Abstract:
In one embodiment, the invention comprises a tray insert for a medication dispenser, the dispenser permitting access to a medication dose after a minimum dosing interval has elapsed since presentation of an immediately previous dose. The dispenser comprises a dispenser cover having an opening through which a patient accesses the medication dose presented through the opening and a carousel for receiving the tray insert. The tray insert comprises a substrate, a plurality of medication retention areas in the substrate each for holding at least one medication dose, each medication retention area received within a depression of the carousel and a cover removably affixed to an upper surface of the substrate for retaining the medication doses in the medication retention areas prior to use, wherein after the tray insert is mated with the carousel the cover.

Description:
FIELD OF THE INVENTION  
       [0001]    The present invention relates generally to a tray insert for mating with a carousel of a medication dispenser, the medication doses carried within the tray insert are accessible to the patient only at certain times to allow the patient to self-administer medication doses according to a prescribed dosing regimen. 
       BACKGROUND OF THE INVENTION  
       [0002]    Fifty percent of post-operative patients report inadequate pain relief. Fifty percent of all cancer patients and ninety percent of advanced cancer patients experience pain. Pain is now defined as “the fifth vital sign” as part of the mandate by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) to develop guidelines for pain management. 
         [0003]    Adequate pain control requires the appropriate medication for the pain level and pain type reported. In a hospital setting, pain medication can be obtained only by a physician&#39;s order. Pain medications such as narcotics and non-steroidal medications (and anxiety medications such as tranquilizers) are frequently ordered on an as-needed basis (referred to as pm orders). This approach requires the patient to initiate a request for each pm drug dose. The nurse determines whether the appropriate time interval has passed between doses, according to the physician&#39;s order. If the required time interval has elapsed the nurse transports the medication to the patient&#39;s bedside and administers the medication to the patient. In some dosing regimens, the patient is given a time-release pain medication at the same time(s) each day, with as-needed (pm) medications for breakthrough pain. Again, the patient must request the medication for each breakthrough pain episode. A common reported patient frustration is the need to issue a request for each and every dose of pm medication. Thus, a busy nurse must determine that the ordered time has elapsed from the last dosage, locate the medication and transport it to the patient in response to each request. This must also be accomplished in a timely fashion, as patients in pain must be administered to as soon as possible. 
         [0004]    The as-needed prescription approach dispenses the minimum medication dose on a schedule that can control pain symptoms without the risk of abuse, overdosing or unnecessary side effects. Disadvantageously, in a hospital or institutional setting each medication that is dispensed on a pm basis requires nursing staff time and extra documentation by nursing and pharmacy staff, since the drugs can be administered only after the lapse of the predetermined time interval between doses. For example, a drug prescribed as needed every six hours may be given no more than four times in 24 hours. Such a drug may be administered from zero to four times in any given 24-hour period, depending upon patient dosage requests. If six hours have passed since the last administration of the drug, the medication is provided to the patient in response to the request. If six hours have not lapsed, the patient must wait the minimum time interval of six hours prior to receiving the next drug dose. In a home pm medication, dosing situation the patient must know when the previous dose was administered and await the prescribed interval before administering the next dose. 
         [0005]    Improved patient pain control leads to better patient outcomes in the hospital setting. This has been well documented in the surgical literature in the post-operative setting, with fewer post-operative complications, earlier rehabilitation, and shorter hospital stays for patients with better pain management. Better pain management is also highly cost effective since earlier discharges and fewer complications save health care dollars and staff time. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS  
         [0006]    The foregoing and other features of the invention will be apparent from the following more particular description of the invention, as illustrated in the accompanying drawings, in which like reference characters refer to the same elements throughout the different figures. The figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. 
           [0007]      FIG. 1  illustrates an embodiment of a medication on demand dispenser device utilizing a tray insert of the present invention. 
           [0008]      FIGS. 2 ,  3  and  4  illustrate different views of a carousel of the medication on demand dispenser device of  FIG. 1 . 
           [0009]      FIGS. 5 ,  6  and  7  illustrate different views of a first embodiment of the tray insert for mating with the carousel of the medication on demand device. 
           [0010]      FIG. 8  illustrates a first embodiment of a tray insert cover for a tray insert of the present invention. 
           [0011]      FIG. 9  illustrates a second embodiment of a tray insert cover for a tray insert of the present invention. 
           [0012]      FIG. 10  illustrates a backing material layer for the first and the second embodiments of the tray insert cover. 
