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|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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  • Appendix - Preparation of Solutions

    Appendix - Preparation of Solutions

    Appendix - Preparation of Solutions PREPARATION OF NEUROLYTIC SOLUTIONS - PHENOL (HYDROXYBENZENE) At 20 0 e one part phenol dissolves in 12 parts of water. Accordingly, phenol may be prepared in aqueous solution only in lower con­ centrations. If a stronger preparation is required a water-glycerin mixture is used as the solvent. Product: phenol injection 5% in glycerin Formula: phenol crystals 5 g glycerin (previously dried at 120 0 e and cooled) to 100 g Method o/preparation: Dissolve the phenol in glycerin with the aid of gentle heat. Whilst still warm pass through a No.3 sintered glass filter. Packaging: Pack in 2 ml or 5 ml ampoules. Protect from light. Store in a cool place. Sterilization: Dry heat at 1500 e for 1 h. Stability: 1 year from date of manufacture. 185 186 Appendix Product: aqueous phenol 5% phenol injection 7% Formula: phenol crystals 5 g phenol crystals 7 g water for injections glycerin 50% v/v in water for injec­ to 100ml tions to 100 ml Method of preparation: Pass through sintered glass filter, pack in ampoules and sterilize by autoclaving at U5°e for 30 min. Packaging: 2 ml or 5 ml ampoules. Protect from light. Store in a cool place. Precautions: Avoid prolonged contact with rubber or plastics. Stability: 1 year from date of sterilization. INJECTION ABSOLUTE ALCOHOL Method ofpreparation: In order to avoid absorption of moisture, the infiltration procedure is best carried out under positive pressure, using solvent inert membrane filters. The preparation is then packed in 2 ml or 5 ml ampoules. Sterilization: Autoclave at 155°e for 30 min.
  • Antipsychotics for Treatment of Delirium in Hospitalised Non-ICU Patients

    Antipsychotics for Treatment of Delirium in Hospitalised Non-ICU Patients

    This is a repository copy of Antipsychotics for treatment of delirium in hospitalised non-ICU patients. White Rose Research Online URL for this paper: https://eprints.whiterose.ac.uk/132847/ Version: Published Version Article: Burry, Lisa, Mehta, S.R., Perreault, M.M et al. (6 more authors) (2018) Antipsychotics for treatment of delirium in hospitalised non-ICU patients. Cochrane Database of Systematic Reviews. CD005594. ISSN 1469-493X https://doi.org/10.1002/14651858.CD005594.pub3 Reuse Items deposited in White Rose Research Online are protected by copyright, with all rights reserved unless indicated otherwise. They may be downloaded and/or printed for private study, or other acts as permitted by national copyright laws. The publisher or other rights holders may allow further reproduction and re-use of the full text version. This is indicated by the licence information on the White Rose Research Online record for the item. Takedown If you consider content in White Rose Research Online to be in breach of UK law, please notify us by emailing [email protected] including the URL of the record and the reason for the withdrawal request. [email protected] https://eprints.whiterose.ac.uk/ Cochrane Database of Systematic Reviews Antipsychotics for treatment of delirium in hospitalised non- ICU patients (Review) Burry L, Mehta S, Perreault MM, Luxenberg JS, Siddiqi N, Hutton B, Fergusson DA, Bell C, Rose L Burry L, Mehta S, Perreault MM, Luxenberg JS, Siddiqi N, Hutton B, Fergusson DA, Bell C, Rose L. Antipsychotics for treatment of delirium in hospitalised non-ICU patients. Cochrane Database of Systematic Reviews 2018, Issue 6.