This invention relates to a spiral medication packaging system and method. More particularly, the spiral medication packaging system and method provides a spiral packaging solution for a plurality of different tablets that are housed by a plurality of medicament containers.
Approximately fifty to seventy percent of all prescription medications in the U.S. are taken incorrectly. The effects of this prescription misuse account for 3.1 million nursing home admissions each year. More patients in the U.S. die each year from medication mismanagement than from AIDS and automobile accidents combined, and it is estimated that 125,000 deaths per year are caused by improper use of prescription drugs.
One of the major problems in taking prescribed daily medications emanates from patients having to take more than one medication in the form of pills or tablets. A principal concern is determining whether all medications are in compliance with the prescribed daily regimen. Many times this concern is compounded by the requirement that portions of the different medications must be taken at different times during the day.
The fear of taking improper dosages of prescribed medication can be particularly acute in the elderly, many of whom have some degree of mental dementia and can easily be confused as to whether they have taken all of their medications at the correct time. Some patients have difficulty sorting out the medications prior to taking them and taking the medication in a timely manner. Providing medications to disabled or incapacitated individuals can also be complicated because one caregiver may oversee the medication of many patients.
One solution to the problem of taking multiple medications is to pre-package the multiple medications so that users can take the pre-packaged medications at a predetermined time. Generally, these methods of pre-packaging medications are targeted to patients that may lack maturity or mental capacity to take the correct medications at the correct time. For example, young children in a school or campground and elderly individuals in elder care centers or nursing homes are target groups for the pre-packaging of medications. Some of the pre-packaged medications are placed in a small plastic bag, which may be easily misplaced. Other pre-packaged medications are placed in sealed cups that are difficult to open.
Solid dose medicines are typically sold in vials, with each specific medicine type and dosage in a separate vial. When multiple medications are required to be taken at the same time (dosage period), typically, a patient will be required to extract the proper medicine from each vial. After the medicine is taken from the vial, there is no way to easily determine that it was actually taken (unless a pre and post count is done). Also, typically the patient (or caregiver) is responsible for determining the proper medicine to take at the proper time. This can be particularly confusing when medicines or medicine groups need to be administered on an irregular schedule (i.e. once a week, every other day, etc.).
There are compartmentalized sealed cups available commercially to assist patients and/or health care providers with this process. These, however, require the patient or caregiver to presort all medicines and to load them into their proper dosage period compartment, typically on weekly basis. This is time consuming and subject to human error. Additionally, these sealed cups lack indicia for identifying individual medications within each cup or pouch, which raises the likelihood of administration error.
There are also some products that are commercially available or are available through institutional groups or hospitals that contain the presorted medicines in individual pouches. The individual pouches can be pre-labeled/printed with the proper time and date. These pouches are filled using automatic equipment that is subject to machine error and possible medicine breakage. Additionally, these pre-filled pouches lack enough printed information to enable a caregiver or patient to determine at a glance which medicament is which. While the patient or caregiver may be able to see the medicaments (through the transparent pouch) and to read their names (printed on the pouches), the patient or caregiver has no way to know which medicament matches to which drug name/dosage amount without consulting other literature.
A spiral medication packaging system and method is described. The spiral medication packaging system has a first shell, a second opposing shell, and a plurality of medicament containers coupled to one another. The second opposing shell interfaces with the first shell. At least one of the shells has a spiral track. The medicament containers are coupled to one another and each of the medicament containers includes a flanged top edge that is configured to interface with the spiral track. Additionally, each medicament container is linked to an adjacent container by a detachable portion and slidably moves on the spiral track.
In one of the illustrative embodiments, the spiral track is included on each of the shells. Additionally, the first shell and the second opposing shell define an opening that each medicament container passes through. Furthermore, a child safety component may be associated with the opening in the wall, in which the child safety component is adjustable to a first position and a second position that prevents the medicament containers from passing through the opening in the first position and permits the medicament containers to pass through the opening when in the second position. Further still, one of the illustrative embodiments may include a rotatable wheel mounted on one of the shells with teeth that releasably engage each of the medicament containers. Further still, a first housing portion and a second housing portion may be mounted respectively on the first shell and the second shell.
In the illustrative embodiments, detailed indicia are affixed to the wall portion such that they can be easily read by the patient or caregiver. These indicia include federally required information plus additional information to maximize compliance and to augment patient safety.
