AND REMOTELY MONITORING HEALTH STATUS

RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No.

62/164, 182 filed on May 20, 2015, and U.S. Provisional Application No. 62/176,878 filed on March 2, 2015, both of which are hereby incorporated by reference in their entirety.

FIELD

[0002] The present disclosure relates to remotely dispensing medications and monitoring patient health status and compliance with medication treatment regimens.

BACKGROUND

[0003] Medical professionals frequently prescribe one or more medications - often in the form of pills - with the intent for patients to ingest according to a treatment regimen and at locations away from the medical professional. Moreover, a medication treatment regimen may include multiple prescriptions, and each prescription may carry its own time and dosage requirements. As such, medication treatment regimens can become increasingly complex and difficult for a patient to follow, let alone for a medical professional to reliably monitor a patient's compliance with the treatment regimen. In some instances, the patient may suffer from one or more conditions that make it difficult for the patient to comply with the treatment regimen, despite the patient's best efforts.

[0004] Further, a patient's reaction to one or more prescriptions may cause various vital signs or other measurements to change. The desired reaction(s) may be monitored through one or more measurements, such as, for example, blood pressure, pulse, blood glucose, and the like. Similarly, adverse reactions, due to medication allergies and the like, failure to comply with a prescription, and/or interactions between medications, may be detected by monitoring a patient's vital signs and other measurements. However, timely assessment of these reactions depends on both real-time (or near real-time) measurement of the patient's vital signs, and timely review of the measurements by one or more medical professionals. [0005] Contemporary technology fails to adequately meet the needs of remotely dispensing medications and monitoring patient health status and compliance with medication treatment schedules. Existing technologies merely dispense pills. One kind of dispenser has paper cups that a person fills sometime in advance. When it's time to take the pills, a light illuminates. The patient presses a button and the paper cup comes out with pills in it. A lot of people don't like that kind of device because cups can jam and spill, the pill filling process is unsecure and unreliable, and it is difficult to verify that a patient actually took the required medication. Some devices incorporate basic communications functions, which provide minimal interaction between the patient or caretaker and the medical professional(s) providing care.

[0006] What is needed, then, is a system for medical professionals to prescribe medications and reliably remotely monitor both the patient's compliance with the medication regimen, and the patient's reactions to the medications.

BRIEF SUMMARY

[0007] The present approach provides a multi-purpose health care hub with not only a pill dispensing and verification mechanism, but also an audio-video interface that can support remote, real-time interaction between a patient and a medical professional. Embodiments of the present approach may also provide data-gathering peripheral devices can be used to collect vital sign data and other medically relevant data for use by medical professionals who not only can use the embodiments to verify delivery of medications, but also can remotely assess the health of a patient, and based on their assessments of the collected data, take immediate action, which can include making changes to medication dispensing orders, and transmit those orders to the dispensing controller within the patient-side device.

[0008] Embodiments of a patient-side medication pill dispensing device may include a device housing, a reservoir within the device housing, and an extendible tray. The reservoir may have one or more reservoir slots for receiving a plurality of pills, either directly or through a pill container such as a blister pack or a cartridge. The reservoir slots also have a chute for dispensing one or more pills. The extendible tray may be movable from a retracted position to an extended position. In the retracted position, the tray is within the device housing and in close proximity to the reservoir slots to receive dispensed pills from the chutes. In the extended position, at least a portion of the tray extends outside the device housing for a user to retrieve dispensed pills. Embodiments may also include a dispensing mechanism that selectively dispenses at least one dispensed pill from at least one reservoir slot to the extendible tray. The dispensing mechanism may be configured to dispense pills according to one or more treatment regimens.

[0009] Some embodiments may include an information display external to the device housing. The display screen may provide instructions relating to at least one treatment regimen, receive input from a user (e.g., patient, caretaker, etc.), and support various interactions between the user and others, such as medical professionals. Some embodiments may include a camera configured for viewing a user of the medication dispensing device. Embodiments may be configured for exchanging voice data and/or image data with a medical professional.

[0010] In some embodiments, the medication pill dispensing device includes one or more ports for connecting to peripheral measurement devices, such as, for example, a digital scale, a thermometer, a spirometer, a blood pressure measurement device, a glucose monitor, a pulse oximeter, and a user wearable device like a smart watch or FitBit. Embodiments may also include an onboard data storage device for storing data received from one or more peripheral measurement devices, and transmitting such data to third parties such as medical professionals.

[0011] Some embodiments of the patient-side medication pill dispensing device may contain pills directly in the reservoir slots. In some embodiments, a blister pack with one or more pills may be received in a reservoir slot. In other embodiments, a plurality of pill cartridges may provide the pills. Each cartridge received in a reservoir slot. The blister pack or cartridge may, in some embodiments, be disposable and replaced with fresh packs or cartridges.

[0012] The pill cartridge may have, for example, a body housing a rotating pill control gear, the pill control gear defining a plurality of pill slots, an indexing drive gear in mechanical connection with the pill control gear and configured to rotate the pill control gear, and a dispensing chute. When the pill control gear rotates by a certain amount, a first pill slot aligned with the dispensing chute becomes unaligned with the dispensing chute, and a second pill slot becomes aligned with the dispensing chute. In this manner, subsequent partial rotations may dispense additional pills. A cartridge may have a cover hingedly connected to the body, such that the cover may be opened to load pills into the cartridge, and locked in a closed position. In some embodiments, a cartridge may include a cartridge identifier with information about, for example, at least one of the cartridge, the pills contained in the cartridge, a treatment regimen, or other instructions for the device or the user. The identifier may include computer-readable information and human-readable information.

[0013] In some embodiments, the reservoir slots may be aligned in a linear array. The dispensing mechanism may take the form of a drive gear and motor assembly configured to move along the array of reservoir slots to one or more engagement positions. At each engagement position, the drive gear engages the indexing drive gear of the cartridge received in the reservoir slot associated with that engagement position. The indexing drive gear may then control rotation of the pill control gear and the dispensing of pills in the cartridge. In some embodiments, the drive gear and motor assembly further comprises an optical encoder configured to determine the position of the drive gear and motor assembly with respect to the array of reservoir slots. In some embodiments, the drive gear and motor assembly have a sensor configured to identify dispensed pills dispensed from the cartridge received in the reservoir slot.

