TAMPER-EVIDENT PACKAGING

• US 20130126379A1
• Filed: 06/22/2012
• Published: 05/23/2013
• Est. Priority Date: 06/24/2011
• Status: Active Grant

• Current Assignee: Abbvie Incorporated
• Original Assignee: Abbvie Incorporated
• Inventors: Phillips, Matthew L., Nathan, Philip, Bruno, Robert H., Medhal, Bhimaprasad, Upchurch, Guy C., Frank, Catherine A., Lavery, James
• Granted Patent: US 8,963,714 B2
• Time in Patent Office: Days
• US Class Current: 206/459.1
• CPC Class Codes: A61J 1/035 Blister-type containers blisters in general B65D75/36
• CPC Class Codes: A61J 7/0436 resulting from removing a drug from, or opening, a container
• CPC Class Codes: A61J 7/0472 of the count-down type, i.e. counting down a predetermined interval after each reset
• CPC Class Codes: B65D 2203/12 Audible, olfactory or visual signalling means B65D51/248, B65D55/028, B65D79/02 and B65D81/24 take precedence
• CPC Class Codes: B65D 2215/04 requiring the combination of different actions in succession
• CPC Class Codes: B65D 2401/00 Tamper-indicating means relating to aerosol containers B65D83/224
• CPC Class Codes: B65D 55/14 Applications of locks, e.g. of permutation or key-controlled locks
• CPC Class Codes: B65D 79/00 Kinds or details of packages, not otherwise provided for
• CPC Class Codes: B65D 83/0409 the dispensing means being adapted for delivering one article, or a single dose, upon each actuation B65D83/0445 takes precedence
• CPC Class Codes: B65D 83/0463 formed in a band or a blisterweb, inserted in a dispensing device or container
• CPC Class Codes: G08B 13/149 with electric, magnetic, capacitive switch actuation

Abstract

A tamper-evident package for pharmaceuticals is described. The package includes a case. A tray holding pharmaceuticals slides in and out of the case. The package includes an alarm that can be set to armed and triggered mode. When the alarm is armed, the system of the package changes the alarm to triggered in response to the tray being opened. The package may engage an access indicator in response to the alarm being triggered. The package may also flash an indicator light upon request, prior to opening the tray, to indicate whether the alarm was triggered since being previously armed. The alarm can be armed again if it is triggered, by entering a security code while the tray is closed.

Claims

1. A tamper-evident package for pharmaceuticals, comprising:

a case, comprising a key pad and one or more indicator lights; and

a tray, wherein the tray is engaged to the case.

2. The tamper-evident package for pharmaceuticals according to claim 1, wherein the tray holds a blister sheet of pharmaceutical tablets;

and wherein the case substantially conceals or encloses the blister sheet within the case when the tray is closed.

3. The tamper-evident package for pharmaceuticals according to claim 2, wherein the blister sheet includes a first side and a second side, wherein the first side folds over on to the second side, and the tablets of the first side and the tablets of the second side are in an interweaving arrangement.

4. The tamper-evident package for pharmaceuticals according to claim 1, wherein the case comprises a logic controller in electrical communication with the indicator lights and the key pad, wherein the tray slides in and out of a side opening of the case, and triggers a switch of the logic controller.

5. The tamper-evident package for pharmaceuticals according to claim 1, wherein the case comprises a logic controller in electrical communication with the indicator lights and the key pad, wherein the key pad comprises a status key to check whether the tamper-evident package has been accessed without entering a security code.

6. The tamper-evident package for pharmaceuticals according to claim 1, wherein the case comprises a logic controller in electrical communication with the indicator lights and the key pad, wherein the key pad comprises a status key to check, wherein the logic controller includes an alarm switchable between an armed state and a triggered state, wherein the logic controller flashes a first color indicator light in response to actuating the status key when the alarm is in the armed state and the logic controller flashes a second color indicator light in response to actuating the status key when the alarm is in the triggered state.

7. A method for managing the status of an alarm associated with a pharmaceutical package, the method comprising:

(a) providing a pharmaceutical package having a logic controller with memory and a user action electronically communicating with the logic controller, the pharmaceutical package containing a pharmaceutical;

(b) programming a security code into the memory;

(c) entering the security code through the user action;

(d) with the logic controller, automatically setting an alarm to a first status in response to the logic controller receiving the security code in step (c); and

(e) after step (d), using the logic controller to automatically set the alarm to a second status, different from the first status, in response to the logic controller sensing access to the pharmaceutical in the container.

