An electrode device for denervating or modulating nerves in the body
By designing an electrode device connected to multiple joints with deformable electrode guides, the problem of inaccurate positioning of the electrode assembly in the prior art is solved, and efficient and reliable nerve blocking or adjustment surgery is achieved, reducing costs.
Patent Information
- Application Number
- CN202080100271.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2020-09-29
- Filing Date
- 2020-10-08
- Publication Date
- 2025-07-18
- Estimated Expiration
- 2040-10-08
AI Technical Summary
In the prior art, it is difficult to accurately and quickly position the electrode assembly around the outer wall of the tube in the body, resulting in insufficient efficiency and reliability of nerve blockade or adjustment of surgery.
An electrode device is designed. The electrode guides connected to multiple joints can be deformed into a winding state, close to the outer circumference of the inner tube, and precise position adjustment is achieved through the driving of the joints. The electrode guides are made of elastically deformable material, and the joints are formed into one, simplifying the manufacturing process.
The reliable fit of the electrode device on the periphery of the inner tube is achieved, which improves the accuracy and efficiency of nerve blocking or adjustment surgery, reduces production costs, and simplifies the manufacturing process.
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Figure CN115461006B_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to an electrode device for denervating or adjusting nerves in the body. Background Art
[0002] Neuroblockade refers to a surgery that controls an abnormally overactive autonomic nervous system by damaging specific nerves. For example, renal denervation can treat hypertension and heart disease by damaging the renal sympathetic nerves leading to the kidneys, and pulmonary denervation can treat lung diseases by damaging the parasympathetic nerves leading to the lungs.
[0003] Nerves usually surround the outer walls of tubes such as blood vessels, bronchi, etc. Therefore, it may be necessary to measure the signals of nerves by surrounding the outer walls of such tubes, or to damage or destroy the nerves by delivering electrical stimuli or various energies to the nerves.
[0004] For example, during surgery on the renal artery, the diameter of the main renal artery, which is the surgical target, is 5 mm to 7 mm, and the accessory renal artery with a diameter of 1 mm to 2 mm can also be the target. In addition, for tubes with nerves distributed, their sizes vary from person to person and also vary depending on the location.
[0005] During the above-mentioned surgery, it is particularly important to accurately position the component including the electrode formed at the end of the catheter around the outer wall of the tube. Specifically, in order to effectively block or adjust the nerve, it is necessary to surround the outer wall of the tube with nerves distributed along the circumferential direction, and an operation of setting the component with an electrode formed in the middle of the tube into a surrounding state needs to be carried out reliably and quickly. Summary of the Invention
[0006] Problems to be Solved by the Invention
[0007] One object of the present invention is to provide an electrode device having a structure in which as a plurality of unit elements are connected to each other and deformed, the electrode is guided to be arranged in a shape surrounding the outer periphery of a tube in the body.
[0008] Another object of the present invention is to provide an electrode device having a structure in which the structure in which a plurality of unit elements are connected and deformed can enable the electrode to completely surround the outer periphery of a tube in the body.
[0009] Another object of the present invention is to provide an electrode device in which the structure for guiding the electrode connected with a plurality of unit elements can be manufactured by one member without assembly.
[0010] However, the technical problems to be solved in this embodiment are not limited to the above technical problems, and there may be other technical problems.
[0011] Solution for Solving Problems
[0012] To achieve one of the objects of the present invention, an electrode device according to the present invention for denervating or adjusting nerves in the body includes: a main body provided with a shaft; an electrode unit protruding from one end of the above-mentioned shaft and denervating or adjusting at least a part of the nerves of the tube in the above-mentioned body; and an electrode guide member coupled to the above-mentioned electrode unit and bringing the above-mentioned electrode unit into contact with the tube in the body by deforming into a wound state, wherein the above-mentioned electrode guide member is provided with a plurality of joint portions, and the plurality of joint portions are arranged to surround the outer periphery of the above-mentioned electrode unit in the above-mentioned wound state.
[0013] The above-mentioned joint portion may include: a hinge portion formed on one or both sides of the above-mentioned joint portion in the long side direction connected to an adjacent joint portion; and a winding support portion formed on one or both sides of the above-mentioned joint portion in the above-mentioned long side direction so as to support the above-mentioned adjacent joint portion in the above-mentioned wound state.
