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OPTIMIZATION OF TIMING FOR DATA

COLLECTION AND ANALYSIS IN
ADVANCED PATIENT MANAGEMENT
SYSTEM

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TECHNICAL FIELD

The present disclosure relates generally to advanced patient management systems. More particularly, the present disclosure relates to the optimization of the timing for data 10 collection and analysis in advanced patient management systems.

BACKGROUND

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Management of patients with chronic disease consumes a significant proportion of the total health care expenditure in the United States. Many of these diseases, such as heart disease, are widely prevalent and have significant annual incidences as well. Patients with chronic heart disease can 20 receive implanted cardiac rhythm management (CRM) devices such as pacemakers, implantable cardioverter defibrillators (ICDs), and heart failure cardiac resynchronization therapy (CRT) devices to provide treatment for the disease. 25

Advanced patient management (APM) systems allow caregivers to remotely gather and analyze data associated with a patient and the patient's CRM device. APM systems provide a vast amount of information to the caregiver in an automated manner. This information can provide insights into a patient's 30 well being and help the caregiver predict significant changes in a patient's health, such as a decompensation event associated with a heart attack. However, the time lag between when data is updated on a CRM device and when it is collected, analyzed, and presented for review by the APM system can 35 reduce the timeliness of the information provided to the caregiver.

For example, CRM devices can update device data stored in the CRM device memory at periodic intervals, such as once per day. One example of device data that can be updated 40 periodically by a CRM device is heart rate variability. For example, the CRM device can be programmed to update an average heart rate variability for a patient once per day. The timing for these device updates is usually arbitrarily set at the time at which the CRM device is originally initiated prior to 45 or at the time of implantation. There can be a significant time lag due to a lack of coordination between the device data update time by a CRM device and the time at which an APM system collects data from (e.g., interrogates) the device.

For example, a CRM device can be arbitrarily set to update 50 device data at time-of-day A in day 1, as shown in FIG. 1. Assume that the APM system interrogates the CRM device at time-of-day B in day 2, and that the caregiver accesses the APM system to review the information that the APM system has collected from the device and analyzed at time-of-day C. 55 Although the entire interval or lag D between device data (time-of-day A) and caregiver review (time-of-day C) spans two days, it is a relatively short period, so that the caregiver is reviewing recently acquired and analyzed information.

However, in another example shown in FIG. 2, assume 60 again that the CRM device is arbitrarily set to update device data at time-of-day A earlier in day 1, and that the APM system interrogates the CRM device at time-of-day B in day 2. Also assume that the caregiver does not review the information on the APM system until later at time-of-day C. In this 65 scenario, lag D is more significant, resulting in less-timely information being provided to the caregiver. In a worst-case

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scenario based on daily device updates and interrogations, the caregiver could be presented with information that is fortyeight (48) hours old. It is desirable to minimize lag D so that the caregiver is given data that is as current as possible so that the caregiver can make timely decisions regarding a patient's health.

In addition to the potential time lag problems associated with the collection of data, an APM system can potentially be used to analyze data associated with thousands or millions of patients at any given time. It is therefore desirable to optimize analysis of data on the APM system such that the APM system can efficiently analyze each patient's data while presenting current data to each, caregiver as the caregiver accesses the APM system.

SUMMARY

The present disclosure relates generally to advanced patient management systems. More particularly, the present disclosure relates to the optimization of the timing for data collection and analysis in advanced patient management systems.

According to one aspect, an advanced patient management system includes a unit for collecting data from a device associated with a patient, and a host in communication with the unit, the host identifying a time for the unit to collect data from the device.

According to another aspect, a method for collecting and analyzing data associated with a device of a patient by an advanced patient management system includes: identifying a time period during which the device is most likely to be available for data collection, setting a device update time based on the time period during which the device is most likely to be available for data collection, and setting a data collection time based on the time period during which the device is most likely to be available for data collection.

According to yet another aspect, a method for gathering and processing data associated with a device of a patient by an advanced patient management system includes: identifying a time period during which data associated with the patient is most likely to be accessed by a caregiver, setting an analysis time for the data based on the time period during which the data associated with the patient is most likely to be accessed, and analyzing the data at the analysis time.

The above summary is not intended to describe each disclosed embodiment or every implementation of the present invention. The figures and the detailed description that follow further describe these embodiments.

DESCRIPTION OF THE DRAWINGS

Aspects of the invention may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which:

FIG. 1 illustrates an example timeline for device data update, interrogation, and review of data associated with a patient's device;

FIG. 2 illustrates another example timeline for device data update, interrogation, and review of data associated with a patient's device;

FIG. 3 illustrates an example advanced patient management system;

FIG. 4 illustrates another example timeline for device data update, interrogation, and review of data associated with a patient's device; and

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FIG. 5 illustrates an example method for an advanced patient management system.

While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in 5 detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention. 10

DETAILED DESCRIPTION

The present disclosure relates generally to advanced patient management systems. More particularly, the present 15 disclosure relates to the optimization of the timing for data collection and analysis in advanced patient management systems.

