METHOD AND APPARATUS FOR PERSONALIZED PHYSIOLOGIC PARAMETERS

• US 20130096395A1
• Filed: 04/01/2011
• Published: 04/18/2013
• Est. Priority Date: 04/05/2010
• Status: Abandoned Application

• Current Assignee: Medtronic Monitoring, Inc. (Medtronic Plc)
• Original Assignee: Corventis
• Inventors: Katra, Rodolphe, Chakravarthy, Niranjan, Libbus, Imad
• Application Number:
  US13/639,822
• Publication Number:
  US 20130096395A1
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/0075 by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/0531 Measuring skin impedance
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/091 Measuring volume of inspired or expired gases, e.g. to determine lung capacity
• CPC Class Codes: A61B 5/1072 measuring distances on the body, e.g. measuring length, height or thickness A61B5/1076 takes precedence
• CPC Class Codes: A61B 5/1073 Measuring volume, e.g. of limbs
• CPC Class Codes: A61B 5/1075 for measuring dimensions by non-invasive methods, e.g. for determining thickness of tissue layer A61B8/0858 takes precedence
• CPC Class Codes: A61B 5/1079 using optical or photographic means
• CPC Class Codes: A61B 5/4872 Body fat
• CPC Class Codes: A61B 5/4875 Hydration status, fluid retention of the body
• CPC Class Codes: A61B 5/4878 Evaluating oedema
• CPC Class Codes: A61B 5/6832 using adhesives A61B5/259 takes precedence
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/7225 Details of analog processing, e.g. isolation amplifier, gain or sensitivity adjustment, filtering, baseline or drift compensation A61B5/30, A61B5/316 take precedence; transformers for specific applications H01F38/00; amplifiers H03F
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 6/482 : involving multiple energy imaging
• CPC Class Codes: A61N 1/00 : Electrotherapy; Circuits therefor A61N2/00 takes precedence; irradiation apparatus A61N5/00

Abstract

Methods and apparatus combine patient measurement data with demographic or physiological data of the patient to determine an output that can be used to diagnose and treat the patient. A customized output can be determined based the demographics of the patient, physiological data of the patient, and data of a population of patients. In another aspect, patient measurement data is used to predict an impending cardiac event, such as acute decompensated heart failure. At least one personalized value is determined for the patient, and a patient event prediction output is generated based at least in part on the personalized value and the measurement data. For example, bioimpedance data may be used to establish a baseline impedance specific to the patient, and the patient event prediction output generated based in part on the relationship of ongoing impedance measurements to the baseline impedance. Multivariate prediction models may enhance prediction accuracy.

Claims

1. An apparatus to monitor a patient, the apparatus comprising:

at least two electrodes coupled to circuitry to measure an impedance of the patient;

at least one processor to receive the measured impedance and patient data, the at least one processor configured to determine an output based on the impedance and the patient data.

2. The apparatus of claim 1, wherein the patient data corresponds to a demographic of the patient.

3. The apparatus of claim 2, wherein the patient demographic corresponds to one or more of a gender of the patient, an age of the patient, or a race of the patient.

5. The apparatus of claim 1, wherein the patient data corresponds to fat of the patient comprising one or more of a percent body fat of the patient, a body mass index, a height of the patient, a weight of the patient, a caliper measure of the fat of the patient, a tape measure test of the patient, a near infrared interactance, images of the patient to determine fat, dual energy x-ray absorptiometry (DXA), expansion based on body volume, body average density measurement, a second impedance measurement of the patient, an anthropometeric measurement of body fat, a circumference of the patient, a circumference of a body part, a thickness of a skin fold, or an estimate of body density.

6. The apparatus of claim 1, wherein the output comprises customized patient data based on patient data corresponding to fat of the patient and at least one patient demographic comprising one or more of a sex, a race, or an age of the patient.

8. The apparatus of claim 1, wherein the patient data comprises one or more of blood pressure, creatinine, blood urea nitrogen (BUN), troponin, ck-mb (creatinine kinase-MB), or a previous event of the patient.

