Abstract:
A system for use in a hospital or other medical facility that protects medications (e.g., injected or orally administered) against diversion by facility personnel when transported from a central pharmacy to the patient. The system includes a portable hand-held carrier to encapsulate the medication, which may be contained within a vial, cartridge, or other container. The hand-held carrier protects and prevents removal or administration of the medication until after it has been transported to the patient. Wireless RFID or similar technology unlocks the hand-held carrier and enables injection, dispensing or other administration at the patient&#39;s bedside. Electronics in a bedside portion of the system communicate through a network to log the injection or other administration event in a central database.

Description:
RELATED APPLICATIONS  
       [0001]    The present application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/021,096, filed Jan. 15, 2008, and entitled “SYSTEM AND PORTABLE APPARATUS FOR SECURELY DISPENSING AND MAINTAINING ACCURATE INVENTORY OF CONTROLLED SUBSTANCES IN A HOSPITAL SETTING”, the disclosure of which is incorporated in its entirety. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]    1. The Field of the Invention 
         [0003]    The present invention is directed to the field of medication dispensing. More particularly, the present invention is directed to a system for securely dispensing and maintaining an accurate inventory of controlled substances in a hospital or similar setting. 
         [0004]    2. The Relevant Technology 
         [0005]    The medical service community stores, transports, and administers controlled substances (e.g., injection administered medications as well as orally administered medications) in response to doctor-ordered treatment authorized via prescriptions. Managing this operation currently requires periodic inventory of all controlled substances so as to balance the inventory as a result of drug administration. As currently conducted, this operation creates opportunities for personnel authorized (e.g., registered nurses and other medical providers) to handle a controlled substance to divert it in an unauthorized manner to either their own illegal use or for illegal resale. 
         [0006]    Although the extent of drug and alcohol abuse within the nursing profession has not been fully documented, at least one industry journal has indicated that as much as 10 percent of the nursing population has an issue with drug and/or alcohol abuse, and that 6 percent of this population has a sufficiently serious problem that it interferes with their ability to safely practice in the field (see “Substance Abuse Among Nurses—Defining the Issue”, AORN Journal, October 2005, Debra Dunn). 
         [0007]    In addition, current methods of inventory and control rely heavily on human input, and as such are prone to medical errors. For example, in a small but significant fraction of cases, either the wrong medication or incorrect dosage is administered to a patient, which can result in serious harm or even death to the patient. 
         [0008]    As such, it would be advantageous to provide a comprehensive system for maintaining control and accurate inventory over controlled substances used within a hospital or similar setting. It would be an added advantage if the system would help prevent medication errors in addition to preventing theft or illegal diversion of controlled substances. 
       SUMMARY OF THE PREFERRED EMBODIMENTS 
       [0009]    The present invention is directed to a system for use in a hospital or other medical facility. The system protects medications (e.g., injected or orally administered) against unauthorized diversion by facility personnel when transported from a central pharmacy to the patient. The system includes a portable hand-held carrier that encapsulates the medication, which may be contained within a vial, cartridge, or other container (e.g., a needle-mounted vial system such as Carpuject® from Hospira/Abbott Labs, or Tubex™ from Wyeth Ayerst Labs). The hand-held carrier protects and prevents removal or administration of the medication until after it has been transported to the designated patient. Wireless RFID or similar technology unlocks the hand-held carrier and enables injection, dispensing or other administration at the patient&#39;s designated location (e.g., bedside). Electronics in the designated location portion of the system communicate through a network to log the injection or other administration event into a central database. The device may advantageously provide visual and voice-response feedback confirming the contents of the vial, both in drug type and dosage. 
         [0010]    The system of the present invention advantageously reduces or eliminates drug theft in hospitals, reduces or eliminates medication errors of drug type and/or dosage, and can be accomplished in a cost-effective manner so as to be readily adopted by hospitals and other medical facilities of moderate or even relatively small size. 
