Remote monitoring and updating of a medical device control unit

• US 10,512,782 B2
• Filed: 06/17/2014
• Issued: 12/24/2019
• Est. Priority Date: 06/17/2013
• Status: Active Grant

• Current Assignee: Nyxoah SA
• Original Assignee: Nyxoah SA
• Inventors: Mashiach, Adi, Mashiach, Itzik, Siman, Guy
• Primary Examiner(s): Flory, Christopher A
• Application Number:
  US14/306,953
• Publication Number:
  US 20140371817A1
• Time in Patent Office: 2,016 Days
• Field of Search: 607 59, 607 60, 607 62, 607109, 607116, 607139
• CPC Class Codes: A61B 17/30 Surgical pincettes without pivotal connectionsfor holding suture needles or materials A61B17/0483; wound clamps A61B17/08 ; hand-held gripping tools without pivotal connections in general B25B9/02
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 2562/16 Details of sensor housings or probes; Details of structural supports for sensors A61B2560/0462 takes precedence
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 2562/227 Sensors with electrical connectors
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/113 occurring during breathing
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4519 Muscles A61B5/389, A61B5/224 take precedence
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/682 Mouth, e.g., oral cavity; tongue; Lips; Teeth
• CPC Class Codes: A61B 5/6822 Neck
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/6876 Blood vessel
• CPC Class Codes: A61B 7/04 Electric stethoscopes microphones, acoustic transducers therefor H04R
• CPC Class Codes: A61F 5/566 Intra-oral devices
• CPC Class Codes: A61N 1/0404 for external use A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0492 : Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/0514 : Electrodes for the urinary tract
• CPC Class Codes: A61N 1/0526 : Head electrodes A61N1/0551 takes precedence
• CPC Class Codes: A61N 1/0553 : Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/36003 : of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/3601 : of respiratory organs
• CPC Class Codes: A61N 1/36014 : External stimulators, e.g. with patch electrodes external pacemakers A61N1/3625
• CPC Class Codes: A61N 1/3605 : Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36057 : adapted for stimulating afferent nerves
• CPC Class Codes: A61N 1/36075 : Headache or migraine
• CPC Class Codes: A61N 1/3611 : Respiration control stimulating respiratory organs A61N1/3601
• CPC Class Codes: A61N 1/36117 : for treating hypertension
• CPC Class Codes: A61N 1/36135 : using physiological parameters
• CPC Class Codes: A61N 1/36139 : with automatic adjustment
• CPC Class Codes: A61N 1/36146 : specified by the stimulation parameters
• CPC Class Codes: A61N 1/37223 : Circuits for electromagnetic coupling
• CPC Class Codes: A61N 1/37229 : Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/3756 : Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3758 : Packaging of the components within the casing
• CPC Class Codes: A61N 1/3787 : from an external energy source
• CPC Class Codes: A61N 2/006 : for magnetic stimulation of nerve tissue
• CPC Class Codes: A61N 2/02 : using magnetic fields produced by coils, including single turn loops or electromagnets A61N2/12 takes precedence
• CPC Class Codes: A61N 2001/37294 : Means for testing medical devices within the package prior to implantation

Abstract

A medical device control unit is provided. The control unit may include a communications interface, a memory, and at least one processing device. The processing device may be configured to cause application of a control signal to a primary antenna associated with a unit external to a subject'"'"'s body. The processing device may further be configured to monitor a feedback signal indicative of the subject'"'"'s breathing and store, in the memory, information associated with the feedback signal. The processing device may also cause transmission of the stored information, via the communications interface, to a location remote from the control unit. The processing device may further be configured to receive an update signal, from the location remote from the control unit, and cause application of an updated control signal to the primary antenna based on the update signal.

