Radiofrequency ablation device

Abstract

The present invention relates to a radiofrequency ablation device, comprising a transmission tube and a plurality of ablation arms; the plurality of ablation arms are respectively connected to the transmission tube, the plurality of ablation arms are collectively ring-shaped, the plurality of ablation arms are respectively provided with ablation parts, the ablation parts are electrically connected to ablation wires, the ablation wires are passed through the ablation arms and the tube walls of the transmission tubes, and the ablation wires are used to connect radiofrequency equipment. The radiofrequency ablation device can guide the ablation segments of the plurality of transmission tubes to fit the pulmonary vein orifices during atrial fibrillation treatment surgery, so as to form a ring ablation, and the operation is simple and convenient, which can greatly shorten the ablation surgery time, is conducive to wide promotion, and meets the surgical needs of a large number of atrial fibrillation patients. In addition, in addition to isolating the pulmonary vein electrical signals, the radiofrequency ablation device can also make a certain degree of improvement to the autonomic nerve plexus outside the pulmonary vein orifices, thereby further improving the effectiveness of atrial fibrillation ablation surgery.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a radiofrequency ablation device. Background Art

[0002] Atrial fibrillation (AF) is the most common clinical arrhythmia, which can lead to serious complications such as stroke and heart failure, seriously affecting the patient's quality of life, and may even cause disability or death. In 2010, the number of AF patients worldwide was estimated to be 33.5 million. Surveys show that the prevalence of AF in my country is 0.77%. Considering my country's huge population base, the total number of AF patients is estimated to be 10 million. AF not only threatens human health, but also imposes a huge economic burden on society. For example, its direct medical cost is US$2,000-14,200 per person per year in the United States and EUR 450-3,000 per person per year in Europe.

[0003] The mechanism of atrial fibrillation is very complex, making its treatment a major clinical problem. Currently, the most common interventional treatments are cryoablation and radiofrequency ablation.

[0004] The general process of cryoablation is: low temperature treatment causes ice crystals to form inside and outside the cells, and then rewarming causes cell necrosis. By removing heat, direct damage is caused to the cells, thereby isolating electrical signals. However, cryoablation is currently mainly used in the treatment of paroxysmal atrial fibrillation in clinical practice, while persistent atrial fibrillation remains to be studied. Although clinical studies in recent years have increasingly shown the good prospects of cryoballoon catheter ablation in the treatment of persistent atrial fibrillation, its common complications such as phrenic nerve injury still need further research to be resolved.

[0005] Radiofrequency ablation is a treatment method that uses thermal effects to ablate. It can be used clinically to treat paroxysmal atrial fibrillation and persistent atrial fibrillation. However, with traditional radiofrequency ablation catheters, only one site can be ablated at a time. It is necessary to continuously ablate about 50 sites to form a closed loop to isolate the pulmonary vein electrical signals. Traditional radiofrequency ablation catheters are difficult and cumbersome to operate, resulting in long interventional procedures and a long learning curve. The treatment results largely depend on the operator's experience, which is not easy to promote widely and cannot meet the surgical needs of the majority of atrial fibrillation patients. Summary of the invention

[0006] Based on this, it is necessary to provide a radiofrequency ablation device to solve the problems of difficult and complicated operation of traditional radiofrequency ablation catheters and long interventional surgery time.

[0007] A radiofrequency ablation device comprises a transmission tube, an ablation wire and a plurality of ablation arms; each of the ablation arms is connected to the transmission tube, and the plurality of ablation arms surround the transmission tube to form a ring structure; each of the ablation arms is provided with an ablation element, and the ablation element is electrically connected to the ablation wire; the ablation wire is passed through the ablation arm and the tube wall of the transmission tube, and the ablation wire is used to connect a radiofrequency device.

[0008] In one embodiment, the radiofrequency ablation device further comprises a head end basket, and the head end basket is connected to the plurality of ablation arms.

