Medical implant and method for secure implant communication

• US 8,644,929 B2
• Filed: 06/26/2012
• Issued: 02/04/2014
• Est. Priority Date: 07/06/2011
• Status: Active Grant

• Current Assignee: Biotronik SE & Company KG
• Original Assignee: Biotronik SE & Company KG
• Inventors: Diebold, Michael
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US13/533,203
• Publication Number:
  US 20130013016A1
• Time in Patent Office: 588 Days
• Field of Search: 607/18
• US Class Current: 607/18
• CPC Class Codes: A61N 1/37254 Pacemaker or defibrillator security, e.g. to prevent or inhibit programming alterations by hackers or unauthorised individuals

Abstract

An implantable medical device includes a telemetry unit wirelessly receiving data signals and control commands; a control unit connected to the telemetry unit; and a comparator unit which compares data signals received via the telemetry unit with data signals generated in or detected by the implantable medical device. Each of the data signals represents specific features, e.g., patient characteristics. The comparator unit generates a release signal if data signals received via the telemetry unit represent one or more features that are similar, according to a specified similarity measure, to one or more features represented by data signals generated in or detected by the implantable medical device. The control unit executes control commands received via the telemetry unit, or receives control commands via the telemetry unit, in response to such a release signal (or, in the absence of the release signal, does not execute or receive control commands).

Claims

1. An implantable medical device including:

a. a telemetry unit configured to wirelessly receive data signals and control commands, and

b. a control unit;

(1) connected to the telemetry unit, and

(2) including a comparator unit configured to;

(a) compare data signals received via the telemetry unit over a period with data signals generated in or detected by the implantable medical device over the same period, and

(b) generate a release signal if the data signals received via the telemetry unit over the period represent one or more features that are similar, according to a defined similarity measure, to one or more features represented by the data signals generated in or detected by the implantable medical device over the same period,

wherein the control unit is configured to;

i. execute control commands received via the telemetry unit in response to the release signal, and

ii. not execute control commands received via the telemetry unit if no release signal is generated.

2. The implantable medical device of claim 1:

a. further including a detection unit connected to the control unit, the detection unit being configured to;

(1) detect current cardiac rhythm signals, and

(2) generate current data signals therefrom,

b. the control unit is configured to;

(1) compare data signals received via the telemetry unit with the current data signals, and

(2) generate a release signal if the data signals received via the telemetry unit represent a cardiac rhythm that is similar, according to a specified similarity measure, to the cardiac rhythm signals represented by the current data signals,

(3) execute control commands received via the telemetry unit, and/or receive control commands via the telemetry unit, in response to the release signal.

3. The implantable medical device of claim 1 wherein the implantable medical device is an implantable cardiac stimulator.

4. The implantable medical device of claim 1 in combination with an external device including:

a. a telemetry interface configured to wirelessly transmit data signals and control commands,

b. a detection unit configured to;

(1) detect a set of features over the period, wherein the set is patient-specific or is generated by an implantable medical device, and

(2) transmit data signals that represent the set of features detected over the period via the telemetry interface to the implantable medical device.

5. The implantable medical device of claim 4 wherein the detection unit is configured to detect a set of features that represents a patient'"'"'s cardiac rhythm over the period.

6. The implantable medical device of claim 5 wherein the detection unit is configured to detect a patient'"'"'s superficial electrocardiogram as the set of features.

7. An implantable medical device including:

a. a telemetry unit configured to wirelessly receive data signals and control commands;

b. a pulse generator configured to generate sub-threshold electrical pulses;

(1) dimensioned such that they do not stimulate muscle cells, and

(2) in a sequence that represents a non-guessable sequence of features;

c. a control unit;

(1) connected to the telemetry unit, and

(2) including a comparator unit configured to;

(a) compare data signals received via the telemetry unit over a period with data signals generated in or detected by the implantable medical device over the same period, and

(b) generate a release signal if the data signals received via the telemetry unit over the period represent one or more features that are similar, according to a defined similarity measure, to one or more features represented by the data signals generated in or detected by the implantable medical device over the same period;

wherein the control unit is configured to;

i. execute control commands received via the telemetry unit, and/or

ii. receive control commands via the telemetry unit, in response to the release signal.