[0014] To achieve another object of the present invention, the above-mentioned electrode guide member may further be provided with a tip joint, the tip joint being arranged to be coupled to the above-mentioned electrode unit and connected to the above-mentioned shaft through the plurality of joint portions, and, in the above-mentioned wound state, the radius of curvature formed by the plurality of joint portions close to the tip joint may be smaller than the radius of curvature formed by the plurality of joint portions close to the above-mentioned shaft.
[0015] To achieve another object of the present invention, the plurality of joint portions are made of an elastically deformable material and formed integrally, and a winding support groove may be formed between the adjacent joint portions of the above-mentioned electrode guide member, wherein at least a part of the winding support groove can be deformed in a closed manner in the above-mentioned wound state.
[0016] The above-mentioned solution for solving problems is only exemplary and should not be construed as limiting the present invention. In addition to the above-mentioned exemplary embodiments, there may be additional embodiments described in the drawings and the detailed description.
[0017] Advantages of the Invention
[0018] According to the electrode device of the present invention, in order to effectively transfer energy by closely attaching the electrode to the outer surface of the tube, the position of the electrode unit can be reliably adjusted by a joint portion driving method of deforming the electrode guide member into a wound state.
[0019] Furthermore, according to the electrode device of the present invention, by making the length or shape of the joint portion different, the shape of the electrode guide member in the wound state can be precisely designed, and the electrode guide member can completely surround the tube in the body. Thus, the operation of denervating or adjusting nerves can be performed more effectively.
[0020] In addition, in the electrode device according to the present invention, by forming an electrode guide member that drives a plurality of joint portions and the joint portions are formed integrally, the manufacturing process of the electrode device can be simplified, the product can be miniaturized, and the manufacturing cost can be reduced. BRIEF DESCRIPTION OF THE DRAWINGS
[0021] Figure 1 FIG. is a side view showing an electrode device according to an embodiment of the present invention.
[0022] Figure 2 FIG. shows Figure 1 a perspective view of the winding state of the electrode guide member shown in.
[0023] Figures 3a to 3c FIG. is a view showing a process in which an electrode guide member according to an embodiment of the present invention is deformed into a wound state.
[0024] Figure 4 FIG. shows Figure 2 a perspective view of the joint portion and the tip joint shown in.
[0025] Figure 5 FIG. shows Figure 4 an exploded perspective view of a part of the joint portion shown in.
[0026] Figure 6 FIG. shows Figure 4 a side view of a part of the joint portion shown in.
[0027] Figure 7 FIG. is a perspective view showing an electrode guide member according to another embodiment of the present invention. DETAILED DESCRIPTION OF THE EMBODIMENTS
[0028] Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings so that those of ordinary skill in the art can easily implement the embodiments of the present invention. However, the present invention can be implemented in various different forms and is not limited to the embodiments described here. And in order to clearly describe the present invention in the drawings, parts irrelevant to the description are omitted, and like reference numerals are used for like parts throughout the specification.
[0029] Throughout the specification, when referring to one part being "connected" to another part, it includes not only the case of "direct connection", but also the case of "electrically connecting" the two through other components. Additionally, when referring to a component "including" a certain component, unless otherwise stated, it means that other components can be further included, rather than excluding other components. It should be understood that there is no exclusion of the additional possibility of one or more other features or quantities, steps, operations, components, parts, or combinations thereof. Furthermore, throughout the specification, when a part is "above" another part, it includes not only the case where one part is tangent to the other part, but also the case where there is another part between the two parts.
[0030] Figure 1 is a side view showing an electrode device according to an embodiment of the present invention, Figure 2 is showing Figure 1 a perspective view of the winding state of the electrode guide shown in Figures 3a to 3c is a view showing the process of the electrode guide being deformed into a wound state according to an embodiment of the present invention. Figure 4 is showing Figure 2 a perspective view of the joint part and the tip joint shown in Figure 5 is showing Figure 4 an exploded perspective view of a part of the joint part shown in Figure 6 is showing Figure 4 a side view of a part of the joint part shown in
[0031] Referring to Figure 1 , an electrode device 100 according to an embodiment of the present invention includes: a main body 110, an electrode unit 120, and an electrode guide 130. The main body 110 may include: a shaft 111 extending in one direction; a grip part 112 formed to be connected to the shaft 111 for a surgeon to hold; a guiding operation part 113 formed on the grip part 112 to operate the movement of the electrode guide 130; and an electrode operation part 114 formed on the grip part 112 to operate the movement of the electrode unit 120. Elements for driving and controlling the electrode unit 120 and the electrode guide 130 may be provided inside the main body 110.
