Electrode device and method for surrounding a tube in a body

Abstract

According to one embodiment of the present invention, an electrode device for surrounding a tube in the body includes: an electrode portion, which surrounds the tube and blocks or regulates nerves of at least a portion of the tube; and a guide portion, which guides the movement of the electrode portion, and the electrode portion may include: a first layer, which is bent so that the electrode portion is wrapped around the tube; a second layer, which is arranged on the first layer and is bent so that the electrode portion is wrapped around the tube in a close manner; an electrode, which is arranged on the second layer and blocks or regulates nerves of at least a portion of the tube by utilizing energy from an energy source generator.

Description

Technical Field

[0001] The present application relates to an electrode device and method for surrounding a tube within a body. Background Art

[0002] A neuroblock is a procedure that damages specific nerves in order to control an abnormally overactive autonomic nervous system. For example, a renal neuroblock can treat high blood pressure and heart disease by damaging the renal sympathetic nerves that go to the kidneys, and a pulmonary neuroblock can treat lung disease by damaging the parasympathetic nerves that go to the lungs.

[0003] Generally, nerves surround the outer wall of tubes such as blood vessels and bronchial tubes, and it may be necessary to measure the signal of the nerve by surrounding the outer wall of the tube as described above, or to transmit electrical stimulation or various energies to the nerve to damage or destroy the nerve. However, when the electrode cannot normally contact the nerve or its surrounding tissue, its efficiency may be hindered. Therefore, the tubes surrounded by the nerves have different diameters, and thus, electrodes of various sizes are required to surround the tubes. For example, when the renal artery is operated on, the diameter of the main renal artery is 5 to 7 mm, and its size varies from person to person, and its size varies according to the location. In addition, there are various anatomical variations of the tubes between different people, and thus there may be branched renal arteries and accessory renal arteries, and their diameters may also be 1 to 2 mm. In addition, when the lungs are subjected to nerve block, the diameter of the bronchus can be expanded to a maximum of 300 to 400 mm during inspiration, and can be reduced to a minimum of 160 to 200 mm during exhalation.

[0004] Therefore, it is inconvenient to replace the electrode with one that matches the size each time depending on the treatment site, and even if the sizes are almost similar, the expected treatment effect may differ significantly depending on the degree of contact. Summary of the invention

[0005] Problems to be solved by the invention

[0006] Therefore, there is a need in the art for a solution that can effectively surround tubes of various diameters with one electrode.

[0007] Solutions for solving problems

[0008] As a technical means for solving the above-mentioned technical problems, an electrode device for surrounding a tube in a body according to an embodiment of the present invention includes: an electrode portion, which surrounds the tube and blocks or regulates nerves of at least a portion of the tube; and a guide portion, which guides the movement of the electrode portion, and the electrode portion may include: a first layer, which is bent so that the electrode portion is wrapped around the tube; a second layer, which is arranged on the first layer and is bent so that the electrode portion is wrapped around the tube in a close manner; an electrode, which is arranged on the second layer and blocks or regulates nerves of at least a portion of the tube by utilizing energy from an energy source generator.

[0009] In addition, according to another embodiment of the present invention, the method of surrounding a tube may include: a step of bending the first layer and wrapping the electrode portion around the tube; a step of bending the second layer and wrapping the electrode portion around the tube in a close fit; and a step of the electrode blocking or regulating nerves of at least a portion of the tube by utilizing energy from an energy source generator.

[0010] It should be added that the above solutions to the problems do not list all the features of the present invention. By referring to the following specific embodiments, the various features, advantages and effects of the present invention can be understood in more detail.

[0011] Effects of the Invention

[0012] According to one embodiment of the present invention, tubes of various diameters in which nerves are distributed can be surrounded in the human body. For tubes of various diameters, only one electrode can be used flexibly without having to replace it with an electrode that matches the size each time. By achieving effective contact between the electrode and the nerve, multiple expected medical purposes can be effectively achieved, such as measuring nerve signals, stimulating nerves, damaging or destroying nerves, etc. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1 is a schematic diagram of an electrode device according to an embodiment of the present invention.

[0014] Figure 2 FIG. 1 is a diagram showing an example of surrounding a renal artery using an electrode device according to an embodiment of the present invention.

