Wearable ambulatory data recorder

• US 20070129622A1
• Filed: 04/28/2006
• Published: 06/07/2007
• Est. Priority Date: 12/02/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Bourget, Duane, Miesel, Keith, Molnar, Gregory
• Granted Patent: US 8,016,776 B2
• Time in Patent Office: Days
• US Class Current: 600/382
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/0431 Portable apparatus, e.g. comprising a handle or case
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• 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 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/112 Gait analysis
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/384 Recording apparatus or displays specially adapted therefor
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/395 Details of stimulation, e.g. nerve stimulation to elicit EMG response
• CPC Class Codes: A61B 5/4082 Diagnosing or monitoring movement diseases, e.g. Parkinson, Huntington or Tourette
• CPC Class Codes: A61B 5/4809 Sleep detection, i.e. determining whether a subject is asleep or not
• CPC Class Codes: A61B 5/4815 Sleep quality
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6831 : Straps, bands or harnesses
• CPC Class Codes: A61B 5/6833 : Adhesive patches
• CPC Class Codes: A61N 1/36021 : for treatment of pain
• CPC Class Codes: A61N 1/36071 : Pain
• CPC Class Codes: A61N 1/3702 : Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: G16H 10/60 : for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/30 : relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16H 40/67 : for remote operation

Abstract

A wearable ambulatory data recorder that senses physiological parameters of a patient, and stores physiological parameter data for later retrieval, as well as techniques for using such a wearable ambulatory data recorder, are described. The data recorder includes one or more sensors located on or within a housing. The data recorder may include an adhesive layer for attachment to a patient. In some embodiments, the housing may be within a patch, e.g., bandage, which includes the adhesive layer. The housing may be waterproof. Features of the data recorder such as size, waterproofness, and inclusion of an adhesive may allow the data recorder to be unobtrusively worn by a patient during a variety of daily activities. The data recorder may be for single use and thereafter disposable.

Claims

1. An external wearable ambulatory data recorder comprising:

a housing;

a sensor that generates a signal as a function of posture of a patient that wears the data recorder within the housing;

a memory within the housing;

a processor within the housing that receives signal from the sensor, and stores posture data within the memory for the patient based on the signal; and

an element removably attached to the data recorder, wherein the processor calibrates the sensor in response to removal of the element.

2. The data recorder of claim 1, wherein the processor identifies a value of the signal in response to the removal, and associates the value with a predetermined posture.

3. The data recorder of claim 1,

further comprising a switch within the housing,

wherein removal of the element actuates the switch to power on the data recorder, and

wherein the processor calibrates the sensor in response to the power on of the data recorder

4. The data recorder of claim 1, wherein the element comprises a magnet.

5. The data recorder of claim 1, further comprising an adhesive, wherein the element comprises a removable layer attached to the adhesive.

6. The data recorder of claim 5, wherein the adhesive is configured to attach the housing to the patient.

7. The data recorder of claim 5, wherein the removable layer includes a magnet.

8. The data recorder of claim 5, further comprising a patch that contains the housing and includes the adhesive as a layer.

9. The data recorder of claim 1, wherein the sensor comprises an accelerometer within the housing.

10. The data recorder of claim 1,

wherein the sensor comprises a plurality of orthogonally aligned accelerometers within the housing, each of the accelerometers generating a signal as a function of posture of the patient, and

wherein the processor receives the plurality of signals, and stores posture data within the memory for the patient based on the signals.

11. The data recorder of claim 1, further comprising a plurality of sensors that sense a plurality of physiological parameters of the patient, wherein the plurality of sensors are located at least one of on or within the housing.

12. The data recorder of claim 11, wherein the plurality of sensors comprises at least one electrode formed on the housing.

13. The data recorder of claim 11, wherein the plurality of sensors sense at least one of activity, heart activity, brain activity, muscle activity, respiration, temperature, blood oxygen saturation, blood pressure, blood flow, partial pressure of oxygen within blood, partial pressure of oxygen within cerebrospinal fluid, tissue oxygenation, or galvanic skin response of the patient.

14. The data recorder of claim 1, wherein of the processor records at least one of an activity level, a posture, an electrocardiogram, an electroencephalogram, an electromyogram, a heart rate, a heart rate variability, a respiration rate, or a respiration rate variability for the patient within the memory.

15. The data recorder of claim 1, wherein the housing is waterproof.

16. The data recorder of claim 1, wherein a thickness of the housing is less than approximately 1.5 centimeters.

17. The data recorder of claim 1, wherein a volume of the housing is less than approximately 20 cubic centimeters.

18. An external wearable ambulatory data recorder comprising:

a housing;

means within the housing for sensing posture of a patient that wears the data recorder and generating posture data;

means within the housing for storing the posture data;

an element removably attached to the housing; and

means for calibrating the posture sensing means in response to removal of the element.

19. The data recorder of claim 18, wherein the means for calibrating comprises means for identifying a sensed posture in response to the removal, and associating the sensed posture with a predetermined posture.

20. The data recorder of claim 18, further means within the housing for powering on the data recorder in response to removal of the element, wherein the calibrating means calibrates the sensor in response to the power on of the data recorder.

21. A method comprising:

sensing posture of a patient via an external ambulatory data recorder worn by the patient;

storing posture data within a memory of the data recorder;

detecting removal of an element from the data recorder; and

calibrating posture sensing in response to the removal.

22. The method of claim 21, wherein calibrating posture sensing comprises:

identifying a sensed posture in response to the removal; and

associating the sensed posture with a predetermined posture.

23. The method of claim 21, further comprising directing the patient to assume the predetermined posture prior to removal of the element.

24. The method of claim 21, wherein calibrating posture sensing comprises:

powering on the data recorder in response to the removal, and

calibrating posture sensing in response to the power on of the data recorder

25. The method of claim 21, wherein detecting removal of an element comprises detecting removal of a magnet.

26. The method of claim 21, further comprising:

adhesively attaching the data recorder to the patient;

directing the patient to assume a predetermined posture; and

removing the element with the patient in the predetermined posture.

27. The method of claim 21, further comprising sensing a plurality of physiological parameters of the patient via the data recorder.

28. The method of claim 21, wherein comprising sensing a plurality of physiological parameters comprises sensing a plurality of activity, heart activity, brain activity, muscle activity, respiration, temperature, blood oxygen saturation, blood pressure, blood flow, partial pressure of oxygen within blood, partial pressure of oxygen within cerebrospinal fluid, tissue oxygenation, or galvanic skin response of the patient via the data recorder.