Electrode device

Abstract

An electrode device for denervating or adjusting a nerve in vivo, 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 a nerve of a tube in the body; and an electrode guide that contacts the electrode unit with the tube in the body by being deformed into a wound state, the electrode guide including: a main body portion formed to be spaced apart from the electrode unit and surround the outer periphery of the tube in the wound state; and a coupling portion formed to be connected to an end portion of the main body portion and hold an end portion of the electrode unit.

Description

Technical Field

[0001] The present invention relates to an electrode device for denervating or adjusting nerves in the body. Background Art

[0002] Neurotomy 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 directed towards the kidneys, and pulmonary denervation can treat lung diseases by damaging the parasympathetic nerves directed towards 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 stimulation 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 object of the surgery, is 5 mm to 7 mm, and the accessory renal artery with a diameter of 1 mm to 2 mm can also be the object. 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 assembly 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 nerves, it is necessary to surround the outer wall of the tube with nerves distributed along the circumferential direction, and it is necessary to reliably and quickly perform the operation of setting the assembly with the electrode formed in the middle of the tube into a surrounding state. At the same time, it is necessary to perform this operation while suppressing or minimizing unnecessary energy transfer and contact in the body. Summary of the Invention

[0006] Problems to be Solved by the Invention

[0007] The object of the present invention is to provide an electrode device, including: an electrode structure in contact with the human body; and an electrode guide that combines and operates the electrode structure in a manner that minimizes contact with the electrode structure.

[0008] However, the technical problems to be solved in this embodiment are not limited to the above-mentioned technical problems, and there may be other technical problems.

[0009] Solutions for Solving the Problems

[0010] As a means of solving the above technical problems, an embodiment of the present invention provides an electrode device for denervating or adjusting nerves in the body, including: 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 that deforms into a wound state to bring the electrode unit into contact with the tube in the body. The electrode guide includes: a main body portion formed to be spaced apart from the electrode unit and surround the outer periphery of the tube in the wound state; and a coupling portion formed to be connected to the end portion of the main body portion and hold the end portion of the electrode unit.

[0011] An embodiment of the present invention can provide an electrode device, wherein the coupling portion includes: a first clamping member formed to be fixed to the main body portion; and a second clamping member formed to be combined with the first clamping member with a part of the electrode unit therebetween.

[0012] An embodiment of the present invention can provide an electrode device, wherein any one of the first clamping member and the second clamping member has a protruding portion formed to protrude in one direction, and the other of the first clamping member and the second clamping member has a fastening groove formed to be recessed corresponding to the protruding portion, and a through hole for the protruding portion to pass through is formed in a part of the electrode unit.

[0013] An embodiment of the present invention can provide an electrode device, wherein the electrode unit extends around the second clamping member and is inserted between the first clamping member and the second clamping member.

[0014] An embodiment of the present invention can provide an electrode device, wherein the electrode guide further includes: a connection wire provided to pass through the main body portion and be combined with the second clamping member to guide the main body portion to form a wound state, and the second clamping member has: a wire groove for inserting the connection wire; and a fixing plate provided to close a part of the wire groove to prevent the end portion of the connection wire from disengaging from the wire groove.

[0015] An embodiment of the present invention can provide an electrode device, wherein the electrode unit includes: a base layer; an electrode layer provided on the base layer; and a top layer provided between the electrode layers and partially superimposed on the electrode layer.

[0016] An embodiment of the present invention can provide an electrode device, wherein the coupling portion includes: a first clamping member formed to be fixed to the main body portion; and a second clamping member formed to be combined with the first clamping member with at least one of the base layer and the top layer therebetween.

[0017] An embodiment of the present invention may provide an electrode device, wherein any one of the first clamping member and the second clamping member has a convex portion formed to protrude in one direction, the other of the first clamping member and the second clamping member has a fastening groove formed to be recessed corresponding to the convex portion, and a through hole through which the convex portion passes is formed in at least one of the base layer and the top layer.

[0018] An embodiment of the present invention may provide an electrode device, wherein at least one of the base layer and the top layer extends around a part of the joint portion and is inserted into the inside of the joint portion.

