The present invention generally relates to the field of medication packaging and particularly to the dispensing of pills.
The health industry is faced with a multibillion dollar problem of prescription controlled drug abuse. Patients often either inadvertently or intentionally take their medication too frequently or outside the guidance of their treating physician. This problem is exacerbated when unauthorized persons attempt to utilize pills or other prescribed medication from an authorized patient's pill supply. Accordingly, there is a need for a secure pill dispensing device that will ensure that patients do not take their medication more frequently than prescribed and that unauthorized persons are unable to access the medication.
A pill dispensing device preferably includes a container and a lid. The container preferably includes a first cylinder, a second cylinder, a bottom, a top ring, a dispensing assembly and a tamper resistance mechanism. The first and second cylinders connect with the bottom of the container, and thereby form a space containing a conductive solution. Any tampering with the device will likely result in a rupture to that space, such that the conductive solution will escape. Alternatively, the conductive solution could be replaced with other substances that can be configured to conduct electricity. Such substances are configured such that any disruption to the integrity of the substance will result in a detectable change in the electrical current. The dispensing assembly preferably includes a hopper, a first trap door, a first chute, a first sensor, a second trap door, a second chute, a second sensor, and a tray. The hopper is configured to accept a plurality of pills, which can then be dispensed through the first chute and the second chute into the tray. The lid engages the container's top ring and preferably includes an RFID reader and a display. The processing unit monitors the conductive solution (or other conductive substance) to ensure that the pill dispensing device has not been tampered with, and when necessary, activates the tamper resistance mechanism to render the plurality of pills unusable.
A preferred second embodiment of the pill dispensing device includes alternative lid and container. The lid engages a top portion of the container. The container includes a hopper assembly and a dispensing assembly. The hopper assembly includes a hopper, a hopper carousel, a carousel shaft, and a tamper resistance mechanism. The hopper carousel is attached to the hopper shaft. The hopper shaft is engaged by a carousel, which functions to rotate the hopper carousel. The tamper resistance mechanism, which includes tamper resistance fluid and jets, is positioned within the hopper. The tamper resistance fluid renders the pills unusable when it is dispensed from the through the jets. The dispensing assembly includes a first dispensing assembly subassembly, a second dispensing assembly subassembly, a third dispensing assembly subassembly, a fourth dispensing assembly subassembly, and a plate driving assembly. The first dispensing assembly subassembly includes a first plate that has a first release, a first chute funnel, a hopper escape slide, and a first chute. The second dispensing subassembly includes a second plate that has a second release, a second chute, a second chute funnel, and a first sensor. The third dispensing subassembly includes a third plate that has a third release, a third chute, a third chute funnel, and a second sensor. The fourth dispensing subassembly includes a fourth plate that has a fourth release, a fourth chute, and a third sensor. The plate driving assembly includes a dispensing assembly motor, a dispensing assembly motor shaft, a first gear, a second gear, a third gear, and a fourth gear. The container attaches to tray, which has a window. The device is capable of releasing pills upon certain parameters being met, and rendering pills unusable if the device is tampered with.
To remedy the issues present in the health industry related to the misuse of pills, two embodiments of a secure pill dispensing device 10, 410 are disclosed below.
In accordance with the first embodiment of the present invention,
In the first embodiment, the container 100 is preferably cylindrical and includes a first cylinder 110, a second cylinder 112, a bottom 114, a top ring 116, a dispensing mechanism 120 and a tamper resistance mechanism 130. The first cylinder 110 and second cylinder 112 are formed so that the diameter of the first cylinder 110 is greater than the diameter of the second cylinder 112. Both the first cylinder 110 and second cylinder 120 engage the bottom 114. It is understood that the positioning of the first cylinder 110 and the second cylinder 112 forms a space 113 between the first cylinder 110 and second cylinder 112. This space 113 is filled with a conductive liquid 115 capable of conducting an electric current. The space 113 may otherwise be filled with a material capable of producing electric current, such as wiring, a pad, foam, or a screen. The material capable of producing electric current may be attached to the inside of the container 100 by an adhesive, instead of occupying the space 113. It will be understood in such embodiments that the second cylinder 112 is optional.
