Patent Publication Number: US-2023157747-A1

Title: Electrode apparatus for nerve denervation or modulation in body

Description:
TECHNICAL FIELD 
     The present disclosure relates to an electrode apparatus for nerve denervation or modulation in body. 
     BACKGROUND 
     A denervation is a surgical procedure intended to control an abnormally overactive autonomic nervous system by damaging specific nerves. For example, a renal denervation can treat hypertension and heart diseases by damaging renal sympathetic nerves directed to the kidney, and a pulmonary denervation can treat lung diseases by damaging parasympathetic nerves directed to the lung. 
     Nerves usually enclose the outer walls of tubes, such as blood vessels, bronchial tubes, etc., and it may be necessary to enclose the outer walls of tubes to measure signals from the nerves or transmit electrical impulses or various energies to the nerves to damage or destroy the nerves. For example, when a surgical procedure is performed on the renal artery, the main renal artery which is a procedure target has a diameter of from 5 mm to 7 mm, and the accessory renal artery having a diameter of from 1 mm to 2 mm may also be a procedure target. Also, the artery with distributed nerves varies in size from person to person and has different sizes depending on the location. 
     When the surgical procedure is performed as described above, it is important to delicately locate a component including an electrode to be formed at the end of a catheter so as to enclose the outer wall of the artery. Specifically, in order to effectively denervate or modulate the nerves, the component needs to enclose the outer wall of the artery with distributed nerves in a circumferential direction. Also, it is necessary to reliably and rapidly enclose the artery with the component including the electrode. 
     DISCLOSURE OF THE INVENTION 
     Problems to Be Solved by the Invention 
     The present disclosure is conceived to provide an electrode device having a component that guides an electrode to be disposed around a tube in the body as a plurality of unit elements are connected to each other and deformed. 
     Also, the present disclosure is conceived to provide an electrode device having a configuration in which a plurality of unit elements are connected and deformed so that an electrode completely surrounds the circumference of a tube in the body. 
     Further, the present disclosure is conceived to provide an electrode apparatus in which a component connected to a plurality of unit elements and configured to guide an electrode is manufactured as a single member without assembly. 
     The problems to be solved by the present disclosure are not limited to the above-described problems. There may be other problems to be solved by the present disclosure. 
     Means for Solving the Problems 
     According to an aspect of the present disclosure, An electrode apparatus for nerve denervation or modulation in body includes a main body including a shaft; an electrode unit formed to be drawn out from one end of the shaft and configured to denervate or modulate at least part of nerves on a tube in the body; and an electrode guide coupled to the electrode unit and deformed into a wound state to bring the electrode unit into contact with the tube in the body. The electrode guide includes a plurality of joint units disposed to enclose the circumference of the tube with the electrode unit interposed therebetween in the wound state. 
     According to the present disclosure, each joint unit includes a hinge unit formed on one or both sides of the joint unit in a longitudinal direction to be connected to an adjacent joint unit; and a winding support unit formed on one or both sides of the joint unit in the longitudinal direction to support the adjacent joint unit in the wound state. 
     According to the present disclosure, the electrode guide further includes a tip joint coupled to the electrode unit and connected to the shaft by the plurality of joint units, and in the wound state, a radius of curvature formed by a plurality of joint units located close to the tip joint is smaller than a radius of curvature formed by a plurality of joint units located close to the shaft. 
     According to the present disclosure, the plurality of joint units is made of an elastically deformable material and formed as one body, and a winding support groove of which at least a part of a space is deformed to be closed in the wound state is formed between adjacent joint units of the electrode guide. 
     The above-described aspects are provided by way of illustration only and should not be construed as liming the present disclosure. Besides the above-described embodiments, there may be additional embodiments described in the accompanying drawings and the detailed description. 
     Effects of the Invention 
     According to an electrode apparatus of the present disclosure, joint units are driven to deform an electrode guide into a wound state in order to bring an electrode into close contact with an outer surface of a tube and efficiently transfer energy. Therefore, it is possible to reliably control the location of an electrode unit. 
     Further, according to the electrode apparatus of the present disclosure, joint units are formed to have different lengths or shapes, and, thus, the shape of the electrode guide in the wound state can be precisely designed and the electrode guide can be located to completely enclose the tube in the body. Accordingly, a surgical procedure for denervating or modulating nerves can be effectively performed. 
