Patent Application
20250025645
The present disclosure relates generally to pharmaceutical oral dose administration devices and computerized oral prescription administration (COPA) devices. For example, a locking cap may be implemented on a medication bottle to prevent unauthorized access to the medication and to facilitate secure dispensing of the medication to only the intended user.
The history of pharmacology has produced a continual evolution of routes of administration, pharmaceutical formulations, dosage forms, and dosing devices in a continuing quest towards maximizing the effective benefit and relative costs of prescription medications. Administration of prescribed substances may begin in controlled healthcare settings, for example, at a healthcare facility or by a physician at a patient's home. Early-stage formulations may include liquid forms for parenteral (e.g., into a blood stream) and enteral (e.g., into a gastro-intestine) administration including elixirs, tonics, solutions, suspensions, syrups and eventually injections, intravenous (IVs), and epidurals. The early-stage formulations may be developed to produce advanced forms, for example, via mechanization and formulation research. The early-stage formulations, the advanced forms, and further research and clinical studies such as patient acceptances of the early-stage formulations and/or the advanced forms may contribute to the routes of administration, pharmaceutical formulations, dosage forms, and dosing devices.
As the healthcare treatment transitioned from limited emergency involvement into longer term chronic illness care, higher percentages of the prescribed medication administration shifted from the controlled healthcare settings to patient managed settings. In a patient managed setting, outside the control of a trained healthcare staff, the administration of liquid formulations may be difficult due to non-specific dosing instructions. Dosing based on teaspoon and/or tablespoon measurements may be vague and variable. Dosing cups may have different measurement formats, and thus may cause confusion in a patient managed setting. In addition, dosing cups are often separated from initial prescription bottles, and thus may lead to erroneous administration.
The advancements of mechanical manufacturing systems and pharmacology research enabled patient managed administrations of prescribed substances to shift from liquid formulations to pills (e.g., tablets or capsule-formulations), which may have increased shelf life and allow for patient case of use, dosing exactness, and production cost reductions. Thus, a majority of oral medications in patient managed settings are now pills. Additionally, there is an increased interest in microparticulate formulations including pellets, granules, micro particles, mini tablets, and the like. However, patients, such as infants, elderly, or impaired patients, that cannot or prefer not to swallow tablets or capsule-formulations may be given enteral oral liquid prescriptions through dosing syringes in patient managed settings. In addition, parenteral liquid formulations are still commonly administered in controlled healthcare settings since the parenteral liquid formulations often have the fastest rate of absorption and the most expedient success in the desired result and can improve localized administration, inventory control, fraud prevention, and administration path audit capability.
Depending on the entity managing the administration of a drug, various forms of the drug may be developed to meet expectations, needs, and challenges of different entities. While there are some exceptions based on effectiveness and toxicity, most pharmaceutical manufacturers may produce multiple formulations of drugs to support different routes of administration and dosing.
There is a growing demand for drug administration in patient controlled or managed settings as consumers increasingly engage in preventative or resultative treatment plans, which involve drug administration in patient controlled settings. For example, outpatient surgeries and/or one-day inpatient surgery stays are increasingly common for significant medical procedures, which may involve subsequent drug administrations at a patient's home. In addition, as the population ages, the demand for prescription management increases. Consumers may take multiple over-the-counter and/or prescribed medicines daily, where the medicines are commonly in the form of pills. Unfortunately, the case-of-use of pills and the increasing number of consumers engaged in chronic patient managed treatment plans has led to misuse and mismanagement of many drug classes.
For example, pill forms are lightweight, portable, recipient non-specific, difficult for inventory management, don't carry individual identification numbers, have extensive shelf life, and are inexpensive to produce. Thus, the intakes or usages of pills are difficult to control once outside of healthcare managed environments. In addition, to achieve the economy of scale in the manufacturing process, pill production is scheduled based on maximizing the output of the machines, materials, and/or ingredients available instead of based on future demands. With a few exceptions, a minimal amount of the pills produced are wasted since pills remain active for a long time. Pills proliferate our society and have become conduits to addiction and abuse.
One such patient managed treatment that is highly susceptible to prescription misuse and mismanagement is opioid pain treatment. For example, according to the Food and Drug Administration (FDA), approximately 100 million people in the United States (US) suffer from pain in a given year. About 9 to 12 million of the pain sufferers have chronic or persistent pain, while the remaining pain sufferers have short-term pain from injuries, illnesses, or medical procedures. In 2014, the Centers for Disease Control and Prevention reported that the number of annual opioid prescriptions in the US is about equal to the number of adults in the US population. While pain sufferers should benefit from skillful and appropriate pain management, the misuse or addiction of opioids needs to be controlled. FDA leaders and physicians attempt to address the opioid epidemic by balancing two complementary principles: deal aggressively with opioid misuse and addiction while protecting the well-being of people experiencing acute or chronic pains. However, the pain sufferers in areas where reforms, policies, and restrictions aimed at opioid misuse have been implemented may not experience the balance. Some states have implemented additional known addict or misuser databases that must be checked by providers prior to prescribing. However, physicians may not check the databases prior to prescribing due to the burden of using the systems and/or they may not want to restrict access by true chronic pain sufferers. Other states have implemented reporting and audit trails to track physicians that have prescribed from the opioid family. However, to avoid the additional steps and potentials for audit scrutiny, some physicians may refuse to offer pain management or short-term pain prescriptions, and may refer all cases to pain clinics.
Attempts at improved patient education, enhanced labeling, and restrictive prescribing have led to higher costs for providers, patients, pharmacies, and insurance companies and less overall effectiveness for the patients. In the end, true pain sufferers struggle to have access to opioids while opioid misusers continue to manipulate the available avenues for access regardless of the apparent oversights put in place. Policies and plans at various levels have not been successful and are not sufficient to control or reduce the misuse of prescription drugs. Accordingly, improved devices, systems, and methods for drug administration are needed.
The following summarizes some aspects of the present disclosure to provide a basic understanding of the discussed technology. This summary is not an extensive overview of all contemplated features of the disclosure, and is intended neither to identify key or critical elements of all aspects of the disclosure nor to delineate the scope of any or all aspects of the disclosure. Its sole purpose is to present some concepts of one or more aspects of the disclosure in summary form as a prelude to the more detailed description that is presented later.
