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(12) United States Patent (10) Patent No.: US 8,983,609 B2 Rezai Et Al

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(12) United States Patent (10) Patent No.: US 8,983,609 B2 Rezai Et Al USOO898.3609B2 (12) United States Patent (10) Patent No.: US 8,983,609 B2 Rezai et al. (45) Date of Patent: Mar. 17, 2015 (54) APPARATUS AND METHOD FORTREATING (56) References Cited PULMONARY CONDITIONS U.S. PATENT DOCUMENTS (75) Inventors: Ali R. Rezai, Shaker Heights, OH (US); 4,795,465. A 1, 1989 Marten Milind Deogaonkar, Broadview 5,024.228 A 6, 1991 Goldstone et al. Heights, OH (US) 5,125,406 A 6, 1992 Goldstone et al. 5,379,765 A * 1/1995 Kajiwara et al. .............. 600,380 (73) Assignee: The Cleveland Clinic Foundation, 5,584,290 A 12/1996 Brain Cleveland, OH (US) 5,716.377 A 2f1998 Rise et al. (Continued) (*) Notice: Subject to any disclaimer, the term of this patent is extended or adjusted under 35 FOREIGN PATENT DOCUMENTS U.S.C. 154(b) by 1596 days. RU 2 108817 C1 4f1998 (21) Appl. No.: 12/129,734 WO WO 93,01862 A1 2, 1993 OTHER PUBLICATIONS (22) Filed: May 30, 2008 Gromova et al., “Sinusoidal Modulated Currents in Comprehensive (65) Prior Publication Data Treatment of Children with Bronchial Asthma'. Voprosy kurortologii fizioterapii, i lechebnoi fizicheskoi kultury, May-Jun; (3):45-7 US 2008/030657OA1 Dec. 11, 2008 (1981). Related U.S. Application Data (Continued) (63) Continuation-in-part of application No. 12/016,115, Primary Examiner — Eric D. Bertram filed on Jan. 17, 2008. (74) Attorney, Agent, or Firm — Tarolli, Sundheim, Covell (60) Provisional application No. 60/932.248, filed on May & Tummino LLP 30, 2007. (57) ABSTRACT (51) Int. C. An apparatus for positioning at a target site and for treating a A6 IN L/36 (2006.01) pulmonary condition in a subject includes a fluid exchange A61N L/05 (2006.01) catheter for insertion into a tracheo-bronchial tree and an (52) U.S. C. inflatable balloon coupled to the fluid exchange catheter. At CPC ............ A61N I/0553 (2013.01); A61N I/3611 least a portion of the inflatable balloon is for engaging a (2013.01); A61N I/0519 (2013.01); A61N luminal wall of the tracheo-bronchial tree at the target site. I/0556 (2013.01); A61N I/361 14 (2013.01) The apparatus further includes an energy delivery mechanism USPC ............................................................ 6O7/42 operably coupled to the inflatable balloon. The energy deliv (58) Field of Classification Search ery mechanism includes at least one energy delivery member CPC. A61N 1/0517: A61N1/0519; A61N 1/3611 for delivering electrical energy to the target site. USPC .................................................... 607/42, 124 See application file for complete search history. 9 Claims, 7 Drawing Sheets so US 8,983,609 B2 Page 2 (56) References Cited 2004/0249416 A1 12/2004 Yun et al. 2005, 0021092 A1 1/2005 Yun et al. U.S. PATENT DOCUMENTS 2005, 0021102 A1 1/2005 Ignagni et al. 2005/OO967O2 A1 5/2005 Denker et al. 6,058,331 A 5, 2000 King 2005/O137645 A1 6/2005 Voipio et al. 6,104,957 A 8, 2000 Alo et al. 2005/0288728 A1 12/2005 Libbus et al. 6,198.970 B1 3, 2001 Freed et al. 2006/0009798 A1 1/2006 Callister et al. ............... 606,200 6,266,548 B1 T/2001 Lamade et al. 2006, OO58852 A1 3/2006 Koh et al. 6,266,564 B1 T/2001 Hill et al. 2006, O155344 A1 7/2006 Rezai et al. 6,292,695 B1 9, 2001 Webster, Jr. et al. 2006/0224211 A1 10, 2006 Durand et al. 6,411,852 B1 6, 2002 Danek et al. 2006/022.9677 A1 10, 2006 Mofitt et al. 6.425,877 B1 T/2002 Edwards 2006/0247729 A1 11/2006 Tehrani et al. 6,449,507 B1 9, 2002 Hill et al. 2006/0282127 A1 12/2006 Zealear 6,572,543 B1 6, 2003 Christopherson et al. 2006/0282131 A1 12/2006 Caparso et al. 6,610,713 B2 8, 2003 Tracey 2006/0282145 A1 12/2006 Caparso et al. 6,633,779 B1 10, 2003 Schuler et al. 2006, O293720 A1 12/2006 DiLorenzo 6,748,275 B2 6, 2004 Lattner et al. 2007/0021795 A1 1/2007 Tehrani 6,885,888 B2 4, 2005 Rezai 2007/0027496 A1 2/2007 Parnis et al. .................... 607/42 7,027,869 B2 4, 2006 Danek et al. 2007, 0100333 A1 5/2007 Jackson et al. 7,072,720 B2 T/2006 Puskas 2007/0106339 A1 5/2007 Errico et al. 7,198,635 B2 * 4/2007 Danek et al. .............. 607.96 2007, 0118183 A1 5/2007 Gelfand et al. 7,200.445 B1 4, 2007 Dalbec et al. 2007/0156198 A1 7/2007 Rossing et al. 7.277,757 B2 10, 2007 Casavant et al. 2007/0156199 A1 7/2007 Koh et al. 7,340,299 B2 3, 2008 Puskas 2007/0173893 A1 T/2007 Pitts 2002fOO 10495 A1 1, 2002 Freed et al. 2007/0213782 A1 9, 2007 Shaw 2002fOO32468 A1 * 3f2OO2 Hill et al. .................. 