Patent Document

CROSS REFERENCE TO RELATED APPLICATIONS  
       [0001]     Not Applicable.  
       STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH  
       [0002]     Not Applicable  
       FIELD OF THE INVENTION  
       [0003]     The present invention relates generally to a medication delivery system and more particularly to a patient-controlled medication delivery system.  
       BACKGROUND OF THE INVENTION  
       [0004]     Many people must take prescribed medication over a period of time. In order for the prescribed medication to be most effective, patients are typically required to take the prescribed medication on a defined schedule (e.g., every 12 hours). A problem associated with taking prescription medications on a defined schedule is non-compliance of patients with respect to the taking of the medication at the appropriate time. Non-compliance with the prescribed medication schedule can lead to several problems. One problem is that such non-compliance can result in the patient suffering from effects the prescribed medication is intended to control (e.g., high blood pressure). Another problem is that patient non-compliance makes it difficult for a doctor or other medical practioner to determine whether the medication is working properly or if the dosage amount or time interval between dosages needs to be changed to provide more effective relief.  
         [0005]     When a patient is prescribed with a controlled substance, such as a narcotic pain killer, non-compliance with the prescribed medication may lead to serious and even fatal consequences.  
         [0006]     In addition, tampering with the prescribed medication could cause serious legal and medical problems. There are several reasons for unintentional non-compliance with a prescribed medication dosage schedule. Patients, especially the elderly or mentally ill, may not remember the time specified or the proper dosage for taking a medication. Further, patients may forget if they have already taken a dosage and inadvertently take another dosage or patients may skip a dosage, thinking they had already taken the dosage. This may result in the patient either not taking the medication or taking too much of the medication, possibly leading to an overdose.  
         [0007]     Another reason for unintentional non-compliance with a medication dosage schedule is people may have schedules that vary every day, and thus they are not available to take medication at the same time every day. The patient may be working, traveling or otherwise unable to follow the schedule for taking their prescribed medication.  
         [0008]     Another problem associated with patient non-compliance with a schedule for taking medication is patient identification regarding the prescription. In a situation wherein multiple people are co-residing, it may be easy for the medications to get confused, with the result that a patient takes a medication intended for another person, which can lead to problems.  
       SUMMARY OF THE INVENTION  
       [0009]     In accordance with the present invention, a method and apparatus for providing patient-controlled medication delivery is presented. The apparatus includes a medication storage subsystem for storing prescribed amounts of a medication, an interval timer coupled to the medication storage subsystem, a patient verification system coupled to the medication storage subsystem, and a delivery subsystem which delivers one of the prescribed amounts of medication when the interval timer has reached an end of a predetermined time interval, when the patient verification system verifies an identity of the patient, and when the patient activates the medication delivery system. The patient selects the delivery time of the first dosage and therefore determines the best time to receive the dosages.  
         [0010]     A method for providing patient-controlled medication delivery includes verifying an identification of an intended patient and providing a first prescribed amount of a medication for the intended patient, wherein the intended patient determines a time to start taking the prescribed amount of the medication. The method further includes waiting a predetermined time interval, the time interval starting from the time the intended patient last requested and received a prescribed amount of the medication, again verifying the identification of the intended patient and providing another prescribed amount of the medication for the intended patient. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0011]     The foregoing features of this invention, as well as the invention itself, may be more fully understood from the following description of the drawings in which:  
         [0012]      FIG. 1  is a perspective view of an apparatus for providing patient-controlled delivery of a medication;  
         [0013]      FIG. 2  is a cross-sectional side view of an apparatus for providing patient-controlled delivery of a medication;  
         [0014]      FIG. 3  is a block diagram of a medication storage subsystem of the patient-controlled medication delivery system;  
         [0015]      FIG. 4  is a diagram of a piston of a medication delivery subsystem; and  
         [0016]      FIG. 5  is a flowchart of a method of providing patient-controlled medication delivery. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0017]     Referring now to  FIG. 1 , an apparatus  10  for providing patient-controlled delivery of a medication includes a container  12  having a movable access panel or cover  14  coupled thereto. The access panel  14  may be secured to the container by a locking mechanism  16  (or more simply a “lock”  16 ) which prevents an unauthorized user from accessing the inside of the container  12 . In the exemplary embodiment shown in  FIG. 1 , the access panel  14  is shown as a top cover  14  to the container  12 . Those of ordinary skill in the art will appreciate of course that access panel  14  can also be provided as a bottom cover or side cover or as any removable portion or portions of container  12 .  
