Handheld cordless non-nutritive suck assessment device

• US 9,974,476 B2
• Filed: 01/21/2014
• Issued: 05/22/2018
• Est. Priority Date: 01/21/2013
• Status: Active Grant

• Current Assignee: Cardinal Health 200 LLC (Cardinal Health, Inc.)
• Original Assignee: Innara Health, Inc.
• Inventors: Aron, Kenneth, Stalling, David L., Kean, John, Ingling, Allen
• Primary Examiner(s): Stout, Michael C
• Assistant Examiner(s): Kolderman, Nicholas E
• Application Number:
  US14/160,254
• Publication Number:
  US 20140207024A1
• Time in Patent Office: 1,582 Days
• Field of Search: 600300, 600301, 600590
• CPC Class Codes: A61B 2503/045 Newborns, e.g. premature baby monitoring
• CPC Class Codes: A61B 2560/0204 of power management
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/4542 Evaluating the mouth, e.g. the jaw
• CPC Class Codes: A61B 5/6803 Head-worn items, e.g. helmets, masks, headphones or goggles
• CPC Class Codes: A61B 5/682 Mouth, e.g., oral cavity; tongue; Lips; Teeth
• CPC Class Codes: A61B 5/6896 Toys
• CPC Class Codes: A61B 5/7225 Details of analog processing, e.g. isolation amplifier, gain or sensitivity adjustment, filtering, baseline or drift compensation A61B5/30, A61B5/316 take precedence; transformers for specific applications H01F38/00; amplifiers H03F
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: A61J 17/001 Baby-comforters

Abstract

A handheld device detects and measures orofacial activity, including oral cavity pressure and one or more compressions, deformations, displacements, or deflections of a pacifier engaged to the device. The compressions, deformations, displacements, or deflections of the pacifier refer to changes in the shape of the pacifier, caused by patient, relative to an initial state of the pacifier. The device translates the oral cavity pressure and compressions into an electrical signal, digitizes the electrical signal, and performs analytical processing of the digitized signal to extract physiological artifacts salient to the patient'"'"'s ability to orally feed using a software application executing on a processor within the device. The device automates and simplifies the assessment of a patient'"'"'s readiness to orally feed by presenting graphical and numeric scores for organization and effort of non-nutritive suck.

Claims

1. A handheld device for a non-nutritive suck (NNS) assessment of a patient comprising:

a device housing containing a non-nutritive suck assessment system, wherein the non-nutritive suck assessment system comprises;

one or more transducers to determine a pacifier displacement caused by the patient and to generate a first electrical signal in response to at least one compression of a pacifier engaged to the device and determine an oral cavity pressure caused by the patient and to generate a second electrical signal in response to the oral cavity pressure;

an analog to digital convertor to convert the first electrical signal and the second electrical signal to NNS data received at a processor of the non-nutritive suck assessment system;

memory to store the NNS data collected from the pacifier and a suck assessment application, wherein the suck assessment application includes instructions executable by the processor;

one or more switches to control the operation of the handheld device, to control execution of the suck assessment application, and to control a display of assessment data on a display device engaged to the device housing;

at least one status indicator light; and

a power source; and

the handheld device further comprising a pacifier adapter configured to connect the device housing to a pacifier, wherein the pacifier adapter is dimensioned to maintain separation of the pacifier and the one or more transducers, wherein the pacifier is removably attached to the pacifier adapter.

2. The handheld device of claim 1, wherein the handheld device is cordless.

3. The handheld device of claim 1 further comprising at least one signal conditioning circuit to filter and amplify the first electrical signal and the second electrical signal generated by the one or more transducers.

4. The handheld device of claim 1 wherein the power source is a rechargeable battery, and the handheld device further comprising:

a battery charging circuit, wherein the battery charging circuit is configured to engage an external power supply.

5. The handheld device of claim 1 further comprising:

a wireless transceiver to transmit the NNS data collected from the pacifier, the suck assessment application, and at least one performance metric to a computing device.

6. The handheld device of claim 1 wherein the suck assessment application comprises:

a self-test module to perform a Power-On Self-Test;

an error-detection module to detect an error in an operation of the suck assessment application and provide a notification of the error;

a data collection module to receive patient oral feeding activity data within the NNS data;

a data analysis module to analyze the patient oral feeding activity data and to determine at least one patient performance metric; and

an output module to generate one or more data displays on the display device.

7. The handheld device of claim 6, wherein the at least one patient performance metric comprises at least one of a peak area under burst, an average area under burst, an active-quiescent ratio, a spatio-temporal index, a rate of bursts per minute, a rate of non-nutritive suck events per minute, and a rate of non-nutritive suck events per burst.

8. The handheld device of claim 1, wherein:

the pacifier adaptor has a first end in fluid communication with the transducer engaged to the device housing and a second end in fluid communication with the pacifier and the pacifier adaptor defining a lumen.

