MEANS FOR MONITORING COMPLIANCE, FACILITATING AUTOMATIC DISPENSING AND CHILDPROOFING STRIP PACKAGED MEDICATIONS

Abstract

There is provided an apparatus for monitoring compliance, facilitating automatic dispensing and childproofing strip packaged medication. In one embodiment a dispenser advances a packet, controls advancement of the packet and detects the presence and absence of the packet, including electronic circuitry for recording events. A replicate for strip package medication can have packets with an open conductive trace, each packet being rupturable at a location to interrupt conductivity of the conductive trace. When the conductive trace of one of the packets completes an external circuit, the circuit is interrupted when the packet is ruptured. In another aspect, each packet has a tuned antenna that is tuned to an external transceiver which detects the detuning of each antenna. In a method of making a replicate for strip package medication, conductive ink is printed on a surface of each packet of the replicate and longitudinal edges of the replicate are reinforced.

Claims

1. A dispenser comprising: advancing means for advancing a packet of a replicate for strip package medication into a dispense position; child resistant means for preventing the advancing means from advancing the packet; and detection means for detecting dispensing of the packet.

2. The dispenser of claim 1 further comprising means for storing information pertaining to detection of the dispensing of the packet.

3. The dispenser of claim 2 further comprising means for transmitting information pertaining to the detection.

4. The dispenser of claim 1 further comprising a replaceable paperboard cover.

5. The dispenser of claim 4 wherein the paperboard cover has cut outs aligned with deformable partial cut-outs of the child resistant means.

6. The dispenser of claim 4 wherein the paperboard cover provides space for instructions and feedback means.

7. The dispenser of claim 1 wherein the advancing means comprises sprockets on a sprocket wheel and the replicate has a longitudinal edge that is perforated in a pattern to coincide with the sprockets.

8. The dispenser of claim 7 wherein the advancing means further comprises a guide dowel over which the replicate is guided during dispensing.

9. The dispenser of claim 1 wherein the advancing means comprises an axle separating two sprocket wheels having sprockets which coincide with perforations on longitudinal edges of the replicate.

10. The dispenser of claim 9 wherein the child resistant means comprises a tab stop and the axle comprises a sprocket wheel stop which is configured to engage the tab stop to limit rotation of the axle.

11. The dispenser of claim 10 wherein the axle further comprises an axle stop which is configured to engage the tab stop to limit further rotation of the axle.

12. The dispenser of claim 11 wherein the axle stop limits the rotation to a full revolution which limits advancement of the replicate by a single packet.

13. The dispenser of claim 1 wherein the detection means further comprises a removable PCB tag comprising a battery, CPU, memory, and wireless communication means.

14. The dispenser of claim 13 wherein the PCB tag further comprises two contact sensors.

15. The dispenser of claim 14 wherein the advancing means advances the packet having a conductive trace thereon so that the contact sensors have electrical continuity with the conductive trace to form a closed circuit when the packet is in the dispense position.

16. The dispenser of claim 15 wherein the PCB tag periodically polls for continuity of the circuit and detects and records when the circuit is broken as by dispensing.

17. The dispenser of claim 16 wherein the CPU comprises a computer readable medium storing statements and instructions thereon that when executed by a processor track compliance of a user.

18. The dispenser of claim 17 further comprising compliance means for motivating the user to comply with medication instructions.

19. The dispenser of claim 18 wherein the compliance means further comprises one or more of a numeric display, pattern of LEDs, pattern of LCDs, colour change of an OLED or display of symbols.

20. The dispenser of claim 18 wherein the compliance means warns the user of non-compliance through alert means.

21. The dispenser of claim 18 further comprising transmission means to transmit data related to the compliance to an external device.

22. The dispenser of claim 21 wherein the external device is selected from the group consisting of a tablet, smart phone and computer.

23. The dispenser of claim 21 wherein the transmission means is selected from the group consisting of USB, wired protocol, a wireless protocol, RFID, Bluetooth, Wi-fi and GSM.

24. The dispenser of claim 1 wherein the advancement means comprises two pairs of pinch rollers that grip the edges of the replicate.

25. The dispenser of claim 1 wherein the detection means comprises an RF transceiver that detects when a tuned antenna of the packet moves to the dispense position.

