CA2128831A1 - Monitoring or diagnostic electrode or sensor - Google Patents
Monitoring or diagnostic electrode or sensorInfo
- Publication number
- CA2128831A1 CA2128831A1 CA002128831A CA2128831A CA2128831A1 CA 2128831 A1 CA2128831 A1 CA 2128831A1 CA 002128831 A CA002128831 A CA 002128831A CA 2128831 A CA2128831 A CA 2128831A CA 2128831 A1 CA2128831 A1 CA 2128831A1
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- Canada
- Prior art keywords
- assembly
- stud
- eyelet
- adhesive
- electrode
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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- Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)
- Electrotherapy Devices (AREA)
Abstract
ABSTRACT OF THE DISCLOSURE
A sensing element of silva\silver chloride or the like is coated on one side with a conductive gel and includes a coated liner as tab which, when removed, will expose the adhesive portion of the substrate by which it is attached to the patient. The preferred embodiment includes a length of carrier material including an adhesive backing and has a substrate electrode assembly secured to the adhesive banding with an eyelet and stud assembly being electrically secured through one end of said substrate electrode. This one end is covered with a plastic strip and a release liner covers the assembly. The preferred embodiment is suited for manufacture by automation and includes a continuous length of carrier material which includes an adhesive backing and rides of the bed of the production machine. The backing is removed as the first step. Substrate electrodes are placed on the adhesive surface of the carrier in spaced apart relationship along the length thereof and a stud and eyelet assembly is secured in one tab end thereof. A release liner covers the adhesive side of the carrier material and the substrate electrode. The assemblies are then die cut to the desired shape and size. The release liner is removed in use and tab end carrying the stud and eyelet assembly can be bent upwardly away from the patient so that the leads snap portion can be engaged with the eyelet by means of the thumb and forefinger of the operator thus eliminating any pressure upon the patient.
A sensing element of silva\silver chloride or the like is coated on one side with a conductive gel and includes a coated liner as tab which, when removed, will expose the adhesive portion of the substrate by which it is attached to the patient. The preferred embodiment includes a length of carrier material including an adhesive backing and has a substrate electrode assembly secured to the adhesive banding with an eyelet and stud assembly being electrically secured through one end of said substrate electrode. This one end is covered with a plastic strip and a release liner covers the assembly. The preferred embodiment is suited for manufacture by automation and includes a continuous length of carrier material which includes an adhesive backing and rides of the bed of the production machine. The backing is removed as the first step. Substrate electrodes are placed on the adhesive surface of the carrier in spaced apart relationship along the length thereof and a stud and eyelet assembly is secured in one tab end thereof. A release liner covers the adhesive side of the carrier material and the substrate electrode. The assemblies are then die cut to the desired shape and size. The release liner is removed in use and tab end carrying the stud and eyelet assembly can be bent upwardly away from the patient so that the leads snap portion can be engaged with the eyelet by means of the thumb and forefinger of the operator thus eliminating any pressure upon the patient.
Description
$ C~
MONITORING OR ~IAGNOSTIC ELEÇTROPE C)R 5ENSOR
This invention relates to new and useful improvements in the design and concept of a dia~nostic and monitoring electrode used as a physiological sensor for electrocardiography (E.C.G. - heart signals), electroencephalography (E.E.G. - brain si~nals), electromyography (E.M.G. -muscle signals, other than heart or brain), nystagmography teye movement -blinking) ! for deliverin~ electrical pulses las opposed to sensing electrical pulses) for transcutaneous electric nerve stimulation ~tens) or peripheral nerve stimulation ~pns) or for other healing or stimulating modes of operation. These electrodes can be used for long term or short term applications.
DE~C~IPTION QF THE DRAWING~
figure 1 is an exploded view of a conventional electrode.
Figure 1 A is a front view of the assembled conventional electrode of Figure 1.
Figure 1 B is a rear view thereof.
Figure 2 shows a plan view of the various components of the new design and concept.
Figure 2A is a plan view of the assembled electrode assembly of Figure 2.
Figure 2B is a view similar to Figure 2A but showing the reverse side thereof.
