CN113331941A

CN113331941A - Bipolar adjustable punctiform ablation catheter and equipment thereof

Info

Publication number: CN113331941A
Application number: CN202110746421.9A
Authority: CN
Inventors: 戴宇峰; 潘炳跃; 唐瑜珅; 董宇国
Original assignee: Shanghai Hanyu Medical Technology Co ltd
Current assignee: Shanghai Hanyu Medical Technology Co ltd
Priority date: 2021-07-01
Filing date: 2021-07-01
Publication date: 2021-09-03

Abstract

The invention relates to a bipolar adjustable punctiform ablation catheter and equipment thereof, belonging to the technical field of medical instruments. Comprises a handle, a fixed sheath tube, a near-end electrode, a moving sheath tube, a driving guide wire, a far-end electrode and a soft connecting ring; a fixed sheath tube is arranged on the handle, and a near-end electrode is arranged on the fixed sheath tube; one end of the fixed sheath tube, which is far away from the handle, is sleeved with a moving sheath tube, and a flexible connecting ring with adjustable length is arranged between the fixed sheath tube and the moving sheath tube; the moving sheath tube is provided with a far-end electrode, and a driving guide wire is also arranged between the moving sheath tube and the handle. The invention can control the range of the ablation electric field by adjusting the interval between the two electrodes; the spot-shaped electrode distribution is adopted, so that the accurate ablation of fixed point and positioning is realized; by adjusting the electrode spacing and the matching voltage, precise ablation for removing a focus is realized, and surrounding healthy tissues are kept as much as possible.

Description

Bipolar adjustable punctiform ablation catheter and equipment thereof

Technical Field

The invention relates to a bipolar adjustable punctiform ablation catheter and equipment thereof, belonging to the technical field of medical instruments. In the invention, one end close to the operator is set as a near end, and the other end far away from the operator is set as a far end.

Background

In a high voltage electrical pulse ablation system (PFA), an ablation catheter electrode is the key device for electrical pulse-forming electric field release in contact with or near the body tissue being treated. The electric pulse electrode is used for converting high-voltage direct current electric pulse into an electric field, and irreversible perforation is formed on cells through the electric field to enable the cells to die, so that focus is eliminated. During the operation, the voltage amplitude on the electrodes of the ablation catheter and the distance between the electrodes have direct influence on the intensity and effective range of an ablation electric field, so that the treatment effect of the ablation operation is influenced. In ablating localized, even punctiform lesions, it is desirable to eliminate the lesion while preserving the surrounding healthy tissue, and therefore, there is a need in the art for punctiform electrodes and catheters that are capable of forming a small range of ablating electric fields.

At present, in the field of electric pulse ablation, the electrodes of most ablation catheters are arranged in three-dimensional structures such as a ring, a sphere, a cylinder and the like during ablation, so that a generated ablation electric field is of an omnibearing structure, the ablation shape on tissues is basically a ring, and the function of point ablation cannot be realized; at present, the spacing between the electrodes of most ablation catheters is a fixed distance, the distance cannot be adjusted, so that the effective range of an ablation electric field cannot be adjusted, and the spacing of the electrodes cannot be adjusted in real time according to the actual conditions of different organ tissues and different parts. Chinese patent nos. CN201780005770 and CN201880033278 disclose an electrode structure, which distributes electrodes on different splines, and a typical structure thereof adopts 5 sets of splines, and 4 electrodes are fixedly distributed on each set of splines, and the spacing of the electrodes cannot be adjusted; it can be unfolded into petal-shaped structure and spherical structure, all of them are all-round structure, can not implement local ablation. Chinese patent No. CN201680046257 discloses an irreversible electroporation ablation electrode structure, which is configured to be a ring-shaped structure, and also cannot adjust the spacing of the electrodes and realize local ablation. Therefore, the technical field needs to adjust the voltage amplitude on the ablation electrode and the spacing distance between the electrodes according to the actual requirements of the operation to realize the adjustment of the intensity and the effective range of the ablation electric field; there is a need for an ablation catheter structure that enables localized spot ablation while preserving surrounding healthy tissue.

