System and method for medication seal tracking using kinetically generated electricity to power containers that self-report changes in seal condition

Abstract

A system, and method tracking medication seal condition through the incorporation of a holding container that translates the kinetic energy used to break a seal into electricity that powers a system to self-report changes in condition such as when the seal of the container has been broken including one or more seals with piezoelectric properties, a complete electrical circuit configured to transmit a signal indicating that the complete circuit has been broken.

Description

SYSTEM AND METHOD FOR MEDICATION SEALTRACKING USING KINETICALLY GENERATED ELECTRICITY TO POWER CONTAINERS THAT SELF-REPORT CHANGES IN SEAL CONDITION BACKGROUND OF THE INVENTIONFIELD OF THE INVENTION

[0001] The present invention generally relates to medication usage and waste and more specifically to systems and methods to track medication seal condition through the incorporation of a holding container that translates the kinetic energy used to break a seal into electricity that powers a system to self-report when the seal of the container has been broken, and the like. DISCUSSION OF THE BACKGROUND

[0002] Recent studies have indicated that "medical non-adherence," defined by the U.S. Centers for Disease Control (CDC) as when a patient "does not take a prescribed medicine or follow the provider's instructions for taking the medicine," is a systemic issue impacting the efficacy and efficiency of public health systems throughout the world. A recent estimate from Kleinsinger in 2018 (Keinsinger, F; "The Unmet Challenge of Medication Nonadherence," The Permanente Journal, 2018; 22: 18-033) suggests that medical non-adherence may cause at least 125,000 preventable deaths and $100 billion in preventable medical costs per year in the United States alone. The Kleinsinger study also states that "medication non-adherence is barely on the radar of most practicing physicians" and suggests that electronic health records (EHRs) have been used to successfully identify patients at risk, defined as those "...with a given diagnosis who have poor control, few visits, or insufficient refills." Kleingsinger also implies that additional electronic data may help bring medication use closer to the 80% threshold of "medical adherence" typically used in studies, improve patient outcomes, and more effectively allocate resources within an integrated health care system.

[0003] The system and method for medication seal tracking using kinetically generated electricity to power containers that self-report changes in medication seal condition will allow for physicians, health care systems, and health insurance providers to more effectively track medication at the tablet or dosage scale without the need for costly and complicated external hardware such as scanners, and the like, or changes in patient behavior. Rates of medication seal breaking can be computed for each patient over various periods of time. Associated assumed rates of taking or administering medication can then be calculated or evaluated at the tablet ormedication dosage scale, and not based on the rate of prescription refill requests or what is stated verbally in physician visits. This higher resolution tracking of when medications seals are broken may allow physicians, caregivers, or family members to develop and target more effective interventions to increase the proportion of medication taken as medically directed and potentially yield more favorable health outcomes for patients. Higher resolution tracking of medication at the dosage scale will also allow health care systems and health insurers to more effectively calculate rates of "medical non-adherence," target interventions to increase adherence, and reduce health care costs at the health care system scale.SUMMARY OF THE INVENTION

[0004] Therefore, there is a need for a system and subsequent method that addresses medical non-adherence and other associated problems derived from medical non-adherence. The above and other associated problems are addressed by the illustrative embodiments of the present invention, which is capable of translating the kinetic energy used to break the seal of a medication container into electricity, through the incorporation of piezoelectric elements into the seal of the container, and allocating the electricity generated to send an electronic signal indicating that the container seal has been broken. Many medication unit-doses are delivered to end users in "blister pack" containers with plastic top sides formed or molded to the shape of tablets, pills, capsules, and the like they are holding with the bottom side often comprised of thin aluminum, and the like. The physical or kinetic act of opening the medication container and breaking the seal, in the case of "blister packs" pushing the tablets through the thin aluminum, concurrently breaks the previously closed electrical circuit of the unbroken seal. Seals with piezoelectric properties may also be integrated into the design of other medication containers such as intravenous (IV) bags, bottles containing liquids administered through injection, topical creams, and the like. This broken electrical circuit indicates that the medication seal has been broken, the container has been opened, and the medication could theoretically be taken. Such a tracking system may also indicate that a seal has been broken inadvertently through mishandling, and the like, and that medications should not be administered to or by the patient in the future. This electronic signal indicating that the medication seal has been broken can be transmitted with relevant metadata including the time and date that container seals were broken, as well as other information such as the general location, and the like, if desired, to isolate incidents of purposeful disposal, when a number of tablet containers are broken simultaneously, potentially suggesting medications were not ingested or otherwise administered, and patterns of non-adherence such as periods when specific caregivers are absent. This electronic signal and relevant metadataindicating that the medication container seal has been broken is transmitted to a corresponding receiver or across an existing network to a database where the time, date, and location when medications seals are broken is summarized and may be evaluated to isolate patterns of nonadherence.

