Drug delivery device with indicator

Systems and methods for monitoring an operational state and/or a fill status of a drug container of a drug delivery device are provided. The drug container can hold a liquid drug. A plunger can be positioned within the drug container. A drive system can advance the plunger to expel the liquid drug from the container. A monitoring system can detect a movement and/or a position of the plunger and/or any component coupled to the plunger. The detection can enable determination of an amount of liquid drug that has been expelled and/or an amount of liquid drug remaining in the drug container. Dosing rates, flow rates, and dosage completion can also be determined.

TECHNICAL FIELD

Embodiments generally relate to medication delivery. More particularly, embodiments relate to wearable drug delivery devices.

BACKGROUND

Many conventional drug delivery devices expel a liquid drug from a drug container for delivery to a patient. These conventional drug delivery devices often fail to inform the patient as to the fill status of the drug container. As a result, the patient is often unaware of how much liquid drug has been provided to the patient, when a desired dose has been completed, and/or how much liquid drug remains in the drug container. Accordingly, there is a need for a monitoring system for use in drug delivery devices that can determine and provide the patient with the fill status of the drug container holding the liquid drug.

DETAILED DESCRIPTION

This disclosure presents various systems, components, and methods related to a wearable drug delivery device and/or monitoring systems for determining a fill status of a drug container of a wearable drug delivery device. Each of the systems, components, and methods disclosed herein provides one or more advantages over conventional systems, components, and methods.

Various embodiments include systems and methods for monitoring an operational state and/or a fill status of a drug container of a drug delivery device. The drug container can hold a liquid drug. A plunger can be positioned within the drug container. A drive system can advance the plunger to expel the liquid drug from the container. A monitoring system can detect a movement and/or a position of the plunger and/or any component coupled to the plunger. The detection can enable determination of an amount of liquid drug that has been expelled and/or an amount of liquid drug remaining in the drug container. Dosing rates, flow rates, and dosage completion can also be determined. Other embodiments are disclosed and described.

FIG. 1illustrates an exemplary drug container102. The drug container102can hold or store a liquid drug or other therapeutic agent104. The drug container102can be used within a drug delivery device such as, for example, a wearable drug delivery device. A plunger106can be used to expel the liquid drug104from the drug container102for delivery to a patient. A drive system or mechanism (not shown inFIG. 1for simplicity) can provide a force on the plunger106to drive or advance the plunger106in a direction108to expel the liquid drug104from the drug container102(e.g., to advance the plunger106from a first position to a second position further into the drug container102to expel the liquid drug104).

A needle conduit110can provide the expelled liquid drug104to a patient. As shown inFIG. 1, the needle conduit110can be coupled to the plunger106such that the expelled liquid drug104exits from a first end112of the drug container102. Alternatively, the needle conduit110can be coupled to a second end114of the drug container102such that the expelled liquid drug104exits from the second end114of the drug container102. The liquid drug104can be provided to the patient over one or more doses based on control of the drive mechanism.

The drug container102can be made of a variety of materials including, for example, glass or plastic. The drug container102is not limited to the shape and size shown inFIG. 1. Instead, the drug container102can be of any size or shape. In various embodiments, the drug container102can be a prefilled or a Tillable container. In various embodiments, the drug container102can be an International Organization for Standardization (ISO) drug container such as, for example, an ISO vial.

Various embodiments described herein provide systems and methods for a patient to readily determine, at any point during use of the drug container102, how much of the liquid drug104is held in the drug container102, how much of the liquid drug104has been expelled from the drug container104, and/or when a desired dose of the liquid drug104has been provided to the patient. Various embodiments described herein provide systems and methods for determining this information based on a position or movement of the plunger106and/or based on a position or movement of the drive mechanism used to advance the plunger106(or any component of a drug delivery device coupled thereto). Such information allows the patient to confirm proper dose delivery and to verify proper operation of the drug delivery device in which the drug container102is used. Without such knowledge, the patient may not be able to confirm whether any liquid drug104remains in the drug container102, how much of the liquid drug104has been delivered to the patient, and/or how much of the liquid drug104remains to be delivered to the patient. Conventional drug delivery devices do not provide mechanisms for readily determining such information regarding the operational state and/or fill status of drug containers such as the exemplary drug container102.

FIG. 2illustrates a first exemplary drug delivery system200. The drug delivery system200can include the drug container102. The drug delivery system200can further include a drive mechanism for driving the plunger106in the direction108to expel the stored liquid drug104. As an example, the drive mechanism can include a drive spring202and a number of spherical elements or components204(e.g., a plurality of spherical elements or spheres204). The spherical elements204can be referred to as spherical energy transfer elements or components, or force transfer spheres. As used herein, the spherical elements204can be referenced using any of these terms including, for example, spheres204.

The spherical elements204can be positioned within a track (not shown inFIG. 2for simplicity). The drive spring202can expand in a direction206to push the spherical elements204towards the plunger106. The force from the drive spring202is transferred to the plunger106by the spherical elements204to drive the plunger106in the direction108, thereby expelling the liquid drug104from the drug container102. A direction of movement of the spherical elements204in response to the expansion of the drive spring202is shown by indicators208.

The drug delivery system200further includes a needle mechanism210. The needle mechanism210is coupled to the needle conduit110. Expelled liquid drug104is transferred to the needle mechanism210by the needle conduit110, which then provides the expelled liquid drug104to the patient. The drug delivery system200can be part of a drug delivery system such as, for example, a wearable drug delivery system. The drive mechanism (e.g., the drive spring202and the spherical elements204) of the drug delivery system200is exemplary as a variety of different drive mechanisms can be used to expel the liquid drug104by advancing the plunger106in the direction108.

The drug delivery system200can include a number of mechanisms and/or systems for determining the position of the plunger106within the drug container106. The position of the plunger106within the drug container102can be used to determine how much liquid drug104remains in the drug container102and/or how much liquid drug104has been expelled from the drug container102. Based on one or more of these determinations, proper operation of the drug delivery system200and dosing of the liquid drug104can be verified. The position of the plunger106within the drug container102can be determined directly and/or can be determined based on positional information of one or more other components of the drug delivery system200as further described herein.

As shown inFIG. 2, the drug delivery system200can further include one or more sensors such as, for example, a first sensor212positioned near the first end112of the drug container102and a second sensor214positioned near the second end114of the drug container102. The sensors212and214can be used to determine how much liquid drug104remains in the drug container102and/or how much liquid drug104has been expelled from the drug container102based on a determination of the position of the plunger106within the drug container102and/or based on a position of one or more components of a drive mechanism used to advance the plunger106.

In various embodiments, the sensors212and214can be Hall effect sensors that can detect the movement and/or position of the plunger106and/or the spherical elements204. For example, as the plunger106and the spherical elements204move in the direction108and into the drug container102, the sensors212and214can detect the movement of the plunger106and/or the spherical elements204. As a result, an indication of the position of the plunger106within the drug container102can be determined, thereby providing a determination of how much liquid drug104has been expelled and/or remains in the drug container102.

In various embodiments, the sensors212and214can determine how many spherical elements204have passed by each respective sensor212and214. Based on a known size of each spherical element204, a determination on the position of the plunger106and/or the rate of movement of the plunger106can be made. In various embodiments, the sensors212and214can determine a position of the plunger106along any portion of the drug container102. In various embodiments, any number of sensors can be used. As Hall effect sensors, the sensors212and214can measure a varying magnetic field resulting from movement and/or a change in position of the plunger106and/or the spherical elements204.

In various embodiments, the spherical elements204can comprise a metallic material. In various embodiments, the spherical elements204can include a metallic core that is surrounded by a non-metallic material such as plastic or rubber. In various embodiments, the spherical elements204can be made of different types of metal such that the magnetic response of each spherical element204as detected by the sensors212and214differs and can be distinguished. In various embodiments, only certain spherical elements204can be comprised of a metallic material that can be detected by one of the sensors212and214. For example, every other spherical element204can comprise a metallic material that can be detected by one of the sensors212and214. Based on a predetermined arrangement of the spherical elements204, as the drive mechanism advances the plunger106, positional information of the plunger106can be determined.

In various embodiments, a portion of the plunger106can comprise a metallic material such that the sensors212and214can detect the position of the plunger106within the drug container102. In various embodiments, any number of sensors can be used and can be arranged along the drug container102. The detection of the position of the plunger106is not limited to the drive mechanism shown inFIG. 2. In general, the drug delivery system200can include any drive system configured such that the sensors212and214can be used to detect the position of the plunger106based on detection of the plunger106position directly and/or detecting a position of any portion of a drive system used to advance the plunger106in the direction108. For example, the drive system can include a push rod, one or more cylinders, and/or one or more springs for driving movement of the plunger106with the sensors212and214operating to detect the position or movement of any of these components. Any of the techniques described herein for determining the fill status of a drug container102and/or a position or movement of the plunger106, either directly or indirectly, are applicable to any such drive mechanism, such as those described above, as will be appreciated by a person of ordinary skill in the art.