     Meanwhile, according to the electrode apparatus of the present disclosure, the electrode guide including the plurality of joint units as one body is formed while implementing driving of the plurality of joint units. Thus, the electrode apparatus can be manufactured through a simple process and produced in a small size, which results in a reduction in manufacturing cost. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1    is a side view of an electrode apparatus according to an embodiment of the present disclosure. 
         FIG.  2    is a perspective view illustrating a wound state of an electrode guide illustrated in  FIG.  1   . 
         FIGS.  3 A through  3 C  illustrate a process of deforming the electrode guide into a wound state according to an embodiment of the present disclosure. 
         FIG.  4    is a perspective view illustrating joint units and a tip joint illustrated in  FIG.  2   . 
         FIG.  5    is an exploded perspective view illustrating a portion of the joint units illustrated in  FIG.  4   . 
         FIG.  6    is a side view illustrating a portion of the joint units illustrated in  FIG.  4   . 
         FIG.  7    is a perspective view of an electrode guide according to another embodiment of the present disclosure. 
     
    
    
     BEST MODE FOR CARRYING OUT THE INVENTION 
     Hereafter, example embodiments will be described in detail with reference to the accompanying drawings so that the present disclosure may be readily implemented by those skilled in the art. However, it is to be noted that the present disclosure is not limited to the example embodiments but can be embodied in various other ways. In the drawings, parts irrelevant to the description are omitted for the simplicity of explanation, and like reference numerals denote like parts through the whole document. 
     Through the whole document, the term “connected to” or “coupled to” that is used to designate a connection or coupling of one element to another element includes both a case that an element is “directly connected or coupled to” another element and a case that an element is “electronically connected or coupled to” another element via still another element. Further, it is to be understood that the term “comprises or includes” and/or “comprising or including” used in the document means that one or more other components, steps, operation and/or existence or addition of elements are not excluded in addition to the described components, steps, operation and/or elements unless context dictates otherwise and is not intended to preclude the possibility that one or more other features, numbers, steps, operations, components, parts, or combinations thereof may exist or may be added. Through the whole document, the term “on” that is used to designate a position of one element with respect to another element includes both a case that the one element is adjacent to the other element and a case that any other element exists between these two elements. 
       FIG.  1    is a side view of an electrode apparatus according to an embodiment of the present disclosure and  FIG.  2    is a perspective view illustrating a wound state of an electrode guide illustrated in  FIG.  1   .  FIG.  3 A  through  FIG.  3 C  illustrate a process of deforming the electrode guide into a wound state according to an embodiment of the present disclosure. Further,  FIG.  4    is a perspective view illustrating joint units and a tip joint illustrated in  FIG.  2   ,  FIG.  5    is an exploded perspective view illustrating a portion of the joint units illustrated in  FIG.  4    and  FIG.  6    is a side view illustrating a portion of the joint units illustrated in  FIG.  4   . 
     Referring to  FIG.  1   , an electrode apparatus  100  according to an embodiment of the present disclosure includes a main body  110 , an electrode unit  120  and an electrode guide  130 . 
     The main body  110  may include the shaft  111  extending in one direction, a grip portion  112  connected to the shaft  111  so as to be gripped by an operator, a guide manipulation unit  113  formed on the grip portion  112  so as to manipulate an operation of the electrode guide  130 , and an electrode manipulation unit  114  formed on the grip portion  112  so as to manipulate an operation of the electrode unit  120 . The components for driving and controlling the electrode unit  120  and the electrode guide  130  may be located inside the main body  110 . 
     The electrode unit  120  is formed to be drawn out from one end of the shaft  111  and configured to denervate or modulate at least part of nerves distributed on a tissue in the body including a tube depending on manipulation by the operator. 
     Referring to  FIG.  2   , the electrode unit  120  may include a substrate portion  121 , an electrode unit  122  and a sensor unit  123 . In the electrode apparatus  100  according to the present disclosure, an electrode encloses an outer surface of a tube or tube-shaped tissue V in the body and energy can be transferred through the electrode. To this end, the substrate portion  121  may be formed as a flexible printed circuit board (FPCB). 
     The electrode unit  122  is formed on the substrate portion  121 , and in the embodiment illustrated in  FIG.  2   , the electrode unit  122  may be composed of two electrodes extending parallel to each other on the substrate portion  121 . In the present embodiment, the substrate portion  121  and the electrode unit  122  may be configured to extend in a circumferential direction and enclose the tube in the body or the like. 