The present disclosure relates generally to pharmaceutical oral dose administration devices and computerized oral prescription administration (COPA) devices. These COPA devices, systems, and methods facilitate the secure dispensing of medication to an intended user. In this regard, the COPA device can be coupled to a housing, which may include a medication housing (e.g., bottle, tube, casing, etc.). The medication housing may include a threaded opening to which a locking cap of the present disclosure is secured. To prevent unauthorized access to the substance (e.g., medication, a prescribed substance, etc.) within the medication housing, the medication housing may be coupled to the locking cap. The locking cap may include a member that is registered to the intended user via a unique identifier. The locking cap can determine whether the intended user is attempting to access the medication within the medication housing. In some instances, the medication may only be dispensed when the unique identifier associated with the intended user is verified. Additional verification devices, systems, and methods may also be used to authenticate the intended user. For example, one or more biometric sensors may be used to detect biometric attribute(s) of the intended user to authenticate the intended user.
In one embodiment, a method for filling a prescription is provided. The method includes providing a housing and a locking cap. The locking cap is configured to be fixedly secured to the housing, and a first member of the locking cap is configured to threadedly engage the housing. The locking cap is configured to be fixedly secured to the housing via a plurality of latching members of the first member of the locking cap, and the plurality of latching members are configured to encase a lip of the housing. The method further includes filling, by an authorized user, the housing with a substance. The method further includes receiving a unique identifier associated with an intended user. The method further includes coupling, by the authorized user, the housing and the locking cap.
In some embodiments, the method further includes securing the housing coupled to the locking cap within a device housing. In some embodiments, the method further includes providing the device housing to the intended user. The substance is configured to be released from the housing to the intended user based on receipt of the unique identifier associated with the intended user. In some embodiments, the method further includes coupling, by the authorized user, the device housing with a docking station. In some embodiments, coupling the housing and the locking cap includes encasing a lip of the housing with a plurality of latching members of a first member of the locking cap, wherein the first member is threadedly engaged to the housing. In some embodiments, coupling the housing and the locking cap further includes coupling a second member of the locking cap with the first member of the locking cap. In some embodiments, coupling the second member of the locking cap to the first member of the locking cap includes encasing the plurality of latching members of the first member with a distal portion of the second member. In some embodiments, when the housing and the locking cap are coupled together, a valve of the locking cap fixedly is in an open state that allows the substance to be dispensed from the housing to the intended user.
In some embodiments, receiving the unique identifier associated with the intended user includes receiving, by one or more detectors of the locking cap, the unique identifier associated with the intended user. In some embodiments, the substance is configured to be dispensed from the housing to the intended user in response to receipt of the unique identifier associated with the intended user. In some embodiments, coupling the housing and the locking cap includes encasing a lip of the housing with a plurality of latching members of a first member of the locking cap and coupling a second member of the locking cap with the first member of the locking cap. In some embodiments, the method further includes biasing a valve of the locking cap to a closed state when the second member is not received within a cavity of a third member of the locking cap. In some embodiments, coupling the housing and the locking cap further includes preventing removal of the first member from the housing in an axial direction via the plurality of latching members and preventing removal of the plurality of latching members from the lip of the housing in a radial direction by encasing the plurality of latching members with a distal portion of the second member.
In some embodiments, the method further includes receiving the prescription from a prescribing physician, and the prescription comprises dosage instructions. In some embodiments, filling the housing with the substance includes filling the housing based on the dosage instructions. In some embodiments, the dosage instructions include a dosage amount. In some embodiments, the method further includes updating a substance management system in response to receiving the prescription. In some embodiments, the substance management system associates the unique identifier of the intended user with dosage instructions of the prescription. In some embodiments, the method further includes refilling, by the authorized user, the housing with the substance based on updated prescription information. In some embodiments, the prescription comprises a prescription history including an identifier corresponding to the authorized user.
In one embodiment, a member for securely dispensing a substance to an intended user is provided. The member includes a first member configured to threadedly engage with a housing containing the substance; a second member coupled to the first member, the second member configured to fixedly secure the first member to the housing; a third member including a cavity sized and shaped to selectively receive the second member; and a valve coupled to the first member such that: when the second member is received within the cavity of the third member, the valve is in an open state that allows the substance to be dispensed from the housing to the intended user in response to a processor determining that a unique biometric attribute of the intended user is detected, and when the second member is not received within the cavity of the third member, the valve is in a closed state that prevents the substance from being dispensed from the housing.
In some embodiments, the member further comprises a biasing member configured to bias the valve to the closed state when the second member is not received within the cavity of the third member. In some embodiments, when the second member is received within the cavity of the third member, the biasing member is compressed. In some embodiments, the first member comprises a plurality of latching members configured to encase a lip of the housing, the plurality of latching members configured to prevent removal of the first member from the housing in an axial direction. In some embodiments, the second member includes a distal portion configured to encase the plurality of latching members to prevent removal of the plurality of latching members from the lip of the housing in a radial direction. In some embodiments, the plurality of latching members are circumferentially arranged around a circumference of the first member. In some embodiments, the first member comprises at least one proximal latching member. In some embodiments, the second member comprises at least one latch configured to engage with the at least one proximal latching member of the first member to prevent removal of the second member from the first member in an axial direction. In some embodiments, the valve includes a longitudinal axis, and the second member is configured to rotate about the longitudinal axis of the valve when the second member is coupled to the first member.
In some embodiments, the unique biometric attribute comprises a unique dentition of the intended user. In some embodiments, the member further comprises a mouthpiece having a sensor array, wherein the substance is dispensed from the housing to a mouth of the intended user through the mouthpiece. In some embodiments, the processor is configured to determine that the unique biometric attribute of the intended user is detected by the sensor array. In some embodiments, the second member comprises one or more sensors positioned on an upper surface of the second member, the one or more sensors configured to provide a unique identifier associated with the intended user. In some embodiments, the third member comprises one or more detectors positioned on a lower surface of the third member, the one or more detectors configured to be in contact with the one or more sensors of the second member when the second member is received within the cavity of the third member. In some embodiments, the one or more detectors of the third member are configured to communicate with the one or more sensors of the second member to receive the unique identifier associated with the intended user. In some embodiments, the processor is further configured to cause the substance to be dispensed from the housing to a mouth of the intended user in response to determining that the one or more detectors received the unique identifier associated with the intended user.
In one embodiment, a method of securely dispensing a substance to an intended user is provided. The method includes moving a valve of a locking cap fixedly secured to a housing containing the substance to an open state that allows the substance to be dispensed from the housing to the intended user; determining that a unique biometric attribute of the intended user is detected; and dispensing the substance from the housing to the intended user in response to determining that the unique biometric attribute of the intended user is detected.
