DK2563466T3 - System til stimulering af sansenerver - Google Patents

System til stimulering af sansenerver Download PDF

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Publication number
DK2563466T3
DK2563466T3 DK11777866.2T DK11777866T DK2563466T3 DK 2563466 T3 DK2563466 T3 DK 2563466T3 DK 11777866 T DK11777866 T DK 11777866T DK 2563466 T3 DK2563466 T3 DK 2563466T3
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Denmark
Prior art keywords
skin
pulse
electrode
electrodes
penetrating
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DK11777866.2T
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English (en)
Inventor
William J Carroll
Erling Jensen Aune Jr
Timothy J Johnson
Jens Olaf Roe Schouenborg
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Meagan Medical Inc
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Publication of DK2563466T3 publication Critical patent/DK2563466T3/da

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/0404Electrodes for external use
    • A61N1/0408Use-related aspects
    • A61N1/0452Specially adapted for transcutaneous muscle stimulation [TMS]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/0404Electrodes for external use
    • A61N1/0408Use-related aspects
    • A61N1/0456Specially adapted for transcutaneous electrical nerve stimulation [TENS]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/0404Electrodes for external use
    • A61N1/0472Structure-related aspects
    • A61N1/0476Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/0404Electrodes for external use
    • A61N1/0472Structure-related aspects
    • A61N1/0492Patch electrodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0502Skin piercing electrodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014External stimulators, e.g. with patch electrodes
    • A61N1/36017External stimulators, e.g. with patch electrodes with leads or electrodes penetrating the skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014External stimulators, e.g. with patch electrodes
    • A61N1/36021External stimulators, e.g. with patch electrodes for treatment of pain
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014External stimulators, e.g. with patch electrodes
    • A61N1/3603Control systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014External stimulators, e.g. with patch electrodes
    • A61N1/3603Control systems
    • A61N1/36034Control systems specified by the stimulation parameters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0551Spinal or peripheral nerve electrodes

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biophysics (AREA)
  • Cardiology (AREA)
  • Pain & Pain Management (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Electrotherapy Devices (AREA)

Claims (15)

1. Elektroterapisystem (100) til stimulering af sansenerver i hudvæv, hvilket system omfatter: en elektrodebærer (104) med en ekstern ikke-ledende coating (602); en pulsgenerator (102) elektrisk forbundet med elektrodebæreren; et array af hudpenetrerende elektroder (110) dannet på elektrodebæreren eller aftageligt fastgjort til, men elektrisk koblet til, elektrodebæreren; mindst en overfladehudelektrode (112) dannet på elektrodebæreren eller adskilt fra, men elektrisk fastgjort til, elektrodebæreren; og et pulskonditioneringskredsløb (128), der er operativt forbundet mellem den mindst ene overfladehudelektrode (112) og pulsgeneratoren (102), hvor pulsgeneratoren er konfigureret til at frembringe en bifaset pulsstrøm omfattende bursts af bifasede pulser, der danner en bifaset bølgeform (1600) ved den mindst ene hudoverfladeelektrode, som kan lede den bifasede pulsstrøm gennem hudvævet, hvor pulsgeneratoren er konfigureret til at frembringe en monofaset pulsstrøm, der danner en monofaset bølgeform (1800) omfattende et tog af individuelle monofasede pulser (1700) ved hver af de hudpenetrerende elektroder, som kan lede den monofasede pulsstrøm gennem hudvævet, og hvor de individuelle monofasede pulser forekommer vekslende i tiden mellem burstene af den bifasede bølgeform.
2. System (100) ifølge krav 1, hvor pulsgeneratoren (102) er konfigureret til at forsyne hver af de hudpenetrerende elektroder (110) med et pulstog på ca. 0,1 til 10 Hertz, idet hver puls i pulstoget er karakteriseret ved en pulsvarighed på ca. 0,5 til 10,0 millisekunder og en strømamplitude på op til ca. 2 mil-liampere, hvor eventuelt: strømamplituden under en pulsstart når et maksimum på ca. 0,5 til 2 milliam-pere inden for højst ca. 0,25 millisekunder fra pulsstarten, idet den maksimale strømamplitude er genereret af pulskonditioneringskredsløbet (128), og hvor strømamplituden reduceres med ca. 5 til 50 procent derefter i den resterende del af pulsvarigheden.
3. System (100) ifølge krav 1, hvor pulsgeneratoren (102) er konfigureret til at forsyne den mindst ene overfladehudelektrode (112) med pulstog med en burst-frekvens på ca. 0,1 til 10 Hertz, en pulsstrengfrekvens inden for burstet på ca. 50 til 400 Hertz, en burst-varighed for hver enkelt af den mindst ene overfladehudelektrode på op til ca. 100 millisekunder, en pulsvarighed på ca. 0,05 til 0,3 millisekunder og en strømamplitude på op til ca. 50 milliampere.
4. System (100) ifølge krav 1, hvor pulskonditioneringskredsløbet (128) indbefatter mindst en blandt en kondensator (130) parallelt med en modstand (132), en halvleder-felteffekttransistor, en digital signalprocessor og en induk-tor.
5. System (100) ifølge krav 1, hvor hver af de hudpenetrerende elektroder (110) er konfigureret til at være rettet mod Αδ- og C-nervefibre i hudvævet, og den mindst ene overfladehudelektrode (112) er konfigureret til at være rettet mod Αβ-nervefibre i hudvævet.
6. System (100) ifølge krav 1, hvor array'et af hudpenetrerende elektroder (110) er aftageligt fastgjort til elektrodebæreren (104) og kan bortskaffes.
7. System (100) ifølge krav 1, yderligere omfattende: et antimikrobielt middel (604) infunderet i eller lagt i lag på array'et af hudpenetrerende elektroder (110) og i eller på den ikke-ledende coating (602) til reduktion af mikrobeformering på hver de hudpenetrerende elektroder og den ikke-ledende coating.
8. System (100) ifølge krav 1, yderligere omfattende: en desinficeringsmekanisme (106) udformet til at reducere mikrobeformering på hver af de hudpenetrerende elektroder (110) og elektrodebæreren (104), når den er koblet til array'et af hudpenetrerende elektroder og elektrodebæreren, hvor desinficeringsmekanismen eventuelt reducerer mikrobeformering med mindst en blandt kogende vand og damp.
9. System (100) ifølge krav 8, yderligere omfattende: en genopladelig strømkilde (114); og en genopladningsmekanisme (106) konfigureret til at genoplade strømkilden; og eventuelt yderligere omfattende et hus udformet til integreret at omslutte desinficeringsmekanismen og genopladningsmekanismen (106).
10. System (100) ifølge krav 1, hvor: elektrodebæreren (104) er et trykt kredsløbskort (PCB) (600), herunder en ekstern ikke-ledende coating (602); den mindst ene overfladehudelektrode (112) er dannet eller monteret på PCB'en og indrettet til elektrisk at komme i kontakt med hudvævet; array'et af hudpenetrerende elektroder (110) er dannet eller monteret på PCB'en og konfigureret til elektrisk at komme i kontakt med hudvævet; og et elektrisk kredsløb (108) er dannet eller monteret på PCB'en og operativt koblet til den mindst ene overfladehudelektrode, til hver hudpenetrerende elektrode i array'et af hudpenetrerende elektroder og til pulsgeneratoren (102); idet systemet yderligere omfatter en desinficeringsmekanisme (106) udformet til at reducere mikrobeformering på PCB'en, når den er koblet dertil.
11. System (100) ifølge krav 10, hvor pulsgeneratoren (102) er konfigureret til at forsyne den mindst ene overfladehudelektrode (112) med pulstog med en burst-frekvens på ca. 0,1 til 10 Hertz, en pulsstrengfrekvens inden for burstet på ca. 50 til 400 Hertz, en burst-varighed for hver enkelt af den mindst ene overfladehudelektrode på op til ca. 100 millisekunder, en pulsvarighed på ca. 0,05 til 0,3 millisekunder og en strømamplitude på op til ca. 50 milliampere.
12. System (100) ifølge krav 10, hvor pulsgeneratoren (102) er konfigureret til at forsyne hver af de hudpenetrerende elektroder (110) med et pulstog på ca. 0,1 til 10 Hertz, idet hver puls i pulstoget er karakteriseret ved en pulsvarighed på ca. 0,5 til 10,0 millisekunder og en strømamplitude på op til 2 milliam-pere, og hvor strømamplituden under en pulsstart når et maksimum på ca. 0,5 til 2 milliampere inden for højst ca. 0,25 millisekunder fra pulsstarten, idet den maksimale strømamplitude er genereret af pulsgeneratoren, og hvor strømamplituden reduceres med ca. 5 til 50 procent derefter i den resterende del af pulsvarigheden.
13. System (100) ifølge krav 10, hvor PCB'en (600) er fleksibel og kan tilpasses til hudvævet.
14. System (100) ifølge krav 10, yderligere omfattende: et antimikrobielt middel (604) infunderet i eller lagt i lag på array'et af hudpe-netrerende elektroder (110) og i eller på den ikke-ledende coating (602) for derved at reducere mikrobeformering på hver de hudpenetrerende elektroder og den ikke-ledende coating.
15. System (100) ifølge krav 10, hvor de bifasede og monofasede pulsstrømme er konfigureret til at give elektroanalgesi ved overfladehudelektro-den (112) og ved hver af de hudpenetrerende elektroder (110) i et mønster af transkutan elektrisk nervestimulation og hudpenetrerende elektrisk nervestimulation.
DK11777866.2T 2010-04-28 2011-04-25 System til stimulering af sansenerver DK2563466T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US12/769,382 US8417352B2 (en) 2004-10-19 2010-04-28 System and method for stimulating sensory nerves
PCT/US2011/033733 WO2011139623A2 (en) 2010-04-28 2011-04-25 System and method for stimulating sensory nerves

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DK2563466T3 true DK2563466T3 (da) 2016-01-04

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US (1) US8417352B2 (da)
EP (1) EP2563466B1 (da)
JP (1) JP5793559B2 (da)
KR (1) KR101464062B1 (da)
CN (1) CN103124583B (da)
AU (2) AU2011248726B2 (da)
CA (1) CA2797078C (da)
DK (1) DK2563466T3 (da)
HK (1) HK1185027A1 (da)
WO (1) WO2011139623A2 (da)

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CA2797078C (en) 2018-07-31
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EP2563466B1 (en) 2015-09-16
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