CA2107836A1 - Integral medical electrode including a fusible conductive substrate and method of manufacture - Google Patents
Integral medical electrode including a fusible conductive substrate and method of manufactureInfo
- Publication number
- CA2107836A1 CA2107836A1 CA002107836A CA2107836A CA2107836A1 CA 2107836 A1 CA2107836 A1 CA 2107836A1 CA 002107836 A CA002107836 A CA 002107836A CA 2107836 A CA2107836 A CA 2107836A CA 2107836 A1 CA2107836 A1 CA 2107836A1
- Authority
- CA
- Canada
- Prior art keywords
- sealant
- electrode
- conductive
- conductor
- conductive additive
- 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
- A61B5/263—Bioelectric electrodes therefor characterised by the electrode materials
-
- 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
- A61B5/271—Arrangements of electrodes with cords, cables or leads, e.g. single leads or patient cord assemblies
- A61B5/273—Connection of cords, cables or leads to electrodes
- A61B5/274—Connection of cords, cables or leads to electrodes using snap or button fasteners
-
- 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
- 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
- A61B5/251—Means for maintaining electrode contact with the body
- A61B5/257—Means for maintaining electrode contact with the body using adhesive means, e.g. adhesive pads or tapes
-
- 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
- A61B5/263—Bioelectric electrodes therefor characterised by the electrode materials
- A61B5/268—Bioelectric electrodes therefor characterised by the electrode materials containing conductive polymers, e.g. PEDOT:PSS polymers
-
- 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
- A61B2562/18—Shielding or protection of sensors from environmental influences, e.g. protection from mechanical damage
- A61B2562/187—Strain relief means
Abstract
ABSTRACT OF THE DISCLOSURE
An integral medical electrode for monitoring and diagnostic applications which includes a fusible conductive substrate to which are fused the other components, such as the conductor, of the electrode. The fusible conductive substrate includes a non-conductive carrier providing a support layer a conductive additive:
and a sealant functioning as a fusible bonding medium to integrate the non-conductive carrier, the conductive additive, and the other components of the electrode. A
method of manufacturing the integral medical electrode of the present invention is also provided.
An integral medical electrode for monitoring and diagnostic applications which includes a fusible conductive substrate to which are fused the other components, such as the conductor, of the electrode. The fusible conductive substrate includes a non-conductive carrier providing a support layer a conductive additive:
and a sealant functioning as a fusible bonding medium to integrate the non-conductive carrier, the conductive additive, and the other components of the electrode. A
method of manufacturing the integral medical electrode of the present invention is also provided.
Description
2~ ~7~3~
SUl~STRATB AND METHOD OF M~NUFACTURl~
Field of the In~en~ion The pre~ent i~vention relate~ generally to a ekin-contacting medical electrode iable to tran~mit low-power, bio-electric ~ignal~ between the ckin ~urface and an electrical conductor. More cpecifically, the present invention relate~ to a conductive aubs~rate, which can be fu~ed to compatible material~ 80 that the variou~
electrode component~ become integral parts of the 3ubstrate, and to a method of manufacturing an electrode ucing ~uch a ~ub~trate.
Ba~kgrou~d of the_Inven~loa There are a variety of ~kin-contacting, medical electrode~ able to transmit low-powerl bio-electric ~ignal~ between the skin ~urface and an electrical conductor. Such electrodes include tho~e for monitoring mf-41 ~ 1~cc-843~c~pp 2 1 0 7 8 ~ ~
and diagno~tic purposes, ~en~ing electrodes, transcutaneous electrical nerve ~timulating (TENS) electrodes, iontophoretic electrode~, electromyographic (EMG) electrodes, and other~. The present invention may 5 be adapted to any of the variou~ electrode~ to provide an improved device.
1. Monitorinq and Di~onostic ~leçtrode~
The focu~ of the pre~ent invention, however, iB
on those ~kin-contacting electrodes which are used to measure bio-electric signal~ from the skin of a patient for medical monitoring and diagno~tic applications.
Various conflguration~ exi~t for such medical or biomedical electrodes; the field i8 relatively crowded.
The two mo~t common type~ of monitoring and diagnoatic electrode~ are "stud"-type electrode~ and tab-type or "~tudle~" electrode~.
2. Stud-~e Ele trod~
The atud-type electrode~ generally have a non-conductive support layer (affixed to the skin by an adhe~ive) which provide~ ~upport ~or the electrode. A
conductor, positioned with~n or over the ~upport layer, tranemit~ the bio-electric ~ignal~ from the ~kin. A
metallic male faatener, or "~tud,~ i~ mounted on the support layer via an eyele~ and i8 elec~rically ~onnected to the conductor.
A female, quick-di~connect, ~nap connector i~
located at one end of an electrical lead. On it0 other end, the lead i8 connected to monitoring or diagnostic equipment. The snap connector hook~, ~nap~, or otherwi~e engage~ the ~tud placed on the electrode to make electrical contact with that electrode and to tran0mit 2~ ~7~
SUl~STRATB AND METHOD OF M~NUFACTURl~
Field of the In~en~ion The pre~ent i~vention relate~ generally to a ekin-contacting medical electrode iable to tran~mit low-power, bio-electric ~ignal~ between the ckin ~urface and an electrical conductor. More cpecifically, the present invention relate~ to a conductive aubs~rate, which can be fu~ed to compatible material~ 80 that the variou~
electrode component~ become integral parts of the 3ubstrate, and to a method of manufacturing an electrode ucing ~uch a ~ub~trate.
Ba~kgrou~d of the_Inven~loa There are a variety of ~kin-contacting, medical electrode~ able to transmit low-powerl bio-electric ~ignal~ between the skin ~urface and an electrical conductor. Such electrodes include tho~e for monitoring mf-41 ~ 1~cc-843~c~pp 2 1 0 7 8 ~ ~
and diagno~tic purposes, ~en~ing electrodes, transcutaneous electrical nerve ~timulating (TENS) electrodes, iontophoretic electrode~, electromyographic (EMG) electrodes, and other~. The present invention may 5 be adapted to any of the variou~ electrode~ to provide an improved device.
1. Monitorinq and Di~onostic ~leçtrode~
The focu~ of the pre~ent invention, however, iB
on those ~kin-contacting electrodes which are used to measure bio-electric signal~ from the skin of a patient for medical monitoring and diagno~tic applications.
Various conflguration~ exi~t for such medical or biomedical electrodes; the field i8 relatively crowded.
The two mo~t common type~ of monitoring and diagnoatic electrode~ are "stud"-type electrode~ and tab-type or "~tudle~" electrode~.
2. Stud-~e Ele trod~
The atud-type electrode~ generally have a non-conductive support layer (affixed to the skin by an adhe~ive) which provide~ ~upport ~or the electrode. A
conductor, positioned with~n or over the ~upport layer, tranemit~ the bio-electric ~ignal~ from the ~kin. A
metallic male faatener, or "~tud,~ i~ mounted on the support layer via an eyele~ and i8 elec~rically ~onnected to the conductor.
A female, quick-di~connect, ~nap connector i~
located at one end of an electrical lead. On it0 other end, the lead i8 connected to monitoring or diagnostic equipment. The snap connector hook~, ~nap~, or otherwi~e engage~ the ~tud placed on the electrode to make electrical contact with that electrode and to tran0mit 2~ ~7~
the bio-electric signal~ from the ~tud to the equipment.
The hook or snap operation of the female snap connector is advantageou~ becau~e it give~ the operator (e.g., a nur~e) affirmative a~urance that connection to the electrode ha~ been made; engagement creates a noticeable feel and, typically, an audible ~ound.
The stud-female ~nap connector type of connection i~ e~pecially de~irable for medical electrod~a ` becau~e it allow~ the electrode to be po~itioned on the patient and then ea~ily connected or disconnected from it~ corre~ponding lead. For that rea~on, most monikor~
u~ed by ho~pital~ and clinics incorporate lead~ which have female ~nap connector~. The lead wire plu~ female snap connector require~, however, that the electrode which it engage~ ha~e a conductive ~tud.
3. T~-Type Electrodes The second prevalent type of monitoring and diagno~tic electrode i~ the tab electrode. The connector (typically an alligator clip) interconnect~ that ~econd type of electrode by engaging the electrode it~elf, u~ually at a lateral exten~ion or tab. An example of a monitoring and diagnostic electrode which avo~d~ the u~e of a ~tud i~ disclosed in Canadian Patent No. 1,269,417 i~ued to ~eaubiah and Moore.
One problem with the tab electrode i~ that, unlike the 3tud electrode, it typically doeH not penmit rotation between the electrode and ~he connector.
Rotation prevent~ the eleetrode from di~engaging when the patient move~. ~nother problem i~ that tab electrode~
cannot be xeadily connected to the female snap connector of the type in wide-~pread uce for making contact with the stud-containing electrode~. Still another problem i~
The hook or snap operation of the female snap connector is advantageou~ becau~e it give~ the operator (e.g., a nur~e) affirmative a~urance that connection to the electrode ha~ been made; engagement creates a noticeable feel and, typically, an audible ~ound.
The stud-female ~nap connector type of connection i~ e~pecially de~irable for medical electrod~a ` becau~e it allow~ the electrode to be po~itioned on the patient and then ea~ily connected or disconnected from it~ corre~ponding lead. For that rea~on, most monikor~
u~ed by ho~pital~ and clinics incorporate lead~ which have female ~nap connector~. The lead wire plu~ female snap connector require~, however, that the electrode which it engage~ ha~e a conductive ~tud.
3. T~-Type Electrodes The second prevalent type of monitoring and diagno~tic electrode i~ the tab electrode. The connector (typically an alligator clip) interconnect~ that ~econd type of electrode by engaging the electrode it~elf, u~ually at a lateral exten~ion or tab. An example of a monitoring and diagnostic electrode which avo~d~ the u~e of a ~tud i~ disclosed in Canadian Patent No. 1,269,417 i~ued to ~eaubiah and Moore.
One problem with the tab electrode i~ that, unlike the 3tud electrode, it typically doeH not penmit rotation between the electrode and ~he connector.
Rotation prevent~ the eleetrode from di~engaging when the patient move~. ~nother problem i~ that tab electrode~
cannot be xeadily connected to the female snap connector of the type in wide-~pread uce for making contact with the stud-containing electrode~. Still another problem i~
4 21~)78~
that the electrical ~ignal~ tran~mltted by tab electrode a~emblies tend to ~uffer from increa~ed noise relative to their stud counterpart~. Such unde~irable nol~e i~
cau0ed, at lea~t in part, by the exposed metal of the connector. Accordingly, in view of the various drawbacka of the tab electrodes, the pre~ent invent~on focu~e~ on the ~tud electrode.
4. Gener~l on~i~Zeratio~
In part becau~e of the prevaillng ri~k~
as~ociated with tran~mi~ion of infectiou~ di~ea~e through medical in~trument~ (~terility in the medical environment muct be maintained), the expense of cleaning ~uch in~trument~, and the neces~ity that the inctruments be reliable in u~e (the electrode may be part of a life ~upport ay~tem), medical electrode3 u~ed ~or monitoring and diagno~tic purpo~e~ are often ~dicposable: they are dl~carded after application to only one patient.
Con~equently, the co~t to manufacture each electrode mu~t be minimized. Even a ~avinga of $0.0025 per electrode le of great importance. The manufacturing ~tep of affixing the ctud to the ~upport layer, conventionally done by punching through an eyelet, con~titutes a large part of the co~t of manu~acturing the ~tud electrode.
For medical electrode~ and, more generally, for direct mea~urement of electrical ~ignal~, a continuou~
electrical path i~ required from the ~ource of the ~ignal to the equipment which monitors that ~ignal. A ~imple path con~i~t~ of wire~ contacting the ~ignal ~ource at one end and eguipment input~ at the other. In practice, connectorc (~uch a~ the medical electrode ~tud) are provided at both tenmination point~ of the path to en~ure that a Htable connection i8 maintained. Secondary connection~ may al~o be provided to extend the path 21~783~
through additional component~ along the ~ignal path.
Each termination point or exten~ion thereof addc both co~t and compl~xity to the circuit and alao increase~ the potential for ~ignal degradation through loccec at the interface ~ite or ~ites.
Because the ~eparate components of the conventional electrode~ are not integrally formed, there i~ an increased potential for cignal degradation at interface~. Moreover, ~ignal integrity relie~ on the proximity of each of the component~ to each other.
Complex a~semblie~ of medical electrode~
require a~tachment of the many component~ deccribed above and frequently uQe manu~acturing method~ including adhe~ion, mechanlcal fastening, weld~ng, soldering, cealing, or other common method~ to ~ecure the component~
together. Such asse~bliec and manufacturing methodc can eubctantially ~ncreaae the co~t of the electrode. It would be pre~erable, therefore, both economically and functionally, to manufacture the electrode ac an integral deviceO
that the electrical ~ignal~ tran~mltted by tab electrode a~emblies tend to ~uffer from increa~ed noise relative to their stud counterpart~. Such unde~irable nol~e i~
cau0ed, at lea~t in part, by the exposed metal of the connector. Accordingly, in view of the various drawbacka of the tab electrodes, the pre~ent invent~on focu~e~ on the ~tud electrode.
4. Gener~l on~i~Zeratio~
In part becau~e of the prevaillng ri~k~
as~ociated with tran~mi~ion of infectiou~ di~ea~e through medical in~trument~ (~terility in the medical environment muct be maintained), the expense of cleaning ~uch in~trument~, and the neces~ity that the inctruments be reliable in u~e (the electrode may be part of a life ~upport ay~tem), medical electrode3 u~ed ~or monitoring and diagno~tic purpo~e~ are often ~dicposable: they are dl~carded after application to only one patient.
Con~equently, the co~t to manufacture each electrode mu~t be minimized. Even a ~avinga of $0.0025 per electrode le of great importance. The manufacturing ~tep of affixing the ctud to the ~upport layer, conventionally done by punching through an eyelet, con~titutes a large part of the co~t of manu~acturing the ~tud electrode.
For medical electrode~ and, more generally, for direct mea~urement of electrical ~ignal~, a continuou~
electrical path i~ required from the ~ource of the ~ignal to the equipment which monitors that ~ignal. A ~imple path con~i~t~ of wire~ contacting the ~ignal ~ource at one end and eguipment input~ at the other. In practice, connectorc (~uch a~ the medical electrode ~tud) are provided at both tenmination point~ of the path to en~ure that a Htable connection i8 maintained. Secondary connection~ may al~o be provided to extend the path 21~783~
through additional component~ along the ~ignal path.
Each termination point or exten~ion thereof addc both co~t and compl~xity to the circuit and alao increase~ the potential for ~ignal degradation through loccec at the interface ~ite or ~ites.
Because the ~eparate components of the conventional electrode~ are not integrally formed, there i~ an increased potential for cignal degradation at interface~. Moreover, ~ignal integrity relie~ on the proximity of each of the component~ to each other.
Complex a~semblie~ of medical electrode~
require a~tachment of the many component~ deccribed above and frequently uQe manu~acturing method~ including adhe~ion, mechanlcal fastening, weld~ng, soldering, cealing, or other common method~ to ~ecure the component~
together. Such asse~bliec and manufacturing methodc can eubctantially ~ncreaae the co~t of the electrode. It would be pre~erable, therefore, both economically and functionally, to manufacture the electrode ac an integral deviceO
5 . Ob~ctf~
Accordingly, the general object o~ the pre3ent invention i~ to provide an electrode which ha~ relatively inexpen~ive components and which can be ac~embled ea~ily, efficiently, and economically. 5uch components al~o must ascure cignal integrity and b~ compatible with each other.
In order to achieve Shat general object, a more cpecific ob;ect i9 to provide an electrode which incorporate~ a conductive cub~trate a~ a connectlon point for ~ignal tran~mi~ion and a~ a mounting ~urface for - 6 - 21~783~
tran~mis~ion components. The conductive 3ubstrate i8 fu~ed to compatible material~ ~o that the component~
become integral part~ of the conductive sub~trate. Thu~, for example, the need for the expen~ive eyelet of the S conventional atud electrode i~ eliminated.
One advantage of an integral electrode ~c minimization of the potential for ~ignal degradation at interfaces. Another ad~antage ic the reduction ~n manufacturing ~tepe required, and consequent decreaced co~t, to form the integral electroda. Still another advantage i~ the reduc~ion in the potential for a~kembly failure due to the reduced number of component~ re~uired for a~embly.
Rotational movement between the external connector (e.g., female ~nap connector) and the electrode may be neces~ary to provide a good electrical connection.
Such connection ~lu~t be a~sured even when the patient movec. It i~ another object of the pre~ent invention, therefore, to aasure significant rotational movement between the external connector and the electrode.
A furthar object i~ to permit adaptation to the conventional lead wire plu9 female ~nap connector as~emblie~ connected ~o mo3t monitor3 and diagno~tic equipment.
~ummary of th~ Inven~ion To achieve the~e and other objects, and in view of ite purpo~e~, the pre~ent invention provide3 an integral medical electrode which include~ a fucible conductive eub~trate to which are fu~ed other componentc, ~uch a~ the conductor, of the electrode. The fu~ibla conductive sub~trate ha~ a non-conductive carrier 7 ~ ~7~3~
providing a ~upport layer; a conductive additive; and a ~ealant functioning a~ a fu~ible bonding medium to integrate the non-conductive carrier, the conductive additive, and the other componente of the electrode.
A method of manufacturing the integral medical electrode of the pre~ent invention is al00 provided.
That method include~ the ~tep~ of providing a ~ealant in the aolid ~tate; converting the ~ealant from the ~olid state to a fluidic fonm; placing a non-conductive carrier, a conductive additive, and a conductor in the ~ealant while the ~ealant i~ in it~ fluidic form; and allowing the ~ealant to return to the eolid ~tate.
Consequently, the ~ealant, non-conductive carrier, and conductive additive fonm a conductive Hub~trate which i~
integrally fueed to the conductor to form the integral medical electrode.
It iY to be underetood that both the foregoing ~eneral de~cription and the following detailed description are ex~mplary, but are not reEtrictive, of the invention.
Brief ~Ç~53i~iQn O~ bÇ Draw~nq The invention is be~t under~tood from the following detailed de~cription when read in connection with the accompanying drawing, in which:
Figure 1 ia a per~pective, partial cut-away view of the fusible conductive subctrate according to the preaent invention;
Accordingly, the general object o~ the pre3ent invention i~ to provide an electrode which ha~ relatively inexpen~ive components and which can be ac~embled ea~ily, efficiently, and economically. 5uch components al~o must ascure cignal integrity and b~ compatible with each other.
In order to achieve Shat general object, a more cpecific ob;ect i9 to provide an electrode which incorporate~ a conductive cub~trate a~ a connectlon point for ~ignal tran~mi~ion and a~ a mounting ~urface for - 6 - 21~783~
tran~mis~ion components. The conductive 3ubstrate i8 fu~ed to compatible material~ ~o that the component~
become integral part~ of the conductive sub~trate. Thu~, for example, the need for the expen~ive eyelet of the S conventional atud electrode i~ eliminated.
One advantage of an integral electrode ~c minimization of the potential for ~ignal degradation at interfaces. Another ad~antage ic the reduction ~n manufacturing ~tepe required, and consequent decreaced co~t, to form the integral electroda. Still another advantage i~ the reduc~ion in the potential for a~kembly failure due to the reduced number of component~ re~uired for a~embly.
Rotational movement between the external connector (e.g., female ~nap connector) and the electrode may be neces~ary to provide a good electrical connection.
Such connection ~lu~t be a~sured even when the patient movec. It i~ another object of the pre~ent invention, therefore, to aasure significant rotational movement between the external connector and the electrode.
A furthar object i~ to permit adaptation to the conventional lead wire plu9 female ~nap connector as~emblie~ connected ~o mo3t monitor3 and diagno~tic equipment.
~ummary of th~ Inven~ion To achieve the~e and other objects, and in view of ite purpo~e~, the pre~ent invention provide3 an integral medical electrode which include~ a fucible conductive eub~trate to which are fu~ed other componentc, ~uch a~ the conductor, of the electrode. The fu~ibla conductive sub~trate ha~ a non-conductive carrier 7 ~ ~7~3~
providing a ~upport layer; a conductive additive; and a ~ealant functioning a~ a fu~ible bonding medium to integrate the non-conductive carrier, the conductive additive, and the other componente of the electrode.
A method of manufacturing the integral medical electrode of the pre~ent invention is al00 provided.
That method include~ the ~tep~ of providing a ~ealant in the aolid ~tate; converting the ~ealant from the ~olid state to a fluidic fonm; placing a non-conductive carrier, a conductive additive, and a conductor in the ~ealant while the ~ealant i~ in it~ fluidic form; and allowing the ~ealant to return to the eolid ~tate.
Consequently, the ~ealant, non-conductive carrier, and conductive additive fonm a conductive Hub~trate which i~
integrally fueed to the conductor to form the integral medical electrode.
It iY to be underetood that both the foregoing ~eneral de~cription and the following detailed description are ex~mplary, but are not reEtrictive, of the invention.
Brief ~Ç~53i~iQn O~ bÇ Draw~nq The invention is be~t under~tood from the following detailed de~cription when read in connection with the accompanying drawing, in which:
Figure 1 ia a per~pective, partial cut-away view of the fusible conductive subctrate according to the preaent invention;
- 8 23.~7~35 Figurea 2A and 2B illustrate a tab-type electrode incorporating the fu~ible conductive ~ub~trate ~hown in Figure 1;
Figures 3A and 3B illustrate a ~tud-type electrode incorporating the fu~ible conductive subctrate shown in Figure 1;
Figure 4 illu~trate~ a flexible, electrically conductive ribbon connector formed uaing the fusible conductive eub~trate ~hown in Figure 1;
Figurea 5A and 5B depict a complex electrode manifold incorporating the fu~ible conductiva ~ubstrate shown in Figure 1; and Figure~ 6A and 6B illu~trate the proce~ of drawing the conductive ad~itive of the fusible conductive substrate shown in Figure 1 into a pre-detenmined pattern under the influence of a masnet.
Detailed De~ri~tlQn o~ Inven~ion Referring now to the drawing, wherein like reference numeral~ refer to like element~ throughout, Figure 1 showa the fu~ible conductive ~ub~trate 10 of the preaen~ invention. Although fuaible aubstrate 10 may be formed a~ a rigid construction for ~ome application~, it will typically be flexible. ~u~ible ~ub~txate 10 ha~ a non-conductive carrier 12 as the aupport layer, a ~ealable material or aealant 1~ as the fusible bonding medium, and a conductive additive 16 which provide~
conductivi~y while maintaining the fusible property of the fusible aubstrate 10. Non-conductive carrier 12 may be, for example, paper or a polymer film auch a~
polyolefin, apun polyolefin, polye~ter, and urethane.
Figures 3A and 3B illustrate a ~tud-type electrode incorporating the fu~ible conductive subctrate shown in Figure 1;
Figure 4 illu~trate~ a flexible, electrically conductive ribbon connector formed uaing the fusible conductive eub~trate ~hown in Figure 1;
Figurea 5A and 5B depict a complex electrode manifold incorporating the fu~ible conductiva ~ubstrate shown in Figure 1; and Figure~ 6A and 6B illu~trate the proce~ of drawing the conductive ad~itive of the fusible conductive substrate shown in Figure 1 into a pre-detenmined pattern under the influence of a masnet.
Detailed De~ri~tlQn o~ Inven~ion Referring now to the drawing, wherein like reference numeral~ refer to like element~ throughout, Figure 1 showa the fu~ible conductive ~ub~trate 10 of the preaen~ invention. Although fuaible aubstrate 10 may be formed a~ a rigid construction for ~ome application~, it will typically be flexible. ~u~ible ~ub~txate 10 ha~ a non-conductive carrier 12 as the aupport layer, a ~ealable material or aealant 1~ as the fusible bonding medium, and a conductive additive 16 which provide~
conductivi~y while maintaining the fusible property of the fusible aubstrate 10. Non-conductive carrier 12 may be, for example, paper or a polymer film auch a~
polyolefin, apun polyolefin, polye~ter, and urethane.
9 2~ 3 :3 Fusible ~ub~trate 10 u~es it~ characteristic of fu~ibility (or ~ealability) to achieve component attachment; it additionally functions a~ the carrier for the conductive additive 16. Thu~, a di~tinct advantage of u~ing fu~ible sub~trate 10 for component attachment i~
a reduction in the potential for as~embly fa~lure due to the reduced number of components required for as0embly.
In discu~sing the pre~ent invention, "fusing~
or "~ealing~ means a proce~ whereby at lea~t the ~urface of the ma~erial to be used a~ ~ealant 14 i~ temporarily converted from a ~olid ~tate into fluidic form. In general, thi~ can be accompli~hed by applying heat or chemlcal inducer~ to sealant 14. While ~ealant 14 i~
fluidic, ~upplemental proce~ing o~ ~ealant 1~ can be performed. Sealant 14 i~ then penmitted to return to its solid ~tate.
Materials suitable a~ ~ealant 14 include thermopla~tic~. Sealant 14 ~hould have the following characteri~tic~: the ability to mel~ without decomposition at the melting tempe:rature, a gla~
traneition temperature (Tg) below the temperature at which the device will be u~ed ~i.e., the sealant mu~t be flexible at the temperature of u~e), and a low melt flow index (the material mu~t flow when melted). Examples of ~harmoplastic~ which have tho~e characteristic~ and, hence, are ~uitable aB sealant 14 include: polyolefins, polyurethane elastomera, ~ome nylon~, pla~ticized polyvinyl chloride, copolymers of ethylene and acrylic acid, and some polymer blenda.
In choosing the appropriate material for ~ealant 14, the characteristic~ outlined above should be considered. For example, polyethylene, which ha~ a Tg of -20C, would be preferred over poly~tyrene, which ha~ a lo - 2 1 ~ 7 ~ 3 ~
Tg of about 33C and ie brittle at room temperature.
Similarly, polybutadiene tTg of -73~C) would be preferred over polyvinyl chloride (Tg of 78C). One ~pecific example of an appropriate material for ~ealant 1~ ic low density polyethylene (LDPE). A ~econd specific example combines an LDPE base with a meltable coating applied to the baae. LDPE ha~ a melting poin~ in the range between 105 and 120C. The meltable coating i6 a copol~mer of ethylene and acrylic acid, having a melting point of le~
than 100C, which can be obtained from Michelman Inc. ae ~Michem 49~3."
Fu~ible ~ub~trate 10 also includec a conductive additive 16 which provides conductivity while maintaining the fu~ible characteristics of sealant 14. Suitable materials for conductive additive 16 include any material or combination of materials with conductive propertie~
which are compatible with sealant 14 as defined above.
Conductive additive 16 may be added to ~ealant 14 to cover the outer ~urface of ~ealant 14. Alternatively, conductive additive 16 may be depo~ited w~thin ~ealant 14. As conductive additive 16 i~ added to ~ealant 14, it may be drawn into a pre-determined pattern under, for example, the influence of a magnet.
Conductive additive 16 may be flakes or ~trip~
o~ metal materials such as ~ilver, tin, and nickel. The metal salts, such as silver chloride, may be u~ed in combination with the metal. Conductive alloy~ ~uch a~
brass or copper nickel alloy~ may be ~uitable for certain applications. Other conductive material~, ~uch as carbon, are also suitable a~ conductive additive 16. If the electrode i~ used for monitoring, which often mandate~ defibrillation, then a metal-metal salt combination ~uch a~ ~ilver-~ilver chloride may be required.
- 11 - 21o783~
A balance between the conductivity provided to fu~ible ~ubstrate 10 by conductive additive 16 and the ~ealability provided by ~ealant 14 i8 extremPly important. Fusible ~ubatrate 10 m~t provide a low-impedance path while fu~ing variou~ component~ into anintegral device. Accordingly, the ratio between the amount of conductive additive 16 and the amount of ~ealant 14 mu~t be controlled carefully. For example, when 15~ ~ilver chloride i8 mechanically diaper~ed in ~ilver flake~ to form conduc~ive additiv~ 16, a ratio of 75~ by weight conductive additive 16 to 25% by weight ~ealant 1~ uitable. The phy~ical shape (e.g., the size of flakea, length and thickness of atrips) of conductive additive 16 i~ al~o important to as~ure the appropriate balance between conductivity and sealability.
A~ it relate~ to the pre~ent invention, sealing can be accomplished by combining the components of the device while at lea~t onP elemen~ of sealant 14 ia in ~luidic form. The component~ are held together, ln clo~e proximity, while that element which i~ in fluidic fonm return~ to the ~olid ~tate. The re3ult is a ~ealed, integral device.
It ~hould be recqgnized that the invention iQ
not limlted to material~ which are heat eealable; rather, chemically ~ealable material~ may al~o be used to achieve the de~ired integral device. An integral device eliminate~ the requirement for multiple componenta aS the electric cignal interface~ and, accordingly, doe~ not rely colely on the proximity of ita component~ to assure ~ignal integrity.
Referring to Figure~ 2A and 2B, fu~ible ~ub~trate 10 may be u~ed to fonm an integral, tab-type electrode 20. Electrode 20 haa a conductor 22 for 8 3 ~
recelving and transmitting bio-electric ~ignal~ from the ~kin of a patient. Conductor 22 may be a eolid gel, a conducti~e polymer, or other conductive medium.
Conductor 22 i8 fu~ed or bonded to conductive, fuæible ~ub~trate 10 at the ~ur~ace of fusible ~ub~trate 10 oppo~ite non-conductive carrier la.
As i3 known in ~he art, tab-type electrode 20 i~ foxmed in a ~hape which include~ a tab 24. Tab 24 ie ea~ily engaged by an ex~ernal electrical connector such a~ an alligator connector 26. Connector 26 recei~e~ the bioelectric ~ignal from electrode 20 for tran~mis~ion over a lead 28 to a monitor 30. Monitor 30 indicate~, for example, the inten~ity and quality of the bio-electric aignal emitted by the heart and tran~mitted through the ~kin. The type o~ monitor 30 which i~
~uitable i~ within the knowledge of a person having ordinary skill in the art and will depend upon the intended uae for electrode 20.
Figure~ 3A and 3B illu~trate the preferred embodiment of the pre~ent invention. The ~tud-type electrode ~0 illustrated in Figures 3A and 3~ i~
~ignif~cantly lea~ complex than existing electrode~.
Specifically, electrode 40 i0 an integral electrode.
Electrode ~0 include~ a non-conductive eupport layer g2 which provide~ support for the other component~
of electrode 40. Support layer 42 may be a foam pad having an aperture 44 either in it~ approximate center or, a~ ~hown, of~aet from ita center. Conductor 22 iH
po~itioned within aperture 44 to tran~mit bio-electric ~ignal~ from the ~kin, ~, of the patient through ~upport layer 42. Conductor 22 may cub~tantially fill aperture 44 in ~upport layer 42 to a~ure proper contact between conductor 22 and ekin ~ when electrode ~0 i~ affixed to 21~7 8 ~
~kin S. An adhesive i~ attached to the bottom ~urface of support layer 42 ~o that conductor 22 is held again~t skin S.
A liner or cover ~heet 46 cover~ ~upport layer ~2 and conductor 22 to protect ~upport layer 42 and conductor 22, preclude premature adhe~ion, and prevent conductor 22 from drying. ~iner 46 i~ a vapor barrter and ha~ a relea~e coating which covers the adhesive on the bottom surface of ~upport layer 42. When electrode 40 i~ to be u~ed, the relea~e coating allow~ liner ~6 to be peeled away.
A:Lternatively, a~ ahown in Figurea 3A and 3~, a conductive adhesive ~8 may be applied to the bottom 3urface~ of conductor 22 and ~upport layer ~2.
~5 Conductive adhesive 48 i~ preferably a hydrogel. Liner 46 i~ then applied over conductive adheeive 48.
Conductive adhesive 48 directly contact~ ~kin S, after liner 46 is removed and electrode 40 ic in use, and receive~ bio-electric signal~ from skin S.
A stud 50 i8 mounted to the top ~urface of support layer 42. Fusible ~ub~trate 10 i8 provided to integrate conductor 22, support layer 4a ~ and stud 50--the e~sential component~ of electrode 40. A hole 54 i9 provided in fusible sub~trate 10 to accommodate stud 50.
Integration i~ accompli~hed a~ de~cribed above. ~ecause fu~ible sub~trate 10 is conductive, it provide~ an electrical path from conductor 22 to stud 50. A
conventional female anap connector 52 can engage stud 50 and receive the electrical signal from atud 50. Lead 28 then carrie~ that aignal from female ~nap connector 52 to monitor 30~
21~7g3~
Thus, the bio-electric ~ignal found ~n ~kin i~ received by conductive adhe~ive 48; tran~mitted through ~upport layer 42 by conductor 22; carried to ~tud 50 by conductive, fu~ible ~ub~trate 10 where it iB
delivered to ~emale ~nap connector 52; and, ~inally, tran~mitted to monitor 30 along lead 28.
When manufacturing a conventional ~tud-type electrode, an opening i~ formed in the support layer. A
relatively expen~ive eyelet i~ in~erted into that opening. Then the ~tud i9 mechanically faatened, ~uch a~
by crimping, to the eyelet. The conventional manufacturing ~tep~ used to attach the stud and eyelet to the ~upport layer include a step and repeat proce~.
In contra~t, elec~rode 40 of the pre~ent invention eliminate~ the need for an eyelet. In addition, the manufacturing ~tep~ used to form electrode 40 do not require a break in the manufacturing proce~s.
~ather, the proce~s u~ed to manufacture electrode 40 i~
continuou~.
Specifically, ~ealant 14 and conducti~e additive 16 may be combined with a l~quid (e.g., water~
to form a di~per~ion mixture. Non-condu~tive carrier 12 i~ coated wi~h the di~per~ion mixture to form, upon evaporation of the li~lid, fusible ~ub~trate 10. ~ole 54 i~ then punched through fu~ible ~ub~trate 10 and ~tud 50 i~ placed in hole 54. Fusible ~ub~trate 10, with ctud 50, i8 placed over support layer 42. Sub~e~uently, ~ealant 14 in fu~ible ~ub~trate 10 i~ activated by heat or chemical reaction. Sealant 14 1~ in it~ fluidic form, following activation, and will flow to engage the compone~ts of electrode ~0. When ~ealant 14 return~ to ita ~olld ~tate, an integral, fused electrode 40 results.
,:. , :.
- 15 - 21~783~
Figura 4 show~ another application for fuaible substrate 10. Fuaible substrate 10 may be fused or bonded to a non-conductive carrier 62 to form a flexible, electrically conductive ribbon connector 60. As shown in Figure 4, fu~ible ~ubstrate 10 and non-conductive carrier 62 may be alternated in layex~ to form ribbon connector 60. Non-conductive carrier 62 function~ a~ a aupport layer for ribbon connector 60.
Figure~ 5A and 5B dep~ct a complex electrode manifold 70 for u3e in measuring bio-potential~.
Electrode manifold 70 include~ multiple ~kin-contacting conductive pad~ 72, typically formed in ~heet~ of separable pad~ 72. Each conduc~ive pad 72 may be electrically and physically interconnected to electrode manifold 70 through fu~ible aub~trate 10. Flexible electric ribbon connector 60, as ~hown in Figure 4, i~
al~o ~uitable for connecting conductive pad3 72 to alectrode manifold 70.
An alligator-type multi-connector 74 engages fu~ible ~ubstrate 10 and receive~ the electric aignal transmitted by fusible ~ub~trate 10. That ~ignal i~
tran~mitted, in turn, from multi-connector 7~ to a ~unction box 76 and then by lead 2B to monitor 3~. Thus, electrode manifold 70 allow~ one connection to a number (ten are illustrated in Figure 5A) of electrode pad~ 72.
Electrode manifold 70 offer~ ~everal important advantages attributable to the flat configuration made possible by fu~ible ~ub~trate 10. A flat configuration i~ desirable becau~e it ~implifies manufacture, ea~e~
packaging and tran~port, protect~ electrode manifold 70 from damage, and facilitates u~e of electrode manifold 70 on the ~kin of the patient.
.. , :
2~783~
A~ mentioned above, conductive additive 16 may be drawn into a pre determined pattern aa it ic added to ~ealant 14 to form fu~ible ~ubetrate 10. If conductive additive 16 ia a magnetic material, auch a nickel, the pat~ern may be induced by the influence of a magnetic force. Figure~ 6A and 6B illustrate that proces~. A
non-conductive carrier 12 i~ provided as a support layer.
Sealant 14 i8 bonded to non-conductive carrier 1~, a~
de~cribed above. Conductive additive 16 i~ then ready for bonding to ~ealant 14 to form fu~ible ~ub~trate 10.
A magnetic template 90, able to induce the de~ired pattern of conductive additive 16 in fu~ible sub~trate 10, i~ po~itioned ad~acent fu~ible aub~trate ~0. The pattern of conductive additive 16a (e.g., nickel) before fusible ~ub~trate 10 i~ influenced by the application of magnetic template 90 i9 ~hown. A1BO ~hown in Figure~ 6A and 6~ ia the pattern of conductive additive 16 after application of the magnetic in~luence ha~ induced the de~ired pattern.
Although illuatrated and described herein with reference to certain ~pecific embodimente, the pre~ent invention ia neverthele~s not intended to be limited to the detail~ ~hown. Rather, variouc modificationa may be made in the detail~ within the ~cope and range of equivalent~ of the claim~ and without departing from the ~pirit of the invention. Specifically, although the pre~ent invention focu~e~ on monitoring and diagn~tic electrode~ and, more particularly, on stud-type monitoring and diagnoatic electrode3, the fu~ible aub~trate di~cloaed can be incorporated in a variety of electrode device~.
a reduction in the potential for as~embly fa~lure due to the reduced number of components required for as0embly.
In discu~sing the pre~ent invention, "fusing~
or "~ealing~ means a proce~ whereby at lea~t the ~urface of the ma~erial to be used a~ ~ealant 14 i~ temporarily converted from a ~olid ~tate into fluidic form. In general, thi~ can be accompli~hed by applying heat or chemlcal inducer~ to sealant 14. While ~ealant 14 i~
fluidic, ~upplemental proce~ing o~ ~ealant 1~ can be performed. Sealant 14 i~ then penmitted to return to its solid ~tate.
Materials suitable a~ ~ealant 14 include thermopla~tic~. Sealant 14 ~hould have the following characteri~tic~: the ability to mel~ without decomposition at the melting tempe:rature, a gla~
traneition temperature (Tg) below the temperature at which the device will be u~ed ~i.e., the sealant mu~t be flexible at the temperature of u~e), and a low melt flow index (the material mu~t flow when melted). Examples of ~harmoplastic~ which have tho~e characteristic~ and, hence, are ~uitable aB sealant 14 include: polyolefins, polyurethane elastomera, ~ome nylon~, pla~ticized polyvinyl chloride, copolymers of ethylene and acrylic acid, and some polymer blenda.
In choosing the appropriate material for ~ealant 14, the characteristic~ outlined above should be considered. For example, polyethylene, which ha~ a Tg of -20C, would be preferred over poly~tyrene, which ha~ a lo - 2 1 ~ 7 ~ 3 ~
Tg of about 33C and ie brittle at room temperature.
Similarly, polybutadiene tTg of -73~C) would be preferred over polyvinyl chloride (Tg of 78C). One ~pecific example of an appropriate material for ~ealant 1~ ic low density polyethylene (LDPE). A ~econd specific example combines an LDPE base with a meltable coating applied to the baae. LDPE ha~ a melting poin~ in the range between 105 and 120C. The meltable coating i6 a copol~mer of ethylene and acrylic acid, having a melting point of le~
than 100C, which can be obtained from Michelman Inc. ae ~Michem 49~3."
Fu~ible ~ub~trate 10 also includec a conductive additive 16 which provides conductivity while maintaining the fu~ible characteristics of sealant 14. Suitable materials for conductive additive 16 include any material or combination of materials with conductive propertie~
which are compatible with sealant 14 as defined above.
Conductive additive 16 may be added to ~ealant 14 to cover the outer ~urface of ~ealant 14. Alternatively, conductive additive 16 may be depo~ited w~thin ~ealant 14. As conductive additive 16 i~ added to ~ealant 14, it may be drawn into a pre-determined pattern under, for example, the influence of a magnet.
Conductive additive 16 may be flakes or ~trip~
o~ metal materials such as ~ilver, tin, and nickel. The metal salts, such as silver chloride, may be u~ed in combination with the metal. Conductive alloy~ ~uch a~
brass or copper nickel alloy~ may be ~uitable for certain applications. Other conductive material~, ~uch as carbon, are also suitable a~ conductive additive 16. If the electrode i~ used for monitoring, which often mandate~ defibrillation, then a metal-metal salt combination ~uch a~ ~ilver-~ilver chloride may be required.
- 11 - 21o783~
A balance between the conductivity provided to fu~ible ~ubstrate 10 by conductive additive 16 and the ~ealability provided by ~ealant 14 i8 extremPly important. Fusible ~ubatrate 10 m~t provide a low-impedance path while fu~ing variou~ component~ into anintegral device. Accordingly, the ratio between the amount of conductive additive 16 and the amount of ~ealant 14 mu~t be controlled carefully. For example, when 15~ ~ilver chloride i8 mechanically diaper~ed in ~ilver flake~ to form conduc~ive additiv~ 16, a ratio of 75~ by weight conductive additive 16 to 25% by weight ~ealant 1~ uitable. The phy~ical shape (e.g., the size of flakea, length and thickness of atrips) of conductive additive 16 i~ al~o important to as~ure the appropriate balance between conductivity and sealability.
A~ it relate~ to the pre~ent invention, sealing can be accomplished by combining the components of the device while at lea~t onP elemen~ of sealant 14 ia in ~luidic form. The component~ are held together, ln clo~e proximity, while that element which i~ in fluidic fonm return~ to the ~olid ~tate. The re3ult is a ~ealed, integral device.
It ~hould be recqgnized that the invention iQ
not limlted to material~ which are heat eealable; rather, chemically ~ealable material~ may al~o be used to achieve the de~ired integral device. An integral device eliminate~ the requirement for multiple componenta aS the electric cignal interface~ and, accordingly, doe~ not rely colely on the proximity of ita component~ to assure ~ignal integrity.
Referring to Figure~ 2A and 2B, fu~ible ~ub~trate 10 may be u~ed to fonm an integral, tab-type electrode 20. Electrode 20 haa a conductor 22 for 8 3 ~
recelving and transmitting bio-electric ~ignal~ from the ~kin of a patient. Conductor 22 may be a eolid gel, a conducti~e polymer, or other conductive medium.
Conductor 22 i8 fu~ed or bonded to conductive, fuæible ~ub~trate 10 at the ~ur~ace of fusible ~ub~trate 10 oppo~ite non-conductive carrier la.
As i3 known in ~he art, tab-type electrode 20 i~ foxmed in a ~hape which include~ a tab 24. Tab 24 ie ea~ily engaged by an ex~ernal electrical connector such a~ an alligator connector 26. Connector 26 recei~e~ the bioelectric ~ignal from electrode 20 for tran~mis~ion over a lead 28 to a monitor 30. Monitor 30 indicate~, for example, the inten~ity and quality of the bio-electric aignal emitted by the heart and tran~mitted through the ~kin. The type o~ monitor 30 which i~
~uitable i~ within the knowledge of a person having ordinary skill in the art and will depend upon the intended uae for electrode 20.
Figure~ 3A and 3B illu~trate the preferred embodiment of the pre~ent invention. The ~tud-type electrode ~0 illustrated in Figures 3A and 3~ i~
~ignif~cantly lea~ complex than existing electrode~.
Specifically, electrode 40 i0 an integral electrode.
Electrode ~0 include~ a non-conductive eupport layer g2 which provide~ support for the other component~
of electrode 40. Support layer 42 may be a foam pad having an aperture 44 either in it~ approximate center or, a~ ~hown, of~aet from ita center. Conductor 22 iH
po~itioned within aperture 44 to tran~mit bio-electric ~ignal~ from the ~kin, ~, of the patient through ~upport layer 42. Conductor 22 may cub~tantially fill aperture 44 in ~upport layer 42 to a~ure proper contact between conductor 22 and ekin ~ when electrode ~0 i~ affixed to 21~7 8 ~
~kin S. An adhesive i~ attached to the bottom ~urface of support layer 42 ~o that conductor 22 is held again~t skin S.
A liner or cover ~heet 46 cover~ ~upport layer ~2 and conductor 22 to protect ~upport layer 42 and conductor 22, preclude premature adhe~ion, and prevent conductor 22 from drying. ~iner 46 i~ a vapor barrter and ha~ a relea~e coating which covers the adhesive on the bottom surface of ~upport layer 42. When electrode 40 i~ to be u~ed, the relea~e coating allow~ liner ~6 to be peeled away.
A:Lternatively, a~ ahown in Figurea 3A and 3~, a conductive adhesive ~8 may be applied to the bottom 3urface~ of conductor 22 and ~upport layer ~2.
~5 Conductive adhesive 48 i~ preferably a hydrogel. Liner 46 i~ then applied over conductive adheeive 48.
Conductive adhesive 48 directly contact~ ~kin S, after liner 46 is removed and electrode 40 ic in use, and receive~ bio-electric signal~ from skin S.
A stud 50 i8 mounted to the top ~urface of support layer 42. Fusible ~ub~trate 10 i8 provided to integrate conductor 22, support layer 4a ~ and stud 50--the e~sential component~ of electrode 40. A hole 54 i9 provided in fusible sub~trate 10 to accommodate stud 50.
Integration i~ accompli~hed a~ de~cribed above. ~ecause fu~ible sub~trate 10 is conductive, it provide~ an electrical path from conductor 22 to stud 50. A
conventional female anap connector 52 can engage stud 50 and receive the electrical signal from atud 50. Lead 28 then carrie~ that aignal from female ~nap connector 52 to monitor 30~
21~7g3~
Thus, the bio-electric ~ignal found ~n ~kin i~ received by conductive adhe~ive 48; tran~mitted through ~upport layer 42 by conductor 22; carried to ~tud 50 by conductive, fu~ible ~ub~trate 10 where it iB
delivered to ~emale ~nap connector 52; and, ~inally, tran~mitted to monitor 30 along lead 28.
When manufacturing a conventional ~tud-type electrode, an opening i~ formed in the support layer. A
relatively expen~ive eyelet i~ in~erted into that opening. Then the ~tud i9 mechanically faatened, ~uch a~
by crimping, to the eyelet. The conventional manufacturing ~tep~ used to attach the stud and eyelet to the ~upport layer include a step and repeat proce~.
In contra~t, elec~rode 40 of the pre~ent invention eliminate~ the need for an eyelet. In addition, the manufacturing ~tep~ used to form electrode 40 do not require a break in the manufacturing proce~s.
~ather, the proce~s u~ed to manufacture electrode 40 i~
continuou~.
Specifically, ~ealant 14 and conducti~e additive 16 may be combined with a l~quid (e.g., water~
to form a di~per~ion mixture. Non-condu~tive carrier 12 i~ coated wi~h the di~per~ion mixture to form, upon evaporation of the li~lid, fusible ~ub~trate 10. ~ole 54 i~ then punched through fu~ible ~ub~trate 10 and ~tud 50 i~ placed in hole 54. Fusible ~ub~trate 10, with ctud 50, i8 placed over support layer 42. Sub~e~uently, ~ealant 14 in fu~ible ~ub~trate 10 i~ activated by heat or chemical reaction. Sealant 14 1~ in it~ fluidic form, following activation, and will flow to engage the compone~ts of electrode ~0. When ~ealant 14 return~ to ita ~olld ~tate, an integral, fused electrode 40 results.
,:. , :.
- 15 - 21~783~
Figura 4 show~ another application for fuaible substrate 10. Fuaible substrate 10 may be fused or bonded to a non-conductive carrier 62 to form a flexible, electrically conductive ribbon connector 60. As shown in Figure 4, fu~ible ~ubstrate 10 and non-conductive carrier 62 may be alternated in layex~ to form ribbon connector 60. Non-conductive carrier 62 function~ a~ a aupport layer for ribbon connector 60.
Figure~ 5A and 5B dep~ct a complex electrode manifold 70 for u3e in measuring bio-potential~.
Electrode manifold 70 include~ multiple ~kin-contacting conductive pad~ 72, typically formed in ~heet~ of separable pad~ 72. Each conduc~ive pad 72 may be electrically and physically interconnected to electrode manifold 70 through fu~ible aub~trate 10. Flexible electric ribbon connector 60, as ~hown in Figure 4, i~
al~o ~uitable for connecting conductive pad3 72 to alectrode manifold 70.
An alligator-type multi-connector 74 engages fu~ible ~ubstrate 10 and receive~ the electric aignal transmitted by fusible ~ub~trate 10. That ~ignal i~
tran~mitted, in turn, from multi-connector 7~ to a ~unction box 76 and then by lead 2B to monitor 3~. Thus, electrode manifold 70 allow~ one connection to a number (ten are illustrated in Figure 5A) of electrode pad~ 72.
Electrode manifold 70 offer~ ~everal important advantages attributable to the flat configuration made possible by fu~ible ~ub~trate 10. A flat configuration i~ desirable becau~e it ~implifies manufacture, ea~e~
packaging and tran~port, protect~ electrode manifold 70 from damage, and facilitates u~e of electrode manifold 70 on the ~kin of the patient.
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2~783~
A~ mentioned above, conductive additive 16 may be drawn into a pre determined pattern aa it ic added to ~ealant 14 to form fu~ible ~ubetrate 10. If conductive additive 16 ia a magnetic material, auch a nickel, the pat~ern may be induced by the influence of a magnetic force. Figure~ 6A and 6B illustrate that proces~. A
non-conductive carrier 12 i~ provided as a support layer.
Sealant 14 i8 bonded to non-conductive carrier 1~, a~
de~cribed above. Conductive additive 16 i~ then ready for bonding to ~ealant 14 to form fu~ible ~ub~trate 10.
A magnetic template 90, able to induce the de~ired pattern of conductive additive 16 in fu~ible sub~trate 10, i~ po~itioned ad~acent fu~ible aub~trate ~0. The pattern of conductive additive 16a (e.g., nickel) before fusible ~ub~trate 10 i~ influenced by the application of magnetic template 90 i9 ~hown. A1BO ~hown in Figure~ 6A and 6~ ia the pattern of conductive additive 16 after application of the magnetic in~luence ha~ induced the de~ired pattern.
Although illuatrated and described herein with reference to certain ~pecific embodimente, the pre~ent invention ia neverthele~s not intended to be limited to the detail~ ~hown. Rather, variouc modificationa may be made in the detail~ within the ~cope and range of equivalent~ of the claim~ and without departing from the ~pirit of the invention. Specifically, although the pre~ent invention focu~e~ on monitoring and diagn~tic electrode~ and, more particularly, on stud-type monitoring and diagnoatic electrode3, the fu~ible aub~trate di~cloaed can be incorporated in a variety of electrode device~.
Claims (40)
1. An integral medical electrode contacting the skin of a patient and comprising:
a conductor transmitting bio-electric signals between the skin and the conductor; and a conductive substrate having:
(a) a non-conductive carrier providing a support layer, (b) a conductive additive, and (c) a sealant sealing, fusing, and bonding said non-conductive carrier, said conductive additive, and said conductor into said integral medical electrode.
a conductor transmitting bio-electric signals between the skin and the conductor; and a conductive substrate having:
(a) a non-conductive carrier providing a support layer, (b) a conductive additive, and (c) a sealant sealing, fusing, and bonding said non-conductive carrier, said conductive additive, and said conductor into said integral medical electrode.
2. The electrode as claimed in claim 1 wherein said sealant is a thermoplastic.
3. The electrode as claimed in claim 2 wherein said thermoplastic sealant is selected from the group consisting of polyolefins, polyurethane elastomers, nylons, plasticized polyvinyl chloride, copolymers of ethylene and acrylic acid, and polymer blends.
4. The electrode as claimed in claim 3 wherein said thermoplastic sealant is a low density polyethylene base coated with an ethylene and acrylic acid copolymer.
5. The electrode as claimed in claim 1 wherein said sealant has an inducer selected from the group consisting of heat and chemical inducers adapted to temporarily convert said sealant from a solid state into fluidic form.
6. The electrode as claimed in claim 1 wherein said conductive additive is selected from the group consisting of metals, metal alloys, metal-metal salt combinations, and carbon.
7. The electrode as claimed in claim 1 wherein said non-conductive carrier is selected from the group consisting of paper and polymer films.
8. The electrode as claimed in claim 1 wherein said conductive additive is fused to said sealant and becomes an element of said substrate in a pre-determined pattern.
9. An integral medical electrode contacting the skin of a patient, adapted for monitoring and diagnostic applications, and comprising:
a conductor receiving and transmitting bio-electric signals from the akin; and a conductive substrate having:
(a) a non-conductive carrier providing a support layer, (b) a conductive additive, and (c) a sealant sealing, fusing, and bonding said non-conductive carrier, said conductive additive, and said conductor into said integral medical electrode, said conductive substrate having a shape which includes a tab adapted to engage an electrical connector electrically interconnected through a lead to a monitor.
a conductor receiving and transmitting bio-electric signals from the akin; and a conductive substrate having:
(a) a non-conductive carrier providing a support layer, (b) a conductive additive, and (c) a sealant sealing, fusing, and bonding said non-conductive carrier, said conductive additive, and said conductor into said integral medical electrode, said conductive substrate having a shape which includes a tab adapted to engage an electrical connector electrically interconnected through a lead to a monitor.
10. The electrode as claimed in claim 9 wherein said sealant is a thermoplastic.
11. The electrode as claimed in claim 10 wherein said thermoplastic sealant is selected from the group consisting of polyolefins, polyurethane elastomers, nylons, plasticized polyvinyl chloride, copolymers of ethylene and acrylic acid, and polymer blends.
12. The electrode as claimed in claim 11 wherein said thermoplastic sealant is a low density polyethylene base coated with an ethylene and acrylic acid copolymer.
13. The electrode as claimed in claim 9 wherein said sealant has an inducer selected from the group consisting of heat and chemical inducers adapted to temporarily convert said sealant from a solid state into fluidic form.
14. The electrode as claimed in claim 9 wherein said conductive additive is selected from the group consisting of metals, metal alloys, metal-metal salt combinations, and carbon.
15. The electrode as claimed in claim 9 wherein said non-conductive carrier is selected from the group consisting of paper and polymer films.
16. The electrode as claimed in claim 9 wherein said conductive additive is fused to said sealant and becomes an element of said substrate in a pre-determined pattern.
17. The electrode as claimed in claim 1 wherein said electrode is adapted for monitoring and diagnostic applications and said conductor receives and transmits bio-electric signals from the skin, said electrode further comprising a stud sealed, fused, and bonded to said substrate by said sealant and adapted to engage a female snap connector electrically interconnected through a lead to a monitor, said substrate forming an electrical path from said conductor to said stud.
18. The electrode as claimed in claim 17 further comprising a non-conductive support layer sealed, fused, and bonded to said substrate by said sealant and supporting said substrate, said conductor, and said stud.
19. The electrode as claimed in claim 18 wherein said support layer has an aperture and said conductor substantially fills said aperture to assure contact between said conductor and the skin.
20. The electrode as claimed in claim 19 further comprising an adhesive, said support layer having a bottom surface to which said adhesive is attached to hold said conductor against the skin.
21. The electrode as claimed in claim 20 further comprising a liner covering said support layer and said conductor when said electrode is not in use.
22. The electrode as claimed in claim 19 further comprising a conductive adhesive, said support layer and said conductor each having a bottom surface to which said conductive adhesive is attached to hold said conductor in electrical contact against the skin.
23. The electrode as claimed in claim 22 further comprising a liner covering said conductive adhesive when said electrode is not in use.
24. An integral medical electrode contacting the skin of a patient, adapted for monitoring and diagnostic applications, and comprising:
a non-conductive support layer;
a conductor supported by said support layer and receiving and transmitting bio-electric signals from the skin;
a stud supported by said support layer and adapted to engage a female snap connector electrically interconnected through a lead to a monitor;
a conductive substrate supported by said support layer, forming an electrical path from said conductor to said stud, and having:
(a) a non-conductive carrier providing a support layer, (b) a conductive additive, and (c) a sealant sealing, fusing, and bonding said non-conductive carrier, said conductive additive, said stud, said support layer, and said conductor into said integral medical electrode.
a non-conductive support layer;
a conductor supported by said support layer and receiving and transmitting bio-electric signals from the skin;
a stud supported by said support layer and adapted to engage a female snap connector electrically interconnected through a lead to a monitor;
a conductive substrate supported by said support layer, forming an electrical path from said conductor to said stud, and having:
(a) a non-conductive carrier providing a support layer, (b) a conductive additive, and (c) a sealant sealing, fusing, and bonding said non-conductive carrier, said conductive additive, said stud, said support layer, and said conductor into said integral medical electrode.
25. The electrode as claimed in claim 2 wherein said sealant is a thermoplastic.
26. The electrode as claimed in claim 25 wherein said thermoplastic sealant is selected from the group consisting of polyolefins, polyurethane elastomers, nylons, plasticized polyvinyl chloride, copolymers of ethylene and acrylic acid, and polymer blends.
27. The electrode as claimed in claim 26 wherein said thermoplastic sealant is a low density polyethylene base coated with an ethylene and acrylic acid copolymer.
28. The electrode as claimed in claim 24 wherein said sealant has an inducer selected from the group consisting of heat and chemical inducers adapted to temporarily convert said sealant from a solid state into fluidic form.
29. The electrode as claimed in claim 24 wherein said conductive additive is selected from the group consisting of metals, metal alloys, metal-metal salt combinations, and carbon.
30. The electrode as claimed in claim 24 wherein said non-conductive carrier is selected from the group consisting of paper and polymer films.
31. The electrode as claimed in claim 24 wherein said conductive additive is sealed, fused, and bonded to said sealant and becomes an element of said substrate in a pre-determined pattern.
32. A method of manufacturing an integral medical electrode having a conductor, said method comprising the steps of:
(a) providing a sealant in the solid state;
(b) converting said sealant from the solid state to a fluidic form;
(c) placing a non-conductive carrier in said sealant while said sealant is in its fluidic form;
(d) placing a conductive additive in said sealant while said sealant is in its fluidic form;
(e) placing said conductor in said sealant while said sealant is in its fluidic form; and (f) allowing said sealant to return to the solid state, whereby said sealant, said non-conductive carrier, and said conductive additive form a conductive substrate which is integrally fused to said conductor to form said integral medical electrode.
(a) providing a sealant in the solid state;
(b) converting said sealant from the solid state to a fluidic form;
(c) placing a non-conductive carrier in said sealant while said sealant is in its fluidic form;
(d) placing a conductive additive in said sealant while said sealant is in its fluidic form;
(e) placing said conductor in said sealant while said sealant is in its fluidic form; and (f) allowing said sealant to return to the solid state, whereby said sealant, said non-conductive carrier, and said conductive additive form a conductive substrate which is integrally fused to said conductor to form said integral medical electrode.
33. The method as claimed in claim 32 wherein said step of converting said sealant from the solid state to a fluidic form includes adding heat.
34. The method as claimed in claim 32 wherein said step of converting said sealant from the solid state to a fluidic form includes adding a chemical inducer.
35. The method as claimed in claim 32 further comprising the step of shaping said conductive substrate to form a tab adapted to engage an electrical connector electrically interconnected through a lead to a monitor.
36. The method as claimed in claim 32 further comprising the step, before step (e) and after step (d), of drawing said conductive additive into a pre-determined pattern in said sealant.
37. The method as claimed in claim 36 wherein said drawing step includes positioning a template having the pre-determined pattern adjacent the fluidic sealant and conductive additive, providing a magnetic force, and allowing said magnetic force to pull said conductive additive into the pre-determined pattern of said template as said conductive additive fuses in said sealant to form said conductive substrate.
38. The method as claimed in claim 32 wherein during said step (d) of placing said conductive additive in said sealant, said sealant having an outer surface, said conductive additive is placed in said sealant to cover said outer surface of said sealant.
39. The method a claimed in claim 32 wherein during said step (d) of placing said conductive additive in said sealant, said conductive additive is deposited within said sealant.
40. A method of manufacturing an integral medical electrode for monitoring and diagnostic applications, said method comprising the steps of:
(a) providing a sealant in the solid state;
(b) adding a conductive additive and a liquid to said sealant to form a dispersion mixture;
(c) coating a non-conductive carrier with said dispersion mixture to form a fusible substrate;
(d) punching a hole through said fusible substrate;
(e) placing a stud, adapted to engage a female snap connector electrically interconnected through a lead to a monitor, in said hole;
(f) placing said fusible substrate, including said stud, over a support layer having an aperture containing a conductor;
(g) activating said sealant in said fusible substrate to place said sealant in fluidic form, (h) allowing said sealant to flow and to engage said support layer, said conductor, said stud, said conductive additive, and said non-conductive carrier;
(i) permitting said sealant to return to its solid state, whereby said fusible substrate formed by said sealant, said non-conductive carrier, and said conductive additive is integrally fused to said conductor, said stud, and said support layer to form said integral medical electrode.
(a) providing a sealant in the solid state;
(b) adding a conductive additive and a liquid to said sealant to form a dispersion mixture;
(c) coating a non-conductive carrier with said dispersion mixture to form a fusible substrate;
(d) punching a hole through said fusible substrate;
(e) placing a stud, adapted to engage a female snap connector electrically interconnected through a lead to a monitor, in said hole;
(f) placing said fusible substrate, including said stud, over a support layer having an aperture containing a conductor;
(g) activating said sealant in said fusible substrate to place said sealant in fluidic form, (h) allowing said sealant to flow and to engage said support layer, said conductor, said stud, said conductive additive, and said non-conductive carrier;
(i) permitting said sealant to return to its solid state, whereby said fusible substrate formed by said sealant, said non-conductive carrier, and said conductive additive is integrally fused to said conductor, said stud, and said support layer to form said integral medical electrode.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US07/957,996 | 1992-10-07 | ||
| US07/957,996 US5400782A (en) | 1992-10-07 | 1992-10-07 | Integral medical electrode including a fusible conductive substrate |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2107836A1 true CA2107836A1 (en) | 1994-04-08 |
Family
ID=25500468
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002107836A Abandoned CA2107836A1 (en) | 1992-10-07 | 1993-10-06 | Integral medical electrode including a fusible conductive substrate and method of manufacture |
Country Status (3)
| Country | Link |
|---|---|
| US (1) | US5400782A (en) |
| EP (1) | EP0596604A1 (en) |
| CA (1) | CA2107836A1 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0635239A1 (en) * | 1993-07-19 | 1995-01-25 | Leonhard Lang | Method and apparatus for manufacturing electrodes |
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-
1993
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- 1993-10-07 EP EP93307985A patent/EP0596604A1/en not_active Withdrawn
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0635239A1 (en) * | 1993-07-19 | 1995-01-25 | Leonhard Lang | Method and apparatus for manufacturing electrodes |
Also Published As
| Publication number | Publication date |
|---|---|
| US5400782A (en) | 1995-03-28 |
| EP0596604A1 (en) | 1994-05-11 |
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| Date | Code | Title | Description |
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| FZDE | Discontinued |