In some embodiments, the method further comprises fixedly securing the locking cap to the housing. In some embodiments, fixedly securing the locking cap to the housing comprises encasing a lip of the housing with a plurality of latching members of a first member of the locking cap, wherein the first member is threadedly engaged to the housing. In some embodiments, fixedly securing the locking cap to the housing further comprises coupling a second member of the locking cap with the first member of the locking cap. In some embodiments, coupling the second member of the locking cap to the first member of the locking cap comprises encasing the plurality of latching members of the first member with a distal portion of the second member. In some embodiments, moving the valve of the locking cap to the open state comprises inserting a second member of the locking cap into a cavity of a third member of the locking cap. In some embodiments, determining that the unique biometric attribute of the intended user is detected comprises determining that a unique dentition of the intended user is positioned within a recess of a mouthpiece. In some embodiments, determining that the unique dentition of the intended user is positioned within the recess of the mouthpiece includes determining, by a processor, that the unique dentition of the intended user is positioned within the recess of the mouthpiece.
In some embodiments, the method further comprises receiving, by one or more detectors of the locking cap, a unique identifier associated with the intended user from one or more sensors of the locking cap. In some embodiments, the dispensing the substance from the housing to the intended user further comprises dispensing the substance in response to determining that the one or more detectors received the unique identifier associated with the intended user.
In one embodiment, a system for securely dispensing a substance to an intended user is provided. The system includes a device housing and a locking cap coupled to the device housing. The locking cap includes a first member configured to threadedly engage with a housing containing the substance; a second member coupled to the first member, the second member configured to fixedly secure the first member to the housing; a third member including a cavity sized and shaped to selectively receive the second member; and a valve coupled to the first member such that: when the second member is received within the cavity of the third member, the valve is in an open state that allows the substance to be dispensed from the housing; and when the second member is not received within the cavity of the third member, the valve is in a closed state that prevents the substance from being dispensed from the housing. The system further includes a mouthpiece coupled to the device housing, the mouthpiece including a recess; and a processor configured to: determine that a unique dentition of the intended user is positioned within the recess of the mouthpiece; and cause the substance to be dispensed from the housing to a mouth of the intended user in response to determining that the unique dentition of the intended user is positioned within the recess of the mouthpiece.
In some embodiments, the mouthpiece includes a capacitive sensor array configured to obtain data regarding dentition positioned within the recess of the mouthpiece. In some embodiments, the data obtained by the capacitive sensor array includes a capacitive map associated with the intended user. In some embodiments, the processor is further configured to compare a capacitive map associated with a user of the mouthpiece to a predetermined capacitive map associated with the intended user.
Additional aspects, features, and advantages of the present disclosure will become apparent from the following detailed description.
Illustrative embodiments of the present disclosure will be described with reference to the accompanying drawings, of which:
For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It is nevertheless understood that no limitation to the scope of the disclosure is intended. Any alterations and further modifications to the described devices, systems, and methods, and any further application of the principles of the present disclosure are fully contemplated and included within the present disclosure as would normally occur to one skilled in the art to which the disclosure relates.
Embodiments of the present disclosure provide mechanisms for securely dispensing a substance to an intended user. In an embodiment, a locking cap includes a first member threadedly engageable with a housing (e.g., a medication bottle) containing a substance. The substance may be a prescription medication or an over-the-counter medication. The locking cap may include a second member coupled to the first member. The second member may fixedly secure the first member to the housing. The locking cap may include a third member including a cavity sized to receive the second member. The second member may be selectively received within the cavity such that the second member may be removed from the cavity after being inserted within the cavity. The locking cap may include a valve coupled to the first member. The valve may be movable between an open state and a closed state. When the second member is received within the cavity of the third member, the valve may be in the open state. The open state allows the substance to be dispensed from the housing to the intended user. The substance may be dispensed to the intended user in response to a processor determining that a unique biometric attribute of the intended user is detected. When the second member is not received within the cavity of the third member, the valve is in the closed state. The closed state prevents the substance from being dispensed from the housing. The processor may be configured to determine when the second member is received within the cavity of the third member. In an embodiment, the second member may be registered to the intended user.
The disclosed embodiments may provide several benefits. For example, the employment of the locking cap can ensure that the prescribed medications within the housing are delivered only to the intended recipient and are not tampered with. Thus, the disclosed embodiments may avoid misuse (intentional and accidental) as well as mismanagement of prescription medications. The disclosed embodiments may deliver a precise dosage of prescribed medications to patients. This may especially benefit patients that are elderly, impaired, or have behavioral issues that may limit their abilities to self-administer prescribed medications. In addition, the employment of the locking cap can facilitate one device housing, which may include the locking cap and the attached medication housing, being used for several users (with only one intended user registered to the locking cap at a time). Thus, the disclosed embodiments may avoid burdensome production costs.
The back cover may be removed to allow an authorized person, such as a pharmacist, to access the medication housing 132 and refill and/or replace the medication housing 132 as needed. In some embodiments, to remove the back cover, the authorized person may unlock the back cover from the device housing 100. Then, the authorized person may remove an empty medication housing 132 from the device housing 100 by pressing the release button 120. In some embodiments, the authorized person may refill the medication housing 132 with a prescribed substance and place the medication housing 132 back into the device housing 100. After placing the medication housing 132 within the device housing 100, the authorized person may lock the back cover onto the device housing 100.
In some embodiments, the COPA device 110, which may include a mouthpiece, may have one or more sensors or sensor arrays used to detect a unique dentition of an intended user. In some examples, the sensors of the mouthpiece may include a capacitive sensor array. The capacitive sensor array may be configured to detect a capacitive map associated with a detected input from a current user of the COPA device 110. The capacitive map may be associated with a dentition of the current user of the COPA device 110. In some examples, the capacitive map is associated with a unique dentition of the intended user. A processor may determine whether the intended user's unique dentition is positioned within a recess of the COPA device 110. For example, the processor may compare the capacitive map associated with the detected input from the current user of the COPA device 110 to a predetermined capacitive map associated with the intended user's unique dentition. From this comparison, the processor determines whether there is a match between the current user of the COPA device 110 and the intended user of the COPA device 110. If there is a match, the processor may cause the substance to be dispensed from the medication housing 132 to the intended user. In some embodiments, the processor is included in the device housing 100. In alternative embodiments, the processor is included in the COPA device 110. In further alternative embodiments, the processor is included in a system separate from the device housing 100 and the COPA device 110.
Additional details regarding the device housing 100 and the COPA device 110 may be found in U.S. patent application Ser. No. 15/406,043, now U.S. Pat. No. 9,731,103, filed Jan. 13, 2017, U.S. patent application Ser. No. 15/674,046, now U.S. Pat. No. 10,188,840, filed Aug. 10, 2017, U.S. patent application Ser. No. 15/708,045, now U.S. Pat. No. 9,981,116, filed Sep. 18, 2017, U.S. patent application Ser. No. 15/958,809, now U.S. Pat. No. 10,441,509, filed Apr. 29, 2018, U.S. patent application Ser. No. 16/001,498, now U.S. Pat. No. 10,792,226, filed Jun. 6, 2018, and U.S. patent application Ser. No. 16/246,122, now U.S. Pat. No. 11,097,085, filed Jan. 11, 2019, each of which are hereby incorporated by reference in their entireties.