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MONITORING OR ~IAGNOSTIC ELEÇTROPE C)R 5ENSOR
This invention relates to new and useful improvements in the design and concept of a dia~nostic and monitoring electrode used as a physiological sensor for electrocardiography (E.C.G. - heart signals), electroencephalography (E.E.G. - brain si~nals), electromyography (E.M.G. -muscle signals, other than heart or brain), nystagmography teye movement -blinking) ! for deliverin~ electrical pulses las opposed to sensing electrical pulses) for transcutaneous electric nerve stimulation ~tens) or peripheral nerve stimulation ~pns) or for other healing or stimulating modes of operation. These electrodes can be used for long term or short term applications.
DE~C~IPTION QF THE DRAWING~
figure 1 is an exploded view of a conventional electrode.
Figure 1 A is a front view of the assembled conventional electrode of Figure 1.
Figure 1 B is a rear view thereof.
Figure 2 shows a plan view of the various components of the new design and concept.
Figure 2A is a plan view of the assembled electrode assembly of Figure 2.
Figure 2B is a view similar to Figure 2A but showing the reverse side thereof.
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Figure 3 shows the front and back elevations of the new ooncept electrode with an optional stud affixed to the tab of the foil type sensor.
Figure 4 ~4,a - 4,o) shows schematically, the method and structure of the preferred embodiment which is particularly suitable for preparation by automation.
Figure 5 shows schematically, one method of assembling the components.
The traditional electrodes consisted of metal suction cups, superseded by the popular and conventional, stud and element pre~elled, wet, foam or tape backed el~cerodos (see Fi0ure 1, lA and 1B) of ~arious confi~urations and sizes, made up of:
1. metal stud connector 2. vinyl disc -~ 3. microporous or foam adhesive 4. plastic ring or well 5. silver, silver chloride sensing element 6. open cell type foam gel pad ~we~) 7. poly-coated liner - ~ ;
8. precision snap fit or bubble type cap The new design and new conc~pt of the subject sensor or electrode, which will perform the same function as the elec~rode in Figure 1, is shown in Figure 2 in an exploded view and in complete view in Figure 2A.
The new concept of the electrode or sensor is made up of three parts instead of ei~ht parts. It is a low profile design ~o lie flat on the ~; surface of the subject: it uses a silver, or tin, metal foil or conductive carbon :
.
i. ~ ',' 3 1 `-foil, all silver chloride (except for the tin~, and coated with a conductive bio-compatible, hypoallergenic solid state substrate (as opposed to the wet open celi ~el pad used in pre~elled stud and element electrodes~, the tab on the silver, tin or conductive carbon foil is the connecting means (as opposed to the stud of the pregelled electrode in Figure 1).
~-This new concept of an electrode performs as well as the wet pregelled stud and element in Figure 1, without any compromise to efficacy, signal quality and strength, in the short or long term, meets all the mechanical and electrical standards and specifications for performance as outiined in the AAMI spec.,f.D.A., H.P.B. re~ulatory requircments; is much less expensive (approximately, 50~ess) to manufacture, arisin0 out of Its fewer components and less need for sophisticated packa~in~;
It is better suited for long term storage, more comfortabl~ for the subject, much less prone to causing skin lesions and irritation in the lon~
term use; can be constructed with microporous tape or closed cell foam;
can be made in all sizes and shapes; is suited to lead wire attachmen~ by `;ultrasonic bonding or other means, to tin, silver or conductive carbon foll);
there is no discomfort to the patient when applyin3 to the desi~nated areas as opposed to the discomfort of physically snapping a lead wirc to th~ metal stud on the conventional pre~elled stud and element electrode, especially sensitive with pediatric neonate or older patients.
Figure 2 shows the three types of sensin~ elements of: tin, silver/silver chloride, or conductive carbon foil, with different substrates of conductive solid gel coated ther~on; the tabs to interface with the cables .
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and instruments (not illustrated); the closed cell foam backin~ (paper tape can be used as well) and a poly coated liner and tab, which when pulled, will expose the conductive substrate and sensin~ foil of the sensin~
element, and the adhesive portion of the closed cell foam tape used to adhere the electrode to the patient.
One of the claims of the desi~n and concept is the slit in the closed cell foam so that the connectin~ sensin~ foil (tin, silver, conductive carbon) can be slipped throu~h the slit to connect to the interfacin~ patient cable set.