[0014] Some embodiments of the patient-side medication pill dispensing device may include a controller layer that controls the dispensing mechanism according to at least one medication treatment regimen. In some embodiments, the controller layer may send data to and receive data from at least one medical professional-side device. The data sent to medical professional-side devices may include, for example, at least one of a measurement from a peripheral measurement device, an indication that a pill was dispensed from the medication dispensing device, and a communication from a user. The data received from medical professional-side devices may include, for example, medication treatment regimens, modifications to a medication treatment regimen, and communications from a medical professional.

[0015] Embodiments of the present approach may take the form of a system of patient- side medication pill dispensing devices and medical professional-side devices. Patient-side medication pill dispensing devices may take the form of the embodiments described above. For example, these devices may include a device housing, a reservoir within the device housing and having a plurality of reservoir slots, each reservoir slot configured for receiving a plurality of pills and having a chute for dispensing at least one dispensed pill, an extendible tray movable from a retracted position to an extended position, such that in the retracted position the tray is in within the device housing in close proximity to the plurality of reservoir slots and configured to receive a dispensed pill from the chutes, and in the extended position at least a portion of the tray extends outside the device housing, and a dispensing mechanism configured to selectively dispense at least one dispensed pill from at least one reservoir slot.

[0016] A one medical professional-side device may be in communication with the patient-side medication pill dispensing devices. The medical professional-side device may transmit medication treatment regimens to the plurality of patient-side medication pill dispensing devices, and receive medication treatment regimen compliance data from the plurality of patient- side medication pill dispensing devices. In some embodiments, the patient-side medication pill dispensing device includes at least one port for connection to a peripheral measurement device. The one medical professional-side device may receive measurement data generated from the plurality of patient-side medication pill dispensing devices.

[0017] In some embodiments, the system may also include one or more pharmacies in communication with medical professional-side devices and, optionally, patient-side devices. The pharmacy can receive a prescription from medical professional-side devices, and provide pills, such as in the form of blister packs or cartridges configured for insertion into a reservoir slot, to the patient-side device.

DESCRIPTION OF THE DRAWINGS

[0018] Fig. 1 is an exemplar embodiment of a patient-side device.

[0019] Fig. 2 is an exemplar embodiment of a patient-side device connected to multiple peripheral devices.

[0020] Fig. 3 shows a system for remote dispensing medications and monitoring patient status.

[0021] Fig. 4 illustrates another embodiment of a patient-side device.

[0022] Figs. 5-7 show side, top, and front views, respectively, of an embodiment of a patient-side device.

[0023] Fig. 8 depicts an embodiment of a cartridge and tray assembly of a patient-side device.

[0024] Fig. 9 shows a medication dispenser cartridge according to an embodiment of the present approach.

[0025] Figs. 10 and 11 illustrate side and top views, respectively, of a medication dispenser cartridge according to an embodiment of the present approach. [0026] Fig. 12 shows an up-close view of a portion of side and top views, respectively, of a medication dispenser cartridge according to an embodiment of the present approach.

[0027] Fig. 13 shows a cross-sectional view of an embodiment of a medication dispenser cartridge, taken along a centerline such that the left-most element of the drawing is the top of the cartridge, and the right-most element is the bottom of the drawing.

[0028] Fig. 14 illustrates the mechanical operation of a cartridge and tray assembly of a patient-side device, according to one embodiment of the present approach.

[0029] Fig. 15 illustrates the cartridge sensing elements in one embodiment of a patient- side device.

[0030] Fig. 16 shows another view of the cartridge sensing elements in one embodiment of a patient-side device.

[0031] Fig. 17 depicts the cartridge tray according to one embodiment of the present approach.

[0032] Fig. 18 shows the mechanical operation of the pill tray according to an embodiment of the present approach.

[0033] Figs. 19-21 show perspective, side, and top views, respectively, of a pill tray, according to an embodiment of the present approach.

DESCRIPTION

[0034] The following description sets forth exemplary embodiments of the present approach. The description is not to be taken in a limiting sense, and is made merely for the purpose of illustrating the general principles of the present approach.

[0035] It should be apparent from the following discussion and drawings that embodiments of the present approach provide more than a mere pill dispenser. The present approach provides a multi-purpose health care hub with not only a pill dispensing and verification mechanism, but also an audio-video interface that can support remote, real-time interaction between a patient and a medical professional. Embodiments also provide data- gathering peripheral devices can be used to collect vital sign data and other medically relevant data for use by medical professionals who not only can use the embodiments to verify delivery of medications, but also can remotely assess the health of a patient, and based on their assessments of the collected data, take immediate action, which can include making changes to medication dispensing orders, and transmit those orders to the dispensing controller within the patient-side device.

[0036] The present approach relates to health management devices and systems that solve a growing problem in the medical field relating to the delivery of medications and monitoring patient compliance with medication treatment regimens. One of the biggest problems encountered after surgery, for example, is discovering and achieving an ideal dosage and delivery schedule of necessary medications. Today, problems resulting from improper medication dosage often cannot be recognized or resolved until a patient returns to the hospital. By that time, the patient may already be exhibiting severe symptoms relating to, among other things, failure to comply with a medication treatment regimen.

[0037] Embodiments of the present approach address such problems by, for example, (1) providing a medication delivery system that delivers medications to patients in a controlled and verified fashion; (2) allowing real-time interaction between medical health professionals and patients; (3) generating real-time physiological measurements relating to a patient's health and well-being; and (4) enabling real-time assessment and revision to medication dosage regimes, which can then be made immediately available to the patient. Some embodiments also provide simultaneous recording of patient vital signs, and permit medical professionals to conduct realtime, interactive assessments of patients on an as-needed basis.

[0038] Embodiments of the present approach may comprise a patient-side health management device with one or more of the following elements: (1) an automated pill dispenser with various security and verification features; (2) a hub for collecting patient vital signs, among other measurements, and relaying data to medical professionals; (3) audio and video observation and/or recording of medication delivery to a patient; (4) recording all medication delivery and vital sign data; (5) automated reporting of collected data to medical professionals via supervisory embodiments; (6) analysis of collected data, on a patient-by-patient basis, as well as on a mass population basis; and (7) real-time, interactive, audio and video interaction between a patient, medical health professionals, and other caregivers and/or guardians.