The method for dispensing medication includes housing a plurality of medicament containers in a dispenser having a first shell and a second shell. A wall portion connects the first shell and the second shell and the wall portion includes an opening. At least one of the shells has a spiral track and the medicament containers are arranged along the spiral track. The medicament containers are linked to an adjacent medication container by a detachable portion. The method also includes sliding the medicament containers along the spiral track so that one of the medicament containers passes through the opening. The method also includes detaching one of the medicament containers that has passed through the opening from the medicament carriers.
The present invention will be more fully understood by reference to the following drawings which are for illustrative, not limiting, purposes.
Persons of ordinary skill in the art will realize that the following description is illustrative and not in any way limiting. Other embodiments of the claimed subject matter will readily suggest themselves to such skilled persons having the benefit of this disclosure. It shall be appreciated by those of ordinary skill in the art that the systems and apparatus described hereinafter may vary as to configuration and as to details. Additionally, the methods may vary as to details, order of the actions, or other variations without departing from the illustrative methods disclosed herein.
The systems, apparatus and methods described herein provide correct medications and dosages at the appropriate times. The spiral packaging is designed with clear images and names to simplify the process of determining the appropriate medications to take at the appropriate time. Additionally, the patient medication management system and method described herein eliminates the worry of taking the wrong medication at the wrong time, and eliminates the need to manually open and organize prescriptions each week. Furthermore, the system and method described herein gathers all the patient's medicines together in one package and clearly shows the proper dosage time.
The systems, apparatus and methods described herein provide a compliant packaging solution. Compliance packaging generally includes three aspects: firstly, an action is initiated by a patient and/or caregiver with the compliance package; secondly, the compliance package dispenses at least one tablet as a result of the action taken by the patient and/or caregiver; and thirdly, the compliance package records the dispensing of the tablet. One illustrative example of a “compliance package” is the birth control “dial pack” package, in which there are twenty-eight tablets in a blister package that are in a circular configuration (not shown). To consume the tablet, the patient pushes on the transparent plastic material and the tablet pierces a foil backing. After the tablet is dispensed from the dial package, a record is left on the dial pack package, i.e. a pressed plastic housing and pierced foil backing.
The systems, apparatus and methods described herein satisfy the requirements for a compliance package because, firstly, an action is required by the patient or caregiver that requires identifying the appropriate dosage period, e.g. morning, and selecting the appropriate pouch or container. Secondly, the patient opens the appropriate container and consumes the medication. Thirdly, the patient or caregiver records the consumption of the medication by removing the container, which advances the compliance wheel of the packaging system as described in further detail below.
The systems, apparatus and methods described herein provide assurances of the proper dosages at the proper period. Additionally, caregivers and patients get the assurance that the patient is getting the right medications and staying compliant with those medications. Furthermore, a time saving solution for dispensing tablets, medications and vitamins is described.
The systems, apparatus and methods described herein also provide for a child resistant medication management system that allows all of the features of a compliant medication management system together with features to prevent improper use by children.
Referring now to
The first 110 and second 130 shell portions include spiral tracks 140 and 150, respectively. Tracks 140 and 150 are configured to hold a plurality of medication receptacles or containers (not shown). Grooves or ridges 160 on the interior surface 170 of wall 120 aid in positioning the pill receptacles within the spiral packaging system 100 and advancing the receptacles along the tracks 140 and 150 as described further below.
The first 110 and second 130 shell portions include central openings 180 and 190, respectively. First shell central opening 180 and second shell opening 190 both include a circular edge or flange, denoted as 200 and 210, respectively. Flanges 200 and 210 are structured and configured to engage each other and secure the first 110 and second 130 shell portions together. In the embodiment of
The outer wall 120 of spiral packaging system 100 further comprises an opening or dispensing aperture 230 configured to allow medication/pill receptacles or containers (not shown) to be removed or ejected from the spiral packaging system 100. The container aperture or opening 230 is positioned on the shell wall portion 120 of the apparatus and is of sufficient size to allow medicament containers to pass through sequentially or one at a time as described further below.