6O7.2 2007,0255379 A1 11/2007 Williams et al. 2002/0107553 A1 8, 2002 Hill et al. 2008.0039904 A1 2/2008 Bulkes et al. 2002fO165586 A1 11, 2002 Hill et al. 2003/OOO4549 A1 1, 2003 Hill et al. OTHER PUBLICATIONS 2003/OO45909 A1 3, 2003 Gross et al. 2003/OO74039 A1 4, 2003 Puskas Karashurov et al., “Radio Frequency Electrostimulation of the 2003/0093.128 A1 5/2003 Freed et al. Gangliated Cord of the Sympathetic Nerve in Patients with Bronchial 2003/0100924 A1 5/2003 Foreman et al. Asthma'. Surgery (Khigurgia), 2000, 1:44-46. 2003/O181951 A1 9, 2003 Cates 2003/O181958 A1 9, 2003 Dobak, III Gudovsky et al., “Surgical Treatment of Bronchial Asthma'. Surgery 2003/O181959 A1 9, 2003 Dobak, III (Khigurgia), 2002, 7:14-18. 2004/003O362 A1 2, 2004 Hill et al. Karashurov et al., “Evolution of Surgical Treatment of Bronchial 2004/O153127 A1 8, 2004 Gordon et al. Asthma'. Surgery (Khigurgia), 1999, 11:57-60. 2004/O23O251 A1 11, 2004 Schuler et al. 2004/0243182 A1 12, 2004 Cohen et al. * cited by examiner U.S. Patent Mar. 17, 2015 Sheet 1 of 7 US 8,983,609 B2 U.S. Patent Mar. 17, 2015 Sheet 2 of 7 US 8,983,609 B2 U.S. Patent Mar. 17, 2015 Sheet 3 of 7 US 8,983,609 B2 ~~'; |) U.S. Patent Mar. 17, 2015 Sheet 4 of 7 U.S. Patent Mar. 17, 2015 Sheet 5 Of 7 US 8,983,609 B2 U.S. Patent US 8,983,609 B2 -D 36 U.S. Patent Mar. 17, 2015 Sheet 7 Of 7 US 8,983,609 B2 US 8,983,609 B2 1. 2 APPARATUS AND METHOD FOR TREATING sufficiently inflated to sandwich at least a portion of the at PULMONARY CONDITIONS least one energy delivery member between the inflatable bal loon and a luminal wall of the tracheo-bronchial tree at the RELATED APPLICATIONS target site. Electrical energy is then delivered to the at least one energy delivery member to effect a change in the ANS of This application is a continuation-in-part of U.S. patent the subject. application Ser. No. 12/016,115, filed Jan. 17, 2008. This application also claims priority from U.S. Provisional Patent BRIEF DESCRIPTION OF THE DRAWINGS Application Ser. No. 60/932.248, filed May 30, 2007, and U.S. patent application Ser. No. 1 1/121,006, filed May 4, 10 The foregoing and other features of the present invention 2005. The subject matter of the aforementioned applications will become apparent to those skilled in the art to which the is incorporated herein by reference in their entireties. present invention relates upon reading the following descrip tion with reference to the accompanying drawings, in which: TECHNICAL FIELD FIG. 1A is a perspective view of an apparatus in a collapsed 15 configuration for treating a pulmonary condition constructed The present invention relates to an apparatus and method in accordance with the present invention; for treating pulmonary conditions, and more particularly to an FIG. 1B is a perspective view of the apparatus in FIG. 1A implantable medical device for delivering electric current to a in an expanded configuration; target site and effecting a change in the autonomic nervous FIG. 2A is a schematic illustration showing the major system of a Subject. nerves contributing to the pulmonary plexus: FIG. 2B is a magnified schematic illustration showing a BACKGROUND OF THE INVENTION posterior view of the pulmonary plexus: FIG. 2C is a magnified schematic illustration showing an Diseases and disorders of the pulmonary system are among anterior view of the pulmonary plexus: the leading causes of acute and chronic illness in the world. 25 FIG. 3 is a schematic representation of the tracheo-bron Pulmonary diseases or disorders may be organized into vari chial tree showing the inputs from the thoracic sympathetic ous categories, including, for example, breathing rhythm dis trunk; orders, obstructive diseases, restrictive diseases, infectious FIG. 4 is a schematic view showing the arrangement of the diseases, pulmonary vasculature disorders, pleural cavity dis trachea, esophagus, and aortic arch; orders, and others. Pulmonary dysfunction may involve 30 FIG. 5 is a magnified view of FIG. 2C showing the appa symptoms such as apnea, dyspnea, changes in blood or res ratus of FIG. 1A being inserted into the tracheo-bronchial piratory gases, symptomatic respiratory Sounds, e.g., cough tree; ing, wheezing, respiratory insufficiency, and/or general deg FIG. 6 is a magnified view of FIG. 2C showing the appa radation of pulmonary function, among other symptoms. ratus of FIG. 1A being deployed from a delivery capsule into A variety of methods are currently used to treat pulmonary 35 the tracheo-bronchial tree; and diseases and disorders including, for example, the use of FIG.
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