8. The implantable medical device of claim 7:

a. further including a feature sequence generator;

(1) connected to the pulse generator, and

(2) configured to generate a non-gues sable set of features,

b. wherein the pulse generator is configured to generate sub-threshold current or voltage pulses that represent the non-gues sable sequence of features.

9. An implantable medical device including:

a. a telemetry unit configured to wirelessly receive data signals and control commands; and

b. a control unit;

(1) connected to the telemetry unit, and

(2) including a comparator unit configured to;

(a) compare data signals received via the telemetry unit over a period with data signals generated in or detected by the implantable medical device over the same period, and

(b) generate a release signal if the data signals received via the telemetry unit over the period represent one or more features that are similar, according to a defined similarity measure, to one or more features represented by the data signals generated in or detected by the implantable medical device over the same period;

wherein the control unit is configured to;

i. execute control commands received via the telemetry unit, and/or

ii. receive control commands via the telemetry unit, in response to the release signal;

wherein the data signals generated in or detected by the implantable medical device over the same period contain time stamp signals;

I. assigned to individual features in the one or more features represented by the data signals generated in or detected by the implantable medical device over the same period, and

II. that indicate the instant at which a feature occurred or was detected according to a timer internal to the implantable medical device.

10. An implantable medical device in combination with an external device,

a. the implantable medical device including:

(1) a telemetry unit configured to wirelessly receive data signals and control commands; and

(2) a control unit;

(a) connected to the telemetry unit, and

(b) including a comparator unit configured to;

(i) compare data signals received via the telemetry unit over a period with data signals generated in or detected by the implantable medical device over the same period, and

(ii) generate a release signal if the data signals received via the telemetry unit over the period represent one or more features that are similar, according to a defined similarity measure, to one or more features represented by the data signals generated in or detected by the implantable medical device over the same period; and

c. the external device including;

(1) a telemetry interface configured to wirelessly transmit data signals and control commands; and

(2) a detection unit configured to;

(a) detect a set of features over the period, wherein the set is patient-specific or is generated by an implantable medical device, and

(b) transmit data signals that represent the set of features detected over the period via the telemetry interface to the implantable medical device;

c. wherein;

(1) the control unit is configured to;

(a) execute control commands received via the telemetry unit, and/or

(b) receive control commands via the telemetry unit, in response to the release signal;

(2) the detection unit is configured to detect a set of features that represents a patient'"'"'s cardiac rhythm over the period; and

(3) the detection unit is configured to detect sounds of a patient'"'"'s heart as the set of features.

11. An implantable medical device in combination with an external device,

a. the implantable medical device including:

(1) a telemetry unit configured to wirelessly receive data signals and control commands; and

(2) a control unit;

(a) connected to the telemetry unit, and

(b) including a comparator unit configured to;

(i) compare data signals received via the telemetry unit over a period with data signals generated in or detected by the implantable medical device over the same period, and

(ii) generate a release signal if the data signals received via the telemetry unit over the period represent one or more features that are similar, according to a defined similarity measure, to one or more features represented by the data signals generated in or detected by the implantable medical device over the same period; and

c. the external device including;

(1) a telemetry interface configured to wirelessly transmit data signals and control commands; and

(2) a detection unit configured to;

(a) detect a set of features over the period, wherein the set is patient-specific or is generated by an implantable medical device, and

(b) transmit data signals that represent the set of features detected over the period via the telemetry interface to the implantable medical device;

c. wherein;

(1) the control unit is configured to;

(a) execute control commands received via the telemetry unit, and/or

(b) receive control commands via the telemetry unit, in response to the release signal; and

the detection unit is configured to detect sub-threshold current or voltage pulses on a patient'"'"'s body as the set of features.

