CA2100915A1 - Snapless, tabless, disposable medical electrode with low profile - Google Patents
Snapless, tabless, disposable medical electrode with low profileInfo
- Publication number
- CA2100915A1 CA2100915A1 CA002100915A CA2100915A CA2100915A1 CA 2100915 A1 CA2100915 A1 CA 2100915A1 CA 002100915 A CA002100915 A CA 002100915A CA 2100915 A CA2100915 A CA 2100915A CA 2100915 A1 CA2100915 A1 CA 2100915A1
- Authority
- CA
- Canada
- Prior art keywords
- disk
- substrate
- electrode
- tabless
- snapless
- 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
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/25—Bioelectric electrodes therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors
- A61B2562/17—Comprising radiolucent components
Abstract
ABSTRACT
A snapless, tabless, disposable medical electrode having a low profile for transmitting electrical signals between the skin of a patient and external monitoring equipment. The electrode has an adhesive substrate with a central opening and a pressure sensitive adhesive layer on its bottom (which faces the patient); a symmetrical, electrically conductive disk secured to the substrate, formed without a tab and without a snap, and positioned over and projecting above the central opening of the substrate; a conductive medium substantially filling the opening of the substrate and electrically contacting the skin of the patient, the substrate, and the disk; a lead wire, attached to the disk without regard to orientation, for connecting the disk to the external monitoring equipment; and a release liner covering the bottom of the substrate and gel before the electrode is secured to the skin of the patient.
A snapless, tabless, disposable medical electrode having a low profile for transmitting electrical signals between the skin of a patient and external monitoring equipment. The electrode has an adhesive substrate with a central opening and a pressure sensitive adhesive layer on its bottom (which faces the patient); a symmetrical, electrically conductive disk secured to the substrate, formed without a tab and without a snap, and positioned over and projecting above the central opening of the substrate; a conductive medium substantially filling the opening of the substrate and electrically contacting the skin of the patient, the substrate, and the disk; a lead wire, attached to the disk without regard to orientation, for connecting the disk to the external monitoring equipment; and a release liner covering the bottom of the substrate and gel before the electrode is secured to the skin of the patient.
Description
2 ~ 0 0 ~
SNAPLESS, TABI-ESS, DISPOSABI-E
MEDICAI. EI.ECTRODE WITH LOW PROFILE
Field of the Invention The present invention relates to a biomedical electrode of the type attached to the body and, more particularly, to a Ynaple~s, tableas, dispo3able medical electrode having a low profile for transmitting electrical signal~ between the akin of a patient and peripheral monitoring equipment.
Background of the Invention Medical electrode~ are well known in the art and vary considerably in their atructure and mt-38 ~cc-793\canawl ~: : .. .
2iO091~
configuration. They generally have a substrate designed to be applied and held to the skin of a patient, an electrical connector, and a conductive lead wire removably and electrically attached to the electrical connector on one end and to a monitoring device on it~
opposite end. The field is relatively crowded.
Designs are usually controlled by, first, a requirement for a secure fastening of the electrical connector to the skin because the electrode may be part of a life support sy~tem. A second requirement of an electrode design is controlled by economics. There is a continuing need for high quality but inexpen~ive medical electrodes. For purposes of convenience and safety (e.g., to maintain sterility in a medical environment), the electrode should be sufficiently inexpensive to manufacture that it is practical to dispose of and to replace the electrode after only one uee (hence, the electrode must be "disposablen).
The various medical electrode de~igns can generally be placed into two categories. In one category are snap-type electrodes in which one end of the electrical connector terminates in a projecting snap or stud. The lead wire is provided with a mating eyelet or socket which receives and secures, by snapping over, the snap. An advantage of such an electrode is that it permits rotation between the electrode and the lead wire.
Rotation aYsures patient comfort, prevents the electrode from disengaging when the patient moves, and allows connection between the lead wire and electrical connector without regard to orientation.
.
It is common to form the projecting snap from a non-conducting ~ubstrate and then to coat that sub~trate with a very thin coating of a conductive material. The ''.
2l0nsl~
thin coating of conducting material i~ easily abraded away, however, when the outer wall of the ~nap frictionally contacts and slides against the eyelet, as happens when the snap electrode rotates with respect to its lead wire. The resulting abrasion of the mating surfaces of the snap and eyelet can eventually degrade the electrical conductivity between the electrode and the lead wire.
To minimize the rotation between the electrode and lead, and the consequent degradation, some electrodes prevent relative rotation. Such electrode~ restrict the versatility and ease of manipulation for the electrode, as well as the equipment to which the electrode i8 connected.
Another problem with the snap-type electrodes is that they have a relatively high profile ~height).
The snap must project from the electrode a significant distance to allow connection of the lead wire eyelet. A
high profile is disadvantageous because it makes the electrode more noticeable and increases the risk of damage by hitting other ob;ect~ during use and ~torage.
The electrical contacts between the ~nap and the lead wire eyelet and between the electrode and the patient are essential; those contacts must be protected from disengagement. Consequently, a low profile electrode i~
preferable.
The second type of electrode ha~ no pro~ecting snap or stud. It i9 usually thin, flat, flexible, disposable, snapless, and, therefore, substantially les~
expensive to manufacture or use. The lead wire interconnect~ the second type of electrode by engaging the electrode itself, uYually at a lateral extension or tab at one ~ide or at the center of the electrode. Thuc, . , . : ..:., -. .;
.. .~ . ~ ,, . ~ . .; ............... .
.. . ., : ~ : . : , -., . , ~. ....... ..
`` - 2~0091~
GCC-790 ~ 4 ~
thi~ second type of electrode is referred to as a "tab"
electrode.
One problem with the tab electrode is that it typically does not permit rotation between the electrode ~`
and the lead wire. A particular orientation of the lead wire with respect to the tab of the electrode is required. Another problem i~ that tab electrodes generally are connected to their lead wires by spring or alligator clip~ affixed to the tab. Such clips typically give the clip-electrode combination a high profile.
Moreover, the clips occasionally slip off the tab, rip through the tab, or tear the tab away from the remainder of the electrode and, therefore, are not entirely satisfactory under certain circum~tances.
Regardle~s of the de~ign, both snap-type and tab-type conventional medical electrodes are relatively complex in their structure. Many of the~e electrodes have hard, bulky components which make them uncomfortable to the patient. Most suffer from motion artifact~.