[0005] Accordingly, in illustrative aspects of the present invention there is provided a system, and method for the tracking of medication seal condition through the incorporation of a holding container that translates the kinetic energy used to break a seal into electricity that powers a system to self-report changes in condition such as when the seal of the container has been broken.

[0006] Still other aspects, features, and advantages of the present invention are readily apparent from the following detailed description, by illustrating a number of illustrative embodiments and implementations, including the best mode contemplated for carrying out the present invention. The present invention is also capable of other and different embodiments, and its several details can be modified in various respects, all without departing from the spirit and scope of the present invention. Accordingly, the drawings and descriptions are to be regarded as illustrative in nature, and not as restrictive.BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The embodiments of the present invention are illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings and in which like reference numerals refer to similar elements and in which:

[0008] FIG. 1 is an illustrative representation of the general process of the system, and method for the tracking of medication seal condition through the incorporation of a container that translates the kinetic energy used to break a seal into electricity that powers a system to selfreport changes in condition such as when the seal of the container has been broken.

[0009] FIG. 2 is an illustrative representation the system and method process for generation and transmitting a signal using the seal condition signal generator and transmitter.DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] The present invention includes recognition that current efforts and technologies to track medication are centralized and limited to the frequency of medication refill at pharmaciesor discussions with physicians. A growing body of literature in the health care field indicates that a significant proportion of medications provided to patients is not taken in a manner consistent with the direction medical practitioners provide. This "medical non-adherence" yields an extensive array of adverse impacts at scales ranging from less favorable health outcomes for the patient to the inefficient allocation of resources at the scale of the integrated health care system. The system and method for the tracking of medication seal condition through the incorporation of a holding container that translates the kinetic energy used to break a seal into electricity that powers a system to self-report changes in condition allows for the tracking of medication at the unit or dosage scale without the need for additional electricity, scanning, or transmission hardware, and the like. Materials with piezoelectric properties could theoretically be incorporated into existing manufacturing processes to replace the thin aluminum or metallic material serving as the readily breakable seal of medication in delivery systems such as "blister packs." Elements comprised of materials with piezoelectric properties could also be integrated into the design of additional medication packaging such as intravenous (IV) bags, bottles containing liquids administered through injection, topical creams, and the like. Available metadata regarding the time, date, and location that the medication seal was broken could be readily compared to relevant use instructions such as an expiration date, and the like, to allow for intervention to prevent the administration of expired medication.

[0011] Generally, the described method and system includes the integration of a piezoelectric element configured to transmit or conduct electricity across a complete circuit, and a signal generation and transmission component into the seal of a medication. The piezoelectric element relies on the well documented and understood piezoelectric effect where a number of materials are capable of converting kinetic energy, sometimes referred to as mechanical energy, into electrical energy due to the deformation of crystalline structures when mechanical stress is applied. This applied mechanical stress effectively shifts the positive and negative charge centers in the material, resulting in the generation of an external electrical field across a crystalline lattice. When the mechanical stress is reversed or reduced, an outer electrical field then compresses or stretches the piezoelectric material. When the mechanical stress is completely removed or attenuated, and the like, the material returns to its steady state or equilibrium based positive and negative charge centers. The described method and system harnesses the electricity generated by piezoelectric materials under mechanical stress and conveys the electricity to power the generation and transmission of a signal that the medication seal and associated electrical circuit, has been broken. A vast array of naturally occurring materials have piezoelectric propertiesincluding, but not limited to, cane sugar, quartz, topaz, and tourmaline, and the like. This naturally occurring array of materials is complemented by human-made materials engineered to have specific piezoelectric properties including, but not limited to, polymers such as poly(vinylidene fluoride) (PVDF), poly(vinylidene fluoride-co-trifluoroethylene) (PVDF-TrFE), and the like. These human-made materials are often engineered to have specific properties such as high polarity, biocompatibility, mechanical flexibility, and the like. The described method and system is produced through the construction, assembly, fabrication, formulation, and the like, of the structural component of a medication seal with a material having piezoelectric properties. The functionality, electricity generation capacity, and range of transmission of the described method and system is increased through the incorporation of one or more strategies to strengthen the piezoelectric effect, increase the structures' capacity to conduct electricity, and the like. Such methods may include, but are not limited to, the use of piezoelectric materials with high polarity, additional methodologies to more effectively align crystalline structures to increase their electrical conductivity. Methodologies to more effectively align crystalline structures may include the use of large magnets or other processes to induce processes such as the corona poling of materials such as PVDF, and the like, during medication seal casting, molding, printing, and the like.

