can record the same bipolar electrogram, the exciting conduction direction of the target tissue part is not favorably and finely marked, and the mapping efficiency and the mapping precision are reduced.
4) Local ultra-high density mapping cannot be performed with monopolar and bipolar electrode matrices.
Disclosure of Invention
The invention provides a quadrature electrode pulsed electric field ablation catheter, aiming at solving the technical problem of improving the treatment effect of the ablation catheter.
An orthogonal electrode pulsed electric field ablation catheter for generating a pulsed electric field for arrhythmia treatment according to an embodiment of the present invention, the ablation catheter comprising:
a pipe body;
the orthogonal electrodes are arranged at the free ends of the tube bodies and comprise a plurality of pairs of electrode pairs for generating a pulse electric field acting on target cells.
According to the orthogonal electrode pulsed electric field ablation catheter provided by the embodiment of the invention, the plurality of pairs of orthogonal electrodes are arranged at the free end of the catheter body, so that the radiated pulsed electric field energy can be adjusted to directionally deliver energy along the long axis direction of the myocardial cells and the myocardial beams, the optimal irreversible electroporation effect is generated, and the consumption efficiency is reduced. Also, diverse pulsed electric fields can be provided, so that the therapeutic effect can be improved.
According to some embodiments of the invention, the orthogonal electrodes include a first electrode pair including a first electrode and a second electrode oppositely disposed in a radial direction of the tube, and a second electrode pair including a third electrode and a fourth electrode oppositely disposed in the radial direction of the tube.
In some embodiments of the present invention, the first electrode, the third electrode, the second electrode, and the fourth electrode are disposed at regular intervals in a circumferential direction of the tube.
According to some embodiments of the invention, the first electrode, the second electrode, the third electrode and the fourth electrode are all the same in size and shape.
In some embodiments of the present invention, the first electrode, the second electrode, and the third electrode are all fan-shaped in cross section of the fourth electrode.
According to some embodiments of the invention, an insulating filler is disposed between the pulse electrodes of the electrode pair.
In some embodiments of the present invention, one end of the tube close to the orthogonal electrode is provided with a plurality of reference electrodes, and the plurality of reference electrodes are arranged in one-to-one correspondence with the pulse electrodes of the plurality of pairs of electrode pairs along the axial direction of the tube.
According to some embodiments of the invention, the reference electrode is no less than 2mm from the corresponding pulse electrode.
In some embodiments of the invention, the end of the tube body near the orthogonal electrode is provided with a pressure sensor.
According to some embodiments of the invention, the end of the tube near the orthogonal electrodes is provided with a plurality of positioning electrodes.
In some embodiments of the invention, an end of the catheter body distal to the orthogonal electrode is provided with a steering handle for controlling movement of the ablation catheter.
Drawings
FIG. 1 is a schematic structural view of an orthogonal electrode pulsed electric field ablation catheter in accordance with an embodiment of the present invention;
FIG. 2 is a schematic partial structure view of an orthogonal electrode pulsed electric field ablation catheter in accordance with an embodiment of the present invention;
fig. 3 is a partial structural schematic view of an orthogonal electrode pulsed electric field ablation catheter in accordance with an embodiment of the present invention.
Reference numerals:
an ablation catheter (100) is provided,
the length of thetubular body 10 is such that,
Detailed Description
To further explain the technical means and effects of the present invention adopted to achieve the intended purpose, the present invention will be described in detail with reference to the accompanying drawings and preferred embodiments.
The cardiac electrode catheter is adopted to deliver radio frequency energy to ablate pathological myocardial tissue, is the most extensive and mature arrhythmia minimally invasive treatment technology clinically used at present, and has the advantages that: the energy transmission is convenient and reliable; the damage range and the depth are controllable and adjustable; the pain is little in the treatment process; can be used for treating arrhythmia in almost all parts. The disadvantages are that: each ablation point has long mapping and discharging time; the injury depth is limited, and the postoperative recurrence is easy; the electrodes need to be in constant and stable contact with endocardial tissue; knocking and scabbing are easy to generate in the ablation process; there is a risk of causing severe complications such as perforation of the heart esophagus, damage to the phrenic nerve, stenosis of the pulmonary veins, etc.
The cardiac pulse electric field ablation is a novel ablation technology taking a high-voltage and high-frequency pulse field as energy, and has the main advantages that: the discharge time is short; does not damage the general structure of the ablated tissue; cell selectivity can be achieved by pulsed field parameter adjustment; heat and scabbing are not generated in the ablation process; does not damage adjacent tissues; ablation electrodes are not required to be in direct contact with endocardial tissue; does not cause complications such as heart esophagus perforation, phrenic nerve injury, pulmonary vein stenosis and the like.