The electrode in question ~three pieces) is very simple to assemble. In a typlcal electrodc of this new concept (smaller or lar~er sizes can be used and would be treated proportionately) cut a slit (b) ~1 1/2"
Ion~) 3/4 of an inch back fro one end of the foam type adhesive ~a) ~in this case 2 1t2" x 2 1/2:); on the other end of (a) opposite the slit tb) cut both sides of ~a) to leave a 5/16" tab Ic) as shown in Figure 2; now remove foam portion from the tab ~c) leavin~ only the vinyl portion as the tab ~c); this will be used as a handle to remove the balance of the poly coated liner o~ the foam adhesive ~a) and the third part of the electrode td) which is a vinyl tape ~1 3/4~ x 1 1/4W~ attached to the clear plastic release liner coverin~ the substrate of the sensing foil (e) and buttin~ on the balance of the closed cell foam backin~ material; now place any one of the tab and substrate sensors le) (in this example the conductive carbon foil sensor was used) throu~h the slit (b) with only the tab showin~ with substrate and protective ~over facin~ down and away from the tab; now cut out the poly liner ~on ~ '~
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the adhesive foam pad (a~) to match the ph~/sical size of the foil and substrate ~3); remove this rectan~le ~or other shape~ of polyliner of ~a) and the top side of the sensor foil ~e) will adhere to the adhesiveh/ exposed; now take the third member (d~ of the new concept electrode (1 314" x ~ 1/4n), remove its liner and stick it (d) over the backin~ of the foil and substrate (e)- and the backing of the foam pad (a); now by lifting on the 5/16" x 5/16"
~- vinyl tab (c), the backing is removed from (e) and the electrode is now ready " to apply to the patient. (All measurements are illustrative only and may vary according to design parameters.) Not only ar~ there fewer parts, three compared to ei~ht, but `; the assembly is simple and does not necessitate complex production machinery normally associated with the stud and element wet type pre~elled - electrodes; it will be appreciated that the foil type solid substrate sensor will ~ be available as a ready-made sub-assembly; it is one of three components `~ ~a), ~d) and le) that 90 to make up this new concept of an electrode.
~:. Two, three, five, ten of these new concept electrodes oan be packaged in foil in much flatter, smaller packases than the conventional -~ :
stud and element electrodes; master cartons will be smaller; dry-out over Iong term will be reduced and long term storage will be extended; the surface area and the solid substrate nature of the new concept electrode make the incidence of noise generated by motions artifact less noticeable ; -and less apparent than with the convention type of stud and element pre~elled wet electrode.
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~ As shown in Figure 3, the new concept electrode may have, as - an option, a stud (F) affixed to the tab of the foil type sensor, makin~
~- electrical and mechanical contact with the tab, as an alternative to the tab - -" only.
.
This alternative means of connection makes the new concept electrode compatible with all the stud, snap type lead wires and cable sets presently bein~ used by the majori~ of end users. This new concept electrode and snap type stud connected thereon, will make the introd~ction and acceptance of this kind of electrode much easi~r and quicker.
A li~ht fl~xlbl~ lead wire t~rminatin~ in a connecting male pin or female socket, attached to the above mentioned stud affixed to the tab of the sensing element, is another connecting option for this new concept dia~nostic electrode.
Figures 4A,B,C,D,E,F,G,H.I.J.K.L.M.N, and O shows the preferred embodiment enablin~ the assernbly to be made by automa~lon~
1) A continuous roll A of an appropriate thickness of foam, clear tap~, paper tape, or cloth type tape, carrier material, with adhesive ~ ~;
backin~, rides on the bed of the automatic production machine; -2) The backin~ A on the carrier material, protectin~ the adhesivs side of the carrier is removed B;
Figure 3 shows the front and back elevations of the new ooncept electrode with an optional stud affixed to the tab of the foil type sensor.
Figure 4 ~4,a - 4,o) shows schematically, the method and structure of the preferred embodiment which is particularly suitable for preparation by automation.
Figure 5 shows schematically, one method of assembling the components.
