Apparatus and methods for assisting breathing

• US 9,956,132 B2
• Filed: 03/17/2017
• Issued: 05/01/2018
• Est. Priority Date: 01/25/2011
• Status: Active Grant

• Current Assignee: Apellis Holdings, LLC
• Original Assignee: Apellis Holdings, LLC
• Inventors: Francois, Cedric, McLachlan, Angus
• Primary Examiner(s): MAHMOOD, NADIA AHMAD
• Application Number:
  US15/461,882
• Publication Number:
  US 20170209334A1
• Time in Patent Office: 410 Days
• Field of Search: 607 42, 607 48
• CPC Class Codes: A61B 5/0806 by whole-body plethysmography measuring blood flow using plethysmography A61B5/0295; impedance plethysmography A61B5/053; measuring volume of the body or parts thereof A61B5/1073
• CPC Class Codes: A61B 5/1135 by monitoring thoracic expansion
• CPC Class Codes: A61B 5/6804 Garments; Clothes
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61H 2011/005 with belt or strap expanding and contracting around an encircled body part
• CPC Class Codes: A61H 2201/10 with further special therapeutic means, e.g. electrotherapy, magneto therapy or radiation therapy, chromo therapy, infrared or ultraviolet therapy
• CPC Class Codes: A61H 2201/1619 Thorax
• CPC Class Codes: A61H 2201/165 Wearable interfaces
• CPC Class Codes: A61H 2201/5007 computer controlled
• CPC Class Codes: A61H 2201/5015 using specific interfaces or standards, e.g. USB, serial, parallel
• CPC Class Codes: A61H 2201/5035 Several programs selectable
• CPC Class Codes: A61H 2201/5046 Touch screens
• CPC Class Codes: A61H 2201/5061 Force sensors
• CPC Class Codes: A61H 2201/5082 Temperature sensors
• CPC Class Codes: A61H 2201/5084 Acceleration sensors
• CPC Class Codes: A61H 2205/083 Abdomen
• CPC Class Codes: A61H 2230/065 used as a control parameter for the apparatus
• CPC Class Codes: A61H 2230/208 used as a control parameter for the apparatus
• CPC Class Codes: A61H 2230/305 used as a control parameter for the apparatus A61H2230/045 takes precedence
• CPC Class Codes: A61H 2230/405 used as a control parameter for the apparatus
• CPC Class Codes: A61H 2230/505 : used as a control parameter for the apparatus
• CPC Class Codes: A61H 2230/605 : used as a control parameter for the apparatus
• CPC Class Codes: A61H 2230/625 : used as a control parameter for the apparatus
• CPC Class Codes: A61H 31/00 : Artificial respiration or heart stimulation, e.g. heart massage artificial respiration by treatment with gas or air, e.g. mouth-to-mouth respiration A61M16/00; applying electric currents by contact electrodes for stimulation, e.g. heart pace-makers A61N1/36 ; teaching or training models, demonstration models for medical purposes G09B23/288
• CPC Class Codes: A61H 9/0078 : with intermittent or alternately inflated bladders or cuffs mattresses for preventing bed-sores with alternated pressurized chambers A61G7/05776
• CPC Class Codes: A61N 1/3601 : of respiratory organs
• CPC Class Codes: A61N 1/36014 : External stimulators, e.g. with patch electrodes external pacemakers A61N1/3625
• CPC Class Codes: A61N 1/36031 : using physiological parameters for adjustment
• CPC Class Codes: A61N 1/36034 : specified by the stimulation parameters
• CPC Class Codes: A61N 2/002 : in combination with another treatment

Abstract

The present invention provides, among other things, apparatus and methods of use for treating a subject in need of assistance with breathing. In some embodiments the subject suffers from airflow obstruction. In some embodiments, the subject suffers from chronic obstructive pulmonary disease.

Claims

1. A method of treating a subject comprising:

(a) sensing an onset of the subject'"'"'s expiratory phase of breathing; and

(b) delivering a stimulus to the subject'"'"'s thorax or abdomen during at least part of the expiratory phase of breathing in response to said sensing, said stimulus effective to cause a contraction in the subject'"'"'s abdominal muscle so as to assist the subject with ventilation, with the proviso that a stimulus is not delivered while the subject is inhaling.

2. The method of claim 1, wherein performing the method decreases the subject'"'"'s end expiratory lung volume (EELV) as compared with the subject'"'"'s EELV when unassisted.

3. The method of claim 1, wherein the subject suffers from a disorder that impairs exhalation.

4. The method of claim 1, wherein the subject suffers from chronic obstructive pulmonary disease (COPD).

5. The method of claim 1, wherein the subject has an abnormally high EELV in the absence of the stimulus.

6. The method of claim 1, wherein the subject suffers from dynamic hyperinflation in the absence of the stimulus.

7. The method of claim 1, wherein step (a) comprises detecting respiratory movement of the subject'"'"'s thorax or abdomen using one or more sensors selected from the group consisting of a strain gauge, a respiratory plethysmography sensor, a piezoelectric sensor, a pressure sensor for measuring air flow caused by breathing of the subject, and combinations thereof.