Motion artifact~ can be defined as motion-induced fluctuation of skin potential. Such artifacts create electrical interference which is often superimpo~ed on the bipotential skin ~ignal measured by the electrode, thereby reducing the electrode's u~efulness as a diagnostic and clinical tool. Motion ~` artifact~ have long been a problem in mea~uring biopotentials, particularly in long-term electrocardiogram (ECG or EKG) monitoring of coronary care patient~ and in exercise (stress) ECG' 9.
Artifacts are generally cau~ed by movement of the patient (who may be on a moving treadmill, for example, to induce increased heart and respiratory rates) , .. . .. .. ,.. . : , ..,. ..,, , , . ..::
' ~ .' ::' ' `:: `'.':, :!: : .. .
-"` 210091~
relative to the electrode applied to the patient'~ ckin.
That movement di~turb~ the skin potential and creates extraneou~ output on the monitor which either ma~k~ the desired bipotential signal or shifts the ba~e line.
As the above di~cussion makes evident, the problem of providing a highly reliable, di~posable, low profile electrode has presented a ma;or challenge to designerc in the health care field. The development of an economical, tabless (80 orientation is eliminated) medical electrode would represent a major technological advance in the field. The advantages of such a device would sati~fy a long-felt need within the medical profession.
Therefore, to overcome the shortcomings of the existing medical electrodes and to ~atiefy the need of ; the medical profession, a new, ~naple~s, tabless, dispo~able medical electrode is provided. A prlmary object of the present invention is to provide an improved medical electrode which can be manufactured at low cost yet meets the structural requirements of the market. A
related object is to provide an electrode which i~
economical and simple in design, yet durable and highly effective to use.
Patient comfort is an overriding concern with any electrode design. Accordingly, it i9 an ob~ect of the present invention to a~sure patient comfort. At the same time, rotational movement between the lead wire and electrode may be necessary to provide a good electrical connection. Such connection must be as~ured even when the patient move~. Accordingly, it is another ob~ect of the pre~ent invention to assure ~ignificant rotational movement between the lead wire and the electrode. It 18 ~..
: .
.`:
,: ., ~ . . ; . ~ , :
~, : " : ,, . . : . : . . - . :. ;: , . -.
210~91~
still another object of the present invention tQ reduce ~-motion artifacts.
An additional ob~ect is to assure that the electrode has a very low profile. Yet another object of this invention i9 to allow for quick and easy attachment and detachment, both to and from the patient and between the electrode and its lead wire, without concern for a specific orientation. Both type~ of attachment and detachment ~hould be sufficiently simple that they can be done in the dark.
Summary of the ~nvention To achieve these and other ob~ects, and in view of its purposes, the present invention provides a snaples3, tabless, disposable medical electrode having a low profile for transmitting electrical signal~ between the skin of a patient and external monitoring equipment.
The electrode has an adhesive substrate with a central opening and a pressure sen~itive adhesive layer on its bottom (which faces the patient); a symmetrical, electrically conductive disk secured to the ~ubstrate, formed without a tab and without a snap, and positioned over and projecting above the central opening of the substrate; a conductive medium (e.g., an adhesive, electrolyte gel) substantially filling the opening of the substrate and electrically contacting the skin of the patient, the substrate, and the di~k; a lead wire, attached to the disk without regard to orientation, for connecting the disk to the external monitoring equipment and a release liner covering the bottom of the ~ubstrate and gel before the electrode is secured to the ~kin of the patient.
. ,- ;, . . . . . .
.. . . . ... . .. ... .. .. ..
., ;. . .
. .
- 21~0~15 It i8 to be understood that both the foregoing general description and the following detailed description are exemplary, but are not restrictive, of the invention.
Brief Description of ~h~ Drawinq The invention is best understood from the following detailed description when read in connection with the accompanying drawing, in which: :
Figure 1 is a cross-sectional view of a snapless, tabless, disposable medical electrode according to a first embodiment of the present invention;
Figure 2 is a top view of the electrode shown in Figure 1;
Figure 3 is an exploded, perspective view of a snapless, tabless, disposable medical electrode according to a second embodiment of the present invention;
Figure 4 is a cross-sectional view of the electrode shown in Figure 3;
Figure 5 is a top view of the electrode shown in Figures 3 and 4;
i Figure 6 is a top view of the electrode shown ~ in Figure 5 illustrating a lead wire electrical connection to the electrode;
Figure 7 is a top view of the electrode shown in Figure 5 illustrating an alligator clip electrical connection to the electrode;
'' :, : , ," ' ' ' .' ' '.'."` ': '"
: . ~ ' :.' '' ' ' ' .
- 2100~
~:
Figure 8 is a side view of the electrode shown in Figure 4 illu~trating an alternate, to that ~hown in Figure 7, alligator clip electrical connection to the electrode;
Figure 9 is a top view of a lead wire adapter which can be used to provide electrical connection to both the first embodiment (shown in Figures 1 and 2) and the second embodiment (shown in Figures 3-5) of the medical electrode of the present invention;
Figure lO i8 a side view of the lead wire adapter shown in Figure 9;
Figure 11 i~ a top view of the lead wire adapter shown in Figure 9 without a top layer; and Figure 12 is front view of the lead wire adapter taken along the section XII-XII of Figure 11.
Detailed escription of the Invention Referring now to the drawing, like reference numerals refer to like elements throughout and the ; elements have been enlarged for clarity; in reality, the ; 20 elements are very thin to form a low profile medical electrode. Figure 1 shows a first embodiment of the snapless, tabless, disposable, low profile medical electrode 10 of the pre~ent invention. Electrode 10 i9 designed to contact the skin S of a patient for transmitting electrical signals between the skin and peripheral monitoring equipment 100 (see Figure 6).
~; Thus, electrode 10 can function to monitor or sen~e, stimulate, or diagnose.
, . .: .. -- ; - .. .. . -.. .: :-:
. . . . . . . . - . . . . :. . : . . . . . . . -.: . .: . ~ . .: : :, .
-`` 2100~15 .