         [0011]    These and other benefits, advantages and features of the present invention will become more full apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]    In order that the manner in which the above recited and other benefits, advantages and features of the invention are obtained, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. Understanding that these drawings depict only typical embodiments of the invention and are not therefore to be considered limiting of its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which: 
           [0013]      FIG. 1A  is a perspective view of an exemplary central system depository for controlled medications including an exemplary hand-held portable carrier for securely transporting medication from the central depository to a patient; 
           [0014]      FIG. 1B  is a close up perspective view better illustrating the exemplary hand-held portable carrier of  FIG. 1A ; 
           [0015]      FIG. 2  is a perspective view of the exemplary hand-held carrier of  FIGS. 1A-1B  and a charging and programming receptacle configured to receive a proximal end of the hand-held carrier; 
           [0016]      FIG. 3  is a close up perspective view of the exemplary hand-held carrier of  FIG. 2 ; 
           [0017]      FIG. 4  illustrates the distal end of the exemplary hand-held carrier in an unlocked and open position so as to allow loading of a vial, cartridge, or other medication container; 
           [0018]      FIG. 5  is a top view of the exemplary hand-held carrier of  FIG. 2 ; 
           [0019]      FIG. 6  is a longitudinal cross-sectional view of the exemplary hand-held-carrier of  FIG. 2 ; 
           [0020]      FIG. 7  is a side view of the exemplary hand-held carrier of  FIG. 2 ; 
           [0021]      FIG. 8  is a bottom view of the exemplary hand-held carrier of  FIG. 2 ; 
           [0022]      FIG. 9  is a distal front end view of the exemplary hand-held carrier of  FIG. 2 ; 
           [0023]      FIG. 10  is a proximal back end view of the exemplary hand-held carrier of  FIG. 2 ; 
           [0024]      FIG. 11  is a cross-sectional view of the exemplary hand-held carrier of  FIG. 2  in which the vial or other container is fully loaded; and 
           [0025]      FIG. 12  is a cross-sectional view of the exemplary hand-held container of  FIG. 2  in which the vial or other container has been fully emptied. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     I. Introduction 
       [0026]    The system of the present invention according to one exemplary embodiment includes a central depository station for storing a plurality of medications. The central depository includes a computer for providing access to a central depository management database, which computer is connected through a network to terminals within a plurality of patient rooms, and one or more hand-held carrier devices. Each hand-held carrier device is configured to securely hold medication (e.g., stored within a vial, cartridge, or other container loaded into the device at the central depository station) for transport from the central depository to patient locales. For example, a typical installation in a large hospital including about 500 beds might be divided into several departments having about 20 to about 30 beds each. Each department might include 1 central depository station and one room terminal for each bed. Of course, if there were multiple beds in a single room, it may be possible to share a room terminal with multiple (e.g., 2) beds. In other words, such a hospital may include about 500 patient room terminals and about 50 carrier devices (e.g., 2 to 3 carrier devices per central depository station). 
       II. Overview of Exemplary System for Maintaining Accurate Inventory 
       [0027]      FIGS. 1A and 1B  illustrate an exemplary central depository  100  including a computer  102  that includes a database that maintains an instant inventory of all medications allocated to it. Such a database maintaining an instant and continuously accurate inventory is advantageous as it is not required to manually inventory the controlled substances every time there is a nurse shift change (e.g., every 12 hours). The central depository station  100  may be located in the hospital pharmacy. In response to doctor orders, personnel in the pharmacy connects an empty hand-held carrier device  104  to a data port interface  106  (which may also charge a battery power source within carrier device  104 ) of the network at the central depository  100 , removes the appropriate medication from inventory, and places it in the carrier  104 . During this process, a bar code or other identification on the vial or other container of medication may be scanned or otherwise entered into the database system. Information relating to the medication type and dosage is saved to the central database as well as within the memory of the hand-held carrier  104 . The hand-held carrier  104  may advantageously include a display  108  so as to show medication type and dosage. Additional information (e.g., patient name, room number) may also be viewed within the electronic display (e.g., by a scrolling feature). Preferably, the system includes multiple data port interfaces  106  for connecting multiple carriers  104 . 