[0039] Embodiments may take the form of a system in which one or more pill dispensing patient-side devices as described herein are interconnected to one or more medical professional- side devices. The connection may be in the form of a network supported by the Internet or other distributed network, such as in individual patient homes in communication with a data center, central network, or other professional device. Other embodiments may be implemented in the form of devices connected wirelessly or by wire in a local area network, such as a hospital or other medical treatment facility. Regardless of the implementation, the patient-side devices may communicate with one or more medical professional devices by exchanging data. For example, the patient-side devices may transmit data relating to the patient's pill dispensing history, vital sign measurements, and the like, and the medical professional devices may transmit data relating to modifications in a patient's treatment regimen and the like. In some embodiments, the patient- side and medical professional-side devices may support audio and/or video data exchange, such that medical professionals may engage in live communications with the user (e.g., patient, caretaker, etc.).

[0040] The patient-side device may include an automated pill dispenser that dispenses one or more pills (e.g., medications in tablet, capsule, caplet, or other forms as are known in the art) from a bank of pill reservoirs. The bank of pill reservoirs may be contained within a locked or closed portion or housing of the patient-side device, thereby reducing the likelihood of tampering with and theft of medications. Each pill reservoir in the patient-side device can be configured to receive a single pill cartridge containing a predetermined number of pills. Pills can be different sizes, shapes, and configurations.

[0041] The bank of pill reservoirs in a patient-side device can be configured with reservoirs of different sizes (e.g., small, medium, large), to accommodate various sizes and kinds of pill cartridges and pills. Some embodiments may have a plurality of the same pill reservoirs, and thus may be configured for use with a plurality of pill cartridges of the same shape and size. Other embodiments may have a variety of pill reservoirs, and thus may be used with various combinations of pill cartridges. The pill reservoirs may be arranged in a variety of patterns and/or configurations, including a rectangular matrix or array, a circular "carousel" array, as well as other configurations, as should be appreciated by those skilled in the art.

[0042] For example, some embodiments may feature a rectangular array of pill reservoirs, such that each column of reservoirs is configured to hold a particular size and/or type of pill (or pill cartridge). As one example, two columns may be configured to hold small pills or a first type of cartridge, two columns may be configured to hold medium pills or a second type of cartridge, and one column may be configured to hold large pills or a third type of cartridge. Some reservoirs can be configured to hold a plurality pills that are prescribed for simultaneous (or nearly simultaneous) administration. Other reservoirs can be configured to hold supplemental pills that can be prescribed on an as-needed basis, such as, for example, when a patient's vital signs or other measurements indicate the need for a supplemental medication.

[0043] Pill cartridges can include an identifier, such as a barcode, QR code, or other symbol, to indicate the contents of the cartridge. Embodiments of the patient-side device can include a sensor, such as a barcode reader, that scans the identifier on a pill cartridge when the cartridge is inserted into a corresponding reservoir, or during operation. The identifier can correspond to a serial number, description, or other code or information that identifies the cartridge, its source, its contents, the prescribing doctor, the filling pharmacy, and the like. The identifier can also include information describing or referencing other information (such as in a database) describing the type of pills contained in the cartridge (e.g., tablet, capsule, caplet), the size of pills contained in the cartridge, the number of pills contained in the cartridge, the date of manufacture of the pills, the medication contained in the pills, the dosage and/or regimen for each pill, and other information about the pills, including recommended storage temperature, recommended storage duration, and recommended destroy and/or replace date. The identifier can also include the name of the patient(s) intended to receive the pills contained in the cartridge, as well as instructions relating to operation of the patient-side device, information to display to the patient, and information to make available to a medical professional, as examples.

[0044] Some embodiments of the patient-side device can be configured to receive and dispense pill cartridges for one patient, whereas other embodiments may be configured for use with a plurality of patients. For example, the patient-side device may include a scanner or input means to identify the patient and determine the pill(s) to dispense for that patient.

[0045] Pill cartridges may be sealed to ensure product freshness, integrity, and security, as well as to control environmental factors (e.g., humidity, temperature). The seal may be broken upon insertion of the cartridge into a pill reservoir, for example, or upon closure of a lid covering the pill reservoir, as another example. The lid may be locked in a number of manners, as should be apparent to those of skill in the art. Pills can be dispensed from a set of given pill cartridges and/or pill reservoirs according to a schedule or regimen set for a patient, which may be sent to the patient-side device electronically, set forth in one or more identifiers on a cartridge or plurality of cartridges, or otherwise made available to the patient-side device. [0046] Each reservoir may be temperature controlled. The temperature may be increased or decreased according to the ambient temperature as well as the ideal prescribed temperature of the pills in a cartridge residing in the reservoir. Reservoirs may therefore be configured to include one or more of a temperature sensor, a humidity sensor, and individualized temperature control mechanisms as are known in the art. The entire pill reservoir may also be configured with a single temperature control mechanism to control the temperature of all pill reservoirs in the health management device.

[0047] Medication can be dispensed using a variety of dispensing technologies, including, for example, a vertical rotating wheel mechanism in a cartridge, in which each pill is funneled by gravity from a slot in the rotating wheel to a chute beneath the cartridge. Some embodiments may also use a vibrating mechanism to ensure the medication is dispensed. Once a pill has exited the cartridge chute and dropped into a landing area, some embodiments may include a further processing stage for, as an example, pill verification, prior to allowing the pill to travel to a dispensing area. A rotating wheel mechanism can be installed in a pill reservoir for some embodiments, and may be integrated into a pill cartridge in some embodiments.

[0048] Embodiments of the invention can include a set of sensors that track the loading of pill cartridges (or collection of pills) into a pill reservoir, and track the dispensing operation of each pill. Sensors can track a pill as it leaves a pill cartridge, as it moves through a dispensing mechanism, and as it travels to a verification area and/or dispensing area.