[0032] The electrode unit 120 protrudes from one end of the shaft 111 and is arranged to denervate or adjust at least a part of the nerves distributed in the tissue of a tube contained in the body according to the operation of the surgeon.
[0033] Referring to Figure 2, the electrode unit 120 may include: a substrate portion 121, an electrode portion 122, and a sensor portion 123. For the electrode device 100 of the present invention, the electrodes surround the outer surface of a tube or tubular tissue V in the body and can transmit energy through the electrodes. To this end, the substrate portion 121 may be formed as a flexible flexible printed circuit board (FPCB).
[0034] The electrode portion 122 is formed on the substrate portion 121. Figure 2 In the illustrated embodiment, the electrode portion 122 may be composed of two electrodes extending parallel to each other on the substrate portion 121. The substrate portion 121 and the electrode portion 122 in this embodiment may be formed to extend in the circumferential direction and surround a tube in the body, etc.
[0035] The electrode portion 122 may be made of a material that is harmless to the human body and capable of conducting electricity, such as stainless steel or gold, etc., to block or denervate or control or modulate nerves. In addition, the electrode portion 122 may transmit various types of energy from an energy source generator. For example, radio-frequency (RF) energy, electrical energy, laser energy, ultrasonic energy, high-intensity focused ultrasound energy, cryogenic energy, and other thermal energies may be used.
[0036] In addition, the electrode portion 122 may be formed as a flexible printed circuit board (Flexible PCB) for transmitting high-frequency energy, a transducer for transmitting ultrasonic energy, a metal electrode for transmitting high-voltage energy, etc., to transmit energy for damaging nerves.
[0037] In addition, a sensor portion 123 may be formed on the substrate portion 121. In one example, the sensor portion 123 may be a thermocouple that measures temperature by contacting a tube in the body, etc. When a nerve resection surgery is performed using the electrode device 100 according to the present invention, the sensor portion 123 may monitor the temperature of the surgical site. In another example, the sensor portion 123 may also measure the nerve signal of the tube.
[0038] The electrode guide 130 performs the function of bringing the electrode unit 120 into contact with a tube in the body. The electrode guide 130 is coupled to the electrode unit 120 and is deformed into a wound state to bring the electrode unit 120 into contact with a tube in the body.
[0039] Further refer to Figures 3a to 3c and Figure 4In order to achieve deformation in the winding state, the electrode guide 130 provided by the present invention is provided with a plurality of joints 131. The plurality of joints 131 are provided to surround the outer circumference of the tube V in the body through the electrode unit 120 in the winding state. For example, the winding state can be Figure 2 as well as Figure 3c The status shown in .
[0040] According to the electrode device 100 of the present invention, in order to adhere the electrode part 122 to the outer surface of the tube in the body to effectively transmit energy, the electrode guide 130 can be deformed into a winding state by driving the joint part 131. Compared with the existing method of using shape memory materials, the action time and shape of the electrode guide 130 can be directly controlled by the action method of the joint type, and the reliability of repeated actions can be improved. Therefore, the electrode device 100 according to the present invention can be used to perform customized and delicate surgery.
[0041] According to an embodiment of the present invention, the electrode guide 130 can be housed inside the shaft 111 together with the electrode unit 120, and can be deformed into a coiled state as it is pulled forward from one end F for performing surgery. Figures 3a to 3c As shown, the plurality of joints 131 may be sequentially pulled out and moved toward one side and formed into a wound state that surrounds the tube V as a whole. However, in the wound state, the electrode guide 130 is disposed apart from the outer peripheral surface of the tube, and the electrode unit 120 disposed inside the wound electrode guide 130 may be closely attached to the outer peripheral surface of the tube V.
[0042] Further reference is made to Figure 5 and Figure 6 The detailed structures of the electrode guide 130 and the joint portion 131 will be described.
