Orthogonal Electrode Pulsed Electric Field Ablation Catheter

Abstract

The present invention provides an orthogonal electrode pulsed electric field ablation catheter. The ablation catheter is used to generate pulsed electric fields for treating arrhythmia. The ablation catheter includes a catheter body and orthogonal electrodes. The orthogonal electrodes are disposed at the free end of the catheter body. The orthogonal electrodes include multiple pairs of electrode pairs for generating pulsed electric fields acting on target cells. According to the orthogonal electrode pulsed electric field ablation catheter of the present invention, by providing multiple pairs of orthogonal electrodes at the free end of the catheter body, the energy of the emitted pulsed electric field can be adjusted to be directed along the long axis direction of myocardial cells and myocardial bundles, generating the best irreversible electroporation effect and reducing the consumption efficiency. Moreover, diverse pulsed electric fields can be provided, thereby improving the treatment effect.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to an orthogonal electrode pulsed electric field ablation catheter. Background Art

[0002] By using pulsed electric field energy to cause irreversible perforation of the myocardial cell membrane, the electrophysiological function of myocardial cells can be lost while maintaining the basic framework of cells and tissues, so as to achieve the purpose of treating arrhythmia. Currently, animal experiments and preliminary clinical trials carried out are all using traditional radiofrequency ablation catheters to deliver and emit pulsed electric fields, so as to complete the irreversible perforation treatment of the cell membrane at the target tissue site.

[0003] The above technical means have the following disadvantages:

[0004] 1) When using the combination of the head columnar electrode and the proximal ring electrode of the traditional radiofrequency catheter to emit pulsed electric field energy, the electric field energy will propagate and attenuate in a concentric circle manner along the columnar electrode, and cannot completely emit energy along the long axis direction of myocardial cells and myocardial bundles, reducing the ablation efficiency.

[0005] 2) When repeatedly emitting pulsed electric field ablation at the same site, the same ablation mode, range and sequence are repeated each time, which is not conducive to creating a homogeneous ablation effect.

[0006] 3) When using the combination of the head columnar electrode and the proximal ring electrode of the traditional radiofrequency catheter to perform mapping and localization of the target point, the recorded bipolar potential cannot reflect the conduction direction of the excitation, and all excitations that are 180 degrees to each other will record the same bipolar electrogram, which is not conducive to finely mapping the conduction direction of the excitation at the target tissue site, reducing the mapping efficiency and accuracy.

[0007] 4) It is impossible to perform local ultra-high density mapping with a unipolar and bipolar electrode matrix. Summary of the Invention

[0008] The technical problem to be solved by the present invention is how to improve the treatment effect of the ablation catheter, and the present invention proposes an orthogonal electrode pulsed electric field ablation catheter.

[0009] According to the orthogonal electrode pulsed electric field ablation catheter of the embodiment of the present invention, the ablation catheter is used to generate a pulsed electric field for treating arrhythmia, and the ablation catheter includes:

[0010] A tube body;

[0011] An orthogonal electrode, the orthogonal electrode is arranged at the free end of the tube body, and the orthogonal electrode includes multiple pairs of electrode pairs for generating a pulsed electric field acting on target cells.

[0012] According to the orthogonal electrode pulsed electric field ablation catheter of the embodiment of the present invention, by arranging multiple pairs of orthogonal electrodes at the free end of the catheter body, the pulsed electric field energy emitted can be adjusted to be directed along the long axis direction of cardiomyocytes and myocardial bundles, generating the best irreversible electroporation effect and reducing the consumption efficiency. Moreover, diverse pulsed electric fields can be provided, thereby improving the treatment effect.

[0013] According to some embodiments of the present invention, the orthogonal electrodes include a first electrode pair and a second electrode pair. The first electrode pair includes a first electrode and a second electrode oppositely arranged along the radial direction of the catheter body, and the second electrode pair includes a third electrode and a fourth electrode oppositely arranged along the radial direction of the catheter body.

[0014] In some embodiments of the present invention, the first electrode, the third electrode, the second electrode, and the fourth electrode are evenly spaced along the circumferential direction of the catheter body.

