APPARATUS AND METHOD FOR TREATING PULMONARY CONDITIONS

• US 20080306570A1
• Filed: 05/30/2008
• Published: 12/11/2008
• Est. Priority Date: 05/30/2007
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Rezai, Ali R., Deogaonkar, Milind
• Granted Patent: US 8,983,609 B2
• Time in Patent Office: Days
• US Class Current: 607/42
• CPC Class Codes: A61N 1/0519 Endotracheal electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/3611 Respiration control stimulating respiratory organs A61N1/3601
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

An apparatus for positioning at a target site and for treating a pulmonary condition in a subject includes a fluid exchange catheter for insertion into a tracheo-bronchial tree and an inflatable balloon coupled to the fluid exchange catheter. At least a portion of the inflatable balloon is for engaging a luminal wall of the tracheo-bronchial tree at the target site. The apparatus further includes an energy delivery mechanism operably coupled to the inflatable balloon. The energy delivery mechanism includes at least one energy delivery member for delivering electrical energy to the target site.

Claims

1. An apparatus for positioning at a target site and for treating a pulmonary condition in a subject, said apparatus comprising:

a fluid exchange catheter for insertion into a tracheo-bronchial tree;

an inflatable balloon coupled to said fluid exchange catheter, at least a portion of said inflatable balloon for engaging a luminal wall of the tracheo-bronchial tree at the target site; and

an energy delivering mechanism operably coupled to said inflatable balloon, said energy delivery mechanism including at least one energy delivery member for delivering electrical energy to the target site.

2. The apparatus of claim 1, wherein said fluid exchange catheter includes a fluid delivery mechanism for selectively inflating said inflatable balloon.

3. The apparatus of claim 2, wherein said fluid delivery mechanism comprises:

at least one opening disposed on said fluid exchange catheter, said at least one opening extending through a wall of said fluid exchange catheter so that a lumen of said fluid exchange catheter and an interior volume of said inflatable balloon are in fluid communication with one another; and

a fluid delivery line operably coupled to said at least one opening for receiving an expansion medium.

4. The apparatus of claim 1, wherein said at least one energy delivery member comprises an electrode.

5. The apparatus of claim 1, wherein said at least one energy delivery member is electrically connected to an electrical lead having distal and proximal end portions, said electrical lead for conveying electrical energy from an energy delivery source to said at least one energy delivery member.

6. The apparatus of claim 1, wherein said at least one energy delivery member comprises a plurality of electrodes arranged in a geometric pattern on said inflatable balloon.

7. The apparatus of claim 6, wherein said geometric pattern comprises at least one of a linear pattern, a parallel pattern, a sinusoidal pattern, a helical pattern, a radial pattern, or a combination thereof.

8. The apparatus of claim 5, wherein said distal end portion of said electrical lead has a Y-shaped configuration.

9. The apparatus of claim 1 further including at least one therapeutic agent for eluting into the tracheo-bronchial tree of the subject.

10. A method for treating a pulmonary condition in a subject, said method comprising the steps of:

providing an apparatus for positioning at a target site innervated by at least one nerve of the autonomic nervous system (ANS), the apparatus comprising a fluid exchange catheter, an inflatable balloon coupled to the fluid exchange catheter, and an energy delivery mechanism including at least one energy delivery member for delivering electrical energy to the target site;

delivering an expansion medium to the apparatus so that the inflatable balloon is sufficiently inflated to sandwich at least a portion of the at least one energy delivery member between the inflatable balloon and a luminal wall of the tracheo-bronchial tree at the target site; and

delivering electrical energy to the at least one energy delivery member to effect a change in the ANS of the subject.

11. The method of claim 10, wherein the target site comprises an inner surface of the trachea adjacent the carina.

12. The method of claim 10, wherein the at least one nerve is selected from the group consisting of a spinal nerve, a preganglionic fiber of a spinal nerve, a postganglionic fiber of a spinal nerve, a sympathetic chain ganglion, a thoracic sympathetic chain ganglion, a superior cervical ganglion, a cervical ganglion, a lower cervical ganglion, an inferior cervical ganglion, an intramural ganglion, a splanchnic nerve, an esophageal plexus, a cardiac plexus, a pulmonary plexus, an anterior pulmonary plexus, a posterior pulmonary plexus, a celiac plexus, a hypogastric plexus, an inferior mesenteric ganglion, a celiac ganglion, and a superior mesenteric ganglion.

13. The method of claim 10, wherein delivery of electrical energy to the at least one energy delivery member effects a change in the parasympathetic nervous system (PNS) of the subject.

14. The method of claim 10, wherein delivery of electrical energy to the at least one energy delivery member effects a change in the sympathetic nervous system (SNS) of the subject.

15. The method of claim 10, wherein delivery of electrical energy to the anterior pulmonary plexus effects a change in the SNS.

16. The method of claim 10, wherein delivery of electrical energy to the posterior pulmonary plexus effects a change in the PNS.

17. The method of claim 10, wherein delivery of electrical energy to the anterior pulmonary plexus effects a change in both the SNS and the PNS.

18. The method of claim 10, wherein delivery of electrical energy to the posterior pulmonary plexus effects a change in both the SNS and the PNS.

19. The method of claim 10, wherein the pulmonary condition is selected from the group consisting of genetic conditions, acquired conditions, primary conditions, secondary conditions, asthma, chronic obstructive pulmonary disease, cystic fibrosis, bronchiolitis, pneumonia, bronchitis, emphysema, adult respiratory distress syndrome, allergies, lung cancer, small cell lung cancer, primary lung cancer, metastatic lung cancer, brochiectasis, bronchopulmonary dysplasia, chronic bronchitis, chronic lower respiratory diseases, croup, high altitude pulmonary edema, pulmonary fibrosis, interstitial lung disease, reactive airway disease, lymphangioleiomyomatosis, neonatal respiratory distress syndrome, parainfluenza, pleural effusion, pleurisy, pneumothorax, primary pulmonary hypertension, psittacosis, pulmonary edema secondary to various causes, pulmonary embolism, pulmonary hypertension secondary to various causes, respiratory failure secondary to various causes, sleep apnea, sarcoidosis, smoking, stridor, acute respiratory distress syndrome, infectious diseases, SARS, tuberculosis, psittacosis infection, Q fever, parainfluenza, respiratory syncytial virus, combinations thereof, and conditions caused by any one or combination of the above.