Systems and methods for controlled drug delivery pumps

Power and control systems for a drug delivery device allow for the activation, control of, and communication with the drug delivery device. The power and control system allows for a delay between device activation, and optionally needle insertion, and commencing drug delivery. The delay may be for a predetermined time. In addition, the power and control system may communicate with one or more external sensors and devices. The inputs from the sensors and devices may automatically, or on demand, adjust the delivery parameters of the device. The power and control systems may control a drive system that delivers a fluid at a variable rate or profile, allowing for the delivery to be tailored to maximize the effectiveness of the treatment.

FIELD

The present invention relates to drug delivery pump devices. Particularly, the present invention relates to systems and sub-systems for drug delivery pumps that control drive mechanisms of the drug pump devices and provide time-controlled delivery of drug substances. The invention further relates to methods of operating such drug delivery pump devices.

BACKGROUND

Parenteral delivery of various drugs, i.e., delivery by means other than through the digestive track, has become a desired method of drug delivery for a number of reasons. This form of drug delivery by injection may enhance the effect of the substance being delivered and ensure that the unaltered medicine reaches its intended site at a significant concentration. Similarly, undesired side effects associated with other routes of delivery, such as systemic toxicity, can potentially be avoided through parenteral delivery. By bypassing the digestive system of a mammalian patient, one can avoid degradation of the active ingredients caused by the catalytic enzymes in the digestive tract and liver and ensure that a necessary amount of drug, at a desired concentration, reaches the targeted site.

Traditionally, manually operated syringes and injection pens have been employed for delivering parenteral drugs to a patient. More recently, parenteral delivery of liquid medicines into the body has been accomplished by administering bolus injections using a needle and reservoir, continuously by gravity driven dispensers, or via transdermal patch technologies. Bolus injections often imperfectly match the clinical needs of the patient, and usually require larger individual doses than are desired at the specific time they are given. Continuous delivery of medicine through gravity-feed systems compromises the patient's mobility and lifestyle, and limits the therapy to simplistic flow rates and profiles. Another form of drug delivery, transdermal patches, similarly has its restrictions. Transdermal patches often require specific molecular drug structures for efficacy, and the control of the drug administration through a transdermal patch is severely limited.

Ambulatory infusion pumps have been developed for delivering liquid medicaments to a patient. These infusion devices have the ability to offer sophisticated fluid delivery profiles accomplishing bolus requirements, continuous infusion and variable flow rate delivery. These infusion capabilities usually result in better efficacy of the drug and therapy and less toxicity to the patient's system. Currently available ambulatory infusion devices are expensive, difficult to program and prepare for infusion, and tend to be bulky, heavy and very fragile. Filling these devices can be difficult and require the patient to carry both the intended medication as well as filling accessories. The devices often require specialized care, maintenance, and cleaning to assure proper functionality and safety for their intended long-term use, and are not cost-effective for patients or healthcare providers.

As compared to syringes and injection pens, pump type delivery devices can be significantly more convenient to a patient, in that doses of the drug may be calculated and delivered automatically to a patient at any time during the day or night. Furthermore, when used in conjunction with metabolic sensors or monitors, pumps may be automatically controlled to provide appropriate doses of a fluidic medium at appropriate times of need, based on sensed or monitored metabolic levels. As a result, pump type delivery devices have become an important aspect of modern medical treatments of various types of medical conditions, such as diabetes, and the like.

While pump type delivery systems have been utilized to solve a number of patient needs, manually operated syringes and injection pens often remain a preferred choice for drug delivery as they now provide integrated safety features and can easily be read to identify the status of drug delivery and the end of dose dispensing. However, manually operated syringes and injection pens are not universally applicable and are not preferred for delivery of all drugs. There remains a need for an adjustable (and/or programmable) infusion system that is precise and reliable and can offer clinicians and patients a small, low cost, light weight, simple to use alternative for parenteral delivery of liquid medicines.

SUMMARY

The present invention provides drive mechanisms for the controlled delivery of drug substances, controlled drug delivery pumps with such drive mechanisms, the methods of operating such devices, and the methods of assembling such devices. Notably, the drive mechanisms of the present invention may enable or initiate several functions, including: (i) controlling the rate of drug delivery by metering, providing resistance, or otherwise preventing free axial translation of the plunger seal utilized to force a drug substance out of a drug container; (ii) triggering a needle insertion mechanism to provide a fluid pathway for drug delivery to a user; and (iii) connecting a sterile fluid pathway to a drug container to permit fluid flow from the drug container to the needle insertion mechanism for delivery to the user. The embodiments of the present invention thus are capable of delivering drug substances at variable rates. The drive mechanisms of the present invention may be pre-configurable or dynamically configurable, such as by control by the power and control system, to meet desired delivery rates or profiles, as explained in detail below. Additionally, the drive mechanisms of the present invention provide integrated status indication features which provide feedback to the user before, during, and after drug delivery. For example, the user may be provided an initial feedback to identify that the system is operational and ready for drug delivery. Upon activation, the system may then provide one or more drug delivery status indications to the user. At completion of drug delivery, the drive mechanism and drug pump may provide an end-of-dose indication. Because the end-of-dose indication is related to the physical end of axial translation and/or travel of one or more components of the drive mechanism, the drive mechanism and drug pump provide a true end-of-dose indication to the user. Through these mechanisms, confirmation of drug dose delivery can accurately be provided to the user or administrator. Accordingly, the devices of the present invention alleviate one or more of the problems associated with prior art devices, such as those referred to above.

In one embodiment, the drug delivery device includes a drug container containing a fluid, a drive system, a power and control system, a timer, and a needle insertion mechanism which may be mechanically activated by a user. In such an embodiment, activation of the needle insertion mechanism causes a cannula to be inserted into a target and also causes the power and control system to enter a delay mode for a predetermined duration which is monitored by the timer and further wherein at the completion of the predetermined duration the power and control system enters a delivery mode in which the power and control system causes the drive system to deliver the fluid from the drug container through the needle insertion mechanism and to a target.

The drug delivery pump may further include a status switch and actuation of the status switch causes the power and control system to enter the delay mode. The status switch may be configured to be actuated by contact with a portion of the needle insertion mechanism after activation of the needle insertion mechanism. The needle insertion mechanism may be a rotational needle insertion mechanism and rotation of a portion of the needle insertion mechanism may cause contact with the status switch.

In at least one embodiment, while in the delay mode the power and control system intermittently enters a communication mode in which the power and control system provides a delay mode indicator. The delay mode indicator may be an audible indication or a visual indication.