The principle of cardiac pulse field ablation is: the high-voltage, high-frequency and short-time pulse electric field acts on target cells to cause rearrangement of phospholipid bilayers of cell membranes to form nano-scale hydrophilic pore canals, thereby increasing the permeability of the cell membranes. The size of such a nanopore is affected by the amount of pulsed electric field energy applied. If the electric field energy is small, the pulse release time is short, the number of generated nanopores is small, the pore diameter is small, after the electric field energy disappears, the pore channels are quickly repaired to form reversible electroporation of cell membranes, and the method is widely used for biological experiments such as cell gene transfection and the like at present. If the electric field energy is large, the pulse release time is long, the number of generated nanopores is large, the pore diameter is large, the permeability of a cell membrane is abnormal, potassium ions and active enzymes in the cell flow out, calcium ions outside the cell flow in, calcium in the cell is overloaded, irreversible electroporation of the cell membrane is formed, and the cell loses functions and dies. The best irreversible electroporation effect can be produced when the field strength is oriented parallel to the long axis of the cell.
The pulse electric field energy is adopted to cause irreversible perforation to the myocardial cell membrane, and the myocardial cell can lose the electrophysiological function under the condition of keeping the basic framework of the cell and the tissue, thereby achieving the purpose of treating arrhythmia. The animal experiments and preliminary clinical tests which are carried out at present adopt the traditional radio frequency ablation catheter to deliver and send a pulse electric field, thereby completing the irreversible perforation treatment of cell membranes of target tissue sites. The main disadvantages are:
1) when the pulse electric field energy is delivered in a combined mode of the head end columnar electrode and the near end annular electrode of the traditional radio frequency catheter, the electric field energy is transmitted and attenuated to the periphery along the columnar electrode in a concentric circle mode, the energy cannot be completely delivered in a directional mode along the long axis direction of the myocardial cells and the myocardial beams, and the ablation efficiency is reduced.
2) When the pulsed electric field is repeatedly released to ablate at the same position, the same ablation mode, range and sequence are repeated each time, which is not beneficial to the homogeneity ablation effect.
3) When the combined mode of the head end columnar electrode and the near end annular electrode of the traditional radio frequency catheter is adopted to carry out mapping and positioning on the target point, the recorded bipolar potential cannot reflect the exciting conduction direction, all excitations within 180 degrees of each other can record the same bipolar electrogram, the exciting conduction direction of the target tissue part is not favorably and finely marked, and the mapping efficiency and precision are reduced.
4) Local ultra-high density mapping cannot be performed with monopolar and bipolar electrode matrices.
In response to the above-mentioned deficiencies in the related art, the present invention provides an orthogonal electrode pulsed electricfield ablation catheter 100. As shown in fig. 1, an orthogonal electrode pulsed electricfield ablation catheter 100 according to an embodiment of the invention, theablation catheter 100 for generating a pulsed electric field for arrhythmia treatment, theablation catheter 100 comprising: abody 10 and aquadrature electrode 20.
As shown in fig. 1 to 3, theorthogonal electrode 20 is disposed at the free end of thetube 10, and theorthogonal electrode 20 includes a plurality of pairs of electrodes for generating a pulsed electric field acting on the target cell.
That is, two or more pairs of electrodes may be provided at the free end of thetube 10. Therefore, the focus part can be treated by emitting the pulse electric field through a plurality of pairs of electrodes. It should be noted that, by arranging a plurality of pairs of electrode pairs and adjusting the positions of the electrode pairs, the pulse electric field energy emitted by the electrode pairs can directionally emit energy along the long axis direction of the diseased myocardial cells and myocardial bundles, thereby generating the optimal irreversible electroporation effect and reducing the consumption efficiency. Moreover, by adjusting the discharge mode, discharge range and discharge sequence of different electrode pairs, diversified pulse electric fields can be generated, thereby improving the treatment effect.
According to the orthogonal electrode pulsed electricfield ablation catheter 100 provided by the embodiment of the invention, the plurality of pairs oforthogonal electrodes 20 are arranged at the free end of thecatheter body 10, so that the radiated pulsed electric field energy can be adjusted to directionally deliver energy along the long axis direction of the myocardial cells and the myocardial beams, the optimal irreversible electroporation effect is generated, and the consumption efficiency is reduced. Also, diverse pulsed electric fields can be provided, so that the therapeutic effect can be improved.
According to some embodiments of the present invention, as shown in fig. 2 and 3, theorthogonal electrodes 20 include a first electrode pair including afirst electrode 211 and asecond electrode 212 oppositely disposed in a radial direction of thetube 10, and a second electrode pair including athird electrode 213 and afourth electrode 214 oppositely disposed in the radial direction of thetube 10.
