Ventilatory assist system and methods to improve respiratory function

• US 20080125828A1
• Filed: 03/09/2007
• Published: 05/29/2008
• Est. Priority Date: 03/09/2006
• Status: Active Grant

• Current Assignee: Synapse Biomedical Inc.
• Original Assignee: Synapse Biomedical Inc.
• Inventors: Ignagni, Anthony R., Onders, Raymond P.
• Granted Patent: US 8,676,323 B2
• Time in Patent Office: Days
• US Class Current: 607/42
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/3601 of respiratory organs

Abstract

Systems and methods are provided to improve respiratory function. Systems include an external electrical stimulator coupled to electrodes that stimulates diaphragm contraction and may optionally include a positive pressure mechanical ventilator. The system further includes an electrode suitable for temporary implantation. Electrical stimulation is provided to specific portions of the diaphragm, such as one hemidiaphragm preferentially over another. By preferentially contracting one hemidiaphragm, a specific portion of a lung may be expanded, such as a posterior portion. By the provision of the negative intrathoracic pressure from diaphragm contraction, greater expansion of specific portion of lung is achieved in relationship to air pressure within the lung, thereby improving compliance. Supplementation of stimulated diaphragm contraction with positive pressure driven air flow from a PPMV directs the air flow to specific portions of the lung. Such portion may include a posterior portion of a lung, and may cause a clearing of atelectasis in that portion.

Claims

1. A method of supporting respiration of a patient with a system,

the system comprising an external stimulator and one or more electrodes implanted at one or more sites in the diaphragm, the external stimulator configured to stimulate the one or more electrodes independently,

the method comprising:

initiating a breath, and

stimulating the diaphragm with the one or more electrodes during the breath to increase tidal volume and/or to decrease maximal lung pressure in a lung during the breath, thereby improving respiratory compliance.

2. The method of claim 1 wherein stimulating comprises preferentially stimulating one hemidiaphragm more than another hemidiaphragm.

3. The method of claim 2 wherein preferentially stimulating one hemidiphragm comprises decreasing a level of atelectasis in a portion of the lung ventilated by the hemidiaphragm.

4. The method of claim 1 further comprising implanting the one or more electrodes at a site in the diaphragm.

5. The method of claim 4 wherein the electrodes are implanted in the diaphragm by way of insertion through the abdominal cavity using laparoscopic techniques.

6. The method of claim 4 wherein the electrodes are implanted in the diaphragm by way of insertion through the abdominal cavity using open surgical techniques.

7. The method of claim 4 wherein the electrodes are implanted in the diaphragm by way of insertion through the thoracic cavity using thoracoscopic techniques.

8. The method of claim 4 wherein the electrodes are implanted in the diaphragm by way of insertion through the thoracic cavity using open surgical techniques.

9. The method of claim 4 wherein the electrodes are implanted in the diaphragm by way of insertion using translumenal endoscopic techniques.

10. The method of claim 1 wherein the breath is initiated by the patient as a breath attempt.

11. The method of claim 10 further comprising sensing the initiation of the breath using electromyographic information sensed by the electrodes.

12. The method of claim 10 further comprising sensing the initiation of the breath using any of a flow sensor or a pressure sensor at the airway.

13. The method of claim 10 wherein the stimulating step comprises stimulating the diaphragm to support completing the breath.

14. The method of claim 1 wherein the breath is initiated by the external stimulator.

15. The method of claim 14 wherein the stimulator provides a baseline breathing rate.

16. The method of claim 1 wherein the stimulating step comprises varying the parameters of the stimulatory signals to the electrodes, the parameters including any of pulse rate, pulse frequency, pulse amplitude, pulse duration, or pulse ramping.

17. The method of claim 16 wherein the signal parameters may vary independently among of the one or more electrodes.

18. The method of claim 1 wherein the method improves any of hemodynamics venous return, cardiac output, alveolar ventilation, type 1 muscle fiber condition.

19. The method of claim 1 wherein the method decreases any of atlectasis, third spacing, time required for weaning from the PPMV, length of hospital stay, occurrence of pneumonia.

20. The method of claim 1 wherein the method stimulates the conversion of Type IIb muscle fibers into Type I muscle fibers.

