CN114748151A

CN114748151A - Electrode assembly, ablation device and radio frequency ablation equipment

Info

Publication number: CN114748151A
Application number: CN202110025101.4A
Authority: CN
Inventors: 马志伟; 刘晓芳; 马帅; 王宇; 周庆亮; 孟坚
Original assignee: Beijing Medipeak Medical Technology Co ltd
Current assignee: Beijing Medipeak Medical Technology Co ltd
Priority date: 2021-01-08
Filing date: 2021-01-08
Publication date: 2022-07-15

Abstract

The invention provides an electrode assembly, an ablation device and radio frequency ablation equipment, wherein the electrode assembly comprises an electrode tip, the electrode tip comprises a protective sheath, an attraction positioning piece arranged on the protective sheath, an electrode and a filling piece which are arranged in the protective sheath, so that the protective sheath is positioned on a tissue to be ablated under the action of the attraction positioning piece; the electrode is extruded by the filling piece to move towards the part to be ablated, so that the electrode can be attached to the inner wall of the protective sheath, and the outer wall of the protective sheath at the corresponding position is attached to the corresponding part to be ablated, so that the electrode can be better acted on the corresponding part to be ablated, and the ablation effect is ensured; therefore, the electrode assembly can solve the problem that the ablation effect of the ablation device in the prior art is not ideal.

Description

Electrode assembly, ablation device and radio frequency ablation equipment

Technical Field

The invention relates to the field of medical instruments, in particular to an electrode assembly, an ablation device and radio frequency ablation equipment.

Background

Ablation is a common measure for treating atrial fibrillation, and the principle of ablation is to create one or more ablation lines in heart tissue, cause tissue necrosis, and cut off abnormal electrical signal conduction for treating atrial fibrillation.

The current ablation treatment comprises surgical ablation and medical intervention ablation, and the surgical ablation has the characteristics of good curative effect and low postoperative recurrence rate, but has the obvious defects of large wound and slow postoperative recovery. Medical interventional ablation is favored by more and more patients because of small wound and fast recovery, but the medical ablation is point ablation, and the biggest defect is that a complete ablation line is difficult to form; and the single-side wall-attaching type ablation is carried out during ablation, the ablation depth is limited, the complete dehydration and denaturation of tissues from inside to outside are difficult to ensure, the ablation is not thorough when the ablation power is small in the operation, the power is high, the control is difficult, and the phenomena of excessive tissue necrosis, even burnthrough and burnout exist during ablation exist, so the success rate of the internal medicine interventional ablation is much lower than that of the surgery.

Disclosure of Invention

The invention mainly aims to provide an electrode assembly, an ablation device and radio frequency ablation equipment, and aims to solve the problems that the conventional ablation device is not firmly attached to a tissue to be ablated, the tissue to be ablated is easy to separate, and the ablation effect is not ideal.

In order to accomplish the above object, according to one aspect of the present invention, there is provided an electrode assembly including an electrode tip including: a protective sheath; the electrode is arranged in the protective sheath; the suction positioning piece is arranged on the protective sheath, so that the protective sheath is positioned on the tissue to be ablated under the action of the suction positioning piece; a filler element disposed within the lumen of the protective sheath, at least a portion of the filler element being arranged to be expandable to press the electrode toward tissue to be ablated when the filler element is expanded.

Furthermore, the protective sheath is strip-shaped, the number of the electrodes is multiple, and the multiple electrodes are arranged at intervals along the extending direction of the protective sheath; and/or the suction positioning pieces are multiple and are arranged at intervals along the extension direction of the protective sheath.

Furthermore, the protective sheath is strip-shaped, the filling pieces are multiple, and the filling pieces are arranged at intervals along the extension direction of the protective sheath and can be independently controlled; and/or the filling piece is in a strip shape and extends along the extending direction of the protective sheath.

Furthermore, the suction positioning piece is of a sucker structure; and/or the filling member is of a balloon structure.

Furthermore, the protective sheath is provided with an opening structure for avoiding the electrode, so that part of the structure of the electrode extends out of the cavity of the protective sheath through the opening structure.

Furthermore, the number of the electrodes is multiple, the opening structure comprises a plurality of avoiding openings, the avoiding openings and the electrodes are arranged in a one-to-one correspondence mode, and therefore partial structures of the electrodes extend out of the protective sheath through the corresponding avoiding openings; and/or the electrodes are multiple, the open pore structure is a strip-shaped opening, the strip-shaped openings are spaced along the extending direction of the protective sheath, and partial structures of the multiple electrodes extend out of the outer side of the protective sheath through the strip-shaped openings.

Furthermore, an accommodating groove is formed in the inner wall of the protective sheath, and when the filling piece is in a contraction state, the filling piece is accommodated in the accommodating groove; when the filling member is in the expanded state, at least part of the filling member is withdrawn from the receiving recess to press the electrode toward the tissue to be ablated.

Further, the electrode assembly further includes a first magnetic member disposed within the protective sheath; and the electrode and/or the first magnetic part are/is provided with a positioning groove for accommodating the filling part.

Further, the electrodes and the first magnetic parts are all multiple, and the multiple electrodes and the multiple first magnetic parts are sequentially arranged in a staggered mode along the extending direction of the protective sheath.

Further, a lead laying groove for accommodating a lead is arranged on the electrode and/or the first magnetic part, and the lead is used for being connected with the electrode.

