WO2012149466A2 - Dispositif associé au corps et son procédé de fabrication - Google Patents

Dispositif associé au corps et son procédé de fabrication Download PDF

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Publication number
WO2012149466A2
WO2012149466A2 PCT/US2012/035650 US2012035650W WO2012149466A2 WO 2012149466 A2 WO2012149466 A2 WO 2012149466A2 US 2012035650 W US2012035650 W US 2012035650W WO 2012149466 A2 WO2012149466 A2 WO 2012149466A2
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WO
WIPO (PCT)
Prior art keywords
substrate
inlay substrate
electrically conductive
inlay
conductive layer
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.)
Ceased
Application number
PCT/US2012/035650
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English (en)
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WO2012149466A3 (fr
Inventor
Lawrence Arne
James Hutchison
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Proteus Digital Health Inc
Original Assignee
Proteus Biomedical Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Proteus Biomedical Inc filed Critical Proteus Biomedical Inc
Publication of WO2012149466A2 publication Critical patent/WO2012149466A2/fr
Publication of WO2012149466A3 publication Critical patent/WO2012149466A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6832—Means for maintaining contact with the body using adhesives
    • A61B5/6833—Adhesive patches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0443—Modular apparatus
    • 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
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0209—Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
    • A61B2562/0214—Capacitive electrodes
    • 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
    • A61B2562/12—Manufacturing methods specially adapted for producing sensors for in-vivo measurements
    • A61B2562/125—Manufacturing methods specially adapted for producing sensors for in-vivo measurements characterised by the manufacture of electrodes
    • 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
    • A61B2562/164—Details of sensor housings or probes; Details of structural supports for sensors the sensor is mounted in or on a conformable substrate or carrier
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802—Sensor mounted on worn items
    • A61B5/681—Wristwatch-type devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6831—Straps, bands or harnesses

Definitions

  • the present disclosure is related generally to various configurations of body associated devices such as a patch and methods for manufacturing such devices.
  • the present disclosure is related to various physical configurations of wearable body associated devices compatible for a web handling manufacturing process.
  • a broad industry with diverse product offerings is developing around body associated devices.
  • Such devices include patches, personal monitors that sense physiologic parameters of a living subject and communicate such information to body-area network devices in
  • Body associated devices can monitor and record individual physiological parameters, e.g., physical activity, heart rate, respiration, temperature, sleep, pulse oxymetry, etc., of the living subject and communicate these parameters beyond the body of the living subject to other devices, e.g., mobile phones, computers, internet servers, etc.
  • physiological parameters e.g., physical activity, heart rate, respiration, temperature, sleep, pulse oxymetry, etc.
  • other devices e.g., mobile phones, computers, internet servers, etc.
  • methods for manufacturing and assembling such body associated devices also become more complex. Therefore, there is room for improvements in manufacturing such body associated devices in high volume manufacturing environments and in particular in a web handling or web processing manufacturing environment to provide for high volume production and lower cost assembled body associated device.
  • a method of manufacturing a body associated device comprises providing an inlay substrate comprising a first side, a second side, and at least one conductive trace and providing an interposer substrate comprising a first side, a second side, and at least one conductive trace.
  • An electrically conductive layer is applied to the first side of the inlay substrate.
  • the at least one conductive trace is electrically coupled to the conductive layer.
  • the first side of the interposer substrate is coupled to the first side of the inlay substrate to form a subassembly.
  • the at least one conductive trace on the interposer substrate is electrically coupled to the at least one conductive trace on the inlay substrate through the electrically conductive layer.
  • FIG. 1 is an exploded view of one aspect of a body associated device.
  • FIG. 2 is a perspective view of a body associated device assembly shown in FIG. 1 .
  • FIG. 3 is a top view of the body associated device shown in FIG. 1 .
  • FIG. 4 is a sectional view of the body associated device shown in FIG. 3 taken along section 4—4.
  • FIG. 5 is a bottom view of the body associated device shown in FIG. 1 .
  • FIG. 6 is a sectional view of the body associated device shown in FIG. 5 taken along section 6—6.
  • FIG. 7 is a side view of the body associated device shown in FIG. 1 .
  • FIG. 8 is a side view of the body associated device shown in FIG. 1 .
  • FIG. 9 is a top view of a two-layer interposer substrate according to one aspect of the body associated device shown in FIG. 1 .
  • FIG. 10 is a bottom view of the two-layer interposer substrate shown in FIG. 9.
  • FIG. 1 1 is a top view of an inlay substrate according to one aspect of the body associated device shown in FIG. 1 .
  • FIG. 12 is a bottom view of the inlay substrate according to one aspect of the body associated device shown in FIG. 1 1 .
  • FIG. 13 is a side view of one aspect of an inlay substrate comprising wet electrodes with a hydrogel interface.
  • FIG. 14 is a side view of one aspect of an inlay substrate comprising dry electrodes and guard traces.
  • FIG. 15 is a side view of one aspect of an inlay substrate comprising dry electrodes, guard traces, and multiple layers.
  • FIG. 16 is a schematic diagram of a bio-potential electrode model.
  • FIG. 17 is a schematic diagram representing unwanted stray capacitance resulting from coupling dry electrodes to the skin of a living subject.
  • FIG. 18 is a schematic diagram representing a guard tracing circuit technique to address unwanted stray capacitance resulting from coupling dry electrodes to the skin of a living subject as shown in FIG. 17.
  • FIG. 19 is a plot showing impedance versus frequency of the bio-potential electrode model shown in FIG. 16.
  • FIG. 20 is a sectional view of printed circuit board signal traces located between upper and lower guard traces.
  • FIG. 21 is a flow diagram of a method of manufacturing one aspect of a body associated device.
  • the present disclosure provides multiple configurations of a body associated device.
  • the body associated device may comprise a patch, a biocollection patch, a patch receiver, a receiver, a wearable personal communication device ("personal communicator"), among others, which may be individually or collectively referred to herein as a "patch," without limitation.
  • a body associated device is attached to the body of a living subject and is electrical communication with the living subject.
  • the body associated device may be in vivo, partially insertible, or ex vivo, i.e., present outside of the body of the living subject during use.
  • the body associated device may be configured to be associated with a desirable skin location.
  • the body associated device may be configured to contact a topical skin location of a subject.
  • Configurations of interest include, but are not limited to: patches, wrist bands, belts, jewelry, watch, apparel, among other configurations. For instance, a watch or belt worn externally and equipped with suitable receiving electrodes can be used as receivers in accordance with the disclosed aspects.
  • the body associated device may provide a
  • the body associated device comprises miniaturized electronic components integrated with one or more electrodes to form a bandage- style patch where electrodes, when applied, contact the skin of the living subject.
  • the bandage- style patch may be removably attachable to the living subject, e.g., via an adhesive layer or other construction.
  • a battery and electronics also may be included.
  • the bandage-style patch may be configured to be positioned on a desirable target skin site of the subject, e.g., on the wrist, chest, back, side of the torso, etc.
  • the bandage circuitry may be configured to receive signals, communications, data and the like from devices inside of the subject, e.g., Implantable Pulse Generator, cardiac lead, an ingestible device such as an identifier of a pharma-informatics enabled pharmaceutical composition, etc., and may be configured to relay this information to an external processing device, e.g., a PDA, smartphone, mobile phone, handheld device, computer, etc., as described in greater detail elsewhere.
  • a PDA personal digital assistant
  • smartphone mobile phone
  • handheld device handheld device
  • computer etc.
  • the disclosed body associated device comprises an interposer substrate (also known as a strap) and an inlay substrate coupled to the interposer substrate.
  • the interposer substrate forms the core of the device assembly and may comprise high density electronics assembled onto a conventional printed circuit board (PCB), for example.
  • the inlay substrate may be a flexible circuit element electrically coupled to electrodes for electrically coupling the body associated device to a living subject. Electrical connections to the interposer substrate couple the electrodes to the electronic components on the inlay substrate.
  • the body associated device may be assembled in a two-phase process.
  • electronic components are assembled onto the interposer substrate using any suitable conventional robotic pick-and-place process.
  • the inlay substrate may be attached to the populated interposer substrate using various attachment techniques as discussed hereinbelow which are compatible with high volume web handling manufacturing processes. Since the precision robotic pick-and-place phase is separate from the web assembly phase, the two-phase process minimizes the amount of precision required during the web assembly process.
  • the body associated device assembly also may comprise a foam housing laminated over the interposer-inlay assembly and sealed into a bandage-style patch, for example.
  • FIG. 1 is an exploded view of one aspect of a body associated device 100.
  • FIG. 2 is a perspective view of a fully assembled body associated device 100 shown in FIG. 1 .
  • FIG. 3 is a top view of a fully assembled body associated device 100 shown in FIG. 1 .
  • FIG. 4 is a sectional view of the body associated device 100 shown in FIG. 3 taken along section 4— 4.
  • FIG. 5 is a top view of a fully assembled body associated device 100 shown in FIG. 1 .
  • FIG. 6 is a sectional view of the body associated device 100 shown in FIG. 5 taken along section 6— 6.
  • FIGS. 7 and 8 are side views of the fully assembled body associated device 100.
  • the body associated device 100 will now be described in connection with FIGS. 1 -8.
  • the body associated device 100 comprises a housing formed of a top portion 102 and a bottom portion 104.
  • the top and bottom housing portions 102, 104 may be made of a closed cell foam material or other suitable resilient material, e.g., injection-moldable or thermo-formable plastic material.
  • the top and bottom housing portions 102, 104 contain the components of the body associated device 100.
  • top and bottom housing portions 102, 104 may be coupled (e.g., sealed, fitted together, connected) using any suitable technique including welding, ultrasonic welding, heat welding, adhesively coupling, riveting, screwing, snap fitting, shrink fitting, button snap fitting, to mention but a few suitable techniques.
  • an inlay substrate 106 e.g., flex circuit
  • an interposer substrate 1 16 e.g., PCB
  • the interposer substrate 1 16 comprises one or more electronic components 1 18 assembled thereon forming an electronic circuit configured to perform a variety of functions.
  • the interposer substrate 1 16 is attached to the bottom portion 126 of the inlay substrate 106 using a variety of techniques discussed hereinbelow.
  • a battery 1 12 is located between a space 128 defined by a flange 1 10 and an interposer coupling portion 130 of the inlay substrate 106.
  • the battery 1 12 may be coupled or attached to the interposer substrate 1 16 along with the electronic components 1 18.
  • the battery may achieve electrical contact to contacts on the interposer substrate 1 16 and/or the inlay substrate 106 using a spring clip, conductive adhesive, low temperature solders or high temperature solders.
  • a dome switch 108 may be provided for communication with the electronic circuit.
  • An indicator 1 14 may be provided for external communication.
  • the indicator 1 14 may be an optical indicator such as a light emitting diode (LED), as depicted in FIG. 1 , or may be an acoustical, electrical, haptic, indicator, among others. These components may achieve electrical contact to contacts on the interposer substrate 1 16 and/or the inlay substrate 106 using a spring clip, conductive adhesive, low temperature solders or high temperature solders.
  • LED light emitting diode
  • a skin adhesive layer 124 is positioned below the bottom housing portion 104.
  • the outer portions of the inlay substrate 106 located laterally from the interposer coupling portion 130, comprise an electrically conductive coating or layer (e.g., usually applied in the form of an ink) formed on a bottom portion thereof to electrically couple the inlay substrate 106 to electrodes 120a, 120b.
  • the electrodes 120a, 120b are positioned through corresponding apertures 132a, 132b formed in the bottom housing portion 104 such that the top portions of the electrodes 120a, 120b make electrical contact with the electrically conductive coating on the bottom portion of the lateral portions of the inlay substrate 106.
  • the electrically conductive coating comprises silver/silver chloride (Ag/AgCI).
  • the electrodes 120a, 120b are received through apertures 134a, 134b defined by corresponding standoffs 122a, 122b, and are received partially through corresponding apertures 136a, 136b defined by a skin adhesive layer 124.
  • the standoffs 122a, 122b may be made of a foam material or other suitable resilient material.
  • the electrodes 120a, 120b may be hydrophilic, hydrophobic, wet, dry, high impedance, low impedance, capacitive, etc.
  • the electrodes 120a, 120b may comprise a hydrogel material (hydrophilic) and in another aspect, the electrodes 120a, 120b may comprise dry electrode material (hydrophobic), as explained in more detail hereinbelow.
  • the standoffs function as a reservoir for hydrogel and to mechanically de-couple the skin adhesive from the electronics housing. In certain applications where a hydrogel is not required, the standoff may be minimized to a simple layer of adhesive.
  • FIGS. 9 and 10 illustrate top and bottom views of one aspect of an interposer substrate 1 16, respectively.
  • the interposer substrate 1 16 comprises an electrical component side 142 and as shown in FIG. 10, an inlay substrate coupling side 144.
  • the inlay substrate coupling side 144 comprises one or more conductive pads 140, which may be employed to electrically couple the interposer substrate 1 16 to the inlay substrate 106.
  • the interposer substrate 1 16 comprises a plurality of conductive traces for signal transmission and conductive pads for receiving electrical components thereon.
  • the interposer substrate 1 16 comprises wirebond connections and surface mounted technology (SMT) pads.
  • SMT surface mounted technology
  • FIGS. 1 1 and 12 show top and bottom views of a two-layer inlay substrate 106 according to one aspect of the body associated device shown in FIG. 1 .
  • the top side shown in FIG. 1 1 comprises a plurality of conductive pads 150 for electrically coupling the inlay substrate 106 to the corresponding conductive pads 140 located on the inlay substrate coupling side 144 of the interposer substrate 1 16, as shown in FIG. 10.
  • the bottom portion of the inlay substrate 106 shown in FIG. 12 comprises a layer or coating of electrically conductive ink, typically made with (a) a polymeric binder and (b) conductive particles of one of following: carbon, copper, gold, nickel, silver, or similar conductive material.
  • the electrically conductive ink comprises a Ag/AgCI ink 152a-d for electrically coupling the electrodes 120a, 120b (FIGS. 1 -8) to the interposer substrate 1 16 through electrically conductive vias 154.
  • the inlay substrate 106 may require three or more (or any suitable number of) electrodes instead of two.
  • the signal detected from the body of the living subject to be coupled for further processing is a dipole, and usually can be measured using two electrodes.
  • a third electrode may be employed due to the characteristics of the front end amplifier and signal conditioning circuits. Whether or not a particular aspect of the body associated device comprises two or three electrodes is in part a function of the impedance versus frequency characteristics of the front end amplifier and signal conditioning circuits. As shown in FIG.
  • a third electrode may be created on section 209 of the inlay substrate 106, which also comprises electrically conductive (e.g., Ag/AgCI) ink layers 152c, 152d. Where the third discrete electrode is omitted from the design, the reference electrode between the device and body is effectively created by the capacitance between the device ground plane (either on the interposer substrate 1 16 or the inlay substrate 106) and the body.
  • electrically conductive e.g., Ag/AgCI
  • the body associated device 100 When fully assembled, the body associated device 100 may be attached to the skin of a living subject with the pressure sensitive skin base adhesive layer 124.
  • the electrodes 120a, 120b make electrical contact with the skin of the living subject and with the Ag/AgCI layer on the bottom of the lateral portions of the inlay substrate 106.
  • Conductive traces formed on the inlay substrate 106 couple the Ag/AgCI portions to the electronic components 1 18 located on the interposer substrate 1 16.
  • the electronic components 1 18 may be configured into a variety of circuits to perform a variety of functions, including, without limitation, monitoring physiological parameters of the living subject, communicating with other ex-vivo devices or in-vivo devices located on or in the living subject (e.g., receivers, transmitters, and/or transceivers),
  • the inlay substrate 106 may be made of any of a variety of suitable materials.
  • suitable materials for the inlay substrate 106 include, but are not limited to, high Tg polycarbonate, polyethylene terephthalate (PET), polyarylate, polysulfone, a norbornene copolymer, poly phenylsulfone, polyetherimide, polyethylenenaphthalate (PEN), polyethersulfone (PES), polycarbonate (PC), a phenolic resin, polyester, polyimide,
  • the inlay substrate 106 may comprise conductive on PET.
  • the inlay substrate 106 may comprise copper (Cu) laminated on PET with Ag/AgCI ink for electrode interface.
  • the inlay substrate 106 may comprise Cu laminated on a flex circuit material known under the trade designation KAPTON with Ag/AgCI ink for electrode interface.
  • the inlay substrate 106 may be flexible, rigid, or semi-rigid.
  • the interposer substrate 1 16 may be made of any of a variety of suitable materials, for example, suitable flexible polymeric materials, such as PET,
  • the interposer substrate 1 16 may be made of glass reinforced epoxy laminate sheets, tubes, or rods made of woven fiberglass cloth with an epoxy resin binder that is flame resistant (self- extinguishing) as designated under the FR-4 specification.
  • the inlay substrate 106 may be flexible, rigid, or semi-rigid.
  • the interposer substrate 1 16 also may comprise electrically conductive connections.
  • the conductive connections may include electrically conductive traces or conductive bumps formed on a layer of the interposer substrate.
  • the conductive connections may include conductive ink traces.
  • the conductive bumps may facilitate operative connection of the interposer substrate 1 16 to the inlay substrate 106.
  • the conductive bumps may be any of a variety of electrically conductive materials, such as suitable metals. Examples of metals used in making conductive bumps are gold, aluminum, copper, nickel, and palladium.
  • the conductive bumps may include a multitude of small, hard particles, providing a multitude of sharp points for penetrating the mating contact surface of the inlay substrate 106, for example.
  • An example of suitable small, hard particles are diamond particles, such as in diamond dust.
  • the inlay substrate 106 may be attached to the interposer substrate 1 16 using any suitable attachment technique.
  • the inlay substrate 106 may be attached to the interposer substrate 1 16 via an adhesive.
  • the adhesive may be a conductive adhesive or may be a non-conductive adhesive, such as pressure-sensitive adhesives or epoxy adhesives.
  • a conductive adhesive may comprise, for example, an anisotropic conductive polymer (ACP), an epoxy filled with conductive particles such as, for example, gold, silver, carbon particles.
  • a nonconductive adhesive may comprise, for example, epoxy, including, polyurethane, acrylic, cyanoacrylate, among other chemistries.
  • the non-conductive adhesive acts as a staple, relieving strain from the conductive adhesive which might not have adequate resistance to strain to function in the application by itself.
  • the epoxy may be a thermosetting or ultraviolet curable epoxy.
  • the adhesive may be omitted and the inlay substrate 106 may be welded to the interposer substrate 1 16 such as by laser welding or ultrasonic welding.
  • the connection may be made using an elastomeric connector, a heat seal connector, or a hot bar bond.
