CN111035447A

CN111035447A - Radio frequency ablation device

Info

Publication number: CN111035447A
Application number: CN201811183255.0A
Authority: CN
Inventors: 方咸宏; 黄晓波; 成正辉; 彭伟; 肖建华; 王昂
Original assignee: APT MEDICAL Inc; Guangzhou Qijun Biotechnology Co ltd
Current assignee: APT MEDICAL Inc; Guangzhou Qijun Biotechnology Co ltd
Priority date: 2018-10-11
Filing date: 2018-10-11
Publication date: 2020-04-21

Abstract

The invention relates to a radio frequency ablation device, which comprises a transmission tube and a plurality of ablation arms; the plurality of ablation arms are respectively connected with the transmission pipe, the ablation arms jointly form a ring shape, ablation pieces are respectively arranged on the ablation arms, the ablation pieces are electrically connected with the ablation wires, the ablation wires penetrate through the ablation arms and the pipe wall of the transmission pipe, and the ablation wires are used for being connected with radio frequency equipment. This radiofrequency ablation device, the guide makes the section of melting of a plurality of transmission pipes laminate in the pulmonary vein mouth when carrying out the atrial fibrillation treatment operation, can the ring formation melt, and easy operation is convenient, can shorten greatly and melt the operation time, is favorable to extensively promoting, satisfies vast atrial fibrillation patient's operation demand. In addition, the radiofrequency ablation device can isolate pulmonary vein signals, and can improve the vegetative nerve plexus outside the pulmonary vein opening to a certain extent, so that the effectiveness of atrial fibrillation ablation operation can be further improved.

Description

Radio frequency ablation device

Technical Field

The invention relates to the field of medical instruments, in particular to a radio frequency ablation device.

Background

Atrial fibrillation (atrial fibrillation) is the most common clinical arrhythmia, can cause serious complications such as cerebral apoplexy, heart failure and the like, seriously affects the life quality of patients and even can cause disability and death. The number of patients with atrial fibrillation worldwide is estimated to be 3350 thousands in 2010, survey shows that the prevalence rate of atrial fibrillation in China reaches 0.77%, and the total number of patients with atrial fibrillation is estimated to be 1000 thousands considering the huge population base in China. Atrial fibrillation not only threatens human health, but also imposes a huge economic burden on society, for example, with direct medical costs of $ 2000-.

The generation mechanism of atrial fibrillation is very complex, so that the treatment of atrial fibrillation becomes a great clinical problem. The current common interventional therapy methods are cryoablation and radiofrequency ablation.

Wherein, the general process of cryoablation is as follows: cryo-treatment forms ice crystals inside and outside the cells, and then rewarming is performed to necrose the cells, and direct damage is caused to the cells by removing heat, thereby cutting off electrical signals. However, cryoablation is mainly clinically applied to the treatment of paroxysmal atrial fibrillation at present, and for persistent atrial fibrillation, the cryoablation still needs to be researched. Although recent clinical studies increasingly show good prospects for cryoballoon catheter ablation in the treatment of persistent atrial fibrillation, its common complications such as phrenic nerve injury need to be addressed by further studies.

The radiofrequency ablation is a therapeutic method for ablation through a thermal effect, and can be clinically applied to the treatment of paroxysmal atrial fibrillation and persistent atrial fibrillation. However, with conventional rf ablation catheters, only one site can be ablated at a time, requiring about 50 sites to be ablated continuously to form a closed loop to isolate the pulmonary venous electrical signal. The traditional radiofrequency ablation catheter is difficult and tedious to operate, so that the interventional operation time is long, the learning curve is long, the treatment result depends on the experience of an operator to a great extent, the popularization is difficult to realize, and the operation requirement of patients with atrial fibrillation cannot be met.

Disclosure of Invention

Based on this, it is necessary to provide a radio frequency ablation device to solve the problems of the conventional radio frequency ablation catheter that the operation is difficult and complicated and the intervention operation time is long.