     The electrode unit  122  may be made of a material such as stainless steel or gold, which is harmless to the human body and conducts electricity well, in order to block or denervate or control or modulate the nerves. Also, the electrode unit  122  may transfer various types of energy from an energy source generator. For example, the energy may include radio-frequency (RF) energy, electrical energy, laser energy, ultrasonic energy, high-intensity focused ultrasound energy, cryogenic energy and other heat energy. 
     Also, the electrode unit  122  may be implemented as a flexible PCB for transferring RF energy, a transducer for transferring ultrasonic energy or a metal electrode for transferring high-voltage energy and thus may transfer energy to damage the nerves. 
     Further, the sensor unit  123  may be formed on the substrate portion  121 . For example, the sensor unit  123  may be a thermocouple that measures a temperature by contacting with the tube in the body or the like, and when neurotomy is performed with the electrode apparatus  100  according to the present disclosure, the sensor unit  123  may monitor a temperature of a treatment site. As another example, the sensor unit  123  may measure signals from the nerves on the tube. 
     The electrode guide  130  functions to bring the electrode unit  120  into contact with the tube in the body. The electrode guide  130  is coupled to the electrode unit  120  and deformed into a wound state to bring the electrode unit  120  into contact with the tube in the body. 
     Referring to  FIG.  3 A  through  FIG.  3 C  and  FIG.  4   , the electrode guide  130  of the present disclosure includes a plurality of joint units  131  in order to be deformed into the wound state. In the wound state, the plurality of joint units  131  is disposed to enclose the circumference of the tube V in the body with the electrode unit  120  interposed therebetween. For example, the state illustrated in  FIG.  2    and  FIG.  3 C  may be the wound state. 
     According to the electrode apparatus  100  of the present disclosure, the joint units  131  may be driven to deform the electrode guide  130  into the wound state in order to bring the electrode unit  122  into close contact with the outer surface of the tube in the body and efficiently transfer energy. Such a joint driving mechanism makes it possible to control an operation timing and the shape of the electrode guide  130  directly and improve the reliability of repetitive operation, as compared to a conventional shape memory material mechanism. Therefore, it is possible to perform a customized and detailed surgical procedure using the electrode apparatus  100  of the present disclosure. 
     According to an embodiment of the present disclosure, the electrode guide  130  is accommodated together with the electrode unit  120  inside the shaft  111  and may protrude from one end in a forward direction F while being deformed into the wound state at the time of surgical procedure. As illustrated in  FIG.  3 A  through  FIG.  3 C , when the plurality of joint units  131  is sequentially drawn out, the plurality of joint units  131  may move toward one direction and thus may overall enclose the tube V in the wound state. In the wound state, the electrode guide  130  is spaced apart from an outer circumferential surface of the tube and the electrode unit  120  located inside the wound electrode guide  130  may be in close contact with the outer circumferential surface of the tube V. 
     Hereafter, the detailed configuration of the electrode unit  130  and the joint units  131  will be described with further reference to  FIG.  5    and  FIG.  6   . 
     The electrode guide  130  may further include a tip joint  132  and a wire  133 . The tip joint  132  may be connected to the shaft  111  by the plurality of joint units  131  and coupled to the electrode unit  120 . As illustrated in  FIG.  3 C , the tip joint  132  may be located close to the tube V in the body in the wound state and may have a shape that gradually decreases in width or thickness toward the end in order to suppress interference with the electrode unit  120  or maximize the surface enclosing the tube in the body. The end of the electrode unit  120  may be fastened and fixed to the tip joint  132 . 
     The wire  133  may be formed to sequentially penetrate the plurality of joint units  131 . Referring to  FIG.  5   , each joint unit  131  may have a through-hole  131   c  in a longitudinal direction to allow penetration of the wire  133 . The end of the wire  133  sequentially penetrating the through-holes  131   c  may be coupled and fixed to the tip joint  132 , and the wire  133  can slide with respect to each joint unit  131  in the through-hole  131   c  in the longitudinal direction. Therefore, the wire  133  can guide the plurality of joint units  131  and the tip joint  132  to be in the wound state and support the tip joint  132  and the plurality of joint units  131  in the wound state. 
