Electrode device for blocking or modulating nerves in the body

Abstract

An electrode device for blocking or regulating nerves in the body, comprising: a main body with a shaft; an electrode unit formed to protrude from one end of the shaft and configured to block or regulate at least some of the nerves in the internal vessel, the electrode unit including a base layer and an electrode layer disposed on the base layer, the electrode unit including a first electrode disposed along the length of one side of the base layer and a second electrode disposed along the length of the other side of the base layer; a current sensor unit formed in an area between the first electrode and the second electrode and configured to measure a current generated from the first electrode or the second electrode; a plurality of temperature sensors disposed at predetermined intervals between the first electrode and the second electrode and configured to sense temperature; and a control unit that calculates resistance based on the current measured by the current sensor unit and calculates the diameter of the internal vessel based on the calculated resistance.

Description

[Technical Field]

[0001] The present invention relates to an electrode device for blocking or modulating nerves in the body. [Background technology]

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

[0003] Nerves are typically wrapped around the outer walls of vessels such as blood vessels, bronchi, etc., and it may be necessary to wrap around the outer walls of such vessels to measure nerve signals, deliver electrical stimuli to the nerve, or deliver various energies to damage or destroy the nerve.

[0004] For example, when performing surgery on the renal artery, the diameter of the main renal artery is 5 to 7 mm, and the accessory renal artery, which is 1 to 2 mm in diameter, may also be targeted. Furthermore, the size of the vessels that carry nerves varies from person to person, and the size changes depending on the location.

[0005] In performing such treatments, it is important to precisely position the component including the electrodes formed at the distal end of the catheter so that it can be wrapped around the outer wall of the vessel. Specifically, in order to effectively block or modulate nerves, the component must be wrapped circumferentially around the outer wall of the vessel through which the nerve is distributed, and the operation of wrapping the component with the electrodes around the vessel must be performed reliably and quickly. In particular, it is important to safely and closely attach the component with the electrodes to the outer wall of the vessel inside the body so as not to damage the vessel, which is easily damaged by external stimuli. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] Korean Patent Publication No. 2013-0108401 (Published on October 2, 2013) Summary of the Invention [Problem to be solved by the invention]

[0007] SUMMARY OF THE INVENTION One object of the present invention is to solve the above-mentioned problems of the prior art and to provide an electrode device that can grasp the diameter of a vessel inside the body and perform nerve blockade based on the diameter of the vessel inside the body.

[0008] However, the technical problems that this embodiment aims to solve are not limited to the above-mentioned technical problems, and other technical problems may exist. [Means for solving the problem]

[0009] As a technical means for solving the above-mentioned technical problems, one embodiment of the present invention may provide an electrode device for blocking or regulating nerves in a body, comprising: a main body with a shaft; an electrode unit formed to protrude from one end of the shaft and configured to block or regulate at least some nerves in a vessel in the body, the electrode unit including a base layer and an electrode layer disposed on the base layer, the electrode unit including: a first electrode disposed along the length of one side of the base layer; and a second electrode disposed along the length of the other side of the base layer; a current sensor unit formed in a region between the first electrode and the second electrode and measuring a current generated from the first electrode or the second electrode; a plurality of temperature sensors disposed at predetermined intervals between the first electrode and the second electrode and configured to sense temperature; and a control unit that calculates resistance based on the current measured by the current sensor unit and calculates a diameter of the vessel in the body based on the calculated resistance.

[0010] The above-described summary of the invention is merely illustrative and should not be construed as limiting the present invention. In addition to the exemplary embodiments described above, there may be additional embodiments described in the drawings and detailed description of the invention. [Effects of the Invention]

[0011] According to any one of the above-mentioned means for solving the problem of the present invention, it is possible to provide an electrode device that can perform nerve blockade based on the diameter of a vessel inside the body.