In at least one embodiment, the drug delivery device delivers a bolus delivery of the fluid.

In at least one embodiment, the power and control system causes activation of an end-of-delivery indicator at completion of delivery of the fluid.

In at least one embodiment, the drug delivery device includes an on-body sensor configured to detect proximity of the drug delivery device to a target and actuation of the on-body sensor causes activation of the power and control system.

In at least one embodiment, the power and control system causes activation of a needle insertion mechanism (NIM) request notification if the needle insertion mechanism is not activated within a predetermined time after activation of the power and control system.

In at least one embodiment, the power and control system causes activation of a delivery mode indicator upon entering the delivery mode. The delivery mode indicator may be a visual indication or an audible indication.

A method of drug delivery may include the steps of: activation by a user of a needle insertion mechanism, activation of a power and control system to enter a delay mode, at the completion of a predetermined duration, the power and control system entering a delivery mode, the power and control system activating a drive system to deliver a fluid from a drug container, through the needle insertion mechanism and to a target. The method may further include the step of actuating a status switch. The status switch may be actuated by contact with the needle insertion mechanism.

The method may further include the step of, while in the delay mode, the power and control system intermittently entering a communication mode to provide a delay mode indicator.

The method may further include the step of actuating an on-body sensor to cause activation of the power and control system.

The method of may further include the step of the power and control system causing activation of a delivery mode indicator upon entering the delivery mode.

The method may further include the step of the power and control system causing activation of a NIM request notification if the needle insertion mechanism is not activated within a predetermined time after activation of the power and control system.

The method may further include the step of the power and control system causing activation of an end-of-delivery indicator at completion of delivery of the fluid.

In at least one embodiment of the present invention, the delivery profile of the medicament is adjustable. For example, it may be desirable to deliver a bolus injection of medicament before, during, or subsequent to certain activities such as eating, exercising, sleeping, etc. A “bolus injection” is any measured drug volume that is delivered often irrespective of the delivery time or duration. Conversely, a “basal injection” is often a controlled rate of delivery and/or a drug delivery profile having various rates of delivery at different time intervals. Similarly, the user may desire to increase or decrease the basal delivery rate of the medicament at these or other times. In at least one embodiment, the delivery profile may be adjustable by the user to achieve this desired drug delivery. The user may adjust the delivery profile by interacting with the drug delivery device itself or, alternatively, may use an external device, such as a smart-phone, to do so. For example, the user may adjust the delivery profile by displacing the activation mechanism or may engage a separate device-integrated or external delivery control mechanism.

In another embodiment of the present invention, the delivery profile may be adjusted automatically based on one or more inputs. For example, the delivery profile may be adjusted based on the patient's activity level, heart rate, blood sugar level, blood pressure, etc. As above, these measurements may be used to determine the need for a bolus injection or for the increase or decrease of the basal injection delivery rate or adjustment to the basal injection delivery profile. In at least one embodiment, these input measurements may be monitored by the device itself. Additionally, or alternatively, they may be monitored by a secondary device such as a smart-phone, smart watch, heart rate monitor, glucose monitor, blood pressure monitor, or the like. In some embodiments, the delivery profile may be adjusted based on these measurements with no required user intervention. In the case of monitoring and/or control by a secondary device, the secondary device and drug delivery device may be in wireless or wired communication with one another. This communication may be through Bluetooth, near field communication, Wi-Fi, or any other method known to one having ordinary skill in the relevant art of device interconnectivity.

In a preferred embodiment, however, the monitoring/adjustment mechanism may alert and make recommendations to the user and the user may have active control to initiate/authorize or disregard the recommendation made by the monitoring/adjustment mechanism. For example, if one or more of the measurements is above or below a specified threshold value the device may emit an audible, visual, or tactile alert to the user. In one example, the alert is provided by a vibration of the device, thereby providing a discrete alert to the user. Additionally or alternatively, the alert may be provided by the user's smart-phone or other secondary device. The user may be able to view the current status of the measurements in a computer program or web interface on the device itself, a computer, smart-phone, or other device. The computer program or web interface may provide a recommended adjustment to the delivery profile. Based on this information, the user may adjust the delivery rate of the drug delivery device. As above, the user may adjust the delivery profile by displacing the activation mechanism or engaging a separate device-integrated or external delivery control mechanism.

In one embodiment, in response to a signal to adjust the delivery profile, either based on user input or based on the measurements described above, the power and control system may cause a change in the rate of movement of the actuator. The change in the rate of movement of the actuator causes a change in the rotation rate of the regulating mechanism which, in turn, controls the rate of drug delivery to the user. Alternatively, the delivery profile may be altered by a change in the characteristics of the flow path of medicament through the conduit connecting the drug container and insertion mechanism. The change may be caused by the introduction, removal, or modification of a flow restrictor which restricts flow of medicament from the drug container to the insertion mechanism. For example, a flow restrictor may have multiple flow paths which may be selectively placed in fluid communication with an input and an output of the flow restrictor. By providing flow paths which are of different length or cross-section the rate of delivery may be controlled. In other embodiments, the delivery profile may be altered by the introduction or removal of an impingement of the conduit. An impingement of the flow path may interrupt or slow flow of medicament through the conduit, thereby controlling the rate of delivery to the user. Accordingly, one or more embodiments of the present invention are capable of producing a change to the rate of medicament delivery from the drug container thereby providing a dynamic control capability to the multi-function drive mechanism and/or the drug delivery device.

Throughout this specification, unless otherwise indicated, “comprise,” “comprises,” and “comprising,” or related terms such as “includes” or “consists of,” are used inclusively rather than exclusively, so that a stated integer or group of integers may include one or more other non-stated integers or groups of integers. As will be described further below, the embodiments of the present invention may include one or more additional components which may be considered standard components in the industry of medical devices. For example, the embodiments may include one or more batteries utilized to power the motor, drive mechanisms, and drug pumps of the present invention. The components, and the embodiments containing such components, are within the contemplation of the present invention and are to be understood as falling within the breadth and scope of the present invention.

DETAILED DESCRIPTION

The present invention provides systems and methods that are related to delivery of drug substances at a predetermined time and at an adjusted delivery rate. Particularly, the present invention relates to drug pump delivery devices that include control systems and sub-systems that are configured to control and drive multi-function drive mechanisms. Additionally, the control systems and sub-systems may be configured to deliver drug substances at appropriate delivery rates after a certain wait or delay time period has elapsed.

