CN101522254A - Electrode assembly and method of using same - Google Patents
Electrode assembly and method of using same Download PDFInfo
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- CN101522254A CN101522254A CNA2007800322003A CN200780032200A CN101522254A CN 101522254 A CN101522254 A CN 101522254A CN A2007800322003 A CNA2007800322003 A CN A2007800322003A CN 200780032200 A CN200780032200 A CN 200780032200A CN 101522254 A CN101522254 A CN 101522254A
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Abstract
An electrode assembly (30, 130, 230, 330, 430, 530, 630) for delivering electrical stimulation to a vestibular system of a user or monitoring a physiological parameter of the user. The apparatus includes a body member (40, 140, 240, 340, 540, 640) comprising an electrode support portion (44, 144, 244, 344, 544, 644) and a curved portion (46, 146, 246, 346, 546, 646)extending from the electrode support portion, and an electrode (42, 142, 242, 342, 442, 542, 642) coupled to the electrode support portion. A method of using such an apparatus is also disclosed. The present invention also provides an electrode assembly that includes a body member, an electrode coupled to the body member, a hydrogel element disposed on at least a portion of the electrode. In one embodiment, the hydrogel element includes a hydrogel material and a insulating material disposed on or in the hydrogel material such that the insulating layer disperses energy transmitted by the electrode through the hydrogel material.
Description
Priority request
According to the regulation of United States code 35 § 119 (e), the application requires to enjoy the U.S. Provisional Patent Application NO.60/841 of JIUYUE in 2006 submission on the 1st, 802 right.
Technical field
The present invention relates to electrode assemblie, it is used to stimulate user's (such as vestibular system of user) and/or monitor user ', the present invention relates more specifically to have the electrode assemblie of main body and electrode, wherein described main-body structure is the suitable external ear that centers on, and described electrode is couple to main component and is provided with, the invention still further relates to the method for using this device so that energy is delivered to user's (such as vestibular system) and/or monitor user '.
Background technology
Vestibular system is responsible for detecting position and the motion of head in the space.The semicircular duct that is arranged in internal ear is the perceptual organ of vestibular system, and collects head position information and movable information and by the 8th cranial nerve it is transferred to the central nervous system.The imbalance of vestibular system can cause disorder, and such as dizzy, dizzy and nauseating, the order of severity scope of its symptom is from slight weak in weak fully.
To semicircular duct, utriculus, sacculus or other otolithic organs' stimulation, and to causing the perception of normal subjects to motion from the nerve fiber of these organ guiding or the stimulation of the 8th cranial nerve or its combination.Can cause the consciousness of uncomfortable light exercise to the adequate stimulus of vestibular system, but can have useful feature, such as the sleep state that promotes the patient.
There are many technology that are used to stimulate vestibular system.These methods comprise calorimetric method, chemical method and electrical method.Calorimetric and chemical stimulation take directly or indirectly hot solution or chemical mixture are directly applied to the form of the 8th cranial nerve usually.Electricity irritation to vestibular system generally includes the placement of electrode in skin surface (for example on the mastoid of ear back), or pierces through tympanum so that directly stimulate semicircular duct with electrode.It also is known stimulating vestibular system by the invasive electrode in the implantation internal ear.
The conventional surface electrode that is used to stimulate vestibular system is not optimum for making the patient comfortable.These electrodes generally include the patch-type electrode, and this patch-type electrode is applied to the patient surface, usually near mastoid process.This type electrode comprises adhesive layer, and the intensity of this adhesive layer is enough to electrode is fixed to the user surface.Can there be the consequence of using this binding agent not expect in nature.For example, removing electrode need be from user's surface isolation binding agent, and this can be the process of pain, especially when binding agent is fixed to hair.
In addition, the layman is difficult to surface electrode is applied to the exact position that stimulation will be provided.When the user attempts electrode is applied to he or she self the time, because the user is not easy to touch and is not easy to see the lateral fact of head, suitably site type electrode even more difficult.If surface electrode suitably is not positioned at user's desired locations, then the stimulation energy that provides of surface electrode can cause unwillingly consequence, such as the modulation of the carotid artery/hole district nerve of the non-specific activation of facial muscle, unconscious tic, anaudia or cervical region.
Use is arranged on electrode in the auditory meatus, and to stimulate vestibular system also be known.Yet the user may dislike having during stimulation therapy object at its in ear, and this bestows when the user is sleeping and/or sleeping in some cases.Really, the crowd who it is believed that about 15-30% dislikes its in ear anything.
Therefore, exist in medical domain a kind of permission the specificity of vestibular system and the long-term needs of Noninvasive activated system, this system is enough comfortable concerning the patient to be worn for a long time being suitable for, such as between sleep period and at quiet rest period.This system should be positioned at the appropriate location on the head with stimulating electrode easily and not need and assist for user he self.In addition, this system should allow many kinds of stimulus frequency and waveform are delivered to the vestibular system of internal ear.
This system also should be comfortable concerning the patient, even when being arranged on this system between patient and the lower layer support, for example lies on the medicated pillow and stimulating system between head and medicated pillow the time when patient's head.In addition, this system should firmly remain on the appropriate location so that stimulation energy is delivered to the anatomical structure position of expectation, and be not subjected to proper motion and contact force (such as between sleep period and attempt tossing about when sleeping) influence.
Summary of the invention
Therefore, target of the present invention provides a kind of vestibular stimulation system, and this system has overcome the defective of conventional vestibular stimulation system.According to one embodiment of present invention, realize this target by a kind of vestibular stimulation system of electrode assemblie that comprises is provided, described electrode assemblie is used for electricity irritation is delivered to user's vestibular system.This electrode assemblie comprises main component, the sweep that this main component has the electrode supporting part and partly extends from electrode supporting.This sweep allow with electrode assemblie be positioned at the external ear back side around, thereby make when electrode assemblie is couple to the user, electrode supporting partly is arranged on user's suitable stimulation on one's body applies the position.The electrode that is coupled to the electrode supporting part is sent stimulation energy.