In direct contact with skin S i~ an adhesive substrate 20. Substrate 20 may be formed of any suitable material, ~uch as foam, tape, cloth, and the like. On its side (bottom) facing skin S, substrate 20 ha~ a pressure sensitive adhesive layer 22 to promote adherence to skin S. Adhesive layer 22 may be made of any electrically conductive, pres~ure ~ensitive adhesive composition. The composition disclosed by Engel in U.S.
Patent No. 4,843,353 is suitable. Substrate 20 is preferably annular in shape and has a central, circular opening 24.
Substrate 20 is sufficiently flexible to move with skin S, minimizing the tendency, e~pecially prevalent for inflexible electrode~, to "grip~ the skin and cause irritation. Such flexibility also help~
sub~trate 20 maintain electrical contact with ~kin S. In addition, substrate 20 may allow skin S to breath or release perspiration. Finally, substrate 20 is light weight. These characteristics--flexibility, breathability, light weight--of ~ubstrate 20 all prevent ~kin irritation and promote patient comfort.
An electrically conductive disk 30 i8 positioned over and projects above central opening 24 of sub~trate 20. To a~eure that electrode 10 has a low profile, disk 30 projects above substrate 20 the minimum di~tance required for attachment of lead wire 80 (see Figure 6). Disk 30 is fonmed without either a tab or a ~nap. Disk 30 is symmetrical and preferably annular in shape. Disk 30 may be thermoformed of an electrically active form of carbon (e.g., graphite) or of a base coated with a conductive metal (e.g., Ag ink on a semi-rigid, nonconductive, thermoplastic material such as polyester, vinyl, or styrene) or of a conducti~e metal and metal ~alt (e.g., Ag/AgCl). Whatever it~ material of ~100915 construction, disk 30 is substantially rigid to llmit the susceptibility of electrode 10 to motion artifact and to provide for secure attachment.
Two embodiments are ~hown in the Figures for connecting disk 30 to substrate 20. In the first embodiment, shown in Figures 1 and 2, an adhesive ring 40 is provided. The adhesive top of ring 40 contacts (or is integral with) the underside 32 of disk 30 while the adhesive base of ring 40 contacts the top 26 of substrate 20. Ring 40 i8 ~ufficiently adhesive to interconnect disk 30 with substrate 20. Ring 40 also has an annular, ~donut" shape which tracks the perimeter of opening 24 ~n substrate 20 to form a cavity 12.
The second and preferred embodiment for connecting disk 30 to substrate 20 is shown in Figures 3-5. That embodiment eliminates adheeive ring 40.
Instead, disk 30 has a hollow center portion 34 which engages opening 24 of substrate 20. An ultra~onic bond 50 is formed around the perimeter of disk 30 between disk 30 and substrate 20. Consequently, a cavity 12 is formed. Disk 30 is preferably saucer-like in configuration to reduce artifact and to facilitate construction.
~' , A conductive medium 60 such an adhesive, electrolytic gel substantially fills opening 24 of substrate 20 and, hence, cavity 12 formed between disk 30 and substrate 20 in either embodiment. Medium 60 also contacts skin S and may cover a portion of adhesive layer 22 of substrate 20. Thus, medium 60 is in electrical contact with ~kin S, substrate 20, and di~k 30. Medium 60 i~ preferably a hydrogel: a copolymer of acrylic acid and hydroxyethylmethacrylic acid with a humectant (glycerin). The amount of acrylic i9 controlled , . , ~ , , i. :: :...... .. . .
:
2l0nsl~
GC~-790 - 11 -~, carefully to a~ure adheslon by the gel. The gel ha~ a low Cl content (about one percent) t~ decrease ~kln irritatlon and to promote pat~ent comfort. Moreover, the gel absorbs moisture to ensure consistent contact with ~kin S.
To prevent unde~irable stick~ng between electrode 10 and various object~ before electrode 10 i~
to be u~ed, a release liner 70 is provided ~o Cover conducting medium 60 and adhesive layer 22 of eubstrate 20. ~iner 70 i~ removed ju~t before electrode 10 i8 applied to skin S, thereby exposing medium 60 and adhe~ive layer 22 of substrate 20.
A lead wire 80 iB provided to electrically connect electrode 10 to an external monitor lno~ Lead wire 80 i8 attached on a fir~t end to disk 30 of electrode 10. Attachment may be achieved by any one of the various techniques known in the art. For example, ; lead wire 80 may have a loop or hook which engage~ disk 30 (cee Figure 6). Alternatively, lead wire 80 may be attached to a spring or alligator clip 90 which, in turn, i8 attached to disk 30. Clip 90 can be any of a number of known configurations. One configuration ~uitable for clip 90 is shown in Figures 7 and 8. Note that, as shown in Figure 7, clip 90 may be po~itioned on its ~ide or, as shown in Figure 8, in an upright position. ~he former configuration advantageously reduces the profile of the ~ clip-electrode a~sembly.
::`
A lead wire adapter 92 suitable for electrically connecting lead wire 80 to electrode 10 i~
~hown in Figure~ 9-12. Lead wire 80 is attached, preferably by welding, to a thin conducting plate 94. A
~tre~ relief component 98 may be provided to a~sure attachment between lead wire 80 and conducting plate 94;
.. . ~ ,, , . .... . ,,. -- 210091~ ~
stre~s relief component 98 may be made of molded rubber or plastic. Conducting plate 94 is provided with a cutout 96, preferably in the shape of a keyhole. To electrically connect lead wire 80 to electrode 10 using lead wire adapter 92, lead wire adapter 92, with lead wire 80 secured, is placed over disk 30 and pulled into engagement (electrical contact) with di~k 30.
A top layer 99 may be applied over conducting plate 94 to protect conducting plate 94 and to prevent inadvertent contact by external ob~ect8 with conducting plate 94. Top layer 99 may be made of plactic material.
The second end of lead wire 80, opposite the first end connected to disk 30, i~ adapted for connection to monitor 100. Accordingly, the ~econd end of lead wire 80 may have a jack 82. Lead wire 80 is made of a durable, high-flex material; offers a low profile; and i9 reusable.
;
The first end (attached to disk 30) and ~econd end (attached to monitor 100) of lead wire 80 can be ; 20 attached to and detached from their respective components quickly and easily. Like existing snap electrodes, the design of electrode 10 allows for easy attachment and detachment (to and from the patient) without concern for a specific orientation. Unlike many existing electrodes, however, attachment between electrode 10 and it~ lead wire 80 can be made without regard to orientation (i.e., attachment at any position around the 360-degree periphery of electrode 10 is possible). Moreover, lead wire 80 can rotate even when attached to electrode 10.
