Devices and Methods for Implant Tracking

• US 20110023343A1
• Filed: 07/30/2009
• Published: 02/03/2011
• Est. Priority Date: 07/30/2009
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Turner, Robin L., Doherty, Casey, Hanna, Thor M.
• Granted Patent: US 8,079,518 B2
• Time in Patent Office: Days
• US Class Current: 40/662
• CPC Class Codes: A61B 17/7002 Longitudinal elements, e.g. rods
• CPC Class Codes: A61B 17/7032 Screws or hooks with U-shaped head or back through which longitudinal rods pass
• CPC Class Codes: A61B 90/90 Identification means for patients or instruments, e.g. tags
• 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: G09F 3/0292 tamper indicating labels
• CPC Class Codes: G09F 3/0317 having bolt like sealing means means for preventing relative axial movement of a pin, spigot, shaft or the like and a member surrounding it F16B21/00
• CPC Class Codes: G09F 3/0376 using a special technique to detect tampering, e.g. by ultrasonic or optical means
• CPC Class Codes: G09F 3/04 to be fastened or secured by the material of the label itself, e.g. by thermo-adhesion by a separate adhesive layer G09F3/10

Abstract

A tag for tracking inventory levels and uses of an implant. The tag has a first component having a proximal portion and a distal portion and a second component having a proximal portion and distal portion. Additionally, the tag has an implant receiving cavity formed by the distal portion of the first component and the distal portion of the second component. Furthermore, the tag has a planar surface formed by the proximal portion of the first component and the proximal portion of the second component. The planar surface extending from the implant receiving cavity such that the planar surface is substantially transverse to a longitudinal axis of the implant received within the implant receiving cavity. In addition, the tag has a tamper evident locking mechanism configured for locking the first component to the second component. Additionally, at least a portion of the first and second components is radiopaque.

Claims

1. A tag for tracking inventory levels and uses of an implant, the tag comprising:

a first component having a proximal portion and a distal portion;

a second component having a proximal portion and distal portion,

an implant receiving cavity formed by the distal portion of the first component and the distal portion of the second component,

a planar surface formed by the proximal portion of the first component and the proximal portion of the second component, the planar surface extending from the implant receiving cavity such that the planar surface is substantially transverse to a longitudinal axis of the implant received within the implant receiving cavity, the planar surface including indicia; and

a tamper evident locking mechanism configured for locking the first component to the second component,

wherein at least a portion of the first and second components is radiopaque.

2. The tag of claim 1, wherein the first and second components further include a plurality of projections extending into the implant receiving cavity to engage a corresponding recess of the implant received within the cavity thereby locking the rotational alignment of the tag with respect to the implant.

3. The tag of claim 1, wherein the tag comprises a material capable of undergoing sterilization without degradation such that the indicia remains readable after sterilization of the tag, the indicia includes at least one of a human readable and computer readable form.

4. The tag of claim 1, wherein the indicia provides identifying information relating to at least one of the implant, a patient receiving the implant, a medical procedure used with the implant, and a material and process of manufacturing associated with the implant.

5. The tag of claim 1, wherein the tamper evident locking mechanism provides an unlocked position for receiving an implant between the first and second components within the implant receiving cavity and a locked position in which the first and second components are locked together preventing the implant from being released from the cavity without detectable evidence.

6. The tag of claim 1, wherein the distal portion of the first component further includes at least one stress relief structure, the at least one stress relief structure ensures that the first and second components separate along a fracture plane that is substantially transverse to a midline of the implant receiving cavity and includes a portion of the tamper evident locking mechanism.

7. The tag of claim 1, wherein at least a portion of the first and second components forming the implant receiving cavity includes a plurality of apertures allowing particulate to drain away from the cavity and the implant received within the cavity while the implant with the tag coupled thereto undergo sterilization.