Disclosure of Invention

The invention aims to solve the problem that how to adjust the voltage amplitude on an ablation electrode and the spacing distance between the electrodes according to the actual requirements of an operation so as to realize the adjustment of the intensity and the effective range of an ablation electric field; and how to achieve local spot ablation while preserving surrounding healthy tissue.

In order to solve the problems, the technical scheme adopted by the invention is to provide a bipolar adjustable punctiform ablation catheter which comprises a handle, a fixed sheath, a proximal electrode, a moving sheath, a driving guide wire, a distal electrode and a soft connecting ring; a fixed sheath tube is arranged on the handle, and a near-end electrode is arranged on the fixed sheath tube; one end of the fixed sheath tube, which is far away from the handle, is sleeved with a moving sheath tube, and a flexible connecting ring with adjustable length is arranged between the fixed sheath tube and the moving sheath tube; the moving sheath tube is provided with a far-end electrode, and a driving guide wire is also arranged between the moving sheath tube and the handle.

Preferably, the outer surface of one end of the fixed sheath far away from the handle is provided with a proximal electrode; and a distal electrode is arranged on the outer surface of one end of the moving sheath far away from the handle.

Preferably, a soft connecting ring is arranged between one end of the fixed sheath far away from the handle and one end of the moving sheath close to the handle.

Preferably, the soft connecting ring is provided with a sealing structure.

Preferably, the handle is provided with a driving push button, and the driving push button is connected with the driving guide wire.

Preferably, one end of the driving guide wire is connected with the driving push button, and the other end of the driving guide wire is arranged at the tail end, far away from the handle, of the moving sheath.

Preferably, an electric connector is arranged on the handle, and insulated wires are respectively arranged between the electric connector and the proximal electrode and between the electric connector and the distal electrode.

Preferably, the proximal and distal electrodes are configured in a complete ring, semi-ring, 1/3 ring, or 1/4 ring.

The invention provides an ablation device consisting of the bipolar adjustable punctiform ablation catheter, which comprises an ablation catheter, a high-voltage pulse generator and a control module; the control module is connected with the ablation catheter through the high-voltage pulse generator.

Compared with the prior art, the invention has the following beneficial effects:

1. the invention can adjust the interval of the two electrodes, so that the range of an ablation electric field is more controllable;

2. the invention has the advantages that the punctiform electrode distribution is arranged, so that the accurate ablation of fixed point and positioning can be realized;

3. according to the invention, through the adjustment of the electrode interval and the adjustment of the matching voltage, the precise ablation of the focus point to be removed can be realized, and meanwhile, the surrounding healthy tissues are kept as much as possible.

Drawings

Fig. 1 is a schematic structural view of a bipolar adjustable punctiform ablation catheter and the equipment thereof.

FIG. 2 is a schematic diagram of an electrode structure according to the present invention.

Fig. 3 is a schematic view of an ablation catheter of the present invention.

FIG. 4 is a schematic diagram of a high voltage pulse waveform according to the present invention.

Fig. 5 is a schematic diagram of the present invention for performing nerve ablation.

Fig. 6 is a schematic illustration of the present invention for performing myocardial tissue ablation.

FIG. 7 is a schematic diagram of different types of electrodes according to the present invention.

FIG. 8 is a schematic view of a fixed-spacing electrode according to the present invention.

Reference numerals: 1. a high voltage pulse generator; 2. a control module; 3. an ablation catheter; 31. a handle; 32. fixing the sheath tube; 33. a proximal electrode; 34. a moving sheath; 35. a distal electrode; 36. a flexible connecting ring; 37. driving the guide wire; 38. an insulated wire; 311. rotating the head; 312. driving the push button; 313. an electrical connector; 4. an electric field; 5. a nerve; 6. a blood vessel.