In some embodiments, the third member 170 includes the release button 120. In alternative embodiments, the third member 170 may be included as part of the device housing 100. The third member 170 further includes a circuit board 200 positioned on a top surface, which may be an upper surface, of the third member 170. In some embodiments, the circuit board 200 may be coupled to one or more detectors or detector arrays. In alternative embodiments, the detector(s) may be integrated within the circuit board 200. In some examples, the detectors are in communication with the sensors of the second member 160. A processor may use the data obtained by the sensors to determine whether the second member 160 is coupled to the third member 170. In some embodiments, the second member 160 is coupled to the third member 170 when the second member 160 is received within a cavity of the third member 170, which will be discussed in further detail below.
In some embodiments, the locking cap 130 includes a valve assembly 180. The valve assembly 180 includes a valve 182, a biasing member 184, and a fluid connector 190. In some embodiments, the valve assembly 180 includes a check valve. It is to be understood that the valve assembly 180 may include any other suitable type of valve, such as a ball valve, a diaphragm valve, a globe valve, a needle valve, a gravity valve, a duck-billed valve, etc. In some embodiments, the biasing member 184 is a spring. In other embodiments, the biasing member 184 may be any other suitable type of component configured to bias the valve 182 in a particular direction. In some examples, the biasing member 184 biases the valve 182 to the closed state when the second member 160 is not received within the cavity 172 of the third member 170. The valve assembly 180 may be integrally formed as part of the first member 140. In other embodiments, the valve assembly 180 may be a separate component received within and coupled to the first member 140. As shown in the embodiment of
In some embodiments, the third member 170 includes a coupling member 220 to couple the valve assembly 180 to the device housing 100. As shown in the embodiment of
In some embodiments, the ledge 154 of the first member 140 is positioned in close proximity to the latching members 148. For example, the ledge 154 may be positioned at a connection point where the latching members 148 connect with a main body 155 of the first member 140. As shown in the embodiment of
In some embodiments, the second member 160 is coupled to the first member 140 by first pushing the second member 160 onto the first member 140 such that each locking tab 166 of the second member 160 travels over a corresponding upper lip 157 and is received by a corresponding locking groove 158 of the first member 140. When the locking tabs 166 are positioned within the locking grooves 158, the second member 160 is in a first position relative to the first member 140. In some embodiments, when the second member 160 is in the first position relative to the first member 140, the second member 160 and the first member 140 are rotationally locked relative to each other. Thus, when the second member 160 is rotated, the first member 140 rotates with the second member 160. Therefore, to attach the first member 140 to the housing 132, the first member 140 is placed on top of the housing 132. The second member 160 may then be rotated (e.g., in a clockwise direction or in a counter-clockwise direction) to screw the first member 140 onto the housing 132. In alternative embodiments, the first member 140 may be screwed onto the housing 132 without being connected to the second member 160. In such embodiments, the second member 160 may be coupled to the first member 140 after the first member 140 is coupled to the housing 132.
In several examples, the distal portion 164 of the second member 160 is made of a harder and/or more rigid material than the latching members 148 of the first member 140. Therefore, the distal portion 164 restrains and/or contains any attempted radial movement of the latching members 148. Radial movement may occur if a user tries to remove the first member 140 from the housing 132. In some embodiments, when the second member 160 is in the second position with respect to the first member 140, the second member 160 and the first member 140 are no longer rotationally locked with respect to each other. Thus, in such embodiments, the second member 160 is freely rotatable around the first member 140. When the housing 132 is coupled to the device housing 100, the authorized person, for example, may rotate the housing 132 to a position where an information label of the housing 132 is facing the back cover of the device housing 100. In this position, a user is able to read the information label while the housing 132 is locked within the device housing 100. The information label may include information about the prescribed substance, such as type of substance, amount of substance, dosage instructions for the substance, etc.
In several examples, the valve 182 may transition between an open state and a closed state. When the valve 182 is in the open state, the prescribed substance is allowed to be dispensed from the housing 132 to the intended user. In some embodiments, the prescribed substance may be dispensed in response to the processor determining that a unique biometric attribute of the intended user is detected, which will be discussed in further detail below. When the valve 182 is in the closed state, the prescribed substance is prevented from being dispensed from the housing 132. In some examples, the valve 182 is in the closed state when the second member 160 is not received within the cavity 172 of the third member 170. In such examples, the valve 182 is in the open state when the second member 160 is received within the cavity 172. In some embodiments, the biasing member 184 biases the valve 182 in the closed state. However, when the second member 160 is received within the cavity 172 of the third member 170, the coupling member 220 contacts the valve 182. In some embodiments, this connection overcomes the biasing force imparted by the biasing member 184 on the valve 182. The biasing member 184 may be compressed as the valve 182 moves from the closed state to the open state. As shown in the embodiment of
As shown in the embodiment of
The second member 160 further includes guide ribs 168a, 168b. The guide ribs 168a, 168b are sized to fit within corresponding guide channels of the third member 170 when the second member 160 is received within the cavity 172 of the third member 170. The guide ribs 168a, 168b ensure that the second member 160 and the third member 170 will be coupled in the same rotational position when the second and third members 160, 170 are coupled together. This ensures that the sensor array 240 will be aligned with a corresponding detector array 250 of the third member 170.
As shown in the embodiment of
At step 402, the method 400 includes moving a valve of a locking cap fixedly secured to a housing containing the substance to an open state that allows the substance to be dispensed from the housing to the intended user. In some embodiments, the locking cap is the locking cap 130, and the housing is the housing 132. In such embodiments, the valve is the valve 182. In some examples, the method 400 may additionally include a step of fixedly securing the locking cap 130 to the housing 132. In some embodiments, fixedly securing the locking cap 130 to the housing 132 may include encasing the lip 138 of the housing 132 with the plurality of latching members 148 of the first member 140 of the locking cap 130. In other embodiments, fixedly securing the locking cap 130 to the housing 132 may include coupling the second member 160 of the locking cap 130 with the first member 140. In some examples, coupling the second member 160 to the first member 140 includes encasing the plurality of latching members 148 with the distal portion 164 of the second member 160. In several examples, moving the valve 182 to the open state comprises inserting the second member 160 into the cavity 172 of the third member 170.