A radiofrequency ablation device comprises a transmission tube, an ablation wire and a plurality of ablation arms; each ablation arm is connected with the transmission pipe, the ablation arms surround the transmission pipe to form an annular structure together, an ablation piece is arranged on each ablation arm and is electrically connected with the ablation wire, the ablation wire penetrates through the ablation arms and the pipe wall of the transmission pipe, and the ablation wire is used for being connected with radio frequency equipment.

In one embodiment, the radiofrequency ablation device further comprises a head end basket connected to the plurality of ablation arms.

In one embodiment, the radiofrequency ablation device further comprises a pull wire and an adjusting handle, the pull wire is arranged in the tube wall of the transmission tube in a penetrating mode, the adjusting handle is connected to the pull wire, and the adjusting handle can adjust the bending direction of the transmission tube by retracting the pull wire so as to adjust the orientation of the head end basket.

In one embodiment, the head end basket is provided with a first developing mechanism.

In one embodiment, the end of the transfer tube near the ablation arm is provided with a second visualization mechanism.

In one of the embodiments, the ablation arm is provided with a mapping mechanism.

In one embodiment, the transmission pipe comprises an inner catheter and an outer catheter, the inner catheter is provided with a first transmission cavity, the outer catheter is sleeved on the inner catheter, a second transmission cavity is formed between the outer catheter and the inner catheter, the ablation arm is provided with a water cavity communicated with the second transmission cavity, and the ablation arm is provided with a circulation hole communicated with the water cavity at the position of the ablation piece.

In one embodiment, the transfer tube is provided with a first transfer nipple in communication with the first transfer chamber, and the transfer tube is further provided with a second transfer nipple in communication with the second transfer chamber.

In one embodiment, the delivery tube is provided with a connector device connected to the ablation line.

In one embodiment, the radiofrequency ablation device further comprises a temperature control wire, and the temperature control wire is arranged in the wall of the ablation arm and the delivery pipe in a penetrating mode.

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

above-mentioned radiofrequency ablation device guides when carrying out the atrial fibrillation treatment operation and makes a plurality of arms that melt laminate in the pulmonary vein mouth, can the annulation melt, and easy operation is convenient, can shorten greatly and melt the operation time, is favorable to extensively promoting, satisfies vast atrial fibrillation patient's operation demand.

The radiofrequency ablation device can isolate pulmonary vein signals, and can improve the vegetative nerve plexus outside the pulmonary vein opening to a certain extent, so that the effectiveness of atrial fibrillation ablation operation can be further improved.

In addition, the radiofrequency ablation device overcomes the following defects of the traditional radiofrequency ablation catheter:

when the traditional radiofrequency ablation catheter is adopted, the incidence rate of various complications is high (about 5 percent) due to the reasons that the operation time is long, certain positions may leak points and an ablation closed loop cannot be formed and the like, and the safety needs to be improved. The radio frequency ablation device is convenient to use, an ablation closed loop is convenient to form, the complication incidence rate can be reduced, and the safety is improved.

When the traditional radiofrequency ablation catheter is used, the operation time is long, and the repeated ablation of certain positions can release excessive heat, so that the pain incidence of a patient is high. The radiofrequency ablation device is short in operation time and can avoid the problem of repeated ablation, so that the pain incidence of a patient is reduced.

When the traditional radiofrequency ablation catheter is adopted, the operation time is long, and no cooling medium is used during ablation, so that the whole structure of cells and fibrous connective tissues around the cells are damaged, the cell surface of an ablation part is relatively unsmooth, and the possibility of thrombosis is increased. The radiofrequency ablation device is short in operation time and can be cooled through the temperature control wire and/or saline, and the possibility of thrombosis can be reduced.

