A) Optimal Medication Monitor(s) and Method of Retrieving  Adherence Record.

or



Alternative Communication Means are found in Alternative displays for Retrieval of Data from the Monitor This includes Retrieval of  Clinical Data on the Patient.

B) Other Dose Removal Monitors.






Strip Package Monitor

Another approach to dispensing medication so that dispensing of each dose can be recorded utilizes medication in strips of packages where each package in a strip contains a medication unit. Such packages can be sequentially removed from the dispenser, and the removal can be recorded.  

As with any monitor, a strip package monitor needs to be able to accommodate different dosages (different numbers of pills) for different weight patients. One way to do this would use a single strip of medication which, for example, would be advanced by two packages if the patient was to take two pills, by three packages if the patient was to take 3 pills, and so on. A second approach is to employ a dispenser which contains a number of strips of medication corresponding to the number of pills that patient would take in a single dose. All of these strips would be advanced by one medication unit (pill) to dispense each dose.

We present conceptual dispensers of both kinds. Each of these conceptual designs represents only one of many design possibilities. First a single strip dispenser / monitor:

Strip Package Monitor for dispensing medication from a single strip

Figures 1 through 6, depict a Strip Package Monitor, which utilizes long strips of packaged medication.

The mechanism for dispensing medication is based on a fluted cylinder that dispenses one pill at a time when the cylinder is rotated by using one finger to move one flute on the cylinder shown in Figure 1 upward in the direction of the arrow.
As shown in Figure 1 the monitor has a button and LED which can be used by the patient to determine whether medication should be dispensed. To determine if he should take medication, the patient would push the button.  If the patient was supposed to take medication the LED would flash green. If the patient was not supposed to take medication, the LED would flash red to notify the patient he should not take medication. In addition, the LED would continue to flash green until the prescribed number of pills was advanced, 2, 3, 4, or 5 depending on the weight of the patient. When the proper number of pills was finally dispensed the LED would flash red. If the patient did not follow these instructions the LED would stop flashing after a reasonable period of time like 2 minutes to save power.

If the patient failed to push the button before he advanced the flute and he was supposed to take medication the LED would flash green and red in the manner described above to guide the patient the patient to take the proper amount of medication.

If the patient failed to push the button before he advanced the flute and was not supposed to take medication at that time, the pill would be advanced but the LED would flash red to advise the patient not to remove and ingest the pill.

This attractive mechanism suffers from the limitation that it would require a long strip of medication. For the patient taking 5 pills a day for thirty days this would be 150 pills which would require that the pills be placed on a reel. And the outside diameter of the device would be around 17 cm.

Perhaps a more serious drawback of this design is that, despite the indication provided by the LED, each time the patient removes medication it is possible for him to remove either more or fewer pills than had been prescribed. This can in some cases lead to irregular dosing. It can also present the caregiver with a difficult challenge when interpreting the compliance record. Overcoming this problem plus offering greater convenience could justify a somewhat higher cost for the modular strip package monitor described below.
As shown in figure 2, this dispenses one pill and moves one pill from the reel. The movement of the flute is detected by the switch which records the removal of the pill.   >> ( NOTE: The flutes shown here are only representational. The flutes shown for the modular strip package monitor below have a more realistic profile.)        
Figure 2 shows a different view of the same array of modules shown in Figure 1 and provides a clearer view of the grooved extensions which couple the fluted cylinders to one another and to the electromechanical module. The view of the couplers in Figure 2, along with Figure 1 demonstrated how these couplers are made to join with one another.
Figure 3 shows the modules of Figures 1 and 2 coupled together to form a dispenser and monitor for dispensing and recording doses of three pills. The electromechanical module in this monitor has a Patient’s button which the patient can press to obtain an indication on the Patient’s LED of whether he should take medication (green) or not take medication (red). The dispensing lever in Figure 3 can be rotated in the direction indicated to dispense one dose of medication. When the dispensing lever is rotated its rotation is coupled to the fluted cylinders of all of the dispensing modules. Ridges in the electromechanical module’s case limit the rotation of the dispensing lever so that it can only dispense one dose of medication at a time.
After the dispensing lever has been rotated to dispense one dose of medication, it is in the position shown in Figure 4. When the dispensing lever is in this position, returning it to the position shown in Figure 3 in preparation for dispensing the next dose requires the patient to move the slider button as shown. This disengages the connection between the dispensing lever and the fluted cylinders in the dispensing modules so that the dispensing lever can be rotated without pulling medication back into the monitor.  
In order for the caregiver to be able to replace the  batteries in the monitor the electromechanical module  has a cover which can be opened by the caregiver, as shown in Figure 5. Removing this cover also provides access to a second switch button, the caregiver’s button, and a second LED, the caregiver’s LED.  These would be used by the clinic worker to retrieve the compliance record as described in the section Retrieval of Adherence Record in Patient’s home using Red/Green/Yellow LED.

