Abstract:
A blister pack may include a first layer, a second layer and a third layer. The first layer may include a hole. The second layer may include an indentation substantially aligned through the hole when the first and second layers are aligned and a second area surrounding the indentation. The third layer, which is in contact with the second layer, may include a third area that is substantially aligned with the second area when the second and third layers are aligned. The indentation may contain a medicament. The blister pack may include adhesives that secure the second layer to the first layer and the third layer. The second and third areas may be scored, cut and/or perforated. When sufficient force is applied to the third area, a blister, including the second and third areas, may be displaced containing the medicament.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]     This patent application claims priority to, and incorporates by reference in its entirety, U.S. patent application Ser. No. 11/013,010 entitled “Universal Medication Carrier” and filed Dec. 15, 2004, which claims priority to, and incorporates by reference in its entirety, U.S. Provisional Patent Application No. 60/565,220 filed Apr. 24, 2004. 
     
    
     STATEMENT REGARDING FEDERAL SPONSORED RESEARCH  
       [0002]     NOT APPLICABLE  
       JOINT RESEARCH AGREEMENT  
       [0003]     NOT APPLICABLE  
       INCOPRORATION BY REFERENCE OF MATERIAL ON DISC  
       [0004]     NOT APPLICABLE  
       BACKGROUND  
       [0005]     1. Technical Field  
         [0006]     The disclosed embodiments generally relate to the fields of medicament storage and dispensing.  
         [0007]     2. Description of the Related Art  
         [0008]     In conventional medicament dispensing systems, prescriptions are typically filled in either thirty-day or sixty-day allotments. With such systems, there is no accurate way to inventory medicaments, to audit patient compliance with a pharmacist&#39;s or physician&#39;s instructions, and/or to audit administration of the medicament. This is due in part because medicaments are dispensed in a lot, and not every pill or dose is separately bar coded and/or otherwise traceable.  
         [0009]     Medicaments can be supplied in a foil- or paper-wrapped blister pack containing a plurality of individual unit doses. A number of devices have been developed to assist physicians, pharmacists, nurses or other medical personnel in administering unit doses contained in a standard blister pack. U.S. Pat. No. 5,489,025 to Romick and U.S. Pat. No. 6,540,081 to Balz et al. are examples of such devices. Romick discloses a medication dispenser having a top plate with at least one aperture for receiving the blister portion of a blister pack, a bottom plate adapted to engage the top plate so as to confine the blister pack between the plates and having at least one aperture in register with the blister portion, and a bridge spanning the top plate and supported by support members. Balz et al. discloses a dispenser for dispensing a unit dose of a solid product contained in a blister pack. The dispenser includes a housing, a back plate, and a dispensing tray. The blister pack containing product is positioned between the housing and the back plate, whereby the product is dispensed through the back plate into the dispensing tray where it can be acquired for use. A puncture tab is integrated into the back plate to assist in rupturing the backing of the blister pack when dispensing the product.  
         [0010]     Although these devices decrease the likelihood of errors in the administration of medication in a health care facility by preventing the unit doses from being removed from the blister portion of the blister pack until the foil backing is ruptured, the subject devices suffer from a number of limitations. Primarily, the devices are not intended for holding a plurality of different medications and/or varying dosages prescribed as part of a complex treatment regimen. In conventional blister pack holders, medicaments are organized according to their respective times of administration. As such, the existing blister pack holders are limited in their ability to provide the flexible dosage administration that is required for situations where the patient&#39;s regimen is the subject of frequent dosage adjustments or the patient is prescribed more than one medication to be administered at varying times over the course of a day or over the course of several weeks or months.  
         [0011]     Moreover, conventional devices are not suited for use by a patient in a home, assisted living facility, or other setting remote from the support of health care professionals. As described above, conventional blister pack holders organize medicaments according to their respective times of administration. However, they fail to provide a mechanism by which the administration of a prescribed medication or dosage can be remotely adjusted in real-time, in response to an unexpected change in a patient&#39;s health condition. A delay of several hours to several days can often result before a patient is enabled to administer a new dosage or medicament. During this period, the patient may be confused as to the correct dosing regimen and continue to take doses according to the predetermined sequence provided in the blister pack. In addition, because a new prescription and allotment of blister packs is required every time a dose is adjusted, the patient must travel to a physician&#39;s office and pharmacy. This is particularly disadvantageous for mobility-impaired patients and is a major source of drug non-compliance. Frequently, the patient&#39;s condition deteriorates because the patient is unable to continue his course of treatment.  