[0019] An embodiment of the present invention may provide an electrode device, wherein the electrode unit further includes a reinforcing layer, a part of which is combined with the base layer, and the other part is inserted and fixed into the inside of the joint portion.

[0020] An embodiment of the present invention may provide an electrode device, wherein at least one of the base layer and the top layer extends around a part of the joint portion and is inserted and fixed into the inside of the joint portion in a direction opposite to the insertion direction of the other part of the joint portion.

[0021] An embodiment of the present invention may provide an electrode device, wherein the electrode unit further includes a sensor portion, which is disposed on the base layer and is used for detecting temperature.

[0022] The above solutions for solving the problems are merely exemplary and should not be construed as limiting the present invention. In addition to the above exemplary embodiments, there may be additional embodiments described in the drawings and the detailed description.

[0023] Advantages of the Invention

[0024] According to any one of the solutions for solving the problems of the present invention, in the wound state, the electrode guide and the electrode unit can be arranged to be spaced apart from each other in most intervals. Thus, surgery can be performed in a state where the space between the electrode unit and the electrode guide is exposed to air or the like, so that the heat generated by the electrode unit can be easily dissipated by convective heat transfer.

[0025] In addition, any one of the solutions for solving the problems of the present invention can not only minimize the bonding (assembly) points of the electrode unit and the electrode guide, but also firmly support the electrode unit through the joint portion of the electrode guide, thereby ensuring durability and reliability. Furthermore, the electrode unit and the electrode guide as described above can be easily assembled.

[0026] In addition, since the electrode guide member that is deformed into a wound state by power and the electrode unit that is in close contact with the tube in the body are provided separately from each other, it is possible to suppress the influence caused by power transmission. For example, vibration or force transmission to the tube in the body can be suppressed. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 is a side view showing an electrode device according to an embodiment of the present invention.

[0028] Figure 2 shows Figure 1 a perspective view of the wound state of the electrode guide member shown in

[0029] Figures 3a to 3c 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.

[0030] Figure 4 shows Figure 2 a perspective view of the main body portion and the coupling portion shown in

[0031] Figure 5 is an exploded perspective view showing an electrode unit and a coupling portion according to an embodiment of the present invention.

[0032] Figure 6 shows Figure 5 a view of a state in which the electrode unit and the coupling portion shown in

[0033] Figure 7 shows Figure 5 a top view of a part of the electrode unit shown in DETAILED DESCRIPTION OF THE EMBODIMENTS

[0034] Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying 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.

[0035] 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 where the two are "electrically connected" through other elements. In addition, when referring to a component "including" a certain component, unless otherwise specified, 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 the existence of one or more other features or quantities, steps, operations, components, parts, or combinations thereof.

[0036] As used in this specification, a "section" includes a unit implemented by hardware, a unit implemented by software, and a unit implemented using both. In addition, one unit may be implemented by two or more pieces of hardware, and two or more units may also be implemented by one unit.

[0037] Some of the operations or functions described in this specification as being performed by a terminal or device may be performed on behalf of the device by a server connected to the device. Similarly, some of the operations or functions described as being performed by a server may be performed on a terminal or device connected to the server.

[0038] Hereinafter, an embodiment of the present invention will be described in detail with reference to the accompanying drawings.

[0039] 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 deforming the electrode guide into a wound state according to an embodiment of the present invention, Figure 4 is showing Figure 2 a perspective view of the main body portion and the coupling portion shown in. In addition, Figure 5 is an exploded perspective view showing an electrode unit and a coupling portion according to an embodiment of the present invention, Figure 6 is showing Figure 5 a view of the state in which the electrode unit and the coupling portion shown in are coupled to each other, Figure 7 is showing Figure 5 a top view of a part of the electrode unit shown in.

[0040] 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 portion 112 formed to be connected to the shaft 111 for a surgeon to hold; a guiding operation portion 113 formed on the grip portion 112 to operate the movement of the electrode guide 130; and an electrode operation portion 114 formed on the grip portion 112 to operate the energy transfer to 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.

[0041] The electrode unit 120 protrudes from one end of the shaft 111 and is configured to denervate or adjust at least a portion of a nerve distributed in tissue containing a tube within the body according to an operation of an operator. For example, the electrode unit 120 can contact the outer periphery of the tube V within the body by surrounding it, thereby delivering electrical stimulation or various energies to the nerve distributed in the tissue V to denervate or adjust at least a portion of the nerve.