[0015] According to some embodiments of the present invention, the first electrode, the second electrode, the third electrode, and the fourth electrode are all of the same size and shape.

[0016] In some embodiments of the present invention, the cross-sections of the first electrode, the second electrode, the third electrode, and the fourth electrode are all fan-shaped.

[0017] According to some embodiments of the present invention, insulating fillers are provided between the pulsed electrodes of the electrode pairs.

[0018] In some embodiments of the present invention, a plurality of reference electrodes are provided at one end of the catheter body close to the orthogonal electrodes, and the plurality of reference electrodes are arranged in one-to-one correspondence with the pulsed electrodes of the multiple pairs of electrode pairs along the axial direction of the catheter body.

[0019] According to some embodiments of the present invention, the distance between the reference electrode and the corresponding pulsed electrode is not less than 2 mm.

[0020] In some embodiments of the present invention, a pressure sensor is provided at one end of the catheter body close to the orthogonal electrodes.

[0021] According to some embodiments of the present invention, a plurality of positioning electrodes are provided at one end of the catheter body close to the orthogonal electrodes.

[0022] In some embodiments of the present invention, a manipulation handle for controlling the movement of the ablation catheter is provided at one end of the catheter body far from the orthogonal electrodes. Description of the Drawings

[0023] Figure 1 It is a schematic structural diagram of an orthogonal electrode pulsed electric field ablation catheter according to an embodiment of the present invention;

[0024] Figure 2 It is a schematic diagram of the local structure of an orthogonal electrode pulsed electric field ablation catheter according to an embodiment of the present invention;

[0025] Figure 3 It is a schematic diagram of the local structure of an orthogonal electrode pulsed electric field ablation catheter according to an embodiment of the present invention.

[0026] Reference numerals:

[0027] Ablation catheter 100,

[0028] Catheter body 10,

[0029] Orthogonal electrode 20, first electrode 211, second electrode 212, third electrode 213, fourth electrode 214, indication mark 230, insulating filler 30, reference electrode 40, first positioning electrode 510, second positioning electrode 520, pressure sensor 60, operating handle 70, tail wire connector 80, extension tail wire 90. Detailed implementation manners

[0030] To further elaborate on the technical means and effects adopted by the present invention to achieve the predetermined purpose, the present invention will be described in detail as follows in conjunction with the accompanying drawings and preferred embodiments.

[0031] Using a cardiac electrode catheter to deliver radiofrequency energy to ablate diseased myocardial tissue is the most widely used and mature minimally invasive treatment technology for arrhythmia in clinical practice at present. Its advantages are: convenient and reliable energy transmission; the damage range and depth can be controlled and adjusted; the treatment process is less painful; it can be used to treat arrhythmia in almost all parts. Its disadvantages are: the mapping and discharging time for each ablation point is long; the damage depth is limited and it is easy to relapse after surgery; the electrode needs to continuously and stably contact the endocardial tissue; shock and crusting are likely to occur during ablation; there is a risk of serious complications such as cardiac esophageal perforation, phrenic nerve injury, and pulmonary vein stenosis.

[0032] Cardiac pulsed electric field ablation is a new ablation technology using high-voltage and high-frequency pulsed fields as energy. Its main advantages are: short discharging time; no damage to the gross structure of the ablated tissue; cell selectivity can be achieved by adjusting the pulsed field parameters; no heat generation and crusting during ablation; no damage to adjacent tissues; no need for the ablation electrode to directly contact the endocardial tissue; no complications such as cardiac esophageal perforation, phrenic nerve injury, and pulmonary vein stenosis.

[0033] The principle of cardiac pulsed-field ablation is as follows: Pulsed electric fields with high voltage, high frequency, and short duration act on target cells, causing the phospholipid bilayer of the cell membrane to rearrange, forming hydrophilic pores at the nanoscale level, which leads to an increase in the permeability of the cell membrane. The size of these nanopores is affected by the energy of the applied pulsed electric field. If the electric field energy is small and the pulse duration is short, the number of nanopores generated is small and the pore diameter is small. After the electric field energy disappears, these pores are quickly repaired, forming reversible electroporation of the cell membrane, which is currently widely used in biological experiments such as cell gene transfection. If the electric field energy is large and the pulse duration is long, the number of nanopores generated is large and the pore diameter is large, causing abnormal permeability of the cell membrane, the outflow of potassium ions and active enzymes inside the cell, the influx of calcium ions outside the cell, and intracellular calcium overload, forming irreversible electroporation of the cell membrane, resulting in the loss of cell function and death. When the direction of the electric field strength is parallel to the long axis of the cell, the best irreversible electroporation effect can be produced.