[0012] That is, the diameter of the vessel inside the body is detected by the electrode device including the electrode unit, and the time for applying voltage to the electrodes or the temperature can be adjusted according to the detected diameter of the vessel inside the body. [Brief explanation of the drawings]

[0013] [Figure 1] 1 is a side view of an electrode device according to an embodiment of the present invention. [Figure 2] FIG. 2 is a plan view of the electrode unit. [Figure 3] 1A and 1B are diagrams showing an electrode unit according to an embodiment of the present invention. [Figure 4] 4A to 4C are diagrams illustrating an operation process of the electrode unit illustrated in FIG. 3. [Figure 5] 10A and 10B are diagrams showing an electrode unit according to another embodiment of the present invention. [Figure 6a] 6A and 6B illustrate the operation process of the electrode unit shown in FIG. 5 according to an embodiment when the diameter of the blood vessel in the body is known. [Figure 6b] 6A and 6B are diagrams illustrating an operation process of the electrode unit shown in FIG. 5 according to an embodiment when the diameter of the blood vessel in the body is unknown. [Figure 7] 6A to 6C are diagrams illustrating an operation process of the electrode unit shown in FIG. 5 according to another embodiment. [Figure 8] FIG. 1 is an exemplary diagram for explaining a thermocouple. DETAILED DESCRIPTION OF THE INVENTION

[0014] Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings so that those skilled in the art can easily carry out the present invention. However, the present invention may be embodied in various different forms and is not limited to the embodiments described herein. In the drawings, parts that are not relevant to the description are omitted in order to clearly explain the present invention, and similar parts are designated by similar reference numerals throughout the specification.

[0015] Throughout the specification, when a part is said to be "connected" to another part, this includes not only "directly connected" but also "electrically connected" with another element interposed therebetween. Furthermore, when a part is said to "comprise" a certain component, this does not mean excluding other components, but may further include other components, unless otherwise specified, and should be understood as not precluding the presence or possibility of addition of one or more other features, numbers, steps, operations, components, parts, or combinations thereof.

[0016] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, an embodiment of the present invention will be described in detail with reference to the accompanying drawings.

[0017] Fig. 1 is a side view of an electrode device according to one embodiment of the present invention, and Fig. 2 is a plan view of an electrode unit. Fig. 3 is a diagram showing an electrode unit according to one embodiment of the present invention, and Fig. 4 is a diagram showing an operation process of the electrode unit shown in Fig. 3. Fig. 5 is a diagram showing an electrode unit according to another embodiment of the present invention, Fig. 6a is a diagram showing an operation process of the electrode unit shown in Fig. 5 according to one embodiment when the diameter of the blood vessel in the body is known, and Fig. 6b is a diagram showing an operation process of the electrode unit shown in Fig. 5 according to one embodiment when the diameter of the blood vessel in the body is unknown. Fig. 7 is a diagram showing an operation process of the electrode unit shown in Fig. 5 according to another embodiment, and Fig. 8 is an exemplary diagram for explaining a thermocouple.

[0018] 1, the electrode device 100 includes a main body 110 and an electrode unit 120. The main body 110 may include a shaft 111 extending in one direction, a grip portion 112 connected to the shaft 111 so as to be gripped by a practitioner, a guide operation portion 113 formed on the grip portion 112 for operating the operation of an electrode guide (not shown), and an electrode operation portion 114 formed on the grip portion 112 for operating energy transmission of the electrode unit 120.

[0019] The electrode unit 120 is formed to be pulled out from one end of the shaft 111, and is configured to block or regulate at least a portion of nerves distributed in tissues including ducts in the body by manipulation by a practitioner, etc. The electrode unit 120 may be housed inside the shaft 111 and pulled out when the electrode device 100 is activated.

[0020] In this application, the term "vessels" may include not only blood vessels including arteries and veins, but also various vessels such as the hepatic artery, splenic artery, and pulmonary artery, and their associated nerves.

[0021] 2, the electrode unit 120 may include a base layer 121, an electrode layer 122, and a top layer 121a. The electrode device 100 may have electrodes wrapped around the outer surface of a vessel or tubular tissue in the body, and may transmit energy via the electrode layer 122. For this purpose, the base layer 121 may be a flexible printed circuit board (Flexible PCB).

