Radio frequency ablation electrode and ablation electrode system

Abstract

The invention relates to a radio frequency ablation electrode and an ablation electrode system, and belongs to the technical field of medical instruments. The ablation electrode system comprises a radio frequency host foot switch and a radio frequency ablation electrode, the radio frequency ablation electrode comprises an outer electrode and an inner electrode which are insulated from each other, the inner electrode is arranged in the outer electrode in a penetrating mode, and the front end of the inner electrode comprises a needle-shaped central electrode tip and at least two lateral electrode tips which can be unfolded towards the two sides or folded inwards. The radiofrequency ablation electrode and the ablation electrode system can be used in cooperation with ultrasonic detection equipment, the radiofrequency ablation electrode can penetrate into hysteromyoma, the front end of the inner electrode is unfolded in the hysteromyoma to be distributed in a plane, a plane-shaped ablation area with a certain thickness or an ablation area similar to a water drop shape is formed, and the radiofrequency ablation electrode can penetrate into the hysteromyoma. The extension length of the front end of the inner electrode determines the size of a single ablation area, other parts of hysteromyoma can be ablated by manually rotating or moving the radiofrequency ablation electrode left and right, and the ablation range is controllable.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a radio frequency ablation electrode and an ablation electrode system. Background Art

[0002] The size of uterine fibroids is generally between 1mm and 10mm, and the treatment options are mainly divided into two categories: oral medication and surgical treatment.

[0003] Among them, oral medication can only relieve some symptoms such as dysmenorrhea or abnormal menstruation, and patients usually need to take medication for a long time and cannot be completely cured.

[0004] Surgical treatment can be divided into several different options: cold knife resection, electrosurgical ablation, electrosurgical ablation including ultrasonic ablation or microwave ablation. Cold knife resection is traumatic, with heavy bleeding, long operation time, long recovery time after surgery, and relatively painful for patients. In severe cases, it may also cause women to lose their fertility. Ultrasonic ablation is not thorough and is prone to recurrence. Microwave ablation has a small ablation range and the thermal impact range cannot be controlled, so it is impossible to achieve fine ablation and is prone to accidental injury to other normal tissues.

[0005] Please refer to the invention patent with authorization announcement number CN105434040B and invention name "Umbrella-shaped radiofrequency ablation electrode needle for endoscope". The prior art provides a radiofrequency ablation electrode that can ablate uterine fibroids through radiofrequency energy. This method has less trauma and faster recovery.

[0006] However, researchers have found that the front end of the inner electrode of the existing radiofrequency ablation electrode is usually an umbrella-shaped structure after it is unfolded. This structure is difficult to enter the uterine fibroids for ablation. It can only be inserted after pre-punching or ablated gradually. Moreover, it is not effective during the ablation process, and the ablation area is not similar to the spherical structure as expected. In addition, because the shape of uterine fibroids is irregular, their depth, width, length, etc. may vary. It is difficult to accurately control the ablation area with an umbrella-shaped front end of the radiofrequency ablation electrode. For example, if the thickness of the uterine fibroids is small, the radiofrequency ablation electrode with a spherical front end may accidentally injure the surrounding normal tissue. Summary of the invention

[0007] In view of this, an object of the present invention is to provide a radiofrequency ablation electrode and an ablation electrode system, which can penetrate into uterine fibroids for ablation, and the ablation area can be precisely controlled to avoid accidental injury to normal tissues.

[0008] The technical solution of the present invention is as follows: The present invention provides a radiofrequency ablation electrode, comprising an outer electrode and an inner electrode insulated from each other, wherein the inner electrode is inserted into the outer electrode and the front end thereof comprises a needle-shaped central electrode head and at least two lateral electrode heads which can be expanded to both sides or retracted inward; the radiofrequency ablation electrode has a puncture state in which the front end of the inner electrode is retracted into the outer electrode and the front end of the central electrode head is exposed, and an ablation state in which the front end of the inner electrode extends from the outer electrode and is expanded into a planar distribution.

[0009] As an optional solution, the inner electrode further comprises at least three independent electrode rods, the front ends of the electrode rods are connected to the central electrode head or the lateral electrode head, and the lateral electrode heads are pre-bent.

[0010] As an optional solution, the inner electrode further comprises an electrode rod, the central electrode head is fixed to or integrally formed with the electrode rod, and the lateral electrode heads are respectively hinged to the electrode rod.

[0011] As an optional solution, the inner electrode further includes a connecting rod, which is connected to the lateral electrode head and is used to control the expansion or contraction of the lateral electrode head.

[0012] As an optional solution, the inner electrode further includes a slider and a connecting rod, the electrode rod is provided with a slide groove in the front-rear direction, the connecting rod is hinged to the slider and the lateral electrode head respectively, and the slider is slidably matched with the slide groove.

[0013] As an optional solution, the outer side of the inner electrode is covered with an inner insulating layer, and the front end of the inner insulating layer is triangular or trapezoidal after being unfolded and matches the front end of the inner electrode.

[0014] As an optional solution, in the direction from back to front, the diameter of the front end of the outer electrode gradually decreases.

[0015] As an optional solution, the radiofrequency ablation electrode further includes a handle with a control member, the rear end of the outer electrode is connected to the handle, and the rear end of the inner electrode is connected to the control member and is pushed forward and backward by the control member.