         [0018]     The apparatus  10  includes a timer  18 , a patient identification verification system  20 , an activation switch  22 , a drawer  24  having a handle  26 , and an indicator  23 . Not visible in this view are internal subsystems such as a medication storage subsystem and a medication delivery subsystem.  
         [0019]     The container  12 , in a preferred embodiment, is tamper proof and made of a relatively strong material such as stainless steel or the like. Container  12  has located therein a medication storage subsystem and a medication delivery subsystem which are used in combination to provide medication at predetermined time intervals to a properly identified patient. The patient selects the delivery time of the first dosage by completing a patient identification process once the time interval has elapsed. Thus, the apparatus  10  functions such that the patient has the freedom to determine the time to begin taking the medication.  
         [0020]     The lock  16  secures cover  14  in a closed position to thus prevent unauthorized access into the container  12 . In one embodiment, the lock is operable by way of a key (not shown). It should be appreciated, however, that other types of lock systems (e.g., a keyless lock system) could also be used. The cover  14  can be opened or removed by an authorized person (e.g., a doctor, nurse or other medical practitioner) for the purpose of replacing the supply of medication, but otherwise is kept locked. This prevents patients or others from removing the medication supply or otherwise tampering with the contents of the container  12 .  
         [0021]     The timer  18  is used to measure the time interval between medication deliveries. In a preferred embodiment, the predetermined time interval between medication deliveries measured by the timer  18  is set by an authorized person such as a physician or nurse (according to physician instruction). The timer  18  is connected to a medication storage subsystem  30  (described below in conjunction with  FIG. 2 ) and the medication delivery subsystem  40  (also described below in conjunction with  FIG. 2 ). In the embodiment shown in  FIG. 1 , the timer  18  is mounted on a front surface of the container  12 . It should, however, be appreciated that the timer may be located on other locations of the apparatus  10 . It should also be appreciated that the timer may be physically separate from the apparatus  10  as long as the timer is coupled (e.g. by a wire or wireless connection) to the medication storage and delivery subsystems  30 ,  40 .  
         [0022]     The timer  18  controls the medication delivery subsystem  40  such that medication is only available after the timer has elapsed as indicated by the front indicator  23 . Indicator  23  may be an audio indicator, a visual indicator, a combination audio and visual indicator or other type of indicator as would be known by one of ordinary skill in the art. Alternately, the indicator could be included as part of activation switch  22 . Thus, once the time interval has elapsed, if the patient desires to have the medication the patient begins a medication dispensing process by performing a patient verification process (e.g. by pushing an appropriate sequence of ID keys).  
         [0023]     Once the verification process is completed correctly, the medication delivery subsystem  40  can be activated. In one embodiment, the activation switch  22  is engaged once the verification process is correctly completed and a patient or other person (e.g. a caregiver) can operate the activation switch  22  (e.g. by pushing the activation switch) to get a single dosage of the prescribed medication. Medication delivery is not available if the time interval has not elapsed. This prevents a patient from taking too much medication during any one time period. After receiving the single dosage, the timer restarts and the patient is prevented from acquiring another dose of medication until the time interval elapses.  
         [0024]     The patient-controlled medication delivery system also includes the patient identification verification system  20  for verifying the identity of the patient or verifying that the patient or other person has the requisite information to operate the system. The system  20  thus prevents unauthorized use of the apparatus  10 .  
         [0025]     In a preferred embodiment, the patient identification device is provided as a Personal Identification Number (PIN) device  20 , although other identification verification systems could also be used (e.g. a biometric verification system could be used). The system  20  is in communication with the medication delivery subsystem  40  such that once a correct PIN is entered, the patient is able to have the medication delivered if the time interval between medication deliveries has passed.  
         [0026]     In one embodiment the system  20  includes a digital touch-tone number pad. To operate the system, an ID number is entered which must match a predetermined patient ID number. Once the correct ID number is entered the patient can receive medication from the system.  