[0043] The electrode guide 130 may further include a tip joint 132 and a guide wire 133. The tip joint 132 is connected to the shaft 111 through a plurality of joint portions 131 and may be combined with the electrode unit 120. Figure 3c As shown in , in the rolled state, the tip joint 132 may be located close to the tube V in the body, and the width and thickness of the tip joint 132 may become thinner toward the end portion to prevent interference with the electrode unit 120 or maximize the surface surrounding the tube in the body. The tip joint 132 may have a structure that allows the end of the electrode unit 120 to be fastened and fixed.
[0044] The wire 133 may be formed to sequentially pass through the plurality of joints 131. Figure 5, in the joint portion 131, a through hole 131c can be formed along the long side direction for the wire 133 to pass through. The end portion of the wire 133 passing through the through hole 131c in sequence can be fixedly coupled to the tip joint 132, and the wire 133 can slide along the long side direction inside the through hole 131c relative to each joint portion 131. Therefore, the wire 133 can guide the plurality of joint portions 131 and the tip joint 132 to be arranged in a wound state and support the tip joint 132 and the plurality of joint portions 131 in the wound state.
[0045] In addition, the joint portion 131 can be provided with a hinge portion 131a and a winding support portion 131b. As a structure for rotatably connecting with an adjacent joint, the hinge portion 131a can be formed on one or both sides in the long side direction where the joint portions 131 are connected side by side. As shown in the figure, the hinge portion 131a can form a rotation axis in a direction crossing the long side direction and be connected to the hinge portion 131a of the adjacent joint portion 131. In each hinge portion 131a, a hinge portion (not shown) can be inserted and fastened along the direction of the formed rotation axis.
[0046] The winding support portion 131b is a structure for maintaining the wound state and can be formed on one or both sides in the long side direction to support each other with the adjacent joint portions 131. As shown in the figure, the winding support portion 131b can be formed at a position adjacent to the hinge portion 131a along the inner side (where the joint portion 131 winds) direction of the electrode guide 130. The winding support portion 131b can be formed as a surface having a predetermined angle and area, for example, and is supported in a surface contact manner with the adjacent winding support portion 131b in the wound state, so that the wound form of the electrode guide 130 can be fixed.
[0047] In Figure 3a and Figure 3c 's embodiment, when the wire 133 is pulled more rearward compared to the electrode guide 130 (when the length of the wire 133 drawn out from the shaft 111 is shorter than the length of the electrode guide 130), tension can be applied to the wire 133 in the winding direction of the electrode guide 130. Conversely, the winding support portion 131b can provide a force for the joint portions 131 to support each other in a direction to inhibit the winding of the electrode guide 130. That is, the wire 133 and the winding support portion 131b can form a force balance in opposite directions, so that the electrode guide 130 can be fixed in the wound state.
[0048] More specifically, the through hole 131c can be formed at a position spaced inward ( Figure 6 the upper side direction in Figure 6When pulled in the right direction (in the right direction in the figure), the plurality of joint portions 131 can be set to bend inward as a whole. When the joint portion 131 rotates with respect to the adjacent joint portion 131 about the hinge portion 131a so that the winding support portions 131b contact each other, the positions of the plurality of joint portions 131 can be fixed to achieve a wound state. At this time, the wire 133 can provide a force (tension) that causes the winding support portions 131b to support each other.
[0049] As described above, since the position in the wound state is suppressed by the wire 133 and the winding support portion 131b, the electrode guide 130 of the electrode device 100 according to the present invention can maintain an accurate position during surgery.
[0050] Hereinafter, an embodiment in which the shape of the electrode guide 130 in the wound state can be set by the difference in the shape between the joint portions 131 will be described.
[0051] According to an embodiment of the present invention, the electrode guide 130 may include: a first joint group 131x and a second joint group 131y. That is, the plurality of joint portions 131 can be divided into a first joint group 131x and a second joint group 131y having different shapes from each other.
[0052] In Figures 2 to 6 the embodiment, the first joint group 131x may include a joint portion 131 having a first length L1 in the long side direction; the second joint group 131y may include a joint portion 131 having a second length L2 longer than the first length L1. In this embodiment, the first joint group 131x and the second joint group 131y may each include joint portions 131 having the same length, for example: 6 joint portions 131.