[0042] Referring to Figure 2 , the electrode unit 120 may include: a base layer 121, an electrode layer 122, and a sensor unit 123. For the electrode device 100 of the present invention, the electrode surrounds the outer surface of a tube or tubular tissue V within the body and can deliver energy through the electrode. To this end, the electrode unit 120 can be formed as a flexible flexible printed circuit board (FPCB).

[0043] The electrode layer 122 is formed on the base layer 121. In Figure 2 the illustrated embodiment, the electrode layer 122 may be composed of two electrodes extending parallel to each other on the base layer 121. In this embodiment, the base layer 121 and the electrode layer 122 can be formed to extend in the circumferential direction and surround the tube V within the body, etc.

[0044] The electrode layer 122 can 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 the nerve. In addition, the electrode layer 122 can deliver various types of energy generated from an energy source generator. For example, radio-frequency (RF) energy, electrical energy, layer energy, ultrasonic energy, high-intensity focused ultrasound energy, cryogenic energy, and other thermal energies can be used.

[0045] In addition, the electrode unit 120 can be formed as a flexible printed circuit board (Flexible PCB) that delivers high-frequency energy, a transducer that delivers ultrasonic energy, a metal electrode that transmits high-voltage energy, etc., to deliver energy for damaging the nerve.

[0046] In addition, a sensor part 123 may be formed on the base layer 121. In one example, the sensor part 123 may be a thermocouple that measures temperature by contacting a tube V or the like in the body, and when the electrode device 100 according to the present invention performs a nerve resection surgery, the sensor part 123 may monitor the temperature of the surgical site. In another example, the sensor part 123 may also measure the nerve signal of the tube V.

[0047] The electrode lead 130 performs a function of contacting the electrode unit 120 with the tube V in the body. The electrode lead 130 is combined with the electrode unit 120 and deformed into a wound state to contact the electrode unit 120 with the tube V in the body.

[0048] Further references Figures 3a to 3c as well as Figure 4 In order to achieve deformation in the winding state, the electrode guide 130 provided by the present invention is provided with a main body 131 and a joint 132. The main body 131 is 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 .

[0049] 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 main body portions 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 spaced apart from the outer peripheral surface of the tube V, 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.

[0050] According to an embodiment of the present invention, the main body 131 may include a first main body group 131x and a second main body group 131y. Figures 3a to 4 In the embodiment, the first body group 131x may have a first length in the long side direction, and the second body group 131y may have a second length longer than the first length. In this embodiment, the first body group 131x and the second body group 131y may respectively include joints with different lengths, for example, 6 joints.

[0051] By the length difference as described above, in the rolled state, the first body group 131x can form a first curvature radius, and the second body group 131y can form a second curvature radius larger than the first curvature radius. Figure 3cIt is confirmed that a joint with a relatively short length (the first body group 131x) can form a small radius of curvature, while a joint with a long length (the second body group 131y) can form a large radius of curvature.

[0052] More specifically, the first body group 131x that forms the first radius of curvature can be disposed on the side closer to the joint 132, and the second body group 131y that forms the second radius of curvature can be disposed on the side closer to the shaft 111.

[0053] In the wound state, when the body part 131 located on the side closer to the joint 132 forms a smaller radius of curvature, as Figure 3c shown, a path for the joint 132 to enter can be formed between the tube V and the shaft 111 in the body. For example, the electrode guide 130 including the body part 131 can have a helical shape as a whole.

[0054] Hereinafter, further reference will be made to Figure 5 and Figure 6 to describe the joint 132. The joint 132 is connected to the end part of the body part 131 and is used to fix the end part of the electrode unit 120. In order to fix or support the end part of the electrode unit 120, the joint 132 may include a first clamping member 132a and a second clamping member 132b. Referring to Figure 5 , the first clamping member 132a can be formed to be fixed to the body part 131, and the second clamping member 132b can be disposed across the first clamping member 132a and a part of the electrode unit 120 and be combined with the first clamping member 132a. For example, the first clamping member 132a can be disposed at the position of the body part 131 close to the electrode guide 130, and the second clamping member 132b can be disposed at the position close to the electrode unit 120.

