Single-use medical device

• US 7,236,827 B2
• Filed: 07/19/2002
• Issued: 06/26/2007
• Est. Priority Date: 07/20/2001
• Status: Expired due to Fees

• Current Assignee: Biotronik Mess-Und Therapiegeraete GmbH & Company Ingenieurbuero Berlin (Biotronik SE & Company KG)
• Original Assignee: Biotronik Mess-Und Therapiegeraete GmbH & Company Ingenieurbuero Berlin (Biotronik SE & Company KG)
• Inventors: Niewalda, Gregor, Schaldach, legal representative Jr., Schaldach, deceased, Vitt, Elmar
• Primary Examiner(s): Getzow; Scott M.
• Application Number:
  US10/200,567
• Publication Number:
  US 20030045903A1
• Time in Patent Office: 1,803 Days
• Field of Search: 607/62,63,27,37,38
• US Class Current: 607/27
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators

Abstract

An electrical therapy device has a blocking triggering unit and a re-use blocking unit. The re-use blocking unit prevents the functions of the electrical therapy device during implantation in dependence on the condition of the blocking triggering unit. The blocking triggering unit is triggered either upon implantation or explantation of the electrical therapy device. In some aspects, an electrical therapy device has a blocking triggering unit and a re-use blocking unit, wherein the re-use blocking unit prevents the functions of the electrical therapy device in dependence on the condition of the blocking triggering unit. The blocking triggering unit is triggered upon explantation of the electrical therapy device.

Claims

1. An electrical therapy device for implantation in a body, wherein the electrical therapy device is a pacemaker or a defibrillator capable of being connected to an electrode line upon implantation into said body, said electrical therapy device comprising:

a blocking triggering unit adapted to be triggered upon separation of said electrode line from the electrical therapy device, indicating explantation of the electrical therapy device from said body; and

a re-use blocking unit adapted to prevent functions of the therapy device in dependence on a condition of the blocking triggering unit, including a condition of said blocking triggering unit indicating a triggering of said blocking triggering unit in response to said separation of said electrode line from said electrical therapy device.

2. The electrical therapy device according to claim 1, wherein the re-use blocking unit is further adapted to prevent said functions of the therapy device in dependence on said condition of the blocking triggering unit during implantation of the therapy device.

3. The electrical therapy device of claim 2, wherein:

the re-use blocking unit triggers the blocking triggering unit upon separation of the electrode line from the electrical therapy device.

4. The electrical therapy device of claim 2, wherein:

the re-use blocking unit comprises an impedance measuring unit for determining an impedance of the electrode line and for triggering the blocking triggering unit if the measured impedance deviates from a predetermined value.

5. The electrical therapy device of claim 2, wherein:

the re-use blocking unit comprises a detection unit for monitoring ECG signals of the heart and to trigger the blocking triggering unit when no more ECG signals are received in a predetermined period of time.

6. The electrical therapy device of claim 2, further comprising:

a temperature sensor connected to the re-use blocking unit for detecting a temperature in the electrical therapy device and to output same to the re-use blocking triggering unit;

wherein the re-use blocking unit comprises a temperature evaluation means for triggering the blocking triggering unit if the temperature in the electrical therapy device which is outputted by the temperature sensor falls below a predetermined threshold value.

7. The electrical therapy device of claim 1, further comprising:

an energy supply unit adapted to supply the therapy device with the necessary energy, and

wherein the re-use blocking unit further comprises a triggering device adapted to disconnect the energy supply unit in dependence on the condition of the blocking triggering unit in order to interrupt the energy supply to the therapy device.

8. The electrical therapy device of claim 7 wherein the re-use blocking unit triggers the blocking triggering unit upon separation of the electrode line from the electrical therapy device.

9. The electrical therapy device of claim 7, wherein:

the re-use blocking unit triggers the blocking triggering unit upon separation of the electrode line from the electrical therapy device.

10. The electrical therapy device of claim 9, wherein:

the re-use blocking unit comprises an impedance measuring unit for determining an impedance of the electrode line and for triggering the blocking triggering unit if the measured impedance deviates from a predetermined value.

11. The electrical therapy device of claim 1, further comprising:

a means for controlling the functions of the therapy device,

wherein the re-use blocking unit instructs the control means to at least partially block electrical control of the therapy device during implantation in dependence on the condition of the blocking triggering unit.

12. The electrical therapy device of claim 11, wherein:

the re-use blocking unit comprises a first telemetric receiving unit that triggers the blocking triggering unit upon reception of a telemetric blocking signal.

13. The electrical therapy device of claim 11, wherein:

the re-use blocking unit comprises a first magnetically activatable receiving unit that triggers the blocking triggering unit upon magnetic activation thereof.

14. The electrical therapy device of claim 11, wherein:

the control means comprises a memory for a works operating program which is adapted to store a patient-specific works operating program for operation of the electrical therapy device and wherein the re-use blocking unit has an initialisation detection unit that triggers the blocking triggering unit upon initialisation of the stored works operating program.

15. The electrical therapy device of claim 11 wherein:

the re-use blocking unit comprises an impedance measuring unit for determining an impedance of said electrode line and for triggering the blocking triggering unit if the measured impedance deviates from a predetermined value.

16. The electrical therapy device of claim 11, wherein:

the re-use blocking unit comprises a detection unit for monitoring ECG signals of the heart and to trigger the blocking triggering unit when no more ECG signals are received in a predetermined period of time.

17. The electrical therapy device of claim 11, further comprising:

a temperature sensor connected to the re-use blocking unit for detecting a temperature in the electrical therapy device and to output same to the re-use blocking triggering unit;

wherein the re-use blocking unit comprises a temperature evaluation means for triggering the blocking triggering unit if the temperature in the electrical therapy device which is outputted by the temperature sensor falls below a predetermined threshold value.

18. The electrical therapy device of claim 11, further comprising:

a blocking deactivation means for overwriting the condition of the blocking triggering unit upon the reception of a blocking deactivation signal.

19. The electrical therapy device of claim 18, wherein:

the blocking deactivation means comprises a second telemetric receiving unit for telemetrically receiving the blocking deactivation signal.

20. The electrical therapy device of claim 19, wherein:

the blocking deactivation means comprises a means for decoding an ecoded password out of a received signal, and a means for verifying the received decoded password and to reset the blocking triggering unit when the received password is correct.

21. The electrical therapy device of claim 12, further comprising:

a blocking deactivation means for overwriting the condition of the blocking triggering unit upon the reception of a blocking deactivation signal.

22. The electrical therapy device of claim 21, wherein:

the blocking deactivation means comprises a second telemetric receiving unit for telemetrically receiving the blocking deactivation signal.

23. The electrical therapy device of claim 22, wherein:

the blocking deactivation means comprises a means for decoding an encoded password out of a received signal, and a means for verifying the received decoded password and to reset the blocking triggering unit when the received password is correct.

24. A packaging for an electrical therapy device as set forth in claim 13 wherein the packaging includes a magnet which is arranged in such a way as to magnetically activate the magnetically activatable receiving unit upon removal of the electrical therapy device from the packaging and thus to trigger the blocking triggering unit.

25. A combination of the electrical therapy device as set forth in claim 13 and a packaging wherein the packaging includes a magnet which is arranged in such a way as to magnetically activate the first magnetically activatable receiving unit upon removal of the electrical therapy device from the packaging and thus to trigger the blocking triggering unit.

26. The electrical therapy device of claim 13, further comprising:

blocking deactivation means for overwriting the condition of the blocking triggering unit upon the reception of a blocking deactivation signal.

27. The electrical therapy device of claim 26 wherein:

the blocking deactivation means comprises a second telemetric receiving unit for telemetrically receiving the blocking deactivation signal.

28. The electrical therapy device of claim 27, wherein:

the blocking deactivation means comprises a means for decoding an encoded password out of a received signal, and a means for verifying the received decoded password and to reset the blocking triggering unit when the received password is correct.

29. The electrical therapy device of claim 14, further comprising:

a blocking deactivation means for overwriting the condition of the blocking triggering unit upon the reception of a blocking deactivation signal.

30. The electrical therapy device of claim 29, wherein:

the blocking deactivation means comprises a second telemetric receiving unit for telemetrically receiving the blocking deactivation signal.

31. The electrical therapy device of claim 30, wherein:

the blocking deactivation means comprises a means for decoding an encoded password out of a received signal, and a means for verifying the received decoded password and to reset the blocking triggering unit when the received password is correct.

32. The electrical therapy device of claim 1, wherein:

the re-use blocking unit comprises a first telemetric receiving unit that triggers the blocking triggering unit upon reception of a telemetric blocking signal.

33. The electrical therapy device of claim 1, wherein:

the re-use blocking unit comprises a first magnetically activatable receiving unit that triggers the blocking triggering unit upon magnetic activation thereof.

34. The electrical therapy device of claim 1, wherein:

the re-use blocking unit comprises an impedance measuring unit for determining an impedance of the electrode line and for triggering the blocking triggering unit if the measured impedance deviates from a predetermined value.

35. The electrical therapy device of claim 1, wherein:

the re-use blocking unit comprises a detection unit for monitoring ECG signals of the heart and to trigger the blocking triggering unit when no more ECG signals are received in a predetermined period of time.

36. The electrical therapy device of claim 1, further comprising:

a temperature sensor connected to the re-use blocking unit for detecting a temperature in the electrical therapy device and to output same to the re-use blocking triggering unit;

wherein the re-use blocking unit comprises a temperature evaluation means for triggering the blocking triggering unit if the temperature in the electrical therapy device which is outputted by the temperature sensor falls below a predetermined threshold value.