[0015] Figure 3 FIG. 1 is a diagram showing a detailed structure of an electrode portion according to an embodiment of the present invention.

[0016] Figure 4 It is a diagram for explaining an operation method of an electrode unit according to an embodiment of the present invention.

[0017] Figure 5 is a diagram showing a detailed structure of an electrode portion according to another embodiment of the present invention.

[0018] Figure 6 and Figure 7 It is a diagram for explaining an operation method of an electrode unit according to another embodiment of the present invention.

[0019] Figure 8 is a flow chart illustrating a method of surrounding a pipe according to another embodiment of the present invention. DETAILED DESCRIPTION

[0020] In the following, in order to enable those skilled in the art to easily implement the present invention, preferred embodiments are described in detail with reference to the accompanying drawings. However, when describing the preferred embodiments of the present invention in detail, if it is considered that the specific description of the relevant well-known functions or structures may unnecessarily obscure the main purpose of the present invention, the detailed description thereof will be omitted. In addition, for parts having similar functions and effects, the same reference numerals are used throughout the drawings.

[0021] It should be added that, throughout the specification, "connection" between a part and another part refers not only to "direct connection", but also to "indirect connection" with other parts between the two. Moreover, when a certain structural element is "included", unless otherwise stated to the contrary, it does not exclude other structural elements, but indicates that other structural elements may also be included.

[0022] This application is derived based on the U.S. patent application US2018 / 0064485 previously applied for by the inventor. When implementing the embodiments of the present invention described later, the contents of the above-mentioned prior application can be cited.

[0023] Figure 1 is a schematic diagram of an electrode device according to an embodiment of the present invention.

[0024] refer to Figure 1 The electrode device 100 according to the embodiment of the present invention may include an electrode portion 110 and a guide portion 120. The electrode device 100 is used to surround tubes 10 of various diameters in a human body.

[0025] In the present application, the tube refers to various tubes such as blood vessels, hepatic arteries, splenic arteries, pulmonary arteries, etc., and nerves thereof.

[0026] The electrode device 100 may further include an in-vivo imaging device such as an endoscope that provides an image of the target vessel surrounded by the electrode device 100. For example, the operator can confirm the damaged or destroyed area through the in-vivo imaging device and monitor the process of the operation in real time through the in-vivo imaging device.

[0027] The electrode part 110 is used to surround the outer wall of a tube in which nerves are distributed in the human body, and when coming out of the guide part 120, it can be wound by itself.

[0028] The electrode part 110 may include a structure in which a first layer, a second layer, and an electrode are laminated from the bottom. The electrode part 110 has a width of 3 mm to 5 mm and a thickness of 0.1 T to 0.2 T.

[0029] The first layer may be formed into a circular shape so that the electrode part 110 surrounds the outer wall of the tube when it is located near the outer wall of the tube. However, this is not necessarily a layer structure formed into a circular shape by a single structure, and may be any structure such as a plurality of connected structures surrounding the outer wall of the tube.

[0030] The second layer adjusts the diameter of the electrode to the same as the diameter of the tube, allowing the electrode to be wrapped more tightly around the tube. Figures 3 to 7 , specifically describing the method of clinging to the tube through the first layer and the second layer.

[0031] For example, the second layer, as a non-conductive insulating material, can be made of an elastic material or an inelastic material that can withstand a temperature above a specified temperature (about 40° C.).

[0032] In addition, the electrodes are used to block (denervation) or modulate (modulation) nerves by surrounding the outer wall of the tube, and can be made of materials that are harmless to the human body and easy to conduct electricity, such as stainless steel, gold, etc. Alternatively, the electrodes can also measure the signals of the nerves of the tube.

[0033] The electrodes can transmit various types of energy from an energy source generator not shown. For example, the energy transmitted by the electrodes can include radio-frequency (RF) energy, electrical energy, laser energy, ultrasonic energy, high-intensity focused ultrasound energy, cryogenic energy, and other thermal energy.

[0034] Here, for example, the energy has a temperature of 50° C. to 60° C. or higher, which is the second phase transition temperature of the first layer.

[0035] According to one embodiment, the electrodes are implemented as a flexible printed circuit board (Flexible PCB, FPCB) for transmitting high-frequency energy, a transducer (Transducer) for transmitting ultrasonic energy, and a metal electrode for transmitting higher high-voltage energy, so that energy for damaging nerves can be transmitted.