[0049] Embodiments of the patient-side device may include additional features to ensure movement of pills as desired. For example, the movement of pills from a reservoir or cartridge, through a dispensing mechanism (such as the rotating wheel described above), and into a verification area or dispensing, area, can be assisted by small puffs of air, such as compressed air, blown into the movement channels to encourage the desired movement. If an embodiment fails to deliver a pill for whatever reason (e.g., a pill gets jammed, a pill gets crushed, a communications network fails, or some other failure), or a data gathering device fails to provide valid data, some embodiments may be configured to alert a medical professional or other third party to contact the patient and inquire about the failure. In some embodiments, the patient-side device may issue a request for maintenance or servicing to determine and repair the problem. In some embodiments, the patient-side device may issue a request for a medical professional to be dispatched to the location within a certain amount of time. [0050] Some embodiments may include a verification area in the patient-side device. The verification area can facilitate visual identification of each pill prior to dispensing, such as, for instance automated identification or separate confirmation by a medical professional. The verification area can include a camera with an automated visual object recognition module for pills that can be identified by appearance. Some pills, particularly certain types of generic medications, cannot be easily identified by appearance, so dispensing of these pills can be tracked by the sensors and verified by barcodes associated with the corresponding pill cartridges.

[0051] Alternatively, some medications or treatment regimens may require verification by a medical professional or other individual prior to delivery to the patient. For example, an optional verification step can be performed by a nurse practitioner, doctor, or other medical professional, who can view the patient on a video camera installed in an embodiment of the invention and observe the patient taking the dispensed medications, especially medications that represent high risk or have high medical importance. Such medical professionals can also use the video camera to verify the medication as it is being delivered to the patient. Some embodiments may be configured for automated verification and visual verification.

[0052] The camera can visually record the dispensing of each pill (or plurality of pills).

Such records can be stored on local memory storage devices in a patient-side device, and/or may be transmitted to a remote data storage device, such as through upload via a network to a server computer for archival storage.

[0053] Some pill cartridges may be loaded into reservoirs for supplemental use in the event they are needed. Such pills can be a low dosage increment so that, for example, upon medical professional authorization, any number of the supplemental pills can be dispensed to a patient, pursuant to the medical professional's instructions. For example, if a diuretic medication such as Lasix (Furosemide) 40 mg is prescribed for a patient on a daily basis (e.g., "1 PO q am"), an embodiment of the patient-side device may include a cartridge of Lasix (Furosemide) 10 mg, so that a medical professional can dynamically add one of the 10 mg pills to the patient's daily dose of 40 mg, to bring the total dose up to 50 mg. As another example, a patient-side device may include one or more cartridges of emergency medication that may be dispensed in the event that a patient's vital signs or other measurement indicate the need for the emergency medication.

[0054] Individual medication dispensing features of the patient-side device are valuable for a number of reasons. For instance, these features save medications from being discarded when a dosage amount is changed. Normally, when a patient has to stop taking a medication at one dosage, the patient must return to a pharmacy and get the same medication at a different dosage. The old medications are then thrown away. Embodiments of the present invention reduce the waste of medications because embodiments can deliver supplemental doses that allow previously prescribed medications to be used up. Similarly, medical professionals may monitor a patient's response to medication in or near real-time, and adjust the treatment regimen (or dispense additional medication) through the patient-side device.

[0055] Another way of packaging medications is through a "blister pack" that contains all of the medications to be taken by a patient at the same time. Typically, the patient receives a blister pack that contains a plurality of various pills. The blister pack may include a date and/or time printed on the outside (e.g., Monday, April 10, 2016, 8:00 am), among other identifying information and useful information. For example, Blister packs can be barcoded or include an identifier in the same manner as pill cartridges as described herein. The information may instruct the patient on when to ingest the contents. In some embodiments, a vendor can deliver multiple blister packs to the patient (e.g., a week's worth of blister packs), so that a patient has them in advance. The patient then merely opens the packet and ingests the various pills. Embodiments of the patient-side device can be configured to receive and dispense blister packs from a corresponding pill reservoir, and alternately from a rotating flat carousel. The blister packs can be loaded into each reservoir tray similar to the loading for pill cartridges into pill reservoirs. Alternatively, an entire carousel containing pre-loaded blister packs can be loaded into an embodiment of the invention.

[0056] Embodiments of the invention can account for and warn patients and medical professionals about drug-to-drug interactions between two medications. For example, some embodiments may be configured to operate software that performs contraindication checks using existing drug databases.

[0057] Embodiments of the patient-side device may confirm the identity of the patient.

For example, some embodiments of the patient-side device may be configured to perform facial recognition, thumbprint or fingerprint authentication, and retinal authentication of a patient. Some embodiments can combine these methods to employ two-factor or three-factor authentication using any combination of the disclosed authentication methods. [0058] Some embodiments of the patient-side device may include a locked pill- dispensing module. For example, the pill-dispensing module can be unlocked physically with a key (for example, to refill the pill reservoirs with pills and/or pill cartridges), or it can be unlocked electronically by an authorized command delivered to an embodiment via a network connection.

[0059] Embodiments of the patient-side device may include an information display screen. For example, some embodiments of the patient-side device include a front-facing screen that may include a touch interface. The screen may be a liquid crystal display, similar to a tablet computer. The screen may be accompanied by one or more speakers, and may be configured for providing visual and audial instructions to a patient. In a demonstrative interaction, an avatar on the display screen may correspond to a user. The avatar may initiate an interaction with a patient by stating, for example, "Good morning, Mr. Smith, you have 5 medications today; please touch the green 'go' sign to begin," via a speech generation device, such as a speaker.

[0060] Fig. 1 is an exemplar embodiment of a patient-side device 1001. Device 1001 includes an information display 1003, that in some embodiments may be responsive to touch or other devices. Speakers 1005 may work in conjunction with display 1003 to provide information, guidance, and instructions, for example, to a user (e.g., patient, caretaker). Device 1001 may include one or more ports 1009 for interfacing with peripheral devices. Display 1003 may also be configured to receive input from a user, such as responses to questions, and use of one or more peripheral devices. Device 1001 includes one or more extendible trays 1011, to dispense one or more medications contained in device housing 1013. Some embodiments may include a camera 1007 to capture images or video of the user, and the device 1001 may be configured to provide live video interaction between a user and a third party, such as a medical professional.

[0061] Fig. 2 is an exemplar embodiment of a patient-side device 2001 connected to multiple peripheral devices. Device 2001 is configured to dispense pills 2003 as described here. Further, it should be appreciated that device 2001 may be connected to and interface with numerous peripheral devices. For example, a device 2001 may connect to peripheral devices such as a digital scale 2005, a thermometer 2007, a spirometer 2009, blood pressure measurement devices 2011, a glucose monitor 2013, pulse oximeter 2015, and the like. The device 2001 may be pre-programmed for interfacing with one or more peripheral devices, and seamlessly receive, analyze, and report patient data to one or more medical professionals. Some embodiments may include one or more universal ports, and may connect with a new peripheral device. Upon connecting, the device 2001 may search for and download operating software and drivers for the new peripheral device.

[0062] A peripheral device can be connected to the patient-side device via known methods of connection, such as, for example, a tether that is attached to the peripheral on one end and attached to the patient-side device via a hook (or similar attachment point) near one or more of the ports. For safety reasons (e.g., the patient tripping over wires), certain peripheral devices, such as digital scales, may connect to the patient-side device wirelessly, in lieu of wired connections.

[0063] Some embodiments may include movable doors over one or more peripheral device ports. During operation, a user may open a door, and the peripheral device behind the door may be extended outward to the user, or alternatively the user can reach into the bay to retrieve the peripheral device. The vital sign peripheral remains tethered to the health management device so the patient cannot misplace them, for example. Each bay door and each bay may be a different size, to accommodate a specific vital sign peripheral.

[0064] In some embodiments, the peripheral device and door may be remotely operated by a third party, such as a medical professional. For example, a medical professional operating a retraction mechanism remotely can retract one or more peripheral devices into its corresponding storage bay upon completion of a data collection process. If a patient does not need one or more measurements, they need not be included with the patient-side device. Thus, the specific complement of peripheral devices can be customized depending on what that patient or treatment regimen requires.

[0065] In some embodiments, peripheral devices may communicate with the patient-side device via Bluetooth or an equivalent wireless network protocol. Peripheral devices can also communicate with the patient-side device via known hardline communications protocol, such as USB, RS-232, TCP/IP, or other similar protocols known in the art. Embodiments of the patient- side device can be configured to interface with connected peripheral devices either serially or in parallel. Some vital sign peripherals may be installed outside the embodiments and plugged into the embodiments for data collection and analysis.

[0066] Embodiments of the patient-side device may be configured to collect data based on the desired data collection schedule. Thus, a medical professional may determine the schedule upon which a patient's vital signs and other measurements should be taken. For example, embodiments of the patient-side device can collect vital sign data from a patient at least once every day, or within a certain time after a patient ingests a pill. The vital sign data can be uploaded to a server immediately or on a periodic basis, and may be configured to alert a medical professional or other third party in the event of a measurement indicating an emergency or other scenario meriting a warning.

[0067] Some embodiments of the patient-side device may collect and anonymize data for mass analysis. Similarly, systems of patient-side devices may be configured to support mass analysis. The value of such data is not just in the quantity, but also in the fact that longitudinal data profiles can be generated, and that there is a direct link in the data to patient behavior. It should be appreciated that embodiments can be tailored to provide customized analytics that build on longitudinal data. Similarly, some embodiments can be given the ability to intervene with respect to behavior modifications.

[0068] Take pharmaceutical research as an example. With respect to large-scale studies, embodiments may be configured to produce data covering populations, measurements, and periods of time, in a way that has not been possible in the past. Similarly, embodiments may be configured to record when each patient ingested a particular medication, the patient's vital signs or other measurements, and document such data for subsequent verification.

[0069] Embodiments of the patient-side device take numerous forms other than as shown in the specific embodiments described herein. For example, some embodiments may take the form of a "thin client" connected to the Internet or other network by any one of several known means (e.g., cellular, WIFI, cable, Ethernet, etc.). Here, "thin client" means that all collected data will be uploaded to a server via the Internet as soon as practicable. Collected data can be stored temporarily in the memory of the patient-side device, but to minimize the risk of data loss, the data will be uploaded whenever possible.

[0070] Embodiments can support a variety of protocols for connecting to the Internet. If, for example, a wireless network goes down but a cable system is operational, embodiments may be able to reconfigure its network connection to use the cable system. The same can occur with respect to using a cellular network or any other means of connecting to the Internet. Embodiments of the patient-side device can support a video camera, a screen or monitor that is capable of displaying video images as well as computer-generated text, graphics, and images. When connected to the Internet, embodiments of the patient-side device can support a variety of protocols for data transfer, including TCP/IP and FTP. Embodiments can also support interactive telephone calls and video calls (e.g., Skype, FaceTime, etc.).

[0071] Fig. 3 shows a system for remote dispensing medications and monitoring patient status. The system may include a plurality of patient-side devices 3001. The patient-side devices may be installed at, for example, patients' homes, throughout a hospital, among other possible sites, and may be connected to the Internet or a network. Patient-side devices 3001 may be in communication with medical professionals 3003, which may include treating physicians, registered nurses, and the like, operating computing devices in communication with patient-side devices 3001. Communication 3002 between patient-side devices 3001 and medical professionals 3003 may involve the exchange of data as described herein, including, for example, medication treatment regimens and instructions to the patient or caretaker, measurement and monitoring of patent vital signs and other data, analysis of data, video and/or voice conferencing, and the like. It should be appreciated that, depending on the implementation, medical professionals 3003 may include professionals other than treating medical specialists, such as research scientists and analysts.

[0072] The system may also include one or more pharmacies 3005, configured to receive prescription and regimen information form medical professionals 3003 through communications 3004. Pharmacies 3005 may prepare pill cartridges and/or blister packs for shipment 3007 to a patient or caretaker. Depending on the embodiment, a pharmacy 3005 or a medical professional 3003 may provide the identifier on a cartridge or blister pack for a patient-side device to read. Although some embodiments include data on the cartridge or blister pack for a patient-side device to read and determine the instructions, in some embodiments the pharmacy may send such data to a patient-side device through data communication 3006. Additionally, the medical professional 3003 may send such instructions and data to the patient-side device, at or near the time the medical professional 3003 sends a prescription to the pharmacy 3005.