           [0013]      FIGS. 11 and 12  illustrate alternative embodiments of a carousel and a tray insert, respectively. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0014]    Before describing tray insert embodiments for use with a medication on demand dispenser, it should be observed that the specification describes and the drawings illustrate only those details that are pertinent to understanding the present invention without obscuring the disclosure with structural and functional details that will be apparent to those skilled in the art having the benefit of the description herein. 
         [0015]    The following embodiments are not intended to define limits as to the structure, function or method of the invention embodiments, but only to provide exemplary constructions. The embodiments are permissive rather than mandatory and illustrative rather than exhaustive. 
         [0016]    One embodiment of the tray insert described herein is intended for use with a medication on demand dispenser described and claimed in a commonly-owned issued patent entitled Patient Controlled Timed Oral Medication Dispenser, U.S. Pat. No. 7,044,302 issued on May 16, 2006, and medication on demand devices described and claimed in two pending non-provisional patent applications: a patent application assigned Ser. No. 11/125,299, filed on May 9, 2005 and entitled Patient Controlled Timed Medication Dispenser, and a patent application assigned Ser. No. 11/412,227, filed on Apr. 26, 2006 and entitled Patient Controlled Timed Medication Dispenser, all of which are incorporated by reference herein. 
         [0017]      FIG. 1  illustrates an embodiment of a medication on demand dispenser (MOD)  400  including a carousel  418  (also referred to as a dispenser wheel) mated with a tray insert  450 . The tray insert  450  carries the mediation doses  66  within medication retention areas  154  that fit within corresponding depressions in the carousel  418 . In one embodiment, a diameter of a tray insert  450  and the carousel  418  is about 5 3/16 inches. 
         [0018]    The medication on demand dispenser  400  further comprises a housing  410 , comprising a lower housing section  410 A and an upper housing section  410 B. The housing  410  rotatably supports the carousel  418  and the mated tray insert  450 . A MOD cover  430 , in one embodiment having a substantially flat or slightly hemispherical shape and releasably attached to the housing  410 , covers the carousel  418  and the tray insert  450  and prevents patient access to the medication doses  66 . However, the MOD cover  430  defines an opening  430 A defines an opening  430 A therein through which a patient gains access to a single medication dose  66  when the carousel/tray insert assembly rotates to present a medication dose  66  at the opening  430 A. 
         [0019]    In different embodiments, the MOD cover  430  comprises transparent, translucent or opaque material. The former two embodiments allow visual inspection of the medication retention areas  154  and the medication dose  66  carried therein. 
         [0020]    The carousel/tray insert assembly is controlled to rotate to align one of the medication retention areas  154  and its corresponding medication dose  66  with the cover opening  430 A, allowing the patient to access and self-administer the medication dose. Carousel rotation is controlled according to the patient&#39;s dosing schedule so that medication doses are not available more frequently than the physician&#39;s pm order. Further details of the rotation control mechanisms are described in the above referenced patent and patent applications. 
         [0021]    In one embodiment, the MOD cover  430  is lockably engaged to the upper housing section  410 B. Unlocking the locking mechanism permits access to the carousel  418 , the tray insert  450  and any medication doses  66  remaining in the dose retention areas  154  of the tray insert  450 . In one embodiment, when in an unlocked configuration the cover  430  is completely removable from the upper housing section  410 B. In another embodiment the cover  430  is hingably attached to the upper housing section  410 B such that in the unlocked configuration the cover  430  swings open, pivoting on hinges (not shown in  FIG. 1 ) to permit access to the carousel  418 , the tray insert  450  and the medication doses  66 . 
         [0022]    Continuing with  FIG. 1 , within a region  432 , the medication on demand device  400  further comprises various visual indicators indicating states and conditions of the device  400  and control elements for controlling operation of the device. These elements are described in the above referenced patent and patent applications. 
         [0023]      FIGS. 2 ,  3  and  4  illustrate respective isometric, top and cross-sectional views of one embodiment of the carousel  418 . The carousel  418  comprises depressions  454  (for receiving the medication retention areas  154  of the tray insert  450 ) and a hold-down tab  460  having an upper surface substantially planar with an upper surface  418 A of the carousel  418 . An opening  462  is defined within the carousel  418  below the tab  460 . 