First shell 110, second shell 130 and wall portion 120 of the spiral medication packaging system 100 may be manufactured from molded plastics, composite materials, engineering resins, metals or metal alloys and the like, or combinations thereof. The various components of the apparatus 100 may be made of transparent, semi-transparent or opaque materials that aid the patient or caregiver in determining the number of pill receptacles left in the spiral packaging system 100. First shell 110, second shell 130, and shell wall 120 may be manufactured separately and configured to enable the first 110 and second 130 shell portions to snap fit together or may be configured to be joined together using adhesives or other fastening means. In certain embodiments, either of the first 110 or second 130 shell portion and the shell wall 120 section may be manufactured as integral components of a single work piece (e.g. injection molded) with the remaining shell portion configured to attach thereto to form the spiral packaging system 100 by snap fitting, tensional engagement or other fastening means.
Referring also to
The apparatus 100 in many embodiments is configured to hold approximately one month's supply that is generally a 30-day supply, but may also include about 28 to about 31 containers of a patient's medication. In some embodiments the spiral packaging system 100 may be configured to only hold one week of medication when the patient needs medication more than once a day. For example, when a patient will require three different medication dosages during a single day, the spiral packaging system 100 may be configured to support 21 containers 240 (i.e. 3 doses per day×7 days=21 containers 240). Various other numbers of containers 240 may be used depending upon the particular use.
Container opening 230 in wall section 120 further comprises first and second edges 260 and 270 that are configured to the shape of the containers 240 to allow the containers to pass through opening 230. First 260 and second 270 edges include top indentations 280 and 290 respectively that are configured to allow the flanged edge 250 of the container 240 to pass from the interior spiral groove(s) through the container opening 230 and out of the spiral packaging system 100. The container opening 230 in many embodiments is configured to include a childproof component (not shown) as is described further below.
In certain embodiments first 110 and second 130 shell portions are reversibly attachable and detachable to allow a user to open the apparatus 100 by detaching shell portion 110 from shell portion 130 so that medicament containers 240 may be inserted into the apparatus 100, after which the shell portions are re-attached. The apparatus 100 is thus re-usable as the user can replace the medicament containers 240 therein when used up. In other embodiments the medicament containers 240 may be inserted into the apparatus 100 by a health care provider or pharmaceutical supplier, with shell portions 110 and 130 then being permanently attached or adhered together so that the end user or patient cannot open the apparatus 100 or access the medicament containers 240 except via the dispensing aperture 230.
To use the apparatus 100, medicament containers 240 are arranged on track 140 or 150 in a spiral arrangement to conform to the shape of tracks 140 and 150, with flanges 250 of containers fitting over the outer edge of tracks 140 and 150. In many embodiments medicament containers 240 are arranged in a linear chain with each medicament container 240 joined to adjacent containers 240 by the frangible interface 255. The medicament containers 240 are positioned so that the first container 240 is adjacent opening 230 as shown in
Each medicament container 240 includes, for example, the required medication for a particular time period. For each such time period, the patient accesses the container 240 adjacent to opening 230, and as each container is advanced and detached, the next container 240, having therein the medication for the next time period, is advanced to opening 230 for use in the following time period. The apparatus may include a timing element and alarm element (not shown), such as an oscillating quartz crystal timing device and a sound chip interfaced thereto, with the timing device and alarm chip powered by a small battery. When the proper time for medication has arrived according to the timing device, the alarm device may make a beeping or other alarm noise to alert the patient.
Referring now to
Housing elements 310 and 330 are structured and configured to fit over first 110 and second 130 shell portions (
Referring now to
In operation of the apparatus 400, a user manually rotates compliance wheel 410. The teeth 430 of the wheel 410 fit through slot 450 and engage the container 240 (
Referring now to
Housing elements 510 and 530 are structured and configured to fit over first and second shell portions 110 and 130 (
The compliance wheel 410 in
Thus, for example, when wheel 410 is rotated such that the letter “W” is adjacent to arrow A, the user will know that the container 240 positioned in or adjacent to opening 230 includes the medication for Wednesday. The user further will know that the corresponding medication container 240 for Tuesday (represented by “T”) has already been removed from the apparatus 500, and that the container 240 containing Thursday (“Th”) medication remains in the apparatus 500 behind the container 240 having the Wednesday (“W”) medication. In this manner, the user can confirm or verify whether or not the appropriate medication for each particular day or other time period has been taken. In the embodiment of
Referring to
The compliance wheel 410 is shown in
While the compliance wheel 410 is shown as being configured for manual operation, various other mechanisms for turning or advancing compliance wheel 410 may be used. For example, a small battery-driven electric motor or a spring-actuated mechanism operating according to force applied to a button may be used to rotate wheel 410.