The term "patient" is used herein to mean any individual from whom information is collected. The term "caregiver" is 20 used herein to mean any provider of services, such as health care providers including, but not limited to, nurses, doctors, and other health care provider staff.

FIG. 3 illustrates an example advanced patient management system 100 made in accordance with the present inven- 25 tion. Advanced patient management (APM) system 100 generally includes the following components: a device 102, an interrogator/transceiver unit 108, a communication system 200, a host 300, and a computer system 400. Each component of the APM system 100 can communicate using the commu- 30 nication system 200. Some components may also communicate directly with one another.

Device 102 can be an implantable device or an external device that provides one or more of the following functions with respect to a patient: (1) sensing, (2) data analysis, and (3) 35 therapy. For example, in one embodiment, device 102 is either an implanted or external device used to measure a variety of physiological, subjective, and environmental conditions of a patient using electrical, mechanical, and/or chemical means. Device 102 can be configured to automati- 40 cally gather data or can require manual intervention by the patient. Device 102 can be configured to store data related to the physiological and/or subjective measurements and/or transmit the data to the communication network 200 using a variety of methods, described in detail below. Although a 45 single device 102 is illustrated in the example embodiment shown, more devices can be used for a given patient.

In the example shown, device 102 is a cardiac rhythm management (CRM) device that is implanted within a patient. Examples of CRM devices include pacemakers, cardiac 50 resynchronization management devices, defibrillators, etc. CRM devices can have the ability to sense and communicate, and may also provide therapy.

In the example shown, device 102 is configured to periodically update data associated with the patient and/or device 55 (collectively referred to as "device data") and store this data in memory. These device data updates can, for example, be configured to occur hourly, daily, weekly, or monthly. In the examples shown, device 102 is configured to update device data daily. For example, device 102 can be configured to 60 update physiological measurements associated with a patient at a given time each day. Examples of such physiological measurements include, without limitation, electrical cardiac activity (e.g., heart rate, heart rate variability, etc.), transpulmonary impedance, physical motion, temperature, activ- 65 ity, blood pressure, breathing patterns, ejection fractions, blood viscosity, blood chemistry, and blood glucose levels.

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The time-of-day at which these device data updates occur is typically initially set prior to or at implantation of device 102. See, e.g., time-of-day A shown in FIGS. 1 and 2 described above. The time-of-day can be reset after implantation by, for example, APM system 100, as described further below.

The example advanced patient management system 100 also includes one or more interrogator/transceiver units ("ITUs"), such as example ITU 108. The ITU 108 can perform one or more of the following functions: (1) data retrieval; (2) data storage; (3) data analysis; and (4) data communication. For example, the ITU 108 facilitates communications between the device 102 and the host 300 using the communication system 200. The ITU 108 can, periodically or in real-time, collect and download into memory (e.g., interrogate) clinically relevant patient data from device 102. This data can include, in the CRM device context, for example, P and R-wave measurements, other physiological data (e.g., HRV, activity, heart rates, etc.), pacing, shocking events, lead impedances, pacing thresholds, battery voltage, capacitor charge times, ATR episodes with electrograms, tachycardia episodes with electrograms, histogram information, and any other clinical information necessary to ensure patient health and proper device function. The ITU 108 can also be configured to ask the patient to report symptoms or current quality of life indications. The data is sent to the ITU 108 by the device 102 in real-time or is periodically uploaded from buffers in the CRM device.

In the examples described herein, a single ITU 108 is described that is located in the home of a patient. The device 102 is therefore generally available for interrogation by the ITU 108 when the patient is at home. In other embodiments, multiple ITUs 108 can be placed, for example, at home and at work so that the availability for interrogation of device 102 is increased.

Additional details regarding an ITU, such as ITU 108, and how an ITU can function as part of an APM system, such as APM system 100, can be found in U.S. patent application Ser. No. 10/330,677, filed on Dec. 27, 2002 and entitled "Advanced Patient Management System Including Interrogator/Transceiver Unit," the entirety of which is hereby incorporated by reference.

Communication system 200 provides for communications between and among the various components of the APM system 100, such as the device 102, ITU 108, host 300, and computer system 400. Communications system 200 can be, for example, a local area network (LAN), wide area network (WAN), or the Internet. A variety of communication methods and protocols can be used to facilitate communication between device 102, ITU 108, communication system 200, host 300, and computer system 400. For example, wired and wireless communications methods can be used. Wired communication methods include, for example and without limitation, traditional copper-line communications such as DSL, broadband technologies such as ISDN and cable modems, and fiber optics. Wireless communication methods include cellular, satellite, radio frequency (RF), Infrared, etc.

In the example embodiment illustrated, host 300 includes one or more computers that store patient information in one or more databases. Host 300 also analyzes the data related to a patient and provides timely and predictive assessments of the patient's well-being. For example, host 300 can store historical data associated with a patient, as well as new data that is transmitted by ITU 108 to host 300. Host 300 can analyze this data and present the analyzed data to the caregiver in one or more formats, as described below. For example, host 300 can compare new heart rate variability data from the CRM device

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