The dispensing assembly 120 is positioned within the second cylinder 112 of the container 100, and includes a hopper 121, a first trap door 122, a first chute 123, a first sensor 124 a second trap door 125, a second chute 126, a second sensor 127 and a tray 128. The hopper 121 is configured to hold pills (pills are marked as P in
In the first embodiment, the tamper resistance mechanism 130 is positioned within the hopper 121 and includes a fluid vessel 132, a tamper resistance fluid 133, and a rupture device 134. The tamper resistance fluid 133 is contained within the tamper resistance vessel 132, and may consist of a variety of fluids that would spoil or otherwise damage the pills upon exposure. Such fluids are known in the art, and include without limitation saline, food dye, black dye, and syrup of ipecac. It will be understood that the particular makeup of the tamper resistance fluid 133 may depend upon the particular makeup of the pills being used in the embodiment of the pill dispensing device 10. The fluid vessel 132 has a first surface 135 that engages the rupture device 134. The rupture device 134 is capable of rupturing the first surface 135 such that the tamper resistance fluid 133 will spill out of the fluid vessel 132 and engage the pills within the hopper 121, rendering such pills less functional or alternatively unusable. It will be understood that while
As depicted in
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In the first embodiment, the communications module 330 is a universal serial bus port that will accepts a standard USB cable and is configured to communicate with a personal computer. It will be understood, however, that the communications module 330 may also support other communications protocols including wifi, bluetooth, etc., so long as the communications module 330 can communicate with a personal computer.
Now referring to
In a preferred second embodiment,
As shown in
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The hopper assembly 519 includes a hopper 520, a hopper carousel 521, a retention slot cover 470, a carousel motor 490, a carousel shaft 492, and a tamper resistance mechanism 435. As previously discussed, the hopper 520 is configured to hold a plurality of pills of varying shapes and sizes. The hopper 520 connects with the hopper carousel 521, as depicted in
Turning back to
The dispensing assembly 450 includes a first dispensing subassembly 610, a second dispensing subassembly 620, a third dispensing subassembly 630, a fourth dispensing subassembly 640, and a plate driving assembly 690. The first dispensing subassembly 610 includes a first plate 650 that has a first release 455, a hopper escape slide 472, a first chute 451, and a first chute funnel 615. The hopper escape slide 472 is configured facilitate the movement of pills from the pill retention slot 471 to the first chute 455. The first chute funnel 615 funnels the pill towards the first release 455. Upon certain parameters being met, the pill to move through the first release 455 of the first plate 650, as described below. A sensor can be added to the first dispensing subassembly 610 to detect the presence of a pill in the first chute 451.
The second dispensing subassembly 620 includes a second plate 660 that has a second release 456, a second chute 452, a second chute funnel 616, and a first sensor 461. The first sensor 461 is configured to determine if a pill is present in the second chute 452. If a pill is present in the second chute 452, and certain parameters are met, the pill may move through the second release 456 of the second plate 660, as described below. The second chute funnel 616 is configured to funnel the pill toward the second release 456 to help facilitate the movement of the pill.
The third dispensing subassembly 630 includes a third plate 670 that has a third release 457, a third chute 453, and a second sensor 462. The second sensor 462 is configured to determine if a pill is present in the third chute 453. If a pill is present in the third chute 453, and certain parameters are met, the pill may move through the third release 457 of the third plate 670, as described below. The third chute funnel 617 is configured to funnel the pill toward the third release 456 to help facilitate the movement of the pill.
The fourth dispensing subassembly 640 includes a fourth plate 680 that has a fourth release 458, a fourth chute 454, a third sensor 463, and a tray 550. The third sensor 463 is configured to determine if a pill is present in the fourth chute 454. If a pill is present in the fourth chute 453, and certain parameters are met, the pill may move through the fourth release 458 of the fourth plate 680 and into the tray 550 where the user can access the pill through window 540, as described below. It will be understood that the fourth plate 680 may be replaced by a gate, a wiper type attachment, a servo arm, or any other mechanism known in the art to allow that is capable of retaining a pill within the fourth chute 454 and then moving to release such pill, or the fourth plate 680 may be replaced by an aperture (if a fourth gear 484, as described below is not needed when the fourth plate 680 is replaced, it will be understood that fourth gear will be removed).
The plate driving assembly 690 includes a dispensing assembly motor 480, a dispensing assembly motor shaft 691, a first gear 481, a second gear 482, a third gear 483, and the fourth gear 484. The dispensing assembly motor 480 engages the dispensing motor shaft 691, which in turn rotates the first gear 481, the second gear 482, the third gear 483, and the fourth gear 484, as described below.
It will be understood that a pharmacist must first setup the pill dispensing device 10 before it can be used by a patient. In the first embodiment the pharmacist must first open the pill dispensing device 10 by bringing an authorized RFID fob in proximity with the RFID reader 230. The RFID reader then signals the processing unit 300 that an authorized RFID fob has been used. The processing unit 300 will then signal the locking mechanism 240 to selectively change the position of the locking pin 244, which thereby either locks or unlocks the lid 200 from the container 100.
