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| Oa Tai Ei to Ka Marratu Wa Kitu |OA TAI EI US009855317B2TO KAMARRATU WA KITU (12 ) United States Patent ( 10 ) Patent No. : US 9 , 855 ,317 B2 Bright (45 ) Date of Patent: Jan . 2 , 2018 ( 54 ) SYSTEMS AND METHODS FOR ( 56 ) References Cited SYMPATHETIC CARDIOPULMONARY NEUROMODULATION U . S . PATENT DOCUMENTS 4 ,029 ,793 A 6 / 1977 Adams et al. (71 ) Applicant : Reflex Medical, Inc. , Los Altos Hills , 4 , 582 , 865 A 4 / 1986 Balazs et al. CA (US ) 6 , 545, 067 B1 4 / 2003 Büchner et al. 6 , 746, 464 B1 6 / 2004 Makower 6 , 932, 971 B2 8 / 2005 Bachmann et al. ( 72 ) Inventor: Corinne Bright , Los Altos Hills , CA 6 , 937 , 896 B1 8 / 2005 Kroll (US ) 7 , 928 ,141 B2 4 / 2011 Li 8 , 175 , 711 B2 5 / 2012 Demarais et al . ( 73 ) Assignee : Reflex Medical , Inc ., Los Altos Hills , 8 , 206 , 299 B2 6 / 2012 Foley et al . 8 , 211 , 017 B2 7 / 2012 Foley et al . CA (US ) 8 ,465 , 752 B2 6 / 2013 Seward 8 , 480, 651 B2 7 / 2013 Abuzaina et al . ( * ) Notice : Subject to any disclaimer, the term of this 8 , 708, 995 B2 4 / 2014 Seward et al. patent is extended or adjusted under 35 9 , 011 , 879 B2 4 / 2015 Seward U . S . C . 154 (b ) by 0 days. 9 , 199 ,065 B2 12 /2015 Seward 2002 /0037919 AL 3 / 2002 Hunter 2005 /0228460 A110 / 2005 Levin et al . ( 21 ) Appl. No. : 15 /140 ,254 2005 /0261672 AL 11 /2005 Deem et al . (22 ) Filed : Apr. 27 , 2016 2006 /0280797 Al 12 /2006 Shoichet et al. (Continued ) (65 ) Prior Publication Data US 2016 /0317621 A1 Nov . 3 , 2016 FOREIGN PATENT DOCUMENTS WO WO 2013165714 * 7 /2013 Related U . S . Application Data OTHER PUBLICATIONS (60 ) Provisional application No . 62 / 179, 027 , filed on Apr. Boezaart 2008 " atlas of peripheral nerve blocks and anatomy for 27 , 2015 . orthopaedic anesthesia ” p . 218published by Elsevier health sci (51 ) Int. CI. ences . * A61K 38 /21 ( 2006 .01 ) (Continued ) A61K 45 /06 ( 2006 .01 ) A61K 31 /55 ( 2006 .01 ) A61B 18 / 14 ( 2006 .01 ) Primary Examiner — Adam Weidner A61B 8 /08 ( 2006 .01 ) ( 74 ) Attorney , Agent, or Firm — Knobbe Martens, Olson A61N 5 / 02 ( 2006 . 01 ) & Bear, LLP A61N 7/ 02 ( 2006 .01 ) A61B 90 / 30 ( 2016 . 01 ) A61B 17 /34 ( 2006 .01 ) (57 ) ABSTRACT A61B 8 / 12 ( 2006 . 01 ) A61B 18 / 18 ( 2006 .01 ) Methods, devices and systems are described for decreasing A61K 31/ 4422 ( 2006 .01 ) the activity of the sympathetic nervous innervation to and A61K 31 /475 ( 2006 . 01) from the lungs and the vessels supplying the lungs to treat A61B 18 /00 ( 2006 .01 ) pulmonary medical conditions such as asthma. In one (52 ) U .S . CI. embodiment, the method may involve advancing an intra CPC . .. .. .. A61K 38 /217 ( 2013 .01 ) ; A61B 8 / 12 ( 2013 . 01 ) ; A61B 173403 ( 2013 .01 ) ; A61B vascular instrument to a target location in a blood vessel 18 / 1492 ( 2013 .01 ) ; A61B 18 / 1815 ( 2013 . 01 ) ; within the intercostal vasculature to ablate either or both the A61B 90 / 30 ( 2016 . 02 ) ; A61K 31/ 4422 sympathetic afferent and efferent nerves lying within the ( 2013 .01 ) ; A61K 31/ 475 ( 2013 . 01 ) ; A61K paravertebral gutter including the visceral fibers that travel 31/ 55 (2013 . 01 ) ; A61K 45 / 06 ( 2013 .01 ) ; A61N to the cardiothoracic cavity and abdominopelvic viscera and 5 / 022 ( 2013 .01 ) ; A61N 7 / 02 (2013 .01 ) ; A61B the T1 to T4 / 5 sympathetic chain . In another embodiment , 8 /0808 ( 2013 . 01 ) ; A61B 2017 / 3413 ( 2013 . 