[0055] Hereinafter, by carefully observing the joint structure between the first clamping member 132a and the second clamping member 132b, it can be seen that according to an embodiment of the present invention, any one of the first clamping member 132a and the second clamping member 132b can have a protruding portion 132a1 formed by protruding along one direction, and the other of the first clamping member 132a and the second clamping member 132b can have a fastening groove 132b1 recessed corresponding to the protruding portion 132a1. For example, as Figure 5 shown, when the protruding portion 132a1 is provided on the first clamping member 132a, the fastening groove 132b1 can be provided on the second clamping member 132b; conversely, when the protruding portion is provided on the second clamping member 132b, the fastening groove can be provided on the second clamping member 132b.

[0056] The protrusion 132a1 provided on the first clamping member 132a can penetrate through the electrode unit 120 and be combined with the fastening groove 132b1 provided on the second clamping member 132b for fastening.

[0057] In addition, a through-hole 120a through which the protrusion 132a1 passes can be formed in a part of the electrode unit 120. Refer to Figure 5 , the through-hole 120a can be formed at the end of the electrode unit 120 and can be formed between the first clamping member 132a and the second clamping member 132b. For example, the through-hole 120a formed in a part of the electrode unit 120 can allow the protrusion 132a1 provided on the first clamping member 132a to pass through.

[0058] The electrode unit 120 according to an embodiment of the present invention can extend around the second clamping member 132b and be inserted between the first clamping member 132a and the second clamping member 132b.

[0059] In addition, refer to Figures 3a to 5 , the electrode guide 130 according to an embodiment of the present invention may further include a connection wire 133, which is provided to pass through the main body portion 131 and be combined with the second clamping member 132b to guide the main body portion 131 to form a wound state. For example, in Figure 5 's embodiment, the connection wire 133 can be formed to sequentially pass through the main body portion 131. The connection wire 133 can guide the electrode guide 130 to be deformed into a shape surrounding the tube V in the body.

[0060] Refer to Figure 5 , the second clamping member 132b can have: a wire groove 132b2 for inserting the end of the connection wire 133; and a fixing plate 132b3 provided to close a part of the wire groove 132b2 to prevent the end of the connection wire 133 from disengaging from the wire groove 132b2.

[0061] For example, the wire groove 132b2 can be formed to accommodate the end of the connection wire 133 between a plurality of fastening grooves 132b1 provided in the second clamping member 132b. Refer to Figure 5 and Figure 6 , the diameter of the end of the connection wire 133 inserted into the wire groove 132b2 is larger than the diameter of the wire 133 or the shape is different from that of the wire 133, so that it can be stuck on the fixing plate 132b3 and fixed in the wire groove 132b2 without disengaging.

[0062] Refer to Figure 7 , the electrode unit 120 according to an embodiment of the present invention may include: a base layer 121, an electrode layer 122, and a top layer 124. In Figure 7In an embodiment, the electrode unit 120 may include: a base layer 121; an electrode layer 122 disposed on the base layer 121; and a top layer 124 disposed between the electrode layers 122 and partially overlapping with the electrode layer 122. Additionally, the sensor unit 123 may be a thermocouple made of a first metal 123a and a second metal 123b. For example, it may be made of a pair of copper and constantan.

[0063] According to an embodiment of the present invention, the electrode unit 120 may further include a reinforcing layer 125 formed such that a part thereof is combined with the base layer 121 and another part is inserted and fixed inside the joint portion 132. Figure 5 In an embodiment, the reinforcing layer 125 may also have a through-hole 120a.

[0064] At least one of the base layer 121 and the top layer 124 extends in a manner surrounding a part of the joint portion 132 (e.g., the second clamping member 132b) and is inserted and fixed inside the joint portion 132 in the opposite direction of the direction in which another part of the reinforcing layer 125 is inserted ( Figure 5 and Figure 6 in, from top to bottom) ( Figure 5 and Figure 6 in, from bottom to top). Thus, the electrode unit 120 can be combined in a manner surrounding a part of the joint portion 132 (e.g., the second clamping member 132b) in two directions.