  • a spring clip may be employed to apply a suitable force to the elastomeric connector to promote a suitable electrical contact.
  • the adhesive may be in the form of a pressure sensitive adhesive (PSA), which is particularly suitable for high speed web manufacturing on web processing equipment made by Muhlbauer High Tech International with offices in Newport News, VA or web converting equipment made by Delta Industrial of Minneapolis, MN.
  • PSA pressure sensitive adhesive
  • any suitable attachment technique that provides an electrically conductive attachment between the inlay substrate 106 and the interposer substrate 1 16 may be employed to connect the substrates.
  • the assembly or sub-assembly formed by the attached the inlay substrate 106 and interposer substrate 106 may be delivered in a variety of suitable forms. Examples of suitable delivery forms include on a roll, in a Z-fold box, trays, or SMT carrier tape.
  • the skin adhesive layer 124 may be a pressure sensitive adhesive (PSA) and may be configured to be applied to the skin of the living subject.
  • PSA pressure sensitive adhesive
  • the adhesive layer 124 provides a strong adhesive connection to the body of a living subject that is suitable for holding the body associated device 100 attached to the living subject during a wear period of, for example, 1 to 3 days, 3 to 7 days, 7 to 14 days, 7 to 21 days, and so on.
  • Such functionality may be achieved, for example, by material selection, design and shape of the adhesion area as well as the location of application to the body of the living subject.
  • the adhesive layer 124 may be selected to provide a non-irritating connection/adhesion to the body of the living subject by selecting suitable biocompatible materials and skin adhesives.
  • suitable biocompatible materials and skin adhesives include, without limitation, any skin adhesive that will successfully maintain the adherence of a dermal dressing to moist (perspiring) skin on a living subject working in hot humid environments, without producing adverse reactions such as rashes and itching.
  • the biologically compatible skin adhesive comprises synthetic emulsions acrylic copolymers which are odorless and pressure sensitive.
  • water-insoluble adhesives may comprise hydrophilic units to permit strong bonding to wet human skin and still retain some water resistance to permit durability.
  • the copolymer may be prepared to achieve better wet tack and water resistance and peel adhesion and peel adhesion as a function of rate, and may not contain any residual monomer, which is a potential source of skin irritation.
  • the adhesive layer 124 comprises rounded edges, which further reduces peeling from the skin as compared to sharp edges.
  • FIG. 13 a side view of one aspect of the inlay substrate 106 according to one aspect of the body associated device 100 is shown.
  • the electrodes 120a, 120b comprise a layer of electrically conductive Ag/AgCI ink 152a, 152b deposited on the bottom portions of the corresponding lateral portions 208a, 208b of the inlay substrate 106.
  • a hydrogel 156a, 156b interface forms a wet electrode.
  • the living subject is electrically coupled to the circuit on the interposer substrate by the electrodes 120a, 120b.
  • the hydrogel is hydrophilic and comes in various forms, such as, for example, a low viscosity gel or a substantially thick pre-gelled form which survives long term storage.
  • the hydrogel based electrodes are non-polarizable and behave electrically much like a galvanic battery where ions are exchanged for electrons at various interfaces and thus conducting the signal from the skin of the living subject to the circuit on the interposer substrate.
  • FIG. 14 is a side view of one aspect of an inlay substrate 200 comprising dry electrodes 202a, 202b and corresponding electrically conductive guard traces 204a, 204b.
  • dry electrodes provide a suitable stable connection to the body of the living subject and are more compatible with low cost high volume manufacturing such as web processing manufacturing.
  • hydrogel (wet) electrodes dry electrodes are polarizable and behave electrically much like a capacitor.
  • the dry electrodes also have higher impedance relative to the wet (Ag/AgCI-hydrogel) electrode. Accordingly, coupling signals from the skin of the living subject with dry electrodes requires techniques such as guard banding to couple a strong-enough signal.
  • FIG. 16 shows a standard bio-potential electrode 300 model. From the front end side, the electrode 300 looks like a 1 nf-1 OnF capacitor in parallel with a 200kQ resistor (R ⁇ . The parallel combination is then in series with a ⁇ 0Q-2kQ resistance (R 2 ).
  • FIG. 17 is a schematic diagram representing unwanted stray capacitance 304 resulting from coupling dry electrodes 300 to the skin of a living subject 302. It is well known that any conductive wire or trace carrying an electrical signal has stray capacitance to conductive elements around it or to free space.
  • the stray capacitance is represented as capacitor 304, which forms the lower leg of a voltage divider with the capacitance of the electrode 300 to the body of the living subject 302, which can be modeled as shown in FIG. 17.
  • the two impedances reduce the signal from the living subject 302 and act as a conventional voltage divider coupled to an amplifier 306.
  • FIG. 18 is a schematic diagram representing a guard tracing circuit technique to address the unwanted stray capacitance 304 resulting from coupling dry electrodes 300 to the skin of the living subject 302 as shown in FIG. 17.
  • a conductive guard 308 is placed around the conductive traces of the electrode 300 and the stray capacitance 304.
  • the guard 308 and the lower leg of the stray capacitance 304 are driven at the same potential by the output 310 of the amplifier 306.
  • the guarding technique essentially nullifies the voltage divider formed by the electrode 300 impedance and the stray capacitance 304 impedance.
  • the guarding techniques enable the use of a higher impedance electrode, such as the dry electrode.
  • the nullification can be modeled by the following formula, where Z cs is the impedance of the stray capacitance 304:
  • guard 308 and the lower leg of the stray capacitance 304 are driven at the same potential by the output 310 of the amplifier 306, the / component drops to zero, and the impedance
  • FIG. 20 is a sectional view of printed circuit board signal tracing technique. As shown, signal trace 400 is located between upper 402 and lower 404 guard traces.
  • the trace 400 may be located on the inlay substrate and in another aspect the trace 400 may be located on the interposer substrate or both.
  • the upper guard 402 is located above the traces 400 and the lower guard 404 is located below the trace 400.
  • the guards 402, 404 intercept the majority of the electric field generated by the trace 400.
  • Lateral guard traces 403 also may be employed.
  • the inlay substrate 200 comprises first and second dry electrodes 202a, 202b with corresponding top guard bands 204a, 204b and bottom electrically conductive guard bands 206a, 206b to nullify any stray capacitance caused by the high impedance capacitive dry electrodes 202a, 202b.
  • Each of the high impedance capacitive dry electrodes 202a, 202b comprises an electrically conductive layer 210a, 210b (e.g., Ag/AgCI layer) and a nonconductive adhesive 212a, 212b formed over the electrically conductive layer 210a, 210b.
  • the electrically conductive layer 210a, 210b may be printed using silver ink or carbon ink, gold plated copper, platinum plated copper, and the like.
  • the nonconductive adhesive 212a, 212b acts as the dielectric of the capacitive dry electrodes 202a, 202b.
  • the nonconductive adhesive also acts to minimize any motion artifacts that are otherwise typical with dry electrodes.
  • the top guards 204a, 204b are located above the electrodes 202a, 202b whereas the lower guard bands 206a, 206b surround or substantially surround the electrically conductive layer 210a, 210b.
  • the inlay substrate 212 may be formed of PET or any of the inlay substrate materials discussed above.
  • FIG. 15 is a side view of one aspect of an inlay substrate 250 comprising dry electrodes 252a, 252b, top electrically conductive guard bands 254a, 254b and bottom electrically conductive guard bands 256a, 256b, and in addition multiple layers 262, 264 of PET materials.
  • the electrodes 252a, 252b each comprise an electrically conductive layer 260a, 260b (e.g., Ag/AgCI layer) printed on the substrate and nonconductive adhesive layers 258a, 258b applied to the electrically conductive layer 260a, 260b.
  • the first layer 262 may be formed by printing a dielectric ink onto a substrate. At least one additional dielectric layer 264 may be stacked on top of each other separated by the electrode guard bands 254a, 254b.
  • One advantage of forming multiple layers by applying inks is in lowering cost and rendering the substrate to remain flexible.
  • the electrodes may be made out of conductive fabric for example, any type of fabric (synthetic or natural) that contains conductive fibers or particles made of any of the following: carbon, copper, gold, or similar electrically conductive material.
  • the conductive fabric electrode may be adhered to the body of the living subject with a PSA.
  • Conductive fabric is typically any type of fabric, e.g., commonplace fabrics and those used in the relevant trade that has been loaded with conductive fibers, nickel, carbon, and other suitable conductive materials.
  • the outside layer may be "guarded" by using a second layer of conductive fabric and separating the layers by an insulating layer.
  • FIG. 21 is a flow diagram of a method 500 of for manufacturing one aspect of a body associated device 100 as described in connection with FIGS. 1 -8.
  • an inlay substrate 106, 200, 250 is provided 502.
  • the inlay substrate 106, 200, 250 comprises a first side, a second side, and at least one conductive trace.
  • An electrically conductive layer is applied 504 to the first side of the inlay substrate 106, 200, 250, wherein the at least one conductive trace is electrically coupled to the conductive layer.
  • An interposer substrate 1 16 is provided 506.
  • the interposer substrate 1 16 comprises a first side, a second side, and at least one conductive trace.
  • the first side of the interposer substrate 1 16 is coupled 508 to the first side of the inlay substrate 1 16, 200, 250 to form a subassembly.
  • the at least one conductive trace on the interposer substrate 1 16 is electrically coupled to the at least one conductive trace on the inlay substrate 106, 200, 250 through the electrically conductive layer.
  • a first and second housing portion is provided.
  • the second housing portion defines at least one aperture configured to receive at least a portion of an electrode therein.
  • the coupled inlay substrate 106, 200, 250 and the interposer substrate 1 16 subassembly is inserted within the first and second housing portions.
  • the first housing portion is coupled to the second housing portion.
  • a skin adhesive layer is applied to a bottom portion of the second housing portion.
  • the body associated device 100 may comprise a wet electrode. Accordingly, a hydrogel material may be applied in electrical contact with the electrically conductive layer on the first side of the inlay substrate. At least one standoff defining an aperture may be inserted over the hydrogel material. At least a portion of the hydrogel material is positioned within the aperture.
  • the body associated device 100 may comprise a dry electrode. Accordingly, a layer of nonconductive adhesive material is applied over the electrically conductive layer formed on the first side of the inlay substrate. At least one electrically conductive guard band is formed on the second side of the inlay substrate substantially opposite to the electrically conductive layer applied to the first side of the inlay substrate. At least one dielectric layer is applied stacked above the at least one electrically conductive guard band. At least one electrically conductive guard band is formed on the first side of the inlay substrate substantially surrounding the electrically conductive layer applied to the first side of the inlay substrate. In one aspect, at least one lateral electrically conductive guard band is formed on the first side of the inlay substrate.
  • IEM Ingestible event markers
  • a method of manufacturing a body associatable device comprising,
  • the interposer substrate comprises a first side, a second side, and at least one conductive trace
  • the first side of the interposer substrate is coupled to the first side of the inlay substrate to form a subassembly
  • the at least one conductive trace on the interposer substrate is electrically coupled to the at least one conductive trace on the inlay substrate through the electrically conductive layer.
  • any of the preceding clauses 3-7 further comprising forming at least one electrically conductive guard band on the second side of the inlay substrate substantially opposite to the electrically conductive layer applied to the first side of the inlay substrate and/or forming at least one electrically conductive guard band on the first side of the inlay substrate substantially surrounding the electrically conductive layer applied to the first side of the inlay substrate, which electrically conductive guard band may be lateral.
  • the second housing portion defining at least one aperture configured to receive at least a portion of an electrode therein;
  • a body associable device obtainable according to any of the preceding clauses.
  • a body associatable device which can monitor and record individual physiological parameters, e.g., physical activity, heart rate, respiration, temperature, sleep, pulse oxymetry, of a living subject and communicate these parameters beyond the body of the living subject to other devices, e.g., mobile phones, computers, internet servers, which device comprises:
  • the inlay circuit is flexible circuit element electrically coupled to the electrodes and the interposer substrate comprises high density electronics and electrical connections to the interposer substrate couple the electrodes to flexible circuit element of the inlay circuit.
  • the body associatable device according to clause 15 further comprising a standoff arranged between the electrode and a skin adhesive layer.
  • the body associatable device according to clause 16 wherein the standoff functions as a reservoir for a hydrogel and/or to mechanically de-couple the skin adhesive layer.
  • the body associatable device according to clause 18 further comprising a guard for guarding against stray capacitance resulting from coupling dry electrodes to a living subject.
  • System comprising a body associatable device according to any of the preceding clauses 15-19 and a receiver for receiving signals from the device.
  • any reference to "one aspect” or “an aspect” means that a particular feature, structure, or characteristic described in connection with the aspect is included in at least one aspect.
  • appearances of the phrases “in one aspect” or “in an aspect” in various places throughout the specification are not necessarily all referring to the same aspect.
  • the particular features, structures or characteristics may be combined in any suitable manner in one or more aspects.
  • connection to indicate that two or more elements are in direct physical or electrical contact with each other.
  • some aspects may be described using the term “coupled” to indicate that two or more elements are in direct physical or electrical contact.
  • Coupled may mean that two or more elements are not in direct contact with each other, but yet still co-operate or interact with each other.

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  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)
  • Combinations Of Printed Boards (AREA)
  • Manufacturing Of Printed Wiring (AREA)

Abstract

L'invention concerne des procédés de fabrication d'un dispositif associé au corps. Les procédés comprennent l'utilisation d'un substrat d'incrustation qui comporte un premier côté, un second côté et au moins une piste conductrice et l'utilisation d'un substrat intermédiaire qui comporte un premier côté, un second côté et au moins une piste conductrice. Une couche conductrice de l'électricité est appliquée sur le premier côté du substrat d'incrustation. Ladite ou lesdites pistes conductrices sont couplées électriquement à la couche conductrice. Le premier côté du substrat intermédiaire est couplé au premier côté du substrat d'incrustation pour former un sous-ensemble. Ladite ou lesdites pistes conductrices du substrat intermédiaire sont couplées électriquement à ladite ou auxdites pistes conductrices du substrat d'incrustation par l'intermédiaire de la couche conductrice de l'électricité. L'invention concerne un dispositif associé au corps, ayant une électrode mouillée, fabriqué selon un premier processus. L'invention concerne en outre un dispositif associé au corps, ayant une électrode sèche, fabriqué selon un second processus.
PCT/US2012/035650 2011-04-29 2012-04-27 Dispositif associé au corps et son procédé de fabrication Ceased WO2012149466A2 (fr)

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US201161480789P 2011-04-29 2011-04-29
US61/480,789 2011-04-29

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US20140275932A1 (en) * 2013-03-12 2014-09-18 Vital Connect, Inc. Disposable biometric patch device
WO2015022327A1 (fr) * 2013-08-14 2015-02-19 Capical Gmbh Électrode capacitive textile et procédé de fabrication et utilisation de ladite électrode
EP2959831A1 (fr) * 2014-06-23 2015-12-30 Samsung Electronics Co., Ltd Bioélectrode et procédé et appareil de traitement de biosignaux utilisant celle-ci
CN105266795A (zh) * 2015-11-05 2016-01-27 北京众云在线科技有限公司 动态心电信号采集装置
US9610225B2 (en) 2012-12-19 2017-04-04 Otsuka Pharmaceutical Co., Ltd. Medical tablet, and manufacturing method and manufacturing apparatus for medical tablet
WO2019092919A1 (fr) * 2017-11-10 2019-05-16 日東電工株式会社 Capteur biologique à fixation adhésive
US12575777B2 (en) 2013-09-25 2026-03-17 Bardy Diagnostics, Inc. Electrocardiography patch
US12599326B2 (en) 2013-09-25 2026-04-14 Bardy Diagnostics, Inc. Moisture-resistant electrocardiography monitor

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US4926879A (en) * 1988-06-13 1990-05-22 Sevrain-Tech, Inc. Electro-tactile stimulator
US5380271A (en) * 1992-09-24 1995-01-10 Alza Corporation Electrotransport agent delivery device and method
US8214007B2 (en) * 2006-11-01 2012-07-03 Welch Allyn, Inc. Body worn physiological sensor device having a disposable electrode module
US20100198034A1 (en) * 2009-02-03 2010-08-05 Abbott Diabetes Care Inc. Compact On-Body Physiological Monitoring Devices and Methods Thereof

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US9610225B2 (en) 2012-12-19 2017-04-04 Otsuka Pharmaceutical Co., Ltd. Medical tablet, and manufacturing method and manufacturing apparatus for medical tablet
US10772522B2 (en) * 2013-03-12 2020-09-15 Vital Connect, Inc. Disposable biometric patch device
US20140275932A1 (en) * 2013-03-12 2014-09-18 Vital Connect, Inc. Disposable biometric patch device
WO2015022327A1 (fr) * 2013-08-14 2015-02-19 Capical Gmbh Électrode capacitive textile et procédé de fabrication et utilisation de ladite électrode
US11298078B2 (en) 2013-08-14 2022-04-12 Capical Gmbh Capacitive textile electrode, method for producing it, and use
CN105451644A (zh) * 2013-08-14 2016-03-30 凯皮考有限公司 电容式纺织电极及其制造方法和使用方法
US20160192881A1 (en) * 2013-08-14 2016-07-07 Capical Gmbh Capacitive textile electrode, method for producing it, and use
US12599326B2 (en) 2013-09-25 2026-04-14 Bardy Diagnostics, Inc. Moisture-resistant electrocardiography monitor
US12575777B2 (en) 2013-09-25 2026-03-17 Bardy Diagnostics, Inc. Electrocardiography patch
JP2016007533A (ja) * 2014-06-23 2016-01-18 三星電子株式会社Ｓａｍｓｕｎｇ Ｅｌｅｃｔｒｏｎｉｃｓ Ｃｏ．，Ｌｔｄ． 生体電極及びこれを用いた生体信号処理装置
US9795313B2 (en) 2014-06-23 2017-10-24 Samsung Electronics Co., Ltd. Bioelectrode, and method and apparatus for processing biosignal using the same
KR102302876B1 (ko) * 2014-06-23 2021-09-17 삼성전자주식회사 생체 전극 및 이를 이용한 생체 신호 처리 장치 및 방법
KR20150146328A (ko) * 2014-06-23 2015-12-31 삼성전자주식회사 생체 전극 및 이를 이용한 생체 신호 처리 장치 및 방법
EP2959831A1 (fr) * 2014-06-23 2015-12-30 Samsung Electronics Co., Ltd Bioélectrode et procédé et appareil de traitement de biosignaux utilisant celle-ci
CN105266795A (zh) * 2015-11-05 2016-01-27 北京众云在线科技有限公司 动态心电信号采集装置
WO2019092919A1 (fr) * 2017-11-10 2019-05-16 日東電工株式会社 Capteur biologique à fixation adhésive

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