In general, as Hall effect sensors, the sensors212and214can detect and measure a magnetic field as it varies as the plunger102and the spherical elements204are advanced in the direction108. The sensors212and214can each generate signals indicative of the measured magnetic field. A controller (not shown inFIG. 2) can be coupled to the sensors212and214and can receive signals generated by the sensors212and214. The controller can detect characteristic waveforms corresponding to the plunger102and/or the spherical elements204(or any other component of a drive system) so as to track a movement or position of the plunger and/or the spherical elements204and/or count a number spherical elements204that pass each of the sensors212and214. In general, based on signals generated by the sensors212and214, the controller can determine a position of the plunger106within the drug container102. In this way, the controller can determine a fill status of the drug container102and/or the beginning or end of the stroke of the plunger106.

In various embodiments, the sensors212and214can be optical sensors. In various embodiments, the sensors212and214can detect the position of the plunger106based on optical detection. As an example, the drug delivery system200can include a first light emitting device or light source216and a second light emitting device or light source218. A first light beam220emitted by the first light emitting device216can be detected by the first sensor212and a second light beam222emitted by the second light emitting device218can be detected by the second sensor214. The first and second light beams220and222emitted from the first and second light emitting devices216and218, respectively, can be interrupted or blocked by the plunger106and/or the spherical elements204(or any other drive mechanism component) as the drive mechanism drives the plunger106in the direction108. As an example, the sensors212and214and corresponding light sources216and218can positioned off center from a central axis of the spherical elements204such that, as the spherical elements204are advanced, reception of the light beams220and222by the sensors212and214, respectively, can be occasionally interrupted.

The sensors212and214can detect these interruptions in detection of the first and second light beams220and222, respectively, and can use the detections to determine the position of the plunger106. In various embodiments, the sensors212and214can count the number of spherical elements204that have passed into the drug container102by counting a number of interruptions, thereby providing an estimate of the position of the plunger106. In various embodiments, the position of the plunger106can be determined as the plunger106itself interrupts light detection by a number of sensors positioned along the drug container102.

In various other embodiments, the sensors212and214themselves can emit light and can detect reflected light from any portion of the plunger106and/or any portion of the drive mechanism (e.g., the spherical elements204). In various embodiments, the plunger106and/or the spherical elements204can be coated with different light absorbing and/or reflecting materials, such that each element reflects and/or absorbs light differently. Based on the light reflected by the elements, the sensors212and214can detect the advancement of the plunger106and/or the spherical elements204and therefore the position of the plunger106.

In general, the sensors212and214and operation thereof to detect the position of the plunger106can be independent of the drive mechanism used to advance the plunger106. As noted above, the position of the plunger106can be determined based on sensors212and214as Hall effect sensors or optical sensors. The sensors212and214can be electrically coupled to a controller (not shown inFIG. 2) that can determine the position of the plunger106based on information collected or determined by the sensors212and214. The sensors212and214can form a portion of a monitoring system for the drug delivery system200that can determine an operational state or fill status of the drug container102such that how much liquid drug104has been expelled or remains in the drug container102can be determined. The monitoring system of which the sensors212and214can be a part can aid this determination based on detection of a position and/or movement of the plunger106and/or any component of a drive system used to advance the plunger106.

FIG. 3illustrates a second exemplary drug delivery system300. The drug delivery system300can operate in a similar manner with respect to the drug delivery system200to expel the liquid drug104from the drug container102for delivery to the patient. As shown inFIG. 3, the drug delivery system300can include a needle conduit302and one or more sensors such as, for example, a first sensor304and a second sensor306. The needle conduit302can be an encoded needle conduit as described further herein. In various embodiments, the needle conduit302can be encoded along its length in a manner to reveal or indicate positional information of the needle conduit302as it moves with the plunger106as the plunger106is advanced into the drug container102. The first and second sensors304and306can detect the encoded positional information of the needle conduit302to thereby determine the position of the plunger106.

In various embodiments, the needle conduit302can comprise a metal tubing that is coated in various regions with a non-conductive coating. The sensors304and306can detect the conductive and non-conductive regions of the needle conduit302. As the needle conduit302advances and passes over the sensors304and306(e.g., making electrical contact with the sensors304and306), the sensors304and306can distinguish the conductive and non-conductive regions. The sensors304and306can be coupled to a controller (not shown inFIG. 3) that tracks the count and/or length of these different regions. Based on a predetermined arrangement of the conductive and non-conductive regions of the encoded needle conduit302—for example, based on the number of different regions and their lengths or sizes—the controller can determine the position of the plunger106. Further, the controller can determine a rate of movement of the plunger106. This information can then be used to determine a fill status of the drug container103and a dosing status of the liquid drug104.

The sensors304and306can be arranged to be coupled to the needle conduit302as the needle conduit302advances in response to movement of the plunger106. The sensors304and306can further be arranged to not interfere with the drive mechanism (e.g., the spherical elements204). Further, any number of sensors can be arranged to be coupled to the needle conduit302.

FIG. 4illustrates a portion of an exemplary encoded needle conduit400. The encoded needle conduit400can represent the needle conduit302depicted inFIG. 3. As shown inFIG. 4, the encoded needle conduit400includes conductive regions402and non-conductive regions404. The conductive regions404can be spaced apart by a distance406. The sizes of the conductive regions402and the non-conductive regions404(and therefore the distance406) of the encoded needle conduit400can be uniform but is not so limited. In general, any known or predetermined arrangement of the conductive regions402and the non-conductive regions404can be used to determine the position of the plunger106. The conductive regions402can exhibit substantially the same or different levels of conductivity that can also be used to determine a position and/or a movement of the plunger106.

As the sensors304and306detect and/or come into electrical contact with the conductive regions402and/or the non-conductive regions404, the sensors304and306can distinguish the conductive regions402from the non-conductive regions404and can determine what portion of the encoded needle conduit400is passing over each of the sensors304and306. The sensors304and306can further detect the rate of movement of the encoded needle conduit400and can estimate a position and/or movement of the plunger106relative to the position and/or movement of the encoded needle conduit400.

In various embodiments, the sensors304and306can be optical sensors. In various embodiments, the needle conduit302can marked in a manner for the sensors304and306to detect positional information of the needle conduit302. For example, the needle conduit302can be laser marked or etched so as to distinguish different segments of the needle conduit302that the sensors304and306can identify. As another example, the needle conduit302can be marked with one or more bar codes along one or more portions of the needle conduit302so as to distinguish different segments of the needle conduit302that the sensors304and306can identify. As the marked needle conduit302passes over the sensors304and306, the sensors304and306(e.g., as barcode readers) can optically detect what portion of the encoded needle conduit302is passing each of the sensors304and306, enabling the position of the plunger106to be determined.

The sensors304and306and the encoded needle conduit302can form a portion of a monitoring system for the drug delivery system300that can determine an operational state and/or fill status of the drug container102such that how much liquid drug104has been expelled or remains in the drug container102can be determined. The monitoring system of which the sensors304and306and the needle conduit302can be a part can aid this determination based on detection of a position and/or movement of the needle conduit302that is coupled to the plunger106.

In various embodiments, a window or viewing area can be positioned on a drug delivery device to enable the patient to view a portion of a drug container and/or a portion of the drive mechanism to enable the patient to determine the fill status of the drug container and/or the operational status of the drug container. The window can be part of any drug delivery device or drug delivery system described herein and can be used in conjunction with any mechanism described herein for determining the fill status of a drug container.

FIG. 5illustrates a top view of an exemplary drug delivery device500. As shown inFIG. 5, the drug delivery device500can include an upper portion502. The upper portion502can be a top portion or a cover of the drug delivery device500. The drug delivery device500can further include a raised portion504. The raised portion504can be elongated and can run along a side of the drug delivery device500. A container for holding a liquid drug can be approximately positioned under the raised portion504such that the raised portion504accommodates the size and positioning of the liquid drug container within the drug delivery device500. As an example, a container such as the drug container102can be positioned under the raised portion504. Any drug delivery system described herein can be positioned within the drug delivery device500.