01 ) ; an intravascular instrument may be advanced to the bron A61B 2018 / 0022 ( 2013 .01 ) ; A61B 2018 / 00023 ( 2013 .01 ) ; A61B 2018 / 0044 ( 2013 .01 ) ; A61B chial vessels to ablate either or both the sympathetic afferent 2018 / 00434 ( 2013 .01 ) ; A61B 2018 /00577 and efferent nerves in and around the posterior pulmonary ( 2013 .01 ) ; A61B 2018 / 1861 (2013 . 01) ; A61B plexus. In one embodiment the ablative agent is a neurolytic 2018 / 1869 (2013 .01 ) ; A61B 2090 /306 agent delivered in a gel . This approach may be utilized to ( 2016 .02 ) treat other cardiac and pulmonary diseases. (58 ) Field of Classification Search None See application file for complete search history . 18 Claims, 17 Drawing Sheets US 9 ,855 ,317 B2 Page 2 ( 56 ) References Cited Dimitrov - Szokodi, D . , G . Balogh , et al . ( 1957 ) . “ Lung denervation in the therapy of intractable bronchial asthma. " J Thorac Surg 33 ( 2 ) : U . S . PATENT DOCUMENTS 166 - 84 . Downing , S . Evans, and John C . Lee. “ Nervous control of the 2007 /0255379 Al 11/ 2007 Williams et al. 2008 / 0147137 A1 6 / 2008 Cohen et al . pulmonary circulation . ” Annual Review of Physiology 42 . 1 ( 1980 ) : 2011 /0104061 AL 5 / 2011 Seward 199 -210 . 2013 /0035682 AL 2 / 2013 Weil Drott , C . and G . Claes ( 1996 ) . “ Hyperhidrosis treated by 2013 /0204068 Al 8 / 2013 Gnanashanmugam et al. thoracoscopic sympathicotomy. ” Cardiovasc Surg 4 ( 6 ) : 788 - 90 ; 2013 / 0225664 AL 8 / 2013 Horsager et al. discussion 790 - 1 . 2013 /0287698 A 10 / 2013 Seward Dumont, Pascal. " Side effects and complications of surgery for 2013 / 0296646 A1 11 / 2013 Barbut et al . hyperhidrosis . " Thoracic surgery clinics 18 . 2 (2008 ) : 193 - 207 . 2014 /0363382 Al 12 / 2014 Campbell et al . Dun , N . J . , and A . G . Karczmar. “ Evidence for a presynaptic 2014 / 0363498 A1 12 / 2014 Sawhney et al . inhibitory action of 5 - hydroxytryptamine in a mammalian sympa thetic ganglion .” Journal of Pharmacology and Experimental Thera OTHER PUBLICATIONS peutics 217 . 3 ( 1981 ) : 714 -718 . Feinberg , Samuel M . “ Progress in Asthma: Literature for 1934 and Finucane 2017 “ complications of regional anesthesia ” published by 1935 .” Journal of Allergy 7 . 3 ( 1936 ) : 268 - 294 . Springer p . 213 . * Fredman , B . , E . Zohar , et al. (2000 ) . “ Video - assisted transthoracic Abbott , O . A ., W . A . Hopkins, et al. ( 1950 ) . “ Therapeutic status of sympathectomy in the treatment of primary hyperhidrosis : friend or pulmonary autonomic nerve surgery .” J Thorac Surg 20 ( 4 ) : 571 - 83 ; foe ? ” Surg Laparosc Endosc Percutan Tech 10 ( 4 ) : 226 - 9 . passim . Freeman , N . E ., R . H . Smithwick , et al . ( 1934 ). “ Adrenal Secretion Abdi, Salahadin , et al . “ A new and easy technique to block the in Man ." Am . J . Physiol. 107 ( 3 ) : 529 . stellate ganglion . " Pain Physician 7 . 3 (2004 ) : 327 - 332 . Gay , L . N . and W . M . Reinhoff ( 1934 ) . “ Further Observations on the Adar , R . , A . Kurchin , et al. ( 1977 ) . “ Palmar hyperhidrosis and its Treatment of Intractable Bronchial Asthma by Bilateral Resection of surgical treatment: a report of 100 cases ” Ann Surg 186 ( 1 ) : 34 -41 . the Pulmonary Plexus . ” J. Allergy 13 ( 6 ) : 626 -631 . Albers , James, et al. “ Interventions for preventing neuropathy Gossot, D . , H . Kabiri, et al . ( 2001 ) . “ Early complications of thoracic caused by cisplatin and related compounds. " Cochrane Database Syst Rev 1 . 