In one example, a user may be provided with a pre-filled drug delivery pump device to inject the drug substance via the parenteral method. In such an example, activation of the pump device may establish short range communication with a mobile device (e.g., a smart phone). In one embodiment, the drug pump delivery device may be activated by press of an activation button or a power button. The mobile device may include one or more mobile applications that may be configured to process, receive and transmit data related to the drug delivery process. The mobile application may communicate with external sensors (e.g., a heart rate sensor and a glucose rate sensor) and receive information (e.g., heart rate of the user, glucose/insulin information, etc.) related to the health and/or state of the patient during a monitoring period. The mobile application may further calculate an adjusted delivery rate for the drug based on the data received from the sensors.

Moreover, the drug pump device may request user-activation for the needle insertion, after the device has been activated. The drug pump device may provide visual or audio cues for the needle activation or, alternatively, cause the mobile device to provide the request notification for needle activation. When the needle insertion has been actuated by the user, the drug pump device may then initiate a timer to track a wait time period, prior to the delivery of the drug. Alternatively, the timer may be initiated upon activation of the device. The drug pump device may optionally monitor the temperature to determine whether the drug has reached an optimal temperature for delivery. Additionally, the power and control system may be configured to determine whether the predetermined wait time period has elapsed, and based on the determination may notify the user about the initiation of the drug delivery process. Optionally, the user may have the option of initiating drug delivery after the predetermined wait time has elapsed.

It is noted that, based on the type of the drug and the dose, the drug pump device may regulate the delivery rate of the drug. The regulation and/or adjustment of the delivery rate may also be based on information received from sensors (e.g., temperature sensor, heart rate sensor, glucose monitor sensor).

The drug pump device may further determine whether the drug delivery has ended, and based on the determination, may transmit the end of drug delivery information to the mobile device.

The mobile device may further provide the received end of delivery information to a remote server (e.g., a cloud computer server). The end of delivery information may include, but not limited to, end of delivery indication, delivery rate, delivery start and end times, total delivery time, drug temperature, and data gathered by the sensors. The information may also include information related to the drug and/or pump device such as drug volume, manufacturing date, filling date, serial/lot number, etc.

Moreover, the drug pump delivery device may switch between an active power mode and a non-active power mode. During the active power mode, the power and control system may interact with one or more motors of a drive control system to actuate one or more drive mechanisms, and as such, both the power and control system and the motors may receive power from an energy source (e.g., batteries). On the other hand, in some instances, the power and control system may not need to interact with the drive control system to execute one or more operations of the drug delivery pump device. For example, the drug pump delivery device may establish and communicate with the mobile device, or monitor temperature of the drug without interacting with the drive control system of the drug pump device. In such instances, the power and control system may only be powered, and the drive control system may not receive power from the batteries. Additionally, one or more components or functions of the pump device may be powered intermittently in one or more modes.

The switching between the active power mode and the non-active power mode may substantially save power resources of the drug pump device. For example, upon switching to the non-active power mode, the drug pump device does not need to provide power to the motors, which may, otherwise, significantly drain the batteries.

Particularly, during the active power mode, the power and control system of the drug delivery pump device controls the multi-function drive mechanisms to initiate several sub-systems or functions, including: (i) controlling the rate of drug delivery by metering, providing resistance, or otherwise preventing free axial translation of the plunger seal utilized to force a drug substance out of a drug container; (ii) triggering a needle insertion mechanism to provide a fluid pathway for drug delivery to a user; and (iii) connecting a sterile fluid pathway to a drug container to permit fluid flow from the drug container to the needle insertion mechanism for delivery to the user.

The drive mechanisms of the present invention may control the rate of drug delivery by metering, providing resistance, or otherwise preventing free axial translation of the plunger seal utilized to force a drug substance out of a drug container and, thus, are capable of delivering drug substances at variable rates and/or delivery profiles. Additionally, the drive mechanisms of the present invention may include integrated status indication features, such as sensors, which may provide feedback to the power and control system, and in turn, to the user before, during, and after drug delivery. For example, the user may be prompted by one or more sensors to identify that the devices are operational and ready for drug delivery. Upon activation of one or more devices, the sensors may provide one or more drug delivery status indications to the user such as an end-of-dose indication at completion of drug delivery.

As used herein to describe the drive mechanisms, drug delivery pumps, or any of the relative positions of the components of the present invention, the terms “axial” or “axially” refer generally to a longitudinal axis “A” around which the drive mechanisms are preferably positioned, although not necessarily symmetrically there-around. The term “radial” refers generally to a direction normal to axis A. The terms “proximal,” “rear,” “rearward,” “back,” or “backward” refer generally to an axial direction in the direction “P”. The terms “distal,” “front,” “frontward,” “depressed,” or “forward” refer generally to an axial direction in the direction “D”. As used herein, the term “glass” should be understood to include other similarly non-reactive materials suitable for use in a pharmaceutical grade application that would normally require glass, including but not limited to certain non-reactive polymers such as cyclic olefin copolymers (COC) and cyclic olefin polymers (COP). The term “plastic” may include both thermoplastic and thermosetting polymers. Thermoplastic polymers can be re-softened to their original condition by heat; thermosetting polymers cannot. As used herein, the term “plastic” refers primarily to moldable thermoplastic polymers such as, for example, polyethylene and polypropylene, or an acrylic resin, that also typically contain other ingredients such as curatives, fillers, reinforcing agents, colorants, and/or plasticizers, etc., and that can be formed or molded under heat and pressure. As used herein, the term “plastic” is not meant to include glass, non-reactive polymers, or elastomers that are approved for use in applications where they are in direct contact with therapeutic liquids that can interact with plastic or that can be degraded by substituents that could otherwise enter the liquid from plastic. The term “elastomer,” “elastomeric” or “elastomeric material” refers primarily to cross-linked thermosetting rubbery polymers that are more easily deformable than plastics but that are approved for use with pharmaceutical grade fluids and are not readily susceptible to leaching or gas migration under ambient temperature and pressure. “Fluid” refers primarily to liquids, but can also include suspensions of solids dispersed in liquids, and gasses dissolved in or otherwise present together within liquids inside the fluid-containing portions of the drug pumps. According to various aspects and embodiments described herein, reference is made to a “biasing member”, such as in the context of one or more biasing members for asserting force on a plunger seal. It will be appreciated that the biasing member may be any member that is capable of storing and releasing energy. Non-limiting examples include a spring, such as for example a coiled spring, a compression or extension spring, a torsional spring, or a leaf spring, a resiliently compressible or elastic band, or any other member with similar functions. In at least one embodiment of the present invention, the biasing member is a spring, preferably a compression spring.