Attachment and detachment of electrode 10 to and from the patient, and of lead wire 80 to and from electrode 10, are ~ufficiently simple that they can be done even in the dark of a hospital room or a dimly lit operating room.
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. . : . , . , . ~ ., ~.~ . , ~` 2iQO~l~
Electrode 10 i8 ea~y to use and eepecially to connect and di~connect. Unlike many exi~ting electrode~, it i8 not at all cumber~ome. Of ~pecial importance ie the low profile, on the order of one-~ixteenth of an inch, of electrode 10. The unique design of electrode 10 minimize~ manufacturing co~t~ yet meets all of the ~tructural requirement~ of the market. Functionally, electrode 10 provide~ a good quality trace, of concictent accuracy, ~ubstantially all of the time. Electrode 10 limits the xisk that active patient~ will cau~e motion artifact; a reduction in artifact ~avee the time and expense of re-running te~t~ and may eave a life.
Although illustrated and described herein with reference to certain specific embodiments, the pre~ent invention i~ neverthele~Y not intended to be limited to the detail~ shown. Rather, various modificatione may be made in the detail~ within the ~cope and range of equivalents of the claims and without departing from the ~pirit of the invention.
.
. . .:. . . ,,., ... ., .., . : . . .~ . , . . ": ,,... . .; :.
SNAPLESS, TABI-ESS, DISPOSABI-E
MEDICAI. EI.ECTRODE WITH LOW PROFILE
Field of the Invention The present invention relates to a biomedical electrode of the type attached to the body and, more particularly, to a Ynaple~s, tableas, dispo3able medical electrode having a low profile for transmitting electrical signal~ between the akin of a patient and peripheral monitoring equipment.
Background of the Invention Medical electrode~ are well known in the art and vary considerably in their atructure and mt-38 ~cc-793\canawl ~: : .. .
2iO091~
configuration. They generally have a substrate designed to be applied and held to the skin of a patient, an electrical connector, and a conductive lead wire removably and electrically attached to the electrical connector on one end and to a monitoring device on it~
opposite end. The field is relatively crowded.
Designs are usually controlled by, first, a requirement for a secure fastening of the electrical connector to the skin because the electrode may be part of a life support sy~tem. A second requirement of an electrode design is controlled by economics. There is a continuing need for high quality but inexpen~ive medical electrodes. For purposes of convenience and safety (e.g., to maintain sterility in a medical environment), the electrode should be sufficiently inexpensive to manufacture that it is practical to dispose of and to replace the electrode after only one uee (hence, the electrode must be "disposablen).
The various medical electrode de~igns can generally be placed into two categories. In one category are snap-type electrodes in which one end of the electrical connector terminates in a projecting snap or stud. The lead wire is provided with a mating eyelet or socket which receives and secures, by snapping over, the snap. An advantage of such an electrode is that it permits rotation between the electrode and the lead wire.
Rotation aYsures patient comfort, prevents the electrode from disengaging when the patient moves, and allows connection between the lead wire and electrical connector without regard to orientation.
.
It is common to form the projecting snap from a non-conducting ~ubstrate and then to coat that sub~trate with a very thin coating of a conductive material. The ''.
2l0nsl~
thin coating of conducting material i~ easily abraded away, however, when the outer wall of the ~nap frictionally contacts and slides against the eyelet, as happens when the snap electrode rotates with respect to its lead wire. The resulting abrasion of the mating surfaces of the snap and eyelet can eventually degrade the electrical conductivity between the electrode and the lead wire.
To minimize the rotation between the electrode and lead, and the consequent degradation, some electrodes prevent relative rotation. Such electrode~ restrict the versatility and ease of manipulation for the electrode, as well as the equipment to which the electrode i8 connected.
Another problem with the snap-type electrodes is that they have a relatively high profile ~height).
The snap must project from the electrode a significant distance to allow connection of the lead wire eyelet. A
high profile is disadvantageous because it makes the electrode more noticeable and increases the risk of damage by hitting other ob;ect~ during use and ~torage.
The electrical contacts between the ~nap and the lead wire eyelet and between the electrode and the patient are essential; those contacts must be protected from disengagement. Consequently, a low profile electrode i~
preferable.
The second type of electrode ha~ no pro~ecting snap or stud. It i9 usually thin, flat, flexible, disposable, snapless, and, therefore, substantially les~
expensive to manufacture or use. The lead wire interconnect~ the second type of electrode by engaging the electrode itself, uYually at a lateral extension or tab at one ~ide or at the center of the electrode. Thuc, . , . : ..:., -. .;
.. .~ . ~ ,, . ~ . .; ............... .
.. . ., : ~ : . : , -., . , ~. ....... ..
`` - 2~0091~
GCC-790 ~ 4 ~
thi~ second type of electrode is referred to as a "tab"
electrode.
One problem with the tab electrode is that it typically does not permit rotation between the electrode ~`
and the lead wire. A particular orientation of the lead wire with respect to the tab of the electrode is required. Another problem i~ that tab electrodes generally are connected to their lead wires by spring or alligator clip~ affixed to the tab. Such clips typically give the clip-electrode combination a high profile.
Moreover, the clips occasionally slip off the tab, rip through the tab, or tear the tab away from the remainder of the electrode and, therefore, are not entirely satisfactory under certain circum~tances.
Regardle~s of the de~ign, both snap-type and tab-type conventional medical electrodes are relatively complex in their structure. Many of the~e electrodes have hard, bulky components which make them uncomfortable to the patient. Most suffer from motion artifact~.
Motion artifact~ can be defined as motion-induced fluctuation of skin potential. Such artifacts create electrical interference which is often superimpo~ed on the bipotential skin ~ignal measured by the electrode, thereby reducing the electrode's u~efulness as a diagnostic and clinical tool. Motion ~` artifact~ have long been a problem in mea~uring biopotentials, particularly in long-term electrocardiogram (ECG or EKG) monitoring of coronary care patient~ and in exercise (stress) ECG' 9.