Drawings

FIG. 1 is a schematic structural view of a radio frequency ablation device according to an embodiment;

FIG. 2 is a schematic structural view of an ablation member and a delivery tube of the RF ablation device shown in FIG. 1;

FIG. 3 is a schematic view of a portion of the RF ablation device of FIG. 1;

FIG. 4 is a schematic cross-sectional view of a delivery tube in the RF ablation device of FIG. 1;

fig. 5 is a schematic cross-sectional view of an ablation arm of the rf ablation device of fig. 1.

Detailed Description

To facilitate an understanding of the invention, the invention will now be described more fully with reference to the accompanying drawings. Preferred embodiments of the present invention are shown in the drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

It will be understood that when an element is referred to as being "secured to" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

As shown in fig. 1, a radiofrequency ablation device 10 of an embodiment of the present invention includes a delivery tube 100, a plurality of ablation arms 200, and an ablation wire 220.

Each ablation arm 200 is connected to the transfer tube 100, and the plurality of ablation arms 200 collectively enclose a ring around the transfer tube 100. Each ablation arm 200 is provided with an ablation piece 210, the ablation piece 210 is electrically connected with an ablation wire 220, the ablation wire 220 is arranged in the wall of the ablation arm 200 and the delivery pipe 100 in a penetrating manner, and the ablation wire 220 is used for connecting radio frequency equipment.

In the application process of the ablation principle of the radio frequency ablation device 10, the position of an abnormal structure causing tachycardia is checked and determined, then high-frequency current is locally released at the position, high temperature is generated in a small range, and water in local tissues is evaporated, dried and necrotized through thermal efficiency, so that the treatment purpose is achieved.

It should be noted that the plurality of ablation arms 200 together form a ring, which may be a closed ring or a ring with a gap, as shown in the figure. Because the ablated tissue site is generally not only the location where the ablation member 210 is attached, but also extends outward a distance from the location where the ablation member 210 is attached, it is not necessary that the plurality of ablation arms 200 (or ablation members 210) together form a closed loop, as long as the ablated tissue site forms a closed loop.

The ablation arm 200 and the ablation member 210 can be formed by winding a resistance wire around the ablation arm 200 or cutting a ring-shaped resistance wire into a wire shape.

With further reference to fig. 2, fig. 3 and fig. 5, the ablation arm 200 is communicated with the delivery tube 100 through a connecting arm 300, one end of the ablation arm 200 is connected with one end of the connecting arm 300, the ablation arm 200 and the connecting arm 300 are arranged at an included angle, and the other ends of the connecting arms 300 are converged and connected with one end of the delivery tube 100. In this example, the connection between the connecting arm 300 and the transfer tube 100 is made by a stainless steel ring.

In one example, there are 3-30 ablation arms 200. In one example, there are 4-20 ablation arms 200. In one example, there are 4-15 ablation arms 200. In one example, there are 4-10 ablation arms 200. In the example shown in fig. 2, there are 6 ablation arms 200.

In one example, the ablation arm 200 is provided with a mapping mechanism 400, and the mapping mechanism 400 can be used to detect and output electrical signals to facilitate understanding of the ablation effect. As shown in fig. 2, a marker ring is provided at each end of a plurality of ablation arms 200. In this example, the mapping mechanism 400 is electrically connected to a mapping wire 410, and the mapping wire 410 is threaded through the wall of the delivery tube 100 and the ablation arm 200.

As shown in fig. 1 and 2, in one example, the radiofrequency ablation device 10 further includes a head-end basket 400, the head-end basket 400 being connected to the plurality of ablation arms 200. Specifically, the head end basket 400 and the transfer tube 100 are located on either side of the ablation arm 200. The head end basket 500 can conveniently enter the pulmonary vein, so that the ablation arm annularly clings to the vestibule of the pulmonary vein.

Specifically, the head end basket 500 is pocket-shaped, and has an opening at the side where it is connected to the ablation arm 200 to facilitate connection. Alternatively, the head end basket 500 may be, but is not limited to, cut from nitinol tube for good flexibility.