8. The method of claim 7, wherein step (b) includes programming the security code into the memory in a nonvolatile state in which the security code cannot be erased or overwritten.

9. The method of claim 7, wherein step (a) includes providing a check key as part of the user input interface;

and wherein step (c) includes pressing the check key after entering the security code.

10. The method of claim 7, wherein step (a) includes providing a check key as part of the user action and providing a system response electronically communicating with the logic controller;

the method further comprising;

after step (c), pressing the check key;

in response to pressing the check key after step (c), providing a first user feedback signal if the alarm is set to the first status and providing a second user feedback signal, different from the first user feedback signal, if the alarm is set to the second status.

11. The method of claim 10, wherein the first user feedback signal includes at least one of a light, a sound, and a vibration detectable by a human.

12. The method of claim 7, wherein step (a) includes providing a system response electronically communicating with the logic controller;

the method further comprising using the logic controller to activate the system response for a predefined time immediately following the alarm being set to the second status.

13. The method of claim 7, further comprising the step of recording in the memory a time and date stamp of access.

14. The method of claim 7, wherein step (a) includes providing the pharmaceutical container with a case and a tray able to slide at least partially into and out of the case, the tray carrying the pharmaceutical;

and wherein access to the pharmaceutical in step (e) includes sliding the tray at least partially out of the case.

15. The method of claim 14, wherein step (a) includes providing an access status switch in the pharmaceutical container;

the method further comprising the step of detecting with the access status switch when the tray is not in a fully closed state; and

disabling step (b) with the logic controller while the access status switch detects that the tray is in the not fully closed state.

16. The method of claim 7, wherein step (b) includes programming a security code having any one of four, five, and six characters.

17. The method of claim 7, wherein step (b) is accomplished manually by way of the user action.

18. The method of claim 7, wherein step (a) includes providing a keypad on the pharmaceutical container as part of the user action;

and wherein step (c) includes manually entering the security code by way of the keypad.

19. The method of claim 7, wherein step (a) includes providing a child-resistant feature;

the method further comprising the step of deterring access to the pharmaceutical in the container unless the child-resistant feature is defeated.

20. An access-evident package for an array of pharmaceuticals, the package comprising:

a case adapted to receive the array in a closed position at least partially within the case, the array being movable into an open position for access to the pharmaceuticals;

a logic controller mounted to the case, the logic controller including memory to receive and store a security code and also including an alarm having an armed state and a triggered state; and

a user action electronically communicating with the logic controller and enabling a user to enter the security code to cause the logic controller to set the alarm to the armed state;

wherein the logic controller switches the alarm to the triggered state in response to the array moving from the closed position to the open position.

21. The access evident package of claim 20, wherein the user action includes a keypad for entering the security code.

22. The access evident package of claim 20, wherein the logic controller prevents entry of the security code while the array is at least partially removed from the case.

23. The access evident package of claim 20, further comprising an access alert electronically communicating with the logic controller;

wherein the logic controller activates the access alert in response to the alarm being in the triggered state.

24. The access evident package of claim 20, further comprising an access alert electronically communicating with the logic controller;

wherein the user action includes a check key; and

wherein the logic controller activates the access alert in response to the alarm being in the triggered state and a user actuating the check key.

25. The access-evident package of claim 20, further comprising a latch preventing movement of the array from the fully closed position;

and a slide lever movable into a disengaging position in which the slide lever disengages the latch to permit movement of the array from the closed position.

26. The access-evident package of claim 25, wherein the slide lever is moved out of the disengaging position in response to moving the array into the fully closed position.

27. The access-evident package of claim 20, further comprising a tray adapted to carry the array, the tray being received within the case and adapted to slide at least partially in and out of the case to provide access the array.

28. The access evident package of claim 27, further comprising engaging structures on each of the case and tray that engage each other to brake movement of the tray with respect to the case as the tray approaches a fully open position in which access is grated to the array of pharmaceuticals.

29. The access evident package of claim 20, further comprising a biasing member acting on the array;

wherein the biasing member is deflected upon movement of the array into the fully closed position, to generate a biasing force in the biasing member;

wherein the biasing force biases the array toward an open position in which at least a portion of the array is removed from the case.

30. The access evident package of claim 29, further comprising a child-resistant mechanism holding the array in the fully closed position against the biasing force;

wherein actuation of the child-resistant mechanism releases the array to enable the biasing member to move the array toward the open position under the influence of the biasing force.