         [0024]    When the tray insert  450  is mated with the carousel  418 , the carousel depressions  454  receive the tray insert medication retention areas  154 . A notch  484  formed in a circumferential region of the tray insert  450  (see  FIG. 5 ) slips into the opening  462  of the carousel  418 . The carousel tab  460  exerts a downward force against a lower surface of the tray insert notch  484  to hold the tray insert  450  against the carousel&#39;s upper surface  418 A. This force is especially beneficial to steady the tray insert  450  during removal of a tray insert cover (described further below) to expose the medication doses within the medication retention areas  154 . 
         [0025]    Returning to  FIG. 2 , the carousel  418  further comprises an indicia  464  (in one embodiment comprising an adhesive-backed machine or human readable label) affixed to a circular recess  483  or another region of the carousel  418 . The indicia  464  may include a unique serial number to identify the medication on demand device  400  and to ensure that the MOD is correctly programmed with the dosing information for the assigned patient. This feature is especially beneficial when the MOD is programmed wirelessly, as use of the serial number during programming avoids programming another MOD that may be proximate the intended MOD. 
         [0026]      FIGS. 5 ,  6  and  7  illustrate a respective top, side and cross-sectional view of one embodiment of the tray insert  450  of the present invention. Generally, the shape and size of the tray insert  450  are substantially similar to the shape and size of the carousel  418 . 
         [0027]    One embodiment of the tray insert  450  comprises bosses  481  (see  FIGS. 5 and 6 ) extending from a lower surface of the tray insert  450  and received within openings  468  (see  FIGS. 2 and 3 ) of the carousel  418 . Insertion of the tray insert bosses  481  into the carousel openings  468  ensures rotation of the tray insert  450  responsive to rotation of the carousel  418 . 
         [0028]    According to one embodiment a material of the tray insert  450  comprises a relatively light and formable clear, transparent, colored or opaque substantially rigid polyvinyl chloride film. In one embodiment the tray insert material is coated with polyvinylidene chloride having a thickness of about 0.01125 inches to ensure long term stability of the medication doses carried within the retention areas  154  of the tray insert  450 . The coating protects against intrusion of water vapor and oxygen into the medication retention areas and is suitable for use with a variety of tray insert cover or lidding materials, including a peelable tray insert cover as described below. 
         [0029]    As is known to those skilled in the art, other tray insert materials, coating materials and coating material thicknesses can be used to form the tray insert  450 . For example, the tray insert  450  can be formed from styrene. Any material suitable for forming pharmaceutical-grade blister packaging can be used to form the tray insert  450 . 
         [0030]    The depicted embodiment comprises eight medication retention areas  154  each carrying a single medication dose  66  and each mating with a corresponding depression  454  in the carousel  418 . Other embodiments may include fewer or more retention areas  154 , and thus the carousel includes fewer or more depressions  454 . In particular, a medication on demand device  400  for home or outpatient use may comprise about fifteen medication retention areas  154 . 
         [0031]    In one embodiment the tray insert  450  defines a recess  486  (see  FIG. 5 ) for facilitating automated tray loading and counting when the tray insert  450  is automatically loaded with the medication doses. 
         [0032]    Each medication tray insert  450  is disposable as it is intended for only a single use. When all the medication doses have been administered, the empty tray insert  450  is removed and a stocked tray insert is loaded into the MOD  400 . To remove the tray insert  450  from the carousel  418 , the MOD cover  430  is opened and the user slips his finger into a carousel recess  488  (see  FIGS. 2 and 3 ) while simultaneously exerting a gentle upward force on the tray insert  450  and sliding the tray insert from beneath the carousel hold-down tab  460  (also illustrated in  FIGS. 2 and 3 ). 
         [0033]    Loading a stocked tray insert proceeds as follows. The tray insert notch  484  is placed into the carousel opening  462  such that the carousel&#39;s hold down tab  460  exerts a downward force against the bottom surface of the notch  484 . The tray insert medication retention areas  154  are also received within the depressions  454  of the carousel  416 . The tray insert cover (described below) is then removed and the MOD cover replaced and locked in a closed configuration. 
         [0034]    Different tray insert covers may be applied to the stocked tray insert depending on the desired shelf life of the medication doses carried within the tray insert. Alternatively, a single tray insert cover may be used for all tray inserts, including those intended for short term and long term storage. 
         [0035]      FIG. 6  illustrates a tray insert cover  490  preferably for use with relatively short shelf-life tray inserts, i.e., where long-term medication stability may not be important. Generally, the tray insert cover  490  is used for tray inserts that have a shelf life of a few days or weeks. 
