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WO2025061886A1 - A method for suppression of seizures, and a related neurological stimulation device - Google Patents

A method for suppression of seizures, and a related neurological stimulation device Download PDF

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Publication number
WO2025061886A1
WO2025061886A1 PCT/EP2024/076334 EP2024076334W WO2025061886A1 WO 2025061886 A1 WO2025061886 A1 WO 2025061886A1 EP 2024076334 W EP2024076334 W EP 2024076334W WO 2025061886 A1 WO2025061886 A1 WO 2025061886A1
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French (fr)
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Christian Hauptmann
Ciamak Abkai
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Precisis GmbH
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Precisis GmbH
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36064—Epilepsy
    • 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
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/369—Electroencephalography [EEG]
    • A61B5/37—Intracranial electroencephalography [IC-EEG], e.g. electrocorticography [ECoG]
    • 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
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/369—Electroencephalography [EEG]
    • A61B5/372—Analysis of electroencephalograms
    • A61B5/374—Detecting the frequency distribution of signals, e.g. detecting delta, theta, alpha, beta or gamma waves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7203—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal
    • A61B5/7217—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal of noise originating from a therapeutic or surgical apparatus, e.g. from a pacemaker
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36135—Control systems using physiological parameters
    • A61N1/36139—Control systems using physiological parameters with automatic adjustment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36146—Control systems specified by the stimulation parameters
    • A61N1/36167—Timing, e.g. stimulation onset
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36067—Movement disorders, e.g. tremor or Parkinson disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36082—Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36146—Control systems specified by the stimulation parameters
    • A61N1/36167—Timing, e.g. stimulation onset
    • A61N1/36171—Frequency

Definitions

  • n nnr mnzn rrnnrmnznnn rnnrnmnn " v mmn vnvrrn:,m:.n "-, rn vnn n mr,n --.rn, vr rn n- r vrnr v .
  • nmr , n,n m nr m nmnr r , m n r, n mr m v.rxm, nr m nvrn n ⁇ n r,n m rmnr r rrn r ⁇ ⁇ , ⁇ & .n nnrr mrxmm nnrv mm nv vnrm n r , mrn r rrnn nr r, rm n r n nr m nv mrmn r.n xm rrn ,r m rmnr rn n, m rnmn rn n nrrn ⁇ ⁇ ' n ⁇ ⁇ .
  • n n nn vn m nr m n r n x , ⁇ m ⁇ m , wwr n ⁇ ' ⁇ rn ⁇ , r nn ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ , ⁇ r ⁇ ⁇ ⁇ ⁇ ' ⁇ ⁇ ⁇ ' r ⁇ ⁇ ⁇ n ⁇ ⁇ n ⁇ ⁇ r ⁇ ⁇ : ⁇ ⁇ ⁇ ⁇ ⁇ n r n ⁇ ⁇ ⁇ ' ⁇ n ⁇ ⁇ ⁇ r nn m mn- nrrmmv nnnnnnnrrrnrvn nrnm, nr.rnnnn r n ⁇ ⁇ ⁇ ' ⁇ n ⁇ ⁇ ⁇ n m nnnnnrrrnrvn nrnm, nr.rnnn
  • rnrnnrnz nnwrrrnnnnnr mr rmn r nnrrn nn w n , m . rrn, rmrrrnrnzn rrn, m rn nr n r n nr r r r nzr. rmrrrn r rrn m rn r -nrnznn nr .
  • nrr vrn rn r w r wrrn n nn m nr, r ⁇ ⁇ ⁇ nn rmr r n ⁇ ⁇ ⁇ ' ⁇ n nr r r ⁇ n v r n.nr wr,rn nn.
  • nr nr r r nr m m rrrmmnr nn nnrmrrn.nnrr mnrnxm r nrmnr,m nnrn mrr nr nmrr rmn,n rrnn,nnr m nv.
  • n nr rrxm m n rmr ⁇ ' rn n n, r rn *'2 n 0 w wnr nr ⁇ *'20 ⁇ ⁇ ' : ⁇ ⁇ mrnn
  • n nr nnnrr mrmxmn nvr .mvnnrvm r xm nr m nv m nr nr r , n rrmrrnr n mn rrmr n rmnrrnr,nrnr.nr r nrr m nv nr,rxm n r rnr, nnrrnrrrn, nr, n rmr nr ,rm rrmr ,n r r.
  • nnrrm n r r r r nrrrrmnnrvnrrnrr ,rnxrm, nn r n, nr r n, n rmr n nr , nm n rmr ,n r r. nr nm n r nr m nv mnnr mrxm nr rnrrm,r n,nrmrrrnrn, nr r n, m n r r n, m n r r r ,rm nnrr mnnr mr mr .

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Neurosurgery (AREA)
  • Biophysics (AREA)
  • Psychiatry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Radiology & Medical Imaging (AREA)
  • Pathology (AREA)
  • Neurology (AREA)
  • Signal Processing (AREA)
  • Psychology (AREA)
  • Physiology (AREA)
  • Artificial Intelligence (AREA)
  • Computer Vision & Pattern Recognition (AREA)
  • Electrotherapy Devices (AREA)
  • Compression, Expansion, Code Conversion, And Decoders (AREA)

Abstract

Disclosed is a method, performed by a neurological stimulation device, for suppression of seizures. The method comprises obtaining a first input signal indicative of a local field potential. The method comprises obtaining a plurality of target frequencies including a primary target frequency and a secondary target frequency for neurological stimulation. The method comprises filtering the first input signal based on the primary target frequency and the secondary target frequency for provision of a primary filter output signal and a secondary filter output signal. The method comprises determining a first primary delay and a second primary delay based on the primary target frequency. The method comprises determining a first secondary delay and a second secondary delay based on the secondary target frequency. The method comprises generating, based on the primary filter output signal, the secondary filter output signal, the first primary delay, and the first secondary delay, a first stimulation signal for a first stimulation electrode of a plurality of electrodes. The method comprises generating, based on the primary filter output signal, the secondary filter output signal, the second primary delay, and the second secondary delay, a second stimulation signal for a second stimulation electrode of the plurality of electrodes, and outputting the first stimulation signal to the first stimulation electrode and the second stimulation signal to the second stimulation electrode.

Description

, rrn r r mrnr r n nrzr,m n. rn m nvn r mr r r m rm. nr rnnmn, nrmnrr mn,r rnv rmvnnnrrnn m r m mnnrnrnnv m nn..r mrnn,mn m.r,rrmnr,n rvrr nnrnmrn r nr m rn, ,r rnv rmn r m nrnrn , . r nrn, , nr nnwr rr,rnnrnr.mn nrnrnnx nrvnrmmn,rnrnnznn mrrnr.wnvmr,rn r,..,n nrnzn mrn ,x v nr mrrnnnn m vr nn. rr, rnn’ , nrmr, ,n nxrmnnrnz nrv nmnr n nrnn. n nnr mnzn rrnnrmnznn rnnrnmnn: " v mmn vnvrrn:,m:.n "-, rn vnn n mr,n --.rn, vr rn n- r vrnr v . mn-nr, w nrnmm rmn r,nmnnn mn-nn,nr rn.m r,rm nnrnvmmnr.n mwvr,r mnn nrn.rrr rrz nrm nrnz vn rr,nnmnnr vrmr n - m nn. m nn. r n rmnrm n n zrr, w n mr n,rv,rmrnvrn m r r nmrv m r mnxnnrvn n r nr rmvnnnnvrnr mn zr.nr r,r r .zr nr r r n zr, w n m nrnz nr vn m rn zr. n mr,rrmm n nvrmrm nv,r r n m mr nnrn nn r r. m mr rmnn, n r v n.rn nnrmr n n, r r nr m rrnn nrrrnr rmrrr nn.n m nmrrrrrnnrrnr n n r nn nr r n vn rmr rrmr n . m mr rmnn m mr rmnnnrmrr nr nnrmrnrrnn. n nrrrn. m mr n r rmr r n, nr r rn, n n r nr , n, rrmr , r r. mrm nnrrm n r n, nr r mnr, nrnn,rmrn,nrmr rn nr , nm nnr nm n r rrm r. m mr n rm nn r.n r n nm nn nm n nr rmn nnrv mmrn mnmvr,r r n zr, r r, w rr,r rrr,n n m rrnnn nr mm nvrn.nr rrm r mrrrmmmrr rnnrrn mmrnnr mrrrm, n w n - , w wnx n rnv m rnn.vr rnv rrmn vnnv mn rvnrnnr rr zrnn nr rm n n nrr , , wnn nrnz nnrv. nr m nvn m n n nznnnrmrnrrn nrn mr vn nrn wn n rn rnm nn, nv. nrr-rn nwn rnzn rn, w r zr wrrn n nrnznnrr-r rrn nrnz n nwn r r n. nrrnnn nr m nvn m n nnnvrnnzn rn’ nnrnnr.nn n rvnn mrnnn :r. --- rrn, n r n mr m nn rnrn v rnm , mr w rn mnnrmrn nr r n rn mnrnnnnrrnrrrnn,m wn r.wnw nrnrnn mrnnrvnrnn, nrmm n n, wr r n mn nrn - -nnr nr n :. - nrm nrnz vnn mnrmn.nr,, nn nrnzn,nnn nrm mn n mrm mr-rnnv. nnr r vrnnr rnnvn rn r w m xmrmmn r w rrrn wn rwnr,n wn: m.-nvw,-rrrrnnnzxrm, mrn,rrm r nr r.r rm rn r xm m nnn zr,nnn n, rn rrn r,r r n . r.rm rnnxm nr m nv rn rrx wmnr rmvn.mnn n r rr mrnr mr, w n rrn n mn mrrrr rwn rrn nmr nnr rrn nnn r rrn. n rr x v mmn. r nnn nn n,nrrnmmnr nr nmvnn rvnr. nwn n.nrrnvn r nnnn w r rmmn mmnvnm n rm,mrn nnxnr rn.n r mnr rrrnnrnm n nmrrr,m w r rnrr,n rrrv m nnr nr.w .r w, nnwrnn n, w mn nrm n rn nrnz vn nrm nrn nnr r rrz m r n zn mvn mrrzr n nn.rnznrmnrvnrn n. r- vr, n rnmrv m- nr nrm n w m , m rnrmr nrnrzmnrxnnnnrv mnrrmn nrnznnrr-r n n m n r . wn m rn n r nrnzr m ,rrm nr m nv,r nrnnrnw. m nrnzn r n zr.nnnrr mrrxmn,rn,r mn n,r zr m- nr nrm n mr.r n m nmr nnr nn v n, nnnrn rr nr m nv. m nv. rv nr vn rr nr vr n m n nn rrn nrn mm rnnr , r . r n, w m nn-vrvnn nn m,, mn n ^^ ^^ ^^ ^^. r n mrmn nr mrxm, n r nrr, r mrmn r n, r nn v m nv. mrmn r m n m nnr.n w n rm n, r r nr mrxm m , mrmn rn m n.nrn n r , n r r nnr mrxmn m ,nr, vnn mr n rrn n, , mr nn, nn mr nn m nr rm nv. rr nr rr n, rv n.nrr nr m nv w nmr mn rnr rrrn m r n nr r-r mnn r rnr rnr r m nv, w r n, rmnrrr nr mr rr nnnn _ _,rx m nr r r n n nr mr nm nrmnnr nrn rr nr m nvn.r n rr r vn,nrr r >.rm mrnmnnnn wn_rn_, nrrrn r nrr m nv n rv r n nr mr ^^ ^^ ^^ n. v wn r m rrrn! rn"#^% nr ^ m^. rnx,mrn m rrr, r rnrrn, rrn mr nn ^^ ^^&.rrrxmr,nn ^^n ^^nrn rn rrn ^^ ^^.nnr m ' ,rnrn mr rmnrxm m , nn r rrn n n nrnrrn,rr n. r wr v rv.nr wr rnrn n, rnrn, rnrn,nrr n n n . rrr nn nrr,n wnrmrnrn m -nrnznrr-rn .n rwnrr n n m rmn nnrnzn rrrnr r n mnnrnrrzn nn,.n, nrnnrrrrr rnn m n nn.rrnmznn.rn n m,nnr mrxm, n r r nr mrn r rrn. rrn nrr nmnrnrn nr rn n, n mmm nr,nn n,nr rn n,nrn rn mrxmr rn n,nr rn n.nnrrn n m m ,n rmnmr n n m v z, rn -z, rn n- mz,n rn n m nrn n m n rn .-z.w rn -z,n n mm, , , ,nr mnvr, nr rn v rnr.rxm, rnnr mrxm m xm n rn -z. mn nrn mnnr mrrn n,rxmn rn nrnzn ^^n ^^ ^^ ^^ =r^v ^^ ^^^nnw mmrn nrn ^^ ^^ ^^ ^^ = ' n rm ^ ^^ ^^,rrrn ^^ ^^' m ^^ ^^ = n ^ ^^ ^^. ^^ ^^' =^ ^^ ^^n nr r n ^^ ^^ m rmn nrn mr r n m rrn n rn nr r n nn r nrr r n n.nnr mrxm m ,rn, v mmrnnnnmrr r nvnr rm rnv.nnnr m mrxmr m w r, rn n nn v n wrr n,rxm rn rrnn r, r nn &r rnr n, ^^ ^^ ^^ ' ^^,n rr rn, r nr n r ^^ ^^ ^^ ^^, rmr r n, r n, w r n ^^ ^^ ^^ ^^. n n- n,rrr r nr rrnnrmrn nm n rv r n m nn.nr wrnnnrr m rr nnrnn,rnrn nrrmr , nr r nrnn ^^ m ^^ ^^ ' ^^n n ^^ ^^ ^^ ^^. r n ^^ ^^ ' r r v r v ^^ ^^n ^^ ^^ ^^ ^^ m n. rn r n nn v nrnnr mrnxmw mn,rvn n nrnznnrr-rn nn nrrn,n, wnrmrrr n ^^r ^^ ^^ ^^n. nv m rnnrnnzn ^n^ ^^ ^^r.r-r n n wnnn ^^ ^^ n , , v ^^&,r rrn n&n mn . nmr , n,n m nr m nmnr r , m n r, n mr m v.rxm, nr m nvrn n ^ n r,n m rmnr r rrn r^ ^,^&.n nnrr mrxmm nnrv mm nv vnrm n r =, mrn r rr ,rrnn nr r, rm n r n nr m nv mrmn r.n xm rrn ,r m rmnr rn n, m rnmn rn nrrn ^^ ^^'n ^^ ^^. ^^ ' n ^^ n n w:
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Figure imgf000010_0001
^' ^ rn ^^ =, r nn ^^ ^^ ^ ^ ^ ^, ^r ^^ ^^ ^^ ' ^^ − ^^' r − ^^ ^ n ^ ^ n ^ ^ r ^ ^^ ^^ : ^^ ^^ − ^^ nr n ^^ ^^ ^^ ' ^^n ^^ ^^ ^^ ^^ r nn m mn- nrrmmv nnnnnnnrrrnrvn nrnm, nr.rnnn r n ^^ ^^ ^^ ' ^^n ^^ ^ n m nn m ^ ^^ ^^ w wn v w rr n ^^ ^^ ^^ ' ^^n ^^ ^^ ^^ ^nn ^^*'…0 ^^^m rm r m n v r ^ wnwrnrm nn. n r n ^^ ^^ ' rm vn rrn n, m n m nn ^^ ^ ^^^n ^^ ^ ^^^ ^^ w ^^ wrrwn vnwr mn v m.r m
Figure imgf000010_0002
nrn v v v m n v nrm nn rzn. rnnr. n vnnnn nr mrxnmr mr, nm n.nnrr wmr, mnnnn rrrn nrnnn wvrnmrnrnvn. nn n mmnn, . nm n,nr, mnrn n rn mvrr m r, m m nn. r. rn n m rn,n rvr x rz r m nn rnnr n rn. rrm.nnr mrx , wn m n r rn m mr ,nv rmr m n rn ^^ ^^ ^^ ^^.r rn rmnmrmnnnn _r_,n rr !"#^%mnrr nnvn vnnrrrnrmn , r n r n,rn,nn nm n rn w n m rmn rvmn. nv m n nr m nnn wm rvr rn r vmn r n rr nr mrmnmr rn .rxm,rmrr nvn r r r r r r , r r n rn r r n, m nr.x, rrnn nn m n rrm. nrr w m nnr m n r nn rm.nrr n w r _ _ m n, wr n xmr, nn r r w >.x,r rn n n ,n nrn _ _,m n rrnr v m m mmnnnnrrmmnnrnrmrnrnnnrm_ rmr n- r n, ^^ ^^ ^^ ' _. nr m ^^n ^^ ^^ ^^ ^^, m nn, m r nr rrn mnnn rrrrv r n m nn.nr rrnr wmnnn, nrnrrnnmnnmv mnmrr, r mvnm.nnmnr m rrrnmnn, wn nmrnnmn rn m nn. rrnr , mn, nr m nv mnrr rr rvnnmnmn r r nrm mnmn r r rrn m n r.n r mm nrnr, m nn, r rn,r,,n m rnrmnn m nn m n r r n. rnvnr mrxm nr m nv, nr m n rmrrr mnrxrmrrmrvnrrr,r rnn. n r n r r , vn r ,r r, rmrn r r. nvn r r rn r r, n wn r r n rmrn n r m. r rr m mnrnr r mrmn r n r m n r. mr m nr rrn nr n rr r rr m nv.nnr mrxm nr r mrmn r, nr m nv, r v,n n n r r mrn nrn r rrvr mr n r rm n r, v. n m nn rr nr m nnrnrn mrxrm nrr,mvnnvr,,rr rr mr r r.wvr,n r n rmrn r mrxm, mr nmrr rrnnnrnr mn nr.nn m nrnr .rrxmn m z nr r rrn, r , r n r xm m n.rr rrnnrnn mrnrn m mr nrnrvv. rm mnrnrwnnrr r m rrnnrrnmmnn nr nr m nv rr rn r.r xm rm n r,rn rvnr n r, nr m n rnm nn m rmn, n rrm. ^^.rm nnrn r vrnr, m rmnnnm m r, w m n rm nn zrr nr nr m nn nr rnrn .rr, mr nrn vr n w nrrr nnmrn,rw. mn mr nr r nrn v, n rrnn, r rmn r, m mmn r rm n nrn r. m n r r r, mm, rrnrrmn,rm nrn mrrmn, mmrrrm. nv m n r xrn nn m m nr n m nn. nrrr n xr rnn nvr nrm rm n r m nv m nn m nr . nn, w r n n w , mn n r nn nr vm , rn m nr m n . vr r vm rn , mr w n mrrm n m nn m n n m , w n vr rn.rn nmmrnn mv. m. nwvw, rmnxmr m ,rrm nr mr rr r n zr. nr m nv r m nrrr,n rw, r. r m nn rr nr m nwv,,r xmm rrwn, n mrnnrrnnrnr rr.nnr mr nrm n m . r n zr m- nr n m. rmr nn ,rn nn vrm r n m n nn rrn nrn v n.nrnrn. mrrnn mn ^^ ^^ ^m^ ^^-.vrnn n n mrmn r, r m rn n m r r.nnr mrxm rmn r, nr r, nrn,n, mrmn r r , nrn nrmrrn,r r n r.v r .mn nnr mn n v nnrm nrn n m nv n rr nrn mnrmrmrrrnnnn nrrrrnrr n ^^ ^^&, m n. nr rrrrrn rnr nr n mr rmrn nr r,nnrn, mwn.nnnnrr mnrxmn, m , nn mr rmnn ,nnrmrrrrn ^^ ^r^nrnn,rrrrnr ^n n,rm rmrrrn ^' ^ ^^ rn m ^ ^^',r nr m n. rr nn nrmrn. rnrnnrnz,nnwrrrnnnnnr mr rmn r nnrrn nn w n , m . rrn, rmrrrnrnzn rrn, m rn nr n r n nr r r r nzr. rmrrrn r rrn m rn r -nrnznn nr . rr-rnnmnrr mrxnm m n,rrmrrnn wrrn mr nr nn-nrrr n, nrrnn nnrnrznnnrrnrrmnrrnn,,wnrrn rn.n rnr.nvn nnrrnznn mrr-nrrnn nr wnn, mwrn, nr rm ^^ ^^ ^^w ^^nn mrrnnn ^^ ^^ ^^.nnnnvr mrxmr mr,rnn mr rvn n rrn m rv vnnn. nn v r nn v r rrr, mmn nnr.rmnrn. n mrxm rvr mnn mrn rn rn n n rmrr wn nr r rrnrrnnrmrrvrmnr rrmr rn.nnr rmr, rn n m r nrn r n nr rn nnrr n rn, nn r nr rr rn m n. rmr r nn n nn v rnv. mrr vrn rn r w r wrrn,.., n nn m nr, r ^^ ^^ ^^nn rmr r n ^^ ^^ ^^ ' ^^n nr r r ^^n v r n.nr wr,rn nn. nrm mr rmr nn ^^ ^^ ^n^ ' ^r mrn- r rnr n. nr r n^ ^ m w rmrr nrrrn.n ^ ^^ ^^ ^^ m w r nr rnnnr mrmmrmn,rnrrmrnnmnnnrrrrnm,nn,rnnrrnnrnnnrnrr,un nr.n- mr, mr rmnn , n r m n r nn rmnrr n.rxm, r m rmnrr rmrnnv ^^ ^^&, ^^mrnrmrrr, ^^ rrnn ^^ ^^'nn nnrrrvrnr ^^ ^^.. m rmn rm mr ^^'mrn rrmmnrnrrrnrmr ^^' 'n n v m mr w ^^ ^^'. nr m n r n nm nmrn.r m, rm n rmnn rrmr , n rm m mr mrmrmnnnnnnrmrrm,nrrr n.r r mn, mrr m nnn nm nmrrr.rn, mrxm nr m nv , rn nnr wvrmr m n r.nnr m nv m m m mr rmnn n mrxm m , ^^', r ' rmr ', rrmr rmr1 rmrrmr r m ^^ mn0, n-rmr ^^
Figure imgf000016_0001
, r rrmn nnr nmrnn.v. mnr ^^mr rmnn r nr ^^
Figure imgf000016_0002
nrn ^^ ^^ n nrrrn, nr r,. nrrmm nv m mr wm n m m mr rmnn r n nm n r. rrn, nmrnnnr , n nr r. m mrrmr rmnn rm n n nrrrn, n nm nnrnn, vn,mrnnmr.nnnvr m mrxwmvr nmrr mmn r.nnr mrxm m , m m m n n nr , r nr ^^, rr rmnn ^^0,m nn-rnr nr ^^
Figure imgf000016_0003
, 1 m nv.nr nr r rnr m m, rrrmmnr nn nnrmrrn.nnrr mnrnxm r nrmnr,m nnrn mrr nr nmrr rmn,n rrnn,nnr m nv. n nr rrxm m , r nr n nmr m nn r nr r nn r v n r mr n nr m nv, r vrnrmr r m n r r n r mr rmr r nn r v nr nr r nn.r r n r vrnr m nmrn mr m vn n nr rrn w r r r .r vr rrnx,mr nr m m nvr mrrnrrxm =m n rmr ^^' rn n n n, r rn *'2n0 w wnr nr ^^*'20 ^^': ^^
Figure imgf000017_0001
mrnnv ^^ n ^^rmn, m rmvrmrmnnn m nr
Figure imgf000017_0002
v, n n r rn…. m mr nrn r m nn, n n.n mnr mmrnnrrn, ',n n rnmr rr n r r n ^^ ^n^ ^^ ^ ^^ ^^ ^^ ^^, nr r n, rmr ^^',n r nr ^, rrmrrrmr ^^'r m nn'rrm n r r ',r m nn m rn n ^^ ^ r. r n rn.rn, rm'^nn “ mnrn, ‘rmnn n r n….rm nn”, mn rm n’nrm^ ^^!r ^^ rnn,n,nnnrn,nrnnnn,rrxr n, rmr , nnrxr rmr ,nr nr mm xr nrv rrm. n nxm vr , rnmrm nn n ‘ n’ m r nrm ‘n wnn’nrn. vr n. mnr rmr nn,rnn,rmrn,nrmr r n, , nm nnr nm n r nrnr rrmn. nnmnnn mrrn.n n ^^ ^^n m rmr m nn ^^ ^^n n m nn ^^ ^^ mr nn ^^ ^^n ^^ ' ^^,n w'rmrrrn, rmr rrn, nrnrmnnn ^^ ^^ ^^ ^^ w.wvr, ^nrr rn mrr rn ^^' ^^r ^' ^^n ^^ ^^ n nr nnrmrrnn nnrnr, nmr ^^ ^r^.nnnr mrrx-mn mrm,rnrrn n ^^ ^r^ ^^ ' ^^mnnnrmr ^^' 'nnrmnr'-n nr r n ^^ ^^ ^^ ^^rmnr r ^^. mnr,mnrnr mrnxrm m- ,nrn nm 'n r nr ^^'n nnr rm-rnr nnr ^^ ^^ ^r^ ^^n n r ^^ ^ ,^ ^^ ^^ mn nnn nr ^^.r n r mr w rn wnnmrnnnrmmrnnn nrnrn mn, wn r,.. mr.nw,n rn nrn m r,mnmn nnrnnrrnm mnnr w n r nrnrnmmnnnnw ‘r’nrrrn nrn.n mmn m r n mn r nrm nr nnr rnrn n. nz vnnnnrrn mrxm mnm,nrnnnmrrmrmnnnn nrnznnrr-rn n v nn nr r n nwn rmr r nrnznnrr n rn n. n nr r -rnn mrnrwzrnnrmrrrr n rn r nrm nrnznn r n .rn n,r wm n,rmr- mm vnr,nnwxm rnnrwn, mnwnr rn n nrnznnr-rn n. w rmnnnnnrrn mrxm mnm,nrn rm nnn , n , nrmnrmr n n n n rm nnn rn nr nr r n m r nrnzmnnnr.rn, n nrr,rrn n. w nr rn, r n n rn nr rn nn r ^^./ ^^v. mr m . n mnnnrv mnrxwmrr mn,n rmnr r nnnnm-vrnnr vr nn.rnznnnrr m-rnrmnn. n rmn nrm mm nn m nrmr r, rm m nn r n rn rmr r nr m nnn nmn nnn.r r n r rm n w vrn w rn wrnn mrn n wn v − ^^^+ ^ w r rm rnm ^. nn m vrnn m nnn nrm, w nrn n nn v m rm wnr nn. nnn m nn m nn, n mnnrmn-r rm rnrn.,nnm mmrzn nn m m nrmvnnnrr wmm mrrmn rr.nrrmr, m vnrrzr. mnnnnrm mrrxm m ,nrn rn nm n rmr r rmnnnn nrm n r r n m nnm.nrn wr rmr nr rrn n, rr,m n r m rrn nn nm n rmr n rr r n. rm n r m rn n ^ nrrn m n r m n ^^ ^'^ ^^^n n m m ^ ^^. m n r m vrnm, m n -vrn, rzn n vmnnrmnnnn. nnrxm, v vn r vnr nrmrrr rnrrmnnnrmrnnrxrrnm.nmnr mrxm m , rm n r rmrnr rrnrnmn nrnv n r n.nnvrnn m r v mrn,vv.nnr mrxmv rxm n m m ,rmnv n mvr rmn nnn v mmxrn rr m nr m nv. v mmxrn rr m n rxvm mn nrmr-m.n mnrrn mrxm m , v v,nr rmn v vv, n wrrmrnr r . mr m mn rmrn nnm nrnm nnn r r.nnr mrxm m , n m n rm nn rm n r, r m mr n rm n r m nn r ,. n m nr nrn n, r nnr nrnm,nnrvnn,rmnrrw r nrnrmnnrv. r m nrrnzmnnnrmnnn n nrrv mmnv n.rn wnn rn n rrnmnr mnrnxm mrm, m mr,rn n r nm n r,rrn r n nm nn r n nm nmnr,, nnrnn mr mrrmn.rm nnrrn.r mrr mxmrm mn,r mr nrr rmr nn r rm n r n nm n r m r rr. r rn rmrn nr r.nn n m , r rr mr nr r mrxm rn nr r, n r nr r rrn rnr r.nn r rn rmrn m r mrxm m , r rr m mr rnrwmnrxnmrr,nn,rrnvnr nmr m n n r rn rmrnn rnnrnrr.r,nnr m nrmxr,mm mn,r mrmrm mnnrnr.nnnmr mn,r mxrm mm,nnrrmnn vmrnrm,n m r rnr n n m nn nr mrmmnr r w mnmn r v rr .nnr xm m , n n m nnm r mr nr mrm n r r w m r rnn mn r v rr . r n, nmr, rnr . n r m . n m nn m n nnrnnn r m wnrnnr mrrrxmn mr. rrm . mrrm rnn rxnm m nn nr n rn r m rrn r. mmnnn . m nn nxmr . mr n nr m nv, nm nn nr m nnv, nxm nm n r n nxm rmrnm nn . m n v,n rm nn . r nr m n xm rm n r nr mmnnn n n, rm nvrnnrr.nnxmn, v. n wnn., r nr r rrr, r. rm n .rw. nrrm nr m nv rn r rr m nv mr mmrrr , mr r ,nnr ,n r r , nrnrm mn rmmnnnnnrr m,r mrn wrrmm.nr,rrnmnnr rv n nrmnrn nn nrrm nv, .nnr mr.xmr nr rm mnvm,rrnn rrrr . mnnr mnrrxm r nr nnm nv nr, mmrnvn mrmmnnr wrnn m n rnrrrvn. mrn m xm nr m nv ., n.n rnr r nr n r r rr mr rmrn nr r. n r rn mrmn r n rnnr rr m r . nr m nv mnr m n m n.-.nr wr rrmn nrr r n z , nr m nv m n r.nnr mrxm nr nrnnv ,mrnrnrrn mmrmrnnrrr r mrn nrn v. rr r r nr m nv nr n,rxm n rrr,rr,n mnrnmnvrr nrnn.r mr mn mnv. nn rn rr nr r nrrrrmnnrvnr n,rn,rxrm nnn rmrrr nn n rrn m n.nnr mrxm, nr rmrnrvnr nnrr rn rrrrnrnnn rmrmrnnr, n rn n, rrnr nr m n. rnn nr r nrrrrm,nrvrn nnr ,nrxmr n n nrrrnrr mrrrn nr r n. vn rmr r nn r nrr,rmmnnrvrmr nr,rxm n r r rmrrr n. n nrmr n r nrrrrm,nrmvnr nnrr,rnxm n n nrrrn. n nr nnnrr mrmxmn nvr .mvnnrvm, r xm nr m nv m nr nr r , n rrmrrnr n mn rrmr n rmnrrnrrnr,nrnr.nr r nrr m nv nr,rxm n r rnr, nnrrnrrrrn,,nr, n rmr nr ,rm rrmr ,n r r. nnrrm n r r r nrrrrmnnrvnrrnrr,,rnxrm, nn r n, nr r n, n rmr n nr , nm n rmr ,n r r. nr nm n r nr m nv mnnr mrxm nr rnrrm,r n,nrmrrrnrn, nr r n, m n r r r ,rm nnrr mnnr mr . nr m nv n, nxrmr nnr, nrrr,mr n,rmr r nr , rm nnr rm n r r r . n r mnrnrn mwrxmmn, r w,nm nrn rm mnnvrmr mv,nnrrm nmn,nrrm n nn,r. mnn r nrrrrmnnrvnrrnrr,,rxmrmnnn mrnmnn rnm n r r n n .nnr mrxm nr mr r r v nr,rxm nv, nr m n nrrr , rm n r rrr nr r r nnrnrmrmnnn r m n r r rr n r n m n r rr ,m.n rnr.r-r nnnnr mrr:r,rmn rn ,,,,,, ., ,rn, , , ,, ,, ,, , m m nr m nv rrm,.nrrrmnx nn-rnr rmn..,n ,wr mmrrr nrx r rrr rr m.m.., mrrmr, nrrn m nrnvm nv m nr w r nnn rn m nr rr., nn mrw wr,rmwrrrn v mmnnwr, mnn rwr.rwrrrmwr,rm rm mvmr mr,r v m mmrn, nr mn-vr mmr,r, rn mmm-r, mrrv, ,r r v.n rrnmn, mrn nn-v mmr mmrrr m nn m m rnrm r n v mmr m mrr r rrr . mmrrr rxnwn w mmrrrrrrrnvrr r.rnrrnnn rnn wnn.. mmrrr m mr r mm. nr nn-rnr mm mrm.rrr m nr rnrmn, nr . nmrmn “r”r, “rnr”, “r,r”n “r”, “rmr”, “nr”, “rr” rvr, rm “r”, “nr”, “nr”n “nr”, “nv mn. “nr”, “rr”. n rmr”, “r” nnrrrmrn, rr rm n, “n”, “r”n “r”, “rmr”, “nr”, “rr”.r “r”, “rmnr”mnrmnr. wr “r”, “n”, “r”n r nn, “r nnnr”n, “rr”n.rn rnrwmrrrrn rrmr, n r mn nm rn rn. mnn v vr. n mr wr nn.m-rmrrrmrrrrrn w r n. rrrrn w rmrn w r r w rrn w rmr n r x n nrrr rrn w rmr n nmmmn. rr mr n,rr, rxmmmn w m n rr rrrrrrrrn w m nn r rrrnn n n nrxmmmn. rrmr, r n rmrnrrrn. xmr rn m rrmnnrrnnnn nmnnr.rm. rm nnr wrn "mrn." n n rx rn rn n r wr ""mrn "n."r nnmn nx xrmrr nmmnn m rrnmmnn nmnr mnm, rrrwrnn wrm,nm vrwrr "m.n", "n"r "v" m vnrrxnmr m ,v,n m r rnr r n mxr mrrm rr , w m mmnnnnnmr-x nr ,m nmr-r mm, mrn nwr nvrnmrn, rrm ,x rmv n nn-r n. mr-r mm mn mr ,nmmv rmrv n,n, nm , n ,.nr,rrmrr mmn rn , vr mnn, rr,. rrm rm,rrm, , r .mr-x n mn rr rn, rr,n mmrr rrrn.nxmr rrm rxn rr rrnxrmnrrnxn nrnr nn r n rr . rmmnnnn r v nwnn r vm , w nr r n r m r,n w m v n mr nr.n m nn mnr m w rnrmnn rv rrn rrv wnr, rn, rr rnv, m n,n vnn.. m rnn vr

Claims

. mzr,,r nrmr nmr m nv,r r n m mr nv mrn r r, - - nnnn: n ,rrn rnnrnvnn n rnn rn, n rmrr m n rrrnr nr - rnnrrrrnnnrrvnn rmrrrnn n nr r n r rmr r n n nrm rmr r - rmnn rrmr n nrmr -nrmnrmrrr n nn nrr nr n n nr - nrn , rnrrmn r n, rr r r n, nr m mr ,n r nr ,r - n nnrrm n r r r rrn n,, nnrmrrmr,rn nn, nr nm nnr nm nr , r n n r r -nnnmrnmnnnnmrmnnr.r.rm m rn m, wr mr n rrmr n n n r nn r rmr r nn rr nmrnnr mnr nnr nr m nv,n nr r nn nm r nn r n nr m n r m n r mr m n r r vn, r rvrnvrrmr rmrr r nnnr rvrvnrnr nrrmr nnr. r. mrm rn nn rv m, wrnnrn mr rmnnnnnnrvn nrnnm nn rnn nnwnrnrmrn.r nznnnrnrr-r. mrm rnnnnnnnrnrv m, wrnnrn mr n n rmnm nn nr r n rm r r nr m nn. nnn n . vr mnnvrnnwrmr, wrn n nn m- n r n. n n rmr r nn. m rmnrn nmnrnmnnvmr,n wrrnnzn n r-rn n. nr. mrn rnnmnnnnrv m, wrnnrn m n r rmr rmnn r m n r mnr r nn n m nn. r r n .m mnrrnr rmmn, wrnnrm n rn n r vrmr r nn vn r nv.n . mnm rnnrrmmr-v, wrnr.n rm n rn . mr mrrnnnnn rv m, wrn r nr r rrrrrrn,nrmr mrmn r nm n r r n r n r n nr r. rn rmrn.m m rn nn rv m, wrn m -r m:nrrn, nmnmn r r m n - nmrmnn mnmn r rnr mr m nn r vrr , n n mnmnn rnr mvrmrnr r. r w.n mmrrrnnnm, wrnnrn n m n mnmn r v mrrrm.n r r w.m mr: rn nn rv m, wrn nn -rrmnnnnn,rmrnrrrnnnn, rn r rnr nr m n. rr.r mrnrnmrm, wnrnrmnn w nrnznn nr mr nr n rrrnnn.n,wnrrnn.r mnrnrnrn nmr, wrrnnrnr.nn n.m mr: rn nn m , wrn nn - wrrnrnnr nm vr rmmvnnnnrn.n v. nmrnvmmrnnv m,mrrrr n zr, nr r, wrn nr mr,r rrr,n r m rn n m-.nv nr rrmn.rmrmr rmrnnrr mn, wm wrnnnxr mrr nrm, nr mr v nr m n r m n m-. v rrmn m
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