[0009] In one embodiment, the radiofrequency ablation device further includes a traction wire and an adjustment handle, wherein the traction wire is passed through the tube wall of the transmission tube, and the adjustment handle is connected to the traction wire. The adjustment handle can adjust the bending direction of the transmission tube and thus adjust the orientation of the head end basket by retracting and releasing the traction wire.

[0010] In one of the embodiments, the head end basket is provided with a first developing mechanism.

[0011] In one embodiment, a second developing mechanism is disposed at one end of the transmission tube close to the ablation arm.

[0012] In one embodiment, the ablation arm is provided with a mapping mechanism.

[0013] In one embodiment, the transmission tube includes an inner catheter and an outer catheter, the inner catheter has a first delivery cavity, the outer catheter is sleeved on the inner catheter, a second delivery cavity is formed between the outer catheter and the inner catheter, the ablation arm has a water cavity connected to the second delivery cavity, and the ablation arm is provided with a flow hole connected to the water cavity at the position where the ablation element is located.

[0014] In one embodiment, the transmission tube is provided with a first transmission joint communicating with the first transmission cavity, and the transmission tube is also provided with a second transmission joint communicating with the second transmission cavity.

[0015] In one embodiment, the transmission tube is provided with a connector device connected to the ablation wire.

[0016] In one embodiment, the radiofrequency ablation device further includes a temperature control wire, and the temperature control wire is passed through the ablation arm and the tube wall of the transmission tube.

[0017] Compared with the existing solutions, the present invention has the following beneficial effects:

[0018] The above-mentioned radiofrequency ablation device can guide multiple ablation arms to fit the pulmonary vein orifices during atrial fibrillation treatment surgery to form a ring ablation. The operation is simple and convenient, and the ablation surgery time can be greatly shortened. It is conducive to wide promotion and meets the surgical needs of the majority of atrial fibrillation patients.

[0019] In addition to isolating the pulmonary vein electrical signals, the above-mentioned radiofrequency ablation device can also improve the autonomic nerve plexus outside the pulmonary vein orifice to a certain extent, thereby further improving the effectiveness of atrial fibrillation ablation surgery.

[0020] In addition, the above-mentioned radiofrequency ablation device also overcomes the following disadvantages of the traditional radiofrequency ablation catheter:

[0021] When using traditional radiofrequency ablation catheters, the operation time is long and some locations may leak points and fail to form an ablation closed loop, resulting in a high incidence of various complications (about 5%), and the safety needs to be improved. The above radiofrequency ablation device is more convenient to use and can easily form an ablation closed loop, which can reduce the incidence of complications and improve safety.

[0022] When using traditional radiofrequency ablation catheters, the operation time is long and repeated ablation of certain locations may release too much heat, resulting in a high incidence of pain in patients. The above radiofrequency ablation device has a short operation time and can avoid the problem of repeated ablation, thereby reducing the incidence of pain in patients.

[0023] When using traditional radiofrequency ablation catheters, the operation time is long and there is no cooling medium during ablation, which destroys the overall structure of cells and the fibrous connective tissue around the cells, and the cell surface at the ablation site is relatively uneven, increasing the possibility of thrombosis. The above-mentioned radiofrequency ablation device has a short operation time and can be cooled by temperature control wire and / or saline, which can reduce the possibility of thrombosis. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 is a schematic structural diagram of a radiofrequency ablation device according to an embodiment;

[0025] Figure 2 for Figure 1 A schematic diagram of the structure of the ablation element and the transmission tube of the radiofrequency ablation device shown;

[0026] Figure 3 for Figure 1 A schematic diagram of a local structure of a radiofrequency ablation device shown;

[0027] Figure 4 for Figure 1 A cross-sectional schematic diagram of a transmission tube in a radiofrequency ablation device shown;

[0028] Figure 5 for Figure 1 The cross-sectional schematic diagram of the ablation arm in the radiofrequency ablation device is shown. DETAILED DESCRIPTION

[0029] In order to facilitate the understanding of the present invention, the present invention will be described more fully below with reference to the relevant drawings. The preferred embodiments of the present invention are given in the drawings. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the understanding of the disclosure of the present invention more thorough and comprehensive.