It should be noted that, when the electrode pairs are arranged in two pairs, as shown in fig. 2 and 3, the two pulse electrodes of each pair are oppositely arranged when viewed from the cross section of theorthogonal electrode 20, that is, a connecting line passing through the centers of the two pulse electrodes passes through the center of the circular cross section.
In some embodiments of the present invention, the position of the tube near the reference electrode is provided with anindicator 230 for distinguishing the electrode group. For example, ared indicator mark 230 may be provided at a position of thetube 10 axially opposite to the first electrode pair, and ablue indicator mark 230 may be provided at a position of thetube 10 axially opposite to the second electrode pair, to distinguish the first electrode pair from the second electrode pair.
In some embodiments of the present invention, thefirst electrode 211, thethird electrode 213, thesecond electrode 212, and thefourth electrode 214 are disposed at regular intervals in the circumferential direction of thetube 10. As shown in fig. 2 and 3, thefirst electrode 211, thesecond electrode 212, thethird electrode 213, and thefourth electrode 214 are sequentially and uniformly spaced in a clockwise direction when viewed from a direction orthogonal to the cross section of the free end of theelectrode 20. This facilitates the layout oforthogonal electrodes 20, and also facilitates the improvement of the uniformity and consistency of the discharge oforthogonal electrodes 20.
According to some embodiments of the present invention, as shown in fig. 2 and 3, thefirst electrode 211, thesecond electrode 212, thethird electrode 213, and thefourth electrode 214 are all the same in size and shape. Therefore, theorthogonal electrodes 20 can be conveniently processed and manufactured, the mass production of theorthogonal electrodes 20 is realized, the production efficiency of theorthogonal electrodes 20 is improved, and the production cost is reduced. Moreover, pulsed electrodes of the same size and shape can improve the uniformity and consistency of the discharge fromorthogonal electrodes 20.
In some embodiments of the present invention, thefirst electrode 211, thesecond electrode 212, and thethird electrode 213 are all fan-shaped in cross section with thefourth electrode 214. As shown in fig. 2 and 3, thefirst electrode 211, thesecond electrode 212, and thethird electrode 213, and thefourth electrode 214 may be disposed in a sector shape having a cross section of 90 degrees. Thereby facilitating a snug fit between thequadrature electrode 20 and thebody 10.
According to some embodiments of the present invention, as shown in fig. 2 and 3, an insulatingfiller 30 is disposed between the pulse electrodes of the electrode pair. It can be understood that by disposing the insulatingfiller 30 between each adjacent pulse electrodes, the problems of short circuit and the like caused by contact between the pulse electrodes can be avoided, and the reliability and safety of the operation of theablation catheter 100 can be improved.
In some embodiments of the present invention, one end of thetube 10 close to theorthogonal electrode 20 is provided with a plurality ofreference electrodes 40, and the plurality ofreference electrodes 40 are arranged in one-to-one correspondence with the pulse electrodes of the pairs of electrodes along the axial direction of thetube 10. As shown in fig. 2 and 3, the free end of thepipe body 10 is provided with a first electrode pair and a second electrode pair, wherein the first electrode pair includes afirst electrode 211 and asecond electrode 212; the second electrode pair includes athird electrode 213 and afourth electrode 214. Fourreference electrodes 40 corresponding to thefirst electrode 211, thesecond electrode 212, thethird electrode 213, and thefourth electrode 214 are provided at one end of thetubular body 10 near theorthogonal electrode 20. Therefore, thefirst electrode 211, thesecond electrode 212, thethird electrode 213 and thefourth electrode 214 can be used as cathodes, the corresponding fourreference electrodes 40 can be used as anodes to record a four-lead bipolar endocardial mapping electrogram, the activation conduction direction of a target tissue part can be precisely marked, and the mapping efficiency and precision are improved.
According to some embodiments of the present invention, thereference electrode 40 is no less than 2mm from the corresponding pulse electrode. Thereby, layout mounting of thereference electrode 40 is facilitated. Also, by setting the distance of thereference electrode 40 from the corresponding pulse electrode to not less than 2mm, the interference influence between the pulse electrode and thereference electrode 40 can be avoided.
In some embodiments of the invention, the end of thetubular body 10 near thequadrature electrode 20 is provided with apressure sensor 60. Thus, the contact pressure at the tip of theablation catheter 100 can be detected by thepressure sensor 60 to determine the contact state of theablation catheter 100 with theablation catheter 100.
According to some embodiments of the present invention, the end of thetube 10 near theorthogonal electrode 20 is provided with a plurality of positioning electrodes. Thus, the positional state of theablation catheter 100 within the patient's body can be acquired by the plurality of positioning electrodes. As shown in fig. 2 and 3, afirst positioning electrode 510 and asecond positioning electrode 520 are provided at an end portion close to theorthogonal electrode 20 at an interval in the axial direction of thetube 10.