     Meanwhile, each join unit  131  may include hinge units  131   a  and winding support units  131   b . The hinge units  131   a  are configured for rotatable connection to adjacent joints and may be formed on one or both sides of the joint unit  131  in the longitudinal direction in which the joint units  131  are connected parallel to each other. As illustrated in  FIG.  5   , the hinge unit  131   a  may have a rotation axis in a direction intersecting the longitudinal direction so as to be connected to the hinge unit  131   a  of the adjacent joint unit  131 . A hinge pin (not illustrated) may be inserted into and fastened to each hinge unit  131   a  in the direction of the rotation axis. 
     The winding support units  131   b  are configured to maintain the wound state and may be formed on one or both sides of the joint unit  131  in the longitudinal direction to support the adjacent joint unit  131 . As illustrated in  FIG.  5   , the winding support unit  131   b  may be located adjacent to the hinge unit  131   a  in an inward direction of the electrode guide  130  (in a direction of winding the joint unit  131 ). For example, the winding support unit  131   b  may be formed as a surface having a predetermined angle and area and supported by the adjacent winding support unit  131   b  in surface contact with each other in the wound state, and, thus, a wound shape of the electrode guide  130  can be maintained. 
     In the embodiment illustrated in  FIG.  3 A  and  FIG.  3 C , when the wire  133  is pulled backwards relative to the electrode guide  130  (when a length of the wire  133  drawn out from the shaft  111  is smaller than that of the electrode guide  130 ), a tensile force may be applied to the wire  133  in a direction of winding the electrode guide  130 . On the other hand, the winding support units  131   b  may provide a force of supporting the joint units  131  to each other in a direction of suppressing winding of the electrode guide  130 . That is, since the wire  133  and the winding support units  131   b  form a balanced force in opposite directions, the electrode guide  130  can be fixed in the wound state. 
     More specifically, the through-hole  131   c  may be formed at a location spaced apart from a rotation center of the hinge unit  131   a  in an inward direction (in an upward direction in  FIG.  6   ). When the wire  133  of which the end is fixed to the tip joint  132  is pulled relatively backwards (toward a right direction in  FIG.  6   ), the plurality of joint units  131  may be bent overall in an inward direction. When the joint unit  131  is rotated around the hinge unit  131   a  with respect to the adjacent joint unit  131  and the winding support units  131   b  are in contact with each other, the locations of the plurality of joint units  131  may be fixed and the plurality of joint units  131  may be in the wound state. Here, the wire  133  may provide a force (tensile force) of supporting the winding support units  131   b  to each other. 
     As described above, a change in location in the wound state is suppressed by the wire  133  and the winding support units  131   b , and, thus, the electrode guide  130  of the electrode apparatus  100  according to the present disclosure can maintain its location during a surgical procedure. 
     Hereafter, an embodiment where the shape of the electrode guide  130  can be set in the wound state due to a difference in shape between the joint units  131  will be described. 
     According to an embodiment of the present disclosure, the electrode guide  130  may include a first joint group  131   x  and a second joint group  131   y . That is, the plurality of joint units  131  may be divided into the first joint group  131   x  and the second joint group  131   y  having different shapes. 
     In the embodiment illustrated in  FIG.  2    through  FIG.  6   , the first joint group  131   x  may include joint units  131  each having a first length L1 in the longitudinal direction, and the second joint group  131   y  may include joint units  131  each having a second length L2 greater than the first length L1. In the present embodiment, each of the first joint group  131   x  and the second joint group  131   y  may include, for example, six joint units  131  each having the same length. 
     Due to such a difference in length, the first joint group  131   x  may form a first radius of curvature and the second joint group  131   y  may form a second radius of curvature greater than the first radius of curvature in the wound state. As can be seen from  FIG.  3 C , the joint units (the first joint group  131   x ) having a relatively small length may form a smaller radius of curvature and the joint units (the second joint group  131   y ) having a relatively great length may form a greater radius of curvature. 
     More specifically, the first joint group  131   x  forming the first radius of curvature may be located close to the tip joint  132 , and the second joint group  131   y  forming the second radius of curvature may be located close to the shaft  111 . 
     When the joint units  131  located close to the tip joint  132  form a smaller radius of curvature in the wound state, a path along which the tip joint  132  enters a space between the tube in the body and the shaft  111  may be formed as shown in  FIG.  3 C . For example, the electrode guide  130  including the joint units  131  may have an overall spiral shape. 