At step 404, the method 400 includes determining that a unique biometric attribute of the intended user is detected. In some embodiments, the processor may determine whether the intended user's unique biometric attribute is positioned on a biometric sensor. The biometric sensor may be located on a surface of the device housing 100. For example, the processor may compare a fingerprint model associated with an input by the biometric sensor to a predetermined fingerprint model associated with the intended user to determine whether there is a match between the current user of the device housing 100 and the intended user of the device housing 100. In some instances, a user's unique biometric attribute is detected by the biometric sensor when the user's unique biometric attribute is positioned on the biometric sensor. In other examples, the user's unique biometric attribute is detected by the biometric sensor when the user's unique biometric attribute is spaced from the biometric sensor. In other embodiments, the determination includes determining that a unique dentition of the intended user is positioned within a recess of a mouthpiece (e.g., the COPA device 110). In such embodiments, this may include determining, by the processor, that the unique dentition of the intended user is positioned within the recess of the mouthpiece. In some embodiments, a capacitive sensor array may be positioned within the recess of the mouthpiece. In several embodiments, the capacitive sensor array may detect a capacitive map associated with the dentition of the current user of the mouthpiece. In some examples, the processor may compare the capacitive map associated with the current user of the mouthpiece with a predetermined capacitive map associated with the intended user. Additional details regarding the COPA device 110 may be found in U.S. patent application Ser. No. 15/958,809, filed Apr. 29, 2018, which is hereby incorporated by reference in its entirety.
At step 406, the method 400 includes dispensing the substance from the housing to the intended user in response to determining that the unique biometric attribute of the intended user is detected. In some embodiments, the dispensing includes dispensing the substance in response to determining, by the processor, that the unique dentition of the intended user is positioned within a recess of the mouthpiece. In other embodiments, the dispensing includes, separately or additionally, dispensing the substance in response to the processor determining that the unique identifier of the second member 160 associated with the intended user is detected by the detector array 250 of the third member 170. In several examples, this determination may include receiving, by the detector array 250, the unique identifier associated with the intended user. The detector array 250 may receive the unique identifier associated with the intended user from the sensor array 240 of the second member 160.
In alternative embodiments, the locking cap 500 may be received within the device housing 100 to securely dispense the prescribed substance from the housing 132. The locking cap 500 includes a first member 510 and a second member 520. The first member 510 includes grooves 512 corresponding to the threads 136 of the housing 132. The grooves 512 receive the threads 136. In this manner, the first member 510 and the housing 132 can be threadedly coupled. The second member 520 includes a lower tab 522. In some embodiments, as discussed above with respect to the locking cap 130, when the second member 520 is rotated, the first member 510 rotates together with the second member 520. Therefore, to attach the first member 510 to the housing 132, the first member 510 is placed on top of the housing 132. The second member 520 may be rotated (e.g., in a clockwise direction or in a counter-clockwise direction) to screw the first member 510 onto the housing 132. In some embodiments, the second member 520 is rotated until the lower tab 522 of the second member 520 travels over and then engages with the lip 138 of the housing 132. Therefore, the second member 520 may be fixedly secured to the housing 132 (e.g., in the axial direction). The second member 520 may then be received within the cavity 172 of the third member 170 as discussed above.
In alternative embodiments, a locking cap 600 may be received within the device housing 100 to securely dispense the prescribed substance from the housing 132. The locking cap 600 includes a stopper 610, an elongate, threaded member 620, a compression member 630, and a threaded nut 640. The elongate, threaded member 620 includes threads 622 and a longitudinal axis LA. The threaded nut 640 includes grooves 642 that correspond to and receive the threads 622. Accordingly, the elongate, threaded member 620 and the threaded nut 640 are threadedly engageable. In some embodiments, the compression member 630 can transition between a non-compressed state and a compressed state. When the compression member 630 is in the non-compressed state, as shown in the embodiment of
In alternative embodiments, a locking cap 700 includes the first member 740, the second member 760, a valve 710, and the pump assembly 730. The valve 710 includes a longitudinal axis V, a valve stem 712, a shaft 714, a biasing member 716, and a cam 718. The pump assembly 730 includes a cam follower 732, an upper member 734, a lower member 736, and a biasing member 738. Therefore, as shown in the embodiment of
In some embodiments, the first member 740 serves the same function as the first member 140. Additionally, the structure of the first member 740 may be the same structure as the first member 140. In other embodiments, the structure of the first member 740 may be a different structure than the first member 140. In some embodiments, the second member 760 serves the same function as the second member 160. Additionally, the structure of the second member 760 may be the same structure as the second member 160. In other embodiments, the structure of the second member 760 may be a different structure than the second member 160.
In some examples, the biasing member 716 biases the valve 710 in a closed position, which may be a position where the prescribed substance is prevented from being dispensed from the housing 132. In some embodiments, the biasing member 716 is a spring. In other embodiments, the biasing member 716 may be any other suitable type of component configured to bias the valve 710 in a particular direction. The valve stem 712 is sized and shaped to be engaged by a third member 770, which will be discussed in further detail below. The shaft 714 is configured to move freely into and out of the cam 718. In the embodiment shown in
As discussed above, to dispense the prescribed substance from the housing 132, the valve 710 can be moved to the open position and also rotated. In some embodiments, the valve 710 may be rotated by rotating the third member 770. This rotation may cause the coupling member 220 to rotate. The valve 710 may then correspondingly rotate with the coupling member 220. In some embodiments, when the valve 710 is rotated, the shaft 714 rotates the cam 718. When the cam 718 rotates, the cam follower 732 of the pump assembly 730 also rotates. The cam follower 732 may ride against and be pushed in the direction V1 by the cam 718. As the cam follower 732 moves in the direction V1, the cam follower 732 causes the upper member 734 to move towards the lower member 736. This may compress the biasing member 738. In several examples, when the biasing member 738 is compressed, the pump assembly 730 transitions from a closed position to an open position. In the open position, the pump assembly 730 may dispense the prescribed substance from the housing 132. The biasing member 738 may bias the upper member 734 in a direction V2 such that the pump assembly 730 remains in the closed position until the biasing member 738 is compressed. In some embodiments, the biasing member 738 is a spring. In other embodiments, the biasing member 738 may be any other suitable type of component configured to bias the upper member 734 in a particular direction. In several embodiments, when the valve 710 is in the open position and the pump assembly 730 is also in the open position, the prescribed substance is capable of being dispensed from the housing 132. In such embodiments, the prescribed substance may be dispensed from the housing 132 to the intended user.
The following table lists reference numerals and corresponding reference names:
Persons skilled in the art will recognize that the apparatus, systems, and methods described above can be modified in various ways. Accordingly, persons of ordinary skill in the art will appreciate that the embodiments encompassed by the present disclosure are not limited to the particular exemplary embodiments described above. In that regard, although illustrative embodiments have been shown and described, a wide range of modification, change, and substitution is contemplated in the foregoing disclosure. It is understood that such variations may be made to the foregoing without departing from the scope of the present disclosure. Accordingly, it is appropriate that the appended claims be construed broadly and in a manner consistent with the present disclosure.
The medication bottle 890 may be used to hold a prescribed substance, which may be the prescribed substance 845. In some embodiments, the prescribed substance 845 may be in liquid form. For example, the prescribed substance 845 may be a liquid form of oxycodone Hydrochloride, morphine concentrate, lorazepam, Zoloft sertraline HCL, or any other suitable substance. In some examples, the prescribed substance 845 may be any of the substances listed above or any substance that has not yet been produced, created, developed, or manufactured, but may be produced, created, developed, or manufactured in the future. The prescribed substance 845 may be a combination of any of the substances listed above or a combination of the substances listed above with substances that have not yet been produced, created, developed, or manufactured, or with any other suitable substance. In other embodiments, the medication bottle 890 may include a prescribed substance in the form of pellets, granules, micro particles, mini tablets, powders, pills, etc. The medication bottle 890 may be sized to contain multiple doses (e.g., a day(s), week(s), month(s), etc.) of the prescribed substance based on the intended user's dosage information. In some instances, the volume of the medication bottle 890 is equal to or greater than 15 ml, 30 ml, 60 ml, 90 ml, 120 ml, 180 ml, 240 ml, 360 ml, 480 ml, or more. The volume of the medication bottle 890 may be sized based on expected dosage sizes, expected substance form (e.g., liquid, pellets, granules, micro particles, mini tablets, powders, pills, etc.), and/or combinations thereof.
The pump 898 can be utilized to dispense the prescribed substance from the medication bottle 890, through the COPA device 825, and into the intended user's mouth via a tubular connector 880 and the tubular member 840. In this regard, the components in the interior of the housing 800 may be similar to a micro-pump unit. In some instances, the tubular connector 880 may be replaced by the tubular member 840, such that the tubular member 840 extends from the COPA device 825, through the pump 898, and connects to the valve 896. In other instances, the tubular member 840 may be replaced by the tubular connector 880, such that the tubular connector 880 extends from the valve 896, through the pump 898, and connects to the COPA device 825.
In some embodiments, a distal end of the dip tube 894 is disposed within the medication bottle 890 so that the distal end of the dip tube 894 terminates just above a base 891 of the medication bottle 890. Thus, substantially all of a length of the dip tube 894 may be positioned within the medication bottle 890. This may allow for the prescribed substance 845 to enter the distal end of the dip tube 894 and flow through the dip tube 894, which may be a hollow tube. A proximal end of the dip tube 894 may be connected to a distal end of the valve 896. A proximal end of the valve 896 may be connected to a distal end of the tubular connector 880. A proximal end of the tubular connector 880 may be connected to a distal end of the pump 898, and a proximal end of the pump 898 may be connected to a distal end of the tubular member 840. A proximal end of the tubular member 840 may terminate within the COPA device 825. In some embodiments, the tubular member 840 connects to the reservoir of the micro-pump unit, which then delivers the prescribed substance 845 into the user's mouth via the exit valves. In other embodiments, the tubular member 840 extends through the COPA device 825 and into the docking port 830, and the prescribed substance 825 is delivered into the user's mouth via an exit port in the docking port 830. In various examples, the tubular member 840 extends through the COPA device 825 and the docking port 830 and connects to the exit port. The prescribed substance 845 is then delivered into the user's mouth via the tubular member 840. Any one of the respective connections such as the connections between one or more of the dip tube 894, the valve 896, the tubular connector 880, the pump 898, the tubular member 840, the docking port 830, the exit port 832, and/or the COPA device 825 described above may be a male/female engagement, a snap fit, a press fit, a threaded engagement, an adhesive connection, a solder engagement, a fastened engagement, a welded connection, a brazing connection, or any other suitable coupling to facilitate transfer of the prescribed substance 845.
In some embodiments, the tubular member 840 may be in fluid communication and mechanical communication, such as physically coupled, with the pump 898 and the COPA device 825, respectively. In other embodiments, the dip tube 894 may be in fluid communication and mechanical communication, such as physically coupled, with the valve 896.
In some embodiments, after placing the cap 892 on the medication bottle 890, the authorized person may insert the medication bottle 890 into the housing 800. To insert the medication bottle 890 into the housing 800, the authorized person may first remove the bottom wall 870 of the housing 800. Then, the authorized person may insert the medication bottle 890 into the lower portion 820 of the housing 800. After inserting the medication bottle 890 into the lower portion 820, the authorized person may replace the bottom wall 870 and lock the bottom wall 870 in place with a locking mechanism to securely seal the bottom wall 870 onto the housing 800 in a manner that prevents unauthorized access to the medication bottle 890. In some embodiments, the locking mechanism may be a key lock, a magnetic lock, an electronic lock, a mechanical lock, a quick connect lock, or any other suitable locking mechanism. In some embodiments, the locking mechanism may securely seal the bottom wall 870 to the front wall 824 when the front wall 824 is coupled to the bottom wall 870.
In some embodiments, after a dosage has been delivered to the intended user, the valve 896 may purge the tubular connector 880, the pump 898, and the tubular member 840 with air. For example, the valve 896 may inject air into the tubular connector 880, the pump 898, and the tubular member 840. The injection of air may ensure that any remaining residue from the dosage of the prescribed substance 845 is removed from the tubular connector 880, the pump 898, and the tubular member 840. In some instances, the valve 896 may be a purge valve, a canister purge valve, a check valve, a pinch valve, a diaphragm valve, a solenoid valve, a ball valve, or any other suitable valve. In some embodiments, the pump 898 may continue to provide dosages, one at a time, of the prescribed substance 845 to the intended user according to a dosage time table and/or a dosage schedule. Doses may continue to be delivered for the prescribed period of time, for the prescribed number of doses, and/or until the amount of the prescribed substance 845 in the medication bottle 890 is depleted.
In other embodiments, after the authorized person removes the empty medication bottle 890 from the housing 800, the authorized person may not need to refill the medication bottle 890 with the prescribed substance 845. For example, the authorized person may not need to refill the medication bottle 890 when the user's dosage schedule is complete. If the user's dosage schedule is complete, then the authorized person may keep the housing 800 with the attached COPA device 825 to be sterilized and then used for a subsequent user. In some embodiments, the authorized user may remove the medication bottle 890 from the housing 800 while the medication bottle is partially full of the prescribed substance 845. For example, the medication bottle 890 may be partially full even after the prescribed period of time has passed and/or after the prescribed number of doses have been administered.
While it has been discussed above with respect to
At a high level, the doctor 910 may prescribe a medication to a patient and the pharmacy 920 may create the mouthpiece for the patient and fill the mouthpiece according to the prescription(s) provided by the doctor 910. The pharmacy 920 may program the micro-pump unit of the mouthpiece to deliver an exact dosage of the prescribed medication and/or a dosage intake time. In this regard, dosage instructions for the patient may be stored in memory of the micro-pump unit. The patient may insert the mouthpiece into the patient's mouth and the micro-pump unit will, upon verification that the user is the intended recipient, dispense the prescribed medication as programmed. The patient may dock the mouthpiece at the docking station when the mouthpiece is not in use. The docking station may charge the mouthpiece and/or communicate with the doctor 910 and/or the pharmacy 920 via wireless and/or wired connections. The doctor 910 and/or the pharmacy 920 may monitor and retrieve information associated with the dispensing of the prescribed medication from the docking station 960. The doctor 910 may provide instructions to adjust the dosage instructions based on the monitoring and/or the retrieval information, and/or based on evaluations of the patient's progress. The pharmacy 920 may send instructions to the docking station 960 to adjust the dosage instructions stored in the memory of the micro-pump unit based on the order from the doctor 910. For example, when the mouthpiece is docked at the docking station, the dosage instructions stored in the memory can be updated or re-programmed accordingly. Alternatively, the dosage instructions stored in the memory can be updated or re-programmed at the pharmacy 920. Similarly, the doctor 910 may prescribe new medication based on the monitoring and/or the retrieval information, and/or based on evaluations of the patient's progress. The pharmacy 920 may refill the micro-pump unit accordingly. In some embodiments, the doctor 910 and/or the pharmacy 920 may monitor and retrieve information associated with the dispensing of the prescribed substance from the housing 800. The pharmacy 920 may refill the housing 800 with a medication bottle filled with a prescribed substance based on the monitoring and/or the retrieval information, and/or based on evaluations of the patient's progress.
The patient/authorized caregiver portal 930 may be stored on a computer server or in cloud storage on the network 940. The management system 950 may be hosted on the network 940. The management system 950 may include a master database that stores information associated with the patient and all COPA activities. For example, the management system 950 may allow doctors (e.g., the doctor 910), assembly or fulfillment technicians, pharmacists (e.g., the pharmacy 920), and any healthcare personnel that partake in the COPA process to access at least some portions of the master database, for example, based on logins. In an embodiment, different personnel may have different login profiles and the accesses to the master database may be based on login profiles. In some embodiments, the patient/authorized caregiver portal 930 may be hosted on the management system 950 and may have certain accesses to the master database. The patient information may include an identification of the patient, health history, prescription history, identification of the processor within the COPA device 825, identification of the docking station 960 at which the COPA device 825 is charged, etc. The patient's identification may include a social security number (SSN) of the patient or other unique identifier. The prescription history may include identifications of doctors (e.g., the doctor 910) who prescribed medications to the patient, identifications of pharmacies (e.g., the pharmacy 920) at which the prescribed medications were filled or refilled, identifications of the prescribed medications, and an identification of the processor within the micro-pump unit where the medications were filled. The prescription history may also be stored and managed by the management system 950. The physicians' identifications may include national provider identifiers (NPIs) of the physicians. The NPIs are unique identification numbers for Health Insurance Portability and Accountability Act (HIPPA) covered physicians. The pharmacies' identifications may include an impression technician identifier (ID), an assembly technician ID, and a registered pharmacy ID. The impression technician ID identifies the technician who created the COPA device 825 for the patient. The assembly technician ID identifies the technician who assembled or filled the prescribed medication into the micro-pump unit of the COPA device 825. The pharmacy ID identifies the pharmacy at which the prescribed medication was filled. The prescribed medications' identifications may include dosage IDs that identify each prescribed substance or formulation filled into the micro-pump unit of the COPA device 825.
In an embodiment, the doctor 910 may examine a patient and determine whether alternative therapies may be helpful to the patient. When the doctor 910 determines that the patient is in need of a particular medication, for example, according to guidelines for drug formulations based on COPA dosing options, the doctor may order a prescription for the patient. The doctor 910 may electronically transmit the prescription to the pharmacy 920 via the network 940, for example, according to HIPPA standards of protection for data and electronic medical record (EMR) formats.
At a COPA fabricator, a technician may create a mold for the COPA device 825, for example, according to COPA guidelines and instructions. The mold may include a sealed sleeve similar to a sealed sleeve. For example, the technician may use a dental tray filled with bio friendly polymers to create the mold. COPA approved dentists, hygienists, and/or other trained professionals (e.g., a COPA device assembly technician) may complete the creation of the mold for the COPA device 100.
An assembly technician may prepare a pre-packaged micro-pump unit. Each micro-pump unit may be identified based on an ID of the processor embedded within the micro-pump unit. The assembly technician may record the ID of the micro-pump unit in the management system 950. For example, the assembly technician may enter the ID into the management system 950, query a COPA device ID database of the management system 950 that stores and tracks IDs of COPA devices (e.g., the COPA device 825), and create a new record for the COPA device 825 created for the patient. The assembly technician may activate the processor within the micro-pump unit, for example, wirelessly. The activation may include programming the processor according to the order received from the doctor 910. The programming may include the dosage instructions for the patient (e.g., a dosage amount and the dosage timing for each prescribed medication). As described above, different chambers may be filled with different formulations. Thus, the programming may include a release sequence, specific release times, and/or release durations for the different formulations, and/or intervals between releases. For example, some formulations may be programmed for instant release (IR) and some formulations may be programmed for extended release (ER).
After activating the micro-pump unit or the processor, the assembly technician may place the activated micro-pump unit into the top center of the mold where the sealed sleeve is positioned. The micro-pump unit may be positioned such that the access cannulas extend outside the sealed sleeve through the access ports and the exit cannulas extend through the base of the mold. The assembly technician may place a top side capacitive sensor array into the base layer of the COPA device 825. The assembly technician may also place an environmental sensor onto the outer face of the back wall portion of the COPA device 825. The assembly technician may attach a hose from an air compressor to the access ports on top of the mold such that pressurized air may be pumped through the access cannulas into the micro-pump unit to ensure that the flow channels are not compressed during the filling of the mold. The assembly technician may pump a liquid polymer into the mold and allow the liquid polymer to set. After the liquid polymer is set, the COPA device 825 is complete.