In some embodiments of the invention, the end of thecatheter body 10 distal from theorthogonal electrode 20 is provided with asteering handle 70 for controlling the movement of theablation catheter 100. It should be noted that the position and attitude of theablation catheter 100 can be conveniently controlled by manipulating thehandle 70. For example, theablation catheter 100 can be controlled to advance, retract, and bend by manipulating thehandle 70.
The orthogonal electrode pulsed electricfield ablation catheter 100 according to the present invention is described in detail below with reference to the accompanying drawings. It is to be understood that the following description is only exemplary in nature and should not be taken as a specific limitation on the invention.
As shown in fig. 1-3, the orthogonal electrode pulsed electric field pressuresensitive ablation catheter 100 includes: atubular body 10, aquadrature electrode 20, anannular reference electrode 40, astrain pressure sensor 60, an annular navigation electrode, ajoystick 70, atail connector 80, and anextension tail 90.
Theorthogonal electrodes 20 include four opposite fan-shaped columnar pulse electrodes, and the pulse electrodes are separated by a biocompatible insulating material. Anannular reference electrode 40 is located proximal to theorthogonal electrode 20, spaced apart by more than 2 mm. Catheter tipstrain pressure sensor 60 is located proximal toorthogonal electrode 20, at a distance of more than 2 mm. The annular navigation electrode includes: thefirst positioning electrode 510 and thesecond positioning electrode 520 are positioned at the proximal end of the baroreceptor, and the distance between the electrodes is more than 10 mm.
The method of use of the orthogonal electrode pulsed electric field pressuresensitive ablation catheter 100 is as follows:
s1, the head end of the orthogonal electrode ablation catheter is sent into a target heart cavity through a long sheath;
s2, recording a four-lead bipolar endocardium mapping electrogram by taking four orthogonal electrodes as cathodes and taking a ring-shaped reference electrode as an anode;
s3, operating an ablation catheter in vitro on the three-dimensional electrocardiogram mapping model, moving the head end of the ablation catheter, and accurately mapping an ablation target point;
s4, enabling the orthogonal electrode at the head end of the ablation catheter to contact an ablation target: the ablation catheter head end deformation pressure sensor senses that the ablation catheter head end electrode contacts endocardial tissue;
s5, the external ablation catheter electrode distributor sends out pulsed electric fields with different electrode combinations and polarity combinations according to a preset program to complete ablation;
s6, each discharge comprises 3-4 high-voltage, high-frequency and biphase pulses are emitted in the absolute refractory period of a single R wave;
s7, discharging for 2-4 times in each polarity combination, discharging for 2-4 times in each electrode combination, and discharging for 2 electrode combinations in each target point according to a preset instruction;
s8, the program change of the electrode combination and the polarity combination is performed by the electrode distributor;
s9, repeating the electrophysiological mapping, and verifying that the ablation is successful;
s10, withdrawing the orthogonal ablation catheter out of the body.
In summary, the orthogonal electrode pulsed electricfield ablation catheter 100 of the present invention has the following advantages:
1) the head end of the catheter adopts a combination mode of theorthogonal electrodes 20, and when pulse electric field energy is delivered in a composite mode of combination of differentorthogonal electrodes 20 and combination of different polarities, the electric field energy can directionally deliver energy along the long axis direction of myocardial cells and myocardial beams, so that the ablation efficiency is improved.
2) When the pulse electric field can be repeatedly released to ablate at the same position, different electrode pair combinations and polarity combinations can be adopted for each discharge, and different ablation modes, ranges and sequences are favorable for causing homogeneous ablation effect.
3) When theorthogonal electrode 20 at the head end of the catheter is used for mapping and positioning a target point, the recorded bipolar potentials can reflect the exciting conduction direction, and different bipolar electrograms can be recorded by exciting at 180 degrees, so that the exciting conduction direction of the target tissue part can be accurately marked, and the mapping efficiency and precision are improved.
4) Local ultra-high density mapping can be performed with monopolar and bipolar electrode matrices.
While the invention has been described in connection with specific embodiments thereof, it is to be understood that it is intended by the appended drawings and description that the invention may be embodied in other specific forms without departing from the spirit or scope of the invention.
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| CN202011465641.6ACN112618002B (en) | 2020-12-14 | 2020-12-14 | Orthogonal Electrode Pulsed Electric Field Ablation Catheter |
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| WO2025153870A1 (en)* | 2024-01-16 | 2025-07-24 | Medtronic, Inc. | Waveform delivery based on tissue fiber orientation |
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