         [0027]     In one particular embodiment, a four-digit ID system is installed. In this embodiment, a patient is allowed a predetermined number of attempts (e.g. three attempts) to enter a combination of digits corresponding to a valid ID number (the digits can be numbers, letters or a combination of letters and numbers). Three attempts are allowed considering the following factors: 1) a four-digit ID system will have 16 combinations and is not easy to break with three tries and 2) in elderly groups, a mistake could be made more than once when entering the ID by pushing the keys. However, after a predetermined number of attempts (e.g. three attempts) if the correct code has not been entered the system will be locked until the time interval between medication deliveries has elapsed.  
         [0028]     Under such circumstances, the patient will not be able to receive medication from the apparatus  10  until the time interval has expired (as measured form the last of the three attempts). If the patient cannot wait that long to receive the medication, the patient will need to acquire the medication from another source, (e.g. by contacting or visiting the appropriate doctor or other medical practitioner or appropriate pharmacist). The patient will also have to contact the pharmacy or medical service provider (with appropriate identification) to have someone provide the patient&#39;s correct PIN number to them. It should be appreciated, of course, that ID&#39;s having fewer or more than four digits may also be used.  
         [0029]     The apparatus  10  also includes the activation switch  22  which is in communication with the medication delivery subsystem such that, if the timer interval has elapsed and the patient identification has been verified, engaging the activation switch  22  activates the medication delivery subsystem and a prescribed dosage of medication is made available to the patient. In a preferred embodiment the medication is deposited in the drawer  24  that the patient can access to remove the dosage of medication. In one particular embodiment, the switch  22  is provided as a pushbutton switch  22  disposed on the front surface of container  22 . It should be appreciated, however, that the activation switch  22  may be coupled to the apparatus  10  in any manner now or later known to one of ordinary skill in the art including via a wireless or hardwired connection.  
         [0030]     In some embodiments there may be an adjustable predetermined time delay (e.g. a 10 to 30 second delay time) after the first push of the delivery activation switch  22  before the timer  18  locks the medication delivery subsystem  40  for the next set time interval. The time delay allows the patient to engage the activation switch  22  one or more additional times such that one or more additional dosages of a desired medication is dispensed. In the case where activation switch  22  is provided as a pushbutton switch, the delay allows the patient time to push the pushbutton switch again to have an additional medication dosage if so desired (according to the physician&#39;s recommendation). In most cases, one or two tablets or capsules are commonly used. However, in some versions of this device more than two pushes may be allowed to accommodate the prescription needs.  
         [0031]     Activation switch  22  may include an indicator  23  (e.g., a light) visible to the user (e.g. from the surface of the activation switch), which is connected with the timer. In the case where the indicator  23  is provided as an indicator light, the indicator light could be seen, for example, as a first color or light pattern (e.g., red or flashing) during the locked interval and as a second color or pattern (e.g. green or solid) after the set time interval has elapsed. There may also be an alarm (e.g. an audio or vibratory alarm signal) system (designated  25  in  FIG. 2 ) connected to the timer to remind the patient that the set time interval has elapsed and the device is ready to deliver the medication again if needed.  
         [0032]     Referring now to  FIG. 2 , a cross-sectional side view of a patient-controlled medication delivery system  28  which may be similar to the system  10  shown in  FIG. 1  includes a medication storage subsystem  30  (described below) coupled to a medication delivery subsystem  40 .  
         [0033]     The medication delivery subsystem  40  includes an activation timer  18 ′ which may be similar to the activation timer  18  described above in  FIG. 1 , an ID verification system  20 ′ which may be similar to the verification system  20  described above in  FIG. 1 , connecting rods  42  and  44 , a piston assembly  46  and an activation switch  22 ′ which may be similar to the activation switch  22  described above in  FIG. 1 .  