[0012] The piezoelectric component is integrated into the design of the medication seal. The kinetic energy or mechanical force applied to the piezoelectric material by the individual opening the medication container generates electricity through the piezoelectric effect. This electricity is conveyed to a small piece of hardware capable of generating and transmitting a signal that the medication container seal has been broken to a receiver or existing network. Additional metadata such as the time and date that the seal was broken as well as potential information such as general location information, and the like, may also be transmitted by the hardware generating and transmitting the signal indicating that the seal has been broken. This small piece of hardware capable of generating and transmitting the signal that the medication seal has been broken may take an array of forms such as a Radio Frequency Identification (RFID) chip paired with a coil embedded in the medication seal, other two-way transmission technologies such as Near Field Communication (NFC), Ultra Wide-band Real-Time LocationSystems, or Wi-Fi Real-Time Location Systems, or other emerging transmission and receiving technologies, and the like.

[0013] Additional strategies to monitor medication seal condition and integrity could also readily be incorporated into designs such as oxygen, nitrogen, argon sensors, and the like, within each medication container set to indicate if and when concentrations in space around the medication change from levels associated with the vacuum or sealed conditions suggesting that ambient or external air has entered the container due to broken or compromised medication seal, and the like. These sensors could be powered by electricity generated during the handling, transport, movement, and the like, of medication containers to provide periodic checks of container seal condition, integrity, and the like.

[0014] Seals with piezoelectric materials and associated signal generation and reporting hardware could also be integrated into non-medical applications where seal integrity is important within supply chains, and the like. The aforementioned oxygen, nitrogen, argon sensors, and the like, could be readily integrated into the vacuum sealed packs for electronic components such as microchips, and the like, that are constructed, assembled, fabricated, and the like in clean rooms, transported to other locations, and then installed, integrated, incorporated, and the like into other electrical devices such as computers, smart phones, automotive electronic systems, and the like. Generally, purchasers of electronic components such as microchips, and the like, expect to receive sealed, clean, and uncontaminated products, and the like from producers. Containers with piezoelectric seals or design elements such as the aforementioned oxygen, nitrogen, argon sensors, and the like, would allow for the tracking of electronic component container vacuum seal integrity and potentially identify "bad batches" or production runs that have been compromised through exposure, contamination, and the like.

[0015] Referring now to the drawings, wherein like reference numerals designate identical or corresponding parts throughout the several views, and more particularly to FIG. 1 thereof, there is shown an illustrative representation of the system and method for the tracking of medication seal condition through the incorporation of a piezoelectric component and complete electrical circuit into a container that translates the kinetic energy used to break a seal into electricity that powers a system to self-report changes in condition. FIG 1. can include elements such as medication 100, in tablet form for the purposes of illustration, unit-dose medication "blister packet" 102 for the purposes of illustration with the plastic element formed, molded, and the like to the size and shape of the medication protected from tampering or contamination by seal with piezoelectric properties 104 on the opposing side made from amaterial with piezoelectric properties arranged to form complete electrical circuit 106, and seal condition change signal generator and transmitter 108. Complete electrical circuit 106, for the purposes is illustration in this instance, is comprised of anode 110, a layer of poly(vinylidene fluoride-co-trifluoroethylene) (PVDF-TrFE) 112, a separating layer 114, another layer of PVDF- TrFE 112, cathode 116, and an RFID antennae 118.