         [0036]      FIG. 8  depicts, exemplary adhesive sealing regions  492 . Preferably, there is no adhesive film in the region of the cover tab  500 , between spokes of the sealing regions  492  and intersecting medication retention regions  154 . One medication retention area  154  is illustrated in  FIG. 8  with dashed lines. As can be appreciated by those skilled in the art, in other embodiments different sealing regions may be used. 
         [0037]    The tray insert cover  490  comprises multiple layers further comprising a laminate material layer  491 , a first adhesive film forming sealing regions  492  (depicted using a cross-hatching symbol), a peelable paper backing material  493  (see  FIG. 10 ) and a second adhesive film  495  disposed generally in areas where the first adhesive film is absent. The second adhesive film temporarily affixes the paper backing material  493  to the laminate material  491 . The peelable paper backing material  493  protects the laminate material  491  and the sealing regions until applied to the upper surface of the tray insert  450 . 
         [0038]    Suitable laminate materials are known in the art; one suitable material is product number TPC-0777A available from Tolas Health Care Packaging of Feasterville, Pa. In the illustrated embodiment the laminate material  491  and the paper backing material  493  have substantially the same size and shape. 
         [0039]    After the medication doses have been loaded into the medication retention areas  154  of the tray insert  450 , the paper backing  493  is removed from the laminate material  491  by separating the laminate and the paper backing starting at the cover tab  500  (illustrated in  FIG. 8 ) and the backing material tab  501  (illustrated in  FIG. 10 ). When completely separated, the laminate&#39;s adhesive-backed surface is placed on an upper surface of the loaded tray insert  450 . Pressure is applied to the laminate material  491  by a roller or a finger to join the laminate material to the upper surface of the tray insert  450 . The stocked tray inserts  450  are now suitable for storing or shipping. 
         [0040]    It is noted that when the tray insert cover  490  is in place over the tray insert  450 , the tray insert notch  484  is accessible to allow the carousel hold down tab  460  to be slipped into the notch  484 . The hold down tab  460  steadies the tray insert  450  while the tray insert cover  490  is removed as described above. 
         [0041]      FIG. 9  illustrates a second embodiment of a tray insert cover  502  including seal regions  504  for sealing the cover  502  to an upper surface of the tray insert  450 . The second embodiment may be better suited than the first embodiment for long term storage of the medication doses  66 . 
         [0042]    The tray insert cover  502  comprises a foil material having a first surface comprising a nitrocellulose material, for example. When the tray insert cover  502  is affixed to the tray insert  450 , the cover&#39;s first surface is exposed. Also, when affixed to the tray insert  450 , the tray insert cover  502  and the seal regions  504  individually seal the medication retention areas  154 , creating a moisture and an air barrier for the medication doses  66 . This configuration provides a relatively long-term shelf life (up to about two years) for the medication doses  66 . Other cover materials and seal region configurations can be used with the tray insert  450 . 
         [0043]    The cover  502  comprises two adhesive regions typically formed by two different adhesive materials. The seal regions  504  encircling the medication retention areas  154  comprise a first adhesive that individually seals the medication retention areas  154 , preventing the intrusion of environmental effects (such as air and water) to the medication doses  66 . In one embodiment the first adhesive is activated by the application of heat and pressure. Second adhesive regions  505 , formed from a second adhesive material having less adhesive binding strength than the first adhesive, comprises a universal sealant material disposed in areas of the cover  502  other than the seal regions  504 . A combination of the first and the second adhesive materials bonds the cover  502  to the tray insert upper surface. 
         [0044]      FIG. 9  also illustrates elements of the tray insert  450  and the cover  502  that hold the tray insert  450  in the carousel  418 . The cover  502  comprises a tab  510  having an opening  514  formed therein. A portion of the tray insert  450  is visible through the opening  514  in  FIG. 9 . The visible portion includes the tray insert notch  484  which slides under the hold down tab  460  (not shown) when the tray insert/cover assembly is mated with the carousel  418 . 
         [0045]    The cover  502  is removable from the tray insert upper surface when the tray insert is mated with the carousel. Like the cover  490  of  FIG. 8 , when the tray insert cover  502  is in place over the tray insert  450 , the tray insert notch  484  is accessible to allow the carousel hold down tab  460  to be slipped into the notch  484 . The hold down tab  460  steadies the tray insert  450  while the tray insert cover  502  is removed as described above. 