[0016] As an optional solution, the control member includes two push buttons, one of which is used to control the forward and backward movement of the inner electrode, and the other push button is used to control the expansion or retraction of the front end of the inner electrode.

[0017] The present invention also provides an ablation electrode system, comprising a radio frequency host, a foot switch and the radio frequency ablation electrode mentioned above, wherein the radio frequency ablation electrode is connected to the radio frequency host and is controlled by the foot switch.

[0018] The beneficial effects of the present invention are: The radiofrequency ablation electrode and ablation electrode system provided by the present invention can be used in conjunction with an ultrasonic detection device. After the ultrasonic detection device detects the location of the uterine fibroid, the radiofrequency ablation electrode can puncture into the uterine fibroid, and the front end of the inner electrode is deployed in a plane distribution in the fibroid to form a planar ablation area with a certain thickness or a teardrop-shaped ablation area. Under the premise that other structures are the same, compared with the conventional umbrella-shaped structure, this planar deployment ablation can not only form an approximate ablation area, but also has a simpler structure, more reliable strength, and is easier to judge the boundary of the ablation area. The extended length of the front end of the inner electrode determines the size of the single ablation area. Manually rotating or moving the radiofrequency ablation electrode left and right can ablate other parts of the uterine fibroid, and the ablation range can be controlled. The use of the radiofrequency ablation electrode and ablation electrode system has a short operation time, small trauma, less bleeding, and fast recovery. The patient has less pain and is not prone to recurrence. In addition, the damage to the uterus is small, which can achieve large-area rapid ablation and ensure precise ablation. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following is a brief introduction to the drawings required for use in the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work. As shown in the accompanying drawings, the above and other purposes, features and advantages of the present invention will be clearer. The same reference numerals in all the drawings indicate the same parts. The drawings are not deliberately scaled to the actual size, and the focus is on illustrating the main purpose of the present invention.

[0020] Figure 1 A schematic diagram of the structure of a radiofrequency ablation electrode (puncture state) provided in the first embodiment of the present invention; Figure 2 A schematic diagram of the structure of a radiofrequency ablation electrode (ablation state) provided in Embodiment 1 of the present invention; Figure 3 A schematic diagram of the front end partial structure of the radiofrequency ablation electrode (ablation state) provided in the first embodiment of the present invention; Figure 4 for Figure 3 Side view of Figure 5 A partial cross-sectional view of a radiofrequency ablation electrode provided in Embodiment 1 of the present invention; Figure 6 Schematic diagram of the end of the central electrode head or the lateral electrode head of the radiofrequency ablation electrode provided in the first embodiment of the present invention Figure 1 ; Figure 7Schematic diagram of the end of the central electrode head or the lateral electrode head of the radiofrequency ablation electrode provided in the first embodiment of the present invention Figure 2 ; Figure 8 A schematic diagram of the ablation area of ​​the radiofrequency ablation electrode provided in the first embodiment of the present invention; Fig. 9 A schematic diagram of the internal structure of the handle of the radiofrequency ablation electrode provided in the first embodiment of the present invention; Fig.10 A schematic diagram of the structure of a push button of a radiofrequency ablation electrode provided in Embodiment 1 of the present invention; Fig.11 A schematic diagram of the structure of a radiofrequency ablation electrode (puncture state) provided in the second embodiment of the present invention; Fig.12 A schematic diagram of the structure of a radiofrequency ablation electrode (ablation state) provided in Embodiment 2 of the present invention; Fig.13 A partial cross-sectional view of a radiofrequency ablation electrode provided in Embodiment 2 of the present invention; Fig.14 for Fig.13 Side view of Fig.15 A partial cross-sectional view of a radiofrequency ablation electrode provided in Embodiment 2 of the present invention; Fig.16 A schematic diagram of the ablation area of ​​the radiofrequency ablation electrode provided in the second embodiment of the present invention; Fig.17 A schematic diagram of the structure of a radiofrequency ablation electrode (puncture state) provided in Embodiment 3 of the present invention; Fig.18 A schematic diagram of the structure of a radiofrequency ablation electrode (ablation state) provided in Embodiment 3 of the present invention; Fig.19 A partial cross-sectional view of a radiofrequency ablation electrode provided in Embodiment 3 of the present invention; Fig. 20 A schematic diagram of the internal structure of a handle of a radiofrequency ablation electrode provided in Embodiment 3 of the present invention; Fig.21 A schematic diagram of the structure of a first push button of a radiofrequency ablation electrode provided in Embodiment 2 of the present invention; Fig. 22 A schematic diagram of the structure of a second push button of a radiofrequency ablation electrode provided in the second embodiment of the present invention; Fig.23 is a schematic structural diagram of an ablation electrode system in a fourth embodiment of the present invention; Fig.24 This is a schematic diagram of an operation of the ablation electrode system in the fourth embodiment of the present invention; Fig.25 It is a partial schematic diagram of the operation of the ablation electrode system in the fourth embodiment of the present invention.

[0021] Icons: 10-ablation electrode system; 20-ultrasound detection equipment; 11-RF host; 12-foot switch; 13-RF ablation electrode; 110-handle; 111-control part; 112-plug; 113-first push button; 114-first push button; 120-outer electrode; 121-outer insulating layer; 130-inner electrode; 131-electrode rod; 132-center electrode head; 133-lateral electrode head; 134-inner insulating layer; 140-connecting rod; 141-slider; 142-connecting rod; 143-slide groove. DETAILED DESCRIPTION

[0022] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Generally, the components of the embodiments of the present invention described and shown in the drawings here can be arranged and designed in various different configurations.