The traditional electrodes consisted of metal suction cups, superseded by the popular and conventional, stud and element pre~elled, wet, foam or tape backed el~cerodos (see Fi0ure 1, lA and 1B) of ~arious confi~urations and sizes, made up of:
1. metal stud connector 2. vinyl disc -~ 3. microporous or foam adhesive 4. plastic ring or well 5. silver, silver chloride sensing element 6. open cell type foam gel pad ~we~) 7. poly-coated liner - ~ ;
8. precision snap fit or bubble type cap The new design and new conc~pt of the subject sensor or electrode, which will perform the same function as the elec~rode in Figure 1, is shown in Figure 2 in an exploded view and in complete view in Figure 2A.
The new concept of the electrode or sensor is made up of three parts instead of ei~ht parts. It is a low profile design ~o lie flat on the ~; surface of the subject: it uses a silver, or tin, metal foil or conductive carbon :
.
i. ~ ',' 3 1 `-foil, all silver chloride (except for the tin~, and coated with a conductive bio-compatible, hypoallergenic solid state substrate (as opposed to the wet open celi ~el pad used in pre~elled stud and element electrodes~, the tab on the silver, tin or conductive carbon foil is the connecting means (as opposed to the stud of the pregelled electrode in Figure 1).
~-This new concept of an electrode performs as well as the wet pregelled stud and element in Figure 1, without any compromise to efficacy, signal quality and strength, in the short or long term, meets all the mechanical and electrical standards and specifications for performance as outiined in the AAMI spec.,f.D.A., H.P.B. re~ulatory requircments; is much less expensive (approximately, 50~ess) to manufacture, arisin0 out of Its fewer components and less need for sophisticated packa~in~;
It is better suited for long term storage, more comfortabl~ for the subject, much less prone to causing skin lesions and irritation in the lon~
term use; can be constructed with microporous tape or closed cell foam;
can be made in all sizes and shapes; is suited to lead wire attachmen~ by `;ultrasonic bonding or other means, to tin, silver or conductive carbon foll);
there is no discomfort to the patient when applyin3 to the desi~nated areas as opposed to the discomfort of physically snapping a lead wirc to th~ metal stud on the conventional pre~elled stud and element electrode, especially sensitive with pediatric neonate or older patients.
Figure 2 shows the three types of sensin~ elements of: tin, silver/silver chloride, or conductive carbon foil, with different substrates of conductive solid gel coated ther~on; the tabs to interface with the cables .
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.
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and instruments (not illustrated); the closed cell foam backin~ (paper tape can be used as well) and a poly coated liner and tab, which when pulled, will expose the conductive substrate and sensin~ foil of the sensin~
element, and the adhesive portion of the closed cell foam tape used to adhere the electrode to the patient.
One of the claims of the desi~n and concept is the slit in the closed cell foam so that the connectin~ sensin~ foil (tin, silver, conductive carbon) can be slipped throu~h the slit to connect to the interfacin~ patient cable set.
The electrode in question ~three pieces) is very simple to assemble. In a typlcal electrodc of this new concept (smaller or lar~er sizes can be used and would be treated proportionately) cut a slit (b) ~1 1/2"
Ion~) 3/4 of an inch back fro one end of the foam type adhesive ~a) ~in this case 2 1t2" x 2 1/2:); on the other end of (a) opposite the slit tb) cut both sides of ~a) to leave a 5/16" tab Ic) as shown in Figure 2; now remove foam portion from the tab ~c) leavin~ only the vinyl portion as the tab ~c); this will be used as a handle to remove the balance of the poly coated liner o~ the foam adhesive ~a) and the third part of the electrode td) which is a vinyl tape ~1 3/4~ x 1 1/4W~ attached to the clear plastic release liner coverin~ the substrate of the sensing foil (e) and buttin~ on the balance of the closed cell foam backin~ material; now place any one of the tab and substrate sensors le) (in this example the conductive carbon foil sensor was used) throu~h the slit (b) with only the tab showin~ with substrate and protective ~over facin~ down and away from the tab; now cut out the poly liner ~on ~ '~
'~ .
:: , ~ , .