[0034] Using pulsed electric field energy to cause irreversible perforation of the myocardial cell membrane can, while maintaining the basic structure of cells and tissues, make myocardial cells lose their electrophysiological functions, thereby achieving the purpose of treating arrhythmias. Currently, animal experiments and preliminary clinical trials being carried out all use traditional radiofrequency ablation catheters to deliver and emit pulsed electric fields, thereby completing the treatment of irreversible perforation of the cell membrane at the target tissue site. Its main disadvantages are:

[0035] 1) When using the combination of the tip columnar electrode and the proximal ring electrode of a traditional radiofrequency catheter to emit pulsed electric field energy, the electric field energy will spread and decay in a concentric circle manner along the columnar electrode, and cannot be emitted energy completely along the long axis direction of myocardial cells and myocardial bundles, reducing the ablation efficiency.

[0036] 2) When repeatedly emitting pulsed electric field ablation at the same site, the same ablation mode, scope, and sequence are repeated each time, which is not conducive to creating a homogeneous ablation effect.

[0037] 3) When using the combination of the tip columnar electrode and the proximal ring electrode of a traditional radiofrequency catheter for mapping and positioning of the target point, the recorded bipolar potential cannot reflect the direction of excitation conduction. All excitations that are 180 degrees to each other will record the same bipolar electrogram, which is not conducive to precisely mapping the direction of excitation conduction at the target tissue site, reducing the mapping efficiency and accuracy.

[0038] 4) It cannot perform local ultra-high density mapping with monopolar and bipolar electrode matrices.

[0039] In view of the above defects in the related technology, the present invention proposes an orthogonal electrode pulsed electric field ablation catheter 100. As Figure 1As shown, the orthogonal electrode pulsed electric field ablation catheter 100 according to an embodiment of the present invention is used to generate a pulsed electric field for treating arrhythmia. The ablation catheter 100 includes a catheter body 10 and orthogonal electrodes 20.

[0040] Among them, as Figures 1-3 shown, the orthogonal electrodes 20 are provided at the free end of the catheter body 10. The orthogonal electrodes 20 include multiple pairs of electrode pairs for generating a pulsed electric field acting on target cells.

[0041] That is to say, two or more pairs of electrode pairs can be provided at the free end of the catheter body 10. Thus, the pulsed electric field can be emitted by multiple pairs of electrode pairs to treat the lesion site. It should be noted that by providing multiple pairs of electrode pairs and adjusting the positions of the electrode pairs, the energy of the pulsed electric field emitted by the electrode pairs can be directed along the long axis direction of the diseased myocardial cells and myocardial bundles, generating the best irreversible electroporation effect and reducing the consumption efficiency. Moreover, by adjusting the discharge mode, discharge range, and discharge sequence of different electrode pairs, a diversified pulsed electric field can be generated, thereby improving the treatment effect.

[0042] In the orthogonal electrode pulsed electric field ablation catheter 100 according to an embodiment of the present invention, by providing multiple pairs of orthogonal electrodes 20 at the free end of the catheter body 10, the energy of the emitted pulsed electric field can be adjusted to be directed along the long axis direction of the myocardial cells and myocardial bundles, generating the best irreversible electroporation effect and reducing the consumption efficiency. Moreover, a diversified pulsed electric field can be provided, thereby improving the treatment effect.

[0043] According to some embodiments of the present invention, as Figure 2 and Figure 3 shown, the orthogonal electrodes 20 include a first electrode pair and a second electrode pair. The first electrode pair includes a first electrode 211 and a second electrode 212 that are oppositely arranged along the radial direction of the catheter body 10. The second electrode pair includes a third electrode 213 and a fourth electrode 214 that are oppositely arranged along the radial direction of the catheter body 10.