Artifacts are generally cau~ed by movement of the patient (who may be on a moving treadmill, for example, to induce increased heart and respiratory rates) , .. . .. .. ,.. . : , ..,. ..,, , , . ..::
' ~ .' ::' ' `:: `'.':, :!: : .. .
-"` 210091~
relative to the electrode applied to the patient'~ ckin.
That movement di~turb~ the skin potential and creates extraneou~ output on the monitor which either ma~k~ the desired bipotential signal or shifts the ba~e line.
As the above di~cussion makes evident, the problem of providing a highly reliable, di~posable, low profile electrode has presented a ma;or challenge to designerc in the health care field. The development of an economical, tabless (80 orientation is eliminated) medical electrode would represent a major technological advance in the field. The advantages of such a device would sati~fy a long-felt need within the medical profession.
Therefore, to overcome the shortcomings of the existing medical electrodes and to ~atiefy the need of ; the medical profession, a new, ~naple~s, tabless, dispo~able medical electrode is provided. A prlmary object of the present invention is to provide an improved medical electrode which can be manufactured at low cost yet meets the structural requirements of the market. A
related object is to provide an electrode which i~
economical and simple in design, yet durable and highly effective to use.
Patient comfort is an overriding concern with any electrode design. Accordingly, it i9 an ob~ect of the present invention to a~sure patient comfort. At the same time, rotational movement between the lead wire and electrode may be necessary to provide a good electrical connection. Such connection must be as~ured even when the patient move~. Accordingly, it is another ob~ect of the pre~ent invention to assure ~ignificant rotational movement between the lead wire and the electrode. It 18 ~..
: .
.`:
,: ., ~ . . ; . ~ , :
~, : " : ,, . . : . : . . - . :. ;: , . -.
210~91~
still another object of the present invention tQ reduce ~-motion artifacts.
An additional ob~ect is to assure that the electrode has a very low profile. Yet another object of this invention i9 to allow for quick and easy attachment and detachment, both to and from the patient and between the electrode and its lead wire, without concern for a specific orientation. Both type~ of attachment and detachment ~hould be sufficiently simple that they can be done in the dark.
Summary of the ~nvention To achieve these and other ob~ects, and in view of its purposes, the present invention provides a snaples3, tabless, disposable medical electrode having a low profile for transmitting electrical signal~ between the skin of a patient and external monitoring equipment.
The electrode has an adhesive substrate with a central opening and a pressure sen~itive adhesive layer on its bottom (which faces the patient); a symmetrical, electrically conductive disk secured to the ~ubstrate, formed without a tab and without a snap, and positioned over and projecting above the central opening of the substrate; a conductive medium (e.g., an adhesive, electrolyte gel) substantially filling the opening of the substrate and electrically contacting the skin of the patient, the substrate, and the di~k; a lead wire, attached to the disk without regard to orientation, for connecting the disk to the external monitoring equipment and a release liner covering the bottom of the ~ubstrate and gel before the electrode is secured to the ~kin of the patient.
. ,- ;, . . . . . .
.. . . . ... . .. ... .. .. ..
., ;. . .
. .
- 21~0~15 It i8 to be understood that both the foregoing general description and the following detailed description are exemplary, but are not restrictive, of the invention.
Brief Description of ~h~ Drawinq The invention is best understood from the following detailed description when read in connection with the accompanying drawing, in which: :
Figure 1 is a cross-sectional view of a snapless, tabless, disposable medical electrode according to a first embodiment of the present invention;
Figure 2 is a top view of the electrode shown in Figure 1;
Figure 3 is an exploded, perspective view of a snapless, tabless, disposable medical electrode according to a second embodiment of the present invention;
Figure 4 is a cross-sectional view of the electrode shown in Figure 3;
Figure 5 is a top view of the electrode shown in Figures 3 and 4;
i Figure 6 is a top view of the electrode shown ~ in Figure 5 illustrating a lead wire electrical connection to the electrode;
Figure 7 is a top view of the electrode shown in Figure 5 illustrating an alligator clip electrical connection to the electrode;
'' :, : , ," ' ' ' .' ' '.'."` ': '"
: . ~ ' :.' '' ' ' ' .
- 2100~
~:
Figure 8 is a side view of the electrode shown in Figure 4 illu~trating an alternate, to that ~hown in Figure 7, alligator clip electrical connection to the electrode;
Figure 9 is a top view of a lead wire adapter which can be used to provide electrical connection to both the first embodiment (shown in Figures 1 and 2) and the second embodiment (shown in Figures 3-5) of the medical electrode of the present invention;
Figure lO i8 a side view of the lead wire adapter shown in Figure 9;
Figure 11 i~ a top view of the lead wire adapter shown in Figure 9 without a top layer; and Figure 12 is front view of the lead wire adapter taken along the section XII-XII of Figure 11.
Detailed escription of the Invention Referring now to the drawing, like reference numerals refer to like elements throughout and the ; elements have been enlarged for clarity; in reality, the ; 20 elements are very thin to form a low profile medical electrode. Figure 1 shows a first embodiment of the snapless, tabless, disposable, low profile medical electrode 10 of the pre~ent invention. Electrode 10 i9 designed to contact the skin S of a patient for transmitting electrical signals between the skin and peripheral monitoring equipment 100 (see Figure 6).
~; Thus, electrode 10 can function to monitor or sen~e, stimulate, or diagnose.
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. . . . . . . . - . . . . :. . : . . . . . . . -.: . .: . ~ . .: : :, .
-`` 2100~15 .
In direct contact with skin S i~ an adhesive substrate 20. Substrate 20 may be formed of any suitable material, ~uch as foam, tape, cloth, and the like. On its side (bottom) facing skin S, substrate 20 ha~ a pressure sensitive adhesive layer 22 to promote adherence to skin S. Adhesive layer 22 may be made of any electrically conductive, pres~ure ~ensitive adhesive composition. The composition disclosed by Engel in U.S.
Patent No. 4,843,353 is suitable. Substrate 20 is preferably annular in shape and has a central, circular opening 24.
Substrate 20 is sufficiently flexible to move with skin S, minimizing the tendency, e~pecially prevalent for inflexible electrode~, to "grip~ the skin and cause irritation. Such flexibility also help~
sub~trate 20 maintain electrical contact with ~kin S. In addition, substrate 20 may allow skin S to breath or release perspiration. Finally, substrate 20 is light weight. These characteristics--flexibility, breathability, light weight--of ~ubstrate 20 all prevent ~kin irritation and promote patient comfort.