[0053] Due to the length difference as described above, in the wound state, the first joint group 131x can form a first radius of curvature, and the second joint group 131y can form a second radius of curvature larger than the first radius of curvature. It can be confirmed from Figure 3c that the joint portion (first joint group 131x) having a relatively short length can form a small radius of curvature, while the joint portion (second joint group 131y) having a long length can form a large radius of curvature.
[0054] More specifically, the first joint group 131x forming the first radius of curvature can be provided on the side close to the tip joint 132, and the second joint group 131y forming the second radius of curvature can be provided on the side close to the shaft 111.
[0055] In the wound state, when the joint portion 131 located on the side close to the tip joint 132 forms a smaller radius of curvature, as Figure 3cAs shown, a path for the tip joint 132 to enter can be formed between the tube and the shaft 111 in the body. For example, the electrode guide 130 including the joint portion 131 can generally have a spiral shape.
[0056] As described above, according to the electrode device 100 of the present invention, the shape of the electrode guide 130 in the wound state can be easily and precisely set by designing the lengths of the plurality of joint portions 131. In addition, good reproducibility of the shape in the wound state can be ensured. Furthermore, by changing the radius of curvature, the electrode guide 130 can completely surround the tube in the body in the wound state, and the nerves around the tube can be denervated or adjusted as a whole only through one operation, thereby improving the surgical efficiency.
[0057] In the above Figures 2 to 6 In the embodiments, it is premised that the angle at which the joint portion 131 is inclined with respect to the adjacent joint portion 131 in the wound state is constant. Specifically, the joint portion 131 can be cross - arranged at an angle of, for example, 30 degrees with respect to the adjacent joint portion 131 in the long - side direction. For this purpose, the surface of the winding support portion 131b of each joint portion 131 can have an inclination angle θ1 and an inclination angle θ2 of, for example, 75 with respect to the long - side direction.
[0058] On the other hand, regarding the electrode guide 130 of the present invention, there can be other embodiments that are premised on the same length of the joint portion 131 and can achieve a wound state with multiple radii of curvature. As described above, in the wound state, during the design of each joint portion 131, the inclination angle between the adjacent joint portions 131 can be determined by the angle at which the surface of the winding support portion 131b is inclined with respect to the long - side direction of the joint portion 131.
[0059] Specifically, the first joint group can include joint portions whose surfaces of the winding support portions have a first angle with respect to the long - side direction, and the second joint group can include joint portions whose surfaces of the winding support portions have a second angle larger than the first angle. Thus, when the first joint group with the first angle has a first radius of curvature in the wound state, the second joint group with the second angle can be set to have a second radius of curvature larger than the first radius of curvature.
[0060] Therefore, even if the lengths of all the joint portions are formed to be the same, different wound states with different radii of curvature can be achieved by designing the winding support portions differently.
[0061] Above, the embodiments in which the joint portion 131 has two joint groups have been described. However, the electrode guide 130 can also be designed to have two or more joint groups with different shapes to design a more delicate winding path.
[0062] Figure 7FIG. is a perspective view showing an electrode guide member 230 according to another embodiment of the present invention. Hereinafter, an embodiment in which the joint portion 231 of the electrode guide member 230 of the present invention is formed integrally will be described.
[0063] The joint portion 231 of the electrode guide member 230 according to another embodiment of the present invention may be made of a material such as an elastically deformable polymer, and may have a structure in which a plurality of joint portions 231 are formed integrally. For example, a living hinge structure.
[0064] As Figure 7 shown, each joint portion 231 may be formed integrally with an adjacent joint portion 231 in the long side direction, and a winding support groove 231b may be formed between the adjacent joint portions 231. In the wound state, at least a part of the groove space of the winding support groove 231b may be reduced or closed.
[0065] Specifically, the winding support groove 231b may be recessed in a wedge shape from the inner side surface (the surface facing the electrode unit 120) of the electrode guide member 230. In the wound state, the wedge-shaped winding support groove 231b may be supported in such a manner that the side surfaces contact each other.
