The present invention generally relates to the field of pharmaceutical containers. In particular, the present invention is directed to mechanisms for sensing the opening and closing of pharmaceutical containers.
Outpatient prescription medication treatments are relied upon heavily for increased quality of life and lower lifetime healthcare costs. Medical experts have long held that taking at least 80% of a prescribed drug is required to achieve desired therapeutic outcomes and lower lifetime healthcare costs. For example, a patient who faithfully takes cholesterol-reducing medicine significantly reduces the likelihood of a coronary event that has attendant cost-intensive medical procedures and diminished quality of life. Outpatients strongly desire to avoid such events and hospital stays, yet only 20% of all outpatients take their prescription medicines according to doctor's instructions.
Pharmaceutical manufacturers also stand to gain from increased outpatient medication compliance in the form of increased medication sales. Accordingly, these manufacturers are actively investing in and testing compliance-increase techniques. A marketing executive at one major pharmaceutical company said that his market research has documented that patients want to comply, but will not take on the burden of any additional actions or otherwise change behavior.
For these reasons, a need exists for reminder mechanisms for increasing patient compliance with dosing regimens. In particular, a need exists for reminder mechanisms that place little or no burden on the patient and that are sufficiently low cost to be practical for use in commercial product applications.
The present invention is a system for sensing the opening and closing of a pharmaceutical container. The system includes a pharmaceutical container, the pharmaceutical container further including a container body, a container neck disposed at one end of the container body, container threads disposed on the container neck, a rim disposed between the container threads and the container body, a container closure removably attached to the container neck via the container threads, control circuitry integrated within the container body, indicators integrated within the container body and an automatic sensing mechanism integrated within the pharmaceutical container body.
In one embodiment the automatic sensing mechanism, includes a first conductor disposed along the outside of the container body, a second conductor disposed along the outside of the container body, and a bridge conductor disposed on the inside of the container closure. The bridge conductor provides an electrical connection between the first conductor and second conductor when the container closure is attached to the container neck, and wherein the first conductor, second conductor, and bridge conductor provide a switch function for sensing the presence or absence of the container closure by detecting when an electrical connection exists or not between the first conductor and second conductor via the bridge conductor.
In another embodiment the automatic sensing mechanism includes a first conductor disposed along the outside of the container body, a second conductor disposed along the outside of the container body, and a micro-switch integrated into the container neck between the first conductor and the second conductor. The location of the micro-switch on the container neck is such that when the container closure is tightened upon the container neck a thread of the container closure makes physical contact with an actuator of the micro-switch to close the micro-switch thus providing an electrical connection between the first conductor and second conductor when the container closure is attached to the container neck, and wherein the first conductor, second conductor, and micro-switch provide a switch function for sensing the presence or absence of the container closure by detecting when an electrical connection exists or not between the first conductor and second conductor via the micro-switch.
In yet another embodiment the automatic sensing mechanism includes a first conductor disposed along the outside of the container body, a second conductor disposed along the outside of the container body, and a compression region formed by flexible insulator materials that are abutted one to another and disposed between the first conductor and second conductor. The placement of the flexible insulator material is in alignment with one or more threads of the container closure when the container closure is tightened upon the container neck, and wherein when the container closure is tightened upon the container, its threads apply pressure to the compression region which displaces the flexible insulator material where they abut one another thus causing the first conductor to flex toward the second conductor and make electrical contact thereto, forming a switch function for sensing the presence or absence of the container closure by detecting when an electrical connection exists or not between the first conductor and second conductor.
In yet another embodiment the automatic sensing mechanism includes a Hall effect sensor disposed on the outside of the container body, and a magnet disposed on an edge of the container closure such that it is in close proximity to the Hall effect sensor when the container closure is tightened to the closed position. An output voltage of the Hall effect sensor is at certain states based on the presence or absence of a magnetic field generated from the magnet and thus detects the presence or absence of container closure, thus providing a switch function for sensing the presence or absence of the container closure by detecting when a magnetic field is present or absent.