An electrically conductive disk 30 i8 positioned over and projects above central opening 24 of sub~trate 20. To a~eure that electrode 10 has a low profile, disk 30 projects above substrate 20 the minimum di~tance required for attachment of lead wire 80 (see Figure 6). Disk 30 is fonmed without either a tab or a ~nap. Disk 30 is symmetrical and preferably annular in shape. Disk 30 may be thermoformed of an electrically active form of carbon (e.g., graphite) or of a base coated with a conductive metal (e.g., Ag ink on a semi-rigid, nonconductive, thermoplastic material such as polyester, vinyl, or styrene) or of a conducti~e metal and metal ~alt (e.g., Ag/AgCl). Whatever it~ material of ~100915 construction, disk 30 is substantially rigid to llmit the susceptibility of electrode 10 to motion artifact and to provide for secure attachment.
Two embodiments are ~hown in the Figures for connecting disk 30 to substrate 20. In the first embodiment, shown in Figures 1 and 2, an adhesive ring 40 is provided. The adhesive top of ring 40 contacts (or is integral with) the underside 32 of disk 30 while the adhesive base of ring 40 contacts the top 26 of substrate 20. Ring 40 i8 ~ufficiently adhesive to interconnect disk 30 with substrate 20. Ring 40 also has an annular, ~donut" shape which tracks the perimeter of opening 24 ~n substrate 20 to form a cavity 12.
The second and preferred embodiment for connecting disk 30 to substrate 20 is shown in Figures 3-5. That embodiment eliminates adheeive ring 40.
Instead, disk 30 has a hollow center portion 34 which engages opening 24 of substrate 20. An ultra~onic bond 50 is formed around the perimeter of disk 30 between disk 30 and substrate 20. Consequently, a cavity 12 is formed. Disk 30 is preferably saucer-like in configuration to reduce artifact and to facilitate construction.
~' , A conductive medium 60 such an adhesive, electrolytic gel substantially fills opening 24 of substrate 20 and, hence, cavity 12 formed between disk 30 and substrate 20 in either embodiment. Medium 60 also contacts skin S and may cover a portion of adhesive layer 22 of substrate 20. Thus, medium 60 is in electrical contact with ~kin S, substrate 20, and di~k 30. Medium 60 i~ preferably a hydrogel: a copolymer of acrylic acid and hydroxyethylmethacrylic acid with a humectant (glycerin). The amount of acrylic i9 controlled , . , ~ , , i. :: :...... .. . .
:
2l0nsl~
GC~-790 - 11 -~, carefully to a~ure adheslon by the gel. The gel ha~ a low Cl content (about one percent) t~ decrease ~kln irritatlon and to promote pat~ent comfort. Moreover, the gel absorbs moisture to ensure consistent contact with ~kin S.
To prevent unde~irable stick~ng between electrode 10 and various object~ before electrode 10 i~
to be u~ed, a release liner 70 is provided ~o Cover conducting medium 60 and adhesive layer 22 of eubstrate 20. ~iner 70 i~ removed ju~t before electrode 10 i8 applied to skin S, thereby exposing medium 60 and adhe~ive layer 22 of substrate 20.
A lead wire 80 iB provided to electrically connect electrode 10 to an external monitor lno~ Lead wire 80 i8 attached on a fir~t end to disk 30 of electrode 10. Attachment may be achieved by any one of the various techniques known in the art. For example, ; lead wire 80 may have a loop or hook which engage~ disk 30 (cee Figure 6). Alternatively, lead wire 80 may be attached to a spring or alligator clip 90 which, in turn, i8 attached to disk 30. Clip 90 can be any of a number of known configurations. One configuration ~uitable for clip 90 is shown in Figures 7 and 8. Note that, as shown in Figure 7, clip 90 may be po~itioned on its ~ide or, as shown in Figure 8, in an upright position. ~he former configuration advantageously reduces the profile of the ~ clip-electrode a~sembly.
::`
A lead wire adapter 92 suitable for electrically connecting lead wire 80 to electrode 10 i~
~hown in Figure~ 9-12. Lead wire 80 is attached, preferably by welding, to a thin conducting plate 94. A
~tre~ relief component 98 may be provided to a~sure attachment between lead wire 80 and conducting plate 94;
.. . ~ ,, , . .... . ,,. -- 210091~ ~
stre~s relief component 98 may be made of molded rubber or plastic. Conducting plate 94 is provided with a cutout 96, preferably in the shape of a keyhole. To electrically connect lead wire 80 to electrode 10 using lead wire adapter 92, lead wire adapter 92, with lead wire 80 secured, is placed over disk 30 and pulled into engagement (electrical contact) with di~k 30.
A top layer 99 may be applied over conducting plate 94 to protect conducting plate 94 and to prevent inadvertent contact by external ob~ect8 with conducting plate 94. Top layer 99 may be made of plactic material.
The second end of lead wire 80, opposite the first end connected to disk 30, i~ adapted for connection to monitor 100. Accordingly, the ~econd end of lead wire 80 may have a jack 82. Lead wire 80 is made of a durable, high-flex material; offers a low profile; and i9 reusable.
;
The first end (attached to disk 30) and ~econd end (attached to monitor 100) of lead wire 80 can be ; 20 attached to and detached from their respective components quickly and easily. Like existing snap electrodes, the design of electrode 10 allows for easy attachment and detachment (to and from the patient) without concern for a specific orientation. Unlike many existing electrodes, however, attachment between electrode 10 and it~ lead wire 80 can be made without regard to orientation (i.e., attachment at any position around the 360-degree periphery of electrode 10 is possible). Moreover, lead wire 80 can rotate even when attached to electrode 10.
Attachment and detachment of electrode 10 to and from the patient, and of lead wire 80 to and from electrode 10, are ~ufficiently simple that they can be done even in the dark of a hospital room or a dimly lit operating room.
