Medical device packaging system

• US 8,219,200 B2
• Filed: 06/29/2010
• Issued: 07/10/2012
• 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., McAdams, Sean B., Lee, Brian B., Stylos, Lee, Salzer, Judy B., Montgomery, G. Jordan, Lu, Steven N.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): KIMBALL, JEREMIAH T
• Application Number:
  US12/825,798
• Publication Number:
  US 20110004265A1
• Time in Patent Office: 742 Days
• Field of Search: 607/36
• US Class Current: 607/36
• CPC Class Codes: A61B 2050/0065 Peelable cover
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/37512 Pacemakers
• 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; and

an implantable medical device (IMD) placed inside the sterilized package, the IMD having a housing with two or more subcutaneous electrodes positioned on an exterior surface of the housing and spaced from one another by a first distance;

wherein

the sterilized package comprises;

a. two electrodes adapted for placement directly on a patient and spaced from one another by the first difference; and

b. an electrical interface, including a flexible substrate, for conveying a physiological signals from the electrodes to the subcutaneous electrodes on the implantable medical device housing within the sterilized package without compromising the sterility of the implantable medical device.

2. The system of claim 1 wherein disposed on the flexible substrate are any of the following:

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

3. The system of claim 1 further including means for transmitting signals received by the implantable medical device from the conveying means electrical interface to an external device.

4. 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.

5. The system of claim 1 wherein further including means for processing signals received by the implantable medical device using the conveying means electrical interface.

6. The system of claim 5 wherein the implantable medical device further includes means for generating a signal corresponding to the signals received by the implantable medical device using the conveying means electrical interface.

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

the inner surface and the outer surface.

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

9. The system of claim 1 further including means for generating pressure for promoting electrical contact between the conveying means electrical interface and the electrodes on the housing of the implantable medical device.

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

11. The system of claim 10 wherein the template includes means for facilitating marking of a selected implant arrangement.

12. The system of claim 1 wherein the conveying means electrical interface includes a means for insulating any portion of the conveying means electrical interface.

13. The system of claim 1 wherein the conveying means electrical interface includes means for creating a short circuit across the conveying means electrical interface for protecting the implantable medical device from electrical signals when the conveying means electrical interface is not in use.

14. The system of claim 1 wherein the conveying means electrical interface includes means for relieving mechanical strain across the conveying means electrical interface.

15. The system of claim 1 further including an outer carton containing the sterilized package and means for electrically coupling to the conveying means electrical interface from outside of the outer carton.

16. The system of claim 1 wherein the conveying means electrical interface includes means for indicating electrical signal conduction by the conveying means electrical interface.