The present invention further provides a method of sensing the opening and closing of a pharmaceutical container. The method includes providing a pharmaceutical container having an automatic sensing mechanism, sensing the opening and/or closing of the pharmaceutical container, triggering the automatic sensing mechanism to automatically generate a dosage reminder signaling a user at dose time via the control circuitry and indicators which are actuated by opening and re-closing of the pharmaceutical container, and tracking container usage and dosage compliance.
The present invention is multiple embodiments of mechanisms for sensing the opening and closing of a container, such as, but not limited to, a pharmaceutical container. In particular, the sensing mechanisms trigger an automatic, built-in, electronic dosage reminder and open/close event logging operation while requiring no additional actions or otherwise changed behavior by the patient, in order to increase patient compliance with dosing regimens. Furthermore, certain embodiments of the sensing mechanisms are reliable and are sufficiently low cost to be practical for use in commercial product applications.
Additionally, integrated within container body 110 of container 100 are control circuitry 120, a set of indicators 122, and an example sensing mechanism 124 of the invention. Sensor circuitry 120 may be installed in a well (not shown) that is provided in the outside of container body 110, such that there is no contact with the contents inside of container body 110.
Control circuitry 120 is the electronics for providing the overall control of the automatic, built-in reminder functions of container 100. For example, control circuitry 120 may include a control means and storage means for managing a dosing reminder operation that corresponds to the patient's prescribed dosing regimen. In one example, the patient's prescribed dosing regimen is one dose every 24 hours. In another example, the patient's prescribed dosing regimen is two doses daily. In yet another example, the patient's prescribed dosing regimen is three doses daily.
Additionally, control circuitry 120 monitors the state of sensing mechanism 124, which is an indicator of whether the patient has consumed a dose of the contents of container 100. More specifically, control circuitry 120 senses an opening and closing event by sensing the removal and replacement of closure 118 by use of sensing mechanism 124. In response to the state of sensing mechanism 124, control circuitry 120 determines the state of indicators 122, which may be standard light-emitting diode (LED) devices. In one example, a first indicator 124 is a “close container” LED for prompting the user to install closure 118 upon container 100, a second indicator 124 is a “status ok” LED for indicating that the current state of the dosing regimen is satisfactory, a third indicator 124 is a “missed dose” LED for indicating to the user that a dose has been missed, and a fourth indicator 124 is a “take prescribed dose” LED for indicating to the user that it is time to consume his/her prescribed dose of medication.
Sensing mechanism 124 is formed of a first conductor 126 and a second conductor 128 that are disposed along the outside of container 100, such that one end of the conductor pair is electrically connected to control circuitry 120 and the opposite end of the conductor pair is disposed at container neck 112. More details of sensing mechanism 124 are described in
The combination of first conductor 126 and second conductor 128 and bridge conductor 130 provide a switch function for sensing the presence or absence of closure 118 and, thereby, sense an opening/closing event. More specifically, control circuitry 120 may detect when an electrical connection exists or not between first conductor 126 and second conductor 128 via bridge conductor 130. This may be accomplished by use of well-known analog or digital circuit elements (not shown) of control circuitry 120. In one example, first conductor 126 may be connected to about ground (i.e., about 0 volts) and second conductor 128 may be connected to a pull-up resistor to a voltage, such as to about 1 volts. Consequently, when there is no electrical connection between first conductor 126 and second conductor 128, first conductor 126 is at about ground and second conductor 128 is at about 1 volts. By contrast, when there is an electrical connection between first conductor 126 and second conductor 128, second conductor 128 is shorted to ground and, thus, both first conductor 126 and second conductor 128 are at about ground. Control circuitry 120 may detect the state of second conductor 128 toggling between about ground and about 1 volt.