[0073] In some embodiments, the system may include one or more servers 3009. Server

3009 may be a central server for an entire system, or may be specific to a particular network, medical professional, or pharmacy. For example, a pharmaceutical research company may maintain a central server in connection with clinical trials, whereas a network of healthcare professionals may maintain separate servers. It should be appreciated that the server(s) 3009 may be used for multiple purposes, and the present approach should not be limited to the specific purposes described herein. For example, server(s) 3009 may retain data generated by patient-side devices 3001, and/or store data generated by and/or provided to medical professionals 3003 and pharmacies 3005. In some embodiments, server(s) 3009 may support communications between parties, such as video and voice conferencing between patients and medical professionals. In some embodiments, server(s) 3009 may perform data anonymizing and analyzing services.

[0074] Although there are numerous potential applications for the present approach, demonstrative use cases with respect to various embodiments include: (1) post-acute care; (2) chronic conditions; and (3) clinical trials. Post-acute care use cases include, for example, post cardiac surgery or other serious surgical procedure such as hip or knee replacement operations; post-hospital diabetes complications; and hospital -acquired infections, for example pulmonary infections. Chronic use cases include, for example: complex polypharmacies, diabetes, Coumadin management, asthma, sleep apnea, mental health, Alzheimer's, and mild cognition impairment. Clinical trial enablement platform use cases include, for example: electronic data capture in-home, the ability to adjust medication, inability to deliver and conduct clinical trials in rural and remote communities, etc.

[0075] A fourth category includes recreational sports and health applications. This category applies to athletes and fitness buffs, who wish to keep track of supplements such as vitamins, minerals, and other preparations, as well as to record and analyze various vital signs that relate to athletic performance. Embodiments of the present approach can provide users with an ability to manage a health portfolio with all supplements, vital sign measurements, and other related data, all linked together in the same device. For example, embodiments of the patient-side device may be configured to collect data from personal data collection devices such as a wearable device like a Fitbit as part of an in integrated wellness program. Embodiments can then export all pill dispense data and vital sign data in a variety of spreadsheet formats (e.g., Excel), among other useful formats. Embodiments of the invention can provide real-time data analysis tools that can identify weaknesses, and can compare collected data to statistical data corresponding to various categories of individuals in a population. Embodiments can determine if a certain vital sign measurement is changing over time and can report that change to the patient or to medical professionals. When that change in a vital sign represents a potential problem, embodiments can then, for example, enable a video conference call with four different callers: nurse, patient, family member, and doctor, for example. Stakeholders can participate and watch the patient. They can perform remote evaluations and coordinate scheduling of a doctor's visit if necessary.

[0076] Medical professionals, including treating physicians, doctors, doctor's offices, registered nurses, clinical trial supervisors, and the like, may have a medical professional-side device configured to, among other things, communicate with patient-side devices and users, receive patient data, and the like. Patient data can be uploaded to the medical professional's system, which in turn can upload the patient data into an EMR (electronic medical record). Nurses can have the same kind of patient-like system as well, so the nurse can demonstrate how to use vital sign devices to a patient who can watch the nurse on the video screen. Doctors and nurses can also have a digital dashboard that can show a history of a patient's vital sign data and drug dispenses. It should be appreciated that the medical professional-side device may take the form of a software application, user interface, or App, installed on an electronic device.

[0077] Additionally, data monitoring protocols can be designed and implemented both at the patient-side device level and at the medical professional-side device or other server. For example, embodiments of the present approach can use a national or average set of protocols (by age, sex, fitness, etc.), or a doctor can set a customized protocol (alarms for various vital signs, for example) for a specific patient.

[0078] Embodiments of the patient-side device may include a microprocessor or computer, which controls and/or monitors all or a part of the device's pill loading operations, pill dispensing operations, vital sign data collection, video interaction, prescription management (including doctor-authorized edits and updates), and data uploading operations. Access to embodiments of the patient-side device may be controlled by various security protocols as are known in the art. For example, medical professional access to and control of a patient-side device may be limited or controlled, as is access by any other medical professionals and even the patients.

[0079] Embodiments may include internal power storage devices. Additionally, an external battery can supply power to embodiments of the patient-side device. The use of an external battery will help to keep the temperature of the medications stable, whereas an internal power storage device may require additional heat sinking features. An external battery can also help to provide power to the embodiments in the event of a failure or spike in external power sources.

[0080] Fig. 4 illustrates another embodiment of a patient-side device 4001, and Figs. 5-7 show side, top, and front views, respectively, of an embodiment of the same embodiment. Device 4001 includes an information display screen 4003 that may be touch-sensitive and/or responsive to devices such as stylus pens and the like. Device 4001 may include one or more speakers 4005 with or without a microphone, to enable audio communications between a user (e.g., a patient or caretaker) and a medical professional, as well as to enable the device 4001 to provide instructions to the user and/or other interactions (e.g., questioning, peripheral device usage, etc.). Device 4001 may include an external camera 4007 to take images or video of the user, such as to support video conferencing or to confirm or record the identity of the user. Some embodiments may include one or more ports 4009 for connection to and interfacing with peripheral devices, as discussed above. Device 4001 includes one or more extendible trays 4011, to receive one or more pills dispensed from inside device housing 4013, and provide the pills to the user. Extendible trays 4011 may include disposable tray liners (not shown). It should be appreciated that patient-side devices may vary significantly in appearance, design, and the like, and that the present approach is not intended to be limited to the embodiments disclosed herein.

[0081] Embodiments of the patient-side device may incorporate various mechanisms for verifying and dispensing medications. Fig. 8 depicts an embodiment of a cartridge and tray assembly 8001 of a patient-side device, as may be located inside a device housing and not readily accessible (in some embodiments). Assembly 8001 includes a medication dispenser bank

8002, having one or more reservoirs configured to receive one or more medication cartridges

8003. It should be appreciated that other embodiments may include pre-loaded pills in a reservoir, or be configured for use with a blister pack or other pill source. Pills from one or more medication cartridges 8003 may be selectively dispensed into extendible tray 8005, which may then extend to outside of the device housing (not shown) and permit a user to retrieve the pills. In some embodiments, tray 8005 may not extend until after one or more pill dispensing verification features have been completed.

[0082] Tray 8005 may include one or more guide rod bores 8008 to receive guide rods

8007. Extension mechanism 8009 may operate to extend and retract tray 8005 pursuant to one or more algorithms. Assembly 8001 also includes a belt drive assembly 8011, which allows pill indexing sensor to travel along a row of cartridges 8003, read information present on one or more identifiers (not visible in this drawing), and dispense pills pursuant to instructions present on local device memory, received from a medical professional-side device, and/or present in the information on the cartridges. In this embodiment, drive assembly 8011 operates similar to a Dot matrix printer head, moving back and forth along the row of cartridges 8003 as needed. It should be appreciated that alternative drive mechanisms may be used if the array of reservoirs and/or cartridges is not linear or contains more than one row.

[0083] Fig. 9 shows a medication dispenser cartridge 9001 according to an embodiment of the present approach. In this embodiment, cartridge 9001 includes a central pill control gear 9005 that defines a plurality of pill slots 9003 around the gear teeth. In this particular embodiment, slots 9003 are circumferentially arranged around the central hub of control gear 9003. Gear 9003 is mechanically engaged to indexing drive gear 9007, such that when indexing drive gear 9007 rotates, pill control gear 9005 rotates. After sufficient rotation, a pill slot 9003 aligns with dispensing chute 9009. Any contents in the pill slot 9003 aligned over chute 9009 then fall from the slot and proceed along a verification and/or dispensing pathway.

[0084] Cartridges may take a number of different forms, and may include various measures to prevent tampering. In this embodiment, cartridge 9001 includes a cover 9011 that may, in some variations, be transparent. Cover 9011 may connect to the cartridge body at hinge 9012, thereby permitting cover 9011 to be opened, and exposure of the pill slots 9003. To prevent tampering, cartridge 9001 may include one or more locking mechanisms 9013 configured to prevent cover 9011 from easily opening. Locking mechanism 9013 may correspond with a separate device (not shown) to unlock the locking mechanism, to permit refilling the cartridge. Additionally, cartridge 9001 includes a pair of handles 9015 to facilitate easy handling and loading into a patient-side device's reservoir (not shown in this drawing).

[0085] Figs. 10 and 11 illustrate side and top views, respectively, of a medication dispenser cartridge according to an embodiment of the present approach. In addition to the features discussed with respect to Fig. 9, cartridge identifier 9021 is visible in these drawings. The cartridge identifier 9021 may include various information to identify the cartridge, its contents (e.g., pills), the source of the cartridge and/or contents, information about the prescription and/or treatment regimen, instructions for the patient or caretaker, and the like. Cartridge identifier 9021 may include both visible information and computer-readable information, such as a barcode or other symbology that a pill indexing sensor can read and interpret. In some embodiments, the identifier may have more than one surface, and different information may be made available on different surfaces. For example, a computer-readable code may be on one surface of the identifier, and human-readable information may be available on an opposing surface.

[0086] Fig. 12 shows an up-close view of a portion of side and top views, respectively, of a medication dispenser cartridge according to an embodiment of the present approach. This view shows locking mechanisms 9013 protruding from the cartridge frame and extending through a corresponding slot in cover 9011. Cartridge identifier 9021 protrudes below the chute 9009, such that it is visible beneath the reservoir. As discussed below, embodiments may include one or more sensor devices configured to scan the identifier 9021 for contents, instructions, and the like. The position of identifier 9021 may vary in other embodiments, depending on factors such as the layout and configuration of the reservoirs, the shape and placement of cartridges, and the path of the drive assembly.

[0087] Fig. 13 shows a cross-sectional of an embodiment of a medication dispenser cartridge, taken along a centerline such that the left-most element of the drawing is the top of the cartridge, and the right-most element is the bottom of the drawing. In this cutaway view, a ratcheting toothed clutch 9031 is visible. The clutch 9031 may prevent rewind of the cartridge, or intended movement of the pill control gear 9005. Also, the cartridge may include one or more wave springs 9003 to support operation of clutch 9031. It should be appreciated that alternative configurations are possible, and will vary depending on the desired mechanical operation of the cartridge. In this view, locking mechanism 9035 is also present. It should be appreciated that a number of mechanisms may be used to secure cover 9011 in the desired position.

[0088] Fig. 14 illustrates the mechanical operation of a cartridge and tray assembly 1401 of a patient-side device, according to one embodiment of the present approach. A plurality of cartridges 1403 are inserted into corresponding slots in reservoir 1405. Drive gear 1407 is configured to engage the indexing drive gear of a cartridge 1403, and operate the pill control gear 9003 as appropriate. Drive gear 1407 is supported on a pair of linear bearings 1409, such that it may travel from one cartridge to the next as stepper motor 1413 moves the drive gear 1407 mechanism along the row of cartridges 1403 using drive pulley 1415 in connection with a timing belt (not shown). Drive gear 1407 may be disengaged from a pill control gear for movement between cartridges, and engaged to the pill control gear for a subsequent cartridge. Some embodiments may include an optical encoder 1417 (or other sensor) for precisely determining the position of the stepper motor 1413 and drive gear 1407 along the linear bearings 1409, relative to each cartridge 1403. For example, optical encoder 1417 (or other sensor) may be configured to identify various surfaces along the row of cartridges 1403. Alternatively, the cartridges 1403 or reservoir 1405 may include various markings for the optical encoder 1417 (or other sensor) to read and determine the position relative to the rest of the assembly 1401. Some embodiments may include a limit switch 1411 to reset the position of the drive gear 1407 and motor 1415 assembly, such as during cartridge replacement events. Guide rods 1419 may connect to or protrude from guide rod bearing 1421. As discussed above, the tray may extend outward along guide rods 1419.

[0089] Fig. 15 illustrates the cartridge sensing elements 8013 in one embodiment of a patient-side device. This view shows space between the cartridge 1403 sitting in the reservoir, and a tray positioned between the exit chute (not visible) of the cartridge 1403. Sensor 8013, which may be a camera or other device capable of identifying a pill in a tray, has a clear line of site into tray slot 1441. The sensor 8013 may scan the contents of slot 1441, and using one or more algorithms determine whether the contents of slot 1441 are as expected (e.g., whether a pill was dispensed from the cartridge, and whether the dispensed pill is the expected medication). In some embodiments, this pill verification may be automated, such that sensor 8013 operates pursuant to one or more algorithms. In some embodiments, pill verification may be supplemented by an image capture for subsequent analysis by a medical professional or other third party. In some embodiments, the pill verification may also be performed live, such that a medical professional or other third party receives the image or video footage from the patient- side device and confirms in or near real-time that the contents of slot 1441 are correct.

