Disposable in-the-ear monitoring instrument and method of manufacture

• US 6,283,915 B1
• Filed: 03/08/1999
• Issued: 09/04/2001
• Est. Priority Date: 03/12/1997
• Status: Expired due to Fees

• Current Assignee: Sarnoff Corporation (SRI International, Inc.)
• Original Assignee: Sarnoff Corporation (SRI International, Inc.)
• Inventors: Aceti, John Gregory, Sjursen, Walter Paul, Leedom, Marvin Allan
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): ASTORINO, MICHAEL C
• Application Number:
  US09/264,655
• Time in Patent Office: 911 Days
• Field of Search: 600/300-301, 600/481-486, 600/490, 600/500, 600/529-538, 128/900-905, 128/897-898, 340/573.1
• US Class Current: 600/300
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/6817 Ear canal
• CPC Class Codes: H04R 25/453 electronically
• CPC Class Codes: H04R 25/456 mechanically
• CPC Class Codes: H04R 25/609 of circuitry of electronic switches or control elements H04R25/603
• CPC Class Codes: H04R 25/652 Ear tips; Ear moulds hybrid ear moulds or post-processing thereof for their customisation H04R25/659
• CPC Class Codes: H04R 25/656 Non-customized, universal ear tips, i.e. ear tips which are not specifically adapted to the size or shape of the ear or ear canal
• CPC Class Codes: H04R 25/658 Manufacture of housing parts
• CPC Class Codes: Y10S 128/903 Radio telemetry

Abstract

A disposable in-the-ear monitoring instrument includes a monitoring assembly for monitoring one or more vital health signs of a user, a transmitter assembly for transmitting the monitored vital health signs to a remote receiving unit, and a battery for energizing the assemblies. The assemblies and battery are mounted on a printed circuit which is disposed in a cylindrical shell. And the cylindrical shell is itself mounted in an earmold. The disposable in-the-ear monitoring instrument is of an optimum design having a minimum number of components, and thus is easy to assemble on an automated basis. The automated assembly of the in-the-ear monitoring instrument and its optimum design reduces costs and allows for the disposability of the monitoring instrument.

Claims

1. A disposable in-the-ear monitoring instrument, comprising:

one or more transducers for monitoring vital health signs of a user,

a transmitter for receiving signals from said one or more transducers representative of monitored vital health signs and for transmitting said signals to a remote location,

a battery permanently electrically connected to the transmitter; and

an earmold of a soft pliable material surrounding the one or more transducers and the transmitter and adapted to fit into and mold to the ear of a user.

2. The disposable in-the-ear monitoring instrument of claim 1, wherein said one or more transducers include a microphone for translating audio signals caused by blood flowing through the user'"'"'s blood vessels into electrical signals.

3. The disposable in-the-ear monitoring instrument of claim 1, wherein said one or more transducers include at least one light source and at least one photodetector which senses color of blood vessels in the user'"'"'s ear drum and translates the sensed color into electrical signals.

4. The disposable in-the-ear monitoring instrument of claim 1, wherein said one or more transducers include a heat sensitive transducer which senses temperature and translates the sensed temperature into an electrical signal.

5. The disposable in-the-ear monitoring instrument of claim 1, wherein said one or more transducers include a microphone for auscultating the user'"'"'s pulse.

6. The disposable in-the-ear monitoring instrument of claim 1, wherein said one or more transducers include a microphone for auscultating the user'"'"'s respiration.

7. The disposable in-the-ear monitoring instrument according to claim 1, wherein said one or more transducers include a microphone for auscultating the user'"'"'s lung sounds to detect abnormal respiratory sounds.

8. The disposable in-the-ear monitoring instrument according to claim 1, wherein said one or more transducers include a microphone for auscultating the user'"'"'s heart to detect fibrillation, arterial gallop, ventricular gallop or other abnormal sounds emitting from the heart.

9. The disposable in-the-ear monitoring instrument of claim 1, wherein said transmitter is a radio frequency transmitter.

