Single-use medical device

• US 20030045903A1
• Filed: 07/19/2002
• Published: 03/06/2003
• Est. Priority Date: 07/20/2001
• Status: Active Grant

• 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: Vitt, Elmar, Schaldach, Max, Niewalda, Gregor, Schaldach, Max Jr.
• Granted Patent: US 7,236,827 B2
• Time in Patent Office: Days
• US Class Current: 607/2
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators

Abstract

The invention is based on the idea of providing an electrical therapy device which 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 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.

The invention is further based on the consideration of providing an electrical therapy device which 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, comprising a blocking triggering unit (9) which is adapted to be triggered upon implantation or explantation of the electrical therapy device, and a re-use blocking unit (2) which is adapted during implantation of the therapy device to prevent the functions of the therapy device in dependence on the condition of the blocking triggering unit (9).

3. An electrical therapy device as set forth in claim 1 or claim 2 comprising an energy supply unit (20) which is adapted to supply the therapy device with the necessary energy, and wherein the re-use blocking unit (2) has a triggering device (3) which is adapted to disconnect the energy supply unit (20) in dependence on the condition of the blocking triggering unit (9) in order to interrupt the energy supply to the therapy device.

4. An electrical therapy device as set forth in claim 3 wherein the reuse blocking unit (2) is adapted to trigger the blocking triggering unit (9) upon separation of an electrode line from the electrical therapy device.

5. An electrical therapy device as set forth in claim 1 and further comprising a control means (1) which is adapted to control the general functions of the therapy device, wherein the re-use blocking unit (2) is adapted to instruct the control means (1) to at least partially block electrical control of the therapy device during implantation in dependence on the condition of the blocking triggering unit (9).

6. An electrical therapy device as set forth in claim 1 or claim 5 wherein the re-use blocking unit (2) has a first telemetric receiving unit (5) which is adapted to activate the blocking triggering unit (9) upon reception of a telemetric blocking signal.

7. An electrical therapy device as set forth in claim 1 or claim 5 wherein the re-use blocking unit (2) has a first magnetically activatable receiving unit (5) which is adapted to activate the blocking triggering unit (9) upon magnetic activation thereof.

8. An electrical therapy device as set forth in claim 5 wherein the control means (1) has a memory (7) 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 (2) has an initialisation detection unit (6) which is adapted to activate the blocking triggering unit (9) upon initialisation of the stored works operating program.

9. An electrical therapy device as set forth in claim 1, claim 2, claim 4 or claim 5 wherein the re-use blocking unit (2) has an impedance measuring unit (14) adapted to determine the impedance of an electrode line and to trigger the blocking triggering unit (9) if the measured impedance deviates from a predetermined value.

10. An electrical therapy device as set forth in one of claims 1 and 5 through 8 comprising a blocking deactivation means (10) which is adapted to overwrite the condition of the blocking triggering unit (9) upon the reception of a blocking deactivation signal.

11. An electrical therapy device as set forth in claim 10 wherein the blocking deactivation means (10) has a third telemetric receiving unit (11) adapted to telemetrically receive the blocking deactivation signal.

12. An electrical therapy device as set forth in claim 11 wherein the blocking deactivation means (10) has a decoding means (12) adapted to decode an encoded password out of a received signal, wherein the blocking deactivation means further has a verification means (13) which is adapted to verify the received decoded password and to reset the blocking triggering unit (9) when the received password is correct.

13. An electrical therapy device as set forth in claim 1, claim 2 or claim 5 wherein the re-use blocking unit (2) has a detection unit (21) which is adapted to monitor ECG signals of the heart and to activate the blocking triggering unit (9) as soon as no more ECG signals are received in a predetermined period of time.

14. An electrical therapy device as set forth in claim 1, claim 2 or claim 5 and further comprising a temperature sensor (23) which is connected to the re-use blocking unit (2) and which is adapted to detect the temperature in the electrical therapy device and to output same to the re-use blocking triggering unit (2), wherein the re-use blocking unit (2) has a temperature evaluation means (25) which is adapted to activate the blocking triggering unit (9) if the temperature in the electrical therapy device which is outputted by the temperature sensor (23) falls below a predetermined threshold value.

15. An electrical therapy device as set forth in claim 7 and a packaging wherein the packaging includes a magnet which is arranged in such a way as to magnetically activate the second magnetically activatable receiving unit (5) upon removal of the electrical therapy device from the packaging and thus to trigger the blocking triggering unit (9).

16. A packaging for an electrical therapy device as set forth in claim 7 and a packaging wherein the packaging includes a magnet which is arranged in such a way as to magnetically activate the magnetically activatable receiving unit (5) upon removal of the electrical therapy device from the packaging and thus to trigger the blocking triggering unit (9).

2. An electrical therapy device for implantation in a body, comprising a blocking triggering unit (9) which is adapted to be triggered upon explantation of the electrical therapy device, and a re-use blocking unit (2) which is adapted to prevent the functions of the therapy device in dependence on the condition of the blocking triggering unit (9).

17. A medical implant comprising a housing wherein the housing has at least in portion-wise manner a biocompatible layer which reacts chemically upon contact with human tissue, wherein the result of that chemical reaction is visible.