Therefore, in operation, when closure 118 is tightened upon container neck 112, bridge conductor 130 comes into contact with first conductor 126 and second conductor 128 and, thus, provides an electrical connection therebetween. In doing so, control circuitry 120 may detect that second conductor 128 is shorted to ground, which indicates that closure 118 is installed (i.e., container 100 is closed). By contrast, when closure 118 is removed from container neck 112, bridge conductor 130 is not present and, thus, there is no electrical connection between first conductor 126 and second conductor 128. In doing so, control circuitry 120 may detect that second conductor 128 is at about 1 volt, which indicates that closure 118 is not installed (i.e., container 100 is open). As a result, a reliable and inexpensive mechanism is provided by use of the example sensing mechanism 124 of
Referring to
In operation, when closure 118 is tightened upon container neck 112, micro-switch 212 is closed and control circuitry 120, therefore, detects the presence of closure 118 and that container 100 is closed. By contrast, when closure 118 is not installed upon container neck 112, micro-switch 212 is open and control circuitry 120, therefore, detects the absence of closure 118 and that container 100 is open. As a result, a reliable and inexpensive mechanism is provided by use of the example sensing mechanism 200 of
Optionally, the color of first conductor 312 and second conductor 314 may be the same as the color of container 300, in order to be inconspicuous such that the user is not prone to tampering therewith.
In operation and referring again to
The Hall effect refers to the potential difference (i.e., Hall voltage) on the opposite sides of an electrical conductor through which an electric current is flowing. The Hall voltage is created by a magnetic field that is applied perpendicular to the current. A Hall effect sensor, such as Hall effect sensor 410, is a type of position sensor that senses magnetic field strength and produces a voltage that changes with this strength. Hall sensors may have digital or analog outputs. In one example, Hall effect sensor 410 may be selected from widely available offerings, such as by Digi-Key Corporation in Thief River Falls, Minn. (www.digikey.com).
In operation, an output voltage of Hall effect sensor 410 is a certain state when closure 118 is tightened upon container neck 112 because Hall effect sensor 410 senses a magnetic field 414 from magnet 412. Consequently, control circuitry 120 detects the presence of closure 118, which indicates that container 100 is closed. By contrast, the output voltage of Hall effect sensor 410 is a certain different state when closure 118 is removed from container neck 112, such as by unscrewing, because Hall effect sensor 410 no longer senses sufficient magnetic field 414 from magnet 412 to register a circuit-closed state. Consequently, control circuitry 120 detects absence of closure 118, which indicates that container 100 is open. The strength of magnetic field 414 of magnet 412 may be optimized for the distance between magnet 412 and Hall effect sensor 410 when closure 118 is in the tightened position upon container neck 112. In one example, magnet 412 is a magnet having a field strength range of several hundred Gauss to several thousand Gauss, depending on the sensitivity of readily available, low-cost Hall effect sensors. Preferably, magnet 412 is a miniature magnet that is installed in an inconspicuous manner in closure 118, such that the user is not prone to tampering therewith.
Additionally, in order to optimize the lifetime of the battery (not shown) of container 400, control circuitry 120 polls the state of Hall effect sensor 410 periodically, such as every 100 milliseconds, instead of continuously.
Referring again to
The present invention is not limited to prescription medication applications only. Alternatively, the invention may apply to any non-prescription medication application. Additionally, the present invention is not limited to pharmaceutical applications only. Alternatively, the invention may apply to any product dispensing application within which it is beneficial to improve the dispensing regimen or usage of a product in a container. In one example, in a paint or urethane container application, it is beneficial to issue a reminder that sufficient time has passed to apply a second coat of paint or urethane. In another example, in a glue container application, it is beneficial to issue a reminder that sufficient time has passed for the glue to set, which indicates that the glued item may be ready to use. In yet another example, wound-dressing regimens require strict observance in order to maximize infection prevention. In yet another example, sunscreen packages may remind parents users when to reapply sunscreen, given its finite life once applied.
The foregoing description of various aspects of the disclosure has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosure to the precise form disclosed, and obviously, many modifications and variations are possible. Such modifications and variations that may be apparent to a person skilled in the art are intended to be included within the scope of the disclosure as defined by the accompanying claims.
This application claims the benefit of, and expressly incorporates herein by reference, the entire disclosure of U.S. provisional patent application Ser. No. 60/948,532, entitled MECHANISMS FOR SENSING THE OPENING AND CLOSING OF PHARMACEUTICAL CONTAINERS, filed Jul. 9, 2007.
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