Wearable ambulatory data recorder

• US 8,016,776 B2
• Filed: 04/28/2006
• Issued: 09/13/2011
• Est. Priority Date: 12/02/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Molnar, Gregory F., Miesel, Keith A., Bourget, Duane
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): DANEGA, RENEE A
• Application Number:
  US11/413,619
• Publication Number:
  US 20070129622A1
• Time in Patent Office: 1,964 Days
• Field of Search: 600/587, 600/382
• US Class Current: 600/587
• 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 5/389 Electromyography [EMG]
• 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. 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;

identifying an initial sensed posture of the patient in response to the detection of removal; and

calibrating posture sensing in response to the removal by associating the initial sensed posture with a predetermined posture,

wherein storing posture data comprises storing posture data corresponding to sensed postures of the patient correlated to the initial sensed posture associated with the predetermined posture.

2. The method of claim 1, further comprising directing the patient to assume the predetermined posture prior to removal of the element.

3. The method of claim 1, 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.

4. The method of claim 1, wherein detecting removal of an element comprises detecting removal of a magnet.

5. The method of claim 1, 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.

6. The method of claim 1, further comprising sensing a plurality of physiological parameters of the patient via the data recorder.

7. The method of claim 1, 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.