Wearable ambulatory data recorder

• US 20070129769A1
• Filed: 04/28/2006
• Published: 06/07/2007
• Est. Priority Date: 12/02/2005
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Bourget, Duane, Miesel, Keith, Molnar, Gregory
• Application Number:
  US11/414,507
• Publication Number:
  US 20070129769A1
• Time in Patent Office: Days
• US Class Current: 607/45
• 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:

delivering a therapy to a patient via a medical device;

sensing a plurality of physiological parameters of the patient via an external wearable ambulatory data recorder during delivery of the therapy, the data recorder separate from the medical device; and

providing the physiological parameter data to a user for evaluation of the therapy, the physiological parameter data determined based on the sensed physiological parameters.

2. The method of claim 1,

wherein delivering a therapy comprises delivering the therapy according to a plurality of parameter sets,

the method further comprising, for each of the parameter sets, associating physiological parameter data determined during delivery of therapy according to the parameter set with the parameter set, and

wherein providing the physiological parameter data to a user comprises providing information relating to the associations of physiological parameter data and parameter sets to the user.

3. The method of claim 2, further comprising, for each of the parameter sets, determining a respective value of a metric that is indicative of sleep quality based on the physiological parameter data associated with the parameter set.

4. The method of claim 3, wherein determining a value of a sleep quality metric comprises determining whether the patient is asleep based on the physiological parameter data.

5. The method of claim 3, wherein determining a value of a sleep quality metric comprises determining a value of at least one of sleep efficiency, sleep latency, amount of time asleep during a period, or amount of time within at least one of an S3 sleep state or an S4 sleep state.

6. The method of claim 2, further comprising, for each of the parameter sets, determining a respective value of a least one of a patient activity metric or a patient posture metric based on the physiological parameter data associated with the parameter set.

7. The method of claim 1, wherein sensing a plurality of physiological parameters comprises sensing a plurality of posture, 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.

8. The method of claim 1, wherein delivering a therapy comprises delivering neurostimulation.

9. The method of claim 1, wherein delivering a therapy via a medical device comprises delivering the therapy via an implantable medical device.

10. The method of claim 1, wherein delivering a therapy comprises delivering therapy via an external trial stimulator.

11. The method of claim 10, further comprising:

identifying an intended implant location for an implantable medical device; and

attaching the data recorder to the patient proximate to the implant location during delivery of therapy by the trial stimulator.

12. The method of claim 1, wherein delivering a therapy comprises delivering at least one of a chronic pain therapy, movement disorder therapy, psychological disorder therapy, spinal cord stimulation therapy, or deep brain stimulation therapy.

13. A system comprising:

a medical device that delivers a therapy to a patient;

a separate external wearable ambulatory data recorder that senses a plurality of physiological parameters of the patient during delivery of the therapy, and stores physiological parameter data based on the sensed physiological parameters; and

a processor that provides the physiological parameter data to a user for evaluation of the therapy.

14. The system of claim 13,

wherein the medical device delivers the therapy according to a plurality of parameter sets, and

wherein, for each of the parameter sets, the processor associates physiological parameter data determined during delivery of therapy according to the parameter set with the parameter set, and provides information relating to the associations of physiological parameter data and parameter sets to the user.

15. The system of claim 14, wherein, for each of the parameter sets, the processor determines a respective value of a metric that is indicative of sleep quality based on the physiological parameter data associated with the parameter set, and provides information relating to the parameter sets and associated sleep quality metric values to the user.

16. The system of claim 15, wherein the processor determines whether the patient is asleep based on the physiological parameter data.

17. The system of claim 15, wherein the processor determines a value of at least one of sleep efficiency, sleep latency, amount of time asleep during a period, or amount of time within at least one of an S3 sleep state or an S4 sleep state for each of the parameter sets.

18. The system of claim 14, wherein, for each of the parameter sets, the processor determines a respective value of a least one of a patient activity metric or a patient posture metric based on the physiological parameter data associated with the parameter set.

19. The system of claim 13, further comprising a separate computing device that comprises the processor, wherein the processor receives the physiological parameter data from the data recorder and information describing the plurality of parameter sets from the medical device.

20. The system of claim 13, wherein the data recorder senses a plurality of posture, 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.

21. The system of claim 13, wherein the medical device delivers neurostimulation to the patient.

22. The system of claim 13, wherein the medical device comprises an implantable medical device.

23. The system of claim 13, wherein the medical device comprises an external trial stimulator.

24. The system of claim 13, wherein the medical device delivers at least one of a chronic pain therapy, movement disorder therapy, psychological disorder therapy, spinal cord stimulation therapy, or deep brain stimulation therapy.

25. The system of claim 13, wherein the processor comprises one or more of a processor of the medical device, a processor of the data recorder, or a processor of a separate computing device.

26. A system comprising:

means for delivering a therapy to a patient;

separately housing external means for sensing a plurality of physiological parameters of the patient during delivery of the therapy;

means for determining physiological parameter data based on the sensed physiological parameters; and

means for providing the physiological parameter data to a user for evaluation of the therapy.

27. The system of claim 26,

wherein the delivering means delivers the therapy according to a plurality of parameter sets,

the system further comprising means for associating physiological parameter data determined during delivery of therapy according to one of the parameter sets with the parameter set for each of the parameter sets, and

wherein the means for providing comprises means for providing information relating to the associations of physiological parameter data and parameter sets to the user.