[0023] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the invention claimed for protection, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0024] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, further definition and explanation thereof is not required in subsequent drawings.

[0025] Furthermore, the terms “first”, “second”, etc. are merely used for distinguishing descriptions and should not be understood as indicating or implying relative importance. Embodiment 1:

[0026] Please refer to Figure 1 , Figure 2 As shown, the first embodiment of the present invention provides a radiofrequency ablation electrode 13, which can be used for ablation and resection of uterine fibroids, etc. Of course, in some embodiments, the radiofrequency ablation electrode 13 can also be used for ablation of other tumors. Plasma ablation is adopted, and a radiofrequency electric field is used to excite an electrolyte such as physiological saline to produce a large number of charged particles, which have enough energy to open the molecular bonds constituting the target tissue cells, so that the tissue is quickly decomposed into low molecular weight molecules and atoms, thereby forming a highly efficient tissue ablation, cutting, coagulation and hemostasis effect at a relatively low temperature, and the range of thermal damage is small.

[0027] The radiofrequency ablation electrode 13 is mainly composed of a handle 110 , an outer electrode 120 and an inner electrode 130 . The following describes in detail each component of the radiofrequency ablation electrode 13 .

[0028] First of all, it should be noted that the "front" and "back" mentioned in this embodiment are determined by the positional relationship with the lesion site. The front is close to the lesion site and the back is far away from the lesion site. The front end is the proximal end and the back end is the distal end. In addition, the directional nouns in this embodiment are artificially defined relative positions, not absolute positions. For example, in other embodiments, the "back" can be close to the lesion site and the "front" can be far away from the lesion site, or it can be defined based on the positional relationship with medical staff.

[0029] The handle 110 is mainly used for medical staff to hold and control. The structure and shape of the handle 110 are not limited and can refer to the existing technology. For example, the handle 110 is roughly cylindrical, prismatic, flat shell, irregular shape, etc. The interior of the handle 110 can be hollow, and wiring can be routed inside. In addition, the handle 110 can also be divided into two half shells that can be separated or buckled together. The rear end of the handle 110 is connected to a plug 112, which is used to electrically connect to an external RF host (please refer to Example 2). The shape and structure of the plug 112 need to match the plug hole of the RF host. When the plug 112 is plugged and matched with the RF host, the RF host can provide RF energy to the RF ablation electrode 13.

[0030] The rear end of the outer electrode 120 is connected to the handle 110 and the two are fixed therebetween, and the connection method between the two is not limited, such as bonding, welding, crimping, clamping, etc. In this embodiment, the rear end of the outer electrode 120 can also be inserted into the handle 110 and fixed by the handle 110.

[0031] The shape of the outer electrode 120 is not limited, and it can be a tubular structure, such as a round tube, a square tube, an irregular tube, etc., and its size can be set as needed. In the present embodiment, the outer electrode 120 is a round tube, and the outer diameter of the outer electrode 120 is 1mm-7mm, preferably 3.6mm, 4.8mm, 6mm, etc.

[0032] The outer electrode 120 is hollow inside and has an opening at the front end. Of course, the rear end of the outer electrode 120 may also be opened. In other embodiments, the outer electrode 120 may also adopt a rod-shaped structure, a C-shaped tubular structure, etc. Generally speaking, the outer electrode 120 needs to have a certain strength so that it is not easy to bend. Of course, it is also possible for the outer electrode 120 to be able to bend at will.

[0033] Part or all of the external electrode 120 can be conductive, and the conductive part can be made of conductive metal material or other materials. In this embodiment, the external electrode 120 is made of conductive material as a whole, and its outer side can be covered with an outer insulating layer 121. The rear end of the external electrode 120 is electrically connected to the plug 112. The outer diameter of the external electrode 120 mentioned above can be the outer diameter including the outer insulating layer 121, or the outer diameter not including the outer insulating layer 121. In other embodiments, the front end or the front half of the external electrode 120 is made of conductive material, and the other parts are made of non-conductive material. In this case, the conductive part needs to be electrically connected to the plug 112 through a conductive structure such as a connecting wire.

[0034] The front end of the external electrode 120 is the working part, which is exposed, that is, the outside of this part is not covered with an insulating layer. The length of the working part is not limited and can be set as needed, for example, 1mm-15mm, preferably 8mm, 10mm. The part outside the working part of the external electrode 120 can be covered by an insulating layer or partially exposed; or, only the working part of the external electrode 120 is made of conductive material, and the other parts are made of non-conductive material.

[0035] The shape of the working portion of the external electrode 120 is not limited, and can be a circular tube with equal front and rear diameters. In this embodiment, the diameter of the working portion gradually decreases from the back to the front, that is, the port of the external electrode 120 shrinks inward, and the bevel angle of the outer surface is A. The angle of the bevel is not limited, for example, ∠A≤20°, preferably 15°. This arrangement makes the front end of the radiofrequency ablation electrode 13 relatively sharp, which facilitates the radiofrequency ablation electrode 13 to puncture into the uterine fibroids or the uterine wall.

[0036] The inner electrode 130 is disposed inside the outer electrode 120 , and the inner electrode 130 can slide inside the outer electrode 120 along the front-to-back direction, and the front end of the inner electrode 130 can extend from or retract from the front end of the outer electrode 120 .