1 ( 2007) . endoscopic sympathectomy: a prospective study of 940 proce Antila , H . , and O . Kirvelä . “ Neurolytic thoracic paravertebral block dures . ” Ann Thorac Surg 71 ( 4 ) : 1116 - 9 . in cancer pain . ” Acta anaesthesiologica scandinavica 42 . 5 ( 1998 ) : Gossot, D ., L . Toledo , et al. ( 1997 ) . “ Thoracoscopic sympathectomy 581 - 585 . for upper limb hyperhidrosis : looking for the right operation .” Ann B Braun Plexus Anaesthesia product guide ( 2014 ) in 10 pages . Thorac Surg 64 ( 4 ) : 975 - 8 . Baumgartner , F . J . ( 2008 ) . “ Surgical approaches and techniques in Haam , Seokjin , et al. “ An anatomical study of the relationship the management of severe hyperrhidrosis .” Thorac Surg Clin 18 ( 2 ) : between the sympathetic trunk and intercostal veins of the third and 167 - 81 . fourth intercostal spaces during thoracoscopy. ” Clinical Anatomy Baumgartner, Fritz J . , et al . “ Thoracoscopic sympathicotomy for 23. 6 ( 2010 ) : 702 -706 . disabling palmar hyperhidrosis: a prospective randomized compari Hayakawa , Kazuhiro , et al. “ Nerve growth factor prevention of son between two levels .” The Annals of thoracic surgery 92 . 6 aged -rat sympathetic neuron injury by cisplatin , vincristine and ( 2011 ) : 2015 - 2019 . taxol - in vitro explant study. ” Neuroscience letters 274 . 2 ( 1999 ): BD PuraMatrix Peptide Hydrogel Brochure ( 2004 ) in 4 pages 103 - 106 . Blades , B . , E . J . Beattie , Jr. , et al. ( 1950 ) . “ The surgical treatment Hsu , C . P . , C . Y . Chen , et al . ( 1998 ). “ Resympathectomy for palmar of intractable asthma ." J Thorac Surg 20 ( 4 ) : 584 - 91 ; passim . and axillary hyperhidrosis . ” Br J Surg 85 ( 11 ) : 1504 - 5 . Carli, Mirjana , et al. “ Tph2 gene deletion enhances amphetamine http : // www . fziomed . com /core - science/ web page last updated Aug . induced hypermotility : effect of 5 -HT restoration and role of striatal 19 , 2016 in 2 pages . noradrenaline release ." Journal of neurochemistry 135 . 4 ( 2015 ) : Huang , B ., et al . “ [ Therapeutic feasibility of percutaneous puncture 674 -685 . and chemical neurolysis of thoracic sympathetic nerve block in Carr, D . and H . Chandler ( 1948 ) . “ Dorsal sympathetic palmar hyperhidrosis under the guidance of computed tomograph ]. " ganglionectomy for intractable asthma. ” J Thorac Surg 17 ( 1 ) : 1 - 12 . Zhonghua yi xue za zhi 91. 38 ( 2011 ) : 2710 - 2713 . Chaibundit , Chiraphon , et al . “ Effect of ethanol on the gelation of Imrich , Richard , et al. “ Functional effects of cardiac sympathetic aqueous solutions of Pluronic F127 . " Journal of colloid and inter denervation in neurogenic orthostatic hypotension .” Parkinsonism face science 351. 1 (2010 ) : 190 - 196 . & related disorders 15 . 2 ( 2009 ) : 122 - 127 . Chaibundit , Chiraphon , et al. “ Effect of Ethanol on the Micellization International Search Report and Written Opinion dated Jul. 14 , 2016 and Gelation of Pluronic P123. ” Langmuir 24 .21 (2008 ) : 12260 in 7 pages for PCT Application No . PCT/ US2016 /029576 . 12266 . Ireland , S . J . , and C . C . Jordan . “ Pharmacological characterization Chang, Jason Y ., Kevin D . Phelan , and Janet A . Chavis . of 5 - hydroxytryptamine - induced hyperpolarization of the rat supe “ Neurotoxicity of 25 -OH - cholesterol on sympathetic neurons ." rior cervical ganglion .” British journal of pharmacology 92 . 2 Brain research bulletin 45 . 6 ( 1998 ) : 615 - 622 . ( 1987 ) : 417 - 427 . Cheema, S . , J . Richardson , and P .
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