[0022] The electrode layer 122 may be configured with two electrodes extending parallel to each other on the base layer 121. The base layer 121 and the electrode layer 122 may be configured to extend in the circumferential direction and be wrapped around a vessel or the like inside the body.

[0023] 2, the electrode unit 120 may include a base layer 121, an electrode layer 122 disposed on the base layer 121, and a top layer 121a disposed between the electrode layers 122 so as to overlap a portion of the electrode layer 122. A through-hole (not shown) may be formed in a portion of the electrode unit 120.

[0024] The electrode layer 122 may be made of a material that is harmless to the human body and capable of conducting electricity, such as stainless steel, gold, etc., for nerve block or denervation or control or modulation.

[0025] The electrode layer 122 may also transmit various types of energy from an energy source generator, such as radio-frequency (RF) energy, electrical energy, laser energy, ultrasonic energy, high-intensity focused ultrasound energy, cryogenic energy, and other thermal energy.

[0026] In addition, the electrode layer 122 may be embodied 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, or the like, and may transmit energy for damaging nerves.

[0027] A sensor unit 123 may also be formed on the base layer 121. In one example, the sensor unit 123 may be a thermocouple that contacts a vessel or the like inside the body to measure temperature, and the sensor unit 123 may monitor the temperature of the treatment site when a nerve cutting procedure is performed by the electrode device 100. In another example, the sensor unit 123 may measure signals from the nerve in the vessel.

[0028] The sensor unit 123 may be, for example, a thermocouple made of a first metal 123a and a second metal 123b, and may be made of, for example, a pair of copper and constantan.

[0029] 3, the electrode unit 120a according to one embodiment may include a first electrode 122a and a second electrode 122b arranged along the length of the base layer 121. For example, the first electrode 122a may be arranged along the length of one side of the base layer 121, and the second electrode 122b may be arranged along the length of the other side of the base layer 121.

[0030] The electrode unit 120a according to one embodiment may include a current sensor unit 123, a temperature sensor unit 124, a control unit (not shown), and a reference current sensor unit 126. The current sensor units 123a and 123b may be formed in a region between the first electrode 122a and the second electrode 122b and may measure a current generated from the first electrode 122a or the second electrode 122b. For example, the first current sensor unit 123a may be arranged in the length direction alongside the first electrode 122a, and the second current sensor unit 123b may be arranged in the length direction alongside the second electrode 122b.

[0031] A plurality of temperature sensor units 124 may be arranged at predetermined intervals between the first electrode 122a and the second electrode 122b to sense temperature. For example, the temperature sensor units 124 may be arranged at predetermined intervals between the first electrode 122a and the second electrode 122b. Specifically, the temperature sensor unit 124 may include a total of n temperature sensors, and the first temperature sensor 124a, the second temperature sensor 124b, the third temperature sensor 124c, and the nth temperature sensor 124n may be arranged at predetermined intervals along the length direction.

[0032] The reference current sensor portions 126a and 126b may be formed in other regions between the first electrode 122a and the second electrode 122b. For example, the first reference current sensor portion 126a and the second reference current sensor portion 126b may have a predetermined length a, and the first reference current sensor portion 126a may be formed in a position aligned with the first electrode 122a, and the second reference current sensor portion 126b may be formed in a position aligned with the second electrode 122b.

[0033] To calculate the reference resistance, the reference current sensor units 126a and 126b may measure the current by applying a predetermined voltage between the first reference current sensor unit 126a and the second reference current sensor unit 126b. Alternatively, the same voltage may be applied to the first current sensor unit 123a and the second current sensor unit 123b to measure the current.

[0034] A control unit (not shown) according to an embodiment may calculate a reference resistance based on the current measured by the current sensor unit 124 and the reference current sensor unit 126. Specifically, the control unit may calculate a diameter of a vessel in the body based on the ratio of the length of the current sensor units 123a and 123b to the length of the reference current sensor units 126a and 126b in contact with the blood vessel, the reference resistance, and the resistance ratio (see Equation 1 below).