[0037] The inner electrode 130 and the outer electrode 120 are insulated from each other. It should be noted that the “insulation” mentioned here means that the two are insulated in the ablation state, and may not be insulated in the non-ablation state.

[0038] For details, please combine Figure 3-Figure 5 As shown, the inner electrode 130 includes a connecting rod 140 and an electrode head assembly, and the electrode head assembly is located at the front end of the connecting rod 140 .

[0039] The electrode rod 131 may be a rod-shaped structure or a tubular structure, etc. The electrode rod 131 needs to have a certain strength to ensure that it can push the electrode head assembly to extend from the front end of the outer electrode 120 or retract into the outer electrode 120 when sliding back and forth in the outer electrode 120 .

[0040] The length of the electrode rod 131 matches the length of the outer electrode 120, and the rear end of the electrode rod 131 can extend from the rear end of the outer electrode 120. Of course, it is also possible that the rear end of the electrode rod 131 cannot extend from the rear end of the outer electrode 120. The number of electrode rods 131 is not limited, for example, one, two, three, etc. The number of electrode rods 131 also determines the connection method between them and the electrode head assembly.

[0041] The electrode head assembly is mainly composed of a central electrode head 132 and a lateral electrode head 133 . The lateral electrode heads 133 are located on both sides of the central electrode head 132 . The central electrode head 132 and the lateral electrode heads 133 may be integrated or separated.

[0042] The style and size of the central electrode head 132 and the lateral electrode head 133 are not limited. For example, the cross-sections of the central electrode head 132 and the lateral electrode head 133 are both circular or square. In this embodiment, the cross-sections of the central electrode head 132 and the lateral electrode head 133 are both circular, wherein the diameter of the central electrode head 132 is 0.3 mm-3 mm, preferably 0.9 mm, 1.2 mm, 1.6 mm, 2.3 mm, etc., and the diameter of the lateral electrode head 133 is 0.3 mm-3 mm, preferably 0.9 mm, 1.2 mm, 1.6 mm, 2.3 mm, etc. The diameters of the central electrode head 132 and the lateral electrode head 133 may be equal or unequal.

[0043] The number of the central electrode head 132 is generally one. Of course, in some embodiments, the number of the central electrode head 132 can be two or three. Figure 6 , Figure 7 As shown, the central electrode head 132 adopts a needle-like structure and has a certain hardness. Its front end can be conical or angular, and the front end is relatively sharp and can penetrate into the uterine fibroids.

[0044] The number of the lateral electrode heads 133 is at least two, for example, two, three, four, etc. In this embodiment, the number of the lateral electrode heads 133 is two, and the two lateral electrode heads 133 are distributed on both sides of the central electrode head 132. The two lateral electrode heads 133 can be symmetrical or asymmetrical. The lateral electrode heads 133 can adopt a needle-like structure or a non-needle-like structure.

[0045] The arrangement of the central electrode head 132 and the lateral electrode head 133 and the connection method between the two and the electrode rod 131 are not limited. In the present embodiment, the central electrode head 132 and the lateral electrode head 133 are independent of each other, and the number of electrode rods 131 is three. The three electrode rods 131 are independent of each other, one of which is fixedly connected to or integrally formed with the central electrode head 132, and the other two electrode rods 131 are respectively fixedly connected to or integrally formed with the two lateral electrode heads 133.

[0046] The central electrode head 132 and the lateral electrode head 133 are made of conductive materials, and together with the outer electrode 120 form two poles for radio frequency ablation. The electrode rod 131 may be conductive or non-conductive.

[0047] If the electrode rod 131 is made of a conductive material, the outer side thereof needs to be covered with an inner insulating layer 134 to insulate two adjacent electrode rods 131 and between the electrode rod 131 and the outer electrode 120. The inner insulating layer 134 can extend to the central electrode head 132 or the lateral electrode head 133, so that the front end of the central electrode head 132 or the lateral electrode head 133 is exposed. The exposed length of the front end of the central electrode head 132 or the lateral electrode head 133 is not limited. For example, the exposed length of the central electrode head 132 is L1, L1 is 1mm-15mm, preferably 8mm, 10mm, and the exposed length of the lateral electrode head 133 is L2, L2 is 1mm-15mm, preferably 6mm, 8mm.

[0048] If the electrode rod 131 is made of non-conductive material, additional connecting wires are required to electrically connect the electrode head assembly to the plug 112. At this time, the outer sides of the central electrode head 132 and the lateral electrode head 133 need to be covered with an inner insulating layer 134, and the front ends of the two are exposed.

[0049] The two lateral electrode heads 133 can be expanded or retracted toward both sides of the central electrode head 132: when the two lateral electrode heads 133 are expanded toward both sides of the central electrode head 132, the electrode head assembly is distributed in a plane, that is, the center lines of the central electrode head 132 and the two lateral electrode heads 133 are located in the same plane. Of course, slight deviations are also allowed; when the two lateral electrode heads 133 are retracted toward the central electrode head 132, the lateral electrode heads 133 and the central electrode head 132 are close to each other with a small spacing, and can be retracted from the front end opening of the outer electrode 120 into the outer electrode 120.

[0050] When the two lateral electrode heads 133 are retracted toward the central electrode head 132 , the front ends of the lateral electrode heads 133 may be flush with the front end of the central electrode head 132 , or may be slightly backward.