Another target of the present invention provides and a kind of stimulation energy is offered the method for vestibular system, and this method is not subjected to the influence of the relevant shortcoming of conventional vestibular stimulation technology.By providing a kind of method that may further comprise the steps to realize this target: at least a portion that holds hard of hearing the circumference of locating of people by at least a portion with electrode assemblie is fixed to the user surface with electrode assemblie, and energy is sent part is provided near mastoid process.Stimulation energy is offered electrode assemblie.
In further embodiment, by being provided, a kind of method that electricity irritation is delivered to the user realizes this target, this method comprises: electrode assemblie is provided; With the part of hydrogel element application to electrode assemblie; Electrode assemblie is affixed to the user; Use electrode assemblie energy is delivered to such user; Remove the hydrogel element from electrode assemblie; With the described part of follow-up hydrogel element application to electrode assemblie; And reuse electrode assemblie energy is delivered to such user.
In another embodiment, the present invention expection provides electrode assemblie, this electrode assemblie to comprise main component, is coupled to the electrode of main component and is arranged on hydrogel element at least a portion of electrode.The hydrogel element comprises hydrogel material, and is arranged on the insulant on the hydrogel material or in the hydrogel material, so that the energy of insulating barrier dispersive electrode transmission.
In embodiment further, the present invention's expection is except being delivered to energy the user or as an alternative, using said system, method and apparatus to come the physiological parameter of monitor user '.
Though the method (as mentioned above) that the electrode assemblie that is used to stimulate vestibular system described above, further object of the present invention provide electrode assemblie and use this electrode assemblie is to stimulate other parts except vestibular system or that replace vestibular system of user.
By the appended accompanying drawing of reference, on the description below considering and the basis of claims, the business efficiency of the function of the related elements of these and other targets of the present invention, feature and characteristic and operational approach, structure, the combination of parts and manufacturing will become apparent, all these constitute the part of this description, and wherein same reference numbers is represented the counterpart in each accompanying drawing.Yet, will be clear that geography separates accompanying drawing only for the purpose of illustration and description, and be not intended to qualification as limitation of the present invention.As employed in description and the claim, singulative " ", " one " and " described " comprise the plural number denotion, unless clearly point out in addition in the context.
Description of drawings
Fig. 1 is the rear view of first embodiment of electrode assemblie in accordance with the principles of the present invention;
Fig. 2 is the decomposition view of the spiral electrode of Fig. 1;
Fig. 3 is the side view of the electrode assemblie of displayed map 1 at the human head of user position on one's body;
Fig. 4 is the perspective view of second embodiment of electrode assemblie in accordance with the principles of the present invention;
Fig. 5 is the decomposition view of the spiral electrode of Fig. 4;
Fig. 6 is the detailed perspective view of a part of the electrode assemblie of Fig. 4;
Fig. 7 A and 7B have illustrated the perspective view that is used for bonded assemblies is attached to the technology of main component;
Fig. 8 is the rear view of the 3rd embodiment of electrode assemblie in accordance with the principles of the present invention;
Fig. 9 is the perspective view of the main component in the electrode assemblie of Fig. 8;
Figure 10 is the perspective view of the electric lead in the electrode assemblie of Fig. 8;
The electric lead that Figure 11 shows Figure 10 is attached to the perspective view of the main component of the Fig. 9 in the electrode assemblie of Fig. 8;
Figure 12 shows the rear view that adhesive member is attached to main component as the step in the manufacture process of the electrode assemblie of Fig. 8.
Figure 13 shows the rear view that conductive member is applied to main component and adhesive member as the step in the manufacture process of the electrode assemblie of Fig. 8;
Figure 14 shows during the manufacture process of electrode assemblie of Fig. 8 the contact pad designed rear view that is applied to the remainder of electrode assemblie of patient;
Figure 15 is the decomposition view of the 4th embodiment of electrode assemblie in accordance with the principles of the present invention;
Figure 16 is the decomposition view of the 5th embodiment of electrode assemblie in accordance with the principles of the present invention;
Figure 17 is the perspective view that has illustrated by band pair of electrodes assembly connected to one another;
Figure 18 is the rear view of the 6th embodiment of electrode assemblie in accordance with the principles of the present invention;
Figure 19 has illustrated the rear view of assembly of the main component in the electrode assemblie of Figure 18 and the detailed view of a main component part;
Figure 20 is the perspective view that the main component in the electrode assemblie of Figure 18 has been described;
Figure 21 is the rear view that the assembling of electrode and main component in the assembling of the electrode assemblie of Figure 18 has been described;
Figure 22 is the perspective view of the illustrated electrode of Figure 21;
Figure 23 has illustrated that electric lead in the assembling of electrode assemblie of Figure 18 is attached to the perspective view of main component;
Figure 24 has illustrated that over cap in the assembling of electrode assemblie of Figure 18 is assembled to the perspective view of main component;
Figure 25 is the perspective view of a part that the electrode assemblie that is assembled of Figure 18 has been described;
Figure 26 is a electrode that electric lead and Figure 22 be described and the cross section perspective view that is connected of lid shown in Figure 24;
Figure 27 A shows the decomposition view that bonded assemblies is attached to the electrode assemblie of Figure 18;
Figure 27 B shows the decomposition view of replaceable configuration of the bonded assemblies of the electrode assemblie that is suitable for Figure 18;
Figure 28 is arranged on the perspective view that is suitable for a plurality of bonded assemblies that the electrode assemblie with Figure 18 uses on the shared backer board;
Figure 29 has illustrated the back decomposition view of the 7th embodiment of electrode assemblie in accordance with the principles of the present invention;
Figure 30 A-30E is the rearview that the various embodiment that are used to be arranged on the insulating barrier on electrode/conductive layer have been described, it is suitable in the electrode assemblie of Figure 28; And
Figure 31 shows the back decomposition view that bonded assemblies is attached to the electrode assemblie of Figure 29.