8. A tag for tracking inventory levels and uses of an implant, the tag comprising:

a first component with a first lobe and a second component with a second lobe forming an implant receiving cavity;

the first lobe and the second lobe extending substantially perpendicular from a longitudinal axis of the implant received within the implant receiving cavity, the first and second lobes forming a planar surface having indicia; and

a web flexibly connecting the first and second lobes such that the lobes are separable along a first plane that is substantially coplanar with the planar surface and along a second plane that is substantially transverse to the planar surface.

9. The tag of claim 8, further comprising a tamper evident locking mechanism having an unlocked position in order for receiving an implant between the first and second components within the implant receiving cavity and a locked position in which the first and second components are locked together preventing the implant from being released from the cavity without detectable evidence.

10. The tag of claim 9, wherein the detectable evidence includes evidence that the tamper evident locking mechanism is unable to assume the locked position.

11. The tag of claim 9, wherein the tamper evident locking mechanism is associated with the at least one lobe from both the first and second components, the tamper evident locking mechanism comprising:

a projection associated with the first lobe, the projection having a frangible connection with the first lobe from the first component; and

a recess associated with the second lobe, the recess sized and shaped to receive the projection,

wherein the projection is secured within the recess when the tamper evident locking mechanism is in the locked position.

12. The tag of claim 11, wherein the frangible connection enables the first lobe have a clean break from the second lobe when the tamper evident locking mechanism is in the locked position, the clean break enabling the projection to remain secured within the recess associated with the second lobe when the tamper evident locking mechanism is broken to release the implant.

13. The tag of claim 12, wherein the projection is secured within the recess via bonding of the projection to an interior of the recess.

14. The tag of claim 8, wherein the indicia provides identifying information relating to at least one of the implant, a patient receiving the implant, a medical procedure used with the implant, and a material and process of manufacturing associated with the implant.

15. A tag for tracking inventory levels and uses of an implant, the tag comprising:

a first component and a second component forming an implant receiving cavity;

a hinge joining the first component to the second component and movable between an open position and a closed position;

a first implant receiving aperture having a first longitudinal axis defined in the first component and an opposing second implant receiving aperture having a second longitudinal axis defined in the second component, the first and second implant receiving apertures sized and shaped for receiving the implant;

a stress relief structure defined on at least one of the first and second components,

wherein in the open position the stress relief structure is in a relaxed condition and the first longitudinal axis is generally aligned with the second longitudinal axis and in the closed position the stress relief structure is in a flexed condition and the first longitudinal axis is generally skewed from the second longitudinal axis.

16. The tag of claim 15, wherein the stress relief structure is aligned with the first longitudinal axis.

17. The tag of claim 15, wherein the first component further comprises a first base bearing surface and a first upper bearing surface opposing a first lower bearing surface, the first upper and lower bearing surfaces extending from the first base surface and tapering towards a first distal end to form the first implant receiving aperture;

wherein the second component further comprises a second base bearing surface and a second upper bearing surface opposing a second lower bearing surface, the second upper and lower bearing surfaces extending from the second base surface and tapering towards a second distal end to form the second implant receiving aperture.

18. The tag of claim 17,wherein the first base bearing surface exerts a first force on the implant received within the first implant receiving aperture such that the implant is forced along the first upper and lower bearing surfaces towards the first distal end,

wherein the second bearing surface exerts a second force on the implant received within the second implant receiving aperture such that the implant is forced along the second upper and lower bearing surfaces towards the second distal end,

wherein the first and second forces are substantially equal to one another thereby locking the rod within the first and second implant receiving apertures.

19. The tag of claim 18, wherein the first base bearing surfaces exerts the first force along a plane substantially opposing the second force exerted by the second base bearing surface.

20. The tag of claim 18, wherein the first base bearing surface exerting the first force forms a three point contact locking mechanism around the implant, the three point contact locking mechanism comprising:

a first contact point between the first base bearing surface and the implant;

a second contact point between the first upper bearing surface and the implant; and

a third contact point between the first lower bearing surface and the implant.