[0044] It should be noted that when the electrode pairs are provided in two pairs, as Figure 2 and Figure 3 shown, from the cross-section of the orthogonal electrodes 20, the two pulsed electrodes of each pair of electrode pairs are oppositely arranged, that is, the line connecting the centers of the two pulsed electrodes passes through the center of the circular cross-section.

[0045] In some embodiments of the present invention, an indication mark 230 for distinguishing electrode groups is provided at a position of the catheter body close to the reference electrode. For example, a red indication mark 230 can be provided at a position of the catheter body 10 axially opposite to the first electrode pair, and a blue indication mark 230 can be provided at a position of the catheter body 10 axially opposite to the second electrode pair to distinguish and mark the first electrode pair and the second electrode pair.

[0046] In some embodiments of the present invention, the first electrode 211, the third electrode 213, the second electrode 212, and the fourth electrode 214 are evenly spaced along the circumferential direction of the tube body 10. As Figure 2 and Figure 3 shown, when viewed from the direction of the cross-section of the free end of the orthogonal electrode 20, the first electrode 211, the second electrode 212, the third electrode 213, and the fourth electrode 214 are evenly spaced in sequence in the clockwise direction. Thereby, it is convenient for the layout setting of the orthogonal electrode 20, and moreover, it is beneficial to improve the uniformity and consistency of the discharge of the orthogonal electrode 20.

[0047] According to some embodiments of the present invention, as Figure 2 and Figure 3 shown, the first electrode 211, the second electrode 212, the third electrode 213, and the fourth electrode 214 are the same in size and shape. Thereby, it is convenient for the processing and manufacturing of the orthogonal electrode 20, realizing the mass production of the orthogonal electrode 20, improving the production efficiency of the orthogonal electrode 20, and reducing the production cost. Moreover, the pulse electrodes with the same size and shape can improve the uniformity and consistency of the discharge of the orthogonal electrode 20.

[0048] In some embodiments of the present invention, the cross-sections of the first electrode 211, the second electrode 212, the third electrode 213, and the fourth electrode 214 are all fan-shaped. As Figure 2 and Figure 3 shown, the first electrode 211, the second electrode 212, the third electrode 213, and the fourth electrode 214 can all be set as fan-shaped with a cross-section of 90 degrees. Thereby, it is convenient for the fitting installation between the orthogonal electrode 20 and the tube body 10.

[0049] According to some embodiments of the present invention, as Figure 2 and Figure 3 shown, an insulating filler 30 is provided between the pulse electrodes of the electrode pairs. It can be understood that by providing the insulating filler 30 between adjacent pulse electrodes, problems such as short circuits caused by contact between the pulse electrodes can be avoided, and the reliability and safety of the operation of the ablation catheter 100 are improved.

[0050] In some embodiments of the present invention, a plurality of reference electrodes 40 are provided at one end of the tube body 10 close to the orthogonal electrode 20, and the plurality of reference electrodes 40 are arranged in one-to-one correspondence with the pulse electrodes of multiple pairs of electrode pairs along the axial direction of the tube body 10. As Figure 2 and Figure 3 ​​​As shown, a first electrode pair and a second electrode pair are provided at the free end of the tube body 10. Among them, the first electrode pair includes a first electrode 211 and a second electrode 212; the second electrode pair includes a third electrode 213 and a fourth electrode 214. At one end of the tube body 10 close to the orthogonal electrode 20, four reference electrodes 40 corresponding to the first electrode 211, the second electrode 212, the third electrode 213, and the fourth electrode 214 are provided. Thus, the first electrode 211, the second electrode 212, the third electrode 213, and the fourth electrode 214 can be used as cathodes, and the corresponding four reference electrodes 40 can be used as anodes to record a four-lead bipolar endocardial mapping electrogram, finely map the excitation conduction direction of the target tissue site, and improve the mapping efficiency and accuracy.