         [0028]    Pharmacy personnel then closes the carrier  104  to lock it and disconnects the hand-held carrier from the terminal port  106 . The central computer logs the various events as they occur, e.g., connection of empty carrier  104  to central depository port terminal  106 , scan of medication, medication loaded, lock and disconnect of the hand-held carrier  104 . 
         [0029]    The nurse transports the carrier to the patient room, holds the carrier near the room terminal, and pushes a button on the carrier (e.g., in an example where the room terminal includes the ability to communicate wirelessly, for example, by RFID with the carrier). Other communication mechanisms may alternatively be employed (e.g., wired connection). If the medication is in the designated location and/or in close proximity to the designated patient, the carrier  104  unlocks and allows the nurse to proceed with the injection or administration of the controlled substance. 
         [0030]    Through the network connection (e.g., wireless RFID), the central computer  102  logs these events and confirms that the proper medication has been delivered to the designated patient as ordered. If the carrier  104  is not in the authorized location, the carrier  104  may remain locked and/or provide a visual and/or auditory alarm. If the carrier  104  is unlocked in the designated location, it may then provide a voice announcement stating the medication type and dosage. This information could alternatively or additionally be provided visually (e.g., on display  108 ). After the injection, the nurse again holds the carrier  104  near the room terminal and pushes a button. This logs the event that the nurse indicates the injection or other medication administration has been completed. 
         [0031]    Significant passage of time between unlock and completion of the injection or other administration event may indicate possible attempts at drug diversion. In one embodiment, if the nurse delays too long (e.g., more than about 6-7 minutes) the carrier may relock and/or provide an alarm (e.g., visual, auditory, and/or inform a supervisor that unauthorized diversion may be occurring). In another embodiment, such an alarm may be provided if the carrier is taken too far away from the central depository station and/or patient room (e.g., more than 500 feet from the central depository station and/or patient room). After the administration has been completed, the nurse returns the carrier to the central depository in the pharmacy for sanitizing, after which the carrier  104  is returned to inventory so that it may be reused. The central computer  102  logs this event to finalize the process. The central database  102  is instantly accurate at all times and has the capability of indicating how much medication is in-route at any given time. This is particularly advantageous as it is not required to manually inventory the controlled substances, and taking an inventory at the end of one nurse shift and the beginning of another can be quickly accomplished (e.g., a matter of seconds to a minute or two as compared to 30 minutes or more for a typical inventory performed at the overlap of each nurse shift change). 
         [0032]    The hand-held carrier  104  may advantageously contain a barcode or other ID scanner which serves to confirm that the identification band of the patient matches the medication order. Optionally, the carrier  104  may provide an audible and/or visual response and/or additional information (e.g., type and dosage of the loaded medication). 
       III. Exemplary Hand-Held Carrier Device 
       [0033]      FIG. 2  illustrates an exemplary hand-held carrier  104  adjacent to a data port interface  106 . As illustrated, a plurality of data port interfaces  106  may be included at central depository station  100 . An exemplary interface  106  may include a data connector  110   a  (e.g., connected to a USB, serial, or other data interface of computer  102 ) and a power connector  110   b  for charging a power source (e.g., a battery) within carrier  104  when carrier  104  is mounted within data port interface  106 . 
         [0034]      FIGS. 3-12  illustrate various views of carrier device  104 . The hand-held carrier device as illustrated is advantageously small, battery-powered dispensing device that monitors and drives the dispensing (e.g., administration by hypodermic injection) under nurse control. The illustrated example of carrier device  104  includes an elongate body  112  extending between a distal delivery end  114  and a proximal gripping end  116 . An electronic display  108  may be provided to display information relative to the contents of the carrier, the patient, etc. A plurality of buttons for providing input are also provided. For example, buttons  118  may be used for scrolling through information on display  108 , and/or making a selection, while buttons  120  may be used to advance or retract a plunger or other mechanism for delivering medication held within carrier  104 . 
         [0035]      FIG. 4  illustrates distal end  114  rotated to an open position where it may receive a vial, cartridge or other container  122  to be loaded into carrier  104 . Where the controlled substance within container  122  is to be injected, a connector (e.g., a luer connector)  124  may be coupled to the distal end of container  122 . As seen in  FIG. 6 , body  112  may be formed of a rubber like grippable material. Various components of the system are provided within carrier  104 . For example, a battery  126  is provided for powering display  108  as well as a motor  128  coupled to reduction gears  129 , which are in turn coupled to a threaded plunger shaft  130 . A distal end of plunger shaft  130  includes a plunger  132  configured so as to force a controlled substance within container  122  out distal end  114  (e.g., through a needle  138 —illustrated as capped in  FIG. 6 ). Although illustrated with specific components (e.g., battery  126 , motor  128 , gears  129 , shaft  130 , plunger  132 ) in specific locations and arrangements, it will be understood that other components and/or arrangements may be employed. 
         [0036]    As perhaps best seen in  FIG. 7 , a transparent window  134  is provided along both sides of body  112  so that the user can easily see the progressive dispensing of medication within vial, cartridge, or other container  122 . The bottom surface of body  112  may include a door  136  for accessing a battery compartment.  FIGS. 9 and 10  illustrate the distal front and proximal rear ends of the device, respectively, showing connector  124  at distal end  114  and a data (e.g., USB) port  111   a  and a battery charging port  111   b  at proximal end  116 . 
         [0037]      FIG. 11  and  FIG. 12  illustrate cross-sections of the carrier device  104  with vial  122  fully loaded and plunger shaft  130  in a retracted position ( FIG. 11 ) and vial  122  completely emptied and plunger shaft  130  in a fully extended position ( FIG. 12 ). 
       IV. Exemplary Method of Use 
       [0038]    The computer  102  in the central dispensing station  100  has access to medical orders in the form of medication schedules associated with particular patients. An authorized operator accesses the computer  102 , places an empty hand-held carrier  104  in the data port  106 , and selects an order to apply to the carrier  104 . The dispensing system responds by allowing access to the selected medication, preparing the carrier mechanically to receive the vial (e.g., unlocking carrier  104  so as to allow loading), and programming the carrier device  104  with the patient, medication, and dosage information as ordered. Such information may be displayed on display  108 . 
         [0039]    The central depository station may include a separate charging station (e.g., other than the integral charging port shown data port interface  106 ) which permits multiple carriers to dock in base unit receptacles that only serve only to maintain a charge on the batteries in each carrier device  104 . 
         [0000]    
       
                 
         
             
             
         
       
     
         [0040]    The above diagram shows the essential components of the system located at the central depository station. The diagram shows two hand-held carrier units, one being programmed and one being charged only. The central depository station may include a barcode or other ID scanner to confirm the type and dosage of the medication selected by the operator before it is loaded into the carrier (e.g., the user may scan a barcode on the container of the medication). 
         [0000]    
       
                 
         
             
             
         
       
     
         [0041]    The diagram above shows the elements contained in an exemplary hand-held carrier device  104 . The microcontroller interfaces with the components on the left, namely the display, control buttons, audio speaker, memory, as well as the data port. It also drives the motor and receives input from a force detector. Control buttons allow the operator to mix medications as necessary, aspirate and inject or otherwise dispense the contents of the vial, and play audio announcing the medication type and dosage programming into the unit and/or visually display this information. 