Turning back to the first embodiment, the pharmacist opens the pill dispensing 10 by plugging a USB cable into the communications module 330 thereby connecting with the personal computer. So long as the USB cable is plugged into the communications module 330, the locking mechanism 240 will maintain the locking pin 244 in an open position. As soon as the USB cable is removed from the communications module 330, the locking mechanism 240 will change the position of the locking pin 244 into a closed position. In a further aspect of this alternative embodiment, once the USB cable is connected to the communication module 330, an authentication code specific to the pharmacist's pharmacy is stored by the processing unit 300. Thereafter, the locking mechanism 240 cannot be disengaged unless the authentication code specific to the pharmacist's pharmacy is transmitted by the pharmacist over the USB cable to the communication module 330. It will be understood that this functionally “pairs” the pill dispensing device 10 with the pharmacists' pharmacy thereby preventing the user from using that pill dispensing device 10 with at a different pharmacy. Optionally, the pill dispensing device 10 can be configured to use encrypted code to allow only a particular computer at a pharmacy to open the pill dispensing device 10.
Once the lid 200 is removed from the container 100, the pharmacist fills the hopper 121 with the desired type and number of pills. The pharmacist then uses a personal computer to communicate with the processing unit 300 via the communications module 330. In particular, the pharmacist will indicate how often a pill can be dispensed, how many pills were loaded into the hopper 121, and a code identifying a patient RFID fob. In alternative embodiments, the pharmacist may indicate what type of pills were loaded into the hopper 121, whether any refills will be allowed, the patient's name and other related personal information. Such information is stored on the data store 320 as needed. Once the pharmacist has indicated all of the desired information, the lid 200 is engaged back onto the top ring 116 of the container 100, which is then locked by the locking mechanism 240, and the pill dispensing device 10 is given to the patient for use.
A patient operates the pill dispensing device 10 by placing a personal RFID fob in close proximity with the RFID reader 230. After detecting the patient's RFID fob, the RFID reader 230 will signal the processing unit 300 that the patient wishes to dispense one of the pills. The processing unit 300 will then evaluate the request against the information previously entered by the pharmacist. In particular, the processing unit 300 will determine if enough time has passed since the last pill was dispensed, and if this particular patient RFID fob is authorized. For example, if the pharmacist desires the particular type of pills in the pill dispensing device 10 to be used only once every 4 hours, then the processing unit 300 will determine whether 4 hours has passed since the last pill was dispensed. If 4 hours have not passed, then the processing unit 300 will signal the display 220 to display the amount of time left until a pill can be dispensed.
The first embodiment may also function through the processing unit 300 determining, based upon the information input by the pharmacist, that a pill can be dispensed, and then signaling the first trap door 122 to open so that a pill can move from the hopper 121 into the first chute 123. When a pill moves from the hopper 121 past the first trap door 122 into the first chute 123, the first sensor 124 signals the processing unit 300 that a pill is now in the first chute 123. The processing unit 300 will then signal the first trap door 122 to close, and then signal the second trap door 125 to open, thus preventing any more pills from moving into the first chute 123 and permitting the pill in the first chute 123 to move through the second chute 126 into the tray 128. As the pill passes through the second chute 126, the second sensor 127 signals the processing unit 300 and indicates that a pill has been dispensed into the tray 128. The processing unit 300 counts the number of pills of dispensed and stores that count in the data store 320. The number of dispensed pills can then be later communicated to the pharmacist via the communications module 330. After a pill is dispensed, the processing unit 300 then signals the second trap door 125 to close. The patient may then open the tray 128 and retrieve the dispensed pill.
It will therefore be understood that unauthorized users (those without an authorized patient RFID fob) are unable to dispense pills from the pill dispensing device 10. It will also be understood that even authorized users (those with an authorized patient RFID fob) can only dispense pills in accordance with the schedule indicated by the pharmacist when the pill dispensing device 10 was setup.
The pill dispensing device 10 is further secured through the operation of the tamper resistance mechanism 130. It will be understood that the processing unit 300 monitors the conductive liquid 113 by passing a current from the first wire 250 through the conductive liquid 113 to the second wire 252. It will be further understood that if a user attempts to tamper with the pill dispensing device 10 by breaking through the first cylinder 110 of the container 100, the conductive liquid 115 will spill through any rupture in the first wall 100 thus breaking the circuit between the first wire 250, the conductive liquid 115 and the second wire 252. Similarly, if a material capable of producing an electric current is used, a rupture in the first wall 100 will cause a detectable fluctuation in the electric current of the material. When the processing unit 300 detects that circuit break or fluctuation in the electric current, it signals the tamper resistance mechanism 130 to activate. As discussed above, activation of the tamper resistance mechanism 130 will result in rending the pills unusable. It will be understood that because the first wire 250 and second wire 252 are preferably of different lengths, the function of the tamper resistance mechanism 130 cannot be circumvented by tilting the pill dispensing device 10 upside down to ensure at the conductive liquid 115 maintains contact with the first wire 250 and second wire 252.