According to another aspect of the present invention, there is provided an ablation device comprising a first electrode assembly and a second electrode assembly, the first electrode assembly being as described above, the electrode of the first electrode assembly being a first electrode, the second electrode assembly comprising a second electrode tip comprising a second electrode, the second electrode tip being disposed opposite the first electrode so as to ablate tissue to be ablated between the first and second electrodes via the first and second electrodes.

According to a further aspect of the invention, a radio frequency ablation apparatus is provided, which includes a radio frequency host and an ablation device, the ablation device being connected to the radio frequency host.

By applying the technical scheme of the invention, the electrode assembly comprises an electrode tip, wherein the electrode tip comprises a protective sheath, an attraction positioning piece arranged on the protective sheath, and an electrode and a filling piece which are arranged in the protective sheath, so that the protective sheath is positioned on the tissue to be ablated under the action of the attraction positioning piece; the electrode is extruded by the filling piece to move towards the part to be ablated, so that the electrode can be attached to the inner wall of the protective sheath, and the outer wall of the protective sheath at the corresponding position is attached to the corresponding part to be ablated, so that the electrode can be better acted on the corresponding part to be ablated, and the ablation effect is ensured; therefore, the electrode assembly can solve the problem that the ablation effect of the ablation device in the prior art is not ideal.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this application, illustrate embodiments of the invention and, together with the description, serve to explain the invention and not to limit the invention. In the drawings:

fig. 1 shows a schematic view of an alternative electrode assembly according to the present invention;

FIG. 2 illustrates an internal perspective structural view of one embodiment of the electrode assembly of FIG. 1;

FIG. 3 shows a cross-sectional view of the electrode assembly of FIG. 2;

FIG. 4 shows a cross-sectional view of another embodiment of the electrode assembly of FIG. 1;

FIG. 5 shows a schematic view of the structure of the electrode assembly of FIG. 1 shielding the side eaves;

fig. 6 illustrates a longitudinal sectional view of a packing of the electrode assembly of fig. 1;

FIG. 7 is a schematic view of a second electrode assembly of an alternative ablation device in accordance with the invention;

FIG. 8 illustrates an enlarged partial view of the second electrode assembly of the ablation device of FIG. 7;

fig. 9 shows an enlarged view of a portion a of the second electrode assembly of the ablation device of fig. 8;

fig. 10 is a schematic structural diagram of a radio frequency host of an alternative radio frequency ablation device in accordance with the present invention;

fig. 11 illustrates an assembly view between a radio frequency host and an ablation device of an alternative radio frequency ablation apparatus according to the present invention;

FIG. 12 illustrates a schematic view of the ablation device of the present invention in ablating tissue to be ablated;

FIG. 13 illustrates a fit between the first and second electrodes and the tissue to be ablated of an embodiment of the ablation device of the invention;

FIG. 14 illustrates an ablation schematic of one state of the ablation device of the invention;

fig. 15 shows an ablation schematic of another state of the ablation device of the invention;

fig. 16 shows a wiring schematic between the rf main unit and the first and second electrode assemblies of the rf ablation device of the present invention;

FIG. 17 is a schematic structural view of a second embodiment of the first electrode assembly of the ablation device of the invention;

fig. 18 is a schematic structural view of a second embodiment of the second electrode assembly of the ablation device of the invention;

fig. 19 illustrates a fit between the first and second electrodes and the tissue to be ablated of another embodiment of the ablation device of the invention.

Wherein the figures include the following reference numerals:

100. a first electrode assembly;

110. an electrode tip; 111. an electrode; 1110. an electrode surface; 1112. a cooling hole; 112. a first magnetic member; 113. a protective sheath; 1130. protecting the sheath surface; 115. shielding the side eaves; 116. a filling member;

117. attracting the positioning piece; 1171. attracting the inner wall; 1172. attracting the outer wall; 1173. attracting the cavity;

1174. a first suction port; 1175. a second suction port; 1176. an air flow channel;

120. a wire laying groove;

200. a second electrode assembly;

210. a second electrode tip; 211. a second electrode; 212. a second magnetic member; 213. a developing member; 214. a second protective sheath;

310. a radio frequency host; 311. an ablation interface; 312. an electromagnetic interface; 313. a display screen; 320. an ablation circuit; 330. an ablation range; 340. the tissue is to be ablated.

Detailed Description

It should be noted that the embodiments and features of the embodiments in the present application may be combined with each other without conflict. The present invention will be described in detail below with reference to the embodiments with reference to the attached drawings.

Referring to fig. 1 to 19, the electrode assembly of the present invention includes an electrode tip 110, wherein the electrode tip 110 includes a protective sheath 113, an electrode 111, a pull-in positioning member 117, and a filling member 116, and the electrode 111 is disposed in the protective sheath 113; the suction positioning member 117 is arranged on the protective sheath 113, so that the protective sheath 113 is positioned on the tissue to be ablated under the action of the suction positioning member 117; a filler 116 is disposed within the lumen of the protective sheath 113, at least a portion of the filler 116 being arranged to be expandable to press the electrode 111 towards the tissue to be ablated when the filler 116 is expanded.

