Pacemaker system with enhanced programmable modification capacity

• US 5,843,138 A
• Filed: 07/09/1997
• Issued: 12/01/1998
• Est. Priority Date: 07/09/1997
• Status: Expired due to Term

• Current Assignee: Vitatron Medical BV
• Original Assignee: Vitatron Medical BV
• Inventors: Evers, Xander, Begemann, Malcolm J.S., van der Veen, Johannes S.
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US08/890,435
• Time in Patent Office: 510 Days
• Field of Search: 607/30, 607/31, 607/32, 607/9
• US Class Current: 607/30
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• 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

Abstract

A pacemaker system is provided which provides for more flexibility in re-programming of the control software, or program which is controlling an implanted pacemaker. The system comprises an external programmer device which is capable both of programming the implanted device in a conventional way, and also downloading new control software to the implanted device, subject to predetermined system conditions. All implanted devices, e.g., pacemakers within the system of the invention, share a hardware platform, and are identified as belonging to a given one of a plurality of groups, each group being characterized as providing therapy aimed at a different condition. Each pacemaker also carries type data, indicating the type of pacemaker within the group, and a set of permissions data representative of different types within the group to which it is permitted to be programmed. Upon interrogating the implanted device, the programmer determines whether the device is part of the system, what its group and type is, and whether it is able to modify the device.

Claims

1. A cardiac pacemaker system, said system having an implantable pacemaker and an external programmer, wherein

said pacemaker comprises pace means for generating pacing pulses, control means for controlling operation of said pacemaker in accord with a stored device program, first memory means for storing said device program, second memory means for storing device data representative of said implantable pacemaker, and transceiver means for transmitting data to and receiving data from said external programmer;

and

said external programmer comprises programming means for programming pacemakers, storage means for storing at least a second device program, means for obtaining said device data and determining whether said implantable pacemaker can be programmed by said programmer, option means for presenting an option to download said device with another program when said pacemaker can not be programmed, and downloading means for exercising said option and for downloading said implantable device with said second device program.

2. The system as described in claim 1, wherein said external programmer comprises device data means for storing data representative of a plurality of device programs with each said program rated in accordance with a predetermined hierarchy, and wherein said downloading means permits downloading of said second device program to said implantable pacemaker when it is of a lower rating than the device program that had been stored in said pacemaker.

3. The system as described in claim 1, wherein said second memory means comprises group means for storing data representing a group of pacemaker types, each respective type in said group corresponding to a respective said device program, and type means for storing permission data representative of types corresponding to device programs which said implantable pacemaker is permitted to use.

4. The system as described in claim 3, wherein said external programmer comprises program storage means for storing a plurality of respective device programs, and restricting means for restricting which of said device programs can be downloaded to said implantable pacemaker based on said permission data.

5. The system as described in claim 4, wherein said program storage means stores a plurality of device programs corresponding to different groups, and wherein said restricting means enables downloading of only device programs corresponding to device types of the group of said implantable pacemaker.

6. A method of changing a control program stored in an implanted medical device, comprising:

storing in said device permission data representative of a set of permitted control programs;

using an external programmer having the capacity of downloading to said device a control program;

interrogating said device with said external programmer to obtain said permission data, and determining therefrom said set of permitted control programs;

comparing said selected control program with said determined set of control programs; and

downloading said selected control program to said device only when it is included in said set.

7. The method as described in claim 6, wherein said programmer has means for ranking the respective control programs of said set in a hierarchy, and enabling means for enabling changing the control program of said device only when said change is an upgrade in terms of said ranking.

8. The method as described in claim 6, comprising downloading changed permission data to said device, thereby changing the set of control programs that can be downloaded to said device.

9. The method as described in claim 6, comprising interrogating said device to determine the control program it is using, storing an upgrade control program in said programmer for upgrading a device which is using a predetermined program, and automatically downloading said upgrade control program to said device when it is determined to be using said predetermined program.

10. A system for controlled changing of a control program stored in an implantable pacemaker, comprising:

an implantable pacemaker, said pacemaker having stimulus means for generating stimulus pulses,

control means for controlling the operation of said pacemaker, said control means comprising memory for storing a device program and processor means for carrying out pacemaker functions in accord with said program,

set means for storing permission data representing a set of respective device programs which said pacemaker is permitted to use, and

device transceiver means for receiving program changes from an external programmer, and for transmitting data representative of said device permission set to said external programmer; and

an external programmer having memory means for storing at least one device program,

programmer transceiver means for transmitting data to and receiving data from a said implanted pacemaker,

determining means for obtaining said permission data and for determining from said permission data whether said at least one device program is permitted for use by said pacemaker, and

downloading means for downloading said at least one program to said implantable pacemaker.

11. The system as described in claim 10, wherein said external programmer comprises memory means for storing a plurality of device programs, each of said plurality of programs being associated within a respective set of programs.

12. The system as described in claim 10, wherein said programmer has permission change means for changing the permitted device set of an implanted pacemaker as a function of the permission data obtained from a said pacemaker.

13. The system as described in claim 10, wherein said permission data represents a grade hierarchy of permitted programs, whereby each of said programs is ranked in grade with respect to the other programs in the set.

14. The system as described in claim 13, wherein said downloading means comprises display means for displaying a message before enabling downloading of a program which is a downgrading of rank of the stored program.

15. The system as described in claim 14, wherein said external programmer comprises means for determining when a pacemaker is to be upgraded to another program, and wherein said downloading means comprises automatic upgrading means for upgrading the device program in an implanted pacemaker when an upgrading determination is made.

16. The system as described in claim 10, wherein said set means comprises a stored bit of data corresponding to each possible device program.