[0030] It should be noted that when an element is referred to as being "fixed to" another element, it may be directly on the other element or there may be an intermediate element. When an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be an intermediate element at the same time.

[0031] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art of the present invention. The terms used herein in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "and / or" used herein includes any and all combinations of one or more related listed items.

[0032] like Figure 1 As shown, a radiofrequency ablation device 10 according to an embodiment of the present invention includes a transmission tube 100 , a plurality of ablation arms 200 , and an ablation wire 220 .

[0033] Each ablation arm 200 is connected to the transmission tube 100, and the multiple ablation arms 200 are arranged in a ring around the transmission tube 100. Each ablation arm 200 is provided with an ablation element 210, and the ablation element 210 is electrically connected to an ablation wire 220, and the ablation wire 220 is passed through the ablation arm 200 and the tube wall of the transmission tube 100, and the ablation wire 220 is used to connect the radio frequency device.

[0034] The ablation principle of the radiofrequency ablation device 10 of this embodiment is the principle of radiofrequency ablation. During the application process, the location of the abnormal structure causing tachycardia is first checked and determined, and then a high-frequency current is released locally at that location to generate a very high temperature in a very small range. Through thermal efficiency, the moisture in the local tissue is evaporated, dried and necrotic, thereby achieving the treatment purpose.

[0035] It should be noted that the multiple 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 in general, the tissue site to be ablated is not just the location where the ablation element 210 is attached, but a certain distance spread outward from the location where the ablation element 210 is attached, it is not necessary for multiple ablation arms 200 (or ablation elements 210) to form a closed ring together, as long as the tissue site to be ablated can form a closed ring.

[0036] The ablation element 210 of the ablation arm 200 may be formed by winding a resistance wire around the ablation arm 200 , or may be formed by cutting a ring-shaped resistor into a wire shape.

[0037] Please further combine Figure 2 , Figure 3 and Figure 5 The ablation arm 200 and the transmission tube 100 are connected through the connecting arm 300, one end of the ablation arm 200 is connected to one end of the connecting arm 300, the ablation arm 200 and the connecting arm 300 are arranged at an angle, and the other ends of the multiple connecting arms 300 converge and are connected to one end of the transmission tube 100. In this example, the connecting arm 300 and the transmission tube 100 are connected by a stainless steel ring.

[0038] In one example, there are 3 to 30 ablation arms 200. In one example, there are 4 to 20 ablation arms 200. In one example, there are 4 to 15 ablation arms 200. In one example, there are 4 to 10 ablation arms 200. Figure 2 In the example shown, there are six ablation arms 200 .

[0039] In one example, the ablation arm 200 is provided with a mapping mechanism 400, which can be used to detect and output electrical signals to facilitate the acquisition of ablation effects. Figure 2 As shown, a mapping ring is disposed at the end of each of the 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 disposed in the ablation arm 200 and the tube wall of the transmission tube 100.

[0040] like Figure 1 and Figure 2 As shown, in one example, the radiofrequency ablation device 10 further includes a head end basket 400, which is connected to a plurality of ablation arms 200. Specifically, the head end basket 400 and the transmission tube 100 are respectively located on both sides of the ablation arm 200. The head end basket 500 can conveniently enter the pulmonary vein, so that the ablation arm is annularly attached to the vestibule of the pulmonary vein.

[0041] Specifically, the head end basket 500 is in the shape of a net bag, and has an opening on the connection side with the ablation arm 200 for easy connection. Optionally, the head end basket 500 can be but is not limited to being made by cutting a nickel-titanium alloy tube, and has good flexibility.