The specific embodiment
Fig. 1-3 has illustrated a kind of vestibular stimulation system 20, and it is used for electricity irritation is delivered to user's vestibular system.Particularly, these description of drawings be used for first embodiment of the electrode assemblie in accordance with the principles of the present invention 30 of vestibular stimulation system.The details and the alternative embodiment thereof of electrode assemblie 30 provide below.Except electrode assemblie 30, vestibular stimulation system 20 also comprises stimulation energy source/controller 32, and electrode assemblie is coupled to this stimulation energy source/controller 32.
Source/controller 32 offers electrode assemblie 30 with current forms with energy usually.Source/controller 32 comprises controller and energy source, its middle controller control energy sending from the energy source to the electrode assemblie, thereby source/controller 32 control stimulation energy or be delivered to user's treatment by electrode assemblie.In its simplest form, controller can be the equipment of manually booting, for example on-off switch.In than complex embodiments, controller is regulated amount and/or the energy model that is delivered to the energy of electrode assemblie 30 by source 32.Controller can comprise that processor, circuit or control offer other electricity/electromechanical equipments of the energy of electrode assemblie.Electric wire or electric lead 34 are coupled to electrode assemblie with energy source.Energy source can provide electric power by AC supply of electric power or DC supply of electric power, and the DC supply of electric power is such as one or more batteries.Certainly, controller/source 32 comprises that necessary circuitry, input-output apparatus, programming and other features provide the function of electric energy to be implemented as electrode assemblie.
Can recognize, in order to provide electricity irritation to the user, must be on one's body the user with at least two positioning of electrodes.In the embodiment shown in fig. 1, schematically illustrated second electrode assemblie 36 that is coupled to controller/source 32 equally.Certainly, can will be attached to energy controller/source more than two electrode assemblies.Second electrode assemblie 36 can have identical configuration or can have not isomorphism type with electrode assemblie 30.
Can construct electrode 42 and electrode supporting part 44, so that electrode is installed on the main component.At last, electrode supporting part 44 comprises opening 48, and this opening 48 is carried out size design and constructs with hold electrodes.Provide notch 50 so that the electrode supporting part is flexible, so that hold electrodes and after electrode is set in the opening 48, be back to its original-shape, thereby electrode is affixed to main component closely.Can be simply by electrode is taken out and electrode is separated from main component from opening.
With the shaped design of the sweep 46 of main component 40 is semicircle, spiral type, avette or oval-shaped form, because these shapes are substantially corresponding to hard of hearing of people's shape.As shown in Figure 3, the outside of people's ear comprises auricle or earflap 52, and auricle or earflap 52 are surperficial from the head outstanding cartilages.Earflap in this from the head or hard of hearing the fine wrinkle of locating (crease) that extend of skull be irregular concave structure, it is indicated substantially at 54 places.With the shaped design of the sweep 56 of main component 40 for mating this part human anatomic structure substantially, so that the sweep rest is near this fine wrinkle place or its.That is to say that the shape of the shape imitation ear of sweep is to provide electrode assemblie suitable to hard of hearing natural torsion.
Sweep is positioned at hard of hearing fine wrinkle place, the electrode part of electrode assemblie suitably can be positioned on one's body the user so that seldom understand or do not understand the people of human anatomic structure, promptly at the mastoid process place, on the mastoid process or near mastoid process.The mastoid that is located immediately at the ear back provides the big relatively target area that is used to provide vestibular stimulation.If adopt the patch-type electrode assemblie, the user who seldom understands human anatomic structure is difficult to electrode suitably is positioned at mastoid process probably.When attempting that electrode is applied to the head side, be difficult to see that the lateral fact of head can increase the weight of above-mentioned situation.The present invention addresses this problem in the following manner: by with hard of hearing as anchor station or reference point so that the user can be only by sweep being arranged in hard of hearing and electrode is placed on desired locations.
Sweep also helps by a part that holds external ear at least a little electrode assemblie to be fixed to the user.The comfortable anchor point of ear contact structures is formed on the top of spiral, and searches the appropriate location in a way automatically " to hook " ear at the ear top.That is to say that in the exemplary embodiment, the far-end 47 of the sweep 46 of main component 40 hooks have sharp ears or ear top.Do like this, easily electrode assemblie is positioned at indoor and hold it in the appropriate location of ear.Electrode assemblie has substantially flat configuration, so that the user can in use be pressed on the electrode assemblie, for example stimulation is delivered to vestibular system to induce or during hypnotic when electrode assemblie.
In the illustrated embodiment, sweep 46 comprises cut-out 56.Provide these cut-out 56 reducing the amount of the material that must be attached to the user, allow electrode assemblie user surface breathing down, and provide some flexibilities for sweep.Be appreciated that shape, size, quantity and the configuration that can change cut-out 56 as required.
Provide bonded assemblies 60 so that electrode assemblie is attached to the user.In this embodiment, bonded assemblies 60 comprises adhesive member 62, is arranged on the bonding support 64 on adhesive member one side and is arranged on removable backing 66 on the adhesive member opposite side.Can in bonding support 64, provide another adhesive layer (not shown), not adhere to electrode assemblie so that do not contact the arbitrary portion of the bonding support of adhesive member 62.Removable backing 66 comprises that tab 68 is to allow the user and catch backing and with backing peeling member layer 62.Can change size, shape and the configuration of bonded assemblies and each individual components thereof.In addition, can in an electrode assemblie, provide a plurality of bonded assemblies.
The present invention expects that adhesive member 62 is any suitable binding agents, and suitably the example of binding agent is a hydrogel.In this illustrated embodiment, adhesive member covers above at least a portion of electrode 42.In this case, this part of adhesive member should be conducted electricity, so that energy is transferred to the patient from electrode by adhesive member.Electroconductive binder is more favourable, because it guarantees the excellent electric contact with the user surface.
To further understand, must on electrode, not provide adhesive member, and electrode (or its each several part) is directly contacted with the user surface.In this case, binding agent must not conduct electricity.Bonding support 64 can also be to support any material of adhesive member or the combination of material.Suitably the example of material is fabric or foamed materials band.