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Electrode 10 i8 ea~y to use and eepecially to connect and di~connect. Unlike many exi~ting electrode~, it i8 not at all cumber~ome. Of ~pecial importance ie the low profile, on the order of one-~ixteenth of an inch, of electrode 10. The unique design of electrode 10 minimize~ manufacturing co~t~ yet meets all of the ~tructural requirement~ of the market. Functionally, electrode 10 provide~ a good quality trace, of concictent accuracy, ~ubstantially all of the time. Electrode 10 limits the xisk that active patient~ will cau~e motion artifact; a reduction in artifact ~avee the time and expense of re-running te~t~ and may eave a life.
Although illustrated and described herein with reference to certain specific embodiments, the pre~ent invention i~ neverthele~Y not intended to be limited to the detail~ shown. Rather, various modificatione may be made in the detail~ within the ~cope and range of equivalents of the claims and without departing from the ~pirit of the invention.
.
. . .:. . . ,,., ... ., .., . : . . .~ . , . . ": ,,... . .; :.
Claims (22)
1. A snapless, tabless, disposable medical electrode having a low profile for transmitting electrical signals between the skin of a patient and external monitoring equipment, said electrode comprising:
an adhesive substrate having a top, a central opening and a pressure sensitive adhesive layer on its bottom, said bottom for facing the patient;
an electrically conductive disk having an underside and formed without a tab and without a snap and positioned over and projecting above said central opening of said substrate by a height of less than about one-sixteenth of an inch;
a conductive electrolytic gel substantially filling said opening of said substrate and adapted to electrically contact the skin of the patient, said substrate, and said disk;
means for securing said disk to said substrate;
a lead wire for connecting said disk to the external monitoring equipment;
means for attaching said lead wire to said disk without regard to orientation; and a release liner covering said bottom of said substrate and said conductive electrolytic gel before the electrode is secured to the skin of the patient.
an adhesive substrate having a top, a central opening and a pressure sensitive adhesive layer on its bottom, said bottom for facing the patient;
an electrically conductive disk having an underside and formed without a tab and without a snap and positioned over and projecting above said central opening of said substrate by a height of less than about one-sixteenth of an inch;
a conductive electrolytic gel substantially filling said opening of said substrate and adapted to electrically contact the skin of the patient, said substrate, and said disk;
means for securing said disk to said substrate;
a lead wire for connecting said disk to the external monitoring equipment;
means for attaching said lead wire to said disk without regard to orientation; and a release liner covering said bottom of said substrate and said conductive electrolytic gel before the electrode is secured to the skin of the patient.
2. A snapless, tabless, disposable medical electrode as claimed in claim 1 wherein the material of said substrate is chosen from the group consisting of foam, tape, and cloth.
3. A snapless, tabless, disposable medical electrode as claimed in claim 2 wherein said substrate is annular in shape and said central opening of said substrate is circular.
4. A snapless, tabless, disposable medical electrode as claimed in claim 3 wherein said substrate is flexible, breathable, and light weight.
5. A snapless, tabless, disposable medical electrode as claimed in claim 1 wherein said disk projects above said-substrate the minimum distance required to attach said lead wire to said disk.
6. A snapless, tabless, disposable medical electrode as claimed in claim 1 wherein said disk is annular and substantially rigid.
7. A snapless, tabless, disposable medical electrode as claimed in claim 6 wherein the material of said disk is chosen from the group consisting of an electrically conductive form of carbon; a non-conductive, thermoplastic base coated with a conductive metal; and a conductive metal and metal salt.
8. A snapless, tabless, disposable medical electrode as claimed in claim 7 wherein the material of said disk is graphite.
9. A snapless, tabless, disposable medical electrode as claimed in claim 7 wherein the material of said disk is silver ink coated on a non-conductive, thermoplastic base.
10. A snapless, tabless, disposable medical electrode as claimed in claim 7 wherein the material of said disk is silver/silver chloride.
11. A snapless, tabless, disposable medical electrode as claimed in claim 1 wherein said conductive gel is a copolymer hydrogel of acrylic acid and hydroxyethylmethacrylic acid with a humectant.
12. A snapless, tabless, disposable medical electrode as claimed in claim 1 wherein said securing means includes an adhesive ring having a top and a base, said top attached to the underside of said disk and said base attached to the top of said substrate.
13. A snapless, tabless, disposable medical electrode as claimed in claim 12 wherein said adhesive ring tracks the perimeter of said central opening in said substrate to form a cavity substantially filled with said conductive electrolytic gel.
14. A snapless, tabless, disposable medical electrode as claimed in claim 1 wherein said securing means includes an ultrasonic bond formed around the perimeter of said disk between said disk and said substrate to form a cavity substantially filled with said conductive gel.
15. A snapless, tabless, disposable medical electrode as claimed in claim 14 wherein said disk has a hollow center portion which engages said central opening of said substrate and a saucer-like configuration.
16. A snapless, tabless, disposable medical electrode having a low profile for transmitting electrical signals between the skin of a patient and external monitoring equipment, said electrode comprising:
a flexible, breathable, and light weight adhesive substrate having a top, a central opening and a pressure sensitive adhesive layer on its bottom, said bottom for facing the patient;
an electrically conductive, substantially rigid disk having an underside and formed without a tab and without a snap, said disk positioned over and projecting above said central opening of said substrate by a height of less than about one-sixteenth of an inch;
a conductive electrolytic gel substantially filling said opening of said substrate and adapted to electrically contact the skin of the patient, said substrate, and said disk;
an adhesive ring having a top and a base, said top attached to the underside of said disk and said base attached to the top of said substrate, for securing said disk to said substrate;
a lead wire for connecting said disk to the external monitoring equipment;
means for attaching said lead wire to said disk without regard to orientation; and a release liner covering said bottom of said substrate and said conductive electrolytic gel before the electrode is secured to the skin of the patient.
a flexible, breathable, and light weight adhesive substrate having a top, a central opening and a pressure sensitive adhesive layer on its bottom, said bottom for facing the patient;
an electrically conductive, substantially rigid disk having an underside and formed without a tab and without a snap, said disk positioned over and projecting above said central opening of said substrate by a height of less than about one-sixteenth of an inch;
a conductive electrolytic gel substantially filling said opening of said substrate and adapted to electrically contact the skin of the patient, said substrate, and said disk;
an adhesive ring having a top and a base, said top attached to the underside of said disk and said base attached to the top of said substrate, for securing said disk to said substrate;
a lead wire for connecting said disk to the external monitoring equipment;
means for attaching said lead wire to said disk without regard to orientation; and a release liner covering said bottom of said substrate and said conductive electrolytic gel before the electrode is secured to the skin of the patient.
