Oxygenation procedures for newborns and devices for use therein

• US 9,649,333 B2
• Filed: 04/08/2014
• Issued: 05/16/2017
• Est. Priority Date: 04/07/2008
• Status: Active Grant

• Current Assignee: UTI Limited Partnership
• Original Assignee: UTI Limited Partnership
• Inventors: Rabi, Yacov
• Primary Examiner(s): Douglas, Steven
• Application Number:
  US14/248,072
• Publication Number:
  US 20140301949A1
• Time in Patent Office: 1,134 Days
• Field of Search: 12820422, 12820423, 12820418, 12820511, 12820524, 12820523, 12820526, 128633, 128634, 12820525
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61M 16/04 Tracheal tubes catheters in general A61M25/00
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/101 using an oxygen concentrator
• CPC Class Codes: A61M 16/12 by mixing different gases
• CPC Class Codes: A61M 16/125 Diluting primary gas with ambient air
• CPC Class Codes: A61M 2202/0007 introduced into the body
• CPC Class Codes: A61M 2202/0208 Oxygen
• CPC Class Codes: A61M 2202/03 Gases in liquid phase, e.g. cryogenic liquids
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/584 having a color code
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/205 partial oxygen pressure (P-O2)
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 15/06 Antiabortive agents; Labour repressants
• CPC Class Codes: A61P 41/00 Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The present disclosure relates to methods and systems for resuscitation of an infant which maintains healthy blood oxygen saturation values in the infant by titration of supplemental oxygen concentrations.

Claims

1. A method of resuscitating a newborn infant comprising:

(a) delivering supplemental oxygen to said newborn infant from an oxygen source at an oxygen concentration of about 90-100%;

(b) monitoring an oxygen saturation value of said newborn infant; and

(c) reducing the concentration of supplemental oxygen being delivered by about 10% to about 20% about every 10 to 20 seconds until said oxygen saturation value reaches approximately 73% to 81% at 1 minute of age.

2. The method of claim 1, wherein said newborn infant is preterm.

3. The method of claim 1, wherein said newborn infant is within about 0-20 minutes of age.

4. The method of claim 1, further comprising providing supplemental oxygen from an oxygen delivery module until said oxygen saturation value reaches approximately 77% to 82% at 2 minutes of age, and then further reducing the concentration of supplemental oxygen.

5. The method of claim 1, further comprising providing supplemental oxygen from an oxygen delivery module until said oxygen saturation value reaches approximately 78% to 87% at 3 minutes of age, and then further reducing the concentration of supplemental oxygen.

6. The method of claim 1, further comprising providing supplemental oxygen from an oxygen delivery module until said oxygen saturation value reaches approximately 79% to 91% at 4 minutes of age, and then further reducing the concentration of supplemental oxygen.

7. The method of claim 1, further comprising providing supplemental oxygen from an oxygen delivery module until said oxygen saturation value reaches approximately 80% to 95% at 5 minutes of age, and then further reducing the concentration of supplemental oxygen.

8. The method of claim 1, further comprising providing supplemental oxygen from an oxygen delivery module until said oxygen saturation value reaches approximately 80% to 93% at 6 minutes of age, and then further reducing the concentration of supplemental oxygen.

9. The method of claim 1, further comprising providing supplemental oxygen from an oxygen delivery module until said oxygen saturation value reaches approximately 82% to 93% at 7 minutes of age, and then further reducing the concentration of supplemental oxygen.

10. The method of claim 1, further comprising providing supplemental oxygen from an oxygen delivery module until said oxygen saturation value reaches approximately 83% to 95% at 8 minutes of age, and then further reducing the concentration of supplemental oxygen.

11. The method of claim 1, further comprising providing supplemental oxygen from an oxygen delivery module until said oxygen saturation value reaches approximately 87% to 95% at 9 minutes of age, and then further reducing the concentration of supplemental oxygen.

12. The method of claim 1, further comprising providing supplemental oxygen from an oxygen delivery module until said oxygen saturation value reaches approximately 91% to 95% at 10 minutes of age, and then further reducing the concentration of supplemental oxygen.

13. The method of claim 1, wherein said oxygen saturation value is monitored by a pulse oximeter.

14. The method of claim 13, wherein said pulse oximeter is placed on a right wrist of said infant.

15. The method of claim 13, wherein said oxygen saturation value is monitored using a two-second averaging time.

16. The method of claim 13, wherein said pulse oximeter uses the maximum sensitivity setting available on the pulse oximeter.

17. The method of claim 1, wherein said supplemental oxygen is delivered by an anaesthesia bag coupled to a face mask or an endotracheal tube.

18. The method of claim 1, wherein said supplemental oxygen is delivered by a mechanical ventilator.

19. The method of claim 1, wherein said supplemental oxygen is delivered by a continuous positive airway pressure system.

20. The method of claim 1, wherein said supplemental oxygen is delivered at an oxygen concentration of at least about 21%.

21. The method of claim 1, wherein said supplemental oxygen is delivered at an oxygen concentration of at least about 29%.

22. The method of claim 1, wherein said supplemental oxygen is delivered at an oxygen concentration of at least about 33%.

23. The method of claim 1, wherein said supplemental oxygen is delivered at an oxygen concentration of at least about 46%.

24. The method of claim 1, wherein said supplemental oxygen is delivered at an oxygen concentration of at least about 63%.

25. The method of claim 1, wherein said oxygen concentration is reduced by about 20%.

26. The method of claim 1, wherein said reducing occurs about every 15 seconds.

27. A system for resuscitation of an infant comprising:

(a) a supplemental oxygen delivery module configured to deliver supplemental oxygen to said infant in accordance with the method of claim 1;

(b) an oxygen monitor for monitoring an oxygen saturation value of said infant;

(c) a display comparing a time-dependent oxygen saturation value of said infant following birth with said desired value;

(d) a warning system to indicate whether said oxygen saturation value disagree with said desired value; and

(e) a control module to adjust concentration of said supplemental oxygen.

28. The system of claim 27, wherein the display comprises a visual graph comprising said desired value with an upper and a lower limit.

29. The system of claim 27, wherein concentration of said supplemental oxygen is adjusted based on the difference between said oxygen saturation values with said desired value.

30. The system of claim 27, wherein at time of birth of said infant, an image of a timer comprised in the display is started, and the oxygen saturation monitor is started to monitor said oxygen saturation value to send to said control module.