ACTIVE MEDICAL IMPLANT

• US 20090012575A1
• Filed: 07/03/2008
• Published: 01/08/2009
• Est. Priority Date: 07/06/2007
• Status: Active Grant

• Current Assignee: Biotronik SE & Company KG
• Original Assignee: Biotronik VI Patent AG (Biotronik SE & Company KG)
• Inventors: Kukla, Volker, Depping, Nicole, Reinke, Joachim
• Granted Patent: US 8,655,447 B2
• Time in Patent Office: Days
• US Class Current: 607/30
• 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

Abstract

The invention consists of a system for remote programming of an implantable medical device such as a heart pacemaker, defibrillator or the like, wherein the system includes a programmable personal device (e.g., an implant) and a service center. The service center has a programming monitoring unit which determines a programming time endpoint which depends on the point in time at which a programming order was sent to the implant, and which cancels or deletes the programming order if the service center has not received a programming confirmation confirming successful receipt, execution, and/or forwarding of the programming order by the implant by the programming time endpoint.

Claims

1. A system for remote programming of a programmable personal medical device including:

a. a programmable personal device (10, 20) and

b. a service center (30),

wherein

(1) the programmable personal device has;

(a) a data communications interface providing at least indirect connection of the programmable personal device to the service center (30), and

(b) a programmable controller controlling functions of the programmable personal device;

(2) the service center (30) has;

(a) a data communications interface providing at least indirect connection of the service center (30) to the programmable personal device, and

(b) a user interface which

(i) compiles programming orders for the programmable personal device, and

(ii) sends compiled programming orders,

and further wherein;

I. the service center (30) has a programming monitoring unit (40) which;

a. determines an ending point in time for programming which depends on the point in time of sending the programming order, and

b. cancels the programming order or deletes it if the service center (30) has not received a confirmation of programming confirming successful execution of the programming order by the programmable personal device by the ending point in time for programming, and

II. the programmable personal device sends a confirmation of programming to the service center (30);

a. after receiving a programming order, or

b. after successfully forwarding a programming order.

2. The system of claim 1 wherein:

a. the programmable personal device is an intermediate patient device (20), and

b. the intermediate patient device (20) includes a short_range wireless interface for data communication with an implant (10).

3. The system of claim 2 wherein the intermediate patient device (20):

a. forwards a received programming order to an implant (10) assigned to the programmable personal device (20), and

b. with each forwarding, sends a forwarding confirmation to the service center (30), the forwarding confirmation defining a confirmation of programming.

4. The system of claim 2 wherein the programmable personal device sends a confirmation of receipt to the service center (30) after receipt of a programming order, the confirmation of receipt defining a confirmation of programming.

5. The system of claim 3 wherein the programmable personal device adds a time stamp to the confirmation of programming, the time stamp being at least partially determined by:

a. the point in time of forwarding of the programming order, or

b. the point in time of receipt of the programming order.

6. The system of claim 1 wherein the programmable personal device is an implant (10) which, upon receiving a programming order, then sends a confirmation of receipt defining a confirmation of programming.

7. The system of claim 6:

a. further including an intermediate patient device (20),

b. wherein;

(1) the implant (10) has a data communications interface providing bidirectional data communication with the intermediate patient device (20), through which the implant (10) receives a programming order from the intermediate patient device (20), and then sends a confirmation of receipt to the intermediate patient device, and

(2) the intermediate patient device (20) then forwards a confirmation of receipt of the implant (10) to the central service center (30), the confirmation of receipt defining a confirmation of programming.

8. The system of claim 6 wherein the implant (10):

a. attempts execution of a received programming order, and

b. in the case of successful execution, sends a message of success to the programmable personal device,

wherein the programmable personal device thereafter forwards a message of success of the implant to the central service center (30), the message of success defining a confirmation of programming.

9. The system of claim 8 wherein:

a. the programmable implant (10) also sends a message of failure to the programmable personal device in the case of unsuccessful execution, and

b. the programmable personal device thereafter forwards a message of failure of the implant to the central service center (30), the message of failure defining a confirmation of programming.

10. The system of claim 7 wherein either the implant or the programmable personal device adds a time stamp to the confirmation of programming.

11. The system of claim 1 wherein the programming monitoring unit (40):

a. stores the status of the transmission and execution of a programming order, and

b. updates the status on the basis of incoming confirmations of programming.

12. The system of claim 11 wherein the programming monitoring unit (40) stores both:

a. the last status of the transmission and execution of the programming order, and

b. prior statuses of the transmission and execution of prior programming orders,

together with time stamps associated with the statuses.

13. The system of claim 1 wherein the programming monitoring unit (40):

a. is connected to a database (34), and

b. determines multiple ending points in time for programming for;

(1) one or more programmable personal devices, and/or

(2) one or more transmission steps or execution steps of a programming order, and

c. assigns corresponding confirmations of programming with time stamps to the multiple ending points.

14. The system of claim 13 wherein the user interface:

a. is defined by a remote programming application (58) running on a device (50) remote from the service center (30), and

b. allows programming of multiple different programmable personal devices, and

c. has an input interface for selection of a programmable personal device, and for compilation of a programming order for a selected programmable personal device.

15. The system of claim 14 wherein the remote programming application (58) has an input unit for entering one or more ending points in time for programming for a respective programming order.

16. A system for remote programming of a programmable personal medical device including:

a. an implant (10) at least partially situated within the body of a patient;

the implant having;

(1) a programmable controller controlling at least some functions of the implant (10) in accordance with programming orders;

(2) an implant data communications interface;

(a) receiving the programming orders to be executed by the programmable controller, and

(b) sending a confirmation of programming after one or more of;

i. receipt of the programming orders, and

ii. successful execution of the programming orders by the programmable controller;

b. a service center (30) remote from the implant (10), the service center having;

(1) a service center data communications interface sending the programming orders to the implant data communications interface;

(2) a programming monitoring unit (40) which;

a. sets an ending point in time for programming, the ending point being dependent on the point in time at which the service center data communications interface sends the programming orders to the implant data communications interface, and

b. cancels or deletes the programming orders if the service center (30) has not received the confirmation of programming by the ending point in time for programming.

17. The system of claim 16 further including one or more intermediate devices (20) spaced between the implant (10) and the service center (30), wherein each intermediate device relays programming orders from the service center (30) toward the implant (10).

18. The system of claim 17 wherein each intermediate patient device (20), upon at least one of:

a. receipt of programming orders from the service center (30), and

b. forwarding of programming orders toward the implant (10), sends a confirmation of programming to the service center (30), wherein the confirmation of programming is indicative of the receipt or forwarding of the programming orders.

19. The system of claim 18 wherein each intermediate patient device (20) adds a time stamp to any confirmation of programming sent by the intermediate patient device (20).

20. A method for remote programming of a programmable personal medical device including the steps of:

a. selecting a programmable personal device to be programmed,

b. compiling a programming order for the selected programmable personal device,

c. determining at least one ending point in time for programming for the programming order, by which ending point at least one of;

(1) transmission of the programming order, and/or

(2) execution of the programming order, is to be concluded,

d. monitoring a respective ending point in time for programming by receiving and analyzing corresponding confirmations of programming, and

e. deleting or cancelling a programming order if a confirmation of programming belonging to a respective ending point in time for programming has not been received by this ending point in time for programming.