[0051] The way of unfolding and retracting the lateral electrode head 133 is not limited. In the present embodiment, the lateral electrode head 133 is pre-bent, that is, when the lateral electrode head 133 is not compressed by external force, it can bend outward naturally. When it is squeezed with a certain force, for example, it is squeezed by the front end opening of the external electrode 120, it can be deformed, straightened, etc. It should be noted that the lateral electrode head 133 needs to have a certain strength after bending, that is, it can only be deformed when a force exceeding a preset force threshold is applied to it, so as to prevent deformation under the compression of uterine fibroids, etc. The preset force threshold can be set artificially, which can be achieved by changing the material of the lateral electrode head 133, etc.

[0052] The pre-bending angle of the lateral electrode head 133 is not limited, and can be 0 (not included) -60°, such as 10°, 20°, 30°, 45°, 50°, 60°, etc., preferably 30°, 45°. It should be noted that the "pre-bending angle" mentioned here refers to the maximum opening angle of the lateral electrode head 133. Under the restriction of the external electrode 120, the opening angle of the lateral electrode head 133 can change within the maximum opening angle. For example, if the pre-bending angle is 30°, then under the action of external force, the opening angle of the lateral electrode head 133 can be 5°, 10°, 20°, 30°, etc. The opening angle of the lateral electrode head 133 is related to the length of the electrode head assembly extending from the outer electrode 120, that is, within the maximum opening angle range, the greater the length of the electrode head assembly extending from the outer electrode 120, the greater the opening angle of the lateral electrode head 133.

[0053] The radiofrequency ablation electrode 13 provided in this embodiment has two states, namely, a puncture state and an ablation state.

[0054] Please combine Figure 1 As shown, when the RF ablation electrode 13 is in the puncture state, the electrode head assembly is retracted into the outer electrode 120, and the lateral electrode head 133 is retracted under the squeezing action of the outer electrode 120 and is close to the central electrode head 132. It should be noted that the "front end of the inner electrode 130 is retracted into the outer electrode 120" in this embodiment does not mean that the electrode head assembly is completely retracted into the outer electrode 120, but partially or mostly retracted into the outer electrode 120, and the front end of the central electrode head 132 needs to be exposed outside the outer electrode 120. Since the front end of the central electrode head 132 is relatively sharp, when the RF ablation electrode 13 is inserted into the uterine fibroids or uterine wall, the inner electrode 130 may not work, and the central electrode head 132 can be inserted until the RF ablation electrode 13 is inserted into place, without the need for additional auxiliary punching equipment.

[0055] In the above state, the front end of the lateral electrode head 133 can be exposed or completely hidden inside the outer electrode 120, that is, the front ends of the central electrode head 132 and the two lateral electrode heads 133 are exposed outside the outer electrode 120. At this time, the lateral electrode head 133 can also adopt a needle-like structure, that is, its front end is relatively sharp, which is convenient for piercing into the uterine fibroids or the uterine wall; or, the front end of the central electrode head 132 is exposed outside the outer electrode 120, and the front ends of the two lateral electrode heads 133 are completely inside the outer electrode 120. At this time, the front end of the lateral electrode head 133 can adopt a needle-like structure or a blunt structure; or, the front end of the central electrode head 132 is exposed outside the outer electrode 120, and the front end of one of the two lateral electrode heads 133 is exposed outside the outer electrode 120 and adopts a needle-like structure, and the front end of the other is completely inside the outer electrode 120 and the front end can adopt a needle-like structure or a blunt structure. Of course, even if the lateral electrode head 133 is exposed, its front end may also adopt a blunt structure.

[0056] Please combine Figure 8 As shown, when the radiofrequency ablation electrode 13 is in the ablation state, the electrode head assembly extends from the front end of the outer electrode 120. The electrode head assembly can be partially extended or fully extended. The extension length of the electrode head assembly is different, and the area after expansion will also change, which can change the size of the ablation area, thereby adapting to the ablation of uterine fibroids of different sizes. At this time, part or all of the lateral electrode head 133 is separated from the extrusion of the outer electrode 120, and automatically resets and expands outward under its own elasticity. The electrode head assembly is expanded into a plane distribution, that is, the lateral electrode head 133 is expanded toward both sides of the central electrode head 132. After expansion, it is similar to a trident shape, and the front end of the central electrode head 132 is farther from the outer electrode 120 than the front end of the lateral electrode head 133. The maximum distance between the front ends of the two lateral electrode heads 133 is L, L is 10mm-120mm, preferably 30mm, 50mm / 80mm, etc. The larger the L value, the larger the ablation area, and radiofrequency ablation electrodes 13 with different L values ​​can be selected according to the size of the uterine fibroids.

[0057] In the above state, the lateral electrode head 133 is positioned further back than the central electrode head 132 , and the front ends of the central electrode head 132 and the lateral electrode head 133 are roughly arc-shaped, and the front ends of the ablation regions thereof are roughly arc-shaped.

[0058] The inner electrode 130 and the outer electrode 120 are electrically connected to the two poles of the radio frequency host through the plug 112. The radio frequency host can provide radio frequency energy to the radio frequency ablation electrode 13 to ablate, cut, coagulate and stop bleeding of tissues.

[0059] The forward and backward movement of the inner electrode 130 can be controlled by the handle 110. The control method and structure of the handle 110 are not limited and can refer to the prior art. Fig. 9 , Fig.10 As shown, a control member 111 is provided on the handle 110, and the control member 111 includes a push button, which can slide along the front-rear direction on the handle 110. The rear end of the inner electrode 130, that is, the rear end of the electrode rod 131, is connected to the push button. By pushing the push button forward and backward, the inner electrode 130 can be driven to move forward and backward.