, , ;
:
the adhesive foam pad (a~) to match the ph~/sical size of the foil and substrate ~3); remove this rectan~le ~or other shape~ of polyliner of ~a) and the top side of the sensor foil ~e) will adhere to the adhesiveh/ exposed; now take the third member (d~ of the new concept electrode (1 314" x ~ 1/4n), remove its liner and stick it (d) over the backin~ of the foil and substrate (e)- and the backing of the foam pad (a); now by lifting on the 5/16" x 5/16"
~- vinyl tab (c), the backing is removed from (e) and the electrode is now ready " to apply to the patient. (All measurements are illustrative only and may vary according to design parameters.) Not only ar~ there fewer parts, three compared to ei~ht, but `; the assembly is simple and does not necessitate complex production machinery normally associated with the stud and element wet type pre~elled - electrodes; it will be appreciated that the foil type solid substrate sensor will ~ be available as a ready-made sub-assembly; it is one of three components `~ ~a), ~d) and le) that 90 to make up this new concept of an electrode.
~:. Two, three, five, ten of these new concept electrodes oan be packaged in foil in much flatter, smaller packases than the conventional -~ :
stud and element electrodes; master cartons will be smaller; dry-out over Iong term will be reduced and long term storage will be extended; the surface area and the solid substrate nature of the new concept electrode make the incidence of noise generated by motions artifact less noticeable ; -and less apparent than with the convention type of stud and element pre~elled wet electrode.
~' ~
. .;
` .
... ~ , . , . ~ . . ~ .
. .
~ As shown in Figure 3, the new concept electrode may have, as - an option, a stud (F) affixed to the tab of the foil type sensor, makin~
~- electrical and mechanical contact with the tab, as an alternative to the tab - -" only.
.
This alternative means of connection makes the new concept electrode compatible with all the stud, snap type lead wires and cable sets presently bein~ used by the majori~ of end users. This new concept electrode and snap type stud connected thereon, will make the introd~ction and acceptance of this kind of electrode much easi~r and quicker.
A li~ht fl~xlbl~ lead wire t~rminatin~ in a connecting male pin or female socket, attached to the above mentioned stud affixed to the tab of the sensing element, is another connecting option for this new concept dia~nostic electrode.
Figures 4A,B,C,D,E,F,G,H.I.J.K.L.M.N, and O shows the preferred embodiment enablin~ the assernbly to be made by automa~lon~
1) A continuous roll A of an appropriate thickness of foam, clear tap~, paper tape, or cloth type tape, carrier material, with adhesive ~ ~;
backin~, rides on the bed of the automatic production machine; -2) The backin~ A on the carrier material, protectin~ the adhesivs side of the carrier is removed B;
3) Concurrently a continuous pre die cut roll of a typical dia~nostic E.C.G. Iab, tab type silver/silver chlorid2, pre~elled solid (conductive) substrate electrodes C: are applied to the adhesive side D of the carrier material with the conductive side of lab, tab type sensor C, upwardly ~.;1"~,~3~
with a hole or aperture already punched in the tab of the Lab, tab type electrode or sensor;
with a hole or aperture already punched in the tab of the Lab, tab type electrode or sensor;
4) E1 shows a typical silver/silver chlorided (Ag/AgCI) eyelet element, and stud E2 used in the production.
5) F now apply the stud E2 and eyelet E1 with the silver/silver chlorided eyelet facing upwardly as in F so that silver/silver . ~ , -ehlorided portion of lab, tab electrode and silver/silver chlorided flat side of eyelet are both facing upwardly.
6) To seperate the jelled portion of the Lab, tab type silvertsilver chlorded electrode (the active part atta~hed to the patient's skin) from the dry silver/silver chlorid~d ayelet tE1), marry a continuous stripof vinyl (G) transversely onto the exposed carrier tB) to eyelet tE1) at one end thereof so that it covers the exposed eyelet (E1) as shown in tF). The vinyl covering (G) is put on, so that the adhesive side of the vinyl faces the exposed eyelet. See tH).
` 7) Now marry a continuous release liner (J) to the ~ . . aforementioned assembly (I) from Roll t11).
8) l:)ie cut carrier (A) to the re~uired overall shape oval, (IC) and (L), round, rectangular, triangular of any dimension.