21. The method of claim 1 wherein the patient is at risk for the development of central hypoventilation syndrome (CHS), and wherein the method supports a regular breathing rate during sleep.

22. The method of claim 21 wherein supporting regular breathing rate during sleep increases occurrence of REM sleep.

23. The method of claim 22 wherein increased occurrence of REM sleep contributes to alleviating severity of or preventing development of intensive care unit (ICU) psychosis.

24. The method of claim 1 further comprising weaning from electrostimulatory support of breathing.

25. The method of claim 1 wherein the patient was previously receiving respiratory support from a system comprising a PPMV, the PPMV support having been discontinued.

26. The method of claim 1 wherein the system of the method of claim 1 further comprises a positive pressure mechanical ventilator (PPMV), the method further comprising ventilating the patient with the PPMV.

27. The method of claim 26 wherein the external stimulator and the PPMV are configured such that the external stimulator controls the PPMV, the method further comprising controlling the PPMV.

28. The method of claim 27 wherein controlling the PPMV comprises controlling operational parameters of PPMV, the parameters including any of breath rate, gas volume delivered per breath, or airway pressure behind delivered gas.

29. The method of claim 26 wherein the external stimulator and the PPMV are configured such that the PPMV controls the external stimulator, the method further comprising controlling the external stimulator.

30. The method of claim 29 wherein controlling the external stimulator comprises triggering stimulator output at a time in relationship to the PPMV reaching peak pressure.

31. The method of claim 26 further comprising controlling the PPMV with a constraint of a maximal tidal volume.

32. The method of claim 26 further comprising controlling the PPMV with a constraint of a maximal airway pressure.

33. The method of claim 26 wherein to achieve a given tidal volume, a combination of negative pressure from stimulating the diaphragm and positive pressure from the PPMV allows the level of airway pressure to be lower than it would be absent diaphragm stimulation, such lower pressure reducing risk of barotrauma.

34. A method of treating a patient with an atelectatic lung region with a system,

the system comprising an external stimulator and one or more electrodes implanted at one or more sites in the diaphragm, the external stimulator configured to stimulate the one or more electrodes independently, and a positive pressure mechanical ventilator (PPMV),

the method comprising:

initiating a breath,

ventilating the patient with the PPMV during the breath,

stimulating the diaphragm with the one or more electrodes during the breath to increase tidal volume and/or to decrease maximal lung pressure during the breath,

wherein the one or more electrodes are implanted and/or stimulated so as to preferentially stimulate a specific portion of the diaphragm such that the volume of atelectatic region is expanded, and

clearing the atelectatic region.

35. An electrode suitable for temporary placement in tissue comprising:

a needle at a first end,

a central portion comprising a straight insulated lead, a helically wound insulated lead portion, and a deinsulated coiled portion, and

a deinsulated barb and a stop at a second end.

36. The electrode of claim 35 wherein the stop comprises soft silicone.

37. The electrode of claim 35 wherein the stop comprises an absorbable suture material thermally bonded to the deinsulated coiled portion.

38. The electrode of claim 35 wherein the needle is a break-away needle.

39. The electrode of claim 35 wherein the straight insulated lead and the helically wound insulated lead are joined at a junction, the electrode further comprising a bonding material disposed at the junction to form a bond configured to prevent the helically wound lead from unwinding.

40. A method of inserting an electrode suitable for temporary placement in a tissue site, the electrode comprising a needle at a first end, a central portion comprising a straight insulated lead, a helically wound insulated lead portion, and a deinsulated coiled portion, and a deinsulated barb and a stop at a second end,

the method comprising inserting the electrode into a tissue site surface by the first end comprising the needle, and pulling the electrode through the tissue until the second end comprising the stop is at the tissue site surface.

41. The method of claim 40 wherein the electrode stop comprises soft silicone.

42. The method of claim 40 wherein the electrode stop comprises an absorbable suture material thermally bonded to the deinsulated coiled portion.

43. The method of claim 40 wherein the electrode needle is a break-away needle.

44. The method of claim 40 wherein the electrode'"'"'s straight insulated lead and the helically wound insulated lead are joined at a junction, the electrode further comprising a bonding material disposed at the junction to form a bond configured to prevent the helically wound lead from unwinding.