[0060] In other embodiments, the control member 111 may also adopt other schemes, for example: the control member 111 includes a knob, which is rotatably set on the handle 110, and the rear end of the inner electrode 130 is connected to a threaded rod, which is rotatably supported in the handle 110, and the external thread is engaged with the internal thread. When the medical staff turns the knob, it can drive the threaded rod to rotate, thereby driving the inner electrode 130 to slide back and forth. Embodiment 2:

[0061] Please refer to Fig.11 , Fig.12 As shown, the second embodiment of the present invention provides a radiofrequency ablation electrode 13, which is an improvement on the first embodiment. The improvement lies in the structure and deployment method of the electrode head assembly. For the parts not mentioned in this embodiment, reference can be made to the first embodiment or the prior art.

[0062] For details, please combine Figure 13-Figure 15 As shown, there is one electrode rod 131 , which is a rod-shaped structure. Slide grooves 143 are provided on both sides of the electrode rod 131 , and the slide grooves 143 extend along the front-rear direction of the electrode rod 131 . The central electrode head 132 and the lateral electrode head 133 are respectively connected to the electrode rod 131 .

[0063] The central electrode head 132 is fixedly connected to the electrode rod 131 or formed integrally therewith, that is, the central electrode head 132 and the electrode rod 131 can be independently arranged and connected, or the front end of the electrode rod 131 can be regarded as the central electrode head 132 .

[0064] The two lateral electrode heads 133 are respectively hinged to the electrode rod 131 . The hinge position and hinge method of the lateral electrode head 133 and the electrode rod 131 are not limited. In the present embodiment, the rear end of the lateral electrode head 133 is hinged to the electrode rod 131 , and the hinge axis can be located in the slide groove 143 .

[0065] If the central electrode head 132 is integrally formed with the electrode rod 131 , and structures such as a slide groove 143 need to be provided on the electrode rod 131 , and the puncture strength of the central electrode head 132 needs to be ensured, the diameter of the central electrode head 132 may be greater than the diameter of the lateral electrode head 133 .

[0066] In addition, the inner electrode 130 further includes a slider 141 and a connecting rod 142 .

[0067] The slider 141 is slidably embedded in the slide groove 143 and the two cooperate with each other, and the slider 141 can slide back and forth along the slide groove 143. The cooperation method of the slider 141 and the slide groove 143 is not limited. For example, the cross-sections of both are T-shaped or arc-shaped.

[0068] The two ends of the connecting rod 142 are respectively hinged to the slider 141 and the lateral electrode head 133, that is, the connecting rod 142 and the slider 141, and the connecting rod 142 and the lateral electrode head 133 can rotate relative to each other. When the slider 141 slides along the slide groove 143, the lateral electrode head 133 can be driven to expand or retract through the connecting rod 140, or when the lateral electrode head 133 is expanded or retracted, the slider 141 can be pushed to slide in the slide groove 143 through the connecting rod 140.

[0069] In addition, it should be noted that the electrode rod 131 and the lateral electrode head 133 need to be electrically conductive, and the electrical conductivity can be achieved through the hinge shaft of the electrode rod 131 and the lateral electrode head 133, or through the electrode rod 131, the slider 141, the connecting rod 140, etc. Therefore, the slider 141, the connecting rod 140, the hinge shaft, etc. are preferably made of a metal material that is conducive to electrical conductivity, and at the same time, sufficient strength must be ensured.

[0070] In the above structure, in order to insulate the electrode head assembly and the outer electrode 120, the following solution can also be adopted: the inner electrode 130 is wrapped in the same inner insulating layer 134. Specifically, the outer side of the inner electrode 130 is coated with the inner insulating layer 134, and the front end of the inner insulating layer 134 is triangular or trapezoidal after unfolding and matches the shape of the electrode head assembly after unfolding. Of course, in other embodiments, the electrode rod 131, the central electrode head 132 and the lateral electrode head 133 can be respectively coated with the inner insulating layer 134.

[0071] When the radiofrequency ablation electrode 13 provided in this embodiment is in the puncture state, the directions of the lateral electrode head 133 and the central electrode head 132 may have a smaller angle. Fig.16 As shown, after the electrode head assembly is pushed out from the front end of the outer electrode 120, during the process of inserting the central electrode head 132 into the uterine fibroid, the lateral electrode head 133 will be expanded under the restriction of the uterine fibroid, and the deeper the insertion, the greater the expansion amplitude of the lateral electrode head 133. Of course, in some embodiments, the expansion or retraction of the lateral electrode head 133 can also be controlled by adding other structures, for example, adding a control rod, the control rod is inserted into the outer electrode 120, the front end of the control rod is connected to the slider 141 or the lateral electrode head 133, and the rear end extends into the handle 110.

