Medical device packaging system

• US 20070119741A1
• Filed: 11/30/2005
• Published: 05/31/2007
• Est. Priority Date: 11/30/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Stylos, Lee, McAdams, Sean, Lee, Brian, Krause, Paul, Montgomery, G., Wenger, William, Plombon, William, Lu, Steven, Salzer, Judy
• Granted Patent: US 8,224,447 B2
• Time in Patent Office: Days
• US Class Current: 206/438
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 2001/37294 Means for testing medical devices within the package prior to implantation

Abstract

A system, comprising a sterilizable package; an implantable medical device placed inside the sterilizable package; and an electrical interface electrically coupled to the implantable medical device and extending from inside the sterilizable package to outside the sterilizable package. In various embodiments, the interface may include package contacts electrically coupled to electrode terminals on the implantable medical device, patient terminals and conductors extending between the package contacts and the patient terminals.

Claims

1. A system, comprising:

a sterilizable package;

an implantable medical device placed inside the sterilizable package;

an electrical interface electrically coupled to the implantable medical device and extending from inside the sterilizable package to outside the sterilizable package.

2. The system of claim 1 wherein the electrical interface includes a package contact and the implantable medical device includes a sensor terminal and the package contact is electrically coupled to the sensor terminal.

3. The system of claim 2 wherein the sensor terminal is adapted for coupling to any of:

an electrode, a blood pressure sensor, an accelerometer, a blood chemistry sensor.

4. The system of claim 2 wherein the electrical interface includes a patient terminal and a conductor circuit extending between the patient terminal and the package contact.

5. The system of claim 1 wherein the patient terminal includes a connecting member for attaching a lead.

6. The system of claim 1 wherein the electrical interface includes any of:

an inductive element, a capacitive element, an antenna, and an optical fiber.

7. The system of claim 1 wherein the electrical interface includes a flexible substrate and, disposed on the flexible substrate, any of:

conductive ink, conductive foil, conductive film, and conductive tape.

8. The system of claim 1 further including an external device having a telemetry circuit and wherein the implantable medical device includes a telemetry circuit adapted for bidirectional communication with the external device telemetry circuitry for transmitting signals received by the implantable medical device using the electrical interface.

9. The system of claim 1 further including:

a computerized database;

a communication network coupled to the database;

means for transmitting data from the implantable medical device to the database via the communication network.

10. The system of claim 1 wherein the implantable medical device includes a processor for processing signals received by the implantable medical device using the electrical interface.

11. The system of claim 10 wherein the implantable medical device further includes an alert module for generating an alert signal corresponding to signals received by the implantable medical device using the electrical interface.

12. The system of claim 1 wherein the sterilizable package includes an inner surface and an outer surface and wherein the electrical interface is formed on a portion of any of the inner surface and outer surface.

13. The system of claim 1 wherein the sterilizable package includes a device tray and a tray lid sealed to the device tray.

14. The system of claim 1 further including a pressure generating member for promoting reliable electrical contact between the electrical interface and the implantable medical device.

15. The system of claim 1 wherein the electrical interface includes a device template corresponding to the shape implantable medical device.

16. The system of claim 15 wherein the device template includes a stencil opening for facilitating marking a selected implant arrangement.

17. The system of claim 1 wherein the implantable medical device includes a connector header having a connector bore, and the electrical interface includes a connector appliance having a connector assembly adapted for insertion into the connector bore.

18. The system of claim 1 wherein the electrical interface further includes a patient terminal, a package contact electrically coupled to the implantable medical device, a conductor circuit extending between the patient terminal and the package contact, and a dielectric layer for insulating at least a portion of the conductor circuit.

19. The system of claim 18 wherein the electrical interface includes a substrate and the dielectric layer includes a foldable portion of the substrate.

20. The system of claim 1 wherein the electrical interface includes a tearing line to facilitate removal of the implantable medical device from the sterilizable package.

21. The system of claim 1 wherein the electrical interface includes a patient terminal, a package contact electrically coupled to the implantable medical device, a conductor circuit extending between the patient terminal and the package contact, and a removable short circuit element for protecting the implantable medical device from electrical signals when the electrical interface is not in use.

22. The system of claim 1 wherein the electrical interface includes a strain relief element extending from the electrical interface to an portion of the sterilizable package.

23. The system of claim 1 wherein the electrical interface includes a patient terminal and a removable insulating material disposed over the patient terminal.

24. The system of claim 1 further including an outer carton containing the sterilizable package wherein the outer carton includes carton contacts adapted for electrical coupling to the electrical interface.

25. The system of claim 1 wherein the electrical interface includes a bifurcated substrate.

26. The system of claim 1 wherein the electrical interface includes a package contact electrically coupled to the implantable medical device and the package contact extends from inside the sterilizable package to outside the sterilizable package.

27. The system of claim 1 wherein the electrical interface includes an LED indicator for indicating electrical signal conduction by the electrical interface.