         [0012]     An additional shortcoming of conventional medication holders is that they are relatively complicated, requiring manufacture and assembly of various moveable parts. A still further shortcoming of conventional containers and storage devices is that they do not provide a practical means of quickly inventorying the exact amount of medication remaining in a prescription, and the amount of medication consumed by a patient.  
         [0013]     Accordingly, what is needed is a convenient device for storing one or more types of medicaments.  
         [0014]     A need exists for a device that permits inventorying of medicaments within a dispensing unit.  
         [0015]     A need exists for a device that dispenses a dose of a medicament in an individual package.  
         [0016]     A need exists for a device that dispenses a dose of a medicament in an individual package including information pertaining to the contained medicament.  
         [0017]     A further need exists for a method of dispensing medicaments to patients in a manner that includes a prescribed treatment regimen.  
         [0018]     The present disclosure is directed to solving one or more of the above-listed problems.  
       SUMMARY  
       [0019]     Before the present methods, systems and materials are described, it is to be understood that this disclosure is not limited to the particular methodologies, systems and materials described, as these may vary. It is also to be understood that the terminology used in the description is for the purpose of describing the particular versions or embodiments only, and is not intended to limit the scope.  
         [0020]     It must also be noted that as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. Thus, for example, reference to a “medicament” is a reference to one or more medicaments and equivalents thereof known to those skilled in the art, and so forth. Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art. Although any methods, materials, and devices similar or equivalent to those described herein can be used in the practice or testing of embodiments, the preferred methods, materials, and devices are now described. All publications mentioned herein are incorporated by reference. Nothing herein is to be construed as an admission that the embodiments described herein are not entitled to antedate such disclosure by virtue of prior invention.  
         [0021]     In an embodiment, a blister pack may include a first layer, a second layer and a third layer. The first layer may include a hole. The second layer may include an indentation that is substantially aligned through the hole when the first layer is aligned with the second layer. The indentation may contain a medicament. The second layer may include a second area surrounding the indentation. The third layer may be in contact with the second layer and may include a third area that is substantially aligned with the second area when the second layer is aligned with the third layer. The second area and the third area may each include one or more of a scoring, a cutting and a perforation. When sufficient force is applied to the third area, the second area and third area may be displaced from the blister pack to form a blister containing the medicament.  
         [0022]     In an embodiment, a method of assembling a blister pack may include placing a first layer, having a hole, in a loading tray of a loading station, placing a second layer, having an indentation that is substantially aligned with the hole when the second layer is placed, placing a medicament in the indentation, placing a third layer on the second layer, and compressing the first layer, the second layer and the third layer in a heat press.  
         [0023]     In an embodiment, a method of removing a medicament from a blister pack may include selecting a first blister containing a medicament from one or more blisters in a blister pack, applying force to a first side of the first blister to dislodge the first blister from the blister pack, and removing the medicament from the first blister.  
         [0024]     In an embodiment, a blister pack may include a ribbing comprising a plurality of blisters, whereby when sufficient force is applied to a blister, the blister is displaced from the ribbing, whereby when one or more blisters have been displaced, the ribbing provides substantially equivalent support to any remaining blisters as the ribbing provided prior to such displacement. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0025]     Aspects, features, benefits and advantages of the embodiments described herein will be apparent with regard to the following description, appended claims and accompanying drawings where:  
         [0026]      FIGS. 1A-1C  depict exemplary layers of a blister pack according to an embodiment.  
         [0027]      FIG. 1D  depicts an alternate exemplary first layer of a blister pack according to an embodiment.  
         [0028]      FIG. 2  depicts an exemplary backing sheet for a blister pack according to an embodiment.  
         [0029]      FIG. 3  depicts a flow diagram for an exemplary method of assembling a blister pack according to an embodiment.  
         [0030]      FIG. 4  depicts a flow diagram for an exemplary method of administering a medicament according to an embodiment. 