This embodiment of electrode assemblie 30 provides two kinds of replaceable modes of the each several part that uses and reuse electrode assemblie.In a scheme, as mentioned above, use back entire electrode assembly discardable at one or many.The user only needs by splicing ear 58 electric lead 34 decoupling zeros just can be separated electrode assemblie from electric lead 34.Abandon this electrode assemblie and new electrode assemblie is attached to electric lead, thereby the major part of electric lead is reused in permission.This electrode assemblie that also allows to have isomorphism type not uses together with identical electric lead 36 and source/controller 32.
In another program, only this part that need use the back to change at one or many of electrode assemblie is that bonded assemblies 60 is discardable with the back.After binding agent no longer can fully be attached to the user, can by removing adhesive member 62 and backing 66 bonded assemblies be removed from main component 40 and electrode 42 simply.Also can remove bonding support 64, but this depends on the type of material that bonding support is used, it also is possible reusing bonding support equally.New adhesive member 62 (then also having bonding support if desired) is applied to electrode body, and the entire electrode assembly is got ready for using now, and do not need to abandon electrode or main component.
Fig. 4-7B has illustrated second embodiment of electrode assemblie 130 in accordance with the principles of the present invention.Electrode assemblie 130 comprises main component 140 and bonded assemblies 160.Main component 140 comprises electrode supporting part 144 and sweep 146.In the exemplary embodiment, sweep 146 is formed by the die compression molding material, and these plastics are such as the Polycarbonate GE Lexan HP1 with about 0.040 inch thickness.For comfortable, sweep can comprise the overlapping flexible material that is molded into the duroplasts part, such as soft elastomer.
Electrode supporting partly is the electrode assemblie 130 attached parts extremely of main component.Electrode supporting partly comprises attached component, and it is used for optionally electrode assemblie being coupled to main component and is used to provide being electrically connected between the electric lead 34 that is attached to main component and the electrode 142 that bonded assemblies is provided.
In this embodiment, electrode 142 is associated with bonded assemblies, rather than embodiment directly is attached to main component like that as described above.More specifically, electrode 142 is arranged in the bonding support 164, for example by with its printing or be coated on the material that forms bonding support 164.Electrode 142 comprises coupling part 148 and major part 150.This major part is covered by adhesive member 162, and coupling part 148 is exposed.
In illustrated exemplary embodiment, protuberance 152 that electrode supporting part 144 provides and the corresponding opening 154 that provides in bonded assemblies 160 are provided the attached component that bonded assemblies 160 is coupled to main component 140.Certainly, the present invention also expect the counter-rotating these parts the orientation so that protuberance is being provided on the bonded assemblies and opening is being provided in main component.
In order between electric lead 34 and electrode 142, to provide electrical connection, provide contact terminal 156 in the end of electric lead.As best image among Fig. 6, contact terminal is coupled to main component, so that extend a little from main component.When bonded assemblies 160 was coupled to main component 140, contact terminal 156 formed and the electrically contacting of the coupling part 148 of electrode 42.Particularly the electrode supporting part is shown in broken lines in Fig. 6 in the cover part of main component.
This embodiment allows bonded assemblies 160 and main component 140 are carried out produce and market as isolating element.Therefore, the user only needs to have a main component, and the bonded assemblies supply, so that by reusing main component and changing bonded assemblies at the appropriate time and repeatedly use stimulating system.The assembling of bonded assemblies and main component has been shown in Fig. 7 A and 7B.This is simple two step process.At first, with directed bonded assemblies of certain angle, shown in arrow 158, bonded assemblies is moved into main component then and contacts, so that protuberance 152 enters opening 154 with respect to main component.
Fig. 8-14 has illustrated the 3rd embodiment of electrode assemblie 230 in accordance with the principles of the present invention.Electrode assemblie 230 comprises main component 240 and bonded assemblies 260.Main component 240 comprises electrode supporting part 244 and sweep 246.In this embodiment, limit main component by from one piece (such as Merlon).Connect lead 250 and be attached to the electrode supporting part.
As in Figure 10 and 11 possibility best image, connect lead 250 and comprise first splicing ear 252, it is inserted in the groove 254 that is provided in the electrode supporting part of main component.In the exemplary embodiment, in groove, splicing ear or the two, provide one or more stop pins, to prevent that splicing ear from being removed from groove.As discussed in more detail below, first splicing ear 252 also is used as the contact point with electrode 242.Connection lead 250 is short relatively and comprise second splicing ear 258, and this second splicing ear 258 uses any suitable connection configuration optionally to be connected to electric lead.
In groove 254, provide after first splicing ear 252, bonded assemblies 260 is coupled to main component 240.Referring to Figure 12.This finishes by following steps: at first bonding support 364 is applied to a side of main component, so that bonding support is attached to the electrode supporting part 244 of main component.The present invention expects that any suitable interconnection technique of employing is coupled to electrode supporting part 244 with bonding support 264.In the exemplary embodiment, bonding support 264 is medical adhesive tapes, such as the MED5322P medical adhesive tape of Avery Dennison sale.
Be applied to electrode 242 on the electrode supporting part 244 then, electrically contact at least a portion of bonding support 264 and with first splicing ear 252.In the illustrated embodiment, electrode 242 is the conduction bands with general rectangular configuration.The example of the suitable material of electrode is the 9713X-Y-Z adhesive tape that 3M makes.Be appreciated that the present invention expects that electrode 242 can be any suitable size or shape, can be positioned at other positions, and can comprise a plurality of electrodes that for example are electrically connected to each other.
Then, adhesive member 262 is arranged on the electrode 242.Referring to Figure 14.In illustrated exemplary embodiment, adhesive member 262 has cardinal principle and the corresponding shape of the shape of bonding support 264, so that electrode 242 is clipped between these two parts fully.Yet should be understood that the present invention expects other configurations of adhesive member.The example that is suitable for use as the material of adhesive member 262 is
The AG603 hydrogel that Technologies sells.
In the exemplary embodiment, backing 266 is attached to adhesive member 262 in advance so that backing and adhesive member the two be attached to electrode assemblie as one.Certainly, after adhesive member is affixed to electrode assemblie, backing can be applied in adhesive member 262 in whole or in part on.Replacedly, can ignore backing fully.Backing 266 comprises optional tab 268, so that the user removes backing easily and exposes adhesive member electrode assemblie is applied on the his or her head.