Further, in one example, the radiofrequency ablation device 10 further comprises a pull wire 610 adjustment handle 600 and a pull wire 610, wherein the pull wire 610 is arranged in the pipe wall of the transmission pipe 100 in a penetrating manner, the pull wire 610 adjustment handle 600 is connected to the pull wire 610, and the adjustment handle 600 can adjust the bending direction of the transmission pipe by retracting the pull wire 610 so as to adjust the orientation of the head-end basket 500. By rotating the adjusting handle 600, the head end basket 500 can be adjusted to align with the pulmonary vein opening, so that the head end basket 500 can be inserted into the pulmonary vein, and the ablation arm 200 can be firmly attached to the pulmonary vein opening to perform ring-forming ablation.

In one example, a first visualization mechanism 520 is provided at an end of the head end basket 500 proximate the ablation arm 200 for imaging tissue proximate the head end basket 500 during a surgical procedure. As shown, a developer ring is welded to the end of the head end basket 500 opposite the transfer tube 100.

In one example, the end of the transfer tube 100 near the ablation arm 200 is provided with a second visualization mechanism 110. As shown in fig. 1, the transfer pipe 100 is provided with a developing ring at the connection with the connection arm 300.

As shown, in one example, the rf ablation device 10 further includes a temperature control wire 700, and the temperature control wire 700 is inserted through the wall of the delivery tube 100 and the ablation arm 200. In the ablation process, the temperature control line 700 at the ablation ring works to reduce the temperature, so that the over-high temperature during ablation is prevented. Further, the damage of the whole structure of the cell and the fibrous connective tissue around the cell can be effectively prevented by the cooling effect of the temperature control wire 700 and the saline, and the possibility of thrombosis is reduced.

As shown in fig. 4, in one example, the transfer tube 100 comprises an inner catheter 110 and an outer catheter 120, the outer catheter 120 is sleeved on the inner catheter 110, the inner catheter has a first delivery cavity 130, a second delivery cavity 140 is formed between the inner catheter 110 and the outer catheter 120, the ablation arm 200 has a water cavity 230 communicated with the second delivery cavity 140, and the ablation arm 200 is provided with a flow hole communicated with the water cavity 230 at the position of the ablation member 210. The first delivery lumen 130 may be used, among other things, to pass other devices or drugs, such as a guidewire, PV coil, etc. The second delivery lumen 140 can be used to deliver saline that flows out of the flow holes for cooling during the ablation process. In this example, transfer tube 100 is provided with a first transfer fitting 150 in communication with first transfer lumen 130, and a second transfer fitting 160 in communication with second transfer lumen 140.

In one example, the transfer tube 100 is further provided with a connector device 170, and the connector device 170 connects the wires in the transfer tube 100.

The operation of an exemplary rf ablation device 10 is described below.

1. Delivering the distal end of the radiofrequency ablation device 10 along the guidewire through the inner catheter 110 to the site of the pulmonary vein ostium;

2. rotating the adjustment handle 600 to adjust the orientation of the head end basket 500 until the head end basket 500 is aligned with the pulmonary vein ostium;

3. inserting the head end basket 500 into the pulmonary vein ostium to fit the ablation arm 200 to the pulmonary vein ostium;

4. connecting the first delivery sub 150, the second delivery sub 160 and the sub device 170 to the respective external devices;

5. mapping the electrical signals of the pulmonary vein ostia by a mapping mechanism 400 on the ablation arm 200;

6. the radiofrequency instrument is started, the ablation piece 200 on the ablation arm 200 will ablate the pulmonary vein ostium, and the temperature control line 700 is cooled down by injecting normal saline through the second delivery connector 160, so as to prevent the temperature at the ablation site from being too high.

7. The electrical signals of the pulmonary vein ostia are processed by the mapping mechanism 400 on the ablation arm 200, and the ablation condition is judged.