Detailed Description

In order to make the invention more comprehensible, preferred embodiments are described in detail below with reference to the accompanying drawings:

as shown in fig. 1-8, the present invention provides a bipolar adjustable punctiform ablation catheter, which comprises a handle 31, a fixed sheath 32, a proximal electrode 33, a moving sheath 34, a driving guide wire 37, a distal electrode 35 and a soft connecting ring 36; a fixed sheath 32 is arranged on the handle 31, and a near-end electrode 33 is arranged on the fixed sheath 32; one end of the fixed sheath 32, which is far away from the handle, is sleeved with a moving sheath 34, and a flexible connecting ring 36 with adjustable length is arranged between the fixed sheath 32 and the moving sheath 34; a distal electrode 35 is arranged on the moving sheath 34, and a driving guide wire 37 is also arranged between the moving sheath 34 and the handle 31. The outer surface of one end of the fixed sheath 32 far away from the handle 31 is provided with a proximal electrode 33; the outer surface of the moving sheath 34 at the end remote from the handle 31 is provided with a distal electrode 35. A soft connecting ring 36 is arranged between one end of the fixed sheath 32 far away from the handle 31 and one end of the moving sheath 34 close to the handle 31. The flexible connecting ring 36 is provided with a sealing structure. The handle 31 is provided with a driving push button 312, and the driving push button 312 is connected with the driving guide wire 37. One end of the driving guide wire 37 is connected to the driving push button 312, and the other end of the driving guide wire 37 is disposed at the end of the moving sheath 34 away from the handle 31. An electrical connector 313 is provided on the handle 31, and insulated wires 38 are provided between the electrical connector 313 and the proximal and

distal electrodes

33 and 35, respectively. The outer shape of the proximal electrode 33 and the distal electrode 35 is provided as a complete ring, a semi-ring, an 1/3 ring, or a 1/4 ring.

The invention provides an ablation device consisting of a bipolar adjustable punctiform ablation catheter 3, which comprises the ablation catheter 3, a high-voltage pulse generator 1 and a control module 2; the control module 2 is connected with the ablation catheter 3 through the high-voltage pulse generator 1.

As shown in fig. 1-8, the ablation apparatus of the present invention is composed of a high voltage pulse generator 1, a control module 2, and an ablation catheter 3, wherein the ablation catheter 3 includes a handle 31, a fixed sheath 32, a proximal electrode 33, a moving sheath 34, a distal electrode 35, a flexible connecting ring 36, a driving guide wire 37, and an insulated wire 38; the handle 31 includes a rotating head 311, a drive push button 312, and an electrical connector 313. Wherein:

1) the high-voltage pulse generator 1 is connected with the ablation catheter 3 through an electric connector 313, parameters of pulses sent by the high-voltage pulse generator 1 are controlled and adjusted by the control module 2, and the electric pulses are transmitted to the near-end electrode 33 and the far-end electrode 35 through the insulated conducting wire 38;

2) the high voltage pulse generator 1 generates an electric pulse waveform as shown in fig. 4;

3) the proximal electrode 33 and the fixed sheath 32 are integrated by adopting the processes of hot melting, gluing, welding and the like; the distal electrode 35 and the moving sheath 34 are integrated by the same processes of hot melting, gluing, welding and the like; the fixed sheath 32 and the moving sheath 34 are respectively connected and sealed with the soft connecting ring 36 through processes of hot melting, gluing, welding and the like;

4) the proximal end of the driving guide wire 37 is connected with the driving push button 312 through common mechanical structures such as gears, racks and the like, and the distal end is connected with the distal end of the moving sheath 34; the forward and backward pushing of the driving push button 312 drives the driving guide wire 37 to move forward and backward, so as to adjust the distance between the proximal electrode 33 and the distal electrode 35, and meanwhile, the length of the soft connecting ring 36 is correspondingly adjusted and the sealing is kept;

5) the adjustable distance between the proximal electrode 33 and the distal electrode 35 ranges from 2mm to 50 mm.

Under the action of an electric field 4 generated by electric pulse, different tissues of a human body, such as cardiac muscle cells, kidneys, livers, blood vessels 6, nerves 5 and the like, the threshold values of irreversible electroporation of the cells are different, the threshold value of the cardiac muscle cells is the minimum, the thresholds of the kidneys, the livers and the blood vessels 6 are sequentially increased, and the nerves 5 are the maximum, so that the structure can directionally ablate different tissue structures by adjusting the distance between the electrodes and the amplitude of voltage released by the electrodes. The specific embodiment is as follows:

1) as shown in fig. 5, when the nerve 5 tissue is ablated, because the voltage threshold of the electroporation is the highest, the driving push button 312 is pushed to adjust the distance between the proximal electrode 33 and the distal electrode 35 to be 2-10mm, the range of the electric field 4 is similar to an ellipse, and the pulse voltage is adjusted to be more than 4000V, so that the fixed-point and positioned irreversible electroporation ablation of the nerve 5 is realized;

2) as shown in fig. 6, when the myocardial tissue is ablated, because the voltage threshold of the electroporation is low, the driving push button 312 is pushed to adjust the distance between the proximal electrode 33 and the distal electrode 35 to be 2-50mm, and when the distance is large, the range of the electric field 4 is similar to that of a peanut shape, the pulse voltage is adjusted to 400-;

3) when tissues such as kidney, liver, blood vessel and the like are ablated, the drive push button 312 is pushed to adjust the distance between the near-end electrode 33 and the far-end electrode 35 to be 2-50mm, the pulse voltage is adjusted to be 2000V-4000V, different ablations such as positioned points, sheets and the like can be realized, and simultaneously, the nervous system is reserved without generating damage;

the specific shape of the ablation electrode can be a complete ring, and can also be a semi-ring, 1/3, 1/4 ring and the like, as shown in detail in fig. 7.

In another embodiment, the spacing between the proximal electrode 33 and the distal electrode 35 is fixed and non-adjustable, allowing for a fixed range of electric field ablation, as shown in detail in FIG. 8.

While the invention has been described with respect to a preferred embodiment, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention. Those skilled in the art can make various changes, modifications and equivalent arrangements, which are equivalent to the embodiments of the present invention, without departing from the spirit and scope of the present invention, and which may be made by utilizing the techniques disclosed above; meanwhile, any changes, modifications and variations of the above-described embodiments, which are equivalent to those of the technical spirit of the present invention, are within the scope of the technical solution of the present invention.

Claims

1. A bipolar adjustable punctual ablation catheter characterized by: comprises a handle, a fixed sheath tube, a near-end electrode, a moving sheath tube, a driving guide wire, a far-end electrode and a soft connecting ring; a fixed sheath tube is arranged on the handle, and a near-end electrode is arranged on the fixed sheath tube; one end of the fixed sheath tube, which is far away from the handle, is sleeved with a moving sheath tube, and a flexible connecting ring with adjustable length is arranged between the fixed sheath tube and the moving sheath tube; the moving sheath tube is provided with a far-end electrode, and a driving guide wire is also arranged between the moving sheath tube and the handle.

2. A bipolar adjustable punctual ablation catheter according to claim 1 characterized in that: the outer surface of one end of the fixed sheath tube, which is far away from the handle, is provided with a near-end electrode; and a distal electrode is arranged on the outer surface of one end of the moving sheath far away from the handle.

3. A bipolar adjustable punctual ablation catheter according to claim 2 characterized in that: and a soft connecting ring is arranged between one end of the fixed sheath far away from the handle and one end of the moving sheath close to the handle.

4. A bipolar adjustable punctual ablation catheter according to claim 3 characterized in that: the flexible connecting ring is provided with a sealing structure.

5. A bipolar adjustable punctual ablation catheter according to claim 4 characterized in that: the handle is provided with a driving push button, and the driving push button is connected with the driving guide wire.

6. A bipolar adjustable punctual ablation catheter according to claim 5 characterized in that: one end of the driving guide wire is connected with the driving push button, and the other end of the driving guide wire is arranged at the tail end, far away from the handle, of the moving sheath tube.

7. A bipolar adjustable punctual ablation catheter according to claim 6 characterized in that: an electric connector is arranged on the handle, and insulated wires are respectively arranged between the electric connector and the near-end electrode and between the electric connector and the far-end electrode.

8. A bipolar adjustable punctual ablation catheter according to claim 7 characterized in that: the proximal and distal electrodes are configured in a complete ring, semi-ring, 1/3 ring, or 1/4 ring.

9. An ablation device in the form of a bipolar adjustable ablation catheter of any of claims 1-8, wherein: the ablation device comprises an ablation catheter, a high-voltage pulse generator and a control module; the control module is connected with the ablation catheter through the high-voltage pulse generator.