8. The method of claim 1, wherein the sensor is incorporated into an adhesive patch suitable for placement on the subject'"'"'s skin.

9. The method of claim 1, wherein the sensing occurs externally to the subject and the stimulus is delivered externally to the subject.

10. The method of claim 1, wherein the sensor, device, or both are incorporated into a garment or belt.

11. The method of claim 1, wherein the sensor and the device are incorporated into the same garment or belt.

12. The method of claim 1, wherein step (b) comprises delivering electrical stimulation to one or more abdominal muscles.

13. The method of claim 1, wherein step (b) comprises delivering electrical stimulation to one or more lower internal intercostal muscles of the anterior thorax.

14. The method of claim 1, wherein step (b) comprises mechanically compressing the subject'"'"'s abdomen or lower anterior thorax.

15. The method of claim 1, wherein the stimulus is delivered during some but not all respiratory cycles within a session.

16. The method of claim 1, wherein the method comprises analyzing a subject'"'"'s posture, breathing pattern or activity level and adjusting one or more stimulus parameters based at least in part on the analysis.

17. An apparatus comprising:

(a) one or more sensors suitable for detecting when a subject is exhaling; and

(b) a device adapted to deliver a stimulus to the subject'"'"'s thorax or abdomen during at least part of an expiratory phase of the subject'"'"'s breathing in response to a signal generated by said one or more sensors, said stimulus effective to cause a contraction in the subject'"'"'s abdominal muscle, with the proviso that the apparatus does not include a device adapted to deliver a stimulus during inhalation.

18. The apparatus of claim 17, wherein the stimulus is effective to assist the subject with exhalation.

19. The apparatus of claim 17, wherein the stimulus is effective to result in a decrease in the subject'"'"'s EELV as compared with the subject'"'"'s EELV without the stimulus.

20. The apparatus of claim 17, wherein the one or more sensors are selected from a strain gauge, a respiratory inductive plethysmography sensor, a piezoelectric sensor, a pressure sensor for measuring air flow caused by breathing of the subject, and combinations thereof.

21. The apparatus of claim 17, wherein at least one sensor is incorporated into an adhesive patch suitable for placement on the subject'"'"'s skin.

22. The apparatus of claim 17, wherein the apparatus comprises a controller that analyzes a subject'"'"'s posture, breathing pattern or activity level and adjusts one or more stimulus parameters based at least in part on the analysis.

23. The apparatus of claim 17, wherein the apparatus is capable of operating in two or more modes, wherein at least one mode comprises delivering, in response to signals generated by said sensor, tactile stimuli that are sufficient to be felt by the subject but are not effective to affect expiratory muscle contraction.

24. The apparatus of claim 23, wherein timing of the tactile stimuli is selected so as to prompt the subject to exhale at least a specified volume or for at least a specified time.

25. The apparatus of claim 24, wherein the apparatus comprises a controller that determines an appropriate stimulus, based at least in part on analyzing the subject'"'"'s breathing over one or more preceding breathing cycles.

28. A biofeedback method for training a subject to breathe more effectively, the method comprising:

utilizing the apparatus according to claim 24.

30. The apparatus of claim 17, wherein the stimulus is effective to promote increased abdominal muscle strength in a subject.

31. The apparatus of claim 17, wherein the device comprises an electroactive polymer to mechanical compress the abdomen.

32. The apparatus of claim 17, wherein the apparatus is programmable so that parameters for delivering the stimulus can be customized for a particular subject and stored.

33. The apparatus of claim 17, wherein the apparatus is portable and is capable of being put on and used without assistance.

26. A method of promoting increased abdominal muscle strength in a subject, the method comprising:

(a) sensing when a subject is inhaling; and

(b) stimulating contraction of at least one of the subject'"'"'s expiratory muscles during at least part of the inhalatory phase of breathing in response to said sensing.

27. The method of claim 26, wherein the subject suffers from an obstructive respiratory disorder.

29. The method of claim 26, wherein the subject is intubated or has recently been extubated.

34. An apparatus comprising:

a device connected with a ventilator, wherein the device is adapted to deliver a stimulus to a subject'"'"'s thorax or abdomen during at least part of an expiratory phase of the subject'"'"'s breathing in response to a signal received from the ventilator, wherein the device is adapted to deliver the stimulus for a stimulus duration after onset of exhalation.

36. The method of claim 34, wherein the subject suffers from an obstructive respiratory disorder.

37. The method of claim 34, wherein the subject is intubated or has recently been extubated.

35. A method of promoting increased abdominal muscle strength in a subject, the method comprising:

(a) sensing when a subject is exhaling; and

(b) stimulating contraction of at least one of the subject'"'"'s expiratory muscles during at least part of the expiratory phase of breathing in response to said sensing.