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

• US 9,186,061 B2
• Filed: 10/14/2013
• Issued: 11/17/2015
• 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): BOCKELMAN, MARK
• Application Number:
  US14/053,375
• Publication Number:
  US 20140039327A1
• Time in Patent Office: 764 Days
• Field of Search: 600300-301, 600/509, 600/312, 128/920, 128/923, 128/312
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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: 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
• 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 are stored, including at least one of direct measures regularly recorded on a substantially continuous basis by an implantable medical device for a patient and measures derived from the direct measures. At least one of those of the physiological measures, which each relate to a same type of physiometry, and those of the physiological measures, which each relate to a different type of physiometry are sampled. A status for the patient is determined through analysis of the sampled physiological measures assembled from a plurality of recordation points. The sampled physiological measures are evaluated. Trends that are indicated by the patient status, 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 periodically collect patient data on a long-term, daily basis, wherein the implantable medical device is further configured to store a collected measures set containing a portion of the patient data;

a comparison module configured to receive the collected measures set and compare the collected measures set to a second collected measures set containing comparison data to determine a trend in the patient data;

an analysis module configured to generate a patient status indicator based on the trend; and

a feedback module configured to provide a notification of a potential medical concern based on the patient status indicator, wherein the patient data comprises the number of device interventions made, the type of device interventions made, and the relative success of any interventions made on a per heartbeat or binned average basis.

2. The system of claim 1, wherein the comparison data in the second collected measures set 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 3, wherein the collection client is selected from the group consisting of:

a programmer, interrogator, recorder, monitor, telemetered signals transceiver, personal computer, digital data processor, and combinations thereof.

5. The system of claim 1, wherein the implantable medical device is further configured to provide cardiac pacing and defibrillation.

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, further comprising a programmer configured to retrieve and display patient data from the implantable medical device.

8. 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.

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

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

periodically collecting, by an implantable medical device, patient data on a long-term, daily basis;

storing, by the implantable medical device, a collected measures set containing a portion of the patient data;

receiving, by a comparison module, the collected measures set and comparing the collected measures set to a second collected measures set containing comparison data to determine a trend in the patient data;

generating, by an analysis module, a patient status indicator based on the trend; and

providing, by a feedback module, a notification of a potential medical concern based on the patient status indicator, wherein the patient data comprises the number of device interventions made, the type of device interventions made and the relative success of any interventions made on a per heartbeat or binned average basis.

11. The method of claim 10, wherein the comparison data in the second collected measures set comprises averaged measures.

12. The method of claim 10, 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.

13. The method of claim 12, wherein the collection client is selected from the group consisting of:

a programmer, interrogator, recorder, monitor, telemetered signals transceiver, personal computer, digital data processor, and combinations thereof.

14. The method of claim 10, providing cardiac pacing and defibrillation by the implantable medical device.

15. The method of claim 10, 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.

16. The method of claim 10, further comprising retrieving and displaying patient data from the implantable medical device by a programmer.

17. The method of claim 10, further comprising storing battery status data by the medical device and providing notification of the battery status by the feedback module.

18. The method of claim 10, 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.