The devices of the present invention provide drive mechanisms with integrated status indication and drug delivery pumps which incorporate such drive mechanisms. Such devices are safe and easy to use, and are aesthetically and ergonomically appealing for self-administering patients. The devices described herein incorporate features which make activation, operation, and lock-out of the device simple for even untrained users. The devices of the present invention provide these desirable features without any of the problems associated with known prior art devices. Certain non-limiting embodiments of the drug delivery pumps, drive mechanisms, and their respective components are described further herein with reference to the accompanying figures.

As used herein, the term “pump” is intended to include any number of drug delivery systems which are capable of dispensing a fluid to a user upon activation. Such drug delivery systems include, for example, injection systems, infusion pumps, bolus injectors, and the like.FIGS.1A-1Cshow an exemplary drug delivery device according to at least one embodiment of the present invention. InFIG.1Bthe top housing is removed so that the internal components are visible. The drug delivery device may be utilized to administer delivery of a drug treatment into a body of a user. As shown inFIGS.1A-1C, the drug pump10includes a pump housing12. Pump housing12may include one or more housing subcomponents which are fixedly engageable to facilitate easier manufacturing, assembly, and operation of the drug pump. For example, drug pump10includes a pump housing12which may include an upper housing and a lower housing (not shown for ease of viewing internal components). The pump housing12may include one or more tamper evidence features to identify if the drug delivery device has been opened or tampered with. For example, the pump housing12may include one or more tamper evidence labels or stickers, such as labels that bridge across the upper housing and the lower housing. Additionally or alternatively, the housing12may include one or more snap arms or prongs connecting between the upper housing and the lower housing. A broken or altered tamper evidence feature would signal to the user, the physician, the supplier, the manufacturer, or the like, that the drug delivery device has potentially been tampered, e.g., by accessing the internal aspects of the device, so that the device is evaluated and possibly discarded without use by or risk to the user. The drug pump may further include an activation mechanism, a status indicator, and a window. The window may be any translucent or transmissive surface through which the operation of the drug pump may be viewed. As shown inFIG.1B, drug pump10further includes assembly platform20, sterile fluid conduit, drive mechanism100having drug container50, insertion mechanism200, fluid pathway connection300, and a power and control system800. One or more of the components of such drug pumps may be modular in that they may be, for example, pre-assembled as separate components and configured into position onto the assembly platform20of the drug pump10during manufacturing.

The pump housing12contains all of the device components and provides a means of removably attaching the device10to the skin of the user. The pump housing12also provides protection to the interior components of the device10against environmental influences. The pump housing12is ergonomically and aesthetically designed in size, shape, and related features to facilitate easy packaging, storage, handling, and use by users who may be untrained and/or physically impaired. Furthermore, the external surface of the pump housing12may be utilized to provide product labeling, safety instructions, and the like. Additionally, as described above, housing12may include certain components, such as one or more status indicators (e.g., LED lights, audio tones via speakerphones) and windows, which may provide operation feedback to the user.

In one example, the power and control system may be configured to provide a number of different status indications to the user. For example, the power and control system may be configured such that after the on-body sensor (e.g., skin sensor) is triggered, the power and control system provides a ready-to-start status signal via the status indicator (e.g., audio tones and/or blinking lights) if device start-up checks provide no errors. After providing the ready-to-start status signal and, in an embodiment with the optional on-body sensor, if the on-body sensor remains in contact with the body of the user, the power and control system will power the drive mechanism100to begin delivery of the drug treatment through the fluid pathway connection300and sterile fluid conduit.

Additionally, the power and control system may be configured to identify removal of the drug pump from its packaging. The power and control system may be mechanically, electronically, or electro-mechanically connected to the packaging such that removal of the drug pump from the packaging may activate or power-on the power and control system for use, or simply enable the power and control system to be powered-on by the user. In such an embodiment, without removal of the drug pump from the packaging the drug pump cannot be activated. This provides an additional safety mechanism of the drug pump and for the user. In at least one embodiment, the drug pump or the power and control system may be electronically or electro-mechanically connected to the packaging, for example, such as by one or more interacting sensors from a range of: Hall effect sensors; giant magneto resistance (GMR) or magnetic field sensors; optical sensors; capacitive or capacitance change sensors; ultrasonic sensors; and linear travel, LVDT, linear resistive, or radiometric linear resistive sensors; and combinations thereof, which are capable of coordinating to transmit a signal between components to identify the location there-between.

Additionally or alternatively, the drug pump or the power and control system may be mechanically connected to the packaging, such as by a pin and slot relationship which activates the system when the pin is removed (i.e., once the drug pump is removed from the packaging).

In a preferred embodiment of the present invention, once the power and control system has been activated, and after a predetermined wait time period, the multi-function drive mechanism is initiated to actuate the drug fluid to be forced from the drug container.

During the drug delivery process, the power and control system may be further configured to provide a dispensing status signal via the status indicator. After the drug has been administered into the body of the user and after the end of any additional dwell time, to ensure that substantially the entire dose has been delivered to the user, the power and control system may provide an okay-to-remove status signal via the status indicator. This may be independently verified by the user by viewing the drive mechanism and drug dose delivery through the window of the pump housing12. Additionally, the power and control system may be configured to provide one or more alert signals via the status indicator, such as for example alerts indicative of fault or operation failure situations.

The power and control system may additionally be configured to accept various inputs (e.g., via an activation button) from the user to dynamically control the drive mechanisms100to meet a desired drug delivery rate or profile. For example, the power and control system may receive inputs, such as from partial or full activation, depression, and/or release of the activation mechanism, to set, initiate, stop, or otherwise adjust the control of the drive mechanism100via the power and control system to meet the desired drug delivery rate or profile. Similarly, the power and control system may be configured to receive such inputs to initiate communication with the mobile device, adjust the drug dose volume, to prime the drive mechanism, fluid pathway connection, and fluid conduit; and/or to start, stop, or pause operation of the drive mechanism100. Such inputs may be received by the user directly acting on the drug pump10, such as by use of the activation mechanism14or a different control interface, or the power and control system may be configured to receive such inputs from a remote device (e.g., a mobile device). Additionally or alternatively, such inputs may be pre-programmed.

Other power and control system configurations may be utilized with the drug pumps of the present invention. For example, certain activation delays may be utilized prior to, or during drug delivery. For example, a wait-time period may be a pre-determined time that may be set in the power and control system, and which may delay the delivery of the drug by the pre-determined amount of time. As mentioned above, one such delay optionally included within the system configuration is a dwell time which ensures that substantially the entire drug dose has been delivered before signaling completion to the user. Similarly, activation of the device may require a delayed depression (i.e., pushing) of the activation mechanism of the drug pump10prior to drug pump activation. Additionally, the system may include a feature which permits the user to respond to the end-of-dose signals and to deactivate or power-down the drug pump. Such a feature may similarly require a delayed depression of the activation mechanism, to prevent accidental deactivation of the device. Such features provide desirable safety integration and ease-of-use parameters to the drug pumps. An additional safety feature may be integrated into the activation mechanism to prevent partial depression and, therefore, partial activation of the drug pumps. For example, the activation mechanism and/or power and control system may be configured such that the device is either completely off or completely on, to prevent partial activation. Such features are described in further detail hereinafter with regard to other aspects of the drug pumps.

In one embodiment, the drug delivery pump device10may include one or more control systems such as, but not limited to, power and control system800and drive control system820. As disclosed above, the drug delivery pump10may further include various mechanisms or sub-systems such as, but not limited to, drive mechanism or sub-system100, needle insertion mechanism (NIM) or sub-system200, sterile fluid pathway connection (SFPC) or sub-system300, and regulating mechanism or sub-system500. In some examples, the control systems may include printed circuit board (PCB), motherboards and/or daughter boards.

In some embodiments, the sub-systems may be included in the control systems. For example, the drive control system820may include the drive sub-system100, NIM sub-system200, and/or the regulating sub-system500. In such examples, the power and control system800may control the sub-systems by sending command signals to the drive control system820.

In other examples, the drive control system820may not include the sub-systems. As such, in those examples, the power and control system800may control the sub-systems via the drive control system820. For example, the power and control system800may send command signals to the drive control system820. The drive control system820, for example, may then selectively control one or more of the sub-systems based on the received command signals from the power and control system810.

Yet in another embodiment, the power and control system800may directly control the sub-systems. In that embodiment, the sub-systems may include respective control units or controller and storage units (not shown) that may be configured to directly communicate with the power and control system800.

Alternatively, in some implementations, the power and control system800may include the drive control system820and the sub-systems, and one or more other control systems and sub-systems.

As shown inFIG.8A, in one exemplary embodiment, the power and control system800may be included in the drug delivery pump10. The power and control system800may include one or more control units that are connected to one or more sensors, timers and storage units of the drug delivery pump10.

In some implementations, the power and control system800may be configured to control a delay time period related to drug delivery. In such implementations, the power and control system800may monitor and control time parameters for initiating and delivering the drug after the activation of the drug delivery pump10. For example, upon the activation of the device10, the power and control system800may monitor a wait period time (e.g., a predetermined delay time) prior to the initiation of the drug delivery. In one example, during the wait period, the power and control system800may optionally prime the device.

In one example, the power and control system800may provide request notification to activate the NIM mechanism after the device has been activated. The request notification may be provided directly by the drug pump delivery device10, or via the mobile device11. Upon notifying the user to initiate the NIM mechanism200, the power and control system may further determine whether an activation/initiation signal (e.g., from the user) is received via the activation button.

When the power and control system800determines that the activation signal is received (e.g., within an NIM activation predetermined time), the power and control system may cause the NIM sub-system to activate. Alternatively, the NIM may be directly activated by the user. The power and control system800may further notify the user that the delivery of the drug has been initiated. It is noted that, the power and control system800may activate the NIM mechanism upon receiving the activation signal related for the NIM activation and, upon further receiving signal from on-body sensor that indicates that the drug pump device10is sensing the skin of the user. Optionally, when the power and control system determines that the activation signal is not received, and/or the on-body sensor is not sensing a skin portion of the user, the power and control system800may notify the user (e.g., via an audible tone), and optionally terminate the drug delivery process.

Moreover, in some implementations, when the power and control system800determines that the wait period time has elapsed, the power and control system may notify the user about the initiation of the delivery of the drug. The power and control system may further notify the user that the delivery of the drug has been initiated.

Optionally, the power and control system800may further notify the user of a time period of the drug delivery (e.g., the total time that will be taken for delivering the drug). The power and control system800may communicate the notification to an external device via the communication unit830.

Upon the initiation of the drug delivery, the power and control system may further control timing and/or rate parameters for the drug delivery. For example, the power and control system may control the regulating sub-system or mechanism to deliver the drug in a given period of time. Moreover, the power and control system may process various data captured by the internal and external sensors to determine the timing and/or rate parameters for the drug delivery. Based on the determination, the power and control system may deliver the drug to the user within the appropriate time period.

The power and control system may or may not include all the elements of the power and control system800, and/or may include additional elements. Additionally, in some examples, the drug pump device10may include one or more control systems, including, but not limited to, the power and control system, and may include additional elements for the operations of the drug pump device.

In some implementations, control system800may include a main control unit or control unit810. The main control unit810may include one or more controllers, microcontrollers, microprocessors, or application specific integrated circuits (ASICs). Main control unit810may be implemented as hardware or a combination of hardware and software that may be programmed with instructions. The main control unit810may be configured to execute such instructions to effect various operations of the drug pump device10. Moreover, the power and control system or the main control unit810may communicate, for example, by receiving and/or sending signal or data to and from the communication unit830, timer unit812, storage unit813, on-body sensor840, temperature sensor880, and I/O unit850. In addition, the power and control system may include one or more of the above, such as, for example, timer unit812. The main control unit810may process and interpret the data collected or monitored by the various elements in the one or more control systems in order to determine and execute various functions and operations of the drug pump device10.

It is noted that, the drug pump device10may operate in two power modes, namely, an active power mode and a non-active power mode. During the active power mode, the power and control system800and the motor101may receive power from the power source (e.g., batteries), and the power and control system800may command the drive control system820to drive various operations, such as the NIM mechanism200, and/or regulating mechanism500. Whereas, during the non-active power mode, the power and control system800may be powered, and the motor101may not be powered. During the non-active power mode, the power and control system800may execute various operations of the drug pump device10that may not require operations related to the motor101. For example, the power and control system800may establish communication link with the mobile device11, and further communicate intermittently or continuously with the mobile device11during the non-active power mode. Additionally, during the non-drive mode, the power and control system800may provide notifications, and alert to the user, and may further communicate with the various sensors (e.g., the temperature sensor and on-body sensor), and/or determine timings of various operations. Optionally, the drug pump device10may be primed during the non-active power mode.

Moreover, the drug pump device10may switch between the active power mode and the non-active power mode.

The different power modes may be initiated, based on: (a) type of activation (e.g., device activation, activation of the drug delivery, control of the drug delivery, initiation of the timer, etc.), (b) predetermined time set (e.g., after, or, during the wait time period), and/or (c) operations (e.g., communication with the mobile device and/or sensors, control of the various operations by the power and control system800) of the drug pump device10. Alternatively, the activation and/or switching between the modes may be performed manually by the user of the drug pump device10.

It will be appreciated that, by appropriately powering up the motor101and the power and control system800, the overall power requirement of the drug pump device10may be reduced. For example, powering the motor101while the motor101is idle may prematurely drain the power source or battery of the drug pump device10. As such, by managing the power cycle, for example, by providing power to the motor101only when activities related to the motor101are initiated, the life of the battery to operate the drug delivery device10may be suitably increased or the demand for power to operate the drug delivery device10over the life of the drug delivery period may be significantly reduced.

Timer unit812may be a digital clock that may be programmed, for example, to set up time periods for various operations of the drug pump device10. For example, the timer unit812may be configured to indicate, to the main control unit810, a wait time or a delay period time for a drug (i.e., a time period before the drug can be forced to be delivered). During the wait time period, the power and control system may enter a delay mode in which power consumption is reduced.

Additionally, timer unit812may indicate a time-out period for receiving an activation signal (i.e., a time period within which a user may provide an activation signal to initiate drug delivery or NIM200). In some embodiments, timer unit812may directly communicate with the control units of various sensors. In some implementations, the timer unit812may be included in the main control unit810.

Control system800may include storage unit813. Storage unit813may include one more storage units, such as a random access memory (RAM) or other dynamic storage device, and/or a read only memory (ROM), and/or an electrically erasable programmable read only memory (EEPROM) for storing temporary parameters, information and instructions for the main control unit810. In some implementations, the storage unit may be implemented as a non-transitory computer readable medium which stores instructions that may be processed and executed by the control unit to control operations of the control system of the drug pump device. Additionally, storage unit813may store error codes or error notification for various operations associated with the sensors and control unit of the drug pump device10. The error codes may be pre-programmed into the storage unit813.

Storage unit813, may additionally, store various predetermined delay or wait time periods related to the drug delivery.

In some examples, power and control system800may include communication unit830. Communication unit830may include one or more 802.11 Wi-Fi transceivers, a cellular transceiver, IEEE 802.14 ZigBee transceiver, a Bluetooth transceiver, and/or a Bluetooth Low Energy (BLE) transceiver, and for other wireless communication protocols, such as near-field communication (NFC), infrared or ultrasonic. The drug pump device10may include appropriate antenna (not shown), for communication with an external computer device, and may receive/transmit data via the communication unit830.

As shown inFIG.8D, the drug pump device10may communicate with an external computing device (via the communication unit830). The external computing device may be mobile computing device11such as a smart phone which may include various mobile applications and may be configured with the appropriate communication protocols.

In one example, the mobile device11may include a pump device mobile application (app)10athat communicates with the drug pump device10. In such an example, the mobile app10amay be provided (from the manufacturer of the drug or drug pump device10) to the user upon purchasing the drug or the drug pump device10. For example, the container or the box of the drug pump device10may include a unique download identifier that the user may use to download the drug pump device mobile app10a. For example, the user may use the download identifier to download the app10afrom Apple Store or Google Play store.

Upon downloading the drug pump app10ato the mobile device10a, the user may communicate with the drug pump device10using the drug pump application10a(e.g., upon establishing a wireless communication link with the drug pump device10). The mobile app10amay be configured to cause the mobile device11to process various information received from the drug pump device10, external entities, such as sensors11aand11b, and/or optionally data received from a cloud server. Based on the processing of such data, the mobile app10amay cause the mobile device11to transfer appropriate data to the external cloud server11c. Mobile app10amay further cause the mobile device11to display appropriate notification to the user based on the processing of such data.

In one example, the user may optionally select the activation button10bto establish a short range wireless connection with the drug pump device10. In one example, the activation button10bmay initiate a Bluetooth discovery and pairing process for the mobile device11.

Moreover, when the drug pump device10is activated and in communication with the mobile device11, mobile app10amay receive a notification from the drug pump device10(via the communication unit830) that indicates activation of the drug pump device10. In some examples, activation button10bmay additionally be configured to initiate, modify and/or terminate various mechanisms of the drug delivery process.

In some examples, drug pump app10amay gather and provide various time period information of the drug delivery process to the user. Particularly, in one example, selection of the timer button10cmay provide information related to various timing periods related to the drug delivery process. The timer button10cmay be triggered, in one example, upon the selection of the activation button10b. In one example, the selection of the timer button10cmay evoke a clock or stop watch application of the mobile device11.

In one example, upon the activation of the drug pump device10and the initiation of the timer unit812, the user may gather information related to the predetermined wait time period prior to the initiation of the drug delivery.

Optionally, drug pump app10amay provide alarm notification. For example, the timer button10cmay be configured to provide alarm notification prior to the initiation of the drug delivery process. In one example, the user may optionally indicate how often to receive alarm notification prior to the drug delivery process. Timer button10cmay be further configured to indicate the delivery time period when the drug is being delivered to the user.

Moreover, drug pump app10amay be configured to receive information, for example, from the drug pump device10. For example, a user may select the Tx/Rx notification and data button10dto receive notification related to the drug delivery process (e.g., from the drug delivery pump device10), and transmit information related to the drug delivery process (e.g., to the cloud server11c).

In one example, upon the selection of the Tx/Rx button10d, the user may view notification related to the drug delivery process, such as the activation of the drug pump device10, and/or end of dose notification.

Additionally, the user may view data via the Tx/Rx button10drelated to the drug delivery process, such as the rate at which the drug was delivered, the total time period of the delivery process. In one example, the user may further transfer the data and/or notification to a cloud server11cof relevant entities (e.g., physician, health insurance company, etc.) In such a scenario, the drug pump application10amay evoke the communication interface (e.g., a cellular communication interface) of the mobile device11to communicate such information that is received from drug pump device10to the external cloud server11c.

In one example, the mobile app10amay collect information from other sensors that are local or external to the mobile device. For example, the mobile app10amay collect information from a wireless heart rate sensor11a, a wireless glucose rate monitor11band cause the mobile device11to process such information. Based on the processed information, the mobile app10amay determine delivery rate for the drug, and provide instruction to the user about the delivery rate information and activation inputs for the drug pump device10.

It is contemplated that, the drug pump device10may wirelessly communicate with the heart rate sensor11aand/or the glucose rate monitor11band process the received information to determine the drug delivery rate for the drug.

Referring back toFIG.8Athe power and control system800may include on-body sensors840, such as mechanical, electro-mechanical skin sensors, and/or electrical skin sensors, for example, a capacitive skin sensor. In one example, the on-body sensor840may be configured to detect whether the pump device10is in contact with the skin of the patient. Based on the determination, the on-body sensor may provide appropriate indication (e.g., signals) to the control unit810. The control unit810may then control various functions of the drug pump10. For example, the control unit810may notify the user to initiate a delivery of the drug only when the pump device10is in contact with the skin of the user. This may be a safety feature of the drug pump10, as the drive control system820may not be activated until the power and control system receives a signal from the on-body sensor840.

In one example, on-body sensor840may be a mechanical switch, and the depression of the mechanical on-body sensor840may trigger the activation of the power and control system810, and/or the drive control system820. In another embodiment, the on-body sensor may be a capacitive- or impedance-based skin sensor, and the power and control system and/or the drive control system820may be functional upon receiving signal from the on-body sensor. These concepts are not mutually exclusive and one or more combinations may be utilized within the breadth of the present invention to prevent, for example, premature activation of the drug pump10. In a preferred embodiment, the drug pump10utilizes one or more mechanical on-body sensors. Additional integrated safety mechanisms are described herein with reference to other components of the drug pumps.

Power and control system800may optionally include one or more temperature sensors880. The temperature sensor880may be suitably positioned near the drug or the drug container50, and configured to detect the temperature of the drug. The temperature sensor may be thermocouples or thermistors (i.e., resistors whose resistances vary significantly with temperature), and electrically coupled to the control unit810. The control unit810may process the detected temperature information that is received from the temperature sensor880to control various operations of the drug pump device10. In one example, based on the detected temperature of the drug, the control unit810may notify the user to initiate the delivery of the drug prior to, or after a predetermined time has elapsed. In such a scenario, the control unit810may be configured to override the pre-defined wait period time related to the drug delivery.

The power and control system800may include a power source, such as batteries (not shown), that provides power to various electrical components of the drug pump device10.

Moreover, the input/output electro-mechanical unit850may include an activation button, one or more feedback mechanisms, for example, audible alarms such as piezo alarms and/or light indicators such as light emitting diodes (LEDs).

In one embodiment, the control unit810of the power and control system800interfaces with the mechanical on-body sensor24or the electrical and/or electro mechanical on-body sensor840to identify when the device is in contact with the user and/or the activation mechanism to identify when the device has been activated.

The power and control system800interfaces and controls the drive control system820through one or more interconnects to relay status indication, such as activation, drug delivery, and end-of-dose, and receives status feedback from the drive control system. The status indication or the status feedback may be presented to the user via the I/O unit850, such as auditory tones or alarms, and/or via visual indicators, such as through the LEDs.

In one embodiment, the control interfaces between the power and control system800and the other components of the drive control system820are not engaged or connected until activation by the user (e.g., via the activation button). This is a desirable safety feature that prevents accidental operation of the drug pump, and may additionally maintain and save the battery power during storage, transportation, and the like.

In one implementation, upon activation of the drug pump device10(e.g., via the activation button of the I/O unit850), the multi-function drive mechanism100of the drive control system820is activated to: insert a fluid pathway into the user; enable, connect, or open necessary connections between a drug container, a fluid pathway, and a sterile fluid conduit; and force drug fluid stored in the drug container through the fluid pathway and fluid conduit for delivery into a user. In at least one embodiment, such delivery of drug fluid into a user is performed by the drive control system multi-function drive mechanism in a controlled manner (e.g., via the flow rate control sub-system825).

FIG.8Billustrates an exemplary drive control system820that may be configured to drive and control various mechanical and electro-mechanical components of the drug pump device10. One or more components of the power and control system800(e.g., the control unit810) may interface with the drive control system820, and instruct the actuator/motor101to drive various elements of the drug pump device10.

In some embodiments, control unit810is electrically coupled and configured to communicate with motor101, and any other elements of the drive control system820.

In some examples, the drive control system820may optionally include various sensors such as, but not limited to, pressure sensor870that may be configured to provide information of the pressure in the container50, tether sensor875that may be configured to provide a status information of the tether525and a valve senor877that may be configured to provide a status information of the fluid pathway connection300that may be provided on the container. The sensors870,875and877may be electrical and/or electro-mechanical components and may communicate with the control unit810by providing status signals corresponding to the respective sensors. The control unit810may process such signals to execute and/or delay execution of the control of various sub-systems via the motor101.

In one example, the drive control system820may optionally include timer unit860. Timer unit860may be a digital clock that is coupled to the control unit810. In one example, the timer unit860may be included in the control unit810. In some examples, the timer unit860may be the same as timer unit812.

The drive control system may include an actuator or motor101. The actuator101may be a number of power/motion sources including, for example, a solenoid, a stepper motor, or a rotational drive motor. In one embodiment, the actuator101is a rotational stepper motor with a notch that corresponds with the gear teeth of the main/star gear102.

In some embodiments (seeFIGS.1A-5D), the actuator101is in vertical alignment and in direct engagement with the main/star gear102. As would be readily appreciated by one having ordinary skill in the mechanical arts, the actuator101could be modified to be in horizontal alignment. Additionally or alternatively, the actuator101may be modified to be in indirect engagement with the main/star gear102, as discussed below with reference toFIGS.7A and7B.

With reference toFIG.8C, the drive control system820may control the drive mechanisms of the drug pump device10. In one example, the drive control system may control the drive mechanism or sub-system100to control the NIM or sub-system200, establish the SFPC300and further control the regulating mechanism500of the drug pump device10.

In one example, the initiation time of the needle insertion mechanism200, time to establish the fluid pathway connection300, and a drug delivery rate of the drug may be determined by the power and control system800based on the various inputs received by the power and control system from external sensors (e.g., the glucose rate, heart rate, etc.) The power and control system800may then transmit the appropriate command signals and information (e.g., the delivery rate information) to the drive control system820.

Furthermore, the storage unit865of the drive control system820, and/or the storage unit813may store, in a lookup table and/or database, pre-programmed configurations and setting information such as ratio of gear assembly information (e.g., ratio of gear assembly516), rate of rotation of gear information (e.g., rate of rotation of the main star gear102), and diameter information of gears and drums. As such, upon receiving the delivery rate information, the control unit810may consult the storage unit865or storage unit813to identify and select the appropriate configuration of the gear assembly and the motor from the lookup table or the database. Based on the selection, the control unit810may drive the motor101to control the drive mechanism100, NIM mechanism200and the regulating mechanism500to deliver the drug at the desired rate.