     
    
     DETAILED DESCRIPTION  
       [0031]     As used herein, a “medicament” may include one or more of an individual, unit-of-issue dose of prescription and/or non-prescription medications, medical supplies, pharmaceuticals, nutraceuticals, injectibles, medical devices, diagnostic materials and other therapeutic products. A medicament may, where applicable, be in liquid, solid or gaseous form. Specific examples of medicaments may include, without limitation, suppositories, pre-filled syringes, inhalers, lotions, suspensions, blood testing strips, pills, tablets and caplets.  
         [0032]      FIGS. 1A-1C  depict exemplary layers of a blister pack according to an embodiment. As shown in  FIG. 1 , a blister pack  100  may include a first layer  105  (shown in  FIG. 1A ), a second layer  110  (shown in  FIG. 1B ) and a third layer  115  (shown in  FIG. 1C ). The first layer  105  of the blister pack  100  may include a bottom board. The bottom board may have one or more holes, such as  120 . In an embodiment, a first area  125  may surround a hole  120 . In an alternate embodiment, shown in  FIG. 1D , no first area may be present surrounding a hole  120 . In an embodiment, an adhesive may be applied to the first layer  105 . In an embodiment, the first layer  105  may include, for example, cardboard and/or a plastic.  
         [0033]     A second layer  110  may include a plastic or PVC material with one or more indentations, such as  130 . Each indentation  130  may be placed such that the indentation aligns with a corresponding hole of the bottom board when the second layer  110  and the bottom board are aligned for use. The number and size of the one or more indentations  130  may vary based on the number and size of one or more medicaments to be contained within the blister pack  100 .  
         [0034]     Each of the first layer  105  and the second layer  110  may be scored, cut and/or perforated to enable an individual unit dose (a “blister”) to be removed from the blister pack  100 .  
         [0035]     A third layer  115  may include, for example, a foil sheet with an adhesive. When the adhesive of the third layer  115  and the adhesive of the first layer  105  are heated and then cooled, each of the third layer and the first layer may become adhered to the second layer.  
         [0036]     The foil sheet may be attached to a backing sheet. The foil sheet and/or the backing sheet may be scored, cut and/or perforated to match the scoring, cutting and/or perforation of the first layer  105  and the second layer  110  when the blister pack  100  is properly aligned. The scoring, cutting and/or perforation of the layers may ease removal of an individual unit dose from the blister pack.  
         [0037]     In an embodiment, the third layer  115  may comprise a foil sheet, a paper sheet and a cardboard sheet. Each sheet may be may be scored, cut and/or perforated. The foil sheet may enable the third layer to be contacted by a heat press during assembly of a blister pack. The cardboard, or a similar material, may be used to stiffen the third layer to enable a blister to be properly removed from a blister pack (as described in more detail below). Additional or alternate materials may also be used within the scope of this disclosure as will be apparent to one of ordinary skill in the art.  
         [0038]     In an embodiment, a blister pack may be assembled using a loading station. A loading station may include a loading tray. The loading tray may include a plurality of spring-loaded pegs and/or pins, which become substantially flush with the loading tray when compressive force is applied to a blister pack  100 . In an embodiment, the amount of force to apply to a blister pack  100  during assembly may be determinable based on the amount of compression of the spring-loaded pegs and/or pins.  
         [0039]     Each layer of a blister pack  100  may include one or more guide holes  150 , for example, on its outer perimeter. Each guide hole  150  may align with a corresponding loading tray guide peg and/or pin. The guide holes  150  may also be used to assist in alignment of a blister pack  100  when loaded into a medicament dispensing unit (“MDU”).  
         [0040]      FIG. 2  depicts an exemplary backing sheet for a blister pack according to an embodiment. The blister pack may include, for example, a barcode  205  and/or information  210  identifying the blister pack and/or identifying a medicament. The barcode  205  and/or information  210  may be printed on, for example, the backing sheet or a label attached to the backing sheet. In an embodiment, if the barcode  205  and/or other information  210  identifies a medicament, the barcode and/or other information may be printed and/or placed on the backing sheet proximate to the location at which the medicament is located within the blister pack.  