In the electrode assembly of the present invention, the electrode assembly includes an electrode tip 110, the electrode tip 110 includes a protective sheath 113, an engaging positioning member 117 provided on the protective sheath 113, and an electrode 111 and a filling member 116 provided in the protective sheath 113, so that the protective sheath 113 is positioned at a tissue to be ablated by the action of the engaging positioning member 117; the filling piece 116 is used for extruding the electrode 111 so that the electrode 111 moves towards the part to be ablated, the electrode 111 can be attached to the inner wall of the protective sheath 113, the outer wall of the protective sheath 113 at the corresponding position is attached to the corresponding part to be ablated, and therefore the electrode 111 can better act on the corresponding part to be ablated, and the ablation effect is guaranteed; therefore, the electrode assembly can solve the problem that the ablation effect of the internal medicine intervention type ablation device in the prior art is not ideal.

Specifically, as shown in fig. 2, the protective sheath 113 is in a strip shape, the plurality of electrodes 111 are arranged at intervals along the extending direction of the protective sheath 113; namely, the plurality of electrodes 111 act on the corresponding parts to be ablated at the same time to form a complete ablation line, so that the ablation effect is ensured, and the ablation efficiency is improved; and the plurality of electrodes 111 are arranged at intervals, so that the mutual influence between two adjacent electrodes 111 can be avoided.

Optionally, the protective sheath 113 is tubular, and the plurality of electrodes 111 are each disposed within a lumen of the protective sheath 113.

In the present embodiment, one structural form of the filling member 116 is: as shown in fig. 6, the filler 116 has a strip shape, the protective sheath 113 has a strip shape, and the filler 116 extends in the extending direction of the protective sheath 113. Specifically, the filling member 116 is a balloon structure to exert a pressing action on the plurality of electrodes 111 when the balloon structure is inflated.

In this embodiment, another structure of the filling member 116 is: the plurality of filling members 116 are arranged at intervals along the extending direction of the protective sheath 113 and can be controlled independently; the plurality of filling members 116 and the plurality of electrodes 111 are arranged in a one-to-one correspondence, so that each filling member 116 can exert a pressing action on the corresponding electrode 111; each filling member 116 is disposed on a side of the corresponding electrode 111 away from the tissue to be ablated, so that when each filling member 116 presses the corresponding electrode 111, each electrode 111 moves toward the corresponding tissue to be ablated. Specifically, each of the filling members 116 is of a balloon structure so as to exert a pressing action on the corresponding electrode 111 when the balloon structure is inflated.

Specifically, the attraction positioning members 117 are arranged in pairs, and each pair of attraction positioning members 117 work independently, so that the number of the attraction positioning members can be determined according to actual needs.

Specifically, the suction positioning member 117 is a suction cup structure.

Specifically, as shown in fig. 3 and 4, the attraction positioning member 117 includes an attraction inner wall 1171 and an attraction outer wall 1172, an attraction cavity 1173, a first attraction port 1174 and a second attraction port 1175 communicated with the attraction cavity 1173 are formed between the attraction inner wall 1171 and the attraction outer wall 1172, and the first attraction port 1174 and the second attraction port 1175 have the same orientation.

The suction inner wall 1171 and the suction inner wall 1171 are both in a U-shaped structure, and the suction inner wall 1171 and the suction outer wall 1172 are arranged around the protective sheath 113.

The attraction positioning member 117 further includes an air flow channel 1176, and an air outlet end of the air flow channel 1176 is communicated with the attraction cavity 1173 so as to charge and exhaust air into the attraction cavity 1173 through the air flow channel 1176.

Optionally, the suction positioning member 117 is plural.

In this embodiment, one arrangement of the plurality of pull-in positioning members 117 is as follows: the plurality of suction positioning members 117 are arranged at intervals along the extending direction of the protective sheath 113, so that the protective sheath 113 is stably positioned on the tissue to be ablated, and the positioning effect of the protective sheath 113 is ensured.

In this embodiment, another arrangement of the plurality of pull-in positioning members 117 is as follows: as shown in fig. 2, the plurality of suction positioning members 117 are arranged in pairs, and the two suction positioning members 117 in pairs are respectively arranged on two opposite sides of the protective sheath 113, so as to ensure that both sides of the protective sheath 113 and the ablated tissue have good fitting degree, and further, the corresponding electrode 111 can better act on the corresponding ablated tissue, thereby ensuring the ablation effect.

The pairs of occlusion positioning pieces 117 are arranged at intervals along the extending direction of the protective sheath 113, so that the protective sheath 113 is stably positioned on the tissue to be ablated, the positioning effect of the protective sheath 113 is ensured, and further the overall attaching degree between the protective sheath 113 and the ablated tissue is ensured, so that each electrode 111 can better act on the corresponding ablated tissue, and the ablation effect is ensured.

Specifically, the protective sheath 113 is provided with an opening structure for avoiding the electrode 111, so that part of the structure of the electrode 111 extends out of the cavity of the protective sheath 113 through the opening structure, and thus, the part of the electrode structure extending out of the cavity of the protective sheath 113 can be in direct contact with the corresponding tissue to be ablated, so that the part of the electrode structure can better act on the corresponding tissue to be ablated, and further the ablation effect is ensured and the ablation efficiency is improved.

In this embodiment, one arrangement of the open pore structure is: when the electrode 111 is a plurality of, the trompil structure includes a plurality of trompils of dodging, and a plurality of trompils of dodging set up with a plurality of electrode 111 one-to-one to make the partial structure of each electrode 111 stretch out to the outside of protecting sheath 113 through corresponding dodging the trompil, and then make the partial structure homoenergetic of each electrode 111 who stretches out the outside of protecting sheath 113 and corresponding waiting to ablate tissue direct contact.