         [0034]     When either of rods  42  or  44  is deployed such that the distal end of the rod ( 50  and  48  respectively) engages the appropriate detent ( 52  and  54 ) in piston assembly  46 , the piston disposed within piston assembly  46  is prevented from moving toward the medication storage subsystem  30 , and the delivery of medication is prevented. On the other hand, when the time interval has elapsed timer  18 ′ will disengage rod  42  from piston assembly  46 . Similarly, when a patient ID has been verified, rod  44  will also disengage from piston assembly  46 . It is only when both rods  42  and  44  have disengaged the piston assembly  46  that piston may be activated by operation of activation switch  22 ′ to release a dosage of medication from medication storage subsystem  30 . While a particular embodiment of the locking mechanism for the piston has been described, it should be appreciated that other locking means could be used, such as an electrically activated lock or the like.  
         [0035]     Also shown in this Figure is a recorder  51 , which is part of the medication storage subsystem  30 . In one embodiment, the recorder  51  imprints the time on a sticker when the patient presses the activation switch  22 ′. This sticker may be removed and transferred to the patient chart to give the physician the exact timing and intervals of the medication uses. This will help physician to further adjust the medication accordingly such as increasing the dosage, decreasing the dosage or changing the time interval between dosages.  
         [0036]     Referring now to  FIG. 3 , a medication storage subsystem  31 , which may be similar to the medication storage subsystem  3   o  described above in  FIG. 2 , includes a medication container  32  in which medications  34  (e.g. tablet, capsules, pills etc.) are disposed. In the exemplary embodiment of  FIG. 3 , the medications  34  are in a medication package  36  have a disk shape (i.e. circular shape). As shown in  FIG. 3 , the medication  34  is disposed around a perimeter of the package  36 . It should be appreciated that although the package  36  and container  32  are here shown having a round shape, those of ordinary skill in the art will appreciate of course that other shapes may also be used. Those of skill in the art should also appreciate that the medication  34  may be arranged in a pattern and location other than a circular pattern along a perimeter of a medication container  32  or package  36 .  
         [0037]     An authorized person (e.g., a medical practitioner such as a physician a nurse or a pharmacist) mounts the medication package  36  into the storage subsystem  30 . At the appropriate time, the storage subsystem  30  dispenses an appropriate dose of the medication  34 .  
         [0038]     Within the subsystem  30  the circular medication package  36  rotates in a clock-wise direction each time a medication  34  (e.g. a pill) is pushed out from the package  36 . When the patient pushes the activation switch  22  a hollow cylindrical shaped part of the piston (described in detail below in conjunction with  FIG. 4 ) cuts the portion of the medication package  36  which serves the medication  34  (e.g. a pill) in the package  36 . In some embodiments, the medication  34  is secured via a plastic or foil cover. A solid portion of the piston then pushes the medication  34  out of the medication storage subsystem  100  and into the delivery drawer. Also shown is a sticker  38 . The sticker is used by the recorder (described above) to record the time the medication was delivered.  
         [0039]     Referring now to  FIG. 4  in conjunction with  FIG. 2 , the medication delivery system comprises a drawer  24  or similar structure for the purpose of receiving the pill after the pill has been dispensed (e.g., by having been pushed by the piston), making it available for the patient to pick-up. This drawer  24  is located at the lower end of the device  10  and extends across the bottom of the device. A patient has to pull the drawer  24  by a handle  26  located on the surface of the draw and is able to pick-up the pill.  
         [0040]     An example of a preferred embodiment of the piston assembly  46  is shown in detail in although it should be appreciated that other types of piston assemblies could be utilized. In this example embodiment piston  56  is a cylindrically shaped structure with two indentations or detents  52  and  54  for the locking mechanism. Detent  52  receives the distal end of rod  48  which extends between the piston assembly  46  and the ID verification system  20 . Detent  54  receives the distal end of rod  42  which extends between the piston assembly  46  and the timer  18 ′ ( FIG. 2 ).  
         [0041]     The piston assembly  46  comprises a cylindrical bar  58  disposed within a hollow structure  56  here shown having a tubular shape for example. The bar  58  may be solid in some embodiments. The tubular structure  56  is provided having a sharp circular edge  60  at a distal end. This tubular structure  56  is movable over a short distance and allows the solid cylinder  58  to slide forward within the tubular structure  56 . The sharp edge  60  of the tubular structure is used to make a cut (in this case circular cut) around the plastic or foil containing the pill in the medication delivery subsystem  30 . The solid bar  58  then pushes the pill out of the foil.  