The upper portion502of the drug delivery device500can include a window or viewing area506. The window506, for example, can be made of plastic and can be transparent. The window506can be of any size and shape and can be positioned on any portion of the drug delivery device500. The window506can allow a patient to view internal components of the drug delivery device500such as, for example, a portion of the drug container positioned within the drug delivery device500(e.g., under a portion of the raised portion504) and/or a portion of the drive mechanism coupled to the drug container. The patient can determine how much liquid drug is in an internal drug container by viewing the drug container through the window506.

In various embodiments, the spherical elements204can be differently colored to indicate a dosing status of the liquid drug104(and/or a fill status of the drug container102). For example, the window506can be positioned on the upper portion502to allow a user to view all or a portion of the drug container102. The spherical elements204can be driven into the drug container102as the spherical elements204push on the plunger106. The user can view the spherical elements204enter the drug cartridge102. The spherical elements204can be colored differently (or marked or otherwise visually distinguished) in a predetermined sequence or manner to indicate how much of the liquid drug104has been expelled from the drug container102. The marking or coloring of the spherical elements204can be adjusted based on the size of a dose of the liquid drug104or an entire amount of liquid drug104stored in the drug container102.

For example, an initial set of spherical elements204can be marked in a first manner (e.g., by a first color such as green) to indicate an initial expulsion of the liquid drug104when the initial set of spherical elements204enter the drug container102and can be viewed. An intermediate set of spherical elements204can be marked in a second manner (e.g., by a second color such as yellow) to indicate an intermediate expulsion of the liquid drug104when the intermediate set of spherical elements204enter the drug container102and can also be viewed. A final set or final spherical element204can be marked in a third manner (e.g., by a third color such as red) to indicate a final expulsion of the liquid drug104(e.g., end of dose or completion of dose) when the final set or final spherical element204enters the drug container102and is visible to the user through the window506.

As will be appreciated by a person of ordinary skill in the art, any type of marking (e.g., coloring) including text or other symbols and any number of groupings and corresponding distinctions (e.g., number of intervals or gradations) can be used to indicate the dosing status or the fill status of the drug container102based on the spherical elements204entering the drug container102. Further, as will be appreciate by a person of ordinary skill in the art, any drive mechanism component used to drive the plunger106—including, for example, a push rod, one or more cylinders, and/or one or more springs—that enters the drug container102can be marked in a manner to indicate dosing status or fill status of the drug container102based on the extent to which any portion of the drive mechanism component has entered the drug container102. Further, any marking or coloring of any component of the drive system can be based on a predetermined dose size and/or a total amount of the liquid drug104stored in the drug container102. In various embodiments, the drive mechanism component or components can be marked to simply indicate a completion of a dose—for example, when a red colored portion of the drive mechanism is visible in the drug container102, dose completion can be indicated.

In various embodiments, a sensor can be positioned adjacent to the drug container102that can track or a count a number of the spherical elements204or other drive system components that enter the drug container102to provide an indication of dosing status or fill status of the drug container102. For example, with reference toFIG. 2, a sensor can be positioned adjacent to a first end112of the drug container102. The sensor can mechanically or can electromechanically count a number of the spherical elements204that pass the sensor as the spherical elements204enter the drug container102. In various embodiments, the sensor can be a switch that is triggered each time a spherical element204passes the sensor. The switch could be implemented as a mechanical switch or can be implemented as an electromechanical switch. As part of an electromechanical system, the sensor can be coupled to a display (e.g., an LED display) for indicating dosing status or fill status of the drug container102. A mechanical implementation can include a wheel that has different colors or symbols indicating dose status that can be rotated by the passing of the spherical elements204.

FIG. 6illustrates a third exemplary drug delivery system600. The drug delivery system600can include features of the drug delivery system200and can further include a dosing wheel602. The dosing wheel602can include a number of arms or spokes604that radially extend from a hub. The dosing wheel602can have any number of arms604. One or more of the arms604can be positioned between adjacent spheres204. The dosing wheel602can rotate in a direction606as shown about an axis of the dosing wheel602to move the spheres204forward toward the drug container102. The drive spring202can provide the force to move the spheres204as regulated by the dosing wheel602. That is, the dosing wheel602can impede forward movement of the spheres204until the dosing wheel602rotates a desired amount in the direction606. The drug delivery device600can operate as a single dose or multiple dose drug delivery device by regulating movement of the spheres204.

In various embodiments, movement of the dosing wheel602can trigger a counter or other device to track rotational movement of the dosing wheel602. For example, a counter coupled to the dosing wheel602can track the number of times the dosing wheel602has advanced a single sphere204forward. In doing so, the counter can provide the patient with an indication of how much liquid drug104has been delivered. In various embodiments, the counter can be coupled to the dosing wheel602mechanically. For example, the counter can be coupled to a gear system of the dosing wheel602and/or can be arranged to be triggered by contact with the arms604as the arms604rotate. In various embodiments, the dosing wheel602can be coupled to a controller (not shown inFIG. 6) that can track the rotational movement of the dosing wheel602and can provide an indication of the filling status of the drug container102to the patient.

In various embodiments, the drug delivery system600can be housed within a device (e.g., the drug delivery device500) having a window608(shown in phantom). The window608can enable a user to view a portion of the dosing wheel602, a portion of the drug container102, and/or a position of the plunger106within the drug container102. In various embodiments, the window608can be positioned over a portion of the dosing wheel602to allow the patient to view the rotation of the arms604. In various embodiments, the arms604of the dosing wheel602can be differently colored (e.g., color coded) or otherwise distinguished visually (e.g., by text or other symbols or markings) to indicate how far the dosing wheel602has rotated, thereby providing an indication of how far the plunger106has advanced into the drug container102.

FIG. 7illustrates an optical monitoring system700for determining the amount of liquid drug stored in a drug container. As shown inFIG. 7, the optical monitoring system700includes a printed circuit board (PCB)702, a drug container704, a plunger706, an attenuating light pipe708, a non-attenuating light pipe710, a light emitting source712, and a detector714.

The drug container704can be positioned adjacent to the PCB102and can store a liquid drug or other therapeutic agent. The plunger706can be positioned within the drug container704and can be used to expel the liquid drug from the drug container704. The plunger706can include a head portion716and a base or rod portion718. The rod718can extend out of the drug container704. A drive mechanism (not shown inFIG. 7) can drive the plunger706in a direction720to expel stored liquid drug from the drug container704for delivery to a patient. The plunger can include a reflective portion722such as, for example, a reflective O-ring. The reflective O-ring722can be positioned on the head portion716of the plunger706. The reflective portion722can reflect light that is incident on the plunger706.

The light emitting source712can be a light emitting diode (LED). The detector714can be a photodiode. The non-attenuating light pipe710can be positioned on top of the attenuating light pipe708. The attenuating light pipe708can be coupled to the light emitting source712. The light pipes708and710can be positioned adjacent to the drug container704. The attenuating light pipe708can be configured to emit light from the light emitting source712out of the attenuating light pipe708. The non-attenuating light pipe710can be configured to receive light reflected off the reflective portion722and to provide the received light to the detector714. In various embodiments, the attenuating light pipe708can be configured to emit light from the attenuating light pipe at a first angle and the non-attenuating light pipe710can be configured to receive light from a second angle that is orthogonal to the first angle. The first and second angles are not limited to being orthogonal to one another. In various embodiments, the first and second angles can be acute or obtuse to one another. In various embodiments, the first and second angles can be oriented to adjust the effective intensity of light energy received by the non-attenuating light pipe710.

The light emitting source712can emit light and provide emitted light into the attenuating light source708. Light provided to the attenuating light pipe708from the light emitting source712can then be emitted from the attenuating light pipe708. The attenuating light pipe708can be configured to attenuate the light it receives along the length of the attenuating light pipe708. Specifically, light emitted from the attenuating light pipe708that is further from the light emitting source712can be attenuated more than light emitted from the attenuating light pipe708that is closer to the light emitting source712. The non-attenuating light pipe710is not specifically configured to attenuate light within the non-attenuating light pipe710. The non-attenuating light pipe710can be coupled to the detector714such that light received by the non-attenuating light pipe710can be provided to the detector714.

A reflector724can be positioned between the attenuating light pipe708and the non-attenuating light pipe710. In various embodiments, the reflector724can be positioned over a top surface of the attenuating light pipe708and below a button surface of the non-attenuating light pipe710. The reflector724can prevent light from passing between the attenuating light pipe708and the non-attenuating light pipe710(e.g., directly passing). The reflector714can be a film or painted component positioned between the attenuating light pipe708and the non-attenuating light pipe710or provided on a surface of one of the attenuating light pipe708and the non-attenuating light pipe710.