In this embodiment, another arrangement form of the open pore structure is: the open pore structure is a strip-shaped opening which is spaced along the extending direction of the protective sheath 113, and part of the structure of the plurality of electrodes 111 extends out of the outer side of the protective sheath 113 through the strip-shaped opening.

In this embodiment, one way of disposing the filling member 116 is: an accommodating groove is formed in the inner wall of the protective sheath 113, and when the filling member 116 is in a contracted state, the filling member 116 is accommodated in the accommodating groove; when the filling member 116 is in the expanded state, at least a portion of the filling member 116 escapes from the receiving recess to press the electrode 111 toward the tissue to be ablated.

In this embodiment, another arrangement of the filling member 116 is as follows: the electrode 111 and/or the first magnetic member 112 are/is provided with a positioning recess for accommodating the balloon structure, when the filling member 116 is in a contracted state, the filling member 116 is received in the positioning recess, and when the filling member 116 is in an expanded state, at least a part of the filling member 116 is pulled out of the positioning recess to press the electrode 111 toward the tissue to be ablated.

Specifically, the electrode assembly further includes a first magnetic member 112, and the first magnetic member 112 is disposed within a protective sheath 113.

Alternatively, the electrode 111 and the first magnetic member 112 are both plural, and the plural electrodes 111 and the plural first magnetic members 112 are sequentially arranged in a staggered manner along the extending direction of the protective sheath 113, so that the plural electrodes 111 are arranged at intervals, that is, the respective two electrodes 111 are separated by the respective first magnetic members 112.

Optionally, the plurality of first magnetic members 112 are each disposed within the lumen of a protective sheath 113.

Specifically, the electrode 111 and/or the first magnetic member 112 are provided with a lead wire laying groove 120 for receiving a lead wire for connection with the electrode 111.

The invention also provides an ablation device, which comprises a first electrode assembly 100 and a second electrode assembly 200, wherein the first electrode assembly 100 is the electrode assembly, the electrode of the first electrode assembly 100 is a first electrode, that is, the first electrode tip of the first electrode assembly 100 is an electrode tip 110, the first electrode is an electrode 111, the second electrode assembly 200 comprises a second electrode tip 210, the second electrode tip 210 comprises a second electrode 211, and the second electrode 211 is arranged opposite to the first electrode, so that the tissue to be ablated between the first electrode and the second electrode 211 is ablated through the first electrode and the second electrode 211.

In some embodiments, the second electrode assembly 200 further includes a plurality of second magnetic members 212, the second electrodes 211 are disposed in a plurality, and the plurality of second electrodes 211 and the plurality of second magnetic members 212 are sequentially staggered along the extending direction of the electrode tip 110.

In some embodiments, the first magnetic element 112 of the first electrode assembly 100 cooperates with the second magnetic element 212 to secure the first electrode tip 110 and the second electrode tip 210 of the first electrode assembly 100 relative to each other.

In some embodiments, the first electrode is a plurality of electrodes, the first magnetic member 112 and the second magnetic member 212 are a plurality of electrodes, the plurality of first magnetic members 112 are alternately disposed with the plurality of first electrodes, and the plurality of second magnetic members 212 are alternately disposed with the plurality of second electrodes 211.

In some embodiments, the adjacent first electrode is insulated from the first magnetic member 112 of the first electrode assembly 100, and the adjacent second electrode 211 is insulated from the second magnetic member 212.

In some embodiments, the facing surfaces between the adjacent first electrodes and the first magnetic members 112 of the first electrode assembly 100 are both coated with insulating varnish, or insulating separators are disposed between the adjacent first electrodes and the first magnetic members 112; insulating paint is sprayed on the opposite surfaces between the adjacent second electrodes 211 and the second magnetic members 212, or an insulating partition plate is arranged between the adjacent second electrodes 211 and the second magnetic members 212. The insulating partition plate and the protective sheath are designed integrally or fixedly set in a split mode.

In some embodiments, the outer surfaces of the first and second

magnetic elements

112 and 212 are coated with an insulating layer.

In some embodiments, the first electrode, the first magnetic element 112 of the first electrode assembly 100, the second electrode 211, and the second magnetic element 212 are each connected to separate energizing circuits for individual control. The plurality of first electrodes, the plurality of second electrodes, the plurality of first magnetic parts and the plurality of second magnetic parts can work independently, so that the magnetism can be adjusted, and the number of the plurality of ablation electrodes can be adjusted. The energizing circuits of two adjacent first electrodes or second electrodes are independently arranged to form an ablation electrode pair so as to realize the ablation function.

In some embodiments, the first electrodes are multiple, and the energizing circuits of the two first electrodes are independently arranged to form a mapping electrode pair, so as to detect the electrical signal transmission condition of the ablated tissue 340 to be ablated by using the energizing circuits; and/or the second electrodes 211 are multiple, and the energizing circuits of two second electrodes 211 are independently arranged to form a mapping electrode pair, so as to detect the electrical signal transmission condition of the ablated tissue 340 to be ablated by using the energizing circuits; and/or the energizing circuits of the first and second electrodes 211 are independently arranged to form a mapping electrode pair, so that the energizing circuits are used for detecting the electric signal transmission condition after the tissue 340 to be ablated is ablated. During calibration, the two first electrodes forming the calibration electrode pair have different polarities and are arranged across voltage to form current so as to realize calibration; the two second electrodes 211 forming the mapping electrode pair have different polarities and are arranged across the voltage to form a current, so as to realize mapping; the first and second electrodes 211 forming the mapping electrode pair are of different polarity, arranged across a voltage to form a current, thereby enabling mapping.