[0035] Here, the control unit may be included within the electrode device 100 or the energy source generator.

[0036] JPEG2025534823000002.jpg20170

[0037] Referring to Equation 1 and FIG. 2, a is the length of the reference current sensor units 126a and 126b, and b is the length of the current sensor units 123a and 123b that are in contact with the blood vessel. ΩT is the resistance of the current sensor units 123a and 123b, and ΩR is the reference resistance of the reference current sensor units 126a and 126b. L is the length of the electrode unit 120 that is in contact with the vessel inside the body, and D is the diameter of the vessel inside the body. Here, a and c are constants. For example, the control unit may compare the resistance ΩT with the reference resistance ΩR to calculate the length of the electrode unit that is in contact with the vessel inside the body, and thereby calculate the diameter of the vessel.

[0038] The control unit may adjust the time for applying voltage to the first electrode 122a and the second electrode 122b or adjust the temperature based on the calculated diameter of the vessel in the body.

[0039] A process for performing nerve blockade using the electrode device 100 including the electrode unit 120a shown in Figure 3 will be described with reference to Figure 4. The electrode device 100 according to one embodiment may wrap the electrode unit 120a around a tube (S410). The electrode device 100 according to one embodiment may check whether the temperature output of the electrode is normal (S420).

[0040] As used herein, "neural blockade" may refer to renal nerve blockade (RDN).

[0041] In one embodiment, the electrode device 100 may calculate the diameter of the vessel in the body by measuring the resistance calculated from the current if the temperature output of the electrode is normal (S421). On the other hand, in one embodiment, the electrode device 100 may return to the previous step and wrap the electrode unit 120 around the vessel again (S410) if the temperature output of the electrode is not normal (S422).

[0042] In one embodiment, the electrode device 100 may adjust the time or temperature at which the voltage is applied to the electrodes based on the diameter of the vessel (S440). In one embodiment, the electrode device 100 may administer a nerve block (S450).

[0043] 5, an electrode unit 120b according to another embodiment may have a first electrode 122a and a second electrode 122b arranged along the length of a base layer 121, and may further include a common line 127 arranged along the length of the base layer 121, parallel to the first electrode 122a and spaced a predetermined distance apart. The common line 127 may apply a voltage to current sensors 128a to 128h.

[0044] 5, the electrode unit 120b may include current sensor units 128a-128h, a temperature sensor unit 124, and a control unit. As shown in Fig. 5, the current sensor units 128a-128h may include a plurality of current sensors at predetermined intervals between the first electrode 122a and the second electrode 122b. The temperature sensor unit 124 may also include a total of n temperature sensors 124a-124n arranged at predetermined intervals between the first electrode 122a and the second electrode 122b.

[0045] The control unit may calculate the resistance based on the current measured by the current sensors 128a to 128h. For example, the control unit may determine the contact state between the base layer 121 and a vessel in the body by comparing the resistance values ​​measured by the common line 127 and the first to eighth current sensors 128a to 128h.

[0046] In another example, the control unit may compare the resistance value measured by the fourth current sensor 128d with the resistance values ​​measured by the remaining current sensors 128a to 128c, 128e to 128h, and may determine that if the resistance value measured by the fourth current sensor 128d is relatively low, the contact between the base layer 121 and the vessel inside the body is poor.

[0047] The control unit may also determine the contact state between the base layer 121 and the vessel inside the body based on a plurality of temperature values ​​sensed by the temperature sensor unit 124. For example, the control unit may determine the contact state between the base layer 121 and the vessel inside the body by comparing the temperature values ​​measured by the first temperature sensor 124a to the n-th temperature sensor 124n.

[0048] In another example, the control unit may detect when the temperature value measured by the second temperature sensor 124b is relatively very low or high by comparing the temperature values ​​measured by the first temperature sensor 124a to the nth temperature sensor 124n, for example, so that the control unit can prevent the contact between the base layer 121 and the vessel inside the body from becoming abnormal.