         [0041]     A barcode  205  may include any electronically scannable and/or readable indicia, such as a barcode, an RFID tag, and/or any other marking that may be scanned and/or read by a device. The barcode  205  may be scanned or read using an electronic scanner, such as a barcode scanner, an optical recognition scanner or a radio frequency identification (“RFID”) scanner. In an embodiment, the barcode  205  may uniquely describe the blister pack. In an embodiment, the barcode  205  may include one or more segments pertaining to features of the blister pack and/or the one or more medicaments contained therein. For example, a first barcode segment may pertain to a layout format for the blister pack, a second barcode segment may pertain to an item number pertaining to at least one medicament in the blister pack, and a third barcode segment may pertain to a unique serial number for each item number. In an embodiment, if more than one type of medicament is included in a single blister pack, at least a segment of the barcode  205  may be used to determine where a medicament of a particular type is located in the blister pack.  
         [0042]     The medicament information  210  may include, for example and without limitation, a lot number of the medicament, an expiration date of the medicament, a name of the medicament, a dosage pertaining to the medicament and/or a patient name. In an embodiment, the medicament information  210  may include any information that identifies the medicament and/or its usage after being removed from the blister pack.  
         [0043]     In an embodiment, the barcode  205  and/or the medicament information  210  may be printed and/or placed such that when a blister containing the medicament is displaced from the blister pack, the barcode and/or medicament information may be on the blister. In an embodiment, the barcode  205  and/or the medicament information  210  may be printed and/or placed such that when a blister containing the medicament is displaced from the blister pack, the barcode and/or medicament information may remain on the blister pack. In an embodiment, if different medicaments and/or different doses of the same medicament are included in a single blister pack, a barcode  205  and/or the medicament information  210  may be printed and/or placed such that the blister containing the medicament is labeled to identify the medicament and/or dosage of the medicament when the blister is removed from the blister pack.  
         [0044]     Unique identifiers may be placed and/or printed on the backing sheet to provide a key for proper orientation of the blister pack  100  when inserted into an MDU. In an embodiment, a first identifier  215  may be placed on a first side of the blister pack  100  and a second identifier  220  may be placed on a second side of the blister pack  100 . The first identifier  215  and the second identifier  220  may each be replicated one or more times on a side of the blister pack  100 . In an embodiment, when a blister pack  100  is inserted in an MDU, the MDU may scan one or more of the first identifier  215  and the second identifier  220  to determine if the blister pack is inserted in the correct orientation. In an embodiment, each of the first identifier  215  and the second identifier  210  may comprise a bar code, an RFID tag, a scannable image, scannable text, and/or the like.  
         [0045]     In an embodiment, a different portion of the blister pack  100 , such as the first layer  105 , may include one or more of a barcode and an identifying label. In an embodiment, additional or alternate information may be printed on the blister pack  100  within the scope of this disclosure.  
         [0046]      FIG. 3  depicts a flow diagram for an exemplary method of assembling a blister pack according to an embodiment. A first layer may be placed  305  in a loading tray. In an embodiment, an adhesive may be applied to the first layer while in the loading tray or prior to placing the first layer in the loading tray.  
         [0047]     The second layer may be placed  310  on the first layer with the indentations facing down. Each of the first layer and the second layer may be aligned using one or more guide pins of the loading tray. In an embodiment, an adhesive may be applied to one or more of the upper and lower surface of the second layer  310  prior to placement in the loading tray. In an embodiment, an adhesive may be applied to the upper surface of the second layer  310  after placement in the loading tray.  
         [0048]     In an embodiment, one or more indentations may be flood-filled  315  with medicaments according to standard pharmacy practices using conventional pharmacy devices for loading blister packs. Other methods of filling one or more indentations may also be performed within the scope of the present disclosure.  
         [0049]     The third layer may have one or more bar codes and identifying labels printed and/or placed  320  on, for example, its backing sheet. In an embodiment, one or more of the bar codes and identifying labels may be printed and/or placed on the third layer prior to the third layer being placed on the second layer. In an embodiment, the printing or placement of one or more bar codes or identifying labels may be performed after the third layer is placed on the second layer.  
         [0050]     When each appropriate indentation is filled, a third layer may be placed  325  on top of the second layer. The third layer may be aligned using the guide pins on the loading tray during placement. An adhesive may be applied to the lower surface of the third layer prior to placement in the loading tray.  
