Foot pulse oximeter for screening congenital heart disease before newborn discharge

• US 9,763,606 B2
• Filed: 08/23/2011
• Issued: 09/19/2017
• Est. Priority Date: 08/23/2010
• Status: Active Grant

• Current Assignee: Los Angeles Biomedical Research Institute At Harbor-Ucla Medical Center (University of California)
• Original Assignee: Los Angeles Biomedical Research Institute At Harbor-Ucla Medical Center (University of California)
• Inventors: Chang, Ruey-Kang, Pan, Yann Ping
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Liu, Chu Chuan (JJ)
• Application Number:
  US13/216,150
• Publication Number:
  US 20120046532A1
• Time in Patent Office: 2,219 Days
• Field of Search: 600310, 600322, 600323, 600324, 600340, 600344, 600473, 600476, 356 41
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/6829 Foot or ankle

Abstract

A method including placing a portion of a foot of a newborn in a device, the device including a light emitter and a corresponding receiver coupled on opposite sides of the device, the device further including a processor for processing data from the light emitter and receiver; and determining a presence of congenital heart disease. An apparatus including a body including a chamber of a size to accommodate a portion of a newborn'"'"'s foot; at least one light emitter and a corresponding detector coupled on opposite sides of the body, the emitter configured to emit light of a prescribed wavelength into the chamber; and a processor coupled to the body and configured to receive a signal from the at least one detector.

Claims

1. A method for screening for congenital heart disease in newborns, the method comprising:

using a device to screen a newborn for congenital heart disease by placing a portion of a foot of a human newborn toes first in a body with a chamber of the device that accommodates the portion of the newborn'"'"'s foot, the portion of the newborn'"'"'s foot including all five toes and a portion of the forefoot;

detecting, by a plurality of receivers, light from corresponding light emitters that passes through the newborn'"'"'s foot when the portion of the newborn'"'"'s foot is inside the chamber;

receiving, via a signal processor, signals conveying information associated with the light detected by the plurality of receivers;

determining, via the signal processor, a best quality signal based on one or both of a quality or strength of the received signals, whether the best quality signal breached a threshold for a given period of time, and an arterial oxygen saturation of hemoglobin (SpO2) based on the received signals;

wherein the device comprises;

a case formed at least in part by plastic and shaped as a concave tubular body with an open front end and a curved closed second end, wherein the chamber is formed in the case;

a cover disposed within an interior of the body to form a double-layer structure, the cover being shaped to fit within the interior of the body;

a power button disposed on a first portion of the case;

a display disposed on a second portion of the case, wherein the display presents information related to one or more of SpO₂, heart rate , or arterial pulse;

three or more light emitter/receiver pairs, each light emitter/receiver pair including a light emitter and a corresponding receiver disposed on opposite sides of the body such that, when the portion of the newborn'"'"'s foot is inside the chamber, light from the light emitter that passes through the newborn'"'"'s foot is detected by the receiver, the receiver is configured to provide a signal conveying information associated with the detected light;

a first indicator configured to convey one or both of a quality or strength of one or more signals provided by the receivers of the three or more light emitter/receiver pairs; and

a second indicator configured to provide a pass/fail indication for congenital heart disease responsive to (1) the foot being placed in the device and (2) whether the determined best quality signal breached the threshold for the given period of time.

2. The method of claim 1, wherein prior to placing a portion of a newborn'"'"'s foot in the chamber, the method comprises covering an internal surface of the chamber with the cover configured to protect skin on the newborn'"'"'s foot from infection.

3. The method of claim 1, wherein the light emitter/receiver pairs are positioned on the device to detect signals from the dorsalis pedis artery at the first toe of the foot or from the plantar arch artery.

4. The method of claim 1, wherein the display displays SpO2, heart rate and arterial pulse waveforms in response to data produced by the light emitter and the receiver.

5. The method of claim 1, wherein the signal processor comprises an algorithm configured to determine a signal quality to process and display a SpO₂, heart rate and waveform results on the display of the device.

6. The method of claim 1, further comprising indicating on the device a determination of a presence of congenital heart disease.

7. The method of claim 6, wherein determining a presence of congenital heart disease is based on the arterial saturation of hemoglobin (SpO₂).

8. The method of claim 7, further comprising indicating a presence of congenital heart disease when the SpO₂ is equal to or lower than a predetermined threshold.

9. The method of claim 8, wherein the SpO₂ threshold is 94 percent.

10. The method of claim 7, wherein the SpO₂ threshold can be configured by a user.

11. The method of claim 1, wherein the body of the device being made of a cellulose-based plastic.

12. An apparatus configured to screen for congenital heart disease in newborns, the apparatus comprising:

a body comprising a chamber that accommodates a portion of a human newborn'"'"'s foot, the portion of the newborn'"'"'s foot including all five toes and a portion of the forefoot, wherein the body includes a case formed at least in part by plastic and shaped as a concave tubular body with an open front end and a curved closed second end, wherein the chamber is formed in the case;

a cover disposed within an interior of the body to form a double-layer structure, the cover being shaped to fit within the interior of the body;

a power button disposed on a first portion of the case;

a display disposed on a second portion of the case, wherein the display presents information related to one or more of SpO₂, heart rate, or arterial pulse;

three or more light emitter/receiver pairs, each light emitter/receiver pair including a light emitter and a corresponding receiver disposed on opposite sides of the body such that, when the portion of the newborn'"'"'s foot is inside the chamber, light from the light emitter that passes through the newborn'"'"'s foot is detected by the receiver, the receiver is configured to provide a signal conveying information associated with the detected light;

a signal processor configured to receive signals conveying information associated with the detected light, and is configured to determine a best quality signal based on one or both of a quality or strength of the received signals, whether the best quality signal breached a threshold for a given period of time, and an arterial oxygen saturation of hemoglobin (SpO2) based on the received signals;

a first indicator configured to convey one or both of a quality or strength of one or more signals provided by the receivers of the three or more light emitter/receiver pairs; and

a second indicator configured to provide a pass/fail indication for congenital heart disease responsive to (1) the foot being placed in the device and (2) whether the determined best quality signal breached the threshold for the given period of time.

13. The apparatus of claim 12, wherein the light emitter/receiver pairs are positioned on the device to detect signals from the dorsalis pedis artery at the first toe of the foot or from the plantar arch artery.

14. The apparatus of claim 12, wherein the display displays SpO₂, heart rate and arterial pulse waveforms in response to data produced by the light emitter and the receiver.

15. The apparatus of claim 12, wherein the signal processor comprises an algorithm configured to determine a signal quality to process and display at least one of a SpO₂, heart rate and a waveform result on display of the device.

16. The apparatus of claim 14, wherein the signal processor is configured to indicate a presence of congenital heart disease based on data the signal processor processes from the at least one emitter and detector.

17. The apparatus of claim 12, wherein the body of the device being made of a cellulose-based plastic.