         [0042]     After the piston assembly  46  is activated by a patient through the activation switch (e.g. activation switch  22 ′ in  FIG. 2 ) and delivers the medication, the connector rods  42  and  44  will lock, and prevent any forward movement of the piston assembly  46  for the set time interval and thus no medication will be delivered during the set time interval. Once the set time interval has elapsed, the connector rod  42  will release from piston assembly  46 . If the patient desires to have the medication after the set time interval has elapsed, he or she is able to activate the piston assembly  46  by pushing the activation switch  22 ′ to get the medication, assuming the patient identification has also been verified and rod  44  has released piston assembly  46 .  
         [0043]     While a particular embodiment has been described, it should be appreciated that other embodiments are also within the scope of the present invention. For example, the timer  18  and the connecting rod  42  is connected together via a spring (may also be a magnetic system) mechanism. When the prescribed time elapses, the connecting rod  42  will un-lock itself from the detent  54  and remain in that position until the patient pushes the activation switch (e.g. activation switch  22 ′) to receive the medication.  
         [0044]     The activation switch pushed by the patient to receive the medication, also has several other functions, including 1) rotating the cartridge containing the pills, 2) recoding the time of medication delivery on the sticker  51 , 3) resetting the timer  18 , and 4) locking the system (e.g. by placing the connecting rod  42  into the dent  54 ).  
         [0045]     The delivery system could also be similar to a sliding door allowing pill(s) to slide out of the pill-cartridge, which may in a vertical fashion under this design.  
         [0046]     A flow chart of the presently disclosed method is depicted in  FIG. 5 . The rectangular elements are herein denoted “processing blocks” and the diamond shaped elements are herein denoted “decision blocks”. It will be appreciated by those of ordinary skill in the art that unless otherwise indicated herein, the particular sequence of processing blocks and/or decision blocks described is illustrative only and can be varied without departing from the spirit of the invention. Thus, unless otherwise stated the processing blocks and/or decision blocks described below are unordered meaning that, when possible, the processing blocks and/or decision blocks can be performed in any convenient or desirable order.  
         [0047]     Referring now to  FIG. 5 , the process for providing patient-controlled medication delivery  100  starts and processing block  102  is executed. In processing block  102  an authorized person sets the time interval. The authorized person may be a physician or nurse (according to physician instruction). The time interval defines the time between medication deliveries.  
         [0048]     In processing block  104  the patient (or other authorized person) selects the time of the first dosage. This is done at a time determined by the patient, not at a predetermined time of day. Thus, the patient has the freedom to determine the time to begin taking the medication.  
         [0049]     In processing block  106  the identity of the patient is verified. In one embodiment, the patient is required to enter a patient ID number via a PIN device. Alternately, other patient verification means could be used, such as scanning a bar code from a patient wrist band, or a medication card having a bar code or magnetic strip thereon or a biometric verification system can be used.  
         [0050]     In processing block  108  the medication is provided to the patient at the patient-determined time of day. One feature of the present invention is that the patient has determined the time of day to start taking the medication.  
         [0051]     In processing block  110  the time interval between dosages of the medication is observed. This time interval is determined by a doctor or other authorized medical practitioner. While the patient determines the starting time to begin taking the medication, the doctor (or other authorized medical practitioner) determines the time interval between dosages of the medication.  
         [0052]     Once the time interval has elapsed, in processing block  112  the patient identification is again verified. This done to assure that the proper patient will be receiving the medication. This step is preferably done in a similar manner as the verification of the patient that was conducted in processing block  106  described above.  
         [0053]     In processing block  114  the medication is delivered. The patient has the medication made available to him or her at the predetermined time interval and after the identification of the patient has been verified.  
         [0054]     In decision block  116  a determination is made whether the supply of medication has been exhausted. If the supply of medication has been exhausted, then the process ends otherwise blocks  110  et seq. are executed.  
         [0055]     Having described preferred embodiments of the invention it will now become apparent to those of ordinary skill in the art that other embodiments incorporating these concepts may be used. Accordingly, it is submitted that the invention should not be limited to the described embodiments but rather should be limited only by the spirit and scope of the appended claims.

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