         [0046]    Those skilled in the art can identify different cover materials and different adhesive materials for use with the tray insert cover  490  and  502 . 
         [0047]    To properly dispense the medication doses  66 , it is necessary to properly orient the tray insert  450  relative to the carousel  418 . In one embodiment proper alignment is assured by sliding the tray insert notch  484  (see  FIG. 5 ) under the carousel hold down tab  460  (see  FIGS. 2 and 3 ). Alternatively, in another embodiment illustrated in  FIGS. 11 and 12 , a tray insert boss  481 A (see  FIG. 12 ) and corresponding carousel opening  468 A (see  FIG. 11 ) are asymmetrically located relative to the tray insert bosses  481  and the corresponding carousel openings  468 . Thus the tray insert  450  and the carousel  418  can be mated in only one orientation. Either technique, as well as others, properly orients the tray insert  450  relative to the carousel  418 . 
         [0048]    Various information labels may be attached to the outside surface of the cover  490  and the cover  502 . The information labels may include an expiration date of the medication doses carried by the tray insert  450  and a bar code indicating the intended patient, the medication dosage, the dosing regimen and the specific medication carried within the tray insert  450 . 
         [0049]    Returning to  FIG. 8 , the tray insert cover  490  (and the tray insert cover  502  of  FIG. 9 ) carries a patient/medication indicia  494  (comprising, for example, a bar code or radio frequency identification (RFID) transmitter/receiver) that identifies the patient, the medication dose and the dosing schedule for the medications carried within the tray insert  450 . The patient/medication indicia  494  can be read electronically or by a human attendant. The medication on demand device  400  comprises a bar code reader or a radio frequency identification interrogator for identifying the patient/medication as embodied in the patient/medication indicia  494 . (The commonly-owned cited patent and patent applications describe these features of the medication on demand device in greater detail.) 
         [0050]    In one embodiment, the information carried by the patient/medication indicia  494  is read by the MOD-based reader to program the MOD to administer the prescribed medication on the prescribed schedule. 
         [0051]    Further, when an empty tray insert  450  is replaced with a stocked insert, the patient/medication information embodied in the patient/medication indicia  494  is determined (for example by machine or human reading of the indicia  494 ) and compared with the patient and medication information programmed into the MOD or indicated on a label affixed to the MOD. The comparison process ensures that the patient is receiving the correct medication on the correct dosing schedule. 
         [0052]    In an embodiment where the patient/medication indicia  494  is carried on the tray insert cover  490 / 502 , after the patient information is validated, the tray insert  450  is inserted into the carousel  418 , the tray insert cover is removed as described above, the patient indicia  494  is removed from the cover  490 / 502  and placed in a transparent holder (not shown) of the MOD  400 . 
         [0053]    The medication retention areas  154  of the tray insert are manually or automatically stocked with the medication doses  66  in a suitable environment such as a pharmacy or by a pharmaceutical medication supplier. During the manual loading process, the tray insert  450  can be mated with a dispenser wheel that resembles the carousel  418  of  FIGS. 2-4 , but without the hold down tab  480 , thereby allowing the tray insert  450  to drop into place in the dispenser wheel. A medication dose is manually placed in each of the medication retention areas  154 . A medication loading machine performs automatic loading. 
         [0054]    One embodiment of the medication on demand device with which the tray insert of the present invention is used can be controlled to present a blank area of the carousel/tray insert assembly through the opening  430 A in the MOD cover  430  (see  FIG. 1 ). A medication dose is presented at the opening  430 A for a limited time after which the carousel/tray insert assembly is rotated by control elements to present a blank area  600  (see  FIG. 5 ) at the opening  430 A; the blank area  600  is disposed between adjacent tray insert medication retention areas  154 . The blank area  600  remains at the opening  430 A for a limited time after which the carousel/tray insert assembly is rotated according to the dosing schedule to present another medication dose at the opening  430 A. 
         [0055]    While the invention has been described with reference to preferred embodiments, it will be understood by those skilled in the art that various changes may be made and equivalent elements may be substituted for elements thereof without departing from the scope of the present invention. The scope of the present invention further includes any combination of the elements from the various embodiments as set forth herein. In addition, modifications may be made to adapt the teachings of the present invention to a particular application without departing from its essential scope thereof. Therefore, it is intended that the invention not be limited to the particular embodiment disclosed as the best mode contemplated for carrying out this invention nor to the other embodiments described and/or illustrated, but that the invention will include all embodiments falling within the scope of the appended claims.