Method and system of follow-up support for a medical device

• US 6,648,823 B2
• Filed: 07/31/2001
• Issued: 11/18/2003
• Est. Priority Date: 07/31/2001
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Thompson, David L.
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): McCrosky, David J.
• Application Number:
  US09/919,519
• Publication Number:
  US 20030028082A1
• Time in Patent Office: 840 Days
• Field of Search: 607/27, 607/29, 607/30, 607/59, 607/60, 714/47, 600/300, 600/301, 128/903, 128/904, 604/891.1, 604/502
• US Class Current: 600/300
• CPC Class Codes: A61B 2560/0271 using a remote monitoring unit
• 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: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: H04W 68/00 User notification, e.g. alerting and paging, for incoming communication, change of service or the like
• CPC Class Codes: Y10S 128/903 Radio telemetry

Abstract

A method and structure for notifying clinicians with patients with implantable medical devices (IMDs), about recalls and upgrades, therapy improvements, longevity estimates/improvements, and follow-up frequency recommendations is implemented in an interactive preferably wireless communications system involving a preferably web-enabled remote expert station. Either the clinician or the patient may initiate and access the remote expert station. During such communications, the patient'"'"'s IMDs are evaluated against a first database comprising patient data and a second database comprising statistical, survivability, probability projections. The patient or the clinician may also access a database containing patient-specific information including other device information. If one or more of the patient'"'"'s IMDs matches with a recalled or an up-gradable unit such message is posted to the clinician and the patient. Remedial action is taken, by replacing the unit, upgrading/reprogramming the unit, adjusting the patient'"'"'s follow-up timing to thereby ensure effective and safe therapy and clinical care.

Claims

1. An integrated bi-directional data communication and follow-up system far an implantable medical device (IMD) having a memory that stores device information, operational parameters including stored diagnostic data, physiological and medical data, and performance logs including battery status, the system comprising:

a remote expert station;

an external interface device in wireless data communication with the IMD and the remote expert station, the external Interface device including a data management system to enable data transfer and exchange between the IMD and the remote expert station;

a network enabling bi-directional communication between the IMD, said external interface device and said remote expert station;

means for reviewing said performance logs including battery status by comparing them to limits for the particular IMD and determining a projection of remaining IMD longevity in view of stored diagnostic data retrieved from the IMD; and

means for generating a recommendation for enhanced device longevity; and

wherein said means for reviewing performance log and said means for generating a recommendation for enhanced device longevity are implemented in one of said external interface device and said remote export station.

2. The system of claim 1 wherein said device data includes data relating to initial implant.

3. The system of claim 1 wherein said performance logs are reviewed by said means for reviewing on a periodic basis.

4. The system of claim 1 wherein said data management system includes statistical survival probability projection data based on the population of implanted medical devices related to the IMD.

5. The system of claim 4 wherein said data management system uses the projection date to generate an implanted medical device safety and performance data set and wherein said data management, system compares said performance logs against said generated performance data set.

6. The system of claim 5 wherein said data set is implemented to identify whether the IMD is out of specification.

7. The system of claim 1 wherein said means for updating includes upgrading/reprogramming the at least one IMD.