Methods, Devices and Systems for the Prevention of Sudden Infant Death Syndrome (SIDS) and the Diagnosis and Treatment of Infants Predisposed to SIDS

• US 20090024043A1
• Filed: 07/15/2008
• Published: 01/22/2009
• Est. Priority Date: 07/17/2007
• Status: Active Grant

• Current Assignee: Ainslie Macleod, Daniel David Rubens
• Original Assignee: Ainslie Macleod, Daniel David Rubens
• Inventors: MacLeod, Ainslie, Rubens, Daniel David
• Granted Patent: US 8,257,268 B2
• Time in Patent Office: Days
• US Class Current: 600/504
• CPC Class Codes: A61B 17/135 inflatable for measuring blood pressure A61B5/022; inflatable pressure pads A61F5/34
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/022 by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
• CPC Class Codes: A61F 2007/0233 connected to or incorporated in clothing or garments A61F2007/023 takes precedence
• CPC Class Codes: A61F 7/02 Compresses or poultices for effecting heating or cooling
• CPC Class Codes: A61F 7/10 Cooling bags, e.g. ice-bags
• CPC Class Codes: A61M 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 16/0666 Nasal cannulas or tubing devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02
• CPC Class Codes: A61M 16/0672 Nasal cannula assemblies for oxygen therapy
• CPC Class Codes: A61M 2205/3606 cooled
• CPC Class Codes: A61M 2230/06 Heartbeat rate only
• CPC Class Codes: A61M 2230/202 partial carbon oxide pressure, e.g. partial dioxide pressure (P-CO2)
• CPC Class Codes: A61M 2240/00 Specially adapted for neonatal use

Abstract

Methods and systems for preventing the underlying anatomical cause that gives rise to a predisposition to SIDS are provided. Methods and systems are provided for the diagnosis of infants predisposed to SIDS. Methods and systems are provided for the therapeutic treatment of infants predisposed to SIDS. A treatment device includes an auditory stimulation system, a monitoring system, a warming system and a response system that can respond to and alleviate crisis situations.

Claims

1. A method for preventing Sudden Infant Death Syndrome (SIDS) in an infant, comprising:

limiting a maximum pressure of blood flow through an umbilical cord connecting a placenta and a newborn infant as soon as the umbilical cord after the infant exits the birth canal during delivery of the infant, said limiting permitting blood flow through the umbilical cord.

2. A method for preventing SIDS according to claim 1, further comprising:

monitoring the pressure of blood flow through the umbilical cord.

3. A method according to claim 1, wherein

said limiting includes attaching a pressure limiting device to the umbilical cord.

4. A method according to claim 3, wherein:

said pressure limited device includes an inflatable cuff.

5. A method according to claim 3, wherein:

said pressure limiting device is attached to the umbilical cord closer to the placenta than to the infant.

6. An apparatus for preventing Sudden Infant Death Syndrome (SIDS) in an infant, comprising:

an inflatable cuff sized to receive and encircle an umbilical cord attached to a newborn human infant, the cuff inflatable to a first inflation pressure that restricts but does not prevent blood flow through the umbilical cord and a second inflation pressure that substantially prevents blood flow through the umbilical cord.

7. An apparatus according to claim 6, wherein:

said inflatable cuff is a plurality of inflatable cuffs.

8. An apparatus according to claim 6, further comprising:

means for monitoring the flow of blood in the umbilical vein prior to cutting the umbilical cord.

9. A method of diagnosing an infant as predisposed with Sudden Infant Death Syndrome (SIDS), comprising:

a) performing at least one of the following on a newborn infant,

i) an elevated blood troponin test within 24 to 48 hours after birth,

ii) a visual evoked potential test within the first hour after the infant'"'"'s umbilical cord cut,

iii) a breath ketone level test,

iv) a clinical inspection for splinter hemorrhage and bleeding spots in the gums, under the fingernails and/or around the umbilicus that indicate high venous pressure during birth,

v) a clinical inspection of broken veins in the inside floor of the eyeball within a one week after birth,

vi) cardiac echogram to indicate cardiac valve injury,

vii) imaging to determine the presence of fluid in the mastoid air cells and, if present, aspirating the fluid to determine whether the fluid is blood; and

.

b) upon the confirmation of one or more of i) to vii), and such confirmation not attributable to any other known cause in the infant, diagnosing the infant as predisposed with SIDS.

10. A method according to claim 9, wherein:

upon confirmation of a plurality of i) to vii), with such confirmation not attributable to any other known cause in the infant, diagnosing the infant as predisposed with SIDS.

11. A method of treating an infant previously diagnosed as predisposed to Sudden Infant Death Syndrome (SIDS), comprising:

a) monitoring the heart rate and CO₂ levels in the infant; and

b) in the event of identifying the heart rate a predetermined level and the CO₂ levels at a predetermined level,

i) delivering oxygen to the lungs of the infant to clear CO₂ from the lungs,

ii) delivering an inhalable dose of epinephrine to enhance heart pumping to remove CO₂ from the lungs, and

iii) cooling a portion of the infant to initiate a gasping reflex.