The compliance wheel 410 may be used with various medical packaging systems other then the spiral packaging system disclosed herein. Any pill packaging system comprising a plurality of containers 240 arranged in a chain can utilize a compliance wheel to aid the user in determining when the last dosage was given and when the next dosage is needed, as well as to move or advance medication containers within a dispensing device. For example, a rectangular box comprising seven medicament containers 240, i.e. a weekly dose, could use the compliance wheel to determine if the current day's dosage had been given. The medicament containers 240 could be arranged in a linear, circular or snake-like alternating chain configuration. Use of the compliance wheel in accordance with this disclosure provides for a variety of medication packaging systems with a dosage compliance feature.
Generally, the flanged top edge 250 of container 240 comprises a first side 680 and second 690 side which are configured such that flange 250 interacts with the spiral grooves or tracks 140 and 150 (
Each container 240 includes protrusions or ribs 720A, 720B on the exterior of tapered body 660 of the container 240. Ribs 720A and 720B each support a tab section 730A and 730B respectively, with tabs 730A and 730B located adjacent top flange 250. The tabs 730A and 730B are configured to interact with sprocket teeth 430 (
The tapered body 660 of each container 240 further comprises an arcuate or concave portion 740 positioned between the ribs 720A and 720B. Top flange 250 includes an arcuate or concave portion adjacent to the concave portion 740 of container body 660. The configuration of the concave portions 740 and 750 of the container 240 allows the teeth 430 of compliance wheel 410 to engage the tab portions 730A and 730B of the container 240 without interference from the tapered body 660 of the container 240.
Referring now to
The lidstock strip 760 may be frangible or breakable at the interface or junction of sides 700, 710 to allow detachment and separation of adjacent containers 240. The lidstock strip 760 may include perforation lines (not shown at edges 700 and 710) to provide frangible interfaces 255. When thus detached, each container 240 retains a portion 770 of the lidstock strip 760 as a cover, which can be removed or broken to access the medication within the container 240.
A plurality of containers 240 may be connected to one another by a single lidstock strip 760, allowing a “chain” of containers to be easily filled, sealed and placed in the spiral groove or track of a packaging system. Each sealed container 240 may be assigned to a specific dosage period and contain the medicines required for that dosage period. The section of lidstock strip 760 adjacent to each container 240 may be printed (using thermal transfer, ink jet, laser, or other suitable electronic printing method) with patient, medicine, and dosage period information, such as patient name; D.O.B.; dosage period; date; medicine contained including type, strength, number of tablets; expiry date, and the like. The lidstock strip 760 may also be printed with images of the medicaments contained therein, and/or a photo of the patient.
Lidstock strip 760 provides a writing surface 780 where patient data, container content and prescription information can be placed. The lidstock strip 760 may be extended between adjacent sealed containers (and then folded up as it is loaded into the dispenser or packaging system) to allow for extra printable area and a larger gripping surface for removing lids 770 from containers 240. The sealed container strip or chain is designed to be filled using a tabletop automated filling system that can include automatic inspection and verification of the medication product with which containers 240 are filled.
The lidstock strip 760 is configured to attach or adhere to the flanged top surface 250 of each of the individual containers 240. Lidstock strip 760 is preferably a laminated film which is heat sealed onto the flanged tops 250 of containers 240. Lidstock strip 760 may further comprise peel tabs (not shown) which extend out past the flanged top edge 250, making the lid 770 of each container 240 removable by peeling to facilitate in the opening of the container 240. Concave portions 740 and 750 facilitate removal of lid 770 from container 240 by a user by providing a “finger groove” to allow grasping of the lid 770 (it may also include a separable plastic gripping tab and/or a feature to enable it to be connected to the dispenser body for one-handed opening). Lid 770 also comprises a printable area 780 where patient data, container content and prescription information can be placed.
The individual containers 240 are preferably manufactured from clear or tinted plastic to allow viewing of the tablets within. The individual container(s) may be made by thermoforming or injection molding techniques. Exemplary plastics utilized for the individual container comprise but are not limited to polyphenysulphone, polystyrene, polypropylene, as well as polyethylene. The lidstock strip may comprise a paper-backed plastic film or foil laminate with sealing material in the structure for a peel seal with the molded plastic sealed flanged cup body.