9) Figure M - in all the embodiments, it is now possible to engage or disengage the snap of any lead wire to or from the die cut assembly, without exerting any pressure or discomfort to the point of attachment to the patient - the pressure applied to engage the snap of the lead (N) to the stud tE2) of the electrode is between the thumb gl forefin~er ~
.
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(M~ of the operator, or nurse, and pressure is not on thle patient. This is another important claim of this invention. Figure ~o) shows this feature with a tab that folds back (dotted line) that makes this manouver possible.
This alternative means of connection, Figures 4A throu~h 40, show the preferred embodiment enabling the assembly to be made by automation. The following description of Figures 4A through 40 describes what is basically a flow diagram of the steps invoived and which can be seen schematically in side elevation in Fi~ure 5.
A continuous role A of an appropriate thickness of foam, clear tape, papsr tape, a cloth tape or the llk~ acts as a carrier material with adhesive backin~ is fed alon~ the bed of an automatic pfoduction machine ~not illustrated) with the backing material A, being peeled off to expose the adhesh,~e surface as indicated at 8.
Concurrently, a continuous pre die cut roll of a typical diagnostic E.C.G., lab, tab type silver/silver chlorided pregelled solid Iconductive) substrate electrodes C are applied onc by one and in spaced relationship along the length thereof to the adhesive side of the carrier material as indicated at D with the individual electrode assemblies being conventional in manufacture and exposin~ the conductive side of the sensor uppermost and including a gelled portion C1 upper most and having an aperture C2 preformed in the tab portion C3 of the electrode as clearly shown in D.
These electrodes are of the laboratory tab type commonly available.
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E1 and E2 show respectively a typical silver/silver chlorided (Ag/A~ Cl) eyelet elem,snt and stud E2 used in the production.
The silver/silver chlorided eyelet surface faces uppermost when the general projection is placed downwardly throu~h tlle apertures C3 as ~,shown in F and the stud portion E2 is mechanically and electrically secured on the other side of the tab portion C3 in a conventional manner.
~-In order to seperate the gelled portion of the lab $ype ,~silvet/silver chlorided electrode, i.e. the active part which attaches to the "
patient's skin, from the d~y silver/silver chlorided eyelet E1, a continuous strip of a vinyl G is adhesively secured onto the exposed carrier B
transversely thereof so that it covers the exposed eyelet portion E1 as clearly shown in H with the adhesive side of the strip of vinyl facin~ the exposed eyelet and to detachably cover same.
Finally, a continuous release liner J is placed over the aforementioned assembly and adhesively secured to the surface of 11 and covers the electrode and the vinyl strip G as shown in I and the assembly advances to a die cutter or punch shown schematically in Fi~ure S by reference character K2.
This permits the individual assembled electrode assemblies to be cut from the continuous carrier strip and liner to the required overall shape which may be oval, round, rectan~ular, ~rian~ular and of ariy dimension. K and L show two oval assemblies, an adult size and a pediatric size which have been reversed after die cutting to show the exposed electrode attachin~ stud E2.
,~
"~
` When used, the r~lease liner portion J is peeled from the electrode assembly which may then be adhesively secured to the skin of the patient by means of the surface of the carrier shown in B.
In this connection, and because of the tran~verse vinyl strip G
covering the silver/silver chloride eyelet 1, a fold line l is formed as indicated in O thus enabling the portion 2 Of the assembly to be folded upwardly as it has not adhered to the skin of the patient. This enables the . .
conventional snap portion N1 of any lead wirs N2 to be engaged or disengaged from thè assembly by squeezing same onto the stud E2 by means of the thumb and forefin~er as clearly shown in M. Thi~ rneans that this engagement and dis~ngag~ment can be made without exertin~ any pressure or dissomfort to the point of attachment to the patient as is usual with conventional electrodes and is particularly important when bein~ used on pediatric patients in which such pressure can be extremely dangerous to the baby. This is one of the most important advantages o~ the present~
assembly over conventional assemblies.
As mentioned, Figure O shows this tab portion which permits this type of attachment and detachment to take place.
In summary, this new electrode concept offers a low profile, solid substrate, low cost, high efficiency electrode with added comfort, without any compromise to overall efficacy and signal quality.