The light emitting source712can provide a stable source of light to the attenuating light pipe708. The light provided to the attenuating light pipe708can be emitted from the attenuating light pipe708along the length of the attenuating light pipe708. The emitted light can illuminate the internal portion of the drug container704and the plunger706. A portion of the light that enters the drug container704from the attenuating light pipe708can be reflected by the reflective portion722. This reflected light can then be received by the non-attenuating light pipe710. The light received by the non-attenuating light pipe710can then be provided to the detector714.

The detector714can determine an intensity of the light received or provided to the detector714. The detector714can generate a signal based on the intensity of light received. As the plunger706moves along the length of the drug container704, light of different intensities will be reflected off of the reflective portion722of the plunger706. In general, the intensity of the reflected light can vary linearly with the movement of the plunger706based on the characteristics of the attenuating light pipe708. The detector714can detect the changing intensity of the received light that is reflected off the reflective portion722. Based on the intensity of the received light, the detector714can determine a position of the reflective portion722and therefore the plunger706within the drug container704. In turn, a determination of how much liquid drug remains in the drug container can be made. Further, the measured signals from the detector714can be used to determine a rate of movement of the plunger706. Depending on the movement of the plunger706relative to the light emitting source712, the intensity of the light detected by the detector714can increase or decrease as the plunger706advances further into the drug container704.

As shown inFIG. 7, the optical monitoring system700is arranged to provide relatively lower attenuated light to the detector714when the plunger706is positioned closer to the light source712(and to provide relatively higher attenuated light to the detector714when the plunger706is positioned closer to the detector714). As a result, the intensity of the light provided to the detector714will increase as the plunger706is advanced to expel additional liquid drug from the drug container704. The optical monitoring system700is not limited to this arrangement. In various embodiments, the optical monitoring system700can be arranged such that the intensity of the light provided to the detector714will decrease as the plunger706is advanced to expel additional liquid drug from the drug container704. Overall, the optical monitoring system700can be arranged to provide light to the detector714that varies in intensity based on movement of the plunger706(e.g., advancement of the plunger706to expel the liquid drug). A controller (not shown inFIG. 7) coupled to the detector714can detect a position of the plunger706based on the signals generated by the detector714that indicate the intensity of light received by the detector714.

The optical monitoring system700can be used with any drug container storing a liquid drug that is expelled by any linear translating component having a reflective portion. For example, the drug container102and the plunger106can be used in the optical monitoring system700. Further, any portion of the plunger706can be reflective including any component coupled to the plunger706that moves with the plunger706to expel a stored liquid drug. The drug container704used with the optical monitoring system can be a transparent container (or a portion thereof can be transparent).

The optical monitoring system700can use any type of radiation emitting/detecting pair such as, for example, an infrared, a visible light, or an ultraviolet source of radiation and corresponding detector. The optical monitoring system700can include a controller (not shown inFIG. 7) that can be coupled to the light emitting source712and the detector714. The controller can be configured to control operation of the light emitting source712and/or the detector714. Signals generated by the detector—for example, signals indicating a position of the plunger706based on a detected intensity of reflected light received—can be provided to the controller. The controller can subsequently determine a position and movement of the plunger706or any component of the drive system for operating the plunger706based on signals generated by the detector714. The controller can further determine how much liquid drug has been expelled and/or how much liquid drug remains in the drug container704.

FIG. 8illustrates an exemplary arrangement of the attenuating light pipe708and the non-attenuating light pipe710depicted inFIG. 7. As shown inFIG. 8, the attenuating light pipe708and the non-attenuating light pipe710can each include windows808for emitting light and receiving light, respectively. Certain windows808can be covered with an anti-reflective (e.g., non-transmissive) coating802such that no light is emitted or received through a window808coated with anti-reflective coating802.

For the attenuating light pipe708, the anti-reflective coating802can be placed on the windows808that are oriented at a first angle relative to the light emitted by the light emitting source712. As such, as shown inFIG. 8, light can only be passed through those windows808that are not covered by the anti-reflective coating802. The windows808of the attenuating light pipe708that can pass light can be oriented at a second angle that is orthogonal to the first angle as shown. Indicator804shows an exemplary direction of light that can be emitted or passed from the attenuating light pipe708.

For the non-attenuating light pipe710, the anti-reflective coating802can be placed on windows808that are orthogonal to the windows808of the attenuating light pipe708that are coated with the anti-reflective coating802as shown inFIG. 8. Accordingly, the non-attenuating light pipe710can receive light through windows808that are orthogonal to the windows808of the attenuating light pipe708that can emit light, but are not so limited. That is, the windows808of the attenuating light pipe708that emit light can be oriented according to any angle with respect to the windows808of the non-attenuating light pipe710. In various embodiments, the windows808for emitting and receiving light can be oriented at an obtuse or an acute angle with respect to one another. In general, the angle of orientation can be adjusted to provide a desired effective intensity for the light energy received by the non-attenuating light pipe710.

Indicator806shows an exemplary direction of light that can be received by the non-attenuating light pipe710. The arrangement of the windows808and the coated windows802of the attenuating light pipe708and the non-attenuating light pipe710can ensure that attenuated light emitted by the attenuating light pipe708is directed toward the detector714after it reflects off the plunger706. In particular, reflected light from the plunger706can pass through an uncoated window808of the non-attenuating light pipe710and then directed toward the detector714.

FIG. 9illustrates an exemplary arrangement of the attenuating light pipe708depicted inFIGS. 7 and 8. Emitted light902represents the light emitted from the light emitting source712and its intensity (e.g., as indicated by a size of the corresponding arrow representing the light). The emitted light902can travel down the attenuating light pipe708and can exit from windows808that are not covered with coating802. Emitted light904-1through904-5represents the light that passes through each corresponding window808and its intensity. The attenuating light pipe708can be configured to have an attenuation profile that attenuates the emitted light902more the further the light is from the light emitting source712(e.g., compare the relatively higher intensity of the emitted light904-1to the relatively lower intensity emitted light904-5). Accordingly, the intensity of the light that is emitted from the windows808that are closer to the light emitting source712—such as, emitted light904-1—can be greater than the intensity of the light that is emitted from the windows808that are further from the light emitting source712—such as, emitted light904-5.

The different levels of intensities of the emitted light904-1through904-5can be reflected off the reflective portion722of the plunger706as the plunger706advances into the drug container704and moves along the length of the attenuating light pipe708as described above. As such, the intensity of the light received by the detector714can change (e.g., increase or decrease as the plunger706moves further into the drug container704depending upon the arrangement of the components of the optical monitoring system700). The varying intensity of the light received by the detector714can be used to determine a position of the plunger706. For example, the emitted light904-1, when reflected off of the reflective portion722and then received by the non-attenuating light pipe710and the detector714, can indicate a first position of the plunger706. Correspondingly, emitted light904-5, when reflected off of the reflective portion722and then received by the non-attenuating light pipe710and the detector714, can indicate a second, different position of the plunger706. In various embodiments, the detector714can generate a signal indicative of the intensity of the received light. The signal can be provided to the controller that can then use the signal to determine a position and/or movement of the plunger706. The fill status of the drug container704(e.g., how much liquid drug remains in the drug container704or has been expelled) can then be determined.

The attenuating light pipe708can be configured to have any attenuation profile. In various embodiments, the attenuating light pipe708can be configured to have a linear attenuation profile. The attenuating light pipe708can be formed of a material having a homogenous attenuation profile that can scatter and/or absorb light to cause attenuation. In general, as light travels further into the attenuation light pipe708, more attenuation is provided, thereby causing larger decreases in intensity in the light as it travels further into the attenuating light pipe708(e.g., further away from the light source712). The attenuating light pipe708can be made from various types of materials including plastics and can be covered with an attenuation coating or other material. In various embodiments, the attenuating light pipe708can be formed from polymethylmethacrylate (PMMA).

FIG. 10illustrates an exemplary operation of the optical monitoring system700. As shown inFIG. 10, the attenuating light pipe708is positioned on top of the non-attenuating light pipe710. The reflector724is positioned between the attenuating light pipe708and the non-attenuating light pipe710. A light beam1002is shown entering the attenuating light pipe708. The light beam1002can be provided by the light emitting source712depicted inFIG. 7. The light beam1002can travel along the attenuating light pipe708and can exit as an attenuated version of the light beam1002from any of the windows808that are not coated windows802. For example, the light beam1002can exit a first window1020along the attenuated light pipe708as a first exit light beam1004. The first exit light beam1004can be an attenuated version of the light beam1002. The first exit light beam1004can be attenuated by a first amount relative to the intensity of the light beam1002.