10. The disposable in-the-ear monitoring instrument of claim 1, wherein said transmitter is an infrared transmitter.

11. The disposable in-the-ear monitoring instrument of claim 1, wherein said transmitter is a microwave transceiver.

12. The disposable in-the-ear monitoring instrument of claim 1, further comprising a shell surrounding said one or more transducers and said transmitter and adapted to fit within said earmold.

13. The disposable in-the-ear monitoring instrument of claim 12, wherein the shell is a flexible, hollow cylindrical element.

14. The disposable in-the-ear monitoring instrument of claim 12, wherein the shell includes means to orient and retain the one or more transducers and the transmitter.

15. The disposable in-the-ear monitoring instrument of claim 13, wherein the earmold is of a soft pliable material selected from the group of cold-cured methacrylate, heat-cured methacrylate, heat-cured silicone, polyvinyl chloride copolymer and polyethylene co-polymer.

16. The disposable in-the-ear monitoring instrument of claim 1 further comprising a printed circuit board on which said one or more transducers and said transmitter are mounted and electrically connected together.

17. The disposable in-the-ear monitoring instrument of claim 1, wherein said battery is electrically connected to said one or more transducers.

18. The disposable in-the-ear monitoring instrument of claim 1, having an opening therethrough for transmission of sound to the user.

19. The disposable in-the-ear monitoring instrument of claim 1, further comprising a hearing aid.

20. The disposable in-the-ear monitoring instrument of claim 19, wherein said hearing aid includes a unity gain amplifier.

21. A disposable in-the-ear monitoring instrument, comprising:

an electronic printed circuit board;

a battery, permanently mounted to the electronic printed circuit board;

one or more monitors for monitoring vital health signs of a user, said one or more monitors permanently mounted to the electronic printed circuit board;

a transmitter for receiving from said one or more monitors a signal representative of a monitored vital health sign of said user and transmitting said signal to a remote location, said transmitter being coupled to the battery;

a shell into which the electronic printed circuit board, with said battery, said one or more transducers and said transmitter, is inserted; and

an earmold of a soft pliable material surrounding the shell and adapted to fit into and mold the ear of said user.

22. The disposable in-the-ear monitoring instrument of claim 21, wherein said one or more transducers are coupled to said battery.

23. A method of making a disposable in-the-ear monitoring instrument, comprising the steps of:

mounting electrical components, monitoring components and batteries onto an elongated printed circuit strip to form there along respective assemblies of a plurality of disposable in-the-ear monitoring instruments;

cutting the printed circuit strip apart to form individual assemblies of one or more monitors, transmitter and battery of a disposable in-the-ear monitoring instrument on a printed circuit;

inserting each assembly into a separate cylindrical shell; and

inserting a shell containing an assembly into an opening in an earmold of a soft, durable and complaint material.

24. The method of claim 23, wherein after said electrical components, monitoring components and batteries are mounted on said flexible printed circuit strip, said strip is mounted on a reel.

25. The method of claim 24, wherein said flexible printed circuit strip on said reel is fed with shells into an assembler which cuts the strip apart into said individual assemblies and inserts each assembly into a separate shell.

26. The method of claim 25, wherein after said assemblies are inserted into said shells, said shells containing said assemblies are disposed into respective packages which are hermetically sealed and which contain a gas, whereby the casings and assemblies are protected from atmospheric contamination and any electrical activity in the batteries is significantly reduced.

27. The method of claim 26, wherein said earmolds are molded and packaged in an hermetically sealed package.

28. The method of claim 27, wherein a suitable earmold and shell suitable for monitoring one or more vital health signs are removed from their individual packages and assembled to form a disposable in-the-ear monitoring instrument.

29. The method of claim 23, wherein said monitoring components are assembled onto said elongated printed circuit strip to form individual monitoring assemblies capable of monitoring, for a particular user, one or a plurality of vital health signs of the user.

30. The method of claim 29, wherein said earmolds are made in a predetermined number of different sizes, and a shell suitable for the particular monitoring needs of the user is inserted into an earmold of an appropriate size for the user.