[0051] According to some embodiments of the present invention, the distance between the reference electrode 40 and the corresponding pulse electrode is not less than 2 mm. Thus, it is convenient for the layout and installation of the reference electrode 40. Moreover, by setting the distance between the reference electrode 40 and the corresponding pulse electrode to be not less than 2 mm, the interference between the pulse electrode and the reference electrode 40 can be avoided.

[0052] In some embodiments of the present invention, a pressure sensor 60 is provided at one end of the tube body 10 close to the orthogonal electrode 20. Thus, the contact pressure at the head end of the ablation catheter 100 can be detected by the pressure sensor 60, so as to determine the contact state of the ablation catheter 100.

[0053] According to some embodiments of the present invention, a plurality of positioning electrodes are provided at one end of the tube body 10 close to the orthogonal electrode 20. Thus, the position state of the ablation catheter 100 in the patient's body can be obtained through the plurality of positioning electrodes. As Figure 2 and Figure 3 shown, a first positioning electrode 510 and a second positioning electrode 520 are provided at intervals along the axial direction of the tube body 10 at the end close to the orthogonal electrode 20.

[0054] In some embodiments of the present invention, a manipulation handle 70 for controlling the movement of the ablation catheter 100 is provided at one end of the tube body 10 away from the orthogonal electrode 20. It should be noted that the position and posture of the ablation catheter 100 can be conveniently controlled through the manipulation handle 70. For example, operations such as advancing, retreating, and bending of the ablation catheter 100 can be controlled through the manipulation handle 70.

[0055] Next, the orthogonal electrode pulsed electric field ablation catheter 100 according to the present invention will be described in detail with reference to the accompanying drawings. It should be understood that the following description is only an exemplary description and should not be construed as a specific limitation of the present invention.

[0056] As Figures 1-3As shown in the figure, the orthogonal electrode pulsed electric field pressure-sensitive ablation catheter 100 includes: a catheter body 10, orthogonal electrodes 20, a ring reference electrode 40, a deformation pressure sensor 60, a ring navigation electrode, a control handle 70, a tail wire connector 80, and an extension tail wire 90.

[0057] Among them, the orthogonal electrodes 20 include four pairwise-opposed fan-shaped columnar pulsed electrodes, and the pulsed electrodes are separated by a biocompatible insulating material. The ring reference electrode 40 is located at the proximal end of the orthogonal electrodes 20, and the distance between the two is more than 2 mm. The deformation pressure sensor 60 at the head end of the catheter is located at the proximal end of the orthogonal electrodes 20, and the distance between the two is more than 2 mm. The ring navigation electrode includes: a first positioning electrode 510 and a second positioning electrode 520, which are located at the proximal end of the pressure sensor, and the electrode spacing is more than 10 mm.

[0058] The usage method of the orthogonal electrode pulsed electric field pressure-sensitive ablation catheter 100 is as follows:

[0059] S1. Insert the head end of the orthogonal electrode ablation catheter into the target heart cavity through a long sheath tube;

[0060] S2. Use the four orthogonal electrodes as cathodes and the ring reference electrode as an anode to record a four-lead bipolar endocardial mapping electrogram;

[0061] S3. Manipulate the ablation catheter outside the body on the three-dimensional electrocardiogram mapping model, move the head end of the ablation catheter, and accurately map the ablation target point;

[0062] S4. Make the orthogonal electrodes at the head end of the ablation catheter contact the ablation target point: the deformation pressure sensor at the head end of the ablation catheter senses that the electrodes at the head end of the ablation catheter contact the endocardial tissue;

[0063] S5. The electrode distributor of the ablation catheter outside the body discharges pulsed electric fields in different electrode combinations and polarity combinations according to a preset program to complete ablation;

[0064] S6. Each discharge includes emitting 3-4 bursts of high-voltage, high-frequency, biphasic pulses during the absolute refractory period of a single R wave;

[0065] S7. According to a preset instruction, each polarity combination discharges 2-4 times, each electrode combination discharges 2-4 times, and each target point discharges 2 electrode combinations;

[0066] S8. The program change of the electrode combination and polarity combination is completed by the electrode distributor;

[0067] S9. Repeat electrophysiological mapping to verify the success of ablation;

[0068] S10. Withdraw the orthogonal ablation catheter from the body.

