System and method for evaluating a patient status for use in heart failure assessment

• US 9,149,237 B2
• Filed: 12/23/2013
• Issued: 10/06/2015
• Est. Priority Date: 06/03/1999
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Bardy, Gust
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US14/139,650
• Publication Number:
  US 20140155765A1
• Time in Patent Office: 652 Days
• Field of Search: 607/30, 607/59, 607/29
• US Class Current: 1/1
• 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 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• 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 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/0826 Detecting or evaluating apnoea events A61B5/4818 takes precedence
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/145 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 5/333 Recording apparatus specially adapted therefor
• CPC Class Codes: A61B 5/4878 Evaluating oedema
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• 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 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61B 7/02 Stethoscopes acoustic details thereof G10K11/00
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: A61N 1/37282 : characterised by communication with experts in remote locations using a network
• CPC Class Codes: A61N 1/39622 : Pacing therapy
• CPC Class Codes: G16H 10/60 : for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 15/00 : ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 40/67 : for remote operation
• CPC Class Codes: G16H 50/00 : ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 : for calculating health indices; for individual health risk assessment
• CPC Class Codes: Y10S 128/92 : Computer assisted medical diagnostics

Abstract

A system and method for evaluating a patient status from sampled physiometry for use in heart failure assessment is presented. Physiological measures, including at least one of direct measures regularly recorded on a substantially continuous basis by a medical device and measures derived from the direct measures are stored. At least one of those of the physiological measures, which relate to a same type of physiometry, and those of the physiological measures, which relate to a different type of physiometry are sampled. A status is determined for a patient through analysis of those sampled measures assembled from a plurality of recordation points. The sampled measures are evaluated. Trends that are indicated by the patient status, including one of a status quo and a change, which might affect cardiac performance of the patient, are identified. Each trend is compared to worsening heart failure indications to generate a notification of parameter violations.

Claims

1. A system for evaluating a patient status for use in heart failure assessment, comprising:

an implantable medical device configured to provide medical interventions and collect patient data on a long-term, daily basis, wherein the patient data comprises the type of medical interventions made and the relative success of any medical interventions made, wherein the implantable medical device is further configured to store a collected measures set containing the patient data;

a database having a comparison measures set containing comparison data;

an analysis module configured to receive the collected measures set and the comparison measures set and compare the collected measures set to the comparison measures set to generate a status indicator for the patient data, wherein the comparison measures set is based on at least one patient characteristic in the group consisting of;

age, geographic region, and gender; and

a feedback module to provide notification of a potential medical concern based on the patient status indicator.

2. The system of claim 1, wherein the comparison data comprises averaged measures.

3. The system of claim 1, further comprising a collection client and a network server, wherein the collection client is configured to:

be communicatively interposed between the implantable medical device and a communication link, retrieve the collected measures set from the implantable medical device, and download the collected measures set into the network server over the communications link.

4. The system of claim 1, wherein the medical interventions of the implantable medical device comprise cardiac pacing and defibrillation.

5. The system of claim 4, wherein the patient data further comprises the number of medical interventions made.

6. The system of claim 1, wherein the feedback module is further configured to provide tiered notifications comprising:

at a first level, an interpretation of the patient status;

at a second level, a notification of potential medical concern based on the patient status;

at a third level, a notification of potential medical concern based on the patient status to medical personnel; and

at a fourth level, a set of reprogramming instructions based on the patient status to an implantable medical device.

7. The system of claim 1, wherein the implantable medical device comprises a battery and is configured to store data comprising battery status, and wherein the feedback module is configured to provide notification of the battery status.

8. The system of claim 1, further comprising a feedback scheme comprising tiered feedback defining a plurality of levels of patient involvement and medical care intervention, wherein the feedback module is further configured to provide the notification consistent with a particular level of patient involvement and medical care intervention from the plurality of levels of patient involvement and medical care intervention.

9. A method for evaluating a patient status for use in heart failure assessment, comprising:

providing medical interventions, by an implantable medical device;

collecting patient data, by the implantable medical device, on a long-term, daily basis, and periodically sending a collected measures set containing the patient data, wherein the patient data comprises the type of medical interventions made and the relative success of any interventions made;

receiving, by an analysis module, the collected measures set and comparing the collected measures set to a comparison measures set containing comparison data, wherein the comparison measures set is based on at least one patient characteristic in the group consisting of;

age, geographic region, and gender;

generating a status indicator for the patient data based on the comparing; and

providing a notification of a potential medical concern, by a feedback module, based on the patient status indicator.

10. The method of claim 9, wherein the comparison measures set comprises averaged measures.

11. The method of claim 9, further comprising retrieving, by a collection client, the collected measures set from the implantable medical device and downloading the collected measures set into a network server over a communications link.

12. The method of claim 9, wherein providing medical interventions comprises providing cardiac pacing and defibrillation by the implantable medical device.

13. The method of claim 12, wherein the patient data comprises the number of device interventions made.

14. The method of claim 9, wherein providing a notification comprises one or more of tiered notifications comprising:

at a first level, providing an interpretation of the patient status;

at a second level, providing a notification of potential medical concern based on the patient status;

at a third level, providing a notification of potential medical concern based on the patient status to medical personnel; and

at a fourth level, providing a set of reprogramming instructions based on the patient status to an implantable medical device.

15. The method of claim 9, further comprising storing battery status data by the medical device and providing notification of the battery status by the feedback module.

16. The method of claim 9, wherein providing the notification is consistent with a particular level of patient involvement and medical care intervention from a plurality of levels of patient involvement and medical care intervention defined by a tiered feedback scheme of the feedback module.