In some embodiments, the first electrode tip 110 and the second electrode tip 210 of the first electrode assembly 100 are each plural.

Specifically, the ablation device further includes an ablation circuit 320, with the first and second electrodes 211 each disposed in the ablation circuit 320 to adjust the radio frequency energy between the first and second electrodes 211 by testing the impedance between the first and corresponding second electrodes 211 to perform ablation.

In particular use, the first electrode assembly 100 and the second electrode assembly 200 are used as an epicardial electrode and an endocardial electrode, respectively, so that the first electrode assembly 100 and the second electrode assembly 200 act on the epicardium and the endocardium, respectively, to achieve simultaneous ablation of the epicardium and the endocardium, thereby achieving a good ablation effect. In addition, the ablation device in the application can realize the internal and surgical hybrid ablation, the technical wound is small, the problems of large surgical ablation wound and slow recovery in the prior art are solved, meanwhile, the epicardium and the endocardium can be jointly and synchronously ablated, the output power is adjusted by testing the actual impedance between tissues, the ablation is accurate and safe, and the machine alarms and ablates after the impedance reaches a certain resistance value, so that excessive ablation is avoided.

In addition, the first electrode and the second electrode 211 are arranged oppositely, the impedance between the first electrode and the second electrode 211 can be tested in real time, the radio frequency energy between the first electrode and the second electrode 211 is adjusted according to the impedance between the first electrode and the second electrode 211 which is detected in real time to perform ablation, and after the impedance reaches a certain resistance value, the machine alarm is performed to complete ablation, so that excessive ablation is avoided, the problems that the ablation depth of an interventional ablation single side is limited, and complete dehydration and denaturation of tissues from inside to outside are difficult to guarantee in the prior art are solved, and meanwhile, the problem that the radio frequency power is not easy to control is solved, the ablation is incomplete due to small power, the excessive ablation is caused by too large power, and the phenomena of tissue necrosis, even burnthrough and burning leakage are caused by too large power.

In a specific ablation process, the impedance of the ablated tissue between the electrodes is changed from low to high; in the first stage of ablation, the impedance of the ablated tissue between the electrodes is gradually increased, and the radio frequency power is kept unchanged so as to accelerate the vibration of molecules in cells; in the second stage of ablation, along with the increase of the impedance of the ablated tissue between the electrodes, the radio frequency power is gradually increased, when the impedance of the ablated tissue between the electrodes is increased to the first preset value, the radio frequency power is also increased to the preset maximum value, and in the ablation stage, cells are rapidly dehydrated to generate irreversible change; in the third stage of ablation, along with the continuous increase of the impedance of the ablated tissue between the electrodes, the radio frequency power is gradually reduced so as to ensure the ablation thoroughness and prevent the phenomenon that the tissue surface is scabbed or a patient is injured due to the radio frequency high-power output; and prompting to end the ablation until the impedance of the ablated tissue between the electrodes is increased to a second preset value.

Preferably, as shown in fig. 2 and 8, the first electrodes and the second electrodes 211 are all multiple, and the multiple first electrodes and the multiple second electrodes 211 are arranged in one-to-one correspondence; by arranging the plurality of first electrodes and the plurality of second electrodes 211, the plurality of first electrodes and the plurality of second electrodes 211 can act on the corresponding tissues at the same time, so that the ablation effect is enhanced, and the ablation efficiency is improved.

Specifically, the first electrode tip and the second electrode tip 210 are both strip-shaped, the plurality of first electrodes are arranged at intervals along the extending direction of the first electrode tip, the plurality of second electrodes 211 are arranged at intervals along the extending direction of the second electrode tip 210, and the first electrodes and the corresponding second electrodes 211 thereof are arranged in a mutually matched manner; namely, the plurality of first electrodes and the plurality of second electrodes 211 act on the corresponding tissues at the same time to form a complete ablation line, so that the ablation effect is ensured; the first electrodes are arranged at intervals, and the second electrodes 211 are arranged at intervals, so that mutual influence between two adjacent first electrodes and between two adjacent second electrodes 211 can be avoided.

In this embodiment, the second electrode tip 210 includes a second magnetic member 212, and the first magnetic member 112 and the second magnetic member 212 cooperate to fix the first electrode tip and the second electrode tip 210 relatively, so that the first electrode of the first electrode tip can be disposed opposite to the corresponding second electrode 211 of the second electrode tip 210.

Specifically, when there are a plurality of first magnetic members 112 and a plurality of second magnetic members 212, the plurality of first magnetic members 112 are arranged at intervals along the extending direction of the first electrode tip, and the plurality of second magnetic members 212 are arranged at intervals along the extending direction of the second electrode tip 210, so as to ensure the overall fixing effect between the first electrode tip and the second electrode tip 210.

Specifically, each pair of the first magnetic member 112 and the second magnetic member 212 work independently, i.e. the number of the magnetic members can be determined according to actual requirements.