         [0051]     The loading tray may then be placed  330  in a heat press. Force may be applied  335  to the loading tray, and one or more guide pins may be compressed to a position level with the blister pack to ensure a complete seal of the blister pack.  
         [0052]      FIG. 4  depicts a flow diagram for an exemplary method of administering a medicament according to an embodiment. As shown in  FIG. 4 , when a medicament is to be administered or delivered, the desired dose (“blister”) may be determined  405  from, for example, the identifying label on the blister card. Force may be applied  410  to a portion of the third layer corresponding to the blister in order to dislodge the blister from the blister pack. A blister may be dislodged  410  manually or by a MDU. The medicament may then be removed  415  from the blister by applying force to an indentation of the blister. The removed medicament may then be administered  420 .  
         [0053]     In an embodiment, the blister pack may be suited for blister administration by a patient in, for example, a home, assisted living facility, or other non-clinical setting via a distribution device. In an alternate embodiment, the blister pack may be used in a hospital, clinic, long-term care facility or other location in which medical personnel are typically present. In such clinical environments, the blister pack may be stored until the patient&#39;s scheduled dosing time. At the designated dosing time, a healthcare practitioner may inspect the blister pack label and scan the barcode to acknowledge the administration of the medicament. The practitioner may extract  410  the sealed blister from the blister pack by applying force to the third layer of the blister pack on the desired blister.  
         [0054]     The blister pack may also serve as a medication management and compliance tool by ensuring accurate delivery of both custom packaged and commercially available sealed unit dose and unit-of-issue therapeutic products to a patient. The blister pack may foster compliance with a prescribed treatment regimen by, for example, ensuring that the patient remains within recommended therapeutic levels. If the health of a patient changes or a dosing change is required, a healthcare practitioner may adjust the prescribed dosage in real-time without the need for a new prescription. The healthcare practitioner may achieve this by reviewing the stored inventory record of medicaments within the patient&#39;s blister pack and directing the patient to take a different medication or dosage having a higher or lower strength, as appropriate.  
         [0055]     The design of the blister pack may enable medicaments to be administered to a patient in a non-consecutive order, without any serial delivery restrictions. As such, a remotely located practitioner may make dosing changes without any disruption to the patient&#39;s course of treatment via a MDU.  
         [0056]     Unlike conventional blister packs, individual blisters may be ejected from the blister pack, and each blister may remain sealed in a unit dose after ejection. This may permit a user to eject a medicament from the blister pack for later use (allowing the patient to be separated from the blister pack at the time of medicament administration).  
         [0057]     In an embodiment, a blister pack may include one or more blisters surrounded by a ribbing. The ribbing may provide support to all blisters when force is applied to a blister. In other words, as a blister is displaced, the ribbing may support the area surrounding the blister that is being displaced and the remaining blisters so that the blister that is being displaced may be properly displaced. After one or more blisters have been displaced, the ribbing may still provide substantially equivalent support to the remaining blisters to permit displacement of the remaining blisters from the blister pack in the future. In an embodiment, the ribbing may surround each blister prior to the blister being displaced from the blister pack. In an embodiment, the ribbing may remain when all blisters have been displaced from the blister pack.  
         [0058]     Conventional medication dispensing systems dispense medicaments in a lot. In other words, such systems do not separately encode each pill or dose. As such, the doses are not traceable. In an embodiment, individual blisters may be labeled to denote the medicament contained therein. Thus, delivery and administration of medicaments may occur on a unit dosage basis in which each dose is inventoried with its own electronically coded identifier. This may enable a healthcare practitioner to accurately monitor patient compliance with a prescribed treatment regimen from a remote location.  
         [0059]     The blister pack may be of a standard pharmacy size and may be filled directly by standard pharmacy tools known to those of ordinary skill in the art. For example, the blister card may be about 9 inches by about 6 inches. The blister card may include one or more guide holes on one or more sides. The guide holes may be used to align the blister card in a loading tray of a loading station. The blister card may further include one or more blisters as described above.  
         [0060]     It will be appreciated that various of the above-disclosed and other features and functions, or alternatives thereof, may be desirably combined into many other different systems or applications. Also that various presently unforeseen or unanticipated alternatives, modifications, variations or improvements therein may be subsequently made by those skilled in the art which are also intended to be encompassed by the following claims.