Turning back to the second embodiment, the pharmacist or medical professional opens the pill dispensing device 410 by connecting a computer to the pill dispensing device 410. If the pill dispensing device 410 recognizes the computer as a pharmacy computer through encrypted code, the servo lock will disengage, unlocking the lid 420. It will be understood that if encrypted code is not used to assist the pill dispensing device 410 in recognizing the computer, some other means known in the art for a device recognizing a computer will be used or the pharmacist will enter some type of code to unlock the lid 420, as described above. The pharmacist or medical professional can then remove the lid and put the number and type of pills desired in the pill dispensing device 410. When a new user or a new plurality of pills is assigned the pill dispensing device 410, the new information, such as the doctor that prescribed the pills, the number of pills, the type of pills, the schedule for taking pills, and/or the patient name can be entered onto label 530. Additionally, parameters may be entered by a pharmacist or medical provider, such as the timing of when a pill should be released from pill dispensing device 410 and the number of pills inside of the pill dispensing device 410 by connecting the pill dispensing device to a computer, as described above. Once programmed with the parameters, the lid screen 421 of lid 420 will display certain parameters (as discussed above, the first button 422 and the second button 423 allow the user to toggle between different parameters). Many of the parameters will update each time such parameters are met.
After the parameters are set and the pill dispensing device 410 is locked, the pill dispensing device 410 will use the first sensor 461, the second sensor 462, and the third sensor 463 to determine if pills are present in the second chute 452, the third chute 453, or the fourth chute 454. If pills are present and the pill dispensing device 410 has not taken any actions since being programmed, an error message will occur that requires the user to return to the location where the user received the pill dispensing device 410 to determine if the wrong pill is in a chute 452, 453, 454, or if the pill dispensing device 410 needs to be reprogrammed or replaced. If the first sensor 461, the second sensor 462, or the third sensor 463 does not detect a pill in a chute 452, 453, 454, then the pill dispensing device 410 will begin the process of placing a pill into chutes 461, 462, and 463.
The initial process of placing pills in the second chute 461, the third chute 462, and the fourth chute 463 occurs upon the first use of the pill dispensing device 410 by a user, or may be set to occur upon the pill dispensing device 410 being programmed by the pharmacist or medical provider. The pill dispensing device 410 will communicate, through a processing unit 300 (shown in
The pill dispensing device 410 will continue to detect through sensors 461, 462, 463 that the third chute 453 and the fourth chute 454 do not contain a pill. The second motor 490 then rotates the hopper shaft 492, which rotates hopper carousel 521. A pill retention slot 471 in the hopper carousel 521 (as shown in
The pill dispensing device 410 will continue to detect through sensors 461, 462, 463 that the fourth chute 454 does not contain a pill. The second motor 490 then rotates the hopper shaft 492, which rotates the hopper carousel 521. A pill retention slot 471 in the hopper carousel 521 (as shown in
Now, the pill dispensing device 410 will communicate with the first sensor 461, the second sensor 462, and the third sensor 463 to determine that pills are in the second chute 452, the third chute 453, and the fourth chute 454. Upon the time parameter being met, the second motor 490 engages hopper shaft gear 491, which moves rotates the hopper shaft 492, which causes the hopper carousel 521 to rotate. A pill retention slot 471 in the hopper carousel 521 (as shown in
If the pill dispensing device 410 is tampered with, the tamper resistance mechanism 435 is ruptured. Methods for puncturing a pouch filled with fluid are known in the art and understood by persons of ordinary skill in the art. In this embodiment, the rupture occurs through heat being applied to the tamper resistance mechanism 435. In an alternative embodiment, a servo and a blade may rupture the tamper resistance mechanism 435. Upon the rupturing of the tamper resistance mechanism 435, the tamper resistance fluid 433 is released onto the pills through jets 510 rendering the pills unusable, either through their destruction or through other known means that renders the pills inoperable for their intended purpose.
Should the hopper assembly 519 fail or experience a jam, the pills in chutes 452, 453, and 454 will continue to be dispensed normally, allowing the user to receive medications until the pill dispensing device can be taken into the pharmacy for repair or replacement.
It is clear that the present invention is well adapted to carry out its objectives and attain the ends and advantages mentioned above as well as those inherent therein. While two embodiments of the invention have been described, it will be understood that the elements and alternative elements of either embodiment may replace the elements of the other embodiment, or be used in conjunction with the other elements and alternative elements of the other embodiment. Additionally, certain embodiments of the invention have been described in varying detail for purposes of disclosure, but it will be understood that numerous changes may be made which will readily suggest themselves to those skilled in the art and which are encompassed within the spirit of the invention disclosed, as defined in the written description and appended claims.
This application is related to and claims the benefit of United States Patent Application No. 2014/704,475, filed May 5, 2015, and United States Patent Application No. 2014/704,570, filed May 5, 2015, both of which are hereby incorporated by reference.