[0066] In addition, the electrode guide member 230 according to other embodiments of the present invention may further include a wire 233. The wire 233 may be formed to penetrate through a plurality of joint portions 231 in sequence. Similar to the above embodiment, compared with the electrode guide member 230, the wire 233 is led out from the shaft 111 at a shorter distance, so that the electrode guide member 230 can be deformed into a shape surrounding the tube, and a force for supporting at least a part of the winding support groove 231b to be closed can be provided.
[0067] The electrode guide member 230 according to another embodiment of the present invention can ensure the driving of the joint portion with reliable operation, and at the same time, the electrode guide member 230 can be integrally formed. Since there is no need for a subsequent assembly process for separately manufactured joint elements, the manufacturing process can be simplified, the product can be miniaturized, and the manufacturing cost can be reduced.
[0068] The above description of the present invention is for illustration purposes. Those of ordinary skill in the art to which the present invention pertains can understand that, without changing the technical idea or essential features of the present invention, it can be easily modified into other specific embodiments. Therefore, it should be understood that the above embodiments are merely exemplary in all aspects and not restrictive.
[0069] In addition, the scope of the present invention will be represented by the following claims rather than the above detailed description, and all modifications or changed embodiments derived from the meaning and scope of the claims and their equivalent concepts should be understood to be included within the scope of the present invention.
Claims
1. An electrode device for denervating or modulating a nerve in the body, characterized in that, Comprising: A main body provided with a shaft; An electrode unit protruding from one end of the shaft and denervating or adjusting at least a part of the nerves of the tube in the body; And An electrode guide member coupled to the electrode unit and bringing the electrode unit into contact with the tube in the body by being deformed into a wound state, wherein the electrode guide member includes: A plurality of joint portions provided spaced apart from the tube and the electrode unit in the body and surrounding the outer circumference of the tube with the electrode unit therebetween in the wound state; and, A wire formed to sequentially penetrate through the plurality of joint portions and guide the plurality of joint portions to be in the wound state.
2. The electrode device according to claim 1, wherein The joint portion includes: A hinge portion formed on one or both sides of the joint portion in the longitudinal direction of connection with an adjacent joint portion; And a winding support portion formed on one or both sides of the joint portion in the longitudinal direction to support the adjacent joint portion in the wound state.
3. The electrode device according to claim 1, characterized in that, The electrode guide member includes: A first joint group including a plurality of joint portions having a first length and forming a first radius of curvature in the longitudinal direction of connection with an adjacent joint portion in the wound state; and A second joint group including a plurality of joint portions having a second length longer than the joint portions of the first joint group and forming a second radius of curvature larger than the first radius of curvature in the longitudinal direction in the wound state.
4. The electrode device according to claim 2, characterized in that, The joint portion includes: A first joint group including a plurality of joint portions that form a first radius of curvature by making the surface of the winding support portion have a first angle with respect to the longitudinal direction in the wound state; and A second joint group including a plurality of joint portions that form a second radius of curvature larger than the first radius of curvature by making the surface of the winding support portion have a second angle larger than the first angle with respect to the longitudinal direction in the wound state.
5. The electrode device according to claim 1, characterized in that, The electrode guide member further includes: A tip joint provided to be coupled to the electrode unit and connected to the shaft through the plurality of joint portions.
6. The electrode device according to claim 5, wherein The wire is coupled to the tip joint and guides the position of the tip joint in the wound state.
7. The electrode device according to claim 2, wherein The joint portion further includes a through hole formed at a position spaced apart from the rotation center of the hinge portion along the longitudinal direction; The wire is inserted into the through hole and provides a force for the winding support portions between adjacent joint portions to support each other.
8. The electrode device according to claim 5, wherein In the wound state, the radius of curvature formed by the plurality of joint portions disposed close to the tip joint is smaller than the radius of curvature formed by the plurality of joint portions disposed close to the shaft.
9. The electrode device according to claim 1, wherein The plurality of joint portions are made of an elastically deformable material and formed integrally, and a winding support groove is formed between the joint portions adjacent to each other of the electrode guide member, wherein at least a part of the winding support groove is deformed in a closed manner in the wound state.
10. The electrode device according to claim 9, wherein the winding support groove is formed to be recessed in a wedge shape on the surface of the electrode guide member facing the electrode unit.
11. The electrode device according to claim 9, wherein the wire provides a force to keep at least a part of the winding support groove in a closed state in the wound state.
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