17. A snapless, tabless, disposable medical electrode as claimed in claim 16 wherein said disk and said substrate are annular.
18. A snapless, tabless, disposable medical electrode as claimed in claim 17 wherein said adhesive ring tracks the perimeter of said central opening in said substrate to form a cavity substantially filled with said conductive electrolytic gel.
19. A snapless, tabless, disposable medical electrode having a low profile for transmitting electrical signals between the skin of a patient and external monitoring equipment, said electrode comprising:
a flexible, breathable, and light weight adhesive substrate having a central opening and a pressure sensitive adhesive layer on its bottom, said bottom for facing the patient;
an electrically conductive, substantially rigid disk formed without a tab and without a snap, said disk positioned over said central opening of said substrate;
a conductive electrolytic gel substantially filling said opening of said substrate and adapted to electrically contact the skin of the patient, said substrate, and said disk;
an ultrasonic bond formed around the perimeter of said disk between said disk and said substrate for securing said disk to said substrate and forming a cavity substantially filled with said conductive gel;
a lead wire for connecting said disk to the external monitoring equipment, said disk projecting above said substrate the minimum distance required to attach said lead wire to said disk;
means for attaching said lead wire to said disk without regard to orientation; and a release liner covering said bottom of said substrate and said conductive electrolytic gel before the electrode is secured to the skin of the patient.
a flexible, breathable, and light weight adhesive substrate having a central opening and a pressure sensitive adhesive layer on its bottom, said bottom for facing the patient;
an electrically conductive, substantially rigid disk formed without a tab and without a snap, said disk positioned over said central opening of said substrate;
a conductive electrolytic gel substantially filling said opening of said substrate and adapted to electrically contact the skin of the patient, said substrate, and said disk;
an ultrasonic bond formed around the perimeter of said disk between said disk and said substrate for securing said disk to said substrate and forming a cavity substantially filled with said conductive gel;
a lead wire for connecting said disk to the external monitoring equipment, said disk projecting above said substrate the minimum distance required to attach said lead wire to said disk;
means for attaching said lead wire to said disk without regard to orientation; and a release liner covering said bottom of said substrate and said conductive electrolytic gel before the electrode is secured to the skin of the patient.
20. A snapless, tabless, disposable medical electrode as claimed in claim 19 wherein said disk and said substrate are annular.
21. A snapless, tabless, disposable medical electrode as claimed in claim 20 wherein said disk has a hollow center portion which engages said central opening of said substrate and a saucer-like configuration.
22. A snapless, tabless, disposable medical electrode as claimed in claim 19 wherein said conductive gel is a copolymer hydrogel of acrylic acid and hydroxyethylmethacrylic acid with a humectant.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US07/916,545 | 1992-07-20 | ||
| US07/916,545 US5261402A (en) | 1992-07-20 | 1992-07-20 | Snapless, tabless, disposable medical electrode with low profile |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2100915A1 true CA2100915A1 (en) | 1994-01-21 |
Family
ID=25437440
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002100915A Abandoned CA2100915A1 (en) | 1992-07-20 | 1993-07-20 | Snapless, tabless, disposable medical electrode with low profile |
Country Status (7)
| Country | Link |
|---|---|
| US (1) | US5261402A (en) |
| EP (1) | EP0582398B1 (en) |
| AT (1) | ATE128839T1 (en) |
| CA (1) | CA2100915A1 (en) |
| DE (1) | DE69300625T2 (en) |
| DK (1) | DK0582398T3 (en) |
| ES (1) | ES2079238T3 (en) |
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| US4635642A (en) * | 1985-07-18 | 1987-01-13 | American Hospital Supply Corporation | Medical electrode with reusable conductor |
| US4699679A (en) * | 1985-07-18 | 1987-10-13 | American Hospital Supply Corporation | Method of manufacturing medical electrode pads |
| US4827939A (en) * | 1985-07-18 | 1989-05-09 | Baxter International Inc. | Medical electrode with reusable conductor and method of manufacture |
| US4674512A (en) * | 1986-02-03 | 1987-06-23 | Lectec Corporation | Medical electrode for monitoring and diagnostic use |
| JPH029771Y2 (en) * | 1986-05-28 | 1990-03-12 | ||
| US4848353A (en) * | 1986-09-05 | 1989-07-18 | Minnesota Mining And Manufacturing Company | Electrically-conductive, pressure-sensitive adhesive and biomedical electrodes |
| US4848351A (en) * | 1987-03-04 | 1989-07-18 | Sentry Medical Products, Inc. | Medical electrode assembly |
| US4798208A (en) * | 1987-12-09 | 1989-01-17 | Faasse Jr Adrian L | Diagnostic electrode |
| US4911657A (en) * | 1989-03-20 | 1990-03-27 | Lec Tec Corporation | Tethered biomedical electrode connector |
| US5042498A (en) * | 1990-04-06 | 1991-08-27 | Hewlett-Packard Company | Intelligent electrocardiogram system |
-
1992
- 1992-07-20 US US07/916,545 patent/US5261402A/en not_active Expired - Fee Related
-
1993
- 1993-07-19 ES ES93305675T patent/ES2079238T3/en not_active Expired - Lifetime
- 1993-07-19 AT AT93305675T patent/ATE128839T1/en not_active IP Right Cessation
- 1993-07-19 DK DK93305675.6T patent/DK0582398T3/en active
- 1993-07-19 EP EP93305675A patent/EP0582398B1/en not_active Expired - Lifetime
- 1993-07-19 DE DE69300625T patent/DE69300625T2/en not_active Expired - Fee Related
- 1993-07-20 CA CA002100915A patent/CA2100915A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| DE69300625D1 (en) | 1995-11-16 |
| EP0582398B1 (en) | 1995-10-11 |
| DK0582398T3 (en) | 1996-02-26 |
| DE69300625T2 (en) | 1996-05-23 |
| ATE128839T1 (en) | 1995-10-15 |
| US5261402A (en) | 1993-11-16 |
| ES2079238T3 (en) | 1996-01-01 |
| EP0582398A1 (en) | 1994-02-09 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |