JPS58127639A - Electrode for external auditory miatus - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to an improved 1' ear canal electrode.

1. Identify hallucination defects 1. Medical testing methods for diagnosis have so far included physical examination of the 1E tract and observation of monovisual responses to acoustic stimuli. In general, subjective sensitivity to :'r tri has been routinely measured at some i'↑ frequency frequencies. More recently, the resulting evoked action potentials resulting from i'phonic stimulation and rf-acoustic brainstem responses have been identified as the cause of hearing loss and other auditory defects, and especially to 'A11I was determined in an attempt to do so. Measurement of the i′1° brainstem response is based on acoustic stimulation and i″??
It involves measuring the magnitude and response time of electrical impulses from the auditory nerve and brainstem in response to spinal impulses. This electromagnetic flux 1) is detected by using non-implantable electrodes that are placed on the skin surface I-.

Devices that are worn in the 1' tract that produce a 1'f stimulation for 1' are known in the art. Tubular components such as those shown in U.S. II. F? is often transmitted to 1[ via
It'f is configured for a V degree fit and thus includes a resilient component. U.S. Patent No. 3.7
83.201! ) is under-represented if) hearing aids with a highly flexible structure. U.S. Patent No. 4.133,
No. 984 describes a hearing aid with a flexible expandable end. Although such a hearing aid is designed to receive 77ql stimulation 1 "Unsuitable for receiving electrical signals from the road surface.

Electrodes suitable for use in transmitting electrical values 1) from the skin surface are generally used in heart rate measurements and the like. These electrodes are described in U.S. Patent No. 3,547,10
No. 4 and it14, 186.453, it is designed to have small IIT, h's: and large sensitivity. Gonagi's US patent is
A body electrode comprising a porous foam disk impregnated with a conductive gel and cooperating other components made of conductive plastic are described. These electrodes are configured for easy access to the f 45H skin surface. These electrodes are 11
) +1ri to 0 Not suitable for humans and does not respond to any acoustic stimulation.

A conductive metal electrode that penetrates the tympanic membrane, ie, a transtympanic membrane electrode, has been developed. These electrodes require the use of anesthetics, are painful, and often lead to infection. These electrodes have been used to pick up particles from the vicinity of the cow's shell to obtain a strong signal strength of the first acoustic wave.

Typical electrodes configured for non-implantable 6-lf path insertion to stabilize AI's acoustic brainstem responses include T,
``Scandanavi'' entitled ``Scandinavian Symposium on the Brainstem 1\'' edited by Lundborg.
anAudiology Supplementum
No. 13” (1981 4J) 711-811
)It is described in. Walter et al.'s paper "Discrimination method of waveform ■ using non-rational type [f'rn'electrode"] 63-
Page 64 describes an 'electrode made from a silver wire supported by a cotton ball with the ends impregnated with saline. La
ng'v;'s paper ``Improved technology for non-rational recording of brainstem reactions using specially structured metal electrodes,'' pages 59-62, states that the terminal is Sherry? A silver wire electrode is described that is covered with a 1Σ pole and configured to be able to reach the F section of the earphone. Papillary itt within the rBRA of Harder et al.
"Comparison of Ir way with pole" is acrylic thread tree 11 with a silver element embedded with a surface layer of 1!1 silver oxide? The i-electrode is described. ``Prior to electrode insertion, electrode paste is applied to the IT path. These devices are F of the present invention.
It does not have the structure of an r electrode and does not provide low resistance and high sensitivity. Also, these devices do not have an f-stage to accommodate acoustic stimulation. In each of the above-mentioned systems, the acoustic stimulation is delivered via an element that is not physically associated with the electrodes in 1. hand! j, I can get it. A further limitation of all of the prior art implantable and non-intrusive electrodes was that they required insertion by a surgeon due to the risk of inadvertent rupture of the eardrum.

An object of the present invention is to provide a non-natural ear canal electrode having low electrical resistance and high electrical sensitivity.

Another object of the present invention is that it can be manufactured easily and inexpensively, and that there is no risk of damage to the tympanic membrane due to inadvertent insertion.
To provide a safe disposable canal electrode that can be easily and safely inserted by an assistant who has at least one experience in surgery.

“In summary, the safe non-manufactured ear canal electrode of the present invention is
In order to transmit electrical signals extracted from the skin surface, also j′? It includes a tube made of electrically conductive material for transmitting acoustic stimulation to the surface of the human Ff Gi.

The end of the tube, which is to be placed in the opposite direction, is fitted with a highly conductive, elastic, open-porous foamed plastic member, which contacts the epidermis of the skin of the auditory canal and from this point on. The tube is configured to pick up and transmit electrical signals to the tube. In a preferred embodiment of the invention, said tube is made of a suitable metal and has a metal coating or outer metal layer, or an electrically conductive metal (a particularly preferred metal is an electrically conductive metal). The foamed plastic member is an annular element surrounding the distal end of the 1111 tube, and the foamed plastic is a continuous material impregnated with an electrolytically conductive medium. It is a foam that has pores that are connected to each other.

In yet another embodiment, the annular foamed plastic member of nrj is compressed within a concentric outer insertion tube configured for reverse insertion. This tube forms a moisture seal with its end to 1) prevent evaporation of moisture from the conductive medium in which the foamed plastic member is impregnated; When the insertion tube is pulled out from around the foamed plastic member, the foamed plastic
expands within the tube to create a reliable electrically conductive skin contact.

This insertion tube is 1 [insertion distance in reverse direction]
However, it has a stomper portion.

In an attempt to diagnose the causes of hearing loss and deafness, and other hearing impairments, techniques for measuring acoustic brainstem response (ABR) and cochlear diagnostics (ECoG) have been developed. 1
The 11-period technique involved measurement of electrical potential fluctuations at the scalp surface within the first 10 milliseconds after acoustic stimulation. This acoustic system was stimulated by the form of a wide wave or burst of 1"1", usually selected waveform, amplitude and frequency. Electrical potentials and diaphragm potential fluctuations along the central acoustic pathway, particularly the neuronal layers of deep brainstem structures, are associated with electrically conductive media volumes (brain cells, transmitted through bone and extracellular fluid).

The amplitude and latency of the potential are γ? of the nervous system. It has been published in relation to specific points along the W-like route. The potentials arising from the transducer portion of the octopus shell and the auditory brainstem are the largest. Irregularities in the amplitude and latency of characteristic waveforms can be used to identify the severity and specific causes of hearing defects.

Many factors have constrained the use of ABR and ECoG. Initially, the sharp waveform is distorted in its passage and propagation in the passageway within 1". The stimulus does not simultaneously stimulate all of the hair cells in the shell. Weak and often obscured due to distortions resulting from passage within the anatomy and the noise of the dorsal (). It has been found that placement of the electrodes in the opposite direction and across the tympanic membrane reduces certain distortions and obtains increased sensitivity. The surface of the auditory canal is adjacent to dense, conductive bony material, with 1"
The electrical potential measured at the surface 1- was transmitted through relatively insulating tissue and fluid. Suitability 11: It was found that a non-reasonable metal auditory canal surface electrode configured as follows can obtain a signal equivalent to a transtympanic membrane electrode. However, the background noise was even louder in electrodes with many unstructured electrodes due to the morphology of the auditory canal surface.

Only by elaborate skin surface preparation by highly skilled researchers, specular insertion [f-way eye dilation and electrode insertion with microsurgical forceps, 10K
A resistance value smaller than ah11 was observed.

The non-rigid ear canal electrodes of the present invention, as described in more detail below, can be installed in a conventional manner by a technician of ordinary medical training to have an electrical resistance as low as 1 Kohm. . The device also transmits sweat through an integrated acoustic horn with minimal distortion.

In FIG. 1, a top view of the electrode of the present invention assembled for insertion into a tube is shown. It is removably held in place by a lip member 6.

A side view in a section taken along line A--A in FIG. 1 is shown in FIG. The tubular electrode 4 has a proximal end 8 and a distal end l.
and θ. This proximal end 8 has a cup-shaped female connector 9 having an internal fixing screw 12 for engaging an engagement element of a sound generator described below with reference to FIG.
It is shown in the removed form (=t t).

The tubular electrode 4 has a circular cross section, and its inner diameter increases as it approaches the distal end, giving it the tapered or expanded shape of an acoustic horn. This configuration delivers the ff generated at the proximal end 8 to the auditory canal with minimal distortion,
Tolerates acoustic stimulation with sharp, well-defined waves.

One end 10 of the far end 13 is reversely bent with respect to the rl and the other to form a tightening part 14. Preferably, the cup-shaped connector is made from a non-conductive plastic such as polyvinyl chloride, polyethylene, or the like. The tubular electrode 4 may be of any physiologically inert electrically conductive material that reacts electrochemically with the electrolytically conductive medium described below. This 7W pole can be made of metal, have a metal coating, or alternatively be filled with a metal that makes it conductive. For example, aluminum, CIF lead, chrome, iron, nickel, lead, amalgam of lead and mercury, platinum, silver, copper, mercury and gold can be used. Preferred metals are stable in aqueous chloride solutions and include stainless steel and silver. The most suitable metal is one that produces the least amount of potential difference between the electrode pair. The silver electrodes have a small potential difference between the electrode pairs, minimizing noise.

This noise can be further reduced by treating the surface of the electrode in contact with the gel having electrolytic conductivity to make it 1U. A silver electrode can be chlorinated by placing it under a stop voltage in an aqueous sodium chloride solution to create a surface composition of silver and silver chloride.

Chlorinated silver surface electrodes are not always optimal because this surface is easily damaged and the photosensitive silver chloride can produce electrical noise in response to light fluctuations. Stainless steel electrodes are also very suitable.

The insertion tube 2 has an outer cylindrical portion 1B formed with a rounded and smooth leading edge 18 for insertion into the F. There is a flange portion or card 22 which 1-[eliminating the risk of inadvertent damage to the eardrum by limiting the depth of insertion of the tube in the opposite direction; It has a circular opening "124" that passes through it in the mated state.

This insertion tube 2 is made of plastic (as shown),
It can be made of metal, or of paper or textile material in a laminated state that can function as a moisture barrier 11-wall.

The cylindrical portion 16 of the insertion tube surrounds and isolates the resilient foam plastic member 26 during the insertion operation. The edge 18 of the insertion tube is an inverted bent portion 1
4 and form a seal that seals moisture with I, +ii? The opening 24 forms a moisture seal 11 with the outer surface of the tubular electrode 4. For this reason, the foamed plastic member 26-1
- Preventing evaporation of moisture and other solvents that may be present in the gel coating.

The insertion tube 2 is held in position surrounding the foamed plastic member 26 by a clip member 6.

FIG. 3 is a sectional view taken along line CC in FIG. 1, showing the clip member 6 in more detail. The clip member 6 is shown as a plastic member consisting of two halves 34, 36 and one integral hinge portion 38. This creep member half 34,38 is attached to the outer surface 4 of the tubular electrode 4.
It has an inner surface of a cylindrical contour 40 that matches the shape of 2. The clip member 6 is made of foamed plastic as shown in the figure.
It can be made of polyethylene or other plastic, or it can also be replaced with a clip made of metal, pole paper or other rigid material. The clip member 6 can be easily removed by unfolding the two halves 34.3B and releasing them from the outer surface 42 of the tubular electrode 4.

FIG. 4 is a plan sectional view with respect to the central axis of the auditory canal electrode of the present invention, showing the device with the clip member 6 removed and the insertion tube 2 pulled out. The connector 9 has a tubular portion 2 which frictionally engages the open portion 30 of the insertion tube 2 when the insertion tube 2 is pulled out to hold the insertion tube in the withdrawn position.

Since the device is shown outside the ear canal area, the foamed plastic member 26 is shown in a relaxed and fully expanded state. The foamed plastic member is preferably cylindrical in shape and has a diameter larger than the auditory canal and a cylindrical passageway 44 from which the tubular electrode 4 projects. The end 46 of the foamed plastic member 17- near the distal end 10 is held in place by the clamping portion 14 of the tubular electrode 4, which clamps and holds the end of the foamed plastic member in a hard compressed state. Alternatively, a tightening ring member can also be used.

The foamed plastic member 26 can be made from any resilient, open, porous foamed plastic material. This member is preferably made from a continuous porous phase material such as FILTERFOAM, a polyurethane, which is a highly tensile product. This foam holds an electrolytically conductive medium which is a liquid, gel, jelly or other dispersing or suspending agent having good conductive properties and which reacts electrolytically with the conductive metal of the tubular electrode 4. Alternatively, it is desirable to impregnate it.

For example, a medium that has conductivity due to electrolytic action is 11!
Dispersed in an aqueous solution of electrolytically conductive salts such as thorium chloride, potassium chloride, or sulfur sulfate.
An electrically conductive 18-emulsion material consisting of an emulsified material and a surface-active dispersant may be used. This medium also contains an aqueous phase of thorium monide gelled with well-known gelling agents such as sodium carbide, dimethyl cellulose, and as a commercially available salt. 1 with conductivity such as potassium chloride, sodium sulfate, sulfur, potassium acid, sodium bromide, potassium bromide, thorium nitride, ammonium fluoride, ammonium bromide, ammonium nitride, ammonium sulfate J1, etc.
A highly conductive seri having Class 11 may be used.

FIGS. 5 and 6 are cross-sectional views of one electrode of the present invention in its initial and final inserted positions within the `ill, respectively.

In FIG. 5, the flange portion 22 is in contact with the outer 11' surface to limit the depth of travel of the device within the canal 50 and prevent contact with the tympanic membrane 51 during initial insertion. The cylindrical portion 16 of the insertion tube 2 is
It is in contact with the skin surface 52 of the road. The insertion tube 2 is held in an open position for insertion by a clip member 6. The foam plastic link member 26 remains sealed by the insertion tube. Because the leading edge 18 is rounded and smooth, damage to the 10n epidermal tissue during the insertion operation is avoided.

FIG. 6 shows the ear canal electrode of the invention after the clip member 6 has been removed and the tubular electrode 4 has been inserted into its final position.
(In this case, the insertion tube 2 is left in the state 11'= pulled out from around the expanded plastic foam member 26. The expanded plastic member 26 is in an expanded state and is securely connected to the skin surface 52 of the lr channel. A thin layer of electrolytically highly conductive medium on the outer surface 48 of the foamed plastic member ensures good electrical contact with the skin surface and minimal electrical resistance. An extra coat of 1" can be applied to the surface before being inserted.

However, the foamed plastic member impregnated with extra medium is 9! Delicious. Owing to the moisture-tight seal provided by the insertion tube 2, evaporation of the solvent from the medium is prevented and the electrode can be inserted at any time even after long-term storage. .

Since the flange portion 22 limits the interlocking distance of the tubular electrode 4, the risk of inadvertent contact with the eardrum 51 or perforation is completely eliminated, and it can be inserted routinely by an ordinary assistant without special training. It is something that makes it possible to do something.

The connector 9 of the tubular electrode 4 is the connector 5 of the acoustic signal generator.
It is engaged with 4. The source of this f7@signal generator is
It has a coupling element 56 which is configured to engage the fixation screw 12 and hold each element to the body.

Connector 54 is provided with an opening 60 for receiving and engaging a tube 64. This tube 64 is connected to the tubular electrode 4 so that the bonding resistance between the two metals is minimized.
It is preferable that it be made from the same metal as. The tube has a proximal end 86 or an end 86 which makes electrical contact with the tubular electrode 4. Wiring 70, which conveys the intuitive signals from tube 64 to an acoustic brainstem response analyzer (not shown), is connected to tube 64 by junction 68.

The J signal generator and its associated magnetic field shield may be of any standard type suitable for providing the acoustic stimulation required for acoustic brainstem responses. The i' signal generator is of standard construction well known in the art and does not form an essential part of the present invention.

1. For an explanation of the method for measuring and analyzing rW-like brainstem responses, please refer to section (1) whose contents are cited in the main text for reference.
rscandanavian Audiolog
y Supplementum No. 11~ of 13J
22 E, Borg, “Physiological Mechanisms and Auditory Cortex Responses of the Brainstem,” and “Auditory Organs,” Vol. 32, No. 8, 198.
Erlkson et al., “H'
"Measurement of acoustically generated potentials and their selection method". The latter article includes a description of currently available devices and auxiliary devices such as acoustic signal generators for the testing and analysis of acoustic brainstem responses.

Interesting moments in the testing of acoustically generated potentials 22 - The problem is that they are recorded directly from the human scalp. ω
F Research has developed this test to provide 41 effective and diverse methods for evaluating hearing. This F method is f
It provides a reaction stage that effectively discriminates between conductor and octopus hearing loss and differentiates between peripheral and central pathologies in patients who are difficult to test using standard methods. Ant shell potentials with increased intensity display pressure in the inner 1'. In some cases, this technique can also reveal clinically subclinical disturbances of central pathways. is the drowsiness signal obtained from the skin surface.
-J, resulting from high noise levels. This noise level becomes a major obstacle to sufficient Ik opening of this test F stage. Since this detected electrical signal is typically less than 1 .mu.volt in magnitude, any external noise produced by the amplifier 111 is a major problem. Ru. history, tree 1
1) The resistance caused by the conductive electrode element and resulting from the large resistance at the interface between the skin' and the electrode greatly reduces the sensitivity.

The 1L tract electrode of the present invention provides the lowest possible ear skin surface resistance and very high sensitivity. In order to keep the electrical resistance and impedance as low as possible, it is important to use a foamed plastic material impregnated with a gel that has electrolytic conductivity. This gel provides optimal electrical conductivity between the skin surface 52 and the conductive tubular electrode 4. It is also important to have a +t1t: type i metal conductor (not a junction of two metals) between the conductive gel and the electrical junction 68. In this way, the normal working resistance is 2 Koh
It was lower than Otori.

Safety of the connection and ease of insertion were achieved. The risk of damaging the tympanic membrane is eliminated even when inserting electrodes by IJ+-# without special training in f procedures. The special guard 22 limits the insertion distance to a depth that does not reach the depth of the eardrum.

[Brief explanation of drawings]

FIG. 1 is a t-plane view showing the non-rational molded external electrode fully assembled prior to use, and FIG. [E Cross-sectional view showing the reverse electrode, 3rd
The figures show a cross-sectional view of the fully assembled Il:reverse electrode of the invention before use, taken along line C--C in figure 1, and figure 4 shows the expanded state of the foamed plastic member after withdrawal of the insertion tube. A sectional view showing the Ir main electrode of the present invention, FIG.
Ir1llll of the present invention in the f-way reverse first insertion position
A cross-sectional side view showing the tt electrode, and FIG. 6 shows the expanded state 1〃i of the foamed plastic member after removing the retaining clip and inserting the '[;t'i electrode to the warp-resistant insertion position. 1 is a cross-sectional side view of the reverse electrode. 2...1 dwarf tube, 4...tubular electrode, 6...
Clip member, 8... proximal end, lO... distal end, 1
2... Fixing screw, 14... Tightening part, 16... Cylindrical part, 18... Leading edge part, 20... Proximal end part, 22
... Guard, 24... Open [1, 26... Foamed plastic part, 28... Tubular part, 30... Open 11
Part 25-minute, 34...half part, 36...half part, 38...hinged part, 40...cylindrical part, 42...outer surface, 44
... Cylindrical passage, 46... End, 48... Outer surface, 50... 1f channel, 51... Eardrum, 52... Skin surface, 54... Connector, 56...・Connection element, 60
...Opening, 64...Tube, 66...End, 6
8... Junction point, 70... Wiring. 26- Procedural amendment (Yamamoto). March 11, 1980 Director-General of the Patent Office'me Wakasugi 41'' Husband 1, case display % order 1988-8844-2, title outside the invention column] n use 11 to pole 3, Nagisa to amend Relationship with CI Patent applicant name Mi Axonics Incorporated (name) 4th representative person 〒1117 7, M correct f'＞Contents Drawing details, 1 (no reversal to contents) 231-

Claims (1)

[Claims] 1. An electrode device made of a material having tetraelectricity for transmitting electrical signals picked up from the surface of the cloth, the electrode device having a proximal end and a distal end. and the distal end portion is
-11 Implantable outer shell 10′ tube pole characterized by placing a highly elastic foamed plastic device with 74 electrical properties for transmitting electric signals () in contact with the skin surface of the body. . 2. The auditory canal electrode according to claim 1, wherein the electrode device is a tubular electrode device. 3. The RF path electrode according to claim 2, wherein the tubular electrode device is made of metal. 4. The non-reasonable type according to claim 2, wherein the tubular electrode device constitutes one L stage for transmitting acoustic stimulation to four channels. 5. The non-integrated external auditory canal electrode according to claim 4, wherein the 91-shaped electrode device is made of metal. 6. The foamed plastic device has an annular foam surrounding the distal end. 1. The auditory canal electrode according to claim 1, characterized in that it is a plastic member. 7. Claim, characterized in that the foamed plastic member is an open porous foamed plastic material. The auditory canal electrode according to claim 6. 8. The auditory canal electrode according to claim 7, wherein the foamed plastic member is impregnated with a medium having conductivity due to electrolytic action. 9. Claim 8, wherein the metal is made of silver or stainless steel.
Road'city pole. 10. The auditory canal electrode according to claim 4, wherein the tubular electrode device is an acoustic horn. +1. characterized in that the end of the foamed plastic member proximal to the distal end of the tubular member is held in compression with respect to the tubular member by an annular tightening device! tJ
1. The electrode according to claim 8. 12. +iii The tubular device is made of metal and its distal end is bent into the !-!AfkL of the 11. A patent characterized in that it forms a tightening device having a diameter 41 larger than the element, and the end of the foamed plastic member near the curved distal end is clamped in compression between said tightening device and a tubular device. 'ii as described in claim 11
71ffi pole. +a, the foamed plastic member described in +iii is compressed into the converted outer insertion tube device for inserting the lf main electrode into the canal, and the outer insertion tube device described in +iii is then pulled out to the non-retracted position. 11 hours after being
7. An If tract electrode according to claim 6, wherein the foamed plastic phase expands within the tract to produce positive contact with the skin surface. +4, the row-side insertion tube device described in +iii is I[
The method according to claim 13, characterized in that it includes a protection device for restricting the number of people Mli # in the canal to a predetermined distance not far from the eardrum.