The light beam1002can further exit a second window1022along the attenuated light pipe708as a second exit light beam1012. The second exit light beam1012can be also be an attenuated version of the light beam1002. Indicator1024can specify a direction of increasing attenuation by the attenuating light pipe708. Specifically, the attenuating light pipe708, as described herein, can attenuate the light beam1002more further along the length of the attenuating light pipe708relative to an entry point of the light beam1002. Accordingly, the first exit light beam1004can be attenuated less than the second exit light beam1012. For purposes of explanation, the first exit light beam1004is shown to be wider than the second exit light beam1012to represent that the second exit light beam1012is more attenuated than the first exit light beam1004. The second exit light beam1012can be attenuated by a second amount relative to the intensity of the light beam1002.

Object1006can represent a first position of the plunger706(and/or a position of any reflective portion of the plunger706). As shown inFIG. 10, the first exit light beam1004is reflected off the object1006as a first reflective light beam1008. The first reflective light beam1008can pass through any of the windows808of the non-attenuating light pipe710that are not coated windows802. The first reflective light beam1008can then travel through the non-attenuating light pipe710and can be provided to the detector714depicted inFIG. 7.

Indicator1010represents a travel path of the plunger706. As shown inFIG. 10, the travel path1010of the plunger706can be substantially parallel to the arrangement of the attenuating and non-attenuating light pipes708and710. Object1014can represent a second position of the plunger706(and/or a position of any reflective portion of the plunger706). As shown inFIG. 10, the second exit light beam1012is reflected off the object1014as a second reflective light beam1016. The second reflective light beam1016can pass through any of the windows808of the non-attenuating light pipe710that are not coated windows802. The second reflective light beam1016can then travel through the non-attenuating light pipe710and can be provided to the detector714depicted inFIG. 7.

Light beam1018can represent light that exits the non-attenuating light pipe710and is provided to the detector714. The light beam1018can be an attenuated version of the light beam1002. The level of attenuation experienced by the light beam1018can be substantially based on the level of attenuation experienced by the initial light beam1002from the attenuating light pipe708, which is then reflected by the plunger706. For example, the light beam1018will experience less attenuation and will be more intense if the plunger706is positioned closer to a first end1024of the attenuating light pipe708in comparison to when the plunger706is positioned closer to a second end1026of the attenuating light pipe708. That is, when the position of the plunger706can be represented by the object1006, the intensity of the light beam1018will be relatively larger (e.g., due to relatively lower experienced attenuation) since the first reflective light beam1008is reflected off of the plunger706. When the position of the plunger706can be represented by the object1014, the intensity of the light beam1018will be relatively smaller (e.g., due to relatively higher experienced attenuation) since the second reflective light beam1016is reflected off the plunger706.

The detector714can detect the light beam1018. As described herein, the detector714can measure an intensity of the light beam1018. For example, the detector714can generate a signal based on the measured intensity of the light beam1018. Signals generated by the detector714can be provided to a controller (not shown inFIG. 10). The controller can determine a position of the plunger706within the drug container704based on the signal provided to the controller by the detector714. For example, the controller can determine the plunger706is positioned closer to the first end1024of the attenuating light pipe708when the detector714generates a signal in response to a relatively more intense light beam1018. The controller can determine the plunger706is positioned closer to the second end1026of the attenuating light pipe708when the detector714generates a signal in response to a relatively less intense light beam1018. The position of the plunger706relative to the drug container704can therefore be determined, enabling a determination of how much liquid drug remains in the drug container or how much liquid drug has been expelled from the drug container704. Further determinations such as a rate of movement of the plunger706can also be determined.

FIG. 11illustrates an exemplary monitoring system1100. The monitoring system1100can include a drug container1102. A portion of the drug container1102is shown inFIG. 11. The drug container1102can hold or store a liquid drug1104. The monitoring system1100can further include a plunger1106positioned in the drug container1102. The plunger1106can be moved or advanced to expel the liquid drug1104from the drug container1102. The drug container1102can represent the drug container102. The plunger1106can be moved to expel the liquid drug1104out of either end of the drug container1102as will be appreciated by a person having ordinary skill in the art, for example as described above in relation toFIG. 2.

As shown inFIG. 11, the monitoring system1100can also include a number of pins1108. The pins1108can be positioned within the drug container1102. The pins1108can be molded into the drug container1102. The pins1108can be made from a conductive material such as a metal. The pins1108can be positioned and shaped so as to be flush (aligned) or approximately flush with an inner or interior surface of the drug container1102. The pins can also be positioned and shaped so as to be flush (aligned) or approximately flush with an outer or outside surface of the drug container1102.

As shown inFIG. 11, seven (7) pins1108are shown as inserted molded into the drug container1102—pins1108-1through1108-7. Any number of pins1108can be positioned in the drug container1102and can be arranged in any manner. The liquid drug1104stored in the drug container1102can provide electrical conductivity between the pins1108. A controller and/or other circuitry coupled to the pins1108(not shown inFIG. 11for simplicity) can monitor the electrical connectivity of the pins1108relative to one another and/or the liquid drug1106. As the plunger1106is moved to expel the liquid drug1104from the drug container1102, a portion of the pins1108can become electrically decoupled from the other pins1108and/or the liquid drug1104. The controller can monitor the changing status of the electrical connectivity of the pins1108to determine a position and/or movement of the plunger1106. In this way, the monitoring system1100can determine a fill status of the drug container1102and/or other information regarding dosing rate, an amount of the liquid drug1104expelled from the drug container1102, and/or a rate of movement of the plunger1106. As shown inFIG. 11, all of the pins1108-1through1108-7can be electrically coupled to one another as each pin1108is coupled to the liquid drug1104.

FIG. 12illustrates the monitoring system1100after a portion of the liquid drug1104has been expelled from the drug container1102. As shown inFIG. 12, the plunger1106has moved past the pins1108-1through1108-3and is positioned adjacent to the pin1108-4. The pins1108-1through1108-4are no longer coupled to the liquid drug1104. Consequently, the pins1108-1through1108-4are no longer electrically connected or coupled to any other pin1108. The controller coupled to the pins1108can determine which pins1108are electrically coupled together (e.g., and/or coupled to the liquid drug1104) and can determine a position of the plunger1104. For example, as shown inFIG. 12, the controller can determine that a front surface of the plunger1106(e.g., a surface of the plunger in contact with the liquid drug1104) can be positioned between the pin1108-4and the pin1108-5. The controller can also determine that pins1108-5through1108-7are electrically connected and coupled to the liquid drug1104. Accordingly, the monitoring system1100allows an approximate position of the plunger1106to be determined. In turn, the monitoring system110can determine how much of the liquid drug1104remains in the drug container1102and how much liquid drug1104has been expelled from the drug container1102.

As mentioned above, the monitoring system1100can use number of pins1108. The pins1108can be spaced apart from one another by a fixed distance but are not so limited. As will be appreciated by a person of ordinary skill in the art, the monitoring system1100can use more pins1108to provide a better or more accurate approximation as to the location of the plunger1106within the drug container (and therefore a better or more accurate approximation of the fill status of the drug container1102).

FIG. 13illustrates a second exemplary monitoring system1300. The monitoring system1300can include a drug container1302. The drug container1302can hold or store a liquid drug1306. The monitoring system1300can further include a plunger1304positioned in the drug container1302. The plunger1304can be moved or advanced to expel the liquid drug1306from the drug container1302. The drug container1302can represent the drug container102. The plunger1304can be moved to expel the liquid drug1306out of the drug container1302through a fluid path1308(e.g., by moving toward the fluid path1308). As will be appreciated by a person of ordinary skill in the art, the plunger1302and the fluid path1308can be arranged to enable the liquid drug1306to be expelled through the plunger1304(e.g., through an opposite end of the drug container1302from what is shown inFIG. 13), for example as described above in relation toFIG. 2.

As shown inFIG. 13, the monitoring system1300can further include a first conductive component or trace1310, a second conductive component or trace1312, a third conductive component or trace1314, a first conductive pin1316, a second conductive pin1318, and a third conductive pin1320. The traces1310,1312, and1314and the pins1316,1318, and1320can be formed of an electrically conductive material. A conductive ring or wiper1322can be positioned around the plunger1034. The ring1322can be formed of an electrically conductive material.

The first trace1310can be coupled to the pin1318. The first trace1310can be positioned inside of the drug container1302. The first trace1310can be coupled to an inner surface of the drug container1302. The first trace1310can extend along a substantial portion of a longitudinal length of the drug container1302.

The second trace1312can be coupled between the pin1318and the pin1316. The second trace can also be coupled to the inner surface of the drug container1302. The second trace can also extend along a substantial portion of the longitudinal length of the drug container1302. The second trace1312can be formed of a material having an increasing resistance (e.g., a linearly increasing resistance).

The third trace1314can be coupled to the pin1316and the pin1320. The third trace1314can be positioned outside of the drug container1302. The third trace1314can be coupled to an outer surface of the drug container1302. The third trace1314can extend along a substantial portion of the longitudinal length of the drug container1302.

A portion of the pin1318can extend into the drug container1302and a portion of the pin1318can extend outside of the drug container1302. A portion of the pin1316can also extend into the drug container1302and a portion of the pin1316can also extend outside of the drug container1302. The pin1320can be positioned on the outside of the drug container1302. The portions of the pins1318and1316that extend into the drug container102and the traces1310and1312can be in contact with the liquid drug1306stored in the drug container1302. The trace1314and the pin1320can be positioned so as to not be in contact with the liquid drug1306.

The pins1318and1320can be coupled to one or more output circuits and/or a controller (not shown inFIG. 13for simplicity). The traces1310,1312, and1314, and the pins1316,1318, and1320can form a variable resistive network. The variable resistive network can be used to determine a position of the plunger1306within the drug container1302, enabling a fill status of the drug container1302to be determined. As the plunger1304moves from an initial position (e.g., at or near a far end of the drug container1302) toward the fluid path1308, the ring1322electrically couples (e.g., shorts) the trace1310to the trace1312along different corresponding portions of the traces1310and1312. Coupling the trace1310to the trace1312completes a circuit. Based on the variable resistivity of the trace1312, the coupling of the trace1310to the trace1312completes a circuit having different resistance values based on the location of the plunger1304.

For example, when the ring1322couples the trace1310to the trace1312at a far end of the drug container1302(e.g., in close proximity to the pin1316), the completed circuit can have a relatively lower resistance, as only a relatively small portion of the trace1312is included in the completed circuit (due to the shorting of the traces1310and1312by the ring1322). When the ring1322couples the trace1310to the trace1312at a near end of the drug container1302(e.g., in closer proximity to the fluid path1308and/or the pin1318), the completed circuit can have a relatively higher resistance, as a relatively larger portion of the trace1312is included in the completed circuit. Inclusion of a larger portion of the trace1312in the completed circuit results in the completed circuit having relatively higher resistance values, such that movement of the plunger1304can result in completed circuits of increasing resistance (e.g., linearly increasing resistance). The completed circuit—referenced to the pins1318and1320—can be provided or coupled to the controller or other output circuits. Based on the variable resistance of the completed circuit, the controller can determine a position of the plunger1304and therefore a fill status of the drug container1302.

FIG. 14illustrates a top view of the monitoring system1300depicted inFIG. 13. The arrangement of the traces1310,1312, and1314along the length of the drug container1302is shown. Further, the electrical coupling of the trace1310and the trace1312by the ring1322is illustrated. The circuit completed by the ring1322includes larger portions of the trace1312as the plunger1304moves closer to the fluid path1308. Accordingly, a controller coupled to the output pins1318and1320can determine the position of the plunger1304based on the variable (e.g., increasing) resistance of the completed circuit.

FIG. 15illustrates a portion of the monitoring system1300. Specifically,FIG. 15illustrates the traces1310,1312, and1314and the pins1316,1318, and1320. These components can be considered to form a variable resistive network as described above (or a portion of a potentiometer as will be appreciated by a person of ordinary skill in the art). The trace1312is shown to have a zigzag shape but is not so limited. In various embodiments, the trace1312can be a form a substantially straight trace.

As described herein, systems and methods for monitoring an operational state and/or fill status of a drug container have been provided. Each of the monitoring systems described herein can be combined with any other described monitoring system. The described monitoring systems can be coupled to a user interface device. For example, a controller of the monitoring systems can be coupled to a remote user interface device (e.g., a mobile device) and can provide a patient or user with notifications regarding a fill status of a drug container. In various embodiments, the notification can alert a user to an amount of liquid drug expelled and/or remaining. In various embodiments, the notification can alert a user to when a desired dose of liquid drug has been provided to a patient and/or when the drug container is empty. In various embodiments, the notification can indicate a dosing rate or flow rate of the liquid drug being delivered to the patient. Notifications to the patient can include audible notifications, visual notifications, and/or vibrational notifications. In various embodiments, any described controller can be considered to be a part of any of the described sensors or can be considered to be a separate component of the monitoring systems described herein. In various embodiments, the monitoring systems can associate plunger position with a time stamp such that flow rates, dosing rate, and/or a dosing profile for delivery of a liquid drug to the patient can be determined. In various embodiments, the monitoring systems described herein can be implemented in a wearable drug delivery device.

The following examples pertain to further embodiments:

Example 1 is an apparatus comprising a drug container configured to hold a liquid drug, a plunger positioned in the drug container, a drive system coupled to the plunger, the drive system configured to advance the plunger to expel a portion of the liquid drug from the drug container for delivery to a patient, and one or more sensors positioned adjacent to the drug container, the one or more sensors configured to detect a position of the plunger within the drug container.

Example 2 is an extension of Example 1 or any other example disclosed herein, further comprising a controller coupled to the one or more sensors.

Example 3 is an extension of Example 2 or any other example disclosed herein, wherein the controller is configured to determine an amount of the liquid drug remaining in the drug container based on the detected position of the plunger.

Example 4 is an extension of Example 2 or any other example disclosed herein, wherein the controller is configured to determine the portion of the liquid drug expelled from the drug container based on the detected position of the plunger.

Example 5 is an extension of Example 2 or any other example disclosed herein, wherein the controller is configured to determine a dosing rate of the portion of the liquid drug expelled from the drug container based on the detected position of the plunger.

Example 6 is an extension of Example 2 or any other example disclosed herein, wherein the controller is configured to determine when a desired dose of the liquid drug has been provided to the patient based on the detected position of the plunger.

Example 7 is an extension of Example 2 or any other example disclosed herein, wherein the controller is configured to provide a notification to the patient indicating a fill status of the drug container based on the detected position of the plunger.

Example 8 is an extension of Example 7 or any other example disclosed herein, wherein the notification indicates a desired dose of the liquid drug has been provided to the patient.

Example 9 is an extension of Example 7 or any other example disclosed herein, wherein the notification comprises at least one of an audible notification, a visual notification, and a vibrational notification.

Example 10 is an extension of Example 2 or any other example disclosed herein, wherein the one or more sensors are configured to detect a position of a component of the drive system within the drug container.

Example 11 is an extension of Example 10 or any other example disclosed herein, wherein the component of the drive system comprises one or more spherical elements.

Example 12 is an extension of Example 11 or any other example disclosed herein, wherein the component of the drive system comprises a drive spring.

Example 13 is an extension of Example 12 or any other example disclosed herein, wherein each of the one or more sensors comprise a Hall effect sensor.

Example 14 is an extension of Example 13 or any other example disclosed herein, wherein each Hall effect sensor is configured to count a number of spherical elements that pass the Hall effect sensor.

Example 15 is an extension of Example 13 or any other example disclosed herein, wherein the one or more Hall effect sensors detect an end of a stroke of the plunger.

Example 16 is an extension of Example 13 or any other example disclosed herein, wherein a first Hall effect sensor is positioned adjacent to a first end of the drug container and a second Hall effect sensor is positioned adjacent to a second, opposite end of the drug container.

Example 17 is an extension of Example 12 or any other example disclosed herein, wherein each of the one or more sensors comprise an optical sensor.

Example 18 is an extension of Example 17 or any other example disclosed herein, further comprising one or more light sources, each light source corresponding to one of the one or more optical sensors.

Example 19 is an extension of Example 18 or any other example disclosed herein, wherein each light source is configured to emit light toward the corresponding optical sensor and wherein each optical sensor is configured to receive the corresponding light.

Example 20 is an extension of Example 19 or any other example disclosed herein, wherein each optical sensor is configured to detect when at least one of the plunger and the spherical elements interrupts reception of the corresponding light beam.

Example 21 is a method comprising positioning a plunger in a drug container holding a liquid drug, advancing the plunger further into the drug container using a drive system to expel the liquid drug from the drug container, delivering the expelled liquid drug to a patient, and detecting a position of the plunger within the drug container using one or more sensors positioned adjacent to the drug container.

Example 22 is an extension of Example 21 or any other example disclosed herein, further comprising determining an amount of the liquid drug remaining in the drug container based on the detected position of the plunger.

Example 23 is an extension of Example 21 or any other example disclosed herein, further comprising determining an amount of the liquid drug expelled from the drug container based on the detected position of the plunger.

Example 24 is an extension of Example 21 or any other example disclosed herein, further comprising determining a dosing rate of the liquid drug expelled from the drug container based on the detected position of the plunger.

Example 25 is an extension of Example 21 or any other example disclosed herein, further comprising determining when a desired dose of the liquid drug has been provided to the patient based on the detected position of the plunger.

Example 26 is an extension of Example 21 or any other example disclosed herein, further comprising providing a notification to the patient indicating a fill status of the drug container based on the detected position of the plunger.

Example 27 is an extension of Example 26 or any other example disclosed herein, wherein the notification indicates a desired dose of the liquid drug has been provided to the patient.

Example 28 is an extension of Example 26 or any other example disclosed herein, wherein the notification comprises at least one of an audible notification, a visual notification, or a vibrational notification.

Example 29 is an extension of Example 21 or any other example disclosed herein, further comprising detecting a position of a component of the drive system within the drug container.

Example 30 is an extension of Example 29 or any other example disclosed herein, further comprising detecting the position of the plunger or the component of the drive system based on measuring a varying magnetic field, wherein each of the one or more sensors are Hall effect sensors.

Example 31 is an extension of Example 21 or any other example disclosed herein, further comprising detecting the position of the plunger or the component of the drive system based on detecting an interruption in receiving an emitted light, wherein each of the one or more sensors are optical sensors.

The following examples pertain to further additional embodiments:

Example 1 is an apparatus comprising a drug container configured to hold a liquid drug, a plunger positioned in the drug container, a needle conduit coupled to the plunger, a drive system coupled to the plunger, the drive system configured to advance the plunger to expel a portion of the liquid drug from the drug container through the needle conduit for delivery to a patient, and one or more sensors coupled to the needle conduit and configured to detect a position of the plunger within the drug container based on corresponding advancement of the needle conduit.

Example 2 is an extension of Example 1 or any other example disclosed herein, wherein the needle conduit comprises one or more conductive regions and one or more non-conductive regions.

Example 3 is an extension of Example 2 or any other example disclosed herein, wherein the one or more conductive regions and the one or more non-conductive regions are arranged in a predetermined manner.

Example 4 is an extension of Example 3 or any other example disclosed herein, wherein each of the one or more conductive regions are of a predetermined size.

Example 5 is an extension of Example 3 or any other example disclosed herein, wherein each of the one or more non-conductive regions are of a predetermined size.

Example 6 is an extension of Example 3 or any other example disclosed herein, wherein each of the one or more sensors are electrical sensors.

Example 7 is an extension of Example 6 or any other example disclosed herein, wherein the one or more sensors detect the one or more conductive regions and the one or more non-conductive regions of the needle conduit as the needle conduit advances in response to advancement of the plunger by the drive system.

Example 8 is an extension of Example 7 or any other example disclosed herein, further comprising a controller coupled to the one or more electrical sensors.

Example 9 is an extension of Example 8 or any other example disclosed herein, wherein the controller is configured to determine the position of the plunger based on electrical signals provided by the one or more electrical sensors.

Example 10 is an extension of Example 9 or any other example disclosed herein, wherein the controller is configured to determine an amount of the liquid drug remaining in the drug container based on the detected position of the plunger.

Example 11 is an extension of Example 9 or any other example disclosed herein, wherein the controller is configured to determine the portion of the liquid drug expelled from the drug container based on the detected position of the plunger.

Example 12 is an extension of Example 9 or any other example disclosed herein, wherein the controller is configured to determine a dosing rate of the liquid drug expelled from the drug container based on the detected position of the plunger.

Example 13 is an extension of Example 9 or any other example disclosed herein, wherein the controller is configured to determine when a desired dose of the liquid drug has been provided to the patient based on the detected position of the plunger.

Example 14 is a method comprising positioning a plunger in a drug container configured to hold a liquid drug, advancing the plunger further into the drug container to expel the liquid drug from the drug container through a needle conduit coupled to the plunger, delivering the expelled liquid drug to a patient, and determining a position of the plunger using one or more sensors coupled to the needle conduit.

Example 15 is an extension of Example 14 or any other example disclosed herein, further comprising determining an amount of the liquid drug remaining in the drug container based on the detected position of the plunger.

Example 16 is an extension of Example 14 or any other example disclosed herein, further comprising determining an amount of the liquid drug expelled from the drug container based on the detected position of the plunger.

Example 17 is an extension of Example 14 or any other example disclosed herein, further comprising determining a dosing rate of the liquid drug based on the detected position of the plunger.

Example 18 is an extension of Example 14 or any other example disclosed herein, further comprising determining when a desired dose of the liquid drug has been provided to the patient based on the detected position of the plunger.

Example 19 is an extension of Example 14 or any other example disclosed herein, further comprising providing a notification to the patient indicating the detected position of the plunger.

Example 20 is an extension of Example 19 or any other example disclosed herein, wherein the notification indicates a desired dose of the liquid drug has been provided to the patient.

Example 21 is an extension of Example 14 or any other example disclosed herein, further comprising detecting one or more conductive regions of the needle conduit using the one or more sensors.

Example 22 is an extension of Example 21 or any other example disclosed herein, further comprising detecting one or more non-conductive regions of the needle conduit using the one or more sensors.

Example 23 is an extension of Example 22 or any other example disclosed herein, wherein determining the position of the plunger comprises detecting the one or more conductive regions of the needle conduit and detecting the one or more non-conductive regions of the needle conduit.

Example 24 is an extension of Example 22 or any other example disclosed herein, wherein the one or more sensors are electrical sensors.

The following examples pertain to further additional embodiments:

Example 1 is an apparatus comprising a drug container configured to store a liquid drug, a plunger positioned in the drug container, a drive system coupled to the plunger, the drive system configured to advance the plunger to expel a portion of the liquid drug from the drug container for delivery to a patient, and an optical monitoring system configured to determine a position of the plunger within the drug container.

Example 2 is an extension of Example 1 or any other example disclosed herein, wherein the optical monitoring system is configured to determine a fill status of the drug container based on the determined position of the plunger.

Example 3 is an extension of Example 2 or any other example disclosed herein, wherein a portion of the drug container is transparent.

Example 4 is an extension of Example 3 or any other example disclosed herein, wherein the plunger comprises a reflective portion.

Example 5 is an extension of Example 4 or any other example disclosed herein, wherein the reflective portion is a reflective O-ring.

Example 6 is an extension of Example 5 or any other example disclosed herein, wherein the reflective O-ring is positioned on a head of the plunger.

Example 7 is an extension of Example 4 or any other example disclosed herein, wherein the optical monitoring system comprises a light source.

Example 8 is an extension of Example 7 or any other example disclosed herein, wherein the light source is a light emitting diode (LED).

Example 9 is an extension of Example 7 or any other example disclosed herein, wherein the optical monitoring system comprises an attenuating light pipe coupled to the light source.

Example 10 is an extension of Example 9 or any other example disclosed herein, wherein the optical monitoring system comprises a non-attenuating light pipe.

Example 11 is an extension of Example 10 or any other example disclosed herein, wherein the optical monitoring system comprises a detector coupled to the non-attenuating light pipe.

Example 12 is an extension of Example 11 or any other example disclosed herein, wherein the detector is a photodiode.

Example 13 is an extension of Example 11 or any other example disclosed herein, wherein the attenuating light pipe is positioned over the non-attenuating light pipe.

Example 14 is an extension of Example 13 or any other example disclosed herein, wherein the attenuating light pipe and the non-attenuating light pipe are positioned adjacent to the drug container.

Example 15 is an extension of Example 14 or any other example disclosed herein, wherein a reflective component is positioned between the attenuating light pipe and the non-attenuating light pipe.

Example 16 is an extension of Example 15 or any other example disclosed herein, wherein the attenuating light pipe is configured to attenuate light emitted by the light source.

Example 17 is an extension of Example 16 or any other example disclosed herein, wherein the attenuating light pipe is configured to attenuate the light emitted by the light source according to an attenuation profile.

Example 18 is an extension of Example 17 or any other example disclosed herein, wherein the attenuation profile is linear.

Example 19 is an extension of Example 17 or any other example disclosed herein, wherein the attenuating light pipe is configured to emit an attenuated version of the light emitted by the light source.

Example 20 is an extension of Example 19 or any other example disclosed herein, wherein the light emitted by the attenuating light pipe is attenuated based on a distance traveled by the light emitted by the light source through the attenuating light pipe.

Example 21 is an extension of Example 19 or any other example disclosed herein, wherein the light emitted by the attenuating light pipe is reflected off of the reflective portion of the plunger.

