Apparatus and method for treating pulmonary conditions

• US 8,989,862 B2
• Filed: 08/16/2011
• Issued: 03/24/2015
• 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
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US13/210,613
• Publication Number:
  US 20110301679A1
• Time in Patent Office: 1,316 Days
• Field of Search: 607/42
• 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

A method for treating a pulmonary condition in a subject is provided. One step of the method includes providing an apparatus for positioning at a target site innervated by at least one nerve of the autonomic nervous system (ANS). The apparatus includes 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. Next, an expansion medium is delivered 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. Electrical energy is then delivered to the at least one energy delivery member to effect a change in the ANS of the subject.

Claims

1. A method for treating asthma in a subject, said method comprising the steps of:

providing an apparatus for positioning at a target site innervated by the pulmonary plexus, the apparatus comprising a fluid exchange catheter, an inflatable balloon coupled to the fluid exchange catheter, and an energy delivery mechanism including a plurality of energy delivery members 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 plurality of energy delivery members between the inflatable balloon and a luminal wall of the tracheo-bronchial tree at the target site; and

delivering electrical energy to the plurality of energy delivery members to stimulate the pulmonary plexus and effect a change in the autonomic nervous system (ANS) of the subject and thereby treat the asthma;

wherein the plurality of energy delivery members is arranged on the inflatable balloon to facilitate focal delivery of the electrical energy to only the pulmonary plexus.

2. The method of claim 1, wherein the target site comprises an inner surface of the trachea adjacent the carina.

3. The method of claim 1, 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.

4. The method of claim 1, 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.

5. The method of claim 1, wherein delivery of electrical energy to an anterior pulmonary plexus effects a change in the SNS.

6. The method of claim 1, wherein delivery of electrical energy to a posterior pulmonary plexus effects a change in the PNS.

7. The method of claim 1, wherein delivery of electrical energy to an anterior pulmonary plexus effects a change in both the SNS and the PNS.

8. The method of claim 1, wherein delivery of electrical energy to a posterior pulmonary plexus effects a change in both the SNS and the PNS.

9. The method of claim 1, 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, and respiratory syncytial virus.

10. The method of claim 1, wherein the entire surface of the inflatable balloon is covered with the multiple energy delivery members.

11. The method of claim 1, wherein the electrical energy delivered to the target site is a charge-balanced bipolar waveform.

12. The method of claim 1, wherein said step of delivering electrical energy to the multiple energy delivery members further includes creating a localized electrical cell to provide focal delivery of the electrical energy to the pulmonary plexus.

13. The method of claim 1, wherein the electrical signal has a frequency of about 5 Hz to about 200 Hz.

14. The method of claim 13, wherein the electrical signal has a frequency of about 5 Hz to about 40 Hz.

15. The method of claim 1, wherein the electrical signal has a current of about 50 μ

s to about 2000 μ

s.

16. The method of claim 15, wherein the electrical signal has a current of about 100 μ

s to about 500 μ

s.

17. A method for treating chronic obstructive pulmonary disease (COPD) in a subject, said method comprising the steps of:

providing an apparatus for positioning at a target site innervated by the pulmonary plexus, the apparatus comprising a fluid exchange catheter, an inflatable balloon coupled to the fluid exchange catheter, and an energy delivery mechanism including a plurality of energy delivery members for delivering electrical energy to the pulmonary plexus;

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

delivering electrical energy to the plurality of energy delivery members to stimulate the at least one nerve of the ANS and effect a change in the ANS of the subject and thereby treat the COPD;

wherein the plurality of energy delivery members is arranged on the inflatable balloon to facilitate focal delivery of the electrical energy to only the pulmonary plexus.

18. A method for treating adult respiratory distress syndrome (ARDS) in a subject, said method comprising the steps of:

providing an apparatus for positioning at a target site innervated by the pulmonary plexus, the apparatus comprising a fluid exchange catheter, an inflatable balloon coupled to the fluid exchange catheter, and an energy delivery mechanism including a plurality of energy delivery members 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 plurality of energy delivery members between the inflatable balloon and a luminal wall of the tracheo-bronchial tree at the target site; and

delivering electrical energy to the plurality of energy delivery members to stimulate the pulmonary plexus and effect a change in the ANS of the subject and thereby treat the ARDS;

wherein the plurality of energy delivery members is arranged on the inflatable balloon to facilitate focal delivery of the electrical energy to only the pulmonary plexus.