Optionally, the magnetic force of the magnetic part is controllable and adjustable, a small magnetic force is used during initial positioning, and a large magnetic force is used during final positioning, so that the inner electrode assembly and the outer electrode assembly are flexible during initial positioning and firm after final positioning, the fitting degree of the electrodes is guaranteed, and the ablation effect is guaranteed.

Optionally, the first magnetic member 112 is an electromagnet; and/or the second magnetic member 212 is an electromagnet.

In this embodiment, the two opposite sides of the protection sheath 113 are respectively provided with a shielding side eaves 115 to form a shielding protection effect on the first electrodes and the first magnetic members 112 inside the protection sheath 113, so as to prevent blood and the like of the pericardial tissue from entering the region between the protection sheath 113 and the epicardium in the ablation process and affecting the adhesion degree between the protection sheath 113 and the epicardium, and prevent the measurement accuracy of the resistance value between the first electrode and the second electrode 211 during ablation, thereby affecting the ablation effect. In addition, by arranging the shielding side eaves 115, the liquid such as tissue fluid and physiological saline outside the ablation line can be shielded from entering the ablation part, so that the measurement precision of the resistance value between the first electrode and the second electrode during ablation is avoided, and the ablation effect is further influenced.

Optionally, as shown in fig. 5, the shielding side eaves 115 are strip-shaped, and the shielding side eaves 115 extend along the extending direction of the protective sheath 113.

In this embodiment, as shown in fig. 8 and 9, the second electrode tip 210 includes a second protective sheath 214, and the second electrode 211 is disposed on the second protective sheath 214; wherein the second electrode tip 210 includes a developing member 213, and the developing member 213 is disposed on the second protective sheath 214 to mark the position of the second electrode tip 210 by the developing member 213; and/or, the second electrode 211 is made of a metal developing material including at least one of the following materials: platinum, platinum-iron alloy, tantalum, gold plated beryllium bronze; and/or the second protective sheath 214 is made of a developing material including barium sulfate (BaSO 4).

Specifically, the plurality of second magnetic members 212 and the plurality of second electrodes 211 are sleeved on the second protective sheath 214; alternatively, the plurality of second magnetic members 212 and the plurality of second electrodes 211 are arranged alternately along the extending direction of the second protective sheath 214, so that the plurality of second electrodes 211 are arranged at intervals, i.e., the respective two second electrodes 211 are separated by each second magnetic member 212. In operation, each pair of the first magnetic member 112 and the second magnetic member 212 work independently, i.e. the number of the magnetic members can be determined according to actual requirements. The magnetic force of the magnetic part is controllable and adjustable, and small magnetic force is used during initial positioning, and large magnetic force is used during final positioning, so that the inner electrode assembly and the outer electrode assembly are flexible during initial positioning, firm after final positioning, the fitting degree of the electrodes is guaranteed, and the ablation effect is further guaranteed.

Alternatively, referring to fig. 13 and 19, the plurality of second magnetic elements 212 and the plurality of second electrodes 211 are both ring-shaped structures, or polygonal, V-shaped, D-shaped, or arched cross-sectional structures. As shown in fig. 19, the cross section of the second electrode 211 is polygonal, and may be square.

The visualization member 213, the second electrode 211 having a visualization function, and the second protective sheath 214 having a visualization function in this embodiment can indicate the position when the second electrode assembly 200 enters the ablation site. Alternatively, the number of the developing members 213 on the second electrode tip 210 is 3 to 6, and may be separately provided or the second electrode 211 may have a developing function. The outer walls of the sheaths of the visualization element 213 and the second protective sheath 214 in this embodiment are flush to prevent injury to the patient during surgery.

In this embodiment, the developing member 213 may be omitted, and the developing member 213 may be plural, and the plural developing members 213 are provided at intervals along the extending direction of the second protective sheath 214; and/or, the outer surface of the second protective sheath 214 is divided into a first surface portion and a second surface portion, wherein the first surface portion corresponds to the developing member 213, the second surface portion is connected with the first surface portion, the first surface portion is a concave structure, the developing member 213 is sleeved on the first surface portion, and the outer surface of the developing member 213 is flush with or lower than the second surface portion.

In operation, the first electrode assembly 100 is first fixed on the epicardium by the positioning member, then the second electrode assembly 200 enters the interior of the heart, the second electrode assembly 200 is placed in the endocardium at the position corresponding to the first electrode assembly 100 by the indication of the developing member 213, and then the first pair of magnetic members, the second pair of magnetic members and the third pair of magnetic members at the first electrode tip 110 and the second electrode tip 210 are synchronously and sequentially turned on, and at this time, the two groups of electrodes complete the initial positioning. And (4) after the initial positioning is finished, the two electrode assemblies are opened in pairs by the rest magnetic parts, and the final positioning is finished.

Specifically, the first electrode and the second electrode 211 are relatively independent when operated, i.e., the number of working electrodes can be controlled.

In this embodiment, as shown in fig. 3, the first electrode has an electrode face 1110 disposed toward the tissue to be ablated, and the protective sheath 113 has a protective sheath face 1130 disposed toward the tissue to be ablated; wherein the electrode face 1110 is located on a side of the protective sheath 1130 adjacent to the tissue to be ablated.