26. The dispenser of claim 1 wherein the advancement means comprises a solenoid and the child resistant means comprises deformable partial cut-outs aligned to activate the solenoid to advance the packet.

27. The dispenser of claim 26 further comprising timing means to limit the release of medication packets by time interval.

28. The dispenser of claim 13 wherein the PCB tag processes, stores and communicates information pertaining to the detection.

29. A replicate for strip package medication comprising: a plurality of packets, each containing the medication therein, each having an open conductive trace, and each packet being rupturable at a location to interrupt conductivity of the conductive trace; whereby when the conductive trace of one of the packets completes an external circuit, the circuit is interrupted when the packet is ruptured.

30. The replicate of claim 29 further comprising tear guides to facilitate rupture of each package.

31. The replicate of claim 29 further comprising a reinforced edge containing perforations therein.

32. The replicate of claim 31 wherein each packet contains a set of double perforations in the reinforced edge.

33. The replicate of claim 29 further comprising opposing reinforced edges containing perforations therein.

34. The replicate of claim 33 wherein each packet contains a set of double perforations in one of the opposing reinforced edges.

35. A replicate for strip package medication comprising: a plurality of packets, each containing the medication therein, each having a tuned antenna, and each packet being rupturable at a location to detune the antenna; whereby each antenna is tuned to an external transceiver which detects the detuning of each antenna.

36. The replicate of claim 35 further comprising tear guides to facilitate rupture of each package.

37. The replicate of claim 35 further comprising a reinforced edge containing perforations therein.

38. The replicate of claim 37 wherein each packet contains a set of double perforations in the reinforced edge.

39. The replicate of claim 35 further comprising opposing reinforced edges containing perforations therein.

40. The replicate of claim 39 wherein each packet contains a set of double perforations in one of the opposing reinforced edges.

41. A method of making a replicate for strip package medication comprising the steps of: printing conductive ink on a surface of each packet of the replicate; and reinforcing longitudinal edges of the replicate.

42. The method of claim 41 wherein the step of reinforcing the longitudinal edges includes heat sealing the edges.

43. The method of claim 41 wherein the step of reinforcing the longitudinal edges includes increasing the thickness of the edges.

44. The method of claim 41 further comprising the step of perforating the edges with perforations.

45. The method of claim 44 wherein the step of perforating the edges involves adding a double perforation in one edge of each packet.

46. The method of claim 41 wherein the conductive ink is formed as a tuned RF antenna.

47. The method of claim 41 wherein the conductive ink is formed in a u-shape.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0052] The invention will be further understood from the following description with reference to the attached drawings.

[0053] FIG. 1 shows a strip package replicate with packets, contents and heat sealed and perforated double thickness strips on both sides of the longitudinal dimension.

[0054] FIG. 2 is an exploded view of the dispenser showing its component parts.

[0055] FIG. 3 shows a container with strip packaged content.

[0056] FIG. 4 shows details of the optional extrusion to facilitate dispensing which is situated on the underside of the cover to ensure that the conductive trace on the packet is broken when the packet is opened.

[0057] FIG. 5 shows the two friction (spring) contact sensors electrically connecting the tag and the packet when the packet is in the dispense position.

[0058] FIG. 6 details the control mechanism that locates the distal packet in the dispense position.

[0059] FIG. 7 shows a variation of the invention that uses RF rather than physical contact to determine the state of the packets.

[0060] FIG. 8 shows a variation of the child resistant function in which the release mechanism is a micro solenoid that prevents the sprocket from advancing until the buttons shown in FIG. 2 are pressed, activating the solenoid to let the sprocket advance and allowing the next cycle to begin.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0061] FIG. 1 shows a section of a strip packet replicate 1 comprising four packets 2 each containing one capsule and one tablet as example contents 3. The replicate shown contains a tablet and a capsule in each packet. The contents can be varied. The dimensions x, y of the packets 2 are variable according to the size of the contents and intended use, i.e. The size of the packet is variable in both dimensions.

[0062] The replicate 1 is typically made of cellophane, thin polymer or similar that may be easily torn. A common means of manufacture is to fold a continuous roll of cellophane over upon itself to enclose the contents and then heat seal it into individual packets 2.