12. An implantable medical device in combination with an external device,

a. the implantable medical device including:

(1) a telemetry unit configured to wirelessly receive data signals and control commands; and

(2) a control unit;

(a) connected to the telemetry unit, and

(b) including a comparator unit configured to;

(i) compare data signals received via the telemetry unit over a period with data signals generated in or detected by the implantable medical device over the same period, and

(ii) generate a release signal if the data signals received via the telemetry unit over the period represent one or more features that are similar, according to a defined similarity measure, to one or more features represented by the data signals generated in or detected by the implantable medical device over the same period; and

c. the external device including;

(1) a telemetry interface configured to wirelessly transmit data signals and control commands; and

(2) a detection unit configured to;

(a) detect a set of features over the period, wherein the set is patient-specific or is generated by an implantable medical device, and

(b) transmit data signals that represent the set of features detected over the period via the telemetry interface to the implantable medical device;

c. wherein;

(1) the control unit is configured to;

(a) execute control commands received via the telemetry unit, and/or

(b) receive control commands via the telemetry unit, in response to the release signal; and

(2) the telemetry unit of the implantable medical device and the telemetry interface of the external device are configured to perform data communication in the MICS frequency band.

13. The implantable medical device of claim 12 further including a second external device which includes a detection unit as recited in claim 4.

14. An implantable medical device in combination with an external device,

a. the implantable medical device including:

(1) a telemetry unit configured to wirelessly receive data signals and control commands; and

(2) a control unit;

(a) connected to the telemetry unit, and

(b) including a comparator unit configured to;

(i) compare data signals received via the telemetry unit over a period with data signals generated in or detected by the implantable medical device over the same period, and

(ii) generate a release signal if the data signals received via the telemetry unit over the period represent one or more features that are similar, according to a defined similarity measure, to one or more features represented by the data signals generated in or detected by the implantable medical device over the same period; and

c. the external device including;

(1) a telemetry interface configured to wirelessly transmit data signals and control commands,

(2) a detection unit configured to;

(a) detect a set of features over the period, wherein the set is patient-specific or is generated by an implantable medical device, and

(b) transmit data signals that represent the set of features detected over the period via the telemetry interface to the implantable medical device;

c. wherein;

(1) the control unit is configured to;

(a) execute control commands received via the telemetry unit, and/or

(b) receive control commands via the telemetry unit, in response to the release signal; and

(2) the telemetry unit of the implantable medical device and the telemetry interface of the external device are configured to perform data communication using sub-threshold electrical pulses.

15. The implantable medical device of claim 14 further including a second external device which includes a detection unit as recited in claim 4.

16. An external device including:

a. a telemetry interface configured to wirelessly transmit data signals and control commands to an implantable medical device; and

b. a detection unit configured to;

(1) detect a set of features from a patient over a period, wherein the set is patient-specific or is generated by an implantable medical device; and

(2) transmit data signals that represent the set of features detected over the period via the telemetry interface to the implantable medical device;

wherein the detection unit is configured to detect;

i. a set of features that represents a patient'"'"'s cardiac rhythm over the period; and

ii. sounds of a patient'"'"'s heart as the set of features.

17. An external device including:

a. a telemetry interface configured to wirelessly transmit data signals and control commands to an implantable medical device; and

b. a detection unit configured to;

(1) detect a set of features from a patient over a period, wherein the set is patient-specific or is generated by an implantable medical device; and

(2) transmit data signals that represent the set of features detected over the period via the telemetry interface to the implantable medical device;

wherein;

i. the detection unit is configured to detect a set of features that represents a patient'"'"'s cardiac rhythm over the period; and

ii. the detection unit is configured to detect a patient'"'"'s superficial electrocardiogram as the set of features.

18. A method for initiating secure data communication between an implantable medical device and an external device, the method including the steps of:

a. obtaining a set of features using an implantable medical device, the set of features representing characteristics of a patient during a time period;

b. obtaining a set of features using an external device and generating data signals therefrom, the set of features representing characteristics of a patient over the same time period;

c. transmitting the data signals representing the set of features detected by the external device to the implantable medical device;

d. comparing the set of features obtained by the implantable medical device with the set of features represented by the data signals transmitted to the implantable medical device by the external device; and

e. only permitting the implantable medical device to execute control commands received from the external device if the data signals received by the implantable medical device represent one or more features that are similar, according to a defined similarity measure, to the set of features obtained by the implantable medical device.