Upon completion of the COPA device 825, the COPA device 825 can be transferred to the pharmacy 920. At the pharmacy 920, a pharmacy staff (e.g., a COPA fulfillment technician) may place the COPA device 825 on a pedestal or other structure configured to allow access to the micro-pump unit for filling. The pedestal may be covered by a sterile sleeve each time prior to placing a COPA device on the pedestal. The pharmacy staff may retrieve a record of the COPA device 825 based on the ID of the processor within the COPA device 825, for example, from the COPA management system 950 via the network 940. The pharmacy staff may procure the medications (e.g., vials, pouches, bottles, etc.) from a drug manufacturer based on the dosage specified in the order received from the doctor 910. The pharmacy staff may update the record for the COPA device 825. The pharmacy staff may activate or open control valves at the access ports to inject or deposit the formulated prescription (e.g., the prescribed substance 845) into one or more chambers of the reservoir via the access ports. After completing the filling, the pharmacy staff may close the control valves. The pharmacy staff may repeat the same process for filling other chambers in the reservoir. Subsequently, the releasing of the formulated prescription is based on matching of the intended recipient's teeth and the COPA device 825 as described above. It should be noted that in some embodiments, the pharmacy 920 and the COPA fabricator may be the same entity.
In other embodiments, at the pharmacy 920, a pharmacy staff (e.g., a COPA fulfillment technician) may place the COPA device 825 on the housing 800 to allow access to the medication bottle 890 for filling. The pharmacy staff may retrieve a record of the COPA device 825 based on the ID of the processor within the COPA device 825, for example, from the COPA management system 950 via the network 940. The pharmacy staff may procure the medications (e.g., vials, pouches, bottles, etc.) from a drug manufacturer based on the dosage specified in the order received from the doctor 910. The pharmacy staff may update the record for the COPA device 825. The pharmacy staff may open one or more walls (e.g., the bottom wall 870) of the housing 800 to insert a medication bottle 890 containing the formulated prescription (e.g., the prescribed substance 845). After completing the insertion, the pharmacy staff may reattach the removed wall(s) of the housing. Subsequently, the releasing of the formulated prescription is based on any one, two, or three of matching of the intended recipient's fingerprint model with a currently detected fingerprint model, detection of environmental attributes within a pre-defined range, and/or matching of the intended recipient's capacitive map with a currently detected capacitive map as described above.
The initial ID (e.g., of the processor) created for the COPA device 825 can be a permanent ID for the COPA device 825. Information associated with the filled prescription may be associated with the ID of the COPA device 825 and recorded in the management system 950 and/or an internal tracking system of the pharmacy 920. Thus, the COPA device 825 is fully traceable through the creation and preparation path. In addition, the mold used to craft the COPA device 825 may be assigned with a mold ID and may be stored in the management system 950 in association with the ID of the processor. Protocols for the use of the stored molds may be documented and records of subsequent mouthpieces may be stored in association in the management system 950. As such, misuse or fraud may be traced via the management system 950.
The pharmacy staff may pair the COPA device 825 with the docking station 960. The pharmacy staff may record an ID of the docking station 400 in association with the COPA device 825 in the management system 950. A wireless transceiver of the docking station 960 may be recorded and registered in the management system 950 for remote access to the processor embedded in the COPA device 825. For example, a pharmacy staff may adjust the dosage of the filled prescribed medication based on the instructions or an order of the prescribing doctor 910 by accessing the processor via the wireless transceiver without the patient returning the mouthpiece to the pharmacy 920 prior to depletion of the active ingredient(s). The adjustment may allow for a limited number of revisions, for example, to the dosing amount per release, the timing of the release, and/or suspension of one or more of the chambers. While the embodiment in
The patient may pick up the COPA device 825 and the docking station 960 from the pharmacy 920 and the pharmacy staff may provide instructions of usage to the patient. The patient may insert the COPA device 825 into the patient's mouth and close the mouth to bite on the COPA device 825 so that the prescription dispensing unit or the micro-pump unit may release the prescribed medication for ingestion. The patient may clean the COPA device 825 and dock the COPA device 825 at the docking station 960 after use.
The patient and/or the authorized care giver may have access to an online COPA account, for example, hosted on the management system 950 via the network 940. The wireless transceiver may detect and transmit data such as activities recorded by the mouthpiece (e.g., dispensing dosages and timings for each medication) to the management system 950. The patient may view records of medications loaded into each chamber of the COPA device 825. The patient may view records of the administration path of medications filled in the COPA device 825 including the initial prescription and any subsequent revisions. The patient may view records of an anticipated depletion timeline for the patient to pick up a second pre-filled COPA device (e.g., the COPA device 825) and drop off the depleted COPA device if the treatment is a recurring treatment.
In an embodiment, the refill process for the COPA device 825 may use similar policies as today's drug refill policies. The COPA device 825 may be used in prolonged treatment plans. A prescribing doctor 910 may adjust and revise the prescription based on the treatment results observed from the patient. The doctor 910 may electronically transfer the revised prescription to the pharmacy 920. The pharmacy staff or the fulfillment technician may send revised instructions to the processor wirelessly through the wireless transceiver of the docking station 960. The management system 950 may house a full record of all revisions. When the intended recipient has depleted the COPA as planned, or as revised, the COPA device 825 may be returned to the pharmacy 920 for refills, for example, as directed by the prescribing doctor 910. The pharmacy staff may flush saline solution into the COPA device 825 through the access ports into the sealed prescription dispensing unit and out the exit valves. After flushing the COPA device 825, the pharmacy staff may refill the COPA device 825 based on the order received from the doctor 910 and may update the record in the management system 950. For example, if a prescription is written for three refills, the record would indicate three dosage IDs in association with the ID of the processor of the COPA device 825 and previous dosage IDs. By recording all information associated with the COPA device 825, the patient and the dosage information in the management system 950 may be retrieved at any time, including when the patient changes providers or pharmacies during a treatment plan.
In an embodiment, when the COPA device 825 is no longer needed, for example, at the end of a treatment plan or change of treatment plan, the COPA device 825 may be deactivated and the management system 950 may be updated to indicate the deactivation of the COPA device 825. In some embodiments, when deactivation time of the COPA device 825 is within a certain time limit, for example, X number of months, an assembly technician may reuse the original impression to build a new COPA device 100. The ID of the processor within the new COPA device 825 may be stored in the management system 950 in association with the old ID of the old COPA device 825. In an embodiment, when a COPA device 825 needs to be recast due to actual change in the dentition of a recipient, the creation and preparation processes described above may be repeated. Information associated with the new mold may be stored on the management system 950 in association with the patient and the prescribed medications. By tracking all COPA devices 825 associated with a particular patient or a particular prescription, it may be less likely for an unintended user to gain access to the prescribed medications or for an intended user to provide false information for misuse of prescribed substances.
The present application is a continuation application of U.S. patent application Ser. No. 16/932,629, now U.S. Pat. No. 12,048,804, filed Jul. 17, 2020, which is a divisional application of U.S. patent application Ser. No. 16/420,002, now U.S. Pat. No. 10,729,860, filed May 22, 2019, each of which is hereby incorporated by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16420002 | May 2019 | US |
| Child | 16932629 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16932629 | Jul 2020 | US |
| Child | 18786181 | US |