9. The handheld device of claim 8, wherein the pacifier adaptor has a length between 2.125″

and 2.25″

to provide a sterile barrier between the handheld device and the patient.

10. The handheld device of claim 1, wherein the display device is a liquid crystal display.

11. The handheld device of claim 1, wherein the display device is integrated with the device housing.

12. The handheld device of claim 1, wherein the memory comprises persistent random access memory.

13. A handheld device for non-nutritive suck assessment in a patient, the device comprising:

a housing containing a computing device having at least one processor and memory;

a pacifier adaptor having a proximal end and a distal end, wherein the pacifier adaptor defines a lumen between the proximal end and the distal end and the proximal end is mechanically engaged to the device housing;

a pacifier removably attached to the distal end of the pacifier adaptor to contact the patient and induce an oral feeding activity in the patient;

a suck assessment application executed by the at least one processor, the suck assessment application to identify the oral feeding activity of the patient and determine at least one oral feeding metric selected from a group consisting of a peak area under burst, an average area under burst, an active-quiescent ratio, a spatio-temporal index, a rate of bursts per minute, a rate of non-nutritive suck events per minute, and a rate of non-nutritive suck events per burst;

a display device connected to the housing;

at least one control switch connected to the housing; and

one or more status indicator lights connected to the housing.

14. The handheld device of claim 13 further comprising the pacifier connected to the pacifier adaptor.

15. The handheld device of claim 13, wherein the display device is integrated with the device housing.

16. A method for using a cordless handheld device comprising at least one processor, memory, a pacifier, a transducer, a control button, and a display to assess oral feeding activity in a patient, the method comprising:

contacting the pacifier with the patient;

actuating the control button to collect oral feeding activity data at the processor;

analyzing, by at least one processor, the oral feeding activity data to identify at least one metric of the oral feeding activity, wherein the metric is at least one member of a group consisting of a peak area under burst, an average area under burst, an active-quiescent ratio, a spatio-temporal index, a rate of bursts per minute, a rate of non-nutritive suck events per minute, and a rate of non-nutritive suck events per burst; and

displaying, by the at least one processor, the at least one metric on the display.

17. A method for assessing a non-nutritive suck of a patient using a handheld device comprising a non-nutritive suck assessment system, the method comprising:

actuating a control button to initiate execution of a non-nutritive suck assessment application on a processor of the handheld device;

contacting a pacifier engaged to the handheld device with the patient;

sensing, by at least one processor, patient oral feeding activity at a data collection module of a non-nutritive suck assessment application, the patient activity identified by a transducer in communication with the pacifier;

collecting, by the at least one processor, patient oral feeding activity data at the data collection module of the non-nutritive suck assessment application;

extracting, by the at least one processor, at least one patient performance metric from the patient oral feeding activity data at a data analysis module of the non-nutritive suck assessment application; and

displaying, by the at least one processor, patient performance data, the performance data based on the at least one patient performance metric on a display of the handheld device.

18. The method of claim 17 further comprising performing a power-on self-test before contacting the patient.

19. The method of claim 17 further comprising:

actuating a first display control button to scroll through the patient performance data in a first direction; and

actuating a second display control button to scroll through the patient performance data in a second direction.

20. The method of claim 17 further comprising storing the patient performance data in a persistent random access memory of the non-nutritive suck assessment system.

21. The method of claim 17 further comprising exporting the patient performance data to a data storage device.

22. A method for assessing a non-nutritive suck, comprising:

simultaneously receiving, by at least one processor, a pacifier pressure responsive to one of compression, deformation, displacement, and deflection of a pacifier, and an oral cavity pressure responsive to a pressure in an open annular tube in the pacifier;

generating, by the at least one processor, a first electrical signal responsive to the pacifier pressure and a second electrical signal responsive to the oral cavity pressure;

converting, by the at least one processor, the first electrical signal and the second electrical signal into non-nutritive suck (NNS) information representing a NNS session;

displaying, by the at least one processor, output responsive to the NNS information; and

analyzing, by the at least one processor, the ratio of pacifier pressure to oral cavity pressure as a function of time during the NNS session to determine at least one of a peak area under burst, an average area under burst, an active-quiescent ratio, a spatio-temporal index, a rate of bursts per minute, a rate of non-nutritive suck events per minute, and a rate of non-nutritive suck events per burst.

23. The method of claim 22, further comprising

storing, by the at least one processor, the NNS information in a patient profile, the patient profile including a patient name, a patient age, and a ratio of pacifier pressure to oral cavity pressure as a function of time during the NNS session.

24. The method of claim 23, further comprising:

determining, by the at least one processor, based on the ratio of pacifier pressure to oral cavity pressure as a function of time during the non-nutritive suck session, a maximum pacifier pressure value, a minimum pacifier pressure value, a maximum oral cavity pressure value, and a minimum oral cavity pressure value.

25. The method of claim 22, wherein the NNS session is two minutes in duration.