Medical device tracking system with capsule and method

• US 20090266890A1
• Filed: 04/25/2008
• Published: 10/29/2009
• Est. Priority Date: 04/25/2008
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Bagozzi, Christopher A., Hanna, Thor M.
• Granted Patent: US 7,909,249 B2
• Time in Patent Office: Days
• US Class Current: 235/385
• CPC Class Codes: A61B 17/7035 Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
• CPC Class Codes: A61B 17/865 Packages or dispensers for bone screws or threaded wires
• CPC Class Codes: A61B 2090/0807 Indication means
• CPC Class Codes: A61B 2090/0814 Preventing re-use
• 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: A61B 90/94 coded with symbols, e.g. text
• CPC Class Codes: A61B 90/96 using barcodes
• CPC Class Codes: A61B 90/98 using electromagnetic means, e.g. transponders
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61L 2/07 Steam
• CPC Class Codes: A61L 2/18 Liquid substances or solutions comprising solids or dissolved gases
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/63 for local operation

Abstract

Embodiments of the invention include systems and methods for tracking a medical device. Systems configured for such tracking may include the capability to either or both detect tampering with the medical device and to effectively expose an encapsulated medical device to sterilization substances and associate the medical device with an identifying characteristic.

Claims

1. A medical device tracking system comprising:

a medical device; and

a capsule for containing the medical device comprising;

a body capable of multiple fluid sterilizations without degradation, the body including openings to permit ingress and egress of fluid sterilization substances, and

a tracking device associated with the body,

wherein the capsule is configured such that removal of the medical device from the capsule is thereafter detectable.

2. The system of claim 1 wherein the medical device is a steam sterilizable implant.

3. The system of claim 1 wherein the medical device is a metal implant.

4. The system of claim 1 wherein the medical device is a surgical screw.

5. The system of claim 1 wherein the medical device is a spinal rod.

6. The system of claim 1 wherein the medical device is a surgical instrument.

7. The system of claim 1 wherein the capsule comprises a first component and a second component that are detachable from one another to permit removal of the medical device from the capsule, wherein detaching the first component from the second component is thereafter detectable.

8. The system of claim 1 wherein the capsule is configured to at least in part be ruptured when the medical device is removed from the capsule.

9. The system of claim 1 wherein the capsule is configured to at least in part non-resiliently deform when the medical device is removed from the capsule.

10. The system of claim 1 wherein the capsule is configured to at least in part change color when the medical device is removed from the capsule.

11. The system of claim 1 wherein the openings in the body are transverse openings along the body.

12. The system of claim 1 further comprising one or more additional capsules coupled with the capsule, each additional capsule for receiving one or more additional medical devices, wherein each of the additional capsules is configured such that removal of a respective medical device from an additional capsule is thereafter detectable.

13. A medical device tracking system comprising:

a medical device;

a first component with transverse openings along the length of the first component to permit ingress and egress of fluid sterilization substances;

a second component coupled with the first component to encapsulate the medical device; and

a tracking device associated with the first component or the second component.

14. The system of claim 13 wherein the medical device is a steam sterilizable implant.

15. The system of claim 13 wherein the medical device is a metal implant.

16. The system of claim 13 wherein the medical device is a surgical screw.

17. The system of claim 13 wherein the medical device is a spinal rod.

18. The system of claim 13 wherein the medical device is a surgical instrument.

19. The system of claim 13 wherein the first component is configured so that a change in the first component is detectable when the first component is decoupled from the second component.

20. The system of claim 13 wherein the second component is configured so that a change in the second component is detectable when the second component is decoupled from the first component.

21. The system of claim 13 further comprising a third component wherein the third component is configured to detect a change when the second component is decoupled from the first component.

22. A steam sterilizable apparatus for containing a medical device comprising:

a capsule formed in an enlarged shape of the medical device to conform to the perimeter of the medical device; and

an enclosure configured to cooperate with the capsule to contain the medical device within the capsule;

wherein one or both of the capsule and the enclosure include openings to permit steam to enter and exit the capsule to sterilize the implant.

23. The apparatus of claim 22 further comprising a medical device.