Claims

1. A control unit external to a subject'"'"'s body, comprising:

a primary antenna configured to pair with a second antenna included in an implant unit within the subject'"'"'s body;

a communications interface configured to communicate with a computing device remote from the control unit and from the subject'"'"'s body;

a memory; and

at least one processing device configured to;

cause application of a control signal to the primary antenna associated with the control unit external to the subject'"'"'s body, wherein application of the control signal causes transmission of a modulation signal from the primary antenna to the secondary antenna associated with the implant unit;

monitor a feedback signal from the implant unit using the primary antenna, the feedback signal being indicative of the subject'"'"'s breathing;

store, in the memory, information associated with the feedback signal;

cause, at a predetermined interval, transmission of the stored information associated with the feedback signal, via the communications interface, to the computing device remote from the control unit and the subject'"'"'s body;

receive an update signal, via the communications interface, from the location remote from the control unit, the update signal being generated in response to the transmitted, stored information associated with the coupled feedback signal; and

cause application of an updated control signal to the primary antenna based on the update signal such that the modulation signal from the primary antenna to the secondary antenna is modified based on the updated control signal.

2. The control unit of claim 1, wherein the control unit is configured to be releasably electronically coupled to an adhesive patch.

3. The control unit of claim 1, wherein the control signal is tailored to cause optimal modulation based on the feedback signal.

4. The control unit of claim 1, wherein the information associated with the feedback signal includes at least one of information about a usage period of the control unit, information about energy expenditure of the control unit, information about tongue movement, information about battery depletion of the control unit, information about tongue movement in response to the modulation signal, information about occurrence of apnea, hypopnea, or snoring, and information about muscular contractions.

5. The control unit of claim 1, wherein the location remote from the control unit includes at least one of a smart phone and a bedside console enabled for at least one of wi-fi and Bluetooth.

6. The control unit of claim 1, wherein the communications interface is configured to transmit using at least one of wi-fi and Bluetooth and RFID.

7. The control unit of claim 1, wherein the communications interface is configured to transmit through a wired electronic connection.

8. The control unit of claim 1, wherein the update signal is received periodically during a sleep period.

9. The control unit of claim 1, wherein the update signal is received once per day.

10. The control unit of claim 1, wherein the information must pass a predetermined threshold for transmission.

11. The control unit of claim 1, wherein the communications interface includes a near field communication device.

12. The control unit of claim 1, wherein the feedback signal is a signal developed on the primary antenna through wireless interaction with the secondary antenna.

13. The control unit of claim 1, wherein the at least one processing device is configured to cause transmission to the computing device on a regular basis.

14. The control unit of claim 13, wherein the regular basis comprises at least one of monthly, weekly, daily, or hourly.

15. The control unit of claim 1, wherein the at least one processing device is further configured to cause transmission to the computing device when the control unit is connected to a charging device.

16. A control unit external to a subject'"'"'s body, comprising:

at least one sensor;

a primary antenna configured to pair with a second antenna included in an implant unit within the subject'"'"'s body;

a communications interface configured to communicate with a computing device remote from the control unit and from the subject'"'"'s body;

a memory; and

at least one processing device configured to;

cause application of a control signal to the primary antenna associated with the control unit external to the subject'"'"'s body, wherein application of the control signal causes transmission of a modulation signal from the primary antenna to the secondary antenna associated with the implant unit;

monitor a feedback signal from the implant unit using the at least one sensor, the feedback signal being indicative of the subject'"'"'s breathing;

store, in the memory, information associated with the feedback signal;

cause transmission, at a predetermined interval, of the stored information associated with the feedback signal, via the communications interface, to the computing device remote from the control unit and the subject'"'"'s body;

receive an update signal, via the communications interface, from the location remote from the control unit, the update signal being generated in response to the transmitted, stored information associated with the coupled feedback signal; and

cause application of an updated control signal to the primary antenna based on the update signal such that the modulation signal from the primary antenna to the secondary antenna is modified based on the updated control signal.

17. The control unit of claim 16, wherein the at least one processing device is configured to cause transmission to the computing device at least one of monthly, weekly, daily, or hourly.

18. The control unit of claim 16, wherein the at least one processing device is configured to cause transmission to the computing device when the control unit is connected to a charging device.