[0063] In one aspect the guide holes may be designed to engage with guide sprockets in a polymer, paperboard or other dispenser. The asymmetry of the guide holes ensures the strip package is inserted in the correct orientation and is indexed to the dispense position.

[0064] In one aspect of the present invention the longitudinal edges 4 of the replicate 1 are continuously reinforced by heat sealing or other means with or without increasing the thickness. The longitudinal edges 4 have perforations 5 in a sequence that is repeated for each packet 2. On one of the two edges 4 more closely spaced double perforations 32 can be formed to correspond to the dispensing end of the packet 2 to be used for indexing the replicate 1 in the dispenser frame 9. The double perforations 32 also ensure that the replicate 1 is inserted in the dispenser frame 9 with the correct side up.

[0065] Tear guides 8 may be cut into the edges of the replicate 1 to facilitate tearing if desired.

[0066] On the surface of each packet there may be printed a conductive trace having larger contact pads at its ends.

[0067] FIG. 2 depicts the dispenser frame 9 and its components. The dispenser frame 9 may be made of a semi-rigid polymer and may be designed for multiple reuse.

[0068] In one embodiment the dispenser frame 9 may contain an axle 13 that locates a fixed sprocket wheel 12 at either end with a small set back to allow the ends of the axle 13 to engage with the axle holes 23 that are partially drilled through the sides of the dispenser frame 9 from the interior. The ends of the axle 13 are a snap fit to the axle holes 23 by bending the sides of the dispenser frame 9 outwards slightly.

[0069] In one aspect, the sprocket wheels 12 may have sprockets 11 to correspond with the perforations 5 on the replicate 1. One of the two sprocket wheels 12 has a double sprocket 17 more closely spaced and located so as to point upwards when the axle stops 15 are engaged with the CR tab stops 16 to define the dispense position.

[0070] As an example, the sprocket assembly may have two sets of stops. The sprocket wheel stops 14 are located on the inner aspects of the sprocket wheels 12. The axle stops 15 are attached to the axle 13 just inboard of the sprocket wheel stops 14 and oriented at 180 degrees to the sprocket wheel stops 14.

[0071] The dispenser frame 9 may include mirror-image CR tab cut outs 20 located on its longitudinal sides. These form part of the dispensing mechanism and also provide the CR feature.

[0072] In a further aspect, a CR tab stop 16 may be attached to the inner aspects of the two CR tab cut-outs 20 in the dispenser frame 9, designed and oriented to interdigitate with the sprocket wheel stops 14 to limit the rotation of the sprocket assembly to 180 degrees. Pressing the CR tab cut-outs 20 inward releases the interdigitation of the sprocket wheel stops 14 with the CR tab stops 16 and the sprocket assembly can rotate a further 180 degrees until the depressed CR tab 20 and associated stops 16 interdigitate with the axle stops 15 and stop the rotation, fixing the packet 2 in the dispense position.

[0073] FIG. 2 shows that the dispenser frame 9 may also have a guide dowel 21 that engages with the sides of the dispenser frame 9 via two dowel holes 22. The ends of the guide dowel 21 are a snap fit to the holes 22 by bending the sides of the dispenser frame 9 outwards slightly.

[0074] In another aspect, the PCB tag 24 may be located on the upper aspect of the dispenser frame 9 by friction or snap fit into a groove on the upper aspect of the frame 9. When so positioned the PCB tag's 24 contact sensors 25 are in electrical continuity with the contact pads 7 printed on the upper aspect of each packet 2 when said packet 2 is fixed in the dispense position.

[0075] FIG. 2 also shows a PCB tag cover 26 that can slide into a groove in the upper aspect of the dispenser frame 9 directly over the PCB tag 24 to provide protection. The PCB tag cover 26 may be designed with a small indentation 18 to facilitate traction on the distal end of the replicate 1 during the dispensing process. To facilitate the tearing of the packet 2 a molded cutter 33 may be incorporated into the underside of the PCB tag cover 24.