Referring now to
Referring also to
In an illustrative reusable embodiment, the apparatus 800 is reusable and the label strip 840 may be interchangeable and removable from the apparatus 800 when the shell portion having the outer wall is disassembled.
In an illustrative disposable embodiment, the apparatus 800 is disposable after each use, and the label strip 840 may be adhered directly to the inner or outer surface of wall 120. An opening 860 at the end of strip 840 conforms in shape to opening 230 so that opening 230 is not blocked by strip 840.
A detailed view of the second label section, including the remainder of the precautions section of the illustrative label 840, is shown in
The second, third, and fourth label portions contain important information about each pharmaceutical or nutriceutical displayed in an easy-to-interpret fashion. A third label portion associated with label 840 is shown in
In
A duplicate of the patient name 804, the patient number 806, and the order number 808 are included in the last portion of the label, shown in
Referring now to
In the embodiment of
To operate the apparatus 900, a user simultaneously pushes on or depresses barrier 910 to the open position while advancing compliance wheel to move container 240 through opening 230. When the container 240 has passed through opening 230, the container 240 is detached and removed from the apparatus 900, and the barrier 910 is released to return to the closed position. The next container 240 is then blocked by barrier 910 from exiting the apparatus 900 until the child proofing barrier 910 is again depressed or moved to the open position. Simultaneous manipulation of the compliance wheel 410 and barrier 910 are sufficiently difficult that small children are unable to access the medication within apparatus 900.
The medication packaging systems may be modular and attachable to each other to form extensible or scalable medication packaging systems.
Alternatively, systems 900A and 900B may comprise a “morning” or “AM” module and an “evening” or “PM” module that are joined together for convenience but which are easily detachable and re-attachable. A user would, for example, access the AM medication from system 900A, then later would detach the AM medication system 900A to access the PM medication from system 900B. The two modular systems 900A and 900B are then re-attached together for convenient storage until the next use.
Operation of the child proof barrier 910 will be more fully understood by making reference to
Referring now to
Referring now to
It is to be understood that the foregoing is a detailed description of illustrative embodiments. The scope of the claims is not limited to these specific embodiments or examples. Therefore, various elements, details, execution of any methods, and uses can differ from those just described, or be expanded on or implemented using technologies not yet commercially viable, and yet still be within the inventive concepts of the present disclosure. The scope of the invention is determined by the following claims and their legal equivalents.
This application Ser. No. 12/418,418 is related to co-filed patent application Ser. Nos. 12/418,422 and 12/418,436, both having a filing date of Apr. 3, 2009. The present patent application claims priority from provisional patent applications 61/045,160, 61/045,166, and 61/045,171, all filed Apr. 15, 2008. The present application is a continuation-in-part of nonprovisional application Ser. No. 11/923,321, filed Oct. 24, 2007, which is a continuation-in-part of nonprovisional patent application Ser. Nos. 11/796,123, 11/796,124, and 11/796,125 filed Apr. 25, 2007, which all claim benefit of provisional applications 60/795,370, 60/795,446, and 60/795,413, filed Apr. 26, 2006, and provisional application 60/854,341, filed Oct. 24, 2006. This application is a continuation-in-part of nonprovisional application Ser. No. 11/241,783, which is related to provisional application 60/615,267, filed Oct. 1, 2004. All applications listed in this paragraph are hereby incorporated by reference.
Number | Date | Country | |
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61042263 | Apr 2008 | US | |
61042262 | Apr 2008 | US | |
60795370 | Apr 2006 | US | |
60795446 | Apr 2006 | US | |
60795413 | Apr 2006 | US | |
60615267 | Oct 2004 | US |
Number | Date | Country | |
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Parent | 11923321 | Oct 2007 | US |
Child | 12418418 | US | |
Parent | 11796123 | Apr 2007 | US |
Child | 11923321 | US | |
Parent | 11796124 | Apr 2007 | US |
Child | 11796123 | US | |
Parent | 11796125 | Apr 2007 | US |
Child | 11796124 | US | |
Parent | 11241783 | Sep 2005 | US |
Child | 11796125 | US |