[0072] Compared with the solution in Example 1, the solution in this embodiment has the following advantages: the exposed area of ​​the central electrode head 132 and the lateral electrode head 133 is larger, the ablation efficiency is higher, and the ablation area is larger; the structure of the electrode head assembly is more stable, which can ensure that the central electrode head 132 and the lateral electrode head 133 are in the same plane after being unfolded; it is easier to rotate the radiofrequency ablation electrode 13, and the central electrode head 132 and the lateral electrode head 133 are not easily deformed or the ablation area is changed under the squeezing of uterine fibroids, etc. Embodiment three:

[0073] Please refer to Fig.17 , Fig.18 As shown, embodiment three of the present invention provides a radiofrequency ablation electrode 13, which is an improvement on embodiment one or embodiment two, and the improvement lies in the structure and deployment method of the electrode head assembly, etc. For the parts not mentioned in this embodiment, reference can be made to embodiment one or embodiment two or the prior art.

[0074] For details, please combine Fig.19 As shown, there is one electrode rod 131 , and the central electrode head 132 and the lateral electrode head 133 are respectively connected to the electrode rod 131 .

[0075] The central electrode head 132 is fixedly connected to the electrode rod 131 or formed integrally therewith, that is, the central electrode head 132 and the electrode rod 131 can be independently arranged and connected, or the front end of the electrode rod 131 can be regarded as the central electrode head 132 .

[0076] The two lateral electrode heads 133 are respectively hinged to the electrode rod 131, and the hinge position and hinge method of the lateral electrode head 133 and the electrode rod 131 are not limited. For example, the rear end of the lateral electrode head 133 is hinged to the electrode rod 131, and the hinge axis extends along the left and right direction of the radiofrequency ablation electrode 13. In this embodiment, a connecting portion is provided on one side of the lateral electrode head 133, and the connecting portion is close to the rear end of the lateral electrode head 133, and the connecting portion is hinged to the electrode rod 131.

[0077] In addition, the inner electrode 130 also includes connecting rods 140. The number of connecting rods 140 is not limited, and can be one or two, that is, one connecting rod 140 can control all lateral electrode heads 133 at the same time, or one electrode rod 131 can control one lateral electrode head 133. In the present embodiment, the number of connecting rods 140 is two, and the two connecting rods 140 correspond one to one to the two lateral electrode heads 133.

[0078] The connecting rod 140 can be inserted into the outer electrode 120, or can be inserted into the electrode rod 131, or can be inserted into the inner insulating layer 134. The front end of the connecting rod 140 is connected to the rear end of the lateral electrode head 133, and the two can be hinged or fixedly connected. The connecting rod 140 can be made of conductive material or non-conductive material. The connecting rod 140 needs to have a certain strength so that when the connecting rod 140 moves forward and backward, it can control the rotation of the lateral electrode head 133 to expand or retract the lateral electrode head 133.

[0079] In the above structure, due to the addition of the connecting rod 140, the forward and backward movement of the inner electrode 130 and the expansion or retraction of the lateral electrode head 133 need to be controlled by different structures. Therefore, in this embodiment, please combine Figure 20-22 As shown, the control member 111 includes two push buttons, which are a first push button 113 and a second push button.

[0080] Among them, the first push button 113 is connected to the rear end of the inner electrode 130, that is, the rear end of the electrode rod 131, and is used to control the forward and backward movement of the inner electrode 130. The second push button is connected to the rear end of the connecting rod 140 and is used to control the expansion or retraction of the front end of the inner electrode 130.

[0081] When the first push button 113 is pushed back and forth, the inner electrode 130 can move back and forth as a whole, so that the electrode head assembly can extend from the front end of the outer electrode 120 or retract into the outer electrode 120; when the electrode head assembly of the inner electrode 130 extends out of the outer electrode 120, when the second push button is pushed back and forth, the connecting rod 140 can move back and forth, so that the lateral electrode head 133 can rotate, and then the lateral electrode head 133 can be expanded or retracted.

[0082] Compared with the solution in the second embodiment, the solution in this embodiment has the following advantages: no slide groove 143, slider 141, etc. are provided, and it is not easy to fill waste tissue, etc.; the structure is simpler and more durable, and less prone to failure; the assembly of the radiofrequency ablation electrode 13 is more convenient and the production is more convenient. Embodiment 4:

[0083] Please refer to Figure 23-Figure 25 As shown, the fourth embodiment of the present invention provides an ablation electrode system 10. The ablation electrode system 10 generally needs to be used in conjunction with an ultrasonic detection device 20. The ultrasonic detection device 20 can detect the location of the uterine fibroids, and the ablation electrode system 10 can penetrate into the uterine fibroids and ablate them.

[0084] The ablation electrode system 10 is mainly composed of a radio frequency host 11, a foot switch 12 and a radio frequency ablation electrode 13. The structure of the radio frequency ablation electrode 13 can refer to the prior art.

[0085] The RF ablation electrode 13 is connected to the RF host 11. The connection method between the two can refer to the existing technology. The outer electrode 120 and the inner electrode 130 of the RF ablation electrode 13 are respectively connected to the two poles of the RF host 11. The RF host 11 can provide RF energy, so that the front end of the RF ablation electrode 13 can ablate the uterine fibroids.

[0086] The radiofrequency ablation electrode 13 can be controlled by a foot switch 12 , and the foot switch 12 can control functions such as, but not limited to, turning on or off the radiofrequency ablation electrode 13 and the amount of radiofrequency energy.