[0036] In addition, the electrode unit 110 may further include various sensors required for controlling the operation of the electrode unit 110 .

[0037] The guide portion 120 is used to guide the movement of the electrode portion 110. According to an example, Figure 1 As shown, one end of the electrode part 110 is inserted into the interior of the guide part 120, so that the electrode part 110 only moves forward and backward to prevent the electrode part 110 from being separated from the left and right, that is, it can be guided to move only in a straight line.

[0038] Figure 2 FIG. 1 is a diagram showing an example of surrounding a renal artery using an electrode device according to an embodiment of the present invention.

[0039] Figure 2 In the figure, the green part represents the kidneys and the red part represents the arteries of the human body. Figure 2 An example of using the electrode device according to the embodiment of the present invention to surround the renal artery extending from the aorta is shown.

[0040] Figure 3 FIG. 1 is a diagram showing a detailed structure of an electrode portion according to an embodiment of the present invention.

[0041] like Figure 3 As shown in (a), the electrode portion is formed into a structure in which a first layer 111, a second layer 112 and an electrode 113 are stacked in sequence from the bottom, wherein when the electrode portion 110 surrounds the tube, the first layer 111 is located at the outer contour, and the electrode 113 is close to the outer wall of the tube.

[0042] At least a portion of the first layer 111 may be formed of a one-way shape memory alloy, a two-way shape memory alloy, or an elastomer after spring heat treatment. For example, at least a portion of the first layer 111 may be formed of nickel (Ni), titanium (Ti), chromium (Cr), copper (Cu), iron (Fe), niobium (Nb), carbon (C), cobalt (Co), hydrogen (H 2 ) and oxygen (O 2 ) is formed by at least one of the nickel-titanium alloys (Nitinol).

[0043] Shape memory alloys are alloys that have the property of returning to their original shape before deformation when the deformed metal is heated to a specific temperature or higher.

[0044] For shape memory alloys, when the temperature is high, it exists in the form of a cubic austenite phase, but when the temperature drops, it changes to a tetragonal martensite phase. Thus, the phase transition from austenite to martensite when cooling from a high temperature is called a martensitic phase transition.

[0045] For the martensitic phase transformation, the phase transformation starts at the phase transformation start temperature (Ms) and ends at the phase transformation end temperature (Mf). If an external force is applied in the martensitic state, the shape memory alloy can be deformed without changing the relative positions of atoms, unlike other metals.

[0046] On the contrary, if heated to austenite transformation start temperature (As) or higher in the martensite state, the original shape is restored at austenite transformation finish temperature (Af).

[0047] On the other hand, two-way shape memory alloys not only return to their original shape when heated, but also return to the shape of the martensite phase when cooled, thereby memorizing the shapes of both the high-temperature side and the low-temperature side.

[0048] According to an embodiment of the present invention, the shape memory alloy as at least a part of the first layer 111 can be bent to a first curvature under the condition of being above a first phase transformation temperature (austenite phase transformation start temperature), and can be bent to a second curvature under the condition of being above a second phase transformation temperature (austenite phase transformation end temperature). The first phase transformation temperature can be 35°C to 40°C equivalent to body temperature, and the second phase transformation temperature can be 50°C to 60°C.

[0049] At this time, the first curvature is greater than the diameter of the tube, and the second curvature may be substantially similar to the diameter of the tube. That is, the first curvature is greater than the second curvature.

[0050] In addition, the shape memory alloy as at least a part of the first layer 111 can be developed into a straight line shape under the condition of a third phase transformation temperature (martensitic phase transformation start temperature) or below. The third phase transformation temperature can be 20° C. to 25° C. That is, the electrode portion maintains a straight line shape inside the guide portion.

[0051] According to this structure, when the electrode part 110 is inserted near the renal artery after exiting the guide part, the first layer 111 is heated to the first phase transition temperature by body temperature, so that the electrode part 110 is wound into the first curvature by the first layer 111. At this time, the electrode part 110 does not completely surround the tube.