[0076] FIG. 2 also shows an optional dispense tray 27 designed to catch the packet 2 contents 3 when the packet 2 is torn open by the user. The dispense tray 27 snaps onto two bosses 28 on the inside aspect of the dispenser frame 9 and can swing down (open) in which position the contents 3 can be removed by the user. The dispense tray 27 is held in its closed position by friction fit between two small bosses 31 on the tray and two corresponding indentations on the interior aspect of the dispenser frame 9.

[0077] In another aspect, FIG. 2 further shows a disposable paperboard cover 10. This is designed to be friction or adhesive fit to the frame whose contents and mechanisms it covers and protects and may be a sleeve or a five-sided box. The cover 10 has two circular cut-outs 30 positioned over the CR tab cut-outs 20 so the latter can be depressed by the user applying pressure through the cover cut-outs 30.

[0078] FIG. 3 shows an example of a loading and dispensing procedure in a container with strip packaged content. The replicate is fan folded and the free end is engaged with the double teeth of the sprocket to locate the distal replicate in the dispense position. In preparing the dispenser frame 9 for use, the guide dowel 21 is snapped into the dowel holes 22 by bending the sides of the dispenser frame 9 slightly outwards. The replicate 1 is fan-folded or loosely rolled to fit in the dispenser frame 9. The distal end of the replicate 1 is then looped upwards around the guide dowel 21 with the conductive traces 6 printed on the packets 2 facing up. The ends of the axle 13 of the sprocket assembly (FIG. 2) may be inserted into the axle holes 23 by bending the sides of the dispenser frame 9 slightly outwards. The sprocket assembly is rotated counterclockwise until the axle stops 15 engage the CR tab stops 16. The user presses the CR tab cut-outs 20 inward, disengaging the axle stops 15 from the CR tab stops 16 allowing the axle to rotate a further 180 degrees at which position the double sprocket 17 on one sprocket wheel 12 points upwards.

[0079] FIG. 3 shows the closely spaced double perforations 32 of the distal aspects of each packet 2 of the replicate. The double perforations 32 of the distal packet 2 are aligned over the double sprocket 17 and the remainder of the perforations 5 are engaged with the sprockets 11. This positions the distal packet 2 in the dispense position.

[0080] FIG. 4 depicts an optional cutter 33 that can be an extrusion attached to or forming part of the underside of the PCB tag cover 26 the function of which is to facilitate dispensing. It is located so as to break the conductive trace 6 on the packet 2 at the time of dispensing.

[0081] In use the user may tear the distal packet 2 open allowing the contents to drop into the dispense tray 27 from which they are retrieved. Tearing the packet 2 open breaks the circuit comprising the conductive trace 6 and PCB tag 24 mounted contact sensors 25 and the CPU detects the increase in resistance and interprets it as an opening event that infers the medication has been taken.

[0082] FIG. 5 shows an example of a spring loaded contact sensor 25 that provides electrical continuity between the CPU of the PCB tag 24 and the conductive trace 6 printed on the packet 2 when the packet 2 is in the dispense position. To facilitate contact between the conductive trace 6 and the contact sensors 25, the proximal ends of the u-shaped conductive trace 6 may be enlarged as shown. When the user tears the packet open the trace is broken and the tag detects the open circuit, recording the time in its memory.

[0083] FIG. 6 shows the sprocket assembly dispensing control mechanism. In FIG. 6a the replicate 1 has been pulled by the user and the CR tab stop 16 has engaged the sprocket wheel stop 14, preventing further extraction of the replicate 1 from the dispenser 9. FIG. 6b is a top view showing the CR tab stops 16 engaged with the sprocket wheel stops 14 preventing further rotation of the sprocket assembly. The top view in FIG. 6c shows the position of the CR tab stops 16 when the CR tab cut-outs 20 are depressed inwards (arrows). The CR tab stops 16 have moved medially and disengaged from the sprocket wheel stops 14 allowing the sprocket assembly to rotate a further 180 degrees as shown in FIG. 6d. At that point the CR tab stops 16 engage with the axle stops 15 preventing further rotation of the sprocket assembly and fixing the distal packet 2 of the replicate 1 in the dispense position.