[0069] In summary, the orthogonal electrode pulsed electric field ablation catheter 100 proposed by the present invention has the following advantages:

[0070] 1) The distal end of the catheter adopts a combination of orthogonal electrodes 20. When delivering pulsed electric field energy in a composite manner with different combinations of orthogonal electrode 20 pairs and different polarity combinations, the electric field energy can be directed along the long axis direction of myocardial cells and myocardial bundles, improving the ablation efficiency.

[0071] 2) When repeatedly delivering pulsed electric field ablation at the same site, different electrode pair combinations and polarity combinations can be used for each discharge. Different ablation modes, ranges, and sequences are beneficial to achieving a homogeneous ablation effect.

[0072] 3) When using the orthogonal electrode 20 pairs at the distal end of the catheter for mapping and positioning the target point, the recorded bipolar potential can reflect the conduction direction of excitation. Excitations that are 180 degrees apart will record different bipolar electrograms, which is beneficial for precisely mapping the conduction direction of excitation in the target tissue site, improving the mapping efficiency and accuracy.

[0073] 4) It can perform local ultra-high density mapping with monopolar and bipolar electrode matrices.

[0074] Through the description of the specific implementation manner, it should be possible to have a more in-depth and specific understanding of the technical means and effects adopted by the present invention to achieve the predetermined purpose. However, the accompanying drawings are only for reference and illustration, and are not used to limit the present invention.

Claims

1. An orthogonal electrode pulsed electric field ablation catheter, characterized in that, The ablation catheter is used to generate pulsed electric fields for the treatment of arrhythmia. The ablation catheter includes: a catheter body; orthogonal electrodes disposed at the free end of the catheter body, the orthogonal electrodes including multiple pairs of electrode pairs for generating pulsed electric fields acting on target cells; The orthogonal electrodes include a first electrode pair and a second electrode pair. The first electrode pair includes a first electrode and a second electrode oppositely disposed along the radial direction of the catheter body. The second electrode pair includes a third electrode and a fourth electrode oppositely disposed along the radial direction of the catheter body; the two pulsed electrodes of each pair of electrode pairs are oppositely disposed such that the line connecting the centers of the two pulsed electrodes passes through the center of the circular cross-section of the orthogonal electrodes; A plurality of reference electrodes are provided at one end of the catheter body close to the orthogonal electrodes, and the plurality of reference electrodes are disposed in one-to-one correspondence with the pulsed electrodes of the multiple pairs of electrode pairs along the axial direction of the catheter body; The orthogonal electrodes and the reference electrodes are configured to: use the first electrode, the second electrode, the third electrode, and the fourth electrode as cathodes, and their respective corresponding four reference electrodes as anodes to record a four-lead bipolar endocardial mapping electrogram for mapping the activation conduction direction of the target tissue site.

2. The orthogonal electrode pulsed electric field ablation catheter according to claim 1, wherein The first electrode, the third electrode, the second electrode, and the fourth electrode are evenly spaced along the circumferential direction of the catheter body.

3. The orthogonal electrode pulsed electric field ablation catheter according to claim 1, wherein The first electrode, the second electrode, the third electrode, and the fourth electrode are identical in size and shape.

4. The orthogonal electrode pulsed electric field ablation catheter according to claim 1, wherein The cross-sections of the first electrode, the second electrode, the third electrode, and the fourth electrode are all fan-shaped.

5. The orthogonal electrode pulsed electric field ablation catheter according to claim 1, wherein Insulating fillers are provided between the pulsed electrodes of the electrode pairs.

6. The orthogonal electrode pulsed electric field ablation catheter according to claim 1, characterized in that, The distance between the reference electrode and the corresponding pulsed electrode is not less than 2 mm.

7. The orthogonal electrode pulsed electric field ablation catheter according to claim 1, wherein A pressure sensor is provided at one end of the catheter body close to the orthogonal electrodes.

8. The orthogonal electrode pulsed electric field ablation catheter according to any one of claims 1-7, characterized in that, A plurality of positioning electrodes are provided at one end of the catheter body close to the orthogonal electrodes.

Images