[0016] FIG. 2 is an illustrative representation the system and method process for generating and transmitting a signal that medication seal has been broken. Individual 200, be it the patient, caregiver, family member, or others, and the like, apply kinetic or mechanical energy 202 to seal with piezoelectric properties 104. This kinetic or mechanical energy 202 is translated into electricity by piezoelectric properties 104 to power seal condition change signal generator and transmitter 108. Once the kinetic or mechanical energy 202 exceeds the tensile strength of the seal with piezoelectric properties 104, the complete electrical circuit 106 is broken indicating that the medication seal condition has been changed and the seal is no longer intact. This change in electrical circuit 106 condition from complete to broken causes seal condition change signal generator and transmitter 108 to transmit a signal indicating that the medication seal has been broken to a signal receiver 204. This signal may be conveyed to a database or other electronic device via a receiver, existing network, or direct connection and the like, along with relevant metadata such as the time, date, and location that the seal was broken. The generating and transmitting of the signal that the medication seal has been broken may take an array of forms such as a Radio Frequency Identification (RFID) chip paired with a coil embedded in the medication seal, other two-way transmission technologies such as Near Field Communication (NFC), Ultra Wide-band Real-Time Location Systems, or Wi-Fi Real-Time Location Systems, or other emerging transmission and receiving technologies, and the like. Software can then be developed to track when medication seals were broken to isolate patterns regarding when seal were not broken in a manner consistent with the schedule prescribed by medical professionals to allow for the development of targeted and patient-specific interventions to increase "medical adherence."

[0017] It is to be understood that the method and system of the illustrative embodiments are for illustrative purposes, as many variations of the specific materials and hardware used to implement the illustrative embodiments are possible, as will be appreciated by those skilled inthe relevant art(s). The functionality of one or more of the components of the illustrative embodiments can be implemented via similar designs. For example, the above-described method and system of the illustrative embodiments can include any number of medication 100 and seal with piezoelectric properties 104 may be made of any piezoelectric material and any shape, size, or design.

[0018] It is to be understood that the devices and subsystems of the illustrative embodiments are for illustrative purposes. While the present inventions have been described in connection with a number of illustrative embodiments, and implementations, the present inventions are not so limited, but rather cover various modifications, and equivalent arrangements, which fall within the purview of the appended claims.

Claims

WHAT IS CLAIMED IS:

1. A system to track medication seal condition through the incorporation of a holding container that translates the kinetic energy used to break a seal into electricity that powers a system to self-report when the seal of the container has been broken comprising: one or medication containers; one or more medication container seals comprised of material with piezoelectric properties; one or more complete electrical circuits that are broken when medication container seals are broken; and one or more mechanisms to generate and transmit electrical signals that a medication container seal has been broken.

2. The system of claim 1 further comprising: one or more medication containers constructed, assembled, fabricated, or formulated to securely contain medication and prevent contamination or tampering.

3. The system of claim 1 further comprising: one or more medication container seals constructed, assembled, fabricated, or formulated of a material having piezoelectric properties such that electricity is generated when kinetic energy is applied to it.

4. The system of claim 1, further comprising: one or more complete electrical circuits that are broken when a medication container seal is broken.

5. The system of claim 1, further comprising: one or more mechanisms to generate and transmit signals that one or more medication seals have been broken using the electricity generated by the piezoelectric material seal being broken.

8. A method to track medication seal condition through the incorporation of a holding container that translates the kinetic energy used to break a seal into electricity that powers a system to self-report when the seal of the container has been broken comprising: one or medication containers; one or more medication container seals comprised of material with piezoelectric properties; one or more complete electrical circuits that are broken when medication container seals are broken; and one or more mechanisms to generate and transmit electrical signals that a medication container seal has been broken.

9. The method of claim 8 further comprising: one or more medication containers constructed, assembled, fabricated, or formulated to securely contain medication and prevent contamination or tampering.

10. The method of claim 8 further comprising: one or more medication container seals constructed, assembled, fabricated, or formulated of a material having piezoelectric properties such that electricity is generated when kinetic energy is applied to it.

11. The method of claim 8, further comprising: one or more complete electrical circuits that are broken when a medication container seal is broken.

12. The method of claim 8, further comprising: one or more mechanisms to generate and transmit signals that one or more medication seals have been broken using the electricity generated by the piezoelectric material seal being broken.