         [0042]    Pharmacy personnel places the hand-held carrier  104  in the data port interface  106  at the central depository station  100 . The computer  102  recognizes the carrier  104  and confirms that a data connection is established. The operator reviews a list of injections and/or controlled substance administrations scheduled (e.g., in the next hour) and selects a scheduled administration by earliest time, by patient, or some other criteria. Upon selection, the system confirms that inventory exists to fill the order and prepares to allow access to the proper drawer and/or bin of the cabinet  103  of station  100 . The cabinets of station  100  may contain both pills and IV vials. Depending on the configuration of the hand-held carrier device received within port  106 , the system may list only injection orders in an embodiment where the carrier is configured only for delivery of injection medications. 
         [0043]    The operator activates the enabled selection, removes the vial from the cabinet  103 , and scans it with a bar code wand attached to the computer  102 . If the bar code does not match the expected contents of the bin, the system indicates the error; otherwise the correct vial has been accessed. The cradled hand-held carrier unit  104  responds by fully extending a plunger shaft (see shaft  130  of  FIG. 11 ) to reveal the plunger-rod threads to mate with the plunger in the vial. 
         [0044]    The operator breaks the seal on the accessed vial  122 , attaches a luer lock needle with cover (where the contents of the vial is to be injected), and places the vial  122  in the hand-held carrier device  104  ( FIG. 4 ). This is accomplished by rotating the distal front end  114  of the carrier  104  to allow the carrier  104  to receive the vial  122 , placing the vial  122  in the carrier  104 , and screwing the vial  122  onto the receiving threads of the motor-driven plunger shaft  130 . At this stage the vial  122  extends well past the end of the hand-held carrier  104 . The operator issues a “Load” command from the computer and/or carrier  104  (e.g., by pressing a button on carrier device  104 ) which causes the plunger  132  to retract, thus pulling the vial  122  into the carrier  104 . A positional sensor detects when the vial  122  is positioned fully in the carrier  104  and causes the plunger shaft  130  to stop moving. At this point, the operator manually rotates the vial lock (i.e., distal front end  114 ) to the closed position locking the vial  122  in place so the plunger shaft  130  can operate either by retracting in or extending out as commanded later by the nurse. 
         [0045]    Closing the vial locking mechanism with a vial confirmed as present inside the carrier sends a signal to the computer of the central depository station that the vial  122  is in place. This triggers the computer  102  to program the carrier with the injection order, including the patient, the room, the medication type and dosage. Of course, this information could alternatively be programmed into the carrier  104  prior to locking vial  122 . 
         [0046]    The nurse then takes the hand-held carrier device  104  to the patient and uses a bar code scanner in the carrier  104  to confirm that the patient matches the order programmed into the carrier (e.g., by scanning the patient&#39;s ID band). The patient&#39;s weight may also be used to confirm dosage information (e.g., typically dosage of a medication is directly linked to patient weight). If the patient scanned does not match the order, then the display may show “Error” on display  108  and provide additional visual/auditory signals (e.g., by a blinking light and/or the unit beeping repeatedly, for example five times). If the patient matches, then the carrier  104  shows the order on the display  108  and may also provide an additional signal (e.g., beeps once) to confirm. Pressing the centrally located display control button  118  causes the unit to audibly announce the medication and dosage. Pressing right or left arrow buttons  118  at this time may cause the announcement volume to temporarily increase or decrease. When the carrier is programmed at the central depository station, it may set the volume to a nominal value so the sound will always initially be enabled at a predictable level. 
