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. 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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.