[0052] Thereafter, as described below, when energy from the electrode is transferred to the first layer 111, the first layer 111 is heated to the second phase transition temperature, whereby the electrode portion 110 is wound into a second curvature through the first layer 111. That is, the second phase transition temperature of the first layer 111 is reached by the energy from the electrode. At this time, the electrode portion 110 can completely surround the tube according to the diameter of the tube. That is, when the diameter of the tube is narrow, the tube can be completely surrounded, but when the diameter is wide, the tube cannot be completely surrounded.

[0053] When the tube is operated, the energy from the electrode is not transmitted to the first layer 111, so that the temperature of the first layer 111 drops to the first phase transition temperature. Thus, the electrode part 110 is deformed from the second curvature to the first curvature through the first layer 111, and the operator can safely remove the electrode part 110 from the tube.

[0054] When all treatments are completed, the electrode unit 110 is removed from the body, and the temperature of the first layer 111 is reduced to the third phase transition temperature. Thus, the electrode unit 110 is spread out in a straight line through the first layer 111 .

[0055] like Figure 3 As shown in (a) and (b), the first layer 111 and the second layer 112 are fixedly connected at only one end, and the adjacent surfaces are not attached to each other. The electrode 113 can be attached to the upper surface of the second layer 112.

[0056] According to an embodiment of the present invention, for the electrode part 110, in a state where the tube is surrounded by the first layer 111, the second layer 112 can be pulled toward the guide part side to match the diameter of the electrode 113 and the tube or adjust the contact force. At this time, if the second layer 112 is pulled toward the guide part side, the diameter of the second layer 112 is adjusted to correspond to the diameter of the tube.

[0057] The electrode 113 may be attached to the upper surface of the second layer 112. The electrode 113 may include two electrodes 113 spaced apart at a prescribed interval and arranged in parallel to form a bipolar structure. Each electrode 113 has a width of 0.5 mm to 1 mm and a thickness of 0.01 T to 0.1 T. In addition, the interval between each electrode 113 may be 1.5 mm to 2 mm.

[0058] By arranging the electrodes 113 in parallel, the current path can be confined between the electrodes 113, thereby completely removing nerves from the tube without damaging organs adjacent to the tube.

[0059] That is, by confining the heat between the electrodes 113, the nerves of the tube can be removed effectively and safely.

[0060] In addition, although Figure 3 Although not shown in the figure, a temperature sensor may be provided between the electrodes 113 on the second layer 112. In addition, a temperature sensor may be provided at a position on the first layer 111 corresponding to the position between the electrodes 113.

[0061] As described above, heat is distributed between the electrodes 113, and the temperature sensor is provided at a position corresponding to the position between the electrodes 113, so that the temperature around the electrodes can be accurately measured.

[0062] Figure 4 It is a diagram for explaining an operation method of an electrode unit according to an embodiment of the present invention.

[0063] First, if Figure 4 As shown in (a), when the electrode portion is inserted near the renal artery and energy from the electrode is transmitted to the first layer, the first layer passes through the first phase transition temperature and reaches the second phase transition temperature, thereby surrounding the outer wall of the tube with the second curvature.

[0064] Afterwards, if Figure 4 As shown in (b), when the second layer is pulled back, the first layer does not move and maintains a circular shape, and one end of the first layer and the second layer are fixedly connected, so the diameter of the second layer is reduced. As a result, the electrode attached to the upper surface of the second layer can be closely attached to the outer wall of the tube in a manner matching the diameter of the tube.

[0065] Figure 5 is a diagram showing a detailed structure of an electrode portion according to another embodiment of the present invention.

[0066] like Figure 5 As shown, the electrode part is formed into a structure in which the first layer 111', the second layer 112' and the electrode 113' are laminated in sequence from the bottom, wherein when the electrode part 110 surrounds the tube, the first layer 111' is located at the outer contour, and the electrode 113' is close to the outer wall of the tube. Figure 5 Although not shown in the figure, various sensors may be provided at any position on the upper part of the second layer 112' or on the electrode 113'.

[0067] In addition, the second layer 112' forms an internal space in which gas or fluid can flow, and one side of the second layer 112' adjacent to the first layer 111' is fixedly attached to the first layer 111', while the other side facing the adjacent side is not fixed. In addition, the electrode 113' can be attached to the other side of the second layer 112'.