The solid subs~rate in the new concept electrode and the fact that the connecting tab or stud is located distally from the main sensin~
element is a large benefit in reducing motion artifact or noise normally .~ associated with the conventional stud and element, wet type, pregelled ~ electrode, where the connecting means is located right over the relatively : small sensing element so that any movement of the connecting means on a conventional electrode affects the performance of this kind of an electrode -the new concept electrode with offsetting connectin~ rneans is a marked :~
improvement.
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:
` 7) Now marry a continuous release liner (J) to the ~ . . aforementioned assembly (I) from Roll t11).
8) l:)ie cut carrier (A) to the re~uired overall shape oval, (IC) and (L), round, rectangular, triangular of any dimension.
9) Figure M - in all the embodiments, it is now possible to engage or disengage the snap of any lead wire to or from the die cut assembly, without exerting any pressure or discomfort to the point of attachment to the patient - the pressure applied to engage the snap of the lead (N) to the stud tE2) of the electrode is between the thumb gl forefin~er ~
.
.. 1 ' ~ .
`: :
(M~ of the operator, or nurse, and pressure is not on thle patient. This is another important claim of this invention. Figure ~o) shows this feature with a tab that folds back (dotted line) that makes this manouver possible.
This alternative means of connection, Figures 4A throu~h 40, show the preferred embodiment enabling the assembly to be made by automation. The following description of Figures 4A through 40 describes what is basically a flow diagram of the steps invoived and which can be seen schematically in side elevation in Fi~ure 5.
A continuous role A of an appropriate thickness of foam, clear tape, papsr tape, a cloth tape or the llk~ acts as a carrier material with adhesive backin~ is fed alon~ the bed of an automatic pfoduction machine ~not illustrated) with the backing material A, being peeled off to expose the adhesh,~e surface as indicated at 8.
Concurrently, a continuous pre die cut roll of a typical diagnostic E.C.G., lab, tab type silver/silver chlorided pregelled solid Iconductive) substrate electrodes C are applied onc by one and in spaced relationship along the length thereof to the adhesive side of the carrier material as indicated at D with the individual electrode assemblies being conventional in manufacture and exposin~ the conductive side of the sensor uppermost and including a gelled portion C1 upper most and having an aperture C2 preformed in the tab portion C3 of the electrode as clearly shown in D.
These electrodes are of the laboratory tab type commonly available.
:
i .. -....................................................................... ': ' ~
E1 and E2 show respectively a typical silver/silver chlorided (Ag/A~ Cl) eyelet elem,snt and stud E2 used in the production.
The silver/silver chlorided eyelet surface faces uppermost when the general projection is placed downwardly throu~h tlle apertures C3 as ~,shown in F and the stud portion E2 is mechanically and electrically secured on the other side of the tab portion C3 in a conventional manner.
~-In order to seperate the gelled portion of the lab $ype ,~silvet/silver chlorided electrode, i.e. the active part which attaches to the "
patient's skin, from the d~y silver/silver chlorided eyelet E1, a continuous strip of a vinyl G is adhesively secured onto the exposed carrier B
transversely thereof so that it covers the exposed eyelet portion E1 as clearly shown in H with the adhesive side of the strip of vinyl facin~ the exposed eyelet and to detachably cover same.
Finally, a continuous release liner J is placed over the aforementioned assembly and adhesively secured to the surface of 11 and covers the electrode and the vinyl strip G as shown in I and the assembly advances to a die cutter or punch shown schematically in Fi~ure S by reference character K2.
This permits the individual assembled electrode assemblies to be cut from the continuous carrier strip and liner to the required overall shape which may be oval, round, rectan~ular, ~rian~ular and of ariy dimension. K and L show two oval assemblies, an adult size and a pediatric size which have been reversed after die cutting to show the exposed electrode attachin~ stud E2.
,~
"~
` When used, the r~lease liner portion J is peeled from the electrode assembly which may then be adhesively secured to the skin of the patient by means of the surface of the carrier shown in B.