Figure 15 has illustrated the 4th embodiment of electrode assemblie 330 in accordance with the principles of the present invention.Electrode assemblie 330 comprises main component 340 and bonded assemblies 360.Main component 340 comprises electrode supporting part 344 and sweep 346.Provide extension 348 from an end of main component, so that catch main component easily and further extend main component around hard of hearing of people.Electrode supporting part 344 comprises that opening 350 is to hold the part of bonded assemblies 360.
The bonded assemblies 360 of this embodiment comprises electrode 342 and is attached to the adhesive member 362 of electrode.Counter electrode 342 carries out size design and constructs to be contained in (shown in arrow 352) in the opening 350, so that adhesive member 362 is arranged between user surface and the electrode 342.In the illustrated embodiment, how there is flexibility to a certain degree aspect directed at bonded assemblies, so that can control the relative position of adhesive member 362 with respect to main component 340.Yet, electrode 342 with respect to main component invariant position, this is because it is by fixing with respect to main component (promptly at opening 350 places).
Though electrode 342 is depicted as general cylindrical and opening 350 is depicted as substantially circular, be appreciated that for these parts of electrode assemblie and also can expect other configurations.Adhesive member 350 is hydrogel elements of abundant self-supporting, so that does not need bonding support.Certainly the present invention's expection comprises the bonding support of the electrical connection between any not interfere with electrode and the user surface.Can on a surface of adhesive member 362 or two surfaces, provide the backing (not shown).
Figure 16 and 17 has illustrated the 5th embodiment of electrode assemblie 430 in accordance with the principles of the present invention.Electrode assemblie 430 comprises main component 340 and bonded assemblies 460, wherein identical in main component 340 and the previous embodiment.Bonded assemblies 460 comprises electrode 442, adhesive member 462 and lid member 470.Bonded assemblies 460 is inserted into shown in arrow 452 in the opening 350 in the main component 340.Structure bonded assemblies 460 is so that be arranged on adhesive member 462 between user surface and the electrode 442.That is to say that first side 472 of electrode assemblie is near user's skin, second side 474 is separated with the user surface that electrode assemblie is installed.As shown in figure 17, provide connect band 476 so that two electrode assemblies are coupled in together so that they are easy to management.
Figure 18-28 has illustrated the 6th embodiment of electrode assemblie 530 in accordance with the principles of the present invention.Electrode assemblie 530 comprises main component 540 and is selectively attached to the bonded assemblies 560 of main component.Main component 540 comprises electrode supporting part 544 and sweep 546.Embodiment as described above, the present invention expect and form the sweep that is formed by die compression molding material (Polycarbonate GE Lexan HP1).In this exemplary embodiment, electrode supporting part 544 is formed by different parts with sweep 546, and as best image among Figure 19, these different parts are coupled in together by attached component 548.
Attached component 548 comprises the mechanism that is used for fixing (forever) connection or separable connected mode electrode supporting part 544 being coupled to sweep 546.In the illustrated embodiment, this mechanism in the attached component 548 comprises a plurality of female opening 550 that is provided in the sweep 546 and the public protuberance (not shown) that is provided in the electrode supporting part 544.Public protuberance cooperates female opening, is fixed on the electrode supporting part with the sweep with main component.Being appreciated that the present invention expects the other technologies that are used for sweep is fixed on electrode supporting part comprises adhesive bond, ultrasonic bonding or snap-fitted (snap-fit) assembly.
At last, in electrode supporting part 544, provide opening 558,, in Figure 22, it is elaborated with hold electrodes 542.Opening 558 is carried out size design and constructs and arrange with substantially corresponding to the size and dimension of at least a portion of electrode, and opening 558 is used to limit electrode position with respect to the miscellaneous part of electrode assemblie on electrode assemblie 530.Figure 20 shows opening 558 and little protuberance or protuberance 564, and it is provided on surface exposure or non-user's contact of electrode supporting part 544.The wall of groove 565 by protuberance is provided.
How Figure 21 illustrated electrode 542 inserted openings 558, and Figure 21-23 shows electrode and the electrode attached details to electrode supporting part 544.Electrode 542 comprises substantially flat or planar base 566 and with the neck part 568 of the form of keyhole shape.Opening 558 mates the keyhole shape of neck 568 substantially, and when with box lunch electrode being inserted opening, neck is positioned at keyhole shaped aperture 558.Groove 565 provides path for electric lead 34, to form and the electrically contacting of the neck part of electrode 542.In neck 568, provide groove 569 to hold electric lead 34.Shown in Figure 24-26, cover 570 so that electric lead is rolled onto on the electrode 542 providing on the neck 542.When being positioned at the appropriate location, lid 570 flushes with the top of protuberance 564 and electric lead 34 firmly be positioned at lid below bolt tightly to electrode.
Figure 27 A has illustrated the exemplary embodiment of the bonded assemblies 560 on the first area 554 that is provided at electrode supporting part 544.In this embodiment, bonded assemblies 560 comprises hydrogel element 572 and backing 574.Hydrogel element 572 comprises hydrogel layer 576 and current-carrying part 578.Current-carrying part 578 is arranged on conducting element or the material in the hydrogel layer or on it.The example of current-carrying part is the conduction backing, and it is provided on the part of hydrogel layer, adjacent electrode 542 when with box lunch bonded assemblies being attached to the electrode supporting part.In use, bonded assemblies 560 is on the electrode supporting part 544, so that at least a portion of current-carrying part 578 and electrode 542 electrically contact.Backing 574 comprises tab 579, and it extends from hydrogel element 572, so that can easily grasp backing and peel off backing from the hydrogel element.
The advantage of this embodiment is that the major part of electrode assemblie can reuse.Unique part that needs periodically to change is a bonded assemblies 560.As shown in figure 28, this can be only by providing a plurality of bonded assemblies 560 that are attached to backer board 580 to realize.The user can remove from backer board one in the bonded assemblies by spurring backing 574 gently, thereby hydrogel element 572 and backing the two (being whole bonded assemblies) are removed from backer board 580.The user is placed on the surface of first area 554 by the surface with the close backer board of same hydrogel element 572 then and contacts, thereby bonded assemblies is applied to the first area 554 of electrode supporting part 544.Current-carrying part 578 must electrically contact with electrode.Another surface of hydrogel element 572 keeps being covered by backing 574, prepares to use electrode assemblie up to the user.When needed, the user removes backing 574 and electrode assemblie is applied to the ear back so that electrode is a vestibular system near mastoid process from hydrogel element 572.
After use, the user removes bonded assemblies 560 from the first area 554 of electrode supporting part 544, for example by hydrogel element 572 is peeled off main component.Electrode supporting part 544 and/or entire body member can be cleaned and by using new bonded assemblies 560 to reuse.
Figure 27 B has illustrated slight deformation that is used for electrode assemblie 530 ' and the bonded assemblies 560 ' that is applicable to electrode assemblie.This embodiment is similar to the embodiment of Figure 27 A, except electrode layer or electrode film 579 are provided on the first area 554 of electrode supporting part 544.In the exemplary embodiment, electrode layer 579 is conduction band or the adhesive tapes that adhere to electrode supporting part 544.In a further exemplary embodiment, electrode layer 579 is not easy to remove, and promptly it forever is coupled to electrode supporting part 544.The bonded assemblies 560 ' that is arranged on removedly at least a portion of electrode layer 579 comprises hydrogel element 572 ' and backing 574.
Figure 29-32 has illustrated the 7th embodiment of electrode assemblie 630 in accordance with the principles of the present invention.Electrode assemblie 630 comprises that main component 640 and selectivity are attached to the bonded assemblies 660 of main component.Main component 640 comprises electrode supporting part 644 and sweep 646.Sweep 646 is similar to the sweep 246 of the main component in the electrode assemblie among Fig. 8-14 substantially.Splicing ear in the groove that electric lead 34 provides by being provided in the sweep is coupled to sweep 646.This connection be similar to above-mentioned about Fig. 8-14 electrode assemblie and the connection discussed.Therefore for simplicity, omit the details that electric lead is attached to main component.
Shown in Figure 30 A-30E, on electrode 642 all or part of, provide insulating barrier 652.In one embodiment, insulating barrier 652 is material patterns of printing or be coated on the conductive layer.Also insulating barrier 652 can be arranged on arbitrary surface of bonded assemblies 660, in the bonded assemblies or its combination in any.Insulating barrier 652 is used for diffusion or disperses electric field, does not concentrate on certain position so that be applied to the stimulating current on user surface.When electric current concentrated on certain position, it was tending towards causing on the user surface not expecting or even sensation that may pain.Insulating barrier prevents that electric current from too concentrating on a position, thereby discrete delivery is to user's electric energy, so that make the comfortable maximization of the stimulation therapy that offers the user.
Insulating barrier 652 can have multiple different mode, as long as can realize the target of transdermal delivery to user's electric energy.In the embodiment shown in Figure 30 A, be interconnective a large amount of annulars in edge or circle with insulating layer conformation.Figure 30 B-30E has illustrated the different embodiment of insulating barrier, i.e. configuration.In these illustrated exemplary embodiments, insulating barrier is a series of ripples (Figure 30 B and 30D), the wire harness (Figure 30 E) of link or the random dispersion (Figure 30 C) of non-conductive fibre.
As shown in figure 31, on insulating barrier 652, provide bonded assemblies 660 so that electrode assemblie is attached to the user.In this embodiment, bonded assemblies 660 is hydrogel layer or element.Embodiment as described above, bonded assemblies can comprise the backing (not shown), this backing can be peeled off to expose hydrogel to use from hydrogel.
In the embodiment shown in Figure 30 A-31, insulating barrier is formed on the electrode or on the electrode.Yet the present invention also expects provides insulating barrier as being selectively attached to the part of main component with the bonded assemblies that forms complete electrode assemblie.In the exemplary embodiment, insulating barrier is arranged on the hydrogel, for example as be arranged on the hydrogel layer or under insulating barrier.The present invention also is expected at and embeds insulant in the hydrogel material.
Should emphasize once more that the feature of various embodiment of the present invention can make up.For example, in the embodiment of Figure 18-27, can on electrode 542, provide strip electrodes, such as electrode 242 or 642.Can on this band electrode, provide the bonded assemblies that comprises hydrogel and insulating barrier 652, with the electric energy of discrete delivery to the user.Resulting electrode has main component 540, electrode 242 or 642 and (having insulating barrier) bonded assemblies 660.In addition, the present invention expection is used for electrode assemblie by a plurality of electrodes are provided on electrode assemblie and will be installed to more than an electrode on one's body the user.
The present invention also is expected at one or more pick offs is provided on the electrode assemblie.For example, can provide temperature sensor, motion sensor, microphone, blood oxygen determination sensor or its combination in any, so that detect user's various physiological parameters.The output of these pick offs can be used for controlling stimulation therapy that the user provides, its storage is monitored purpose, transmitted it to remote location being used to, or its combination in any.
Other parts that can be used for stimulating the patient as the electrode assemblie of stimulating system of the present invention.As stimulating apparatus, the present invention can be used for stimulating nervus facialis, cutaneous nerve, carotid sinus district nerve (for example conspicuous order is neural), perhaps can be used for using ear's Screw Anchor fixed point conduct with reference to the head of point or any other nerve of cervical region.Can also apply stimulation energy in due form, such as, the user is waken up or arouses from sleep or sleepiness, perhaps for example in interactive entertainment or stimulating course as haptic feedback functions.
The present invention further contemplates that electrode assemblie of the present invention does not need to be used for delivery of energy, but can be used for monitoring in the multiple physiological parameter of patient one or more, such as electric physiology impedance signal, physiological resistance etc.This can realize separately, does not promptly need also delivery of energy to the user, perhaps in conjunction with the energy delivery functions.Can comprise impedance variation between skin stream electroresponse and ear by other parameters of electrode assemblie monitoring of the present invention.Electrode assemblie can also be provided near the reference platform of (even temple or forehead) monitoring electricity physiological signal ear.
In the illustrated embodiment, electric lead is used for energy is delivered to electrode assemblie.The present invention also expects and removes electrode, thereby it is wireless that electrode assemblie is become.In this case, need power source so that energy is offered electrode.Also may need transceiver sending with the control stimulation energy.
Can recognize that from foregoing description of the present invention the present invention can realize removing bonded assemblies (being hydrogel) from electrode assemblie simply fast, so that with up-to-date hydrogel it is changed when needed.The major part of main component and the electric lead of electrode assemblie are reusable in the long term, and removable (being adhesive member) can be to use and once just abandon, or user's reusable storage box of cut-and-dried convenience before needs.
Though think the most practical or preferred embodiment is described in detail the present invention for illustrative purposes based on current, but be appreciated that this details only is used for illustrative purposes and the invention is not restricted to the disclosed embodiments, and opposite, the invention is intended to cover modification and equivalent arrangement in the spirit and scope that are in appended claims.For example, be appreciated that the present invention is expected on the possible degree, one or more features of any embodiment can be combined with one or more features of any other embodiment.
Claims (35)
1, a kind of electrode assemblie (30,130,230,330,430,530,630) is used for electricity irritation is delivered to user, monitoring or such as user's physiological parameter, perhaps is used for this two purposes, and described electrode assemblie comprises:
(a) main component (40,140,240,340,540,640), it comprises electrode supporting part (44,144,244,344,544,644) and the sweep (46,146,246,346,546,646) that partly extends from described electrode supporting; With
(b) electrode (42,142,242,342,442,542,642) is coupled to described electrode supporting part with it.
2, device according to claim 1 also comprises adhesive member (62,162,262,362,462,560,660), it is coupled to described main component, described electrode or the two, perhaps it is arranged on described main component, described electrode or the two.
3, electrode assemblie according to claim 2 also comprises removable backing (66,166), and it is arranged at least a portion of described adhesive member.
4, electrode assemblie according to claim 2, wherein, described adhesive member is limited by hydrogel, hydrogel element, foamed materials, adhesive tape or its combination in any at least in part.
5, electrode assemblie according to claim 2 wherein, is arranged on described adhesive member on the first area of described main component, and wherein, described main component also comprises around the flange of at least a portion of described first area.
6, electrode assemblie according to claim 2 wherein, at least a portion of described adhesive member is arranged on the described electrode, and wherein, at least a portion that is arranged on the described part of the described adhesive member on the described electrode is conducted electricity.
7, electrode assemblie according to claim 1, wherein, described sweep has helical configuration substantially or substantially corresponding to the shape of the circumference at the back side of people's ear outside.
8, electrode assemblie according to claim 1, wherein, at least a portion of described sweep is plastics, paper, rubber, silicon or its combination in any.
9, electrode assemblie according to claim 1, also comprise insulating barrier (652), it is suitable for being coupled to the described electrode supporting part of described main component, and wherein, and described electrode comprises and is arranged on the described insulating barrier or conductive material in the described insulating barrier or conductive layer.
10, electrode assemblie according to claim 1, wherein, described electrode is suitable for optionally being coupled to the described electrode supporting part of described main component.
11, electrode assemblie according to claim 10, also comprise the supporting member (164 that is coupled to described electrode, 648), wherein, the described electrode supporting of described main component partly comprises the electrode supporting coupler, and wherein, described supporting member comprises mating part, and described mating part is suitable for being coupled to described electrode supporting coupler so that described electrode is attached to described main component.
12, electrode assemblie according to claim 11 also comprises hydrogel or hydrogel element, and it is arranged on described electrode, described supporting member or the two at least a portion.
13, electrode assemblie according to claim 11, wherein, described electrode is arranged on the basic flat bands in the described supporting member surface.
14, electrode assemblie according to claim 11 also comprises insulating barrier, and it is suitable for being coupled to described supporting member, and wherein, is arranged on described electrode on the described insulating barrier or in the described insulating barrier.
15, electrode assemblie according to claim 1 also comprises the hydrogel element, and it is suitable for being arranged at least a portion of described electrode.
16, electrode assemblie according to claim 15, wherein, described hydrogel element comprises:
Hydrogel material; With
Be arranged on the described hydrogel material or the insulant in the described hydrogel material.
17, electrode assemblie according to claim 16 also comprises back lining materials, and it is arranged at least a portion of described hydrogel element.
18, electrode assemblie according to claim 1 also comprises:
(c) stimulation energy source; With
(d) controller, it is suitable for controlling described stimulation energy sending to described electrode.
19, electrode assemblie according to claim 18, wherein, described stimulation energy source is that (1) is arranged on the described electrode by main component, perhaps (2) are away from described electrode.
20, a kind of electrode assemblie (30,130,230,330,430,530,630) is used for electricity irritation is delivered to user, monitoring or such as user's physiological parameter, perhaps is used for this two purposes, and described electrode assemblie comprises:
Stimulation tool (42,142,242,342,442,542,642), it is used for electricity irritation is offered the user;
Supporting tool (40,140,240,340,540,640), it is used for described stimulation tool is fixed to described user, so that at least a portion of described supporting tool holds at least a portion of hard of hearing the circumference of locating of people.
21, electrode assemblie according to claim 20 also comprises setting tool (62,162,262,362,462,560,660), and it adheres to the user surface with described stimulation tool, described supporting tool or the two.
22, electrode assemblie according to claim 21, wherein, described setting tool comprises interchangeable elements, described replaceable components is suitable for being selectively attached to described stimulation tool, described supporting tool or the two.
23, electrode assemblie according to claim 20, wherein, described stimulation tool comprises the instrument that is used to spread the energy that offers such user.
24, electrode assemblie according to claim 20 also comprises attachment tool, and it is used for optionally described stimulation tool being attached to described supporting tool.