         [0047]    Once the order is confirmed and the patient matches the order, the nurse administers the injection. The nurse removes the protective cover from the needle  138 . The nurse holds the needle vertically oriented upwards and presses the inject button  120  until liquid squirts out the needle  138 . This pushes air out of the adapter  124  between the vial  122  and the needle  138  and purges the needle. The nurse then places the needle  138  into the patient. The nurse then presses and holds the pull-back button  120  to aspirate. The carrier  104  responds by pulling back a fixed distance on the plunger shaft  130  and holding. The nurse then inspects the distal end of the vial  122  behind the needle  138  for blood (e.g., through window  134 . If there is no blood visible, then the nurse releases the pull-back button  120  and the plunger shaft  130  returns to its original position. If there is blood visible, then the needle  138  is in a blood vessel and must be relocated. During the aspiration cycle, the display  108  include a spiraling graphic (e.g., representing a “backwards” rotation of threaded plunger shaft  130 ) to indicate that the aspiration is in process, and then stopping at the end of the aspiration cycle. Alternatively, the user may be able to view the backwards rotational motion of the threaded plunger shaft  130  (as well as it&#39;s reverse axial movement) through window  134 . Similarly, the user may view the forward rotational motion of threaded plunger shaft  130  through window  134  as the medicine is delivered to the patient. Display  108  could also be configured to provide a “forward” spiraling graphic during delivery of the medicine to the patient. 
         [0048]    It is advantageous for the plunger stem  130  to return automatically to the starting point as this establishes the base, zero-calibration point for measuring the amount of medicine delivered. This also prevents air from entering the needle  138  if blood is detected and it becomes necessary to pull the needle out and reinsert it in a different location. 
         [0049]    If blood is not detected during the aspiration cycle, then the nurse delivers the medication by pressing and holding the inject arrow button  120 . Pressing the inject arrow button  120  (the distally located of buttons  120 ) may advantageously deliver the medication at a slow, steady rate. Releasing the inject arrow button  120  may pause the delivery of medication. Because there is a direct relationship between the plunger displacement and the amount of medication delivered, the carrier  104  is able to measure the amount of medication delivered, and since it was programmed with the ordered dosage, injection will automatically stop when that amount of medication has been delivered. Also during the injection, the display  108  may shows information (e.g., a dial or other indicator) indicating the force on the plunger  132 . Excessive force indicates that there is resistance at the injection site which may be cause to stop the injection. 
         [0050]    In the situation where it is desired to combine medications within the vial or other container prior to the injection, the central depository operator (e.g., pharmacist) selects a vial containing the desired amount of the primary medication. The vial is only partly full in the sense that there is room for additional secondary medicament to be aspirated into the vial and mixed with the original contents of the vial. The vial is loaded into the carrier as described previously. The needle is exposed and the seal membrane of the secondary medication vial is impaled on top of the exposed needle of the carrier. The operator issues the command to aspirate the secondary medicament. The carrier device responds by drawing in liquid from the secondary vial in the amount specified by the order in the computer. The vial in the carrier is now properly loaded and contains the desired mixture of medications. At the end of the aspiration cycle, the computer may program the carrier with the patient, medication, and dosage and indicates that the carrier is ready for use on the specified patient. Note that this mechanism allows mixing only at the central depository station. 
         [0051]    The carrier device  104  preferably allows easy viewing of the contents of the vial  122  directly behind the needle  138  in order to determine if the needle is in a blood vessel when aspirating. Having a clear view of the entire vial  122  allows feedback to the nurse as to the position of the plunger  132  at all times during the injection. The distal end portion of the carrier may be formed of tapered thin and transparent plastic. A design of this type would allow viewing to the distal end of vial  122  and into connector  124  and possibly even the proximal end of needle  138 . 
         [0052]    Pharmacy personnel use a bar code reader to move medications into pharmacy inventory so the central computer  102  will indicate the additional inventory. In response to doctor orders, personnel in the pharmacy connects an empty carrier  104  to a computer data port interface  106  on the network, removes the appropriate medication from inventory, and places it in a carrier  104 . During this process the bar code on the vial is scanned and information relating to medication type and dosage is communicated to the central database and also to the carrier memory via a wireless or wired interface (e.g., information may be relayed to carrier  104  through a wireless interface rather than the illustrated wired data port interface  106 ). 
         [0053]    It will be appreciated that the present claimed invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative, not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.