[0042] Furthermore, in one example, the radiofrequency ablation device 10 further includes a traction line 610 adjustment handle 600 and the traction line 610, the traction line 610 is inserted into the tube wall of the transmission tube 100, the traction line 610 adjustment handle 600 is connected to the traction line 610, and the adjustment handle 600 can adjust the bending direction of the transmission tube by retracting and releasing the traction line 610 to adjust the orientation of the head end basket 500. By rotating the adjustment handle 600, the head end basket 500 can be adjusted to align with the pulmonary vein opening, thereby ensuring that the head end basket 500 can be inserted into the pulmonary vein, so that the ablation arm 200 is firmly attached to the pulmonary vein opening for loop ablation.

[0043] In one example, a first developing mechanism 520 is provided at one end of the head end basket 500 near the ablation arm 200 for imaging tissue near the head end basket 500 during surgery. As shown in the figure, a developing ring is welded to one end of the head end basket 500 opposite to the transmission tube 100.

[0044] In one example, a second developing mechanism 110 is disposed at one end of the transmission tube 100 close to the ablation arm 200. Figure 1 As shown, the transmission tube 100 is provided with a developing ring at the connection with the connecting arm 300 .

[0045] As shown in the figure, in one example, the radiofrequency ablation device 10 further includes a temperature control wire 700, which is inserted into the ablation arm 200 and the wall of the transmission tube 100. During the ablation process, the temperature control wire 700 at the ablation ring works to reduce the temperature to prevent the temperature from being too high during ablation. Furthermore, through the combined cooling effect of the temperature control wire 700 and saline, the overall structure of the cells and the fibrous connective tissue around the cells can be effectively prevented from being destroyed, reducing the possibility of thrombosis.

[0046] like Figure 4 As shown, in one example, the transmission tube 100 includes 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 lumen 130, a second delivery lumen 140 is formed between the inner catheter 110 and the outer catheter 120, the ablation arm 200 has a water lumen 230 connected to the second delivery lumen 140, and the ablation arm 200 is provided with a flow hole connected to the water lumen 230 at the position where the ablation element 210 is located. Among them, the first delivery lumen 130 can be used to pass other instruments or drugs such as a guide wire and a PV coil. The second delivery lumen 140 can be used to deliver saline, and during the ablation process, the saline flows out from the flow hole for cooling. In this example, the transmission tube 100 is provided with a first delivery connector 150 connected to the first delivery lumen 130, and a second delivery connector 160 connected to the second delivery lumen 140.

[0047] In one example, the transmission tube 100 is further provided with a connector device 170 , and the connector device 170 connects the wires in the transmission tube 100 .

[0048] The following describes the working process of an exemplary radiofrequency ablation device 10 .

[0049] 1. Deliver the distal end of the radiofrequency ablation device 10 to the position of the pulmonary vein orifice through the inner catheter 110 along the guide wire;

[0050] 2. Rotate the adjustment handle 600 to adjust the direction of the head end basket 500 until the head end basket 500 is aligned with the pulmonary vein opening;

[0051] 3. Insert the head end basket 500 into the pulmonary vein opening, so that the ablation arm 200 fits the pulmonary vein opening;

[0052] 4. Connect the first delivery joint 150, the second delivery joint 160 and the joint device 170 to corresponding external devices;

[0053] 5. Mapping the electrical signal of the pulmonary vein orifice by the mapping mechanism 400 on the ablation arm 200;

[0054] 6. Start the radiofrequency instrument, and the ablation element 200 on the ablation arm 200 will ablate the pulmonary vein opening. At the same time, physiological saline is injected through the second delivery connector 160 and the temperature control line 700 is used to cool down to prevent the temperature at the ablation site from being too high.

[0055] 7. The mapping mechanism 400 on the ablation arm 200 measures the electrical signal at the pulmonary vein orifice to determine the ablation status.

[0056] The radiofrequency ablation device 10 can guide multiple ablation arms 200 to fit the pulmonary vein openings during atrial fibrillation treatment surgery to form a ring ablation. The operation is simple and convenient, and the ablation surgery time can be greatly shortened, which is conducive to wide promotion and meets the surgical needs of a large number of atrial fibrillation patients.