25, electrode assemblie according to claim 20 also comprises:
The energy provisioning tools, it is used for energy is offered described stimulation tool; With
Control tool, it controls sending of described electricity irritation by controlling described energy provisioning tools.
26, a kind of electricity irritation is delivered to the method for user's vestibular system, comprises:
(a) at least a portion that holds hard of hearing the circumference of locating of people by at least a portion with the electrode supporting of main component part is fixed to the user surface with electrode, thereby electrode is set near mastoid process; With
(b) energy is offered described electrode.
27, method according to claim 26 also comprises described electrode is adhered to the user surface.
28, method according to claim 26 comprises that also diffusion is offered such user's energy by described electrode.
29, a kind of electricity irritation is delivered to user's method, comprises:
Electrode assemblie is provided;
With the part of hydrogel element application to described electrode assemblie;
Described electrode assemblie is affixed to the user;
Use described electrode assemblie energy is delivered to such user;
Described hydrogel element is removed from described electrode assemblie;
With the described part of follow-up hydrogel element application to described electrode assemblie; And
Reuse described electrode assemblie energy is delivered to such user.
30, method according to claim 29 wherein, uses described electrode assemblie to comprise the described surface that described electrode assemblie is affixed to described user by described hydrogel is contacted with the user surface energy is delivered to the user.
31, method according to claim 29 wherein, comprises the described part of described hydrogel element application to described electrode assemblie:
Select the hydrogel assembly, described hydrogel assembly comprises described hydrogel element and is arranged on backing at least a portion of described hydrogel element;
With the described part of described hydrogel component application to described electrode assemblie; And
Before being affixed to the user, described electrode assemblie removes described backing.
32, a kind of electrode assemblie comprises:
(a) main component;
(b) be coupled to the electrode of described main component; With
(c) hydrogel element is arranged on it at least a portion of described electrode, and wherein, described hydrogel element comprises:
(1) hydrogel material; With
(2) insulant, be arranged on it on described hydrogel material or in the described hydrogel material so that described insulating barrier disperses the energy by described electrode transmission.
33, electrode assemblie according to claim 32 also comprises removable backing, and it is arranged at least a portion of described hydrogel element.
34, electrode assemblie according to claim 32 wherein, is arranged on described insulant in the described hydrogel material or on the described hydrogel material.
35, electrode assemblie according to claim 32 wherein, is arranged on described hydrogel element on the first area of described main component, and wherein, described main component also comprises around the flange of at least a portion of described first area.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US84180206P | 2006-09-01 | 2006-09-01 | |
| US60/841,802 | 2006-09-01 | ||
| US11/846,895 | 2007-08-29 |
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| CN101522254A true CN101522254A (en) | 2009-09-02 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2007800322003A Pending CN101522254A (en) | 2006-09-01 | 2007-08-30 | Electrode assembly and method of using same |
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| CN102946942A (en) * | 2010-06-22 | 2013-02-27 | 皇家飞利浦电子股份有限公司 | System and method of delivering vestibular stimulation customizable to individual subjects |
| CN105073187A (en) * | 2013-03-01 | 2015-11-18 | Empi有限公司 | Systems and methods for wireless control of noninvasive electrotherapy |
| CN105148395A (en) * | 2014-05-25 | 2015-12-16 | 塞恩克公司 | Cantilever electrodes for transdermal and trnascranial stimulation |
| CN105188836A (en) * | 2013-02-14 | 2015-12-23 | Med-El电气医疗器械有限公司 | Vestibular stimulation electrode |
| CN105658185A (en) * | 2013-09-06 | 2016-06-08 | Med-El电气医疗器械有限公司 | Electrode contact with hydrogel covering |
| CN107427362A (en) * | 2015-03-05 | 2017-12-01 | Med-El电气医疗器械有限公司 | Noninvasive vestibular stimulation and measuring electrode |
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| CN102946942B (en) * | 2010-06-22 | 2016-10-19 | 皇家飞利浦电子股份有限公司 | Feed the system and method for vestibular stimulation customizable for individual subject |
| CN102946942A (en) * | 2010-06-22 | 2013-02-27 | 皇家飞利浦电子股份有限公司 | System and method of delivering vestibular stimulation customizable to individual subjects |
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| CN105188836B (en) * | 2013-02-14 | 2016-11-30 | Med-El电气医疗器械有限公司 | vestibular stimulation electrode |
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| CN105073187A (en) * | 2013-03-01 | 2015-11-18 | Empi有限公司 | Systems and methods for wireless control of noninvasive electrotherapy |
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| US11160986B2 (en) | 2013-03-01 | 2021-11-02 | Djo, Llc | Systems and methods for wireless control of noninvasive electrotherapy |
| US9630013B2 (en) | 2013-03-01 | 2017-04-25 | Empi, Inc. | Systems and methods for wireless control of noninvasive electrotherapy |
| US10071251B2 (en) | 2013-03-01 | 2018-09-11 | Empi, Inc. | Systems and methods for wireless control of noninvasive electrotherapy |
| CN105658185B (en) * | 2013-09-06 | 2017-09-08 | Med-El电气医疗器械有限公司 | Electrode contacts with hydrogel covering |
| CN105658185A (en) * | 2013-09-06 | 2016-06-08 | Med-El电气医疗器械有限公司 | Electrode contact with hydrogel covering |
| CN105148395B (en) * | 2014-05-25 | 2018-11-16 | 赛威医疗公司 | The method for being used to support the electrode equipment of wearable egersimeter and the egersimeter being attached to user head with the electrode equipment |
| CN105148395A (en) * | 2014-05-25 | 2015-12-16 | 塞恩克公司 | Cantilever electrodes for transdermal and trnascranial stimulation |
| CN107427362A (en) * | 2015-03-05 | 2017-12-01 | Med-El电气医疗器械有限公司 | Noninvasive vestibular stimulation and measuring electrode |
| CN107427362B (en) * | 2015-03-05 | 2019-01-22 | Med-El电气医疗器械有限公司 | Noninvasive vestibular stimulation and measuring electrode |
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Application publication date: 20090902 |