METHODS AND SYSTEMS FOR SCREENING SUBJECTS

• US 20120302909A1
• Filed: 11/11/2010
• Published: 11/29/2012
• Est. Priority Date: 11/11/2009
• Status: Active Application

• Current Assignee: Nuvaira, Inc.
• Original Assignee: Nuvaira, Inc.
• Inventors: Mayse, Martin L., Dimmer, Steven C.
• Application Number:
  US13/509,582
• Publication Number:
  US 20120302909A1
• Time in Patent Office: Days
• US Class Current: 600/532
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance

Abstract

A screening method can be used to determine whether a subject is a suitable candidate for interventional therapy. The method can be used to determine the likelihood the subject will receive a therapeutic effect from denervation therapy. The determination is based, at least in part, on lung information obtained by performing lung function tests with and without treating the subject'"'"'s lungs with a test agent. Based on the response to a test agent, the subject'"'"'s response to a therapy is predicted.

Claims

1. A method of evaluating a subject, comprising:

obtaining a first pulmonary test result for the subject'"'"'s lungs from a first lung function test performed on the subject;

administering a test agent to the subject;

obtaining a second pulmonary test result for the subject'"'"'s lungs treated with the test agent from a second lung function test performed on the subject; and

determining whether the subject'"'"'s respiratory response, if any, to the test agent meets at least one acceptance criterion for denervation therapy based on a comparison of the first pulmonary test result and the second pulmonary test result.

2. The method of claim 1, further comprising:

denervating at least a portion of the subject'"'"'s lungs based on the comparison of the first pulmonary test result and the second pulmonary test result.

3. The method of claim 1, further comprising:

administering the first lung function test on the subject to obtain the first pulmonary test result; and

administering the second lung function test on the subject to obtain the second pulmonary test result after the subject'"'"'s lungs are treated with the test agent.

4. The method of claim 3, wherein administering the first and second lung function tests includes using a spirometer to perform spirometry.

5. The method of claim 1, further comprising categorizing the subject based on the first pulmonary test result and the second pulmonary test result.

6. The method of claim 5, wherein categorization includes identifying the subject for a candidate group for denervation or a non-candidate group for denervation.

7. The method of claim 5, wherein categorization is performed by a computing system that executes a program to determine whether the subject'"'"'s respiratory response, if any, to the test agent meets at least one acceptance criterion for denervation therapy based on the comparison of the first pulmonary test result and the second pulmonary test result.

8. The method of claim 1, further comprising comparing at least one baseline lung function measurement of the first pulmonary test result to at least one lung function measurement of the second pulmonary test result.

9. The method of claim 1, further comprising:

obtaining a bronchial challenge test result from a bronchial challenge test performed on the subject; and

wherein the determination is based, at least in part, on the bronchial challenge test result.

10. The method of claim 1, further comprising determining a lung denervation protocol based on the first and second pulmonary test results.

11. The method of claim 1, further comprising applying the first lung function test to measure at least one of forced expiratory volume in 1 second for the subject, forced vital capacity for the subject, and total lung capacity for the subject.

12. The method of claim 11, further comprising allowing the subject to inhale the test agent before performing the second lung function test such that the subject'"'"'s lungs are effected by the test agent.

13. The method of claim 11, wherein at least one of the first and second lung function tests includes measuring forced expiratory volume in 1 second, forced vital capacity, total lung capacity, or airway resistance of the subject.

14. The method of claim 1, further comprising denervating an airway based at least in part on a difference between the first pulmonary test result and the second pulmonary test result.

15. A method of evaluating a subject, comprising:

applying a first lung function test on the subject to obtain first information;

applying a second lung function test on the subject to obtain second information after administering an anticholinergic agent to the subject; and

comparing the first information and the second information to determine whether the subject'"'"'s lung function increases to a threshold level corresponding to lung denervation therapy in response to the anticholinergic agent.

16. The method of claim 15, further comprising denervating at least a portion of a lung if the subject'"'"'s lung function increases to the threshold level in response to the anticholinergic agent.

17. The method of claim 15, wherein the threshold level includes at least one of a desired threshold forced expiratory volume in 1 second for the subject, a desired threshold forced vital capacity for the subject, and a desired threshold total lung capacity for the subject.

18. A method, comprising:

evaluating a subject'"'"'s lung function utilizing a bronchial challenge test;

evaluating the subject'"'"'s respiratory system that has been treated with a therapeutic agent using a lung function test; and

comparing test information from the bronchial challenge test and test information from the lung function test to determine whether the subject'"'"'s lung function increases to a threshold level corresponding to a lung denervation therapy in response to the therapeutic agent.

19. The method of claim 18, further comprising electrical stimulating of the vagus nerve for the bronchial challenge test.

20. The method of claim 18, further comprising performing a surgical procedure on the subject'"'"'s bronchial tree or at least one of the subject'"'"'s lungs based, at least in part, on the comparison.

21. The method of claim 18, wherein the threshold level is a pre-determined increase of at least one of forced expiratory volume in one second, force vital capacity, total lung capacity, and airway resistance.

22. The method of claim 18, further comprising administering the therapeutic agent which comprises a bronchodilator.

23. A system for evaluating a subject, comprising:

a storage device including first test results corresponding to a first lung function test performed on the subject and second test results corresponding to a second lung function test performed on the subject; and

a computing system configured to compare the stored first test results and the stored second test results and configured to categorize the subject based on the comparison and/or generate a denervation treatment protocol.

24. The system of claim 23, further comprising a spirometer for obtaining the first and second test results, the spirometer is in communication with the computing system.

25. The system of claim 23, wherein the computing system has circuitry configured to generate the denervation treatment protocol based on the comparison of the stored first test results and the stored second test results.