[0065] According to the electrode device 100 of the present invention, in the wound state, that is, in the state of being located during surgery, the electrode guide 130 and the electrode unit 120 are disposed at intervals in an interval excluding most of the joint portion 132. That is, since the space between the electrode unit 120 and the electrode guide 130 is exposed to the environment such as air, the heat generated by the electrode unit 120 during energy transfer can be easily dissipated by convective heat transfer.

[0066] In addition, according to the electrode device 100 of the present invention, not only can the bonding (assembly) points of the electrode unit 120 and the electrode guide 130 be minimized, but also the electrode unit 120 can be firmly supported by the joint portion 132 of the electrode guide 130. Therefore, the durability and reliability of the device can be ensured, and it has the advantage of being easy to assemble the electrode unit 120 and the electrode guide 130.

[0067] In addition, since the electrode guide 130 deformed into the wound state by power and the electrode unit 120 in close contact with the tube V in the body are separately provided from each other, the influence caused by power transfer during the operation of the device can be suppressed. For example, the influence caused by the transfer of physical energy such as vibration or force to the tube in the body.

[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 implementation manners. Therefore, it should be understood that the above embodiments are merely exemplary in all aspects and not restrictive. For example, each component described as a single type can be implemented in a dispersed form, and similarly, components described as distributed can be implemented in a combined form.

[0069] The scope of the present invention is represented by the claims hereinafter rather than the above detailed description. All modifications or changed implementation manners 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 that contacts the electrode unit with the tube in the body by deforming into a wound state, wherein the electrode guide includes: a main body portion formed to be spaced apart from the electrode unit and surround the outer periphery of the tube in the wound state; and A coupling portion formed to be connected to the end portion of the main body portion and fix the end portion of the electrode unit, The electrode unit includes: A base layer; An electrode layer provided on the base layer; and A top layer provided between the electrode layers and partially superimposed on the electrode layers, At least one of the base layer and the top layer extends around a part of the coupling portion and is inserted into the interior of the coupling portion.

2. The electrode device according to claim 1, characterized in that The coupling portion includes: a first clamping member formed to be fixed to the main body portion; and A second clamping member formed to be combined with the first clamping member with a part of the electrode unit therebetween.

3. The electrode device according to claim 2, characterized in that Any one of the first clamping member and the second clamping member has a protruding portion formed to protrude in one direction, The other of the first clamping member and the second clamping member has a fastening groove formed to be recessed corresponding to the protruding portion, A through hole for the protruding portion to pass through is formed in a part of the electrode unit.

4. The electrode device according to claim 2, characterized in that The electrode unit extends around the second clamping member and is inserted between the first clamping member and the second clamping member.

5. The electrode device according to claim 2, characterized in that The electrode guide further includes: a connection wire provided to penetrate the main body portion and combined with the second clamping member to guide the main body portion to form a wound state, The second clamping member has: A wire groove for inserting the end portion of the connection wire; and A fixing plate provided to close a part of the wire groove to prevent the end portion of the connection wire from detaching from the wire groove.

6. The electrode device according to claim 1, characterized in that The coupling portion includes: A first clamping member formed to be fixed to the main body portion; and A second clamping member formed to be combined with the first clamping member with at least one of the base layer and the top layer therebetween.

7. The electrode device according to claim 6, characterized in that Any one of the first clamping member and the second clamping member has a protruding portion formed to protrude in one direction, The other of the first clamping member and the second clamping member has a fastening groove formed to be recessed corresponding to the protruding portion, and A through hole for the protruding portion to pass through is formed in at least one of the base layer and the top layer.

8. The electrode device according to claim 1, characterized in that The electrode unit further includes a reinforcing layer, a part of the reinforcing layer is combined with the base layer, and the other part is inserted and fixed into the interior of the coupling portion.

9. The electrode device according to claim 8, characterized in that at least one of the base layer and the top layer extends in a manner surrounding a part of the joint portion, and is inserted and fixed into the interior of the joint portion in a direction opposite to the insertion direction of the other part of the joint portion.

10. The electrode device according to claim 1, characterized in that the electrode unit further includes a sensor portion, which is disposed on the base layer and is used for detecting temperature.

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