Medical device packaging system

• US 8,224,447 B2
• Filed: 11/30/2005
• Issued: 07/17/2012
• Est. Priority Date: 11/30/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Wenger, William K., Krause, Paul G., Plombon, William J., Lu, Steven N., McAdams, Sean B., Lee, Brian B., Stylos, Lee, Salzer, Judy B., Montgomery, G. Jordan
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): KIMBALL, JEREMIAH T
• Application Number:
  US11/291,030
• Publication Number:
  US 20070119741A1
• Time in Patent Office: 2,421 Days
• Field of Search: 607/36
• US Class Current: 607/36
• 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 sterilized package having an outer surface;

an implantable medical device placed inside the sterilized package;

the sterilized package comprising an electrical interface electrically coupled to the implantable medical device and extending form inside the sterilized package to the outer surface of the sterilized package without compromising the sterility of the implantable medical device;

and a patient electrode coupled to the electrical interface, wherein said patient electrode is located on the outer surface of said electrical interface.

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 electrical interface includes a conductor circuit extending between the patient electrode and the package contact.

4. 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.

5. 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.

6. 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.

7. 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.

8. The system of claim 7 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.

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

10. 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.

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

12. The system of claim 11 wherein the device template includes a stencil opening for facilitating marking a selected implant arrangement.

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

14. The system of claim 1 wherein the electrical interface includes a removable short circuit element for protecting the implantable medical device from electrical signals when the electrical interface is not in use.

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

16. The system of claim 1 wherein the electrical interface includes a removable insulating material disposed over the patient electrode.

17. The system of claim 1 further including an outer carton containing the sterilized package wherein the outer carton includes a carton contact adapted for electrical coupling to the electrical interface.

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

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