CONDITIONAL REQUIREMENTS FOR REMOTE MEDICAL DEVICE PROGRAMMING

• US 20090281598A1
• Filed: 06/18/2009
• Published: 11/12/2009
• Est. Priority Date: 06/18/2004
• Status: Abandoned Application

• Current Assignee: Christopher M. Peterson, David S. Jennings, Gregory J. Haubrich, James E. Willenbring, Javaid Masoud, John P. Vandanacker
• Original Assignee: Christopher M. Peterson, David S. Jennings, Gregory J. Haubrich, James E. Willenbring, Javaid Masoud, John P. Vandanacker
• Inventors: Masoud, Javaid, Petersen, Christopher M., Willenbring, James E., Haubrich, Gregory J., VanDanacker, John P., Jennings, David S.
• Application Number:
  US12/486,779
• Publication Number:
  US 20090281598A1
• Time in Patent Office: Days
• US Class Current: 607/60
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
• CPC Class Codes: A61N 1/37254 Pacemaker or defibrillator security, e.g. to prevent or inhibit programming alterations by hackers or unauthorised individuals
• 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 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A remote programming method is provided for safe and secure programming of a medical device at a remote location. A centralized programming instrument for use by a clinician or third party is provided with a network communication connection with a remote external medical device, such as a home programmer or monitor. The external medical device is located in the vicinity of a patient having an implantable medical device (IMD) and is in bi-directional telemetric communication with the IMD to allow instructions received from the centralized programming instrument to be transferred to the IMD. The remote programming method used for transferring information between the central programming instrument and an IMD includes measures to promote safe and secure remote programming of the IMD, which measures may include authorization requirements, programming condition requirements, implementation of programmed data requirements, and maintenance of a remote programming log.

Claims

1. A system for remotely programming a medical device, comprising:

a centralized programming instrument;

a data communications network;

a programmable medical device capable of communicating with the centralized programming instrument via the data communications network; and

a verification module for determining if one or more remote programming requirements are satisfied and, if the one or more remote programming requirements are satisfied, allowing a remote programming instruction set to be transferred from the centralized programming instrument to the remote medical device wherein the remote programming instruction set is implemented by the remote medical device and, if the one or more remote programming requirements are not satisfied, preventing a set of remote programming instructions from being transferred to or implemented by the remote medical device.

2. The system of claim 1 wherein at least a portion of the verification module is implemented in the centralized programming instrument.

3. The system of claim 1 wherein at least a portion of the verification module is implemented in the remote medical device.

4. The system of claim 1 wherein at least a portion of the verification module is implemented in the data communications network.

5. A system for remotely programming a medical device, comprising:

means for generating a remote programming instruction set;

means for transmitting the remote programming instruction set from the generating means to the medical device;

means for verifying one or more predetermined remote programming requirements are satisfied, wherein, if one or more remote programming requirements are satisfied, verifying means allows the remote programming instruction set to be transferred from the generating means to the medical device and implementation of the remote programming instruction set by the medical device, and, if one or more remote programming requirements are not satisfied, verifying means prevents a set of remote programming instructions from being transferred to or implemented by the remote medical device.

6. A computer readable medium containing instructions that when implemented in a medical device programming system, cause the system to:

determine if one or more predetermined remote programming requirements are satisfied;

allow a remote programming instruction set generated by a centralized programming instrument to be transferred to and implemented by a medical device if one or more remote programming requirements are determined to be satisfied; and

prevent the remote programming instruction set to be transferred to or implemented by the medical device if one or more remote programming

requirements are determined not to be satisfied.