In this connection, and because of the tran~verse vinyl strip G
covering the silver/silver chloride eyelet 1, a fold line l is formed as indicated in O thus enabling the portion 2 Of the assembly to be folded upwardly as it has not adhered to the skin of the patient. This enables the . .
conventional snap portion N1 of any lead wirs N2 to be engaged or disengaged from thè assembly by squeezing same onto the stud E2 by means of the thumb and forefin~er as clearly shown in M. Thi~ rneans that this engagement and dis~ngag~ment can be made without exertin~ any pressure or dissomfort to the point of attachment to the patient as is usual with conventional electrodes and is particularly important when bein~ used on pediatric patients in which such pressure can be extremely dangerous to the baby. This is one of the most important advantages o~ the present~
assembly over conventional assemblies.
As mentioned, Figure O shows this tab portion which permits this type of attachment and detachment to take place.
In summary, this new electrode concept offers a low profile, solid substrate, low cost, high efficiency electrode with added comfort, without any compromise to overall efficacy and signal quality.
The solid subs~rate in the new concept electrode and the fact that the connecting tab or stud is located distally from the main sensin~
element is a large benefit in reducing motion artifact or noise normally .~ associated with the conventional stud and element, wet type, pregelled ~ electrode, where the connecting means is located right over the relatively : small sensing element so that any movement of the connecting means on a conventional electrode affects the performance of this kind of an electrode -the new concept electrode with offsetting connectin~ rneans is a marked :~
improvement.
-:, `
,~`
:
Claims
a) a carrier portion having adhesive on one side thereof;
b) a substrate electrode adhesively secured to said one side of said carrier portion;
c) a stud and eyelet assembly electrically conductively secured through one end of said substrate electrode;
d) a plastic backing portion adhesively secured over the side of said stud and eyelet assembly on the said one side of said carrier portion;
e) and a removable release liner selectively covering said one side of said carrier portion and said substrate electrode.
(2) The assembly according to Claim 1 in which said plastic backing portion over said stud and eyelet assembly forms a foldable tab portion of said assembly which includes said stud and eyelet assembly whereby when adhesively secured to the patient, the associated snap fastener of a lead assembly can be snap engaged with said stud and eyelet assembly portion by thumb and finger pressure on either side of said tab thereby eliminating any pressure upon said patient.
(3) A process for the manufacture of electrode assemblies of
Claim 1 which includes the steps of:
a) moving a continuous length of carrier portion material over a planar surface with the adhesive side facing upwardly;
b) removing the backing material covering on said adhesive side;
c) feeding a carrier strip onto said adhesive side, said carrier strip having spaced apart solid strate electrodes secured thereon, said electrodes having an aperture preformed through one end thereof;
d) securing a stud and eyelet assembly through said aperture in electrical conducting relationship with the substrate electrode;
e) securing a transverse strip of plastic material across said one end of said carrier portion covering said stud and eyelet assembly thereby forming a non adhesive tab portion on said one end;
f) covering said carrier portion, said substrate electrode and said tab portion thereof with a release liner;
g) die cutting each substrate electrode and the associated carrier material and the release liner to a predetermined size and shape to form the electrode assembly, said assembly having set tab portion on said one end thereof.
a) moving a continuous length of carrier portion material over a planar surface with the adhesive side facing upwardly;
b) removing the backing material covering on said adhesive side;
c) feeding a carrier strip onto said adhesive side, said carrier strip having spaced apart solid strate electrodes secured thereon, said electrodes having an aperture preformed through one end thereof;
d) securing a stud and eyelet assembly through said aperture in electrical conducting relationship with the substrate electrode;
e) securing a transverse strip of plastic material across said one end of said carrier portion covering said stud and eyelet assembly thereby forming a non adhesive tab portion on said one end;
f) covering said carrier portion, said substrate electrode and said tab portion thereof with a release liner;
g) die cutting each substrate electrode and the associated carrier material and the release liner to a predetermined size and shape to form the electrode assembly, said assembly having set tab portion on said one end thereof.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US9690193A | 1993-07-26 | 1993-07-26 | |
| US096,901 | 1993-07-26 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2128831A1 true CA2128831A1 (en) | 1995-01-27 |
Family
ID=22259638
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002128831A Abandoned CA2128831A1 (en) | 1993-07-26 | 1994-07-26 | Monitoring or diagnostic electrode or sensor |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA2128831A1 (en) |
-
1994
- 1994-07-26 CA CA002128831A patent/CA2128831A1/en not_active Abandoned
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |