`
`(12) United States Patent
`Kim et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 8,712,546 B2
`*Apr. 29, 2014
`
`(54) NEUROSTIMULATION SYSTEM
`(75) Inventors: Daniel H. Kim, Los Altos, CA (US);
`Mir A. Imran, Los Altos, CA (US)
`(73) Assignees: Spinal Modulation, Inc., Menlo Park,
`CA (US); The Board of Trustees of the
`Leland Stanford Junior University,
`Palo Alto, CA (US)
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`This patent is Subject to a terminal dis
`claimer.
`
`(*) Notice:
`
`(21) Appl. No.: 12/051,770
`
`(22) Filed:
`
`Mar 19, 2008
`
`(65)
`
`Prior Publication Data
`US 2008/O167698 A1
`Jul. 10, 2008
`
`Related U.S. Application Data
`(63) Continuation of application No. 1 1/221,576, filed on
`Sep. 7, 2005, now abandoned.
`(60) Provisional application No. 60/608,357, filed on Sep.
`8, 2004.
`
`(2006.01)
`
`(51) Int. Cl.
`A61N L/05
`(52) U.S. Cl.
`USPC .......................................................... 6O7/118
`(58) Field of Classification Search
`USPC ............................................ 607/46, 117, 118
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`525,891 A
`3,724.467 A
`
`9, 1894 Fricke
`4/1973 Avery et al.
`
`3,845,770 A 11/1974 Theeuwes et al.
`3,916,899 A 11/1975 Theeuwes et al.
`4,141,367 A
`2f1979 Ferreira
`4,232,679 A 11/1980 Schulman
`4,298,003 A 11/1981 Theeuwes et al.
`4,313,448 A
`2f1982 Stokes
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`
`CN
`EP
`
`2401143 Y 10, 2000
`O779080 A
`6, 1997
`(Continued)
`
`OTHER PUBLICATIONS
`
`Abdulla et al.; AXotomy- and autotomy-induced changes in the excit
`ability of rat dorsal root ganglion neurons; J Neurophysiol; 85(2), pp.
`630-643; Feb. 2001.
`
`(Continued)
`
`Primary Examiner — Allen Porter, Jr.
`(74) Attorney, Agent, or Firm — Shay Glenn LLP
`
`(57)
`
`ABSTRACT
`
`Some embodiments of the present invention provide neuro
`stimulation systems and components for selective stimulation
`and/or neuromodulation of one or more dorsal root ganglia
`through implantation of an electrode on, in or around a dorsal
`root ganglia. Some other embodiments of the present inven
`tion provide neurostimulation systems adapted for selective
`neurostimulation of one or more nerve root ganglia as well as
`techniques for applying neurostimulation to the spinal cord.
`Still other embodiments of the present invention provide
`stimulation systems and components for selective stimulation
`and/or neuromodulation of one or more dorsal root ganglia
`through implantation of an electrode on, in or around a dorsal
`root ganglia in combination with a pharmacological agent.
`
`28 Claims, 47 Drawing Sheets
`
`
`
`Petitioner - Avation Medical, Inc.
`Ex. 1034, p. 1
`
`
`
`US 8,712,546 B2
`Page 2
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`2f1983 Iversen
`4.374,527 A
`4479.491 A 10, 1984 Martin
`4,549,556. A 10/1985 Tarjan et al.
`4,573,481 A
`3, 1986 Bullara
`4.577642 A
`3, 1986 Stokes
`4.590,946 A
`5, 1986 Loeb
`4,607,639 A
`8/1986 Tanagho et al.
`4,739,764 A
`4, 1988 Lue et al.
`4,786,155 A 11, 1988 Fantone et al.
`4,803.988 A
`2f1989 Thomson
`4920,979 A * 5/1990 Bullara. 607.118
`4,940,065. A
`7, 1990 Tanagho et al.
`5,135,525 A
`8/1992 Biscoping et al.
`5,270,099 A 12/1993 Kamiyama et al.
`5,299,569 A
`4, 1994 Wernicke et al.
`5.344,438 A
`9, 1994 Testerman et al.
`5358,514 A 10, 1994 Schulman et al.
`5,370,644 A * 12/1994 Langberg ........................ 606.33
`5,411,537 A
`5, 1995 Munshi et al.
`5.411.540 A
`5, 1995 Edell et al.
`541779 A
`5, 1995 Hull et al.
`5.458,626 A 10, 1995 Krause
`5,489,294 A
`2f1996 McVenes et al.
`5,505,201 A * 4, 1996 Grill et al. ..................... 600,371
`5,514,175 A
`5/1996 Kim et al.
`5,584.835. A 12/1996 Greenfield
`5,634.462 A
`6/1997 Tyler et al.
`5,643,330 A
`7, 1997 Holsheimer et al.
`5,702,429 A 12/1997 King
`5,711,316 A
`1/1998 Elsberry et al.
`5,713,922 A
`2/1998 King
`5,720,099 A
`2f1998 Parker et al.
`5,733,322 A
`3, 1998 Starkebaum
`5,741,319 A * 4, 1998 Woloszko et al. ............ 607.118
`5,755,750 A *
`5/1998 Petruska et al. ................ 6O7.75
`5,807.339 A
`9, 1998 Bostrom et al.
`5.834,021 A
`10/1998 Rise
`5.865,843. A
`2f1999 Baudino
`5871531 A
`2, 1999 Struble
`5.885.290 A
`3, 1999 Guerrero et al.
`5938,690 A
`8, 1999 Law et al.
`5.948,007 A
`9, 1999 Starkebaum et al.
`5,983,141 A 1 1/1999 Sluijter et al.
`5.984,896 A 11/1999 Boyd
`6.002.964. A 12/1999 Feller et al.
`6,044.297 A
`3, 2000 Sheldon et al.
`6045.532 A.
`4/2000 Eggers et al.
`6,051,017 A
`4/2000 Loeb et al.
`6.104,957 A
`8, 2000 Alo et al.
`6.130.467 A
`9, 2000 Schallhorn
`6,161,048. A
`12/2000 Siter et al.
`6,175,764 B1
`1/2001 Loeb et al.
`6,181965 B1
`1/2001 Loeb et al.
`6.185.455 B1
`2/2001 Loeb et al.
`6,205.359 B1
`3/2001 Bovea
`6,208.902 B1
`3/2001 Boveja
`6,214,016 B1
`4/2001 Williams et al.
`6,259,952 B1
`7/2001 Sluijter et al.
`6,298.256 B1
`10/2001 Meyer
`6,314.325 B1
`11, 2001 Fitz
`6,319.241 B1
`1/2001 King et al.
`6.349.233 B1
`2, 2002 Adams
`6,353.762 B1
`3/2002 Baudino et al.
`6.356,786 B1
`3/2002 Rezaietal.
`6,360,750 B1
`3/2002 Gerber et al.
`6,366,814 B1
`4/2002 Boveja et al.
`6,393,325 B1
`5, 2002 Mann et al.
`6.425,887 B1
`7/2002 McGuckin et al.
`6,438,423 B1
`8/2002 Rezai et al.
`6,440,090 B1
`8/2002 Schallhorn
`6,466,821 B1
`10/2002 Pianca et al.
`6,493.588 B1
`12/2002 Malaney et al.
`6,510,347 B2
`1/2003 Borkan
`6,512,958 B1
`1/2003 Swoyer et al.
`6,516,227 B1
`2/2003 Meadows et al.
`
`2/2003 Papay et al.
`6,517,542 B1
`2/2003 Kieval et al.
`6,522,926 B1
`3/2003 Kronberg
`6,535,767 B1
`6/2003 He et al.
`6,582,441 B1
`6,587,725 B1* 7/2003 Durand et al. .................. 607/42
`6,605,094 B1
`8, 2003 Mann et al.
`6,606,521 B2
`8/2003 Paspa et al.
`6,611,715 B1
`8/2003 Boveja
`6,625,496 B1* 9/2003 Olivier ......................... 607,122
`6,638,276 B2 10/2003 Sharkey et al.
`6,658.302 B1
`12/2003 Kuzma et al.
`6,714,822 B2
`3/2004 King et al.
`6,748,276 B1
`6/2004 Daignault, Jr. et al.
`6,754,539 B1
`6/2004 Erickson et al.
`6,788.975 B1
`9/2004 Whitehurst et al.
`6,792.318 B2
`9, 2004 Chitre et al.
`6,832,115 B2 12/2004 Borkan
`6,835,194 B2 12/2004 Johnson et al.
`6,839,588 B1* 1/2005 Rudy ............................ 600,523
`6,862.479 B1
`3/2005 Whitehurst et al.
`6,871,099 B1
`3/2005 Whitehurst et al.
`6,873,342 B2
`3/2005 Perry et al.
`6,889,094 B1
`5/2005 Kuzma et al.
`6,901,287 B2
`5/2005 Davis et al.
`6,902,547 B2
`6/2005 Aves et al.
`6,909,917 B2
`6/2005 Woods et al.
`6,928,320 B2
`8/2005 King
`6,971,391 B1
`12/2005 Wang et al.
`6,978,180 B2 12/2005 Tadlock
`7,047,082 B1
`5, 2006 Schromet al.
`7,096,070 B1
`8/2006 Jenkins et al.
`7,127.287 B2 10/2006 Duncan et al.
`7,181,289 B2
`2/2007 Pflueger et al.
`7.333,857 B2
`22008 Campbell
`2001/0003799 A1
`6/2001 Boveja
`2002fOO77684 A1
`6/2002 Clemens et al.
`2002O099.430 A1
`7/2002 Verness
`2002/01 16030 A1
`8/2002 Rezai
`2002/0128694 A1
`9, 2002 Holsheimer
`2002/0147486 Al 10/2002 Soukup et al.
`2003, OO18367 A1
`1/2003 Dillorenzo
`2003/0023241 A1
`1/2003 Drewry et al.
`2003/0045919 A1
`3/2003 Swoyer et al.
`2003, OO69569 A1
`4/2003 Burdette et al.
`2003/0088301 A1
`5/2003 King
`2003.0114905 A1
`6, 2003 Kuzma
`2003/O130577 A1
`7/2003 Purdy et al.
`2003. O144657 A1
`7/2003 Bowe et al.
`2003. O144709 A1
`7/2003 Zabara et al.
`2003/0181958 A1
`9/2003 Dobak, III
`2003. O187490 A1 10, 2003 Gliner
`2003/0195602 A1 10/2003 Boling
`2004/0015202 A1
`1/2004 Chandler et al.
`2004/00 19359 A1
`1/2004 Worley et al.
`2004/00 19369 A1
`1/2004 Duncan et al.
`2004/0059404 A1
`3/2004 Bjorklund et al.
`2004/O116977 A1
`6, 2004 Finch et al.
`2004/O122360 A1
`6/2004 Waldhauser et al.
`2004/O122477 A1
`6/2004 Whitehurst et al.
`2004/O122497 A1
`6/2004 Zhang et al.
`2004/0122498 A1
`6/2004 Zhang et al.
`2004/0147992 A1
`7/2004 Bluger et al.
`2004/0172089 A1
`9, 2004 Whitehurst et al.
`2004/0210290 A1 10, 2004 Omar-Pasha
`2004/0215286 Al 10/2004 Stypulkowski
`2004/0230273 A1 11/2004 Cates et al.
`2004/0230280 A1 11/2004 Cates et al.
`2004/0243210 Al 12/2004 Morgan et al.
`2005/0O273.38 A1
`2/2005 H11
`2005/OO33295 A1
`2/2005 Wisnewski
`2005/OO33393 A1
`2/2005 Daglow
`2005, OO38489 A1
`2/2005 Grill
`2005, 0070982 A1
`3, 2005 Heruth et al.
`2005, 0080325 A1
`4, 2005 Erickson
`2005, 0096718 A1
`5.2005 Gerber et al.
`2005, 014.9154 A1
`7, 2005 Cohen et al.
`2005/0159799 A1
`7/2005 Daglow et al.
`2005/0203599 A1
`9, 2005 Garabedian et al.
`2005/0222647 A1 10, 2005 Wahlstrand et al.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1034, p. 2
`
`
`
`US 8,712,546 B2
`Page 3
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`2005/025 1237 A1
`2006, OOO4364 A1
`2006,000982O A1
`2006,0041295 A1
`2006, OO52826 A1
`2006, OO52827 A1
`2006, OO52828 A1
`2006, OO52835 A1
`2006, OO5283.6 A1
`2006, OO52837 A1
`2006, OO52838 A1
`2006, OO52839 A1
`2006, OO52856 A1
`2006, OO64150 A1
`2006.0089609 A1
`2006.0089696 A1
`2006/009.5088 A1
`2006, O155344 A1
`2006.0161235 A1
`2006, O195169 A1
`2006/0206118 A1
`2006/0241716 A1
`2007.0043400 A1
`2007, OO60954 A1
`2007/O123954 A1
`2007/0213671 A1
`2008.OOO9927 A1
`2008. O18891.6 A1
`2011/O257693 A1
`2011/0276056 A1
`2012/0158094 A1
`2012/O19737O A1
`2012,031 O140 A1
`2013,0165991 A1
`
`11/2005 Kuzma et al.
`1/2006 Green et al.
`1/2006 Royle
`2/2006. Osypka
`3, 2006 Kim et al.
`3, 2006 Kim et al.
`3, 2006 Kim et al.
`3, 2006 Kim et al.
`3, 2006 Kim et al.
`3, 2006 Kim et al.
`3, 2006 Kim et al.
`3, 2006 Kim et al.
`3, 2006 Kim et al.
`3, 2006 Heist et al.
`4/2006 Bleich et al.
`4/2006 Olsen et al.
`5, 2006 DeRidder
`7/2006 Rezai et al.
`7/2006 King
`8, 2006 Gross et al.
`9, 2006 Kim et al.
`10, 2006 Finch et al.
`2/2007 Donders et al.
`3/2007 Cameron et al.
`5, 2007 Gielen et al.
`9, 2007 Hiatt
`1/2008 Vilims
`8, 2008 Jones et al.
`10/2011 Burdulis
`11/2011 Grigsby et al.
`6/2012 Kramer et al.
`8, 2012 Kim et al.
`12/2012 Kramer et al.
`6, 2013 Kim et al.
`
`FOREIGN PATENT DOCUMENTS
`
`4/2003
`1304135 A2
`EP
`6, 1991
`O3O41191 B2
`JP
`8, 1994
`HO6-218.064 A
`JP
`3, 1996
`808O353 A
`JP
`9, 1998
`10243954 A
`JP
`4/2004
`2004.5.12105
`JP
`10, 2004
`2006523215
`JP
`6, 2005
`2005516697
`JP
`T 2008
`2008526.299
`JP
`WOO2O965.12 A1 12/2002
`WO
`WO 03/041559 A2
`5, 2003
`WO
`WO 03/043690 A1
`5, 2003
`WO
`WOO3,063692
`8, 2003
`WO
`WO 03/066154 A2
`8, 2003
`WO
`WO 03/090599 A2 11/2003
`WO
`WO WO 2005/092432 A1 10/2005
`WO WO 2006/084635 A2
`8, 2006
`
`OTHER PUBLICATIONS
`
`Burton et al.; The organization of the seventh lumbar spinal ganglion
`of the cat; J Comp Neurol. 149(2); pp. 215-232; May 15, 1973.
`Myles et al.; Effects of different methods of peripheral nerve repair on
`the number and distribution of muscle afferent neurons in rat dorsal
`root ganglion; J Neurosurg: 77(3); pp. 457-462; Sep. 1992.
`Prats-Galino et al. Prats; Representations of hindlimb digits in rat
`dorsal root ganglia; J Comp Neurol; 408(1), pp. 137-145; May 24,
`1999.
`Waxman et al.; Sodium channels, excitability of primary sensory
`neurons, and the molecular basis of pain; Muscle Nerve; 22(9), pp.
`1177-1187; Sep. 1999.
`Wessels et al.; A rostrocaudal Somatotopic organization in the
`brachial dorsal root ganglia of neonatal rats; Clin Neurol NeuroSurg;
`95 Suppl; pp. S3-11; 1993.
`Wessels et al.; Evidence for a rostrocaudal organization in dorsal root
`ganglia during development as demonstrated by intra-uterine WGA
`
`HRP injections into the hindlimb of rat fetuses; Brain Res Dev Brain
`Res; 54(2); pp. 273-281; Jul. 1, 1990.
`Wessels et al.; Somatotopic organization in the sensory innervation of
`the rathindlimb during development, using half dorsal root ganglia as
`Subsegmental units; Eur J. Morphol; 28(2-4); pp. 394-403; 1990.
`Wessels et al.; The rostrocaudal organization in the dorsal root gan
`glia of the rat: a consequence of plexus formation?: Anat Embryol
`(Berl); 190(1): pp. 1-11: Jul. 1994.
`Imran et al.; U.S. Appl. No. 12/607.009 entitled "Selective stimula
`tion systems and signal parameters for medical conditions.” filed Oct.
`27, 2009.
`Linker et al.; U.S. Appl. No. 12/687,737 entitled "Stimulation leads,
`delivery systems and methods of use.” filed Jan. 14, 2010.
`Kishawi et al.; U.S. Appl. No. 12/730.908 entitled “Pain management
`with stimulation subthreshold to parasthesia,” filed Mar. 24, 2010.
`Kocsis et al.; NR2B receptors are involved in the mediation of spinal
`segmental reflex potentials but not in the cumulative motoneuronal
`depolarization in vitro; Brain Research Bulletin, Elsevier Science
`Ltd.; vol. 64; No. 2: pp. 133-138; Aug. 30, 2004.
`Lopez et al., Excitatory and inhibitory effects of serotonin on spinal
`nociceptive reflexes are mediated by 5-HT2 and 5-HT1B receptors;
`(Database Biosis Biosciences information service, Philadelphia, PA.
`US, XP002567533, accession No. PREV200100573757); Abstract;
`2001.
`Kim et al.; U.S. Appl. No. 12/369,706 entitled "Methods for stimu
`lating a dorsal root ganglion.” filed Feb. 11, 2009.
`Nannini et al.; Muscle recruitment with intrafascicular electrodes;
`IEEE Trans on Biomedical Engineering; vol. 38; No. 8; pp. 769
`776Aug. 1991.
`Brounstein et al.; U.S. Appl. No. 12/780,696 entitled “Methods,
`systems and devices for neuromodulating spinal anatomy,” filed May
`14, 2010.
`Ma et al.; Enhanced excitability of dissociated primary sensory neu
`rons after chronic compression of the dorsal root ganglion in the rat;
`Pain; 113(1-2); pp. 106-112; Jan. 2005.
`Van Zundert, Janet al. 2005. Pulsed Radiofrequency in Chronic Pain
`Management: Looking for the Best Use of Electrical Current. World
`Institute of Pain. 5 (2):74-76.
`Van Zundert, J. et al. 2005. Pulsed and Continuo Radiofrequency
`Current Adjacent to the Cervical Dorsal Root Ganglion of the Rat
`Induces Late Cellular Activity in the Dorsal Horn. Anesthesiology.
`102 (1): 125-31.
`Clark, Robert K. “Anatomy and physiology: understanding the
`human body”: Jones & Bartlett Publishers; Sudbury, MA; ISBN
`0-7637-4816-6; Chapter 12: pp. 213-215; Feb. 28, 2005.
`Kramer et al.; U.S. Appl. No. 13,458,697 entitled "Selective stimu
`lation to modulate the sympathetic nervous system.” filed Apr. 27.
`2012.
`Kim et al.; U.S. Appl. No. 13/550,439 entitled “Methods for Stimu
`lating a Dorsal Root Ganglion.” filed Jul. 16, 2012.
`Wedleyetal. Handbook of ClinicalTechniques in the Management of
`Chronic Pain. Taylor & Francis; pp. 17-19. Nov. 27, 1996.
`Kishawi et al.; U.S. Appl. No. 13/753,326 entitled “Pain management
`with stimulation subthreshold to parasthesia,” filed Jan. 29, 2013.
`Burdulis; U.S. Appl. No. 13/975,083 entitled “Hard Tissue Anchors
`and Delivery Devices.” filed Aug. 23, 2013.
`Dorsal Root Ganglion; www.biology-online.org/dL)orsal root
`ganglion; downloaded Nov. 5, 2013; 4pgs.
`The Peripheral Nervous System: http://cnx.org/content/m44751/lat
`est; downloaded Nov. 5, 2013; 7 pgs.
`Imran etal; U.S. Appl. No. 11/952,062 entitled “Implantable flexible
`circuit leads and methods of use.” filed Dec. 6, 2007.
`Burdulis, Albert; U.S. Appl. No. 1 1/952,065 entitled “Expandable
`stimulation leads and methods of use.” filed Dec. 6, 2007.
`Imran, Mir; U.S. Appl. No. 11/952,049, entitled “Grouped leads for
`spinal stimulation.” filed Dec. 6, 2006.
`Imran, Mir; U.S. Appl. No. 11/952,053 entitled “Delivery devices,
`systems and methods for stimulating nerve tissue on multiple spinal
`levels, filed Dec. 6, 2007.
`Burdulis, Albert; U.S. Appl. No. 1 1/952,081 entitled “Hard tissue
`anchors and delivery devices.” filed Dec. 6, 2007.
`Imran et al; U.S. Appl. No. 12/022, 135 entitled “Sutureless lead
`retention features, filed Jan. 29, 2008.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1034, p. 3
`
`
`
`US 8,712,546 B2
`Page 4
`
`(56)
`
`References Cited
`
`OTHER PUBLICATIONS
`
`Advanced Neuromodulation Systems, Inc. (ANSI) Research Brief
`ing dated Aug. 20, 2004 by Stephens Inc. Investment Bankerspp. 1-4.
`Advanced Neuromodulation Systems, Inc. (ANSI) Research Bulletin
`dated Jul. 2, 2004 by Stephens Inc. Investment Bankers pp. 1-7.
`Advanced Neuromodulation Systems, Inc. (ANSI) Research Bulletin
`dated Jul. 27, 2004 by Stephens Inc. Investment Bankers pp. 1-9.
`Advanced Neuromodulation Systems, Inc. Equity Research dated
`Jan. 16, 2003 by Pacific Growth Equities pp. 1-8.
`Alo, Kenneth M. 2002. New Trends in Neuromodulation for the
`Management of Neuropathic Pain. Neurosurgery, 50 (4): 690-703.
`Aoki, Yasuchika et al. 2004. Distribution and Immunocytochemical
`Characterization of Dorsal Root Ganglion Neurons Innervating the
`Lumbar Intervertebral Disc in Rats: A Review. LifeSciences. 74 (21):
`2627-2642.
`Askar, Zahid, et al. 2003. Scott Wiring for Direct Repair of Lumbar
`Spondylolysis. Spine. 28 (4): 354-357.
`Baba, Hiroshi et al. 1999. Peripheral Inflammation Facilitates A?
`Fiber-Mediated Synaptic Input to the Substantia Gelatinosa of the
`Adult Rat Spinal Cord. The Journal of Neuroscience. 19 (2): 859
`867.
`Bajwa, Zahid H. etal. 2001. Herpetic Neuralgia: Use of Combination
`Therapy for Pain Relief in Acute and Chronic Herpes Zoster. Geri
`atrics. 56 (12): 18-24.
`Barendse, G.A. et al. 2001. Randomized Controlled Trial of
`Percutaneo Intradiscal Radiofrequency Thermocoagulation for
`Chronic Discogenic Back Pain: Lack of Effect From a 90-Second 70
`C Lesion. Spine. 26 (3): 287-92. (Abstract Only).
`Barlocher, C.B. et al. 2003. Kryorhizotomy: An Alternative Tech
`nique for Lumbar Medial Branch Rhizotomy in Lumbar Facet Syn
`drome. J Neurosurg.98 (1): 14-20. (Abstract Only).
`Blau, A. et al. 1997. Characterization and Optimization of
`Microelectrode Arrays for In Vivo Nerve Signal Recording and
`Stimulation. Biosens Bioelectron. 12 (9-10): 883-92. (Abstract
`Only).
`Boston Scientific a Neuromodulation Primer dated Jun. 9, 2004 in
`Medical Supplies and Devices, published by Susquehanna Financial
`Group, LLLP pp. 1-17.
`Brammah, T.B. et al. 1994. Syringomyelia as a Complication of
`Spinal Arachnoiditis. Spine. 19 (22): 2603-5. (Abstract Only).
`Braverman D.L. et al. 2001. Using Gabapentin to Treat Failed Back
`Surgery Syndrome Caused by Epidural Fibrosis: A Report of 2 Cases.
`Arch Phys Med Rehabil. 82 (5): 691-3. (Abstract Only).
`Carlton, Susan M. et al. 2001. Tonic Control of Peripheral Cutaneo
`Nociceptors by Somatostatin Receptors. Journal of Neuroscience. 21
`(11): 4042-4049.
`Chaplan, S.R. et al. 1994. Quantitative Assessment of Tactile
`Allodynia in the Rat Paw. Journal of Neuroscience Methods. 53 (1):
`55-63.
`Cho, J. 1997. Percutaneo Radiofrequency Lumbar Facet Rhizotomy
`in Mechanical Low Back Pain Syndrome. Stereotact Funct
`Neurosurg, 68(1-4): 212-7. (Abstract Only).
`Crampon, M.-A. et al. 2002. Nerve Cuff Electrode With Shape
`Memory Alloy Armature: Design and Fabrication. Bio-Medical
`Materials and Engineering. 12 (4): 397-410.
`Cuoco, Jr., Frank A. et al. 2000. Measurement of External Pressures
`Generated by Nerve Cuff Electrodes. IEEE Transactions on Reha
`bilitation Engineering. 8 (1): 35-41.
`Cyberonics, Inc. Equity Research dated Jan. 16, 2003 by Pacific
`Growth Equities pp. 1-14.
`Denny, N.M. et al. 2003. Evaluation of an Insulated Tuohy Needle
`System for the Placement of Interscalene Brachial Plex Catheters.
`Anaesthesia. 58 (6): 554-7. (Abstract Only).
`Dreyfuss, Paul et al. 2000. Efficacy and Validity of Radiofrequency
`Neurotomy for Chronic Lumbar Zygapophysial Joint Pain. Spine. 25
`(10): 1270-1277.
`Dubuisson, D. 1995. Treatment of Occipital Neuralgia by Partial
`Posterior Rhizotomy at C1-3.J Neurosurg, 82 (4): 581-6. (Abstract
`Only).
`
`Eschenfelder, Sebastianetal. 2000. Dorsal Root Section Elicits Signs
`of Neuropathic Pain Rather than Reversing Them in Rats With L5
`Spinal Nerve Injury. Pain. 87 (2): 213-219.
`Firth, Ava et al. 1999. Development of a Scale to Evaluate Postop
`erative Pain in Dogs. JAmVetMed Assoc. 214 (5): 651-659.
`Garcia Cosamalon, P. J.
`et al. 1991. Dorsal Percutaneo
`Radiofrequency Rhizotomy Guided With CT Scan in Intercostal
`Neuralgias. Technical note. Acta Neurochir (Wien). 109 (3-4): 140-1.
`Giorgi, C. etal. 1984. Surgical Treatment of Glossopharyngeal Neu
`ralgia and Pain From Cancer of the Nasopharynx. A 20-Year Expe
`rience. J NeuroSurg. 61 (5): 952-5. (Abstract Only).
`Gocer, A.I. et al. 1997. Percutaneo Radiofrequency Rhizotomy of
`Lumbar Spinal Facets the Results of 46 cases. Neurosurg Rev. 20(2):
`114-6. (Abstract Only).
`Haller, H. et al. Treatment of Chronic Neuropathic Pain After Trau
`matic Central Cervical Cord Lesion with Gabapentin. Journal of
`Neural Transmission. 110 (9): 977-981, Dated 2003.
`Herron, L.D. 1989. Selective Nerve Root Block in Patient Selection
`for Lumbar Surgery: Surgical Results. J Spinal Disord. 2 (2): 75-9.
`(Abstract Only).
`Higuchi, Yoshinori, et al. 2002. Exposure of the Dorsal Root Gan
`glion in Rats to Pulsed Radiofrequency Currents Activates Dorsal
`Horn Lamina I and II Neurons. Neurosurgery, 50 (4): 850-856.
`Holsheimer, J. et al. 1995. Effects of Electrode Geometry and Com
`bination on Nerve Fibre Selectivity in Spinal Cord Stimulation.
`Medical & Biological Engineering & Computing. 33 (5): 676-682.
`Igarashi, T. et al. 2004. Lysis of Adhesions and Epidural Injection of
`Steroid. Local Anaesthetic During Epiduroscopy Potentially Allevi
`ate Low Back and Leg Pain in Elderly Patients With Lumbar Spinal
`Stenosis. British Joumal of Anaesthesia. 93 (2): 181-.
`Julius, David et al. 2001. Molecular Mechanisms of Nociception.
`Nature. 413 (6852): 203-210.
`Kanpolat, Yucel et al. 2001. Percutaneo Controlled Radiofrequency
`Trigeminal Rhizotomy for the Treatment of Idiopathic Trigeminal
`Neuralgia: 25-Year Experience with 1600 Patients. Neurosurgery. 48
`(3): 524-534.
`Kapadia, N.P. etal. 2000. Gabapentin for Chronic Pain in Spinal Cord
`Injury: A Case Report. Arch Phys Med Rehabil. 81 (10): 1439-41.
`(Abstract Only).
`Kapoor, Vibhu et al. 2003. Refractory Occipital Neuralgia: Preopera
`tive Assessment With CT-Guided Nerve Block Prior to Dorsal Cervi
`cal Rhizotomy. American Journal of Neuroradiology. 24 (10): 2105
`10.
`Karai, Laszlo et al. 2004. Deletion of Vanilloid Receptor 1-Express
`ing Primary Afferent Neurons for Pain Control. Journal of Clinical
`Investigation. 113 (9): 1344-1352.
`Kline, David G. et al. 1998. Management and Results of Sciatic
`Nerve Injuries: a 24-Year Experience. Joumal of Neurosurgery. 89
`(1): 13-23.
`Kobayashi, Shigeru et al. 2004. Pathology of Lumbar Nerve Root
`Compression Part 1: Intraradicular Inflammatory Changes Induced
`by Mechanical Compression. Journal of Orthopaedic Research. 22
`(1): 170-179.
`Kobayashi, Shigeru et al. 2004. Pathology of Lumbar Nerve Root
`Compression Part 2: Morphological and Immunohistochemical
`Changes of Dorsal Root Ganglion. Journal of Orthopaedic Research.
`22 (1): 180-188.
`Koszewski, W. et al. 2003. The DREZ Lesion as an Effective Treat
`ment for Chronic Hypothetically Post-Herpetic Neuropathic Pain.
`Case Report and Review of Literature). NeurolNeurochir Pol. 37 (4):
`943-53. (Abstract Only).
`Lawrence, Stephen M. et al. 2002. Long-Term Biocompatibility of
`Implanted Polymer-Based Intrafascicular Electrodes. Journal of Bio
`medical Materials Research. 63 (5): 501-506.
`Lee, In-Seopetal. 2002. Characterization of Iridium Film as a Stimu
`lating Neural Electrode. Biomaterials. 23 (11):2375-2380.
`Lew, Henry L. etal. 2004. Preganglionic Approach to Transforaminal
`Epidural Steroid Injections. Am. J. Phys. Med. Rehabil. 83 (5): 378.
`Maher, C.O. et al. 1999. Lateral Exit-Zone Stenosis and Lumbar
`Radiculopathy. J Neurosurg.90 (1): 52-8. (Abstract Only).
`Mailley, Sophie et al. 2004. Thin Film Platinum Cuff Electrodes for
`Neurostimulation: In Vitro Approach of Safe Neurostimulation
`Parameters. Bioelectrochemistry, 63: 359-364.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1034, p. 4
`
`
`
`US 8,712,546 B2
`Page 5
`
`(56)
`
`References Cited
`
`OTHER PUBLICATIONS
`
`Masini, Michelle et al. 1996. Activated Pyrolytic Carbon Tip Pacing
`Leads: An Alternative to Steroid-Eluting Pacing Leads? PACE. 1:
`1832-1835.
`Medtronic, Inc. Equity Research dated Dec. 18, 2002 by Pacific
`Growth Equities pp. 1-20.
`Medtronic. Analysis of Sales/Eamings-F1Q05: Many Gives and
`Takes in the Quarter dated Aug. 20, 2004 by Morgan Stanley pp. 1-25.
`Methods of Placement of Neurostimulation Lead, Infusion, Catheter,
`and/or Sensor Via Peripheral Vasculature. From IP.com
`Prior ArtDatabase–Apr. 10, 2003 #0000 12136 http://www.
`priorartdatabase.com/IPCOM/0000 12136.
`Mond, Harry G. et al. 2004. Implantable Transveno Pacing Leads:
`The Shape of Things to Come. PACE. 27: 887-893.
`Monti, Enrico. 2004. Peripheral Nerve Stimulation: A Percutaneo
`Minimally Invasive Approach. Neuromodulation. 7 (3): 193.
`(Abstract Only).
`Naples, Gregory G. 1988. A Spiral Nerve Cuff Electrode for Periph
`eral Nerve Stimulation. IEEE Transactions on Biomedical Engineer
`ing. 35 (11):905-916.
`Narozny, Martin et al. 2001. Therapeutic Efficacy of Selective Nerve
`Root Blocks in the Treatment of Lumbar Radicular Leg Pain. Swiss
`Med Wkly. 131 (5-6): 75-80.
`Nashold, Blaine S. et al. 1979. Peripheral Nerve Stimulation for Pain
`Relief Using a Multicontact Electrode System. Technical note. Jour
`nal of Neurosurgery. 51 (6): 872-873.
`Nashold, Blaine S. et al. 1982. Long-Term Pain Control by Direct
`Peripheral-Nerve Stimulation. The Journal of Bone and Joint Sur
`gery. 64 (1): 1-10.
`Neumann, Simona et al. 2002. Regeneration of Sensory Axons
`Within the Injured Spinal Cord Induced by Intraganglionic cAMP
`Elevation. Neuron. 34 (6): 885-93.
`Nielson, K.D. etal. 1976. Peripheral Nerve Injury From Implantation
`of Chronic Stimulating Electrodes for Pain Control. Surg Neurol. 5
`(1): 51-3. (Abstract Only).
`North, Richard B. et al. 1991. Dorsal Root Ganglionectomy for
`Failed Back Surgery Syndrome: A 5-Year Follow-Up Study. J
`Neurosurg, 74: 236-242.
`North, Richard B. et al. 2000. Chapter 123: Current Concepts in the
`Neurosurgical Management of Persistent Pain (pp. 1634-1637).
`Operative Neurosurgical Techniques 4th Edition (Henry H.
`Schmidek et al. eds.). Philadelphia: W.B. Saunders Company.
`Nygaard, Oystein P. et al. 1998. The Function of Sensory Nerve
`Fibers in Lumbar Radiculopathy: Use of Quantitative Sensory Test
`ing in the Exploration of Different Populations of Nerve Fibers and
`Dermatomes. Spine. 23 (3): 348-352.
`Obata, K. et al. 2004. Activation of Extracellular Signal-Regulated
`Protein Kinase in the Dorsal Root Ganglion Following Inflammation
`Near the Nerve Cell Body. Neuroscience. 126 (4): 1011-1021.
`Obata, Koichi, et al. 2002. Expression of Neurotrophic Factors in the
`Dorsal Root Ganglion in a Rat Model of Lumbar Disc Herniation.
`Pain. 99 (1-2): 121-132.
`Olby, Natasha J. et al. 2001. Development of a Functional Scoring
`System in Dogs With Acute Spinal Cord Injuries. Am J Vet Res.62
`(10): 1624-1628.
`Parlier-Cuau, Caroline et al. 1999. Symptomatic Lumbar Facet Joint
`Synovial Cysts: Clinical Assessment of Facet Joint Steroid Injection
`After 1 and 6 Months and Long-Term Follow-Up in 30 Patients.
`Radiology. 210 (2): 509-513.
`Pedrolli, C. et al. 1990. Dorsolumbar Arachnoid Cysts. A Case
`Report. Recenti Prog Med. 81 (11): 699-701. (Abstract Only).
`Rodriguez, Francisco J. et al. 2000. Polyimide Cuff Electrodes for
`Peripheral Nerve Stimulation. Journal of Neuroscience Methods. 98
`(2): 105-118.
`Rokugo, Tomoyuki et al. 2002. A Histochemical Study of Substance
`P in the Rat Spinal Cord: Effect of Transcutaneo Electrical Nerve
`Stimulation.J Nippon Med Sch. 69 (5): 428-433.
`Romero, E. etal. 2001. Neural Morphological Effects of Long-Term
`Implantation of the Self-Sizing Spiral CuffNerve Electrode. Medical
`& Biological Engineering & Computing. 39 (1): 90-100.
`
`Rongstad, K. et al. 1996. Popliteal Sciatic Nerve Block for Postop
`erative Analgesia. Foot Ankle Int. 17 (7): 378-82. (Abstract Only).
`Ruetten, S. et al. 2003. Endoscopic Surgery of the Lumbar Epidural
`Space (Epiduroscopy): Results of Therapeutic Intervention in 93
`Patients. Minim Invasive Neurosurg, 46 (1): 1-4. (Abstract Only).
`Sairyo, K. etal. 2003. A New Endoscopic Technique to Decompress
`Lumbar Nerve Roots Affected by Spondylolysis. Technical Note. J
`Neurosurg.98 (3): 290-3. (Abstract Only).
`Salame, K. et al. 2003. Surgical Treatment of Spasticity by Selective
`Posterior Rhizotomy 30 Years Experience. Isr Med Assoc J. 5 (8):
`543-6. (Abstract Only).
`Saris, S.C. etal. 1986. Sacrococcygeal Rhizotomy for Perineal Pain.
`Neurosurgery. 19 (5): 789-93. (Abstract Only).
`Sauvage, P.J. et al. 2000. Intraspinal Synovial Cysts of the Lumbar
`Spine: Imaging Findings and Treatment by Percutaneo Steroid Injec
`tion. Review of 13 Cases. Kystes Synoviaux Intraspinaux
`Lombaires: Imagerie et Traitement Par Infiltration. A Propos De.
`Schwartzman, Robert J. et al. 2001. Neuropathic Central Pain: Epi
`demiology, Etiology, and Treatment Options. Arch Neurol. 58 (10):
`1547-1550.
`Sedan, R. et al. 1978. Therapeutic Electrical Neurostimulation.
`French Language Society of NeuroSurgery 28th Annual Con
`gress—Athens, May 29-30, 1978. Neurochirurgie. 24: 3-& Suppl. 1
`(in French with English Summary pp. 121-125.
`Sheth, Rishi N. et al. 2002. Mechanical Hyperalgesia. After an L5
`Ventral Rhizotomy or an L5 Ganglionectomy in the Rat. Pain. 96:
`63-72.
`Siddall, Philip J. et al. 2004. Persistent Pain as a Disease Entity:
`Implications for Clinical Management. Anesth Analg.99: 510-20.
`Silvers, H.R. 1990. Lumbar Percutaneo Facet Rhizotomy. Spine. 15
`(1): 36-40. (Abstract Only).
`Slappendel, R. etal. 1997. The efficacy of Radiofrequency Lesioning
`of the Cervical Spinal Dorsal Root Ganglion in a Double Blinded
`Randomized Study: No difference Between 40 Degrees C and 67
`Degrees C Treatments. Pain. 73 (2): 159-63. (Abstract Only).
`Sluijter, Menno E. etal. 1998. The Effects of Pulsed Radiofrequency
`Fields Applied to the Dorsal Root Ganglion—A Preliminary Report.
`The Pain Clinic. 11 (2): 109-117.
`Smith, H.P. et al. 1981. Radiofrequency Neurolysis in a Clinical
`Model: Neuropathological Correlation. J Neurosurg, 55(2): 246-53.
`(Abstract Only).
`Spaic, M. etal. 1999. Drez Surgery on Con Medullaris (After Failed
`Implantation of Vascular Omental Graft) for Treating Chronic Pain
`Due to Spine (Gunshot) Injuries. Acta Neurochir(Wein). 141 (12):
`1309-1312.
`Spaic, M. et al. 2002. MicroSurgical DREZotomy for Pain of Spinal
`Cord and Cauda Equina Injury Origin: Clinical Characteristics of
`Pain and Implications for Surgery in a Series of 26 Patients. Acta
`Neurochir (Wien). 144(5): 453-462.
`Stanton-Hicks, M. etal. 1997. Stimulation of the Central and Periph
`eral Nervo System for the Control of Pain. Journal of Clinical
`Neurophysiology. 14 (1): 46-62.
`Steinbok, P. et al. 1998. Complications After Selective Posterior
`Rhizotomy for Spasticity in Children With Cerebral Palsy. Pediatr
`Neurosurg. 28 (6): 300-13. (Abstract Only).
`Stolker, Robert J. et al. 1994. The Treatment of Chronic Thoracic
`Segmental Pain by Radiofrequency Percutaneo Partial Rhizotomy. J
`Neurosurg. 80: 986-992.
`Strait, T.A. et al. 1981. Intraspinal Extradural Sensory Rhizotomy in
`Patients With Failure of Lumbar Disc Surgery. J NeuroSurg. 54 (2):
`193-6. (Abstract Only).
`Taha, J.M. et al. 1995. Long-Term Results of Radiofrequency
`Rhizotomy in the Treatment of Cluster Headache. Headache. 35 (4):
`193-6. (Abstract Only).
`Taub, Arthur et al. 1995. Dorsal Root Ganglionectomy for Intractable
`Monoradicular Sciatica: A Series of 61 Patients. Stereotact Funct
`Neurosurg. 65 (1-4): 106-110.
`Percutaneo
`106:
`Chapter
`Uematsu,
`Sumio.
`1988.
`Electrothermocoagulation of Spinal Nerve Trunk, Ganglion, and
`Rootlets(pp. 1207-1221). Operative Neurosurgical Techniques, Indi
`cations, Methods and Results 2nd edition. (Henry H. Schmideketal.
`eds.).
`
`Petitioner - Avation Medical, Inc.
`Ex. 1034, p. 5
`
`
`
`US 8,712,546 B2
`Page 6
`
`(56)
`
`References Cited
`
`OTHER PUBLICATIONS
`
`Van De Kraats, Everine B. et al. 2004. Noninvasive Magnetic Reso
`nance to Three-Dimensional Rotational X-Ray Registration of Ver
`tebral Bodies for Image-Guided Spine Surgery. Spine. 29 (3): 293
`297.
`Van Kleef, M. et al. 1993. Effects and Side Effects of a Percutaneo
`Thermal Lesion of the Dorsal Root Ganglion in Patients with Cervi
`cal Pain Syndrome. Pain. 52(1): 49-53.
`Van Kleef. M. et al. 1996. Radiofrequency Lesion Adjacent to the
`Dorsal Root Ganglion for Cervicobrachial Pain: A Prospective
`Double Blind Randomized Study. Neurosurgery. 38 (6): 1127-31.
`Van Kleef, Maarten et al. 1998. Chapter 160: Radiofrequency
`Lesions in the Treatment of Pain of Spinal Origin (pp. 1585-1599).
`Textbook of Stereotactic and Functional Neurosurgery 1st Edition.
`(Philip L. Gildenberg et al. eds.). New York: McGraw-Hill.
`Vaughan, R. 1975. Percutaneo Radiofrequency Gangliotomy in the
`Treatment of Trigeminal Neuralgia and Other Facial Pain. Aust NZ
`J Surg.