[0090] As discussed above, cartridges 1403 may include an identifier 9021 with various information about the cartridge and its contents. In some embodiments, sensor 8013 may also read a portion of identifier 9021, to confirm the expected contents of the cartridge. Because multiple cartridges may be placed in near proximity, some embodiments may include a baffle 1431 on the reservoir, such that sensor 8013 does not inadvertently suffer from identifier crosstalk 9021 (e.g., receiving information from a neighboring cartridge's identifier). [0091] Fig. 16 shows another view of the cartridge sensing elements in one embodiment of a patient-side device. In this view, the line of sight from indexing sensor 8013 is visible. Additionally, the position of limit switch 1411 is visible. In some embodiments, sensor 8013 may include an LED backlight, to assist in capturing an image or useful data relating to the dispensed contents and/or the cartridge.

[0092] A number of mechanisms may be used to securely position a cartridge in a reservoir. For example, force-fitting may be used, in which one or more detent members and corresponding structures allow the cartridge to 'snap' into the reservoir. Fig. 17 depicts the cartridge tray according to one embodiment of the present approach. Tray 1701 includes multiple reservoirs, and each reservoir is configured to receive a cartridge. As discussed above, reservoirs may be configured to receive similar or dissimilar cartridges. A surface of tray 1701 may include a plurality of bar magnets 1703, such that one magnet 1703 corresponds to one reservoir slot for receiving a cartridge. When the cartridge is inserted into the reservoir slot, magnet detention clips 1705 may be inserted to lock an individual cartridge in place.

[0093] Fig. 18 shows the mechanical operation of the pill tray 8005 according to an embodiment of the present approach. Tray 8005 may extend outside of the device housing or retract inside the device housing along guide rods 1419. Extension mechanism 8009 provides the mechanical force to extend and retract tray 8005. Motor 1801, which in this embodiment is a high torque servo motor for precision control, provides torque to the extension mechanism 8009. The torque rotates one segment of the extension mechanism 8009 connected to the motor 1801. The displacement causes a reciprocal extension or retraction of the opposing end of the extension mechanism connected to the tray 8005. In response, tray 8005 moves outward or inward along guide rods 1419. This view also shows the cone of the viewing angle for indexing sensor 8013.

[0094] Some applications and pharmaceutical regulations may require disposable containers for dispensed medications. Embodiments of the present approach may feature removable and/or disposable pill trays. Figs. 19-21 show perspective, side, and top views, respectively, of a pill tray 1901 according to an embodiment of the present approach. Pill tray 1901 may be removably inserted into tray 8005, such that pill tray 1901 is disposable. Ledges 1905 and 1907 may be used to secure pill tray 19 into tray 8005, such that pill tray 1901 is unlikely to become dislodged during tray 8005 extension and jammed in the patient-side device. Each tray may include one or more slots 1903 for receiving dispensed pills. The shape of the slot 1903 may correspond with the shape of tray 8005. Slot 1903 may take a number of forms, depending on design preferences. As shown in Fig. 20, a slot 1903 may be trapezoidal, to conform with tray 8005 and also make it easier for a user to retrieve pill(s) dispensed into the slot 1903.

[0095] As will be appreciated by one of skill in the art, aspects or portions of the present approach may be embodied as a method, system, and/or process, and at least in part, on a computer readable medium. For example, the various algorithms for dispensing pills, measuring patient vital signs, identifying pills dispensed, communicating with and receiving instructions from medical professionals, and the like, may be embodied in a computer readable medium. The computer readable medium may be used in connection with, or to control and/or operate, various pneumatic, mechanical, hydraulic, and/or fluidic elements used in systems, processes, and/or apparatus according to the present approach. Accordingly, the present approach may take the form of combination of apparatus, hardware and software embodiments (including firmware, resident software, micro-code, etc.) or an embodiment combining software and hardware aspects that may all generally be referred to herein as a "circuit," "module" or "system." Furthermore, the present approach may include a computer program product on a computer readable medium having computer-usable program code embodied in the medium, and in particular control software. The present approach might also take the form of a combination of such a computer program product with one or more devices, such as a modular sensor brick, systems relating to communications, control, an integrate remote control component, etc.

[0096] Any suitable non-transient computer readable medium may be utilized. The computer-usable or computer-readable medium may be, for example but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, device, or propagation medium. More specific examples (a non-exhaustive list) of the non- transient computer-readable medium would include the following: a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), an optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a device accessed via a network, such as the Internet or an intranet, or a magnetic storage device. Note that the computer-usable or computer-readable medium could even be paper or another suitable medium upon which the program is printed, as the program can be electronically captured, via, for instance, optical scanning of the paper or other medium, then compiled, interpreted, or otherwise processed in a suitable manner, if necessary, and then stored in a computer memory. In the context of this document, a computer-usable or computer-readable medium may be any non- transient medium that can contain, store, communicate, propagate, or transport the program for use by or in connection with the instruction execution system, apparatus, or device.

[0097] Computer program code for carrying out operations of the present approach may be written in an object oriented programming language such as Java, C++, etc. However, the computer program code for carrying out operations of the present approach may also be written in conventional procedural programming languages, such as the "C" programming language or similar programming languages. The program code may execute entirely on the user's computer, partly on the user's computer, as a stand-alone software package, partly on the user's computer and partly on a remote computer or entirely on the remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer through a local area network (LAN) or a wide area network (WAN), or the connection may be made to an external computer (for example, through the Internet using an Internet Service Provider).

[0098] The present approach may include computer program instructions that may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks.

[0099] These computer program instructions may also be stored in a non-transient computer-readable memory, including a networked or cloud accessible memory, that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable memory produce an article of manufacture including instruction means which implement the function/act specified in the flowchart and/or block diagram block or blocks.

[00100] The computer program instructions may also be loaded onto a computer or other programmable data processing apparatus to specially configure it to cause a series of operational steps to be performed on the computer or other programmable apparatus to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide steps for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks. Any prompts associated with the present approach may be presented and responded to via a graphical user interface (GUI) presented on the display of the mobile communications device or the like. Prompts may also be audible, vibrating, etc.

[00101] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the approach. As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.

[00102] The invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the claims of the application rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.