[0057] The radiofrequency ablation device 10 can not only isolate the pulmonary vein electrical signals, but also improve the autonomic nerve plexus outside the pulmonary vein orifice to a certain extent, thereby further improving the effectiveness of atrial fibrillation ablation surgery.

[0058] In addition, the above-mentioned radiofrequency ablation device 10 also overcomes the following disadvantages of the traditional radiofrequency ablation catheter:

[0059] When using traditional radiofrequency ablation catheters, the operation time is long, some positions may leak points and fail to form an ablation closed loop, resulting in a high incidence of various complications (about 5%), and the safety needs to be improved. The above radiofrequency ablation device 10 is more convenient to use and can easily form an ablation closed loop, which can reduce the incidence of complications and improve safety.

[0060] When using a traditional radiofrequency ablation catheter, the operation time is long and some parts may be repeatedly ablated to release too much heat, resulting in a high incidence of pain in patients. The radiofrequency ablation device 10 has a short operation time and can avoid the problem of repeated ablation, thereby reducing the incidence of pain in patients.

[0061] When using a traditional radiofrequency ablation catheter, due to the long operation time and the lack of cooling medium during ablation, the overall structure of the cells and the fibrous connective tissue around the cells are destroyed, and the cell surface at the ablation site is relatively uneven, which increases the possibility of thrombosis. The above-mentioned radiofrequency ablation device 10 has a short operation time and can be cooled by the temperature control line 700 and / or saline, which can reduce the possibility of thrombosis. The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, all possible combinations of the technical features in the above-mentioned embodiments are not described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0062] The above-mentioned embodiments only express several implementation methods of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. A radiofrequency ablation device, characterized in that: It includes a transmission tube, an ablation wire, a head-end mesh basket and a plurality of ablation arms; there are 3 to 30 ablation arms, each of which is connected to the transmission tube, and the plurality of ablation arms surround the transmission tube to form a ring structure together, each of the ablation arms is provided with an ablation component, and the ablation component is electrically connected to the ablation wire, the ablation wire is passed through the ablation arm and the tube wall of the transmission tube, the ablation wire is used to connect to the radio frequency equipment, and the head-end mesh basket is connected to the plurality of ablation arms.

2. The radiofrequency ablation device according to claim 1, characterized in that: The head end basket is made by cutting a nickel-titanium alloy tube.

3. The radiofrequency ablation device according to claim 1, characterized in that: It also includes a traction line and an adjustment handle, wherein the traction line is passed through the tube wall of the transmission tube, and the adjustment handle is connected to the traction line. The adjustment handle can adjust the bending direction of the transmission tube by retracting and releasing the traction line, thereby adjusting the direction of the head end basket.

4. The radiofrequency ablation device according to claim 1, characterized in that: The head end basket is provided with a first developing mechanism.

5. The radiofrequency ablation device according to claim 1, characterized in that: A second developing mechanism is disposed at one end of the transmission tube close to the ablation arm.

6. The radiofrequency ablation device according to claim 1, characterized in that: The ablation arm is provided with a mapping mechanism.

7. The radiofrequency ablation device according to claim 1, characterized in that: The transmission tube includes an inner catheter and an outer catheter, the inner catheter has a first delivery cavity, the outer catheter is sleeved on the inner catheter, a second delivery cavity is formed between the outer catheter and the inner catheter, the ablation arm has a water cavity connected to the second delivery cavity, and the ablation arm is provided with a flow hole connected to the water cavity at the position where the ablation element is located.

8. The radiofrequency ablation device according to claim 7, characterized in that: The transmission tube is provided with a first transmission joint communicating with the first transmission cavity, and the transmission tube is also provided with a second transmission joint communicating with the second transmission cavity.

9. The radiofrequency ablation device according to claim 1, characterized in that: The transmission tube is provided with a connector device connected to the ablation line.

10. The radiofrequency ablation device according to any one of claims 1 to 9, characterized in that: It also includes a temperature control line, which is passed through the walls of the ablation arm and the transmission tube.

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