WO2006059430A1 - 痛覚神経刺激用電極 - Google Patents
痛覚神経刺激用電極 Download PDFInfo
- Publication number
- WO2006059430A1 WO2006059430A1 PCT/JP2005/018270 JP2005018270W WO2006059430A1 WO 2006059430 A1 WO2006059430 A1 WO 2006059430A1 JP 2005018270 W JP2005018270 W JP 2005018270W WO 2006059430 A1 WO2006059430 A1 WO 2006059430A1
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- WIPO (PCT)
- Prior art keywords
- electrode
- stimulation
- needle
- skin
- pain
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0502—Skin piercing electrodes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/48—Other medical applications
- A61B5/4824—Touch or pain perception evaluation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/48—Other medical applications
- A61B5/4824—Touch or pain perception evaluation
- A61B5/4827—Touch or pain perception evaluation assessing touch sensitivity, e.g. for evaluation of pain threshold
Definitions
- the present invention relates to an electrode that is attached to the surface of the skin of a mammal, particularly a human, and stimulates only pain nerves.
- Non-patent Document 2 Patent Document 1
- this method is extremely simple, since it is a stimulation of the skin surface force, it has a drawback that the mechanical receptor excitement related to the sense of touch cannot be avoided at the stimulation intensity that induces pain.
- Non-patent Documents 3 and 4 Non-patent Documents 3 and 4
- nociceptors can be stimulated very easily without using special equipment.
- Patent Document 1 Japanese Patent Publication 3-64127
- Non-Patent Document 1 Pain 107 (2004) 91-98
- Non-Patent Document 2 Clinical Neurophysiology 111 (2000) 413-416
- Non-Patent Document 3 Clinical EEG vol.44, No.5, 2002/5
- Non-Patent Document 4 Pain 96 (2002) 247-252
- Non-Patent Documents 3 and 4 skin Ad Elta fibers can be selectively stimulated, but when this electrode is attached to the measurement site (skin), the distance between the cathode and the anode can be very long, or the distance between the cathode and anode can be different for each measurement.
- multiple electrodes are used to increase the signal strength, if the distance between the negative electrode and the anode is extremely different, the target pain sensation will not be selectively stimulated, and the non-target region will be stimulated. When the possibility of occurrence of a stimulus (such as tactile sensation) increased, a problem occurred.
- an object of the present invention is to provide a multipolar needle electrode having a stimulation target electrode (needle) and a terminal electrode force for selectively stimulating only the pain sensation of the skin.
- a stimulation target electrode needle
- a terminal electrode force for selectively stimulating only the pain sensation of the skin.
- the present inventors can provide a stimulation target electrode (cathode) at any depth up to the nipple with only a plurality of terminal electrodes (anode) or, if necessary, a support added thereto.
- the end electrode is placed in contact with the skin, and the distance from the stimulation target electrode (needle) to the end electrode (anode) on the skin surface is within 20 mm.
- the present inventors have found that the above problems can be solved by a multipolar needle electrode configured to be within 1.5 times the shortest distance, and have completed the present invention.
- the present invention is a multipolar needle electrode comprising a stimulation target electrode and a terminal electrode, the stimulation target electrode having a needle shape for piercing a mammalian skin, and the terminal electrode is a skin surface. At least two electrodes in contact with each other or an electrode having an area larger than the area of the stimulation target electrode, and the stimulation target electrode is formed from a plane formed by the terminal electrode and an insulating support used as necessary.
- the height from the flat surface to the tip of the stimulation target electrode is not more than the depth to the target mammal's skin surface force papilla, and the distance from the stimulation target electrode to the terminal electrode on the plane is It is a multipolar needle electrode for pain sensory nerve stimulation within 20mm and the longest distance of parentheses is within 1.5 times the shortest distance.
- the present invention also provides a pain sensory nerve comprising a multipolar needle electrode for pain sensory nerve stimulation, and a power source capable of applying a pulsed current of 0.5 mA or less between the stimulation target electrode and the terminal electrode. It is a device for stimulation.
- the present invention provides a multipolar needle electrode for pain sensory nerve stimulation in contact with mammalian skin. It is a pain sensory nerve stimulation method comprising piercing the stimulation target electrode into the skin and applying a pulsed current of 0.5 mA or less between the stimulation target electrode and the terminal electrode.
- the mechanoreceptors of fibers involved in tactile sensation are in the deeper dermis.
- This dermis is composed of the nipple layer and the reticular layer force.
- the distance from the epidermis surface (hereinafter referred to as “skin surface”) to the epidermis closest to the epidermis (hereinafter referred to as “papillae”) is approximately 0.3 mm in humans, but varies depending on the animal.
- the stimulation target electrode has a structure capable of being stabbed into the skin surface so as to reach the skin surface force at the maximum depth to the nipple.
- a structure may be of any kind, but a support that forms a flat surface is provided, and the height of the needle electrode from the flat surface formed by this support is less than the depth to the nipple.
- the lower limit of this height should be deep enough to pierce the epidermis, but in humans it is 0. Olmm, preferably 0.1 mm, but it depends on the target animal.
- the stimulation target electrode is preferably stabbed into the skin as much as possible within the above range, this height is higher within this range (for example, the skin surface force is more than half of the depth to the nipple (human In this case, about 0.15 mm or more) is preferable.
- the stimulation target electrode of the present invention has a needle shape for piercing the skin, and the tip thereof may be sharp, spherical, or cut with a thin line.
- a needle-like one having a pointed tip is used, and in this specification, the stimulation target electrode may be simply expressed as a needle for convenience, but there may be a plurality of stimulation target electrodes.
- the material for the stimulation purpose electrode is not particularly limited. For example, stainless steel, gold, iron, platinum iridium, tungsten, and the like are mentioned. Stainless steel is preferred for reasons of impact strength, reactivity, and cost.
- the terminal electrode of the present invention has at least two electrodes or an area larger than the area of the stimulation target electrode (contact area) in order to reduce the loop current other than the direct current to the stimulation target site. It consists of an electrode having an area (cross-sectional area).
- the target site in the skin communicates with the non-target site in all directions, and it is considered that current flows through all routes in normal bipolar stimulation.
- the number of terminal electrodes is two (tripolar)
- a certain degree of loop circuit mitigation is not enough to suppress all the loop circuits.
- a larger number of terminal electrodes are preferred, and therefore a myriad of concentric electrodes are most preferred.
- anodal excitation may occur at the terminal electrode when the current is cut off, and a short rectangular wave of 0.5 to 1.0 ms is applied to the stimulation pulse. Considering the normal use, there is a great disadvantage.
- the terminal electrode preferably has an area equal to or larger than that of the stimulation target electrode.
- the terminal electrode does not pierce the skin but is brought into contact with the skin surface. This is to minimize current propagation to layers deeper than the epidermis, which is the target site for stimulation.
- the tip thereof is usually a flat surface but may be a sphere having a large radius.
- the material of the terminal electrode is not particularly limited as long as it has conductivity.
- the electrode force for stimulation on the skin surface is within 20 mm, preferably 0.3 to L0 mm, more preferably 1.0 to LOmm.
- the distance between any needle electrode and the anode must be within this range.
- the stimulation target electrode (cathode) is formed into a needle shape, and one terminal electrode (anode) is brought into contact with the skin separated to some extent from this stimulation target electrode. Used (see Comparative Example 1 below).
- the current finally flows in a concentrated manner at the tip of the needle (cathode), but there are numerous routes to that point, such as those that pass through a shallow place, deep places, and detours. Therefore, when increasing the current or stimulating multiple electrodes simultaneously, it is desirable.
- the current density at the missing part also increases (for example, lmm deep at the tip of the needle), which increases the possibility of exciting non-pain receptors.
- the distance from the stimulation target electrode to the terminal electrode is preferably such that the longest distance is 1.5 times or less, particularly 1.2 times or less of the shortest distance.
- the terminal electrodes will not be equipotential, so the current distribution centered on the stimulation target electrode (needle) will be distorted, Other than the straight line connecting these terminal electrodes, a detour current is generated, and the probability of occurrence of an undesired portion of the stimulus increases.
- the stimulation target electrode is equidistant with respect to all parts of the terminal electrode. From this point of view, it can be said that it is most preferable that the electrode has a substantially concentric circular shape centering on the stimulation target electrode (needle) on the skin plane.
- the concentric electrodes are theoretically a collection of a myriad of tripolar electrodes, and are expected to have very little current spread outside the target site (negative electrode). That is, it is considered that a very limited current concentration occurs at the tip of the needle placed in the epidermis where nociceptive receptors are present.
- a plane is formed only by the terminal electrode, or a plane is formed by adding an insulating support (insulator) to the terminal electrode as necessary, and the stimulation target electrode protrudes from the plane to a predetermined height. Structure.
- the terminal electrode and the insulating support used as needed form at least three points to form a plane (for example, Fig. 2 (2)). Because there is a certain amount, even two points do not work (for example, Fig. 2 (1) (3)).
- the needle depth can be easily fixed by inserting it from the human skin surface. it can.
- a structure surrounding the needle with an insulator may be used (for example, Fig. 2 (6) (9)).
- this electrode it is preferable to use and throw away this electrode to prevent infection, and to use the power by thoroughly disinfecting the skin and electrode with alcohol. Since there are no blood vessels in the epidermis, there is no bleeding due to electrode insertion.
- the electrode is configured using, for example, fluorine resin, epoxy resin, vinyl chloride, polyethylene, ceramics, or the like can be used as the insulator.
- a plurality of such multipolar needle electrodes may be used in a bundle.
- the terminal electrode may be further shared.
- a structure in which two or more holes are formed in a plate may be used as a terminal electrode, and a stimulation target electrode may be provided in each hole.
- the stimulation target electrode is a cathode and the terminal electrode is an anode.
- the current stimulated by passing a rectangular or triangular wave current of 0.5 to 1.0 milliseconds is usually 0.5 mA or less, preferably 0.1 to 0.3 mA.
- High currents can excite tactile receptors.
- the terminal electrode positive electrode
- no current flows outside the line force connecting the negative electrode and the positive electrode.
- the tissue is not uniform, and the degree of contact between the electrode and the skin cannot be completely uniform, so that a certain current distribution width occurs.
- the electrode of the present invention is used, it is substantially reduced. It can stimulate the pain sensation quite effectively.
- the multipolar needle electrode of the present invention is used for the study of pain sensory nerves that need to stimulate only pain sensation, as a clinical examination of peripheral nerves, for the treatment of living bodies by pain sensation, and for pain and stiff shoulders. It can be used to relieve itching and can be easily used for various pain-related applications.
- a stainless steel tube with an outer diameter of 1.2 mm and an inner diameter of 0.9 mm (made of Terumone earth, the needle tube of an 18G syringe needle) is used as the outer cylinder, and the tip is very sharp (made by Terumo Corporation, 27G syringe needle Concentric electrodes with a needle tube as the inner core were manufactured.
- the needle tip protrudes 0.2mm from the outer cylinder, and the outer cylinder and inner core are insulated by a vinyl insulator.
- Figure 3 shows the photograph.
- the tip of the inner core is placed in the skin.
- the outer cylinder is in close contact with the skin surface.
- the outer cylinder was used as a positive electrode (positive electrode) and the inner core was used as a negative electrode (negative electrode).
- Non-patent Document 4 Using this electrode, stimulation was performed under the following conditions and the cerebral evoked potential was measured by the same recording technique as previously reported (Non-patent Document 4).
- Stimulation condition Constant current stimulation with a square wave of 0.5 ms stimulation width. Stimulation interval 10 seconds.
- Stimulation site left hand and shoulder.
- peripheral conduction velocity during tactile stimulation measured in this subject in a similar manner was 51 mZs (shoulder 230 ms, hand back 241 ms).
- the central circular electrode is expected to have improved current concentration at the tip of the needle compared to the conventional unipolar stimulation method needle electrode (Non-patent Document 4).
- Non-patent Document 4 the conventional unipolar stimulation method needle electrode
- Example 2 Insert the same concentric circle electrode as in Example 1 near the metacarpal bone of the left dorsal dorsal finger, and select the two items: weakest feeling pain, strength (pain threshold) and weakest feeling tactile sensation, strength (tactile threshold). I studied. Ten stimulations were performed and a significant difference test was performed.
- the pain threshold was 0.17 mA and the tactile threshold was 0.83 mA.
- Example 5 As the cathode, the one obtained by removing the outer cylinder from the electrode force used in Example 1 (FIG. 5) was used. Further, as a positive electrode, a dish electrode having a diameter of 1 cm was arranged so that the center of the dish electrode was 4 cm away from the needle electrode (cathode), and the same measurement as in Example 2 was performed.
- the tactile threshold was 0.31 mA, and Example 2 (0.83 mA) was significantly higher than this (t-test, p ⁇ 0.0001).
- the tactile threshold can be a pain-selective stimulus that is higher than the pain threshold, but the current width that allows the pain-selective stimulus is clearly widened by the electrode of Example 2 into the epidermis. It shows that the current limiter is better.
- a needle electrode was inserted in the center of the left back of the left hand, and an outer cylinder with a diameter of 1.0 mm, 3.5 mm, 10 mm, 20 mm, 30 mm, or 40 mm was placed around the needle electrode as a positive electrode.
- an outer cylinder with a diameter of 1.0 mm, 3.5 mm, 10 mm, 20 mm, 30 mm, or 40 mm was placed around the needle electrode as a positive electrode.
- a needle electrode and a monopolar positive electrode with a diameter of 10 mm were placed so that the center of the monopolar positive electrode was 50 mm from the needle electrode. Arranged.
- the thresholds when the diameter force is 0, 30, 20, 10, 3.5, and 1 mm are 0.49, 0.52, 0.53, 0.59, 0.88, and 1.62, respectively, as shown in FIG. there were.
- the current concentration at the target site is considered to be excellent.
- a silver ball with a diameter of 0.4 mm is located at the center where the needle electrode (cathode) is located and the distance from the needle electrode is 2.5, 2.0, 1.8, 1.5, 1.5, 1.2, 1.0, 0.5 mm.
- An electrode (positive electrode) was placed.
- Four electrode pairs of 2.5 mm and 0.5 mm, 2.0 mm and 1.0 mm, 1.8 mm and 1.2 mm, 1.5 mm and 1.5 mm are on a straight line passing through the needle electrode, and the distance between the terminal electrodes is 3.0 mm. ing.
- the longer end electrodes are 5, 2, 1.5, and 1 times the distance from the needle, respectively.
- Tripolar stimulation threshold is the percentage of threshold for bipolar stimulation. Expressed in Data from a total of 18 trials were collected from two subjects and tested for significance using analysis of variance. Stimulation was performed in the center of the left hand. The electrode insertion site was moved slightly for each trial. The higher the ratio (tripolar Z bipolar), the higher the selectivity of painful stimulation.
- the effect of the 1.5 / 1.5mm triode electrode (15% increase in tactile threshold) is inferior to that of the concentric electrode of 3.5mm diameter in Example 3 (approximately 80% increase). It shows that the concentric circle is more effective than the two cases.
- the terminal electrode surrounding the stimulation target electrode is more preferably concentric with the stimulation target electrode, which is preferably equidistant from the stimulation target electrode because of the potential distribution.
- FIG. 1 shows the structure of mammalian skin and a view in which the electrode of the present invention is attached to the skin.
- the epidermis is about 0.3 mm, the dermis is deeper, and the thickness is about 1-2 mm.
- the most dermal part of the dermis is the nipple. Deeper than that is the subcutaneous tissue. What is shown by the line is the pain sensory nerve.
- the dark lines show mechano-receptive mechano-receptors and the fibers that connect to them.
- the epidermis has only nociceptive nerves.
- the stimulation target electrode (needle shape) of the present invention is pierced into the epidermis. With the terminal electrode in contact with the epidermis, the stimulation target electrode is the cathode and the terminal electrode is the positive electrode, and a pulsed current is applied to stimulate pain.
- FIG. 2 is a view showing an example of a multipolar needle electrode of the present invention.
- (1) shows a structure with two terminal electrodes equidistant from one stimulation target electrode.
- (2) shows a structure with three terminal electrodes.
- (3) shows a structure in which the two end electrodes have different distances from the stimulation target electrode.
- (4) shows a structure with a cylindrical terminal electrode centered on one stimulation target electrode
- (5) shows the structure in (4) where the stimulation target electrode is offset from the center.
- (6) shows the structure in (4) in which the space between the stimulation target electrode and the terminal electrode is filled with an insulator.
- (7) shows a structure in which part of the cylindrical end electrode of (4) is missing.
- (8) shows a structure in which a part of the cylindrical end electrode of (4) is an insulator.
- (9) shows a structure in which the stimulation target electrode is surrounded by a cylindrical insulator and has a plurality of terminal electrodes around it.
- Example IV is a graph showing the evoked brain potential measured in Example 1.
- ⁇ 5 A view showing a needle electrode used in Comparative Example 1.
- FIG. 6 is a diagram showing the relationship between the diameter of the outer cylinder of the concentric electrode and the tactile threshold.
- FIG. 7 is a diagram showing a stimulation target electrode used in Example 4 and a terminal electrode surrounding it.
- the black spot at the center indicates the stimulation target electrode (needle electrode), and the surrounding white dot indicates the terminal electrode (silver ball electrode).
- the diameter of the terminal electrode is 0.4 mm, and the numerical value next to the white dot indicates the distance (mm) from the center of the needle electrode to the center of the terminal electrode. (1) shows the actual photo, and (2) shows the layout.
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JP2006547670A JPWO2006059430A1 (ja) | 2004-11-30 | 2005-10-03 | 痛覚神経刺激用電極 |
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Cited By (12)
Publication number | Priority date | Publication date | Assignee | Title |
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WO2009154308A1 (ja) * | 2008-06-20 | 2009-12-23 | 国立大学法人宮崎大学 | 電極 |
EP2174589A1 (en) | 2008-10-10 | 2010-04-14 | Inter-University Research Institute Corporation National Institutes of Natural Sciences | Pain sensory nerve stimulation apparatus |
JP2010213929A (ja) * | 2009-03-17 | 2010-09-30 | Morioka Seiko Instruments Inc | 表皮刺激電極装置 |
CN102145205A (zh) * | 2010-02-09 | 2011-08-10 | 大学共同利用机关法人自然科学研究机构 | 痛觉神经刺激装置 |
JP2012235825A (ja) * | 2011-05-10 | 2012-12-06 | Nippon Koden Corp | 交感神経皮膚反応測定装置 |
JP2013154026A (ja) * | 2012-01-31 | 2013-08-15 | Seiko Instruments Inc | 生体刺激電極 |
JP2014039878A (ja) * | 2013-11-06 | 2014-03-06 | Seiko Instruments Inc | 生体刺激電極 |
CN104523226A (zh) * | 2014-11-18 | 2015-04-22 | 邹最 | 测痛装置 |
JP2017131287A (ja) * | 2016-01-25 | 2017-08-03 | 裕 渡邊 | コードレスつぼ探索器 |
CN108577811A (zh) * | 2018-04-17 | 2018-09-28 | 李勇 | 一种便携式避免交叉感染的神经内科检测器 |
US10820823B2 (en) | 2015-06-18 | 2020-11-03 | Inter-University Research Institute Corporation National Institutes Of Natural Sciences | Evaluation of inhibitory circuit and use thereof |
EP3881764A4 (en) * | 2018-11-13 | 2022-07-06 | Nihon Kohden Corporation | PERIPHERAL NERVE EXAMINATION DEVICE, PERIPHERAL NERVE EXAMINATION METHOD AND PROGRAM |
-
2005
- 2005-10-03 WO PCT/JP2005/018270 patent/WO2006059430A1/ja active Application Filing
- 2005-10-03 JP JP2006547670A patent/JPWO2006059430A1/ja not_active Withdrawn
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JP4984102B2 (ja) * | 2008-06-20 | 2012-07-25 | 国立大学法人 宮崎大学 | 電極 |
WO2009154308A1 (ja) * | 2008-06-20 | 2009-12-23 | 国立大学法人宮崎大学 | 電極 |
CN105662390A (zh) * | 2008-06-20 | 2016-06-15 | 国武孝人 | 电极 |
KR101623607B1 (ko) | 2008-06-20 | 2016-05-23 | 다까또 구니따께 | 전극 |
US8608664B2 (en) | 2008-06-20 | 2013-12-17 | University Of Miyazaki | Electrode |
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JP2010088802A (ja) * | 2008-10-10 | 2010-04-22 | National Institutes Of Natural Sciences | 痛覚神経刺激装置 |
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JP2012235825A (ja) * | 2011-05-10 | 2012-12-06 | Nippon Koden Corp | 交感神経皮膚反応測定装置 |
JP2013154026A (ja) * | 2012-01-31 | 2013-08-15 | Seiko Instruments Inc | 生体刺激電極 |
JP2014039878A (ja) * | 2013-11-06 | 2014-03-06 | Seiko Instruments Inc | 生体刺激電極 |
CN104523226A (zh) * | 2014-11-18 | 2015-04-22 | 邹最 | 测痛装置 |
US10820823B2 (en) | 2015-06-18 | 2020-11-03 | Inter-University Research Institute Corporation National Institutes Of Natural Sciences | Evaluation of inhibitory circuit and use thereof |
JP2017131287A (ja) * | 2016-01-25 | 2017-08-03 | 裕 渡邊 | コードレスつぼ探索器 |
CN108577811A (zh) * | 2018-04-17 | 2018-09-28 | 李勇 | 一种便携式避免交叉感染的神经内科检测器 |
CN108577811B (zh) * | 2018-04-17 | 2021-04-02 | 陈丽成 | 一种便携式避免交叉感染的神经内科检测器 |
EP3881764A4 (en) * | 2018-11-13 | 2022-07-06 | Nihon Kohden Corporation | PERIPHERAL NERVE EXAMINATION DEVICE, PERIPHERAL NERVE EXAMINATION METHOD AND PROGRAM |
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