     As described above, in the electrode apparatus  100  according to the present disclosure, 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 units  131 . Also, it is possible to secure excellent repeatability in the shape in the wound state. Further, the electrode guide  130  can be located to fully enclose the tube in the body in the wound state by varying the radius of curvature. Therefore, it is possible to generally denervate or modulate the nerves around the tube in a one-time surgical procedure and thus possible to increase the treatment effect. 
     In the embodiment illustrated in  FIG.  2    through  FIG.  6   , it is assumed that all of the joint units  131  have a uniform tilt angle with respect to the adjacent joint units  131 . Specifically, each joint unit  131  may be disposed in the longitudinal direction to intersect the adjacent joint unit  131  at a tilt angle of, for example, 30°. To this end, the respective surfaces of the winding support units  131   b  of the joint units  131  may have tilt angles θ1 and θ2 of, for example, 75° with respect to the longitudinal direction. 
     In another embodiment of the electrode guide  130  of the present disclosure, the joint units  131  having the same length may have a plurality of radiuses of curvature in the wound state. As described above, a tilt angle between the adjacent joint units  131  in the wound state may be determined by tilt angles of the surfaces of the winding support units  131   b  with respect to the longitudinal direction of the joint units  131  when the joint units  131  are designed. 
     Specifically, a first joint group may include joint units in which surfaces of winding support units have a first angle with respect to the longitudinal direction, and a second joint group may include joint units in which surfaces of winding support units have a second angle greater than the first angle. Thus, when the first joint group having the first angle has a first radius of curvature in the wound state, the second joint group having the second angle may be disposed to have a second radius of curvature greater than the first radius of curvature. 
     Therefore, even if all of the joint units have the same length, it is possible to implement a wound state where the joint units have different radiuses of curvature by designing the winding support units differently from each other. 
     Although the embodiment where the joint units  131  include two joint groups has been described above, it is also possible to more delicately design a winding path by designing the electrode guide  130  to include two or more joint groups having different shapes. 
       FIG.  7    is a perspective view of an electrode guide  230  according to another embodiment of the present disclosure. Hereafter, an embodiment where joint units  231  of the electrode guide  230  of the present disclosure are formed as one body will be described. 
     The joint units  231  of the electrode guide  230  according to another embodiment of the present disclosure may be made of a material such as elastically deformable polymer, and a plurality of joint units  231  may be formed as one body, for example, a living hinge structure. 
     As illustrated in  FIG.  7   , each joint unit  231  may be formed as one body with another joint unit  231  adjacent to each other in the longitudinal direction, and a winding support groove  231   b  may be formed between the adjacent joint units  231 . At least a part of a space in the winding support groove  231   b  may be reduced or closed in the wound state. 
     Specifically, the winding support groove  231   b  may be formed to be recessed in a wedge shape in the electrode guide  230 ’ s  inner surface (a surface facing the electrode unit  120 ). In the wound state, side surfaces of the wedge-shaped winding support grooves  231   b  may be in contact with each other and may be supported by each other. 
     The electrode guide  230  according to another embodiment of the present disclosure may further include a wire  233 . The wire  233  may be formed to sequentially penetrate the plurality of joint units  231 . As in the above-described embodiment, a length of the wire  233  drawn out from the shaft  111  is smaller than that of the electrode guide  230 , and, thus, the wire  233  can guide the electrode guide  230  to be deformed into a shape enclosing the tube and provide a force of closing and supporting at least part of the winding support grooves  231   b . 
     The electrode guide  230  according to another embodiment of the present disclosure can be manufactured as one body while implementing a reliable operation of the joint units. Since it is not necessary to assemble separately manufactured joint elements, the electrode guide  230  can be manufactured through a simple process and produced in a small size, which results in a reduction in manufacturing cost. 
     The above description of the present disclosure is provided for the purpose of illustration, and it would be understood by a person with ordinary skill in the art that various changes and modifications may be made without changing technical conception and essential features of the present disclosure. Thus, it is clear that the above-described embodiments are illustrative in all aspects and do not limit the present disclosure. 
     The scope of the present disclosure is defined by the following claims rather than by the detailed description of the embodiment. It shall be understood that all modifications and embodiments conceived from the meaning and scope of the claims and their equivalents are included in the scope of the present disclosure.