[0068] according to Figure 5 The electrode unit 110 of the second embodiment of the present invention shown in FIG. 1 is operated as follows: in a state of surrounding a tube, the volume of the second layer 112' is changed by using gas or fluid, etc., so as to adjust in a manner to match the diameter of the electrode 113' and the tube. For this purpose, the second layer 112' can be formed of a softer and more stretchable material. At this time, when the volume of the second layer 112' is changed, the diameter of the second layer 112' is adjusted to correspond to the diameter of the tube.

[0069] Figure 6 and Figure 7 is a diagram for explaining an operation method of an electrode unit according to another embodiment of the present invention. Figure 6 It is a stereogram. Figure 7 It is a side view.

[0070] First, if Figure 6 (a) and Figure 7 As shown in (a), the first layer 111' is formed into a circular shape so as to surround the outer wall of the tube. Figure 6 (b) and Figure 7As shown in (b), when the internal space of the second layer 112' is filled with gas or fluid to increase the volume, the diameter of the other side of the second layer 112' is reduced. As a result, the electrode 113' attached to the other side of the second layer 112' can be closely attached to the outer wall of the tube in a manner matching the diameter of the tube.

[0071] Figure 8 is a flow chart illustrating a method of surrounding a pipe according to another embodiment of the present invention.

[0072] Reference Figure 8 In step S810, the first layer is bent so that the electrode portion can surround the tube.

[0073] In step S820, the second layer is bent so that the electrode portion can surround the tube in a close contact manner.

[0074] In step S830, the electrode may block nerves in at least a portion of the tube by utilizing energy from the energy source generator.

[0075] The electrode according to the above-described embodiment of the present invention can be used not only for nerve block but also as an electrode surrounding a nerve for measuring a nerve signal.

[0076] The present invention is not limited to the above embodiments and drawings. It is obvious to those skilled in the art that the structural elements according to the present invention can be replaced, deformed and changed without departing from the technical concept of the present invention.

Claims

1. An electrode device, which is an electrode device for surrounding a tube in a body, It is characterized in that include: an electrode portion that surrounds the circumference of the tube and blocks or modulates nerves in at least a portion of the tube; and a guide portion that guides movement of the electrode portion, The electrode portion comprises: a first layer that implements bending so that the electrode portion is wrapped around the tube; A second layer is disposed on the first layer and is bent so that the electrode portion is wrapped around the tube in a close fit; an electrode disposed on the second layer and configured to block or modulate nerves in at least a portion of the tube by utilizing energy from an energy source generator, wherein the first layer and the second layer are fixedly connected at only one end, and adjacent surfaces of the first layer and the second layer are not attached to each other, After the first layer surrounds the periphery of the tube, the second layer is pulled toward the guide portion to adjust the diameter of the second layer to correspond to the diameter of the tube.

2. The electrode device according to claim 1, It is characterized in that At least a portion of the first layer is formed from a shape memory alloy.

3. The electrode device according to claim 2, It is characterized in that The shape memory alloy is bent into a first curvature under a condition above a first phase transition temperature, and is bent into a second curvature under a condition above a second phase transition temperature.

4. The electrode device according to claim 3, It is characterized in that The first layer is heated by body temperature to the first phase transition temperature so as to bend around the tube to the first curvature.

5. The electrode device according to claim 3, It is characterized in that The first layer is heated to the second phase change temperature by energy from the energy source generator to bend to the second curvature around the tube.

6. The electrode device according to claim 3, It is characterized in that The second curvature is smaller than the first curvature.

7. The electrode device according to claim 3, It is characterized in that The first phase transition temperature is 35°C to 40°C, and the second phase transition temperature is 50°C to 60°C.

8. The electrode device according to claim 3, It is characterized in that The shape memory alloy is a bidirectional shape memory alloy.

9. The electrode device according to claim 8, It is characterized in that The bidirectional shape memory alloy is expanded into a straight line shape under the condition below the third phase transition temperature.

10. The electrode device according to claim 9, It is characterized in that The third phase transition temperature is 20°C to 25°C.

11. The electrode device according to claim 1, It is characterized in that The second layer forms an internal space in which gas or fluid can flow, and one surface of the second layer adjacent to the first layer is fixedly attached to the first layer, while the other surface of the second layer facing the one surface is not fixed.

12. The electrode device according to claim 11, It is characterized in that After the first layer surrounds the circumference of the tube, the diameter of the second layer is adjusted to correspond to the diameter of the tube by changing the volume of the second layer.

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