[0049] 6a and 6b, a process for performing nerve blockade using an electrode device 100 including the electrode unit 120b shown in Fig. 5 according to one embodiment will be described. Fig. 6a illustrates a case where the diameter of a blood vessel in the body is known, while Fig. 6b illustrates a case where the diameter of the blood vessel in the body is unknown. First, referring to Fig. 6a, an electrode device 100 according to another embodiment may wrap an electrode unit 120 around a tube (S610).

[0050] The electrode device 100 according to another embodiment may measure the resistance values ​​up to the nth electrode (S611). The electrode device 100 according to another embodiment may check whether all N resistance values ​​are within an allowable range (S612).

[0051] In another embodiment of the electrode device 100, if all of the N resistance values ​​are within the allowable range (S612a), the temperature and time may be set (S613). On the other hand, in another embodiment of the electrode device 100, if all of the N resistance values ​​are not within the allowable range (S612b), the electrode device 100 may re-wrap the electrode unit around the tube (S610).

[0052] The electrode device 100 according to another embodiment may administer nerve blockade based on the set temperature and time (S614). The electrode device 100 according to another embodiment may measure the resistance values ​​up to the n-th electrode during administration of the nerve blockade (S615).

[0053] The electrode device 100 according to another embodiment may check whether all of the N resistance values ​​are within the acceptable range (S616). If all of the N resistance values ​​are within the acceptable range (S616a), the electrode device 100 according to another embodiment may continue to administer the nerve block (S617).

[0054] In another embodiment, the electrode device 100 may stop nerve blockade (S618) if all of the N resistance values ​​are not within the allowable range (S616b), and may then set the temperature and time again (S613).

[0055] 6b, an electrode device 100 according to another embodiment including the electrode unit 120b shown in FIG. 5 may wind the electrode unit 120 around a tube (S620). The electrode device 100 according to another embodiment may measure the resistance values ​​of all the electrodes (S621).

[0056] In another embodiment, the electrode device 100 may determine which N electrodes have been contacted by comparing the measured resistance values. The electrode device 100 may check whether all of the N resistance values ​​are within an acceptable range (S622).

[0057] In another embodiment of the electrode device 100, if all of the N resistance values ​​are within the allowable range (S622a), the temperature and time may be set (S623). On the other hand, in another embodiment of the electrode device 100, if all of the N resistance values ​​are not within the allowable range (S622b), the electrode unit may be wound around the tube again (S620).

[0058] The electrode device 100 according to another embodiment may administer nerve blockade based on a set temperature and time (S624).

[0059] The electrode device 100 according to another embodiment may measure the resistance values ​​up to the nth electrode during nerve blockade (S625). The electrode device 100 according to another embodiment may check whether all N resistance values ​​are within an acceptable range (S626).

[0060] In another embodiment, the electrode device 100 may continue nerve blockade (S627) if all N resistance values ​​are within the acceptable range (S626a). On the other hand, in another embodiment, the electrode device 100 may stop nerve blockade (S628) if all N resistance values ​​are not within the acceptable range (S626b). The electrode device 100 may then set the temperature and time again (S623).

[0061] Referring to FIG. 7, a process for performing nerve blockade using an electrode device 100 including the electrode unit 120b shown in FIG. 5 according to another embodiment will be described.

[0062] 7, the electrode device 100 may wrap the electrode unit 120 around the tube (S710). The electrode device 100 may measure the temperatures of all sensors (S720).

[0063] In another embodiment, the electrode device 100 may determine which N sensors have been contacted by comparing the measured temperatures. The electrode device 100 may check whether all N temperature values ​​are within an acceptable range (S730).

[0064] In another embodiment, the electrode device 100 may set the temperature and time (S740) if all N temperature values ​​are within the allowable range (S731). On the other hand, in another embodiment, the electrode device 100 may re-wrap the electrode unit around the tube (S710) if all N temperature values ​​are not within the allowable range (S732).

[0065] The electrode device 100 according to another embodiment may administer nerve blockade based on the set temperature and time (S750). The electrode device 100 according to another embodiment may measure the temperature up to the nth temperature sensor during administration of the nerve blockade (S760).