Example 22 is an extension of Example 21 or any other example disclosed herein, wherein the non-attenuating light pipe receives light reflected off of the reflective portion of the plunger.

Example 23 is an extension of Example 22 or any other example disclosed herein, wherein the received light is provided to the detector.

Example 24 is an extension of Example 23 or any other example disclosed herein, wherein the detector generates a signal based on the received light.

Example 25 is an extension of Example 24 or any other example disclosed herein, wherein the signal indicates an amount of attenuation of the light emitted by the light source.

Example 26 is an extension of Example 25 or any other example disclosed herein, wherein the signal is provided to a controller coupled to the detector.

Example 27 is an extension of Example 25 or any other example disclosed herein, wherein the controller determines the position of the plunger based on the signal.

Example 28 is a method, comprising providing light from a light source to an attenuating light pipe, attenuating the light according to an attenuation profile of the attenuating light pipe, emitting the attenuated light from the attenuating light pipe, reflecting the attenuated light from a reflective portion of a plunger positioned in a drug container configured to hold a liquid drug, and providing the reflected attenuated light to a detector.

Example 29 is an extension of Example 28 or any other example disclosed herein, further comprising receiving the reflected attenuated light in a non-attenuating light pipe.

Example 30 is an extension of Example 29 or any other example disclosed herein, further comprising generating a signal based on the reflected attenuated light.

Example 31 is an extension of Example 30 or any other example disclosed herein, further comprising indicating an amount of attenuation of the light provided to the attenuating light pipe in the generated signal.

Example 32 is an extension of Example 31 or any other example disclosed herein, further comprising providing the generated signal to a controller.

Example 33 is an extension of Example 32 or any other example disclosed herein, further comprising determining a relative position of the plunger in the drug container based on the generated signal.

Example 34 is an extension of Example 33 or any other example disclosed herein, further comprising determining an amount of the liquid drug expelled from the drug container based on the determined position of the plunger.

Example 35 is an extension of Example 33 or any other example disclosed herein, further comprising determining an amount of the liquid drug remaining in the drug container based on the determined position of the plunger.

Example 36 is an extension of Example 33 or any other example disclosed herein, further comprising determining when a desired dosage of the liquid drug is provided to a patient based on the determined position of the plunger.

Example 37 is an extension of Example 33 or any other example disclosed herein, further comprising notifying the patient of the determined position of the plunger.

Example 38 is an extension of Example 37 or any other example disclosed herein, further comprising notifying the patient by at least one of a visual indication, an audible indication, and a vibrational indication.

The following examples pertain to further additional embodiments:

Example 1 is an apparatus comprising a drug container configured to hold a liquid drug, a plunger positioned in the drug container, a drive system coupled to the plunger, the drive system configured to advance the plunger to expel a portion of the liquid drug from the drug container for delivery to a patient, a plurality of conductive pins positioned in the drug container, and a controller electrically coupled to each of the plurality of conductive pins.

Example 2 is an extension of Example 1 or any other example disclosed herein, wherein an inner surface of the drug container is aligned with a first end surface of each conductive pin.

Example 3 is an extension of Example 2 or any other example disclosed herein, wherein the first end surface of each conductive pin is disposed in an interior of the drug container.

Example 4 is an extension of Example 2 or any other example disclosed herein, wherein an outer surface of the drug container is aligned with a second end surface of each conductive pin.

Example 5 is an extension of Example 4 or any other example disclosed herein, wherein the second end surface of each conductive pin is disposed in an exterior of the drug container.

Example 6 is an extension of Example 4 or any other example disclosed herein, wherein the second end surface of each conductive pin is electrically coupled to the controller.

Example 7 is an extension of Example 1 or any other example disclosed herein, wherein the plurality of conductive pins are positioned through the drug container.

Example 8 is an extension of Example 1 or any other example disclosed herein, wherein the controller is configured to monitor an electrical connectivity of each of the plurality of conductive pins.

Example 9 is an extension of Example 8 or any other example disclosed herein, wherein the controller is configured to monitor an electrical connectivity of each of the plurality of conductive pins relative to one another.

Example 10 is an extension of Example 8 or any other example disclosed herein, wherein the controller is configured to monitor an electrical connectivity of each of the plurality of conductive pins relative to the liquid drug.

Example 11 is an extension of Example 8 or any other example disclosed herein, wherein the controller is configured to determine a position of the plunger within the drug container based on the monitored electrical connectivity of the plurality of conductive pins.

Example 12 is an extension of Example 11 or any other example disclosed herein, wherein the controller is configured to determine a fill status of the drug container based on the determined position of the plunger.

Example 13 is an extension of Example 1 or any other example disclosed herein, wherein the conductive pins are evenly spaced along the drug container.

Example 14 is a method comprising advancing a plunger positioned in a drug container holding a liquid drug to expel the liquid drug from the drug container, delivering the expelled liquid drug to a patient, and detecting an electrical connectivity between a plurality of conductive pins disposed in the drug container.

Example 15 is an extension of Example 14 or any other example disclosed herein, further comprising determining a position of the plunger within the drug container based on the determined electrical connectivity between the plurality of conductive pins.

The following examples pertain to further additional embodiments:

Example 1 is an apparatus comprising a drug container configured to hold a liquid drug, a plunger positioned in the drug container, a drive system coupled to the plunger, the drive system configured to advance the plunger to expel a portion of the liquid drug from the drug container for delivery to a patient, and a variable resistive circuit disposed on an inner surface of the drug container.

Example 2 is an extension of Example 1 or any other example disclosed herein, wherein the variable resistive circuit comprises a first conductive trace positioned on the inner surface of the drug container and coupled to a first conductive pin, a second conductive trace positioned on the inner surface of the drug container and coupled between the first conductive pin and a second conductive pin, and a conductive ring positioned around an outer surface of the plunger adjacent to the inner surface of the drug container, the conductive ring electrically coupling the first conductive trace to the second conductive trace at a first position corresponding to a position of the plunger within the drug container.

Example 3 is an extension of Example 3 or any other example disclosed herein, wherein the second conductive trace is configured to have a linearly increasing resistance.

Example 4 is an extension of Example 3 or any other example disclosed herein, wherein the first conductive pin comprises a first portion disposed inside of the drug container and a second portion disposed outside of the drug container.

Example 5 is an extension of Example 4 or any other example disclosed herein, wherein the second conductive pin comprises a first portion disposed inside of the drug container and a second portion disposed outside of the drug container.

Example 6 is an extension of Example 5 or any other example disclosed herein, wherein the second conductive pin is coupled to a third conductive trace positioned on an outer surface of the drug container.

Example 7 is an extension of Example 6 or any other example disclosed herein, wherein the third conductive trace is coupled to a third conductive pin disposed on the outer surface of the drug container.

Example 8 is an extension of Example 7 or any other example disclosed herein, wherein a controller is electrically coupled to the first and third conductive pins.

Example 9 is an extension of Example 8 or any other example disclosed herein, wherein the controller is configured to monitor a resistance of the variable resistance circuit.

Example 10 is an extension of Example 9 or any other example disclosed herein, wherein the resistance of the variable resistance circuit increases as the plunger is advanced from a first position to a second position to expel the portion of the liquid drug.

Example 11 is an extension of Example 10 or any other example disclosed herein, wherein the controller is configured to determine the position of the plunger based on the monitored resistance of the variable resistance circuit.

Example 12 is an extension of Example 11 or any other example disclosed herein, wherein the controller is configured to determine a fill status of the drug container based on the determined position of the plunger.

Example 13 is a method comprising advancing a plunger positioned in a drug container holding a liquid drug to expel the liquid drug from the drug container, delivering the expelled liquid drug to a patient, and monitoring a resistance of a variable resistance circuit disposed in the drug container to determine a position of the plunger within the drug container.

Example 14 is an extension of Example 13 or any other example disclosed herein, further comprising coupling a first conductive trace of to a second conductive trace to form the variable resistive circuit, the first and second conductive traces disposed on an inner surface of the drug container.

Example 15 is an extension of Example 14 or any other example disclosed herein, wherein coupling further comprises electrically coupling the first and second conductive traces together by a conductive ring positioned around the plunger.

Example 16 is an extension of Example 15 or any other example disclosed herein, further comprising measuring the resistance of the variable resistance circuit.

Example 17 is an extension of Example 16 or any other example disclosed herein, further comprising determining the position of the plunger based on the measured resistance.

Example 18 is an extension of Example 17 or any other example disclosed herein, further comprising determining a fill status of the drug container based on the position of the plunger.