12. A method according to claim 11, wherein:

said monitoring further includes measuring environmental CO₂ proximate the infant.

13. A method according to claim 11, wherein:

said monitoring further includes monitoring a respiration rate to identify increased respiration in the infant, wherein said response system is activated by an increase in said respiration rate to above a predetermined level.

14. A method according to claim 13, wherein:

said monitoring further includes,

monitoring a core temperature of the infant, and

monitoring a peripheral temperature of the infant, such that the core and peripheral temperatures can be compared.

15. A method according to claim 14, wherein:

said monitoring further monitoring brain oximetry in the infant.

16. A method according to claim 11, further comprising:

during said monitoring, applying an auditory stimulus of a melodic and harmonic arrangement of tones to the infant.

17. A method according to claim 14, further comprising:

during said monitoring, warming the infant to a constant body temperature.

18. A method according to claim 11, further comprising:

during said monitoring, warming the infant to a constant body temperature.

19. A treatment system for treating an infant previously diagnosed as predisposed to Sudden Infant Death Syndrome (SIDS), comprising:

a) an auditory stimulation system that reproduces a melodic and harmonic arrangement of tones through at least one sound transducer to stimulate the auditory system of the infant;

b) a monitoring system including,

i) a heart rate monitor that monitors a heart rate of the infant, and

ii) a first CO₂ monitor that measures a blood CO₂ of the infant;

c) a warming system that maintains a body of the infant at a substantially constant core temperature; and

d) a response system activated when the monitoring system indicates that there is a decrease in the heart rate and an increase in the blood CO₂, the response system including,

i) an oxygen delivery system to deliver inhalable oxygen to the infant,

ii) an epinephrine delivery system to deliver inhalable epinephrine to the infant, and

iii) a cooling system to cool a portion of the infant to initiate a gasping reflex.

20. A treatment system according to claim 19, wherein:

said at least one sound transducer of said auditory system includes a pair of earphones that are couplable directly to the ears of the infant.

21. A treatment system according to claim 19, wherein:

said auditory stimulation system is automatically activated to reproduce said tones upon signal from said monitoring system.

22. A treatment system according to claim 19, wherein:

said monitoring system further includes a second CO₂ monitor that measures environmental CO₂ proximate the infant.

23. A treatment system according to claim 19, wherein:

said monitoring system further includes a respiration rate monitor that identifies increased respiration of the infant, said response system activated by an increase in respiration rate to above a predetermined level.

24. A treatment system according to claim 19, wherein:

said monitoring system further includes a core temperature monitor to measure the core temperature of the infant,

a peripheral temperature monitor to measure the peripheral temperature of the infant, such that the core and peripheral temperatures can be compared relative to each other, and

a cerebral oximeter to detect a drop in brain oximetry in the infant.

25. A treatment system according to claim 19, wherein:

said warming system includes an enclosure through which a warming fluid is circulated.

26. A treatment system according to claim 19, wherein:

said warming system includes an insulated suit that is worn about the body of the infant.

27. A treatment system for treating an infant previously diagnosed as predisposed to Sudden Infant Death Syndrome (SIDS), comprising:

a) a monitoring system including,

i) a heart rate monitor that monitors a heart rate of the infant, and

ii) a first CO₂ monitor that measures a blood CO₂ of the infant; and

b) a response system activated when the monitoring system indicates that there is a decrease in the heart rate and an increase in the blood CO₂, the response system including,

i) an oxygen delivery system to deliver inhalable oxygen to the infant, and

ii) a cooling system to cool a portion of the infant to initiate a gasping reflex.

28. A treatment system according to claim 27, wherein:

said monitoring system further includes a second CO₂ monitor that measures environmental CO₂ proximate the infant.

29. A treatment system according to claim 27, wherein:

said monitoring system further includes a respiration rate monitor that identifies increased respiration of the infant, said response system activated by an increase in respiration rate to above a predetermined level.

30. A treatment system according to claim 27, wherein:

said monitoring system further includes a core temperature monitor to measure the core temperature of the infant,

a peripheral temperature monitor to measure the peripheral temperature of the infant, such that the core and peripheral temperatures can be compared relative to each other, and

a cerebral oximeter to detect a drop in brain oximetry in the infant.

31. A treatment system according to claim 27, wherein:

said response system includes an epinephrine delivery system to deliver inhalable epinephrine to the infant.

32. A stimulation system for an infant predisposed to Sudden Infant Death Syndrome (SIDS), the infant having an auditory system, and the stimulation system for use with a heart rate monitor, comprising:

an auditory stimulation system that, when activated, produces a melodic and harmonic arrangement of tones through at least one sound transducer to stimulate the auditory system of the infant, said auditory stimulation system including an input to receive a signal from the heart rate monitor such that when said auditory stimulation system receives a signal from the heart rate monitor indicating that the infant heart rate has reached a predetermined rate, the auditory stimulation system is automatically activated.

33. A stimulation system according to claim 32, wherein:

said sound transducer is integrated into an earphone, and said monitoring system includes a temperature sensor integrated into said earphone.