In this embodiment, the first electrode is a plurality of first electrodes, and the plurality of first electrodes are arranged at intervals along the extending direction of the first electrode tip 110; the minimum distance between the electrode face 1110 and the protective sheath face 1130 of the plurality of first electrodes is the same. The minimum distance between the electrode surface 1110 of the first electrode and the protective sheath surface 1130 ranges from 0 mm to 0.5mm, and the first electrode can be fully contacted with the ablated surface due to the height difference, so that the ablation effect is ensured. The height difference between the electrode face 1110 of the first electrode and the protective sheath face 1130 preferably amounts to 0.2 mm.

In this embodiment, the electrode face 1110 and the protective sheath face 1130 are both planar.

In order to achieve cooling of the first electrode tip 110, as shown in fig. 2, the first electrodes are plural, and the plural first electrodes are arranged at intervals along the extending direction of the first electrode tip 110; at least one of the first electrodes is provided with a cooling hole 1112 for circulating cooling fluid; and/or, a cooling pipe for circulating cooling fluid is provided in the protective sheath 113. The cooling holes 1112 are provided in the embodiment for local cooling during the ablation process, so as to protect other parts except the ablation part from being damaged. By providing cooling channels, cooling can be carried out at the side of the electrode.

In the present embodiment, at least one of the plurality of first electrodes has 1 to 4 cooling holes 1112 disposed thereon. The number of cooling holes on each first electrode is 0-4 to ensure temperature control during ablation.

The invention also provides radio frequency ablation equipment, as shown in fig. 11, the radio frequency ablation equipment comprises a radio frequency host 310 and the ablation device, and the ablation device is connected with the radio frequency host 310.

Specifically, as shown in fig. 10, a display screen 313 is disposed on the rf host 310, and the display screen 313 is used for displaying the measured impedance and/or rf power of the ablated tissue between the two corresponding first and second electrodes 211.

Specifically, the rf main unit 310 is further provided with an ablation interface 311, each of the first electrode assembly 100 and the second electrode assembly 200 includes a plurality of lead assemblies, each lead assembly includes a lead connector and a plurality of parallel leads connected to the lead connector, and each lead is used for connecting to a corresponding electrode; the ablation interface 311 has a first ablation interface portion having a plurality of first ablation interfaces for insertion of the plurality of wire connectors of the first electrode assembly 100 and a second ablation interface portion having a plurality of second ablation interfaces for insertion of the plurality of wire connectors of the second electrode assembly 200 to provide suitable rf power to the respective first and second electrodes 211 via the respective first and second ablation interfaces.

Specifically, when the first magnetic member 112 and the second magnetic member 212 are both electromagnets, the rf main unit 310 is further provided with an electromagnetic interface 312, each of the first electrode assembly 100 and the second electrode assembly 200 includes a plurality of electromagnet assemblies, each of the electromagnet assemblies includes an electromagnetic joint and a plurality of electromagnetic wires connected to the electromagnetic joint and arranged in parallel, and each of the electromagnetic wires is used for connecting to a corresponding electromagnet; the electromagnetic interface 312 has a first electromagnetic interface portion having a plurality of first magnetic interfaces for inserting the plurality of electromagnetic connectors of the first electrode assembly 100, and a second electromagnetic interface portion having a plurality of second magnetic interfaces for inserting the plurality of electromagnetic connectors of the second electrode assembly 200, so as to supply power to the corresponding first magnetic member 112 and the corresponding second magnetic member 212 through the respective first magnetic interfaces and the respective second magnetic interfaces, thereby generating attraction force between the corresponding first magnetic member 112 and the corresponding second magnetic member 212.

Referring to fig. 12 to 15, the ablation principle of the ablation device to the tissue to be ablated 340 in the present embodiment can be seen, and the ablation range 330 of the ablation device can be embodied.

From the above description, it can be seen that the above-described embodiments of the present invention achieve the following technical effects:

With the technical scheme of the invention, the ablation device comprises a first electrode assembly with a first electrode tip and a second electrode assembly with a second electrode tip. The first electrode assembly and the second electrode assembly can be independently used, and the first electrode tip comprises a first protective sheath and a plurality of first electrodes arranged in the first protective sheath; and, first protective sheath is the bar, and a plurality of first electrodes are arranged along the extending direction interval of first protective sheath, act on epicardial tissue simultaneously through a plurality of first electrodes promptly to form a complete ablation line, when protective sheath used flexible material, can solve when current surgical instruments used angle limited, the inconvenient problem of operation.

The first electrode and the second electrode of the ablation device are oppositely arranged so as to ablate the tissue to be ablated between the first electrode and the second electrode through the first electrode and the second electrode. When the ablation device is used specifically, the first electrode assembly and the second electrode assembly are respectively used as an epicardial electrode and an endocardial electrode, so that the first electrode assembly and the second electrode assembly are respectively used for epicardial and endocardium to achieve simultaneous ablation of epicardial and endocardium, thereby achieving a good ablation effect, and solving the problems that the internal medicine interventional ablation energy is constant, the output power cannot be adjusted timely according to the ablation effect, the wall overheating or wall impermeability is caused, and the cardiac surgery is dynamic ablation, but the surgical ablation wound is large, and the postoperative recovery is slow; thereby realizing good ablation effect and improving ablation efficiency; therefore, the ablation device can solve the problem that the ablation effect of the ablation device in the prior art is not ideal.

The ablation device of the present invention includes the electrode assembly described above, and thus the ablation device has at least the same technical effect as the electrode assembly.