[0087] The working method of the ablation electrode system 10 provided in this embodiment is as follows: Sending the ultrasonic detection device 20 into the uterus to detect the location of the fibroids, and displaying the location and size of the uterine fibroids on an external display; The radiofrequency ablation electrode 13 is inserted into the uterus. At this time, the radiofrequency ablation electrode 13 is in a puncture state; At the front end of the radiofrequency ablation electrode 13, the central electrode head 132 and the outer electrode 120 form a sharp front end that can puncture into the uterine fibroids; Push the push button on the handle 110 forward, so that the electrode head assembly extends from the front end of the outer electrode 120, and the lateral electrode head 133 is expanded outward, so that the electrode head assembly is expanded into a plane distribution until the entire fibroid is covered, so that the radiofrequency ablation electrode 13 is in an ablation state. According to the size of the fibroid, different ablation areas can be obtained by controlling the extension length of the electrode head assembly; The medical staff steps on the foot switch 12, and the radio frequency host 11 provides energy to make the radio frequency ablation electrode 13 work, and perform radio frequency ablation on the myoma; During the ablation of the fibroid, the radiofrequency ablation electrode 13 can be slowly moved or rotated on both sides so that the electrode head assembly can ablate the surrounding uterine fibroids. The manual rotation angle or moving distance determines the ablation range, making the ablation range controllable and ensuring that the entire fibroid can be ablated. After ablation is completed, the push button on the handle 110 is pushed backward, so that the inner electrode 130 slides backward relative to the outer electrode 120, and the electrode head assembly is retracted into the outer electrode 120, so that the radiofrequency ablation electrode 13 is in a puncture state. At this time, the front end of the central electrode head 132 can be exposed; The radiofrequency ablation electrode 13 and the ultrasound probe are pushed out in sequence; Treat the wound and complete the surgery.

[0088] During the ablation process, a planar ablation area with a certain thickness is formed in the first few seconds of operation (generally within 5 seconds, depending on the output gear of the RF host 11). If the operation time is too long, a teardrop-shaped ablation area will eventually be formed due to the thermal effect of plasma ablation. When precise ablation is required, only the first few seconds of operation can be performed, and then the target area can be rotated or moved for precise ablation. Even if the ablation is not in place in the first few seconds, the overlapping part of the ablation area can be continued by manually rotating or moving the RF ablation electrode 13.

[0089] The above steps can be increased, decreased, modified, and the order can be adjusted as needed. For example, the puncture work can also select the punching mode of the RF host 11 to assist in puncture and punching, that is, the RF ablation electrode 13 does not need to puncture, and after positioning at the target site, the ablation mode of the RF host 11 is selected for ablation; or during the puncture process, the electrode head assembly is gradually unfolded, and after the puncture is completed, the central electrode head 132 and the lateral electrode head 133 are ablated at the same time; if the extension and front end expansion of the inner electrode 130 are controlled by two push buttons, it can be adaptively adjusted, and the first push button 113 controls the front end of the inner electrode 130 to extend, and then the second push button controls the front end of the inner electrode 130 to expand.

[0090] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A radiofrequency ablation electrode, characterized in that: It comprises an outer electrode and an inner electrode insulated from each other, wherein the inner electrode is inserted into the outer electrode and the front end comprises a needle-shaped central electrode head and at least two lateral electrode heads which can be expanded to both sides or retracted inward; the radio frequency ablation electrode has a puncture state in which the front end of the inner electrode is retracted into the outer electrode and the front end of the central electrode head is exposed, and an ablation state in which the front end of the inner electrode extends from the outer electrode and is expanded into a planar distribution.

2. The radiofrequency ablation electrode according to claim 1, characterized in that: The inner electrode further comprises at least three independent electrode rods, the front ends of the electrode rods are connected to the central electrode head or the lateral electrode head, and the lateral electrode head is pre-bent.

3. The radiofrequency ablation electrode according to claim 1, characterized in that: The inner electrode further comprises an electrode rod, the central electrode head is fixed to or integrally formed with the electrode rod, and the lateral electrode heads are respectively hinged to the electrode rod.

4. The radiofrequency ablation electrode according to claim 3, characterized in that: The inner electrode further comprises a connecting rod, which is connected to the lateral electrode head and is used to control the expansion or contraction of the lateral electrode head.

5. The radiofrequency ablation electrode according to claim 3, characterized in that: The inner electrode further comprises a slider and a connecting rod. The electrode rod is provided with a sliding groove in the front-rear direction. The connecting rod is hinged to the slider and the lateral electrode head respectively. The slider is slidably matched with the sliding groove.

6. The radiofrequency ablation electrode according to claim 3, characterized in that: The outer side of the inner electrode is covered with an inner insulating layer, and the front end of the inner insulating layer is triangular or trapezoidal after being unfolded and matches the front end of the inner electrode.

7. The radiofrequency ablation electrode according to claim 1, characterized in that: In the direction from back to front, the diameter of the front end of the outer electrode gradually decreases.

8. The radiofrequency ablation electrode according to claim 1, characterized in that: The radio frequency ablation electrode further comprises a handle with a control member, the rear end of the outer electrode is connected to the handle, and the rear end of the inner electrode is connected to the control member and is pushed forward and backward by the control member.

9. The radiofrequency ablation electrode according to claim 8, characterized in that: The control member includes two push buttons, one of which is used to control the forward and backward movement of the inner electrode, and the other push button is used to control the expansion or retraction of the front end of the inner electrode.

10. An ablation electrode system, characterized in that: It comprises a radio frequency host, a foot switch and the radio frequency ablation electrode according to any one of claims 1 to 9, wherein the radio frequency ablation electrode is connected to the radio frequency host and is controlled by the foot switch.

Images