[0066] In other embodiments, the electrode device 100 may check whether all N temperature values ​​are within the acceptable range (S770). If all N temperature values ​​are within the acceptable range (S771), the electrode device 100 may continue to administer the nerve block (S780).

[0067] On the other hand, in another embodiment, the electrode device 100 may stop nerve blockade (S790) if all N temperature values ​​are not within the allowable range (S772), and may then set the temperature and time again (S740).

[0068] 8, in order to improve the accuracy of temperature measurement, the temperature sensor unit 124 may further include a thermocouple 128. For example, the temperature sensor unit 124 may be configured to include at least one temperature chip and a thermocouple 128.

[0069] As shown in FIG. 8, the thermocouple 129 may be formed as a T-type and include copper (not shown) and constantan 129c.

[0070] For example, one side of the thermocouple 129 may be a hot junction area 129a, and the other side may be a cold junction area 129b. The hot junction area 129a is an area that comes into direct contact with the vessel inside the body, and in order to accurately measure the temperature of the hot junction area 129a, the temperature of the cold junction area 129b must first be known.

[0071] The cold junction area 129b of the thermocouple 128 may be the area where the constantan 129c meets the copper. The thermocouple 128 may include a temperature tip 129d at the cold junction area 129b to sense the temperature of the cold junction area 129b.

[0072] The thermocouple 128 may be configured in various ways, such as J-type, K-type, T-type, E-type, N-type, R-type, S-type, and the like.

[0073] The above description of the present invention is for illustrative purposes only, and those skilled in the art will understand that the present invention can be easily modified into other specific forms without changing the technical spirit or essential features of the present invention. Therefore, it should be understood that the above-described embodiments are illustrative in all respects and not limiting. For example, each component described as a single component may be implemented in a distributed form, and similarly, each component described as a distributed component may be implemented in a combined form.

[0074] The scope of the present invention is indicated by the claims that follow rather than by the above detailed description, and all modifications and variations that fall within the meaning and scope of the claims and their equivalents should be interpreted as being included within the scope of the present invention.

Claims

1. An electrode device for blocking or modulating nerves in the body, a body having a shaft; an electrode unit formed to protrude from one end of the shaft, for blocking or modulating nerves in at least a part of the body vessel, the electrode unit including a base layer and an electrode layer disposed on the base layer; The electrode unit comprises: a first electrode disposed along a length of one side of the base layer; an electrode layer including a second electrode disposed along the length of the other side of the base layer; a current sensor unit formed in a region between the first electrode and the second electrode, for measuring a current generated from the first electrode or the second electrode; a plurality of temperature sensor units arranged at predetermined intervals between the first electrode and the second electrode, the temperature sensor units detecting temperature; a control unit that calculates a resistance based on the current measured by the current sensor unit and calculates a diameter of a vessel in the body based on the calculated resistance; An electrode device comprising:

2. The control unit 2. The electrode device according to claim 1, wherein the time for applying a voltage to the first electrode and the second electrode or the temperature is adjusted based on the calculated diameter of the vessel in the body.

3. a reference current sensor unit formed in another region between the first electrode and the second electrode, for measuring a current generated from the first electrode and the second electrode in order to calculate a reference resistance; The electrode device of claim 1 further comprising:

4. The control unit calculating the reference resistance based on the current measured by the reference current sensor unit; 4. The electrode device according to claim 3, wherein the diameter of the vessel within the body is calculated based on a ratio between the length of the current sensor portion and the length of the reference current sensor portion, and a ratio between the reference resistance and the resistance.

5. a common line arranged in parallel with the first electrode at a predetermined interval along the length direction, for applying a voltage to the first electrode; The electrode device of claim 1 further comprising:

6. The control unit The electrode device according to claim 1 , wherein the contact state between the base layer and the vessel within the body is determined based on a plurality of temperature values ​​sensed by the temperature sensor unit.

7. The temperature sensor unit is configured by a thermocouple, 10. The electrode device of claim 1, wherein the thermocouple includes a temperature tip at a cold junction.

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