The radio frequency ablation device comprises the ablation device, so that the radio frequency ablation device has at least the same technical effect as the ablation device.

Spatially relative terms, such as "above … …," "above … …," "above … … surface," "above," and the like, may be used herein for ease of description to describe one device or feature's spatial relationship to another device or feature as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is turned over, devices described as "above" or "on" other devices or configurations would then be oriented "below" or "under" the other devices or configurations. Thus, the exemplary term "above … …" can include both an orientation of "above … …" and "below … …". The device may be otherwise variously oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of example embodiments according to the present application. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, and it should be understood that when the terms "comprises" and/or "comprising" are used in this specification, they specify the presence of stated features, steps, operations, devices, components, and/or combinations thereof, unless the context clearly indicates otherwise.

It should be noted that the terms "first," "second," and the like in the description and claims of this application and in the drawings described above are used for distinguishing between similar elements and not necessarily for describing a particular sequential or chronological order. It is to be understood that the data so used is interchangeable under appropriate circumstances such that the embodiments of the application described herein are, for example, capable of operation in sequences other than those illustrated or otherwise described herein. Furthermore, the terms "comprises," "comprising," and "having," and any variations thereof, are intended to cover a non-exclusive inclusion, such that a process, method, system, article, or apparatus that comprises a list of steps or elements is not necessarily limited to those steps or elements expressly listed, but may include other steps or elements not expressly listed or inherent to such process, method, article, or apparatus.

The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. An electrode assembly, comprising an electrode tip (110), the electrode tip (110) comprising:

a protective sheath (113);

an electrode (111), the electrode (111) being disposed within the protective sheath (113);

the suction positioning piece (117) is arranged on the protective sheath (113), so that the protective sheath (113) is positioned on the tissue to be ablated under the action of the suction positioning piece (117);

a filler (116), the filler (116) being disposed within the lumen of the protective sheath (113), at least a portion of the filler (116) being arranged to be expandable and contractible to press the electrode (111) towards the tissue to be ablated when the filler (116) is expanded.

2. The electrode assembly according to claim 1, wherein the protective sheath (113) is strip-shaped,

the electrodes (111) are arranged in a plurality, and the electrodes (111) are arranged at intervals along the extending direction of the protective sheath (113); and/or

The attracting positioning pieces (117) are arranged in a plurality of ways, and the attracting positioning pieces (117) are arranged at intervals along the extending direction of the protective sheath (113).

3. The electrode assembly according to claim 1, wherein the protective sheath (113) is strip-shaped,

the filling pieces (116) are multiple, and the filling pieces (116) are arranged at intervals along the extending direction of the protective sheath (113) and can be controlled independently; and/or

The filling member (116) is in a strip shape, and the filling member (116) extends along the extending direction of the protective sheath (113).

4. The electrode assembly of claim 1, wherein the pull-in positioning member (117) is of a suction cup structure; and/or the filling member (116) is of a balloon structure.

5. The electrode assembly according to claim 1, characterized in that the protective sheath (113) is provided with an open structure for avoiding the electrode (111) such that part of the structure of the electrode (111) protrudes from the lumen of the protective sheath (113) through the open structure.

6. The electrode assembly of claim 5,

the number of the electrodes (111) is multiple, the open pore structure comprises a plurality of avoiding open pores, the avoiding open pores and the electrodes (111) are arranged in a one-to-one correspondence manner, so that part of the structure of each electrode (111) extends out of the protective sheath (113) through the corresponding avoiding open pores; and/or

The electrode (111) is a plurality of, the open pore structure is the bar opening, the bar opening is along the extending direction interval of protection sheath (113), a plurality of partial structure of electrode (111) stretches out to the outside of protection sheath (113) through the bar opening.

7. The electrode assembly according to claim 1, wherein a receiving groove is provided on an inner wall of the protective sheath (113), the filler (116) being received in the receiving groove when the filler (116) is in a contracted state; when the filling member (116) is in an expanded state, at least part of the filling member (116) is withdrawn from the receiving recess to press the electrode (111) towards the tissue to be ablated.

8. The electrode assembly of claim 1, further comprising a first magnetic member (112), the first magnetic member (112) being disposed within the protective sheath (113); the electrode (111) and/or the first magnetic part (112) are provided with positioning grooves for accommodating the filling part (116).

9. The electrode assembly according to claim 8, wherein the electrode (111) and the first magnetic member (112) are each provided in plurality, and the plurality of electrodes (111) and the plurality of first magnetic members (112) are sequentially arranged in a staggered manner in an extending direction of the protective sheath (113).

10. The electrode assembly according to claim 8, wherein the electrode (111) and/or the first magnetic member (112) is provided with a lead laying groove (120) for receiving a lead for connection with the electrode (111).

11. An ablation device comprising a first electrode assembly (100) and a second electrode assembly (200), wherein the first electrode assembly (100) is an electrode assembly according to any one of claims 1 to 10, the electrode of the first electrode assembly (100) is a first electrode, the second electrode assembly (200) comprises a second electrode tip (210), the second electrode tip (210) comprises a second electrode (211), and the second electrode (211) is disposed opposite the first electrode so as to ablate tissue to be ablated between the first and second electrodes (211) through the first and second electrodes (211).

12. An rf ablation apparatus comprising an rf host (310) and an ablation device connected to the rf host (310), wherein the ablation device is the ablation device of claim 11.