[0084] FIG. 7 shows an example means of determining the position and state of the packets using radio frequency (RF). In this variation, a tuned RF antenna 34 is printed on or otherwise attached to each packet 2 with conductive ink or other conductive substance. An RF transceiver is incorporated into the PCB tag 24. The presence of the tuned RF field is detected by the receiver module of the PCB tag 24 when the antenna 34 comes into close proximity with the receiver of the PCB tag 24 at the dispense position. As for FIGS. 3 to 6 above, the packet 2 is moved into position by traction on the distal end of the replicate 1 and by the sprocket assembly. When the user tears the packet 2 open the antenna 34 is broken (detuned) and the PCB tag's 24 CPU records the time of detuning as a dispense event and a means of inferring content use.

[0085] FIG. 8 shows a variation in which the CR function is provided by a solenoid 35 attached to the sprocket wheel 12. The solenoid 35 prevents the sprocket wheel 12 from advancing until the CR tab cut-outs 20 are pressed simultaneously, activating the solenoid 35 to let the sprocket wheel 12 advance 360 degrees allowing the next cycle to begin. In this variation axle stops 15 and sprocket wheel stops 14 are not required as the solenoid 35 performs their functions.

[0086] In a further embodiment the sprocket assembly is equipped with a solenoid 35 and the PCB tag 24 with a CPU having timing means as a locking or safety feature. When a dose is dispensed the solenoid 35 is locked preventing further dispensing until the time of the next prescribed dose.

[0087] In one embodiment the dispenser is programmed with dosing intervals or other pharmacokinetic (PK) information. The use data collected by opening events are compared to the PK data to determine the extent to which the use data are consistent with the PK data.

[0088] In a further embodiment the CPU is programmed with an algorithm to track the patient's compliance and the dispenser can display this by way of motivating the patient's behavior as, for example, continually updating, rating and displaying the patient's medication-taking compliance. This information can be displayed, for example, on the cover of the dispenser. For example, the cover can display compliance data numerically, by patterns of LEDs or LCDs (liquid crystal display), by colour changes via OLEDs and/or by symbols or other means.

[0089] In another embodiment the CPU is programmed to continually compare the most recent opening to previous openings using a dynamic algorithm and to compare the patient's compliance pattern to a preprogrammed ideal PK pattern. Using regression analysis or other widely taught trend analytical techniques the CPU develops a dynamic algorithm to predict problematic trends in the patient's compliance. Warnings and feedback can then be provided using a visual output, auditory output or tactile devices to alert the user to maladaptive medication-taking trends and potential problems.

[0090] In another embodiment the dispenser is additionally equipped with the ability to be plugged into a computer using USB or other wired protocol. The compliance data can be summarized and displayed in graphic format to motivate the patient.

[0091] In a further embodiment, the dispenser incorporates means of emitting an RF signal that permits communication with an external smart device such as a tablet or phone using RFID, Bluetooth, NFC, sigFox, qual2 or other data transmission protocol. These devices can be used to display reminders, compliance summaries or other information via apps.

[0092] In a further embodiment the dispenser incorporates the ability to communicate by GSM (Groupe Special Mobile) with devices which can be used to display reminders, compliance summaries or other information via graphic user interfaces or apps.

[0093] In a variant, other parties of interest other than the user may be given permission to access the dispenser's data via apps on smart devices or computers in the interests of monitoring the user's compliance with prescribed medication and detecting maladaptive patterns of use.

[0094] In another embodiment the dispenser can communicate wirelessly by Wi-Fi or GSM to an app forming part of a larger eHealth network from which the user and her designate(s) can access the data to receive motivational feedback and warnings about maladaptive medication-taking patterns and assessing the need for early intervention to prevent health deterioration.

[0095] The dispenser frame is reusable and can be returned to the pharmacy for reuse or retained to be reused on a subsequent refill of the same medication for the same patient. Any power source (e.g. battery) or electronic module (PCB) can be replaced as required.

[0096] It will be appreciated by one skilled in the art that variants can exist in the above-described arrangements and applications. The specific examples provided herein relate to a means of monitoring patient compliance, facilitating automated dispensing and including child resistance in strip packaged medication; however, the materials, methods of application and arrangements of the invention can be applied to other similar packaging and contents.

[0097] The scope of the claims should not be limited by the preferred embodiments set forth in the examples, but should be given the broadest interpretation consistent with the description as a whole.