9. The apparatus of claim 1, wherein the output comprises one or more of a patient hydration indicator, an adjusted impedance, a patient population statistic adjusted based on the patent data, the hydration indicator over time, or a patient event prediction output.

11. The apparatus of claim 1, wherein the at least one processor is configured to increase an hydration amount of the patient hydration indicator based on the impedance measurement and in response to a decrease of fat of the patient and wherein the at least one processor is configured to decrease the hydration amount of the patient hydration indicator based on the impedance measurement and in response to an increase of the fat of the patient.

12. The apparatus of claim 11, wherein the hydration indicator comprises an adjusted impedance of the patient and wherein the adjusted impedance corresponds inversely to the hydration of the patient.

13. The apparatus of claim 1, wherein the output comprises the adjusted impedance.

16. The apparatus of claim 1, wherein the output comprises a spot check output based on a spot check impedance measurement of the patient and the patient data.

19. The apparatus of claim 1 wherein the output comprises a first marker and a second marker, the first marker determined based on data of a population of patients and the patient data, the second marker determined based on the data of the population of patients and the patient data, the first marker corresponding to dehydration of the patient, the second marker corresponding to excess body fluid of the patient.

31. The apparatus of claim 1, further comprising one or more of a cardioverter, an implantable cardioverter-defibrillator (ICD), cardiac a defibrillator, a resynchronization therapy defibrillator (CRT-D) or a pacemaker coupled to the at least one processor to treat the patient.

34. The apparatus of claim 1, wherein the at least two electrodes comprise gel electrodes to adhere to a skin of the patient.

4. (canceled)

7. (canceled)

10. (canceled)

14-15. -15. (canceled)

17-18. -18. (canceled)

20-30. -30. (canceled)

32-33. -33. (canceled)

35-36. -36. (canceled)

37. A method of predicting an impending patient cardiac event, the method comprising:

receiving impedance data measured from the patient;

establishing at least one patient-specific value for the patient based at least in part on the impedance data; and

generating, based at least in part on the impedance data and the at least one patient-specific value, a patient event prediction output predictive of the impending patient cardiac event.

38. The method of claim 37, further comprising receiving patient descriptive data indicating at least one descriptive characteristic of the patient;

and wherein establishing the at least one patient-specific value for the patient comprises establishing the at least one patient-specific value for the patient based at least in part on the patient descriptive data.

44. The method of claim 37, wherein receiving impedance data measured from the patient comprises:

affixing an adherent device to the patient, the adherent device comprising electrodes in electrical contact with the patient'"'"'s skin, and the adherent device generating an impedance output indicating an impedance between at least two of the electrodes; and

receiving the impedance output.

39-43. -43. (canceled)

45-62. -62. (canceled)

63. A system for predicting a cardiac event of a patient, the system comprising;

an adherent device attachable to a patient to electronically measure impedance data from the patient; and

a processor and a tangible memory readable by the processor;

wherein the memory stores instructions that, when executed by the processor, cause the system to

receive the impedance data;

establish at least one personalized value for the patient based on the impedance data; and

generate, based at least in part on the impedance data and the at least one personalized value, a patient event prediction output predictive of a patient cardiac event.

64. The system of claim 63, further comprising an input mechanism for receiving patient descriptive data indicating at least one descriptive characteristic of the patient, and wherein the instructions, when executed by the processor, further cause the system to:

receive patient descriptive data indicating at least one descriptive characteristic of the patient;

establish at least one personalized value based on the patient descriptive data; and

generate the patient event prediction output based at least partly on the personalized value established from the patient descriptive data.

65. The system of claim 63, wherein the adherent device further comprises:

at least two electrodes in contact with the patient'"'"'s skin; and

an electronics module that measures the impedance between at least two of the electrodes and transmits the impedance data representing the impedance to the computer system.

66-86. -86. (canceled)