Removing the cover also gives access to a fluted disc which is part of the coupler which connects the electromechanical module to the stack of dispensing modules. This coupler is used when the monitor is assembled and again when it is disassembled for refilling.
Figure 6 shows the details of a simple design for the removable cover. This cover incorporates a groove which engages a ridge in the base of the electromechanical module’s case. When the cover is connected to the electromechanical module, this groove slides over its mating ridge. Then, a pair of latch tabs spring into place to secure the cover by engaging depressions in the inside of the fixed part of the electromechanical module’s case.
Figures 7, 8, and 9 show the mechanical elements in the electromechanical module. The multifunction cylinder corresponds to the fluted cylinders which move the strips of medication packages in the dispensing modules. It couples to the first fluted cylinder with a grooved extension as described above and as shown in Figures 1, and 2, and again in Figure 10. The grooved extension of the multifunction cylinder is not visible in Figure 7 since it is behind the flange and extends through the module's case. In addition, the multifunction cylinder incorporates several features:

1.
Adjacent to the base plate of the electromechanical module’s case is a flange which orients the multifunction cylinder relative to the case.
2.
Next is a lobed cylinder which closes a circuit board mounted switch briefly each time the cylinder is rotated to dispense one dose of medication.
3.
Adjacent to the lobed cylinder is a ratchet. A spring mounted to the case acts as a pawl for this ratchet which permits the multifunction cylinder to rotate only in the direction which causes medication to be dispensed while preventing rotation in the direction which could pull medication back into the dispenser.
4.
A notched cylinder next to the ratchet is engaged by a slide which is incorporated into the dispensing lever and couples rotation of the dispensing lever to the multifunction cylinder. This slide is normally held in engagement with a notch in the notched cylinder by a spring which is also incorporated in the dispensing lever.
5.
A smooth cylinder in the center of the hollow multifunction cylinder functions as a shaft upon which the dispensing lever can rotate when its slide is disengaged from the notched cylinder.
The elements shown in Figure 7 are shown again in Figure 8 with the dispensing lever added as a partially transparent part. This illustrates how the slide and spring are incorporated into the dispensing lever.
In Figure 9, the dispensing lever is shown as opaque, and the slider button has been added. The slider button is moved to disengage the slide in the dispensing lever from the notched cylinder so that the dispensing lever can be returned to the orientation in which it is ready for dispensing a dose of medication while rotation of the multifunction cylinder is prevented by the ratchet.  
Figure 10 shows the side of the electromechanical module which mates with a dispensing module. This more clearly shows the features seen in Figure 2.
Figure 11 shows the open side of a dispensing module and more clearly shows the features seen in Figure 1.
Modular Strip Package Monitor with several strips of medication

Figure 1 shows an exploded view of a modular dispenser which has one dispensing module for each of three coiled strips of medication packages. Each of these modules incorporates a fluted cylinder which engages the medication packages and is rotated to advance the strip of packages for dispensing. When the dispensing modules are joined together, a splined central hole in the fluted cylinder of one module engages a grooved extension on the fluted cylinder of the adjacent module so that all of the fluted cylinders rotate as a single unit. The fluted cylinders are then rotated by a grooved extension of a “multifunction cylinder” in the electromechanical module. The electromechanical module controls and records the dispensing of medication. The number of dispensing modules will vary according to the number of pills the patient is supposed to take in one dose.

Adjacent modules are coupled together by a screw coupler incorporated in each module.
With this arrangement the patient or a child might take hold of a pill or pills that have been moved out of the dispenser and pull out multiple pills or the entire strip.  To prevent this a mechanism shown in figures 3,4, and 5 makes it necessary for the patient to first move the flute laterally to the left before advancing one pill.

Figure 3 shows one side of the cylinder, which has a spring plate that moves the cylinder to the right.
Figure 4 depicts the other side of the fluted cylinder, which has a depression on each flute.
Figure 5 shows projections extending out from the case of the dispenser. These projections interact with the depressions on the flutes which prevent the patient from rotating the cylinder unless it is first moved laterally to the left. This mechanism would prevent a child from pulling on the strip of pills.
Figure 6 shows ratchet teeth molded into the inside of the case. This feature is included to prevent the patient from making a mistake and pushing the flute shown in figure 1 downward, opposite the direction of the arrow, which if repeated several times could disengage the flutes from the strip of packages.