Above-mentioned radiofrequency ablation device 10 guides when carrying out the atrial fibrillation treatment operation and makes a plurality of arms 200 that melt laminate in the pulmonary vein mouth, can the ring formation melt, and easy operation is convenient, can shorten greatly and melt the operation time, is favorable to extensively promoting, satisfies vast atrial fibrillation patient's operation demand.

The radiofrequency ablation device 10 can isolate pulmonary vein signals, and can improve the vegetative nerve plexus outside the pulmonary vein opening to a certain extent, so that the effectiveness of atrial fibrillation ablation operation can be further improved.

In addition, the above-described rf ablation device 10 overcomes the following disadvantages of conventional rf ablation catheters:

when the traditional radiofrequency ablation catheter is adopted, the incidence rate of various complications is high (about 5 percent) due to the reasons that the operation time is long, certain positions may leak points and an ablation closed loop cannot be formed and the like, and the safety needs to be improved. The radiofrequency ablation device 10 is convenient to use, an ablation closed loop is convenient to form, the complication rate can be reduced, and the safety is improved.

When the traditional radiofrequency ablation catheter is used, the operation time is long, and the repeated ablation of certain positions can release excessive heat, so that the pain incidence of a patient is high. The radiofrequency ablation device 10 has short operation time and can avoid the problem of repeated ablation, thereby reducing the pain incidence of patients.

When the traditional radiofrequency ablation catheter is adopted, the operation time is long, and no cooling medium is used during ablation, so that the whole structure of cells and fibrous connective tissues around the cells are damaged, the cell surface of an ablation part is relatively unsmooth, and the possibility of thrombosis is increased. The radiofrequency ablation device 10 has a short procedure time and can be cooled by the temperature control wire 700 and/or saline, reducing the likelihood of thrombosis. The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. A radio frequency ablation device is characterized by comprising a transmission tube, an ablation wire and a plurality of ablation arms; each ablation arm is connected with the transmission pipe, the ablation arms surround the transmission pipe to form an annular structure together, an ablation piece is arranged on each ablation arm and is electrically connected with the ablation wire, the ablation wire penetrates through the ablation arms and the pipe wall of the transmission pipe, and the ablation wire is used for being connected with radio frequency equipment.

2. The radiofrequency ablation device of claim 1, further comprising a head end basket coupled to the plurality of ablation arms.

3. The radiofrequency ablation device of claim 2, further comprising a pull wire disposed through a wall of the transfer tube and an adjustment handle coupled to the pull wire, the adjustment handle being capable of adjusting the orientation of the head end basket by retracting the pull wire to adjust the bend of the transfer tube.

4. The radiofrequency ablation device of claim 2, wherein the head end basket is provided with a first visualization mechanism.

5. The rf ablation device of claim 1 wherein the transfer tube is provided with a second visualization mechanism at an end proximate the ablation arm.

6. The radiofrequency ablation device of claim 1, wherein the ablation arm is provided with a mapping mechanism.

7. The radiofrequency ablation device of claim 1, wherein the delivery tube comprises an inner catheter having a first delivery lumen and an outer catheter fitted over the inner catheter, a second delivery lumen being formed between the outer catheter and the inner catheter, the ablation arm having a water lumen communicating with the second delivery lumen, the ablation arm having a flow aperture communicating with the water lumen at a location where the ablation element is located.

8. The radiofrequency ablation device of claim 7, wherein the transfer tube is provided with a first delivery fitting in communication with the first delivery lumen, the transfer tube further provided with a second delivery fitting in communication with the second delivery lumen.

9. The radiofrequency ablation device of claim 1, wherein the delivery tube is provided with a connector device connected to the ablation wire.

10. The radiofrequency ablation device of any one of claims 1 to 9, further comprising a temperature control wire, the temperature control wire being disposed through the wall of the delivery tube and the ablation arm.