Moreover, the drive control system820may interact with the power and control system810and receive command signals after a predetermined time to control the various drive mechanisms of the drug pump device10.

For example, the drive control system820may receive the command signal and timing information to control or initiate the driving mechanism after a predetermined time. In this example, the control unit810may consult the timer unit860or timer unit812to determine the initiation time of the activation of the drive mechanism. Upon determination, control unit810may command the actuator/motor101after the predetermined time to initiate a drug delivery process by controlling the drive mechanisms as discussed below.

After the initiation of the drug delivery, the control unit810may further consult the timer unit860or timer unit812to complete the drug delivery in a predetermined time. The power and control system800may determine the timing periods, and may send command signals to the drive control system820prior to, during, and after the drug delivery process to control the drug delivery process.

It is noted that, the drive mechanism100, insertion mechanism200, fluid pathway connection300and the regulating mechanism500may be controlled by the drive control system820, concurrently, sequentially and/or non-sequentially, based on a timing period set by the power and control system810.

In some examples, the drive control system820may drive or control the insertion mechanism or sub-system200via the drive mechanism100. The controlling of the insertion mechanism200may be performed based on the predetermined wait time period or delay time period, either directly by the power and control system810, or by the drive control system820.

In one example, the drive control system820may additionally control the insertion mechanism200to concurrently provide a fluid pathway connection for drug delivery to a user.

Alternatively, the drive control system820may separately (and prior to or after the insertion mechanism200) establish the sterile fluid pathway connection300by connecting a sterile fluid pathway to a drug container to permit fluid flow from the drug container to the needle insertion mechanism for delivery to the user. Details of the control of the insertion mechanism200are discussed below.

Insertion Mechanism

A number of insertion mechanisms may be utilized within the drug pumps to activate the needle insertion into the body of the patient. The pump-type delivery devices of the present invention may be connected in fluid flow communication to a patient or user, for example, through any suitable hollow tubing. A solid bore needle may be used to pierce the skin of the patient and place a hollow cannula at the appropriate delivery position, with the solid bore needle being removed or retracted prior to drug delivery to the patient. The fluid may be introduced into the body through any number of means, including but not limited to: an automatically inserted needle, cannula, micro-needle array, or infusion set tubing.

In one example, the control unit810of the power and control system800may receive activation inputs to initiate the drug pump device10. After a predetermined time or after the determination that the on-body sensor840is sensing a skin portion of the user, the power and control system800may instruct the drive control system820to initiate the NIM200. After the wait time period, the control unit810may actuate one or more biasing members to initiate the needle insertion mechanism or sub-system200. For example, a biasing member such as a spring may be actuated by the motor101to provide sufficient force to cause the needle and cannula to pierce the skin of the patient. The same spring, an additional spring, or another similar mechanism may be utilized to retract the needle from the patient.

In one embodiment, the power and control system800and/or the drive control system820may actuate the insertion mechanism200as described in International Patent Application No. PCT/US2012/53174, which is included by reference herein in its entirety for all purposes. Such a configuration may be utilized for insertion of the drug delivery pathway into, or below, the skin (or muscle) of the patient in a manner that minimizes pain to the patient. Other known methods for insertion of a fluid pathway may be utilized and are contemplated within the bounds of the present invention, including a rigid needle insertion mechanism and/or a rotational needle insertion mechanism as developed by the assignee of the present invention.

In at least one embodiment, the insertion mechanism200includes an insertion mechanism housing having one or more lockout windows, and a base for connection to the assembly platform and/or pump housing (as shown inFIG.1BandFIG.1C). The connection of the base to the assembly platform20may be, for example, such that the bottom of the base is permitted to pass-through a hole in the assembly platform to permit direct contact of the base to the body of the user. In such configurations, the bottom of the base may include a sealing membrane that is removable prior to use of the drug pump10. The insertion mechanism may further include one or more insertion biasing members, a needle, a retraction biasing member, a cannula, and a manifold. The manifold may connect to sterile fluid conduit to permit fluid flow through the manifold, cannula, and into the body of the user during drug delivery.

As used herein, “needle” is intended to refer to a variety of needles including but not limited to conventional hollow needles, such as a rigid hollow steel needles, and solid core needles more commonly referred to as “trocars.” In a preferred embodiment, the needle is a 27 gauge solid core trocar and in other embodiments, the needle may be any size needle suitable to insert the cannula for the type of drug and drug administration (e.g., subcutaneous, intramuscular, intradermal, etc.) intended. A sterile boot may be utilized within the needle insertion mechanism. The sterile boot is a collapsible sterile membrane that is in fixed engagement at a proximal end with the manifold and at a distal end with the base. In at least on embodiment, the sterile boot is maintained in fixed engagement at a distal end between base and insertion mechanism housing. The base includes a base opening through which the needle and cannula may pass-through during operation of the insertion mechanism, as will be described further below. Sterility of the cannula and needle are maintained by their initial positioning within the sterile portions of the insertion mechanism. Specifically, as described above, needle and cannula are maintained in the sterile environment of the manifold and sterile boot. The base opening of base may be closed from non-sterile environments as well, such as by for example a sealing membrane (not visible).

According to at least one embodiment of the present invention, the insertion mechanism is initially locked into a ready-to-use stage by lockout pin(s) which are initially positioned within lockout windows of the insertion mechanism housing. In this initial configuration, insertion biasing member and retraction biasing member are each retained in their compressed, energized states. In one example, the power and control system800may send command signals to the drive control system820to initiate the needle insertion mechanism200after the wait time period. Upon receiving the command signal, the actuator101may cause displacement of the lockout pin(s), such as pulling, pushing, sliding, and/or rotation. This may cause the insertion biasing member to decompress from its initial compressed, energized state. Particularly, the decompression of the insertion biasing member drives the needle and, optionally, the cannula into the body of the user. At the end of the insertion stage or at the end of drug delivery (as triggered by the multi-function drive mechanism100and/or the regulating mechanism500), the retraction biasing member is permitted to expand in the proximal direction from its initial energized state. This axial expansion in the proximal direction of the retraction biasing member retracts the needle. If an inserter needle/trocar and cannula configuration are utilized, retraction of the needle may occur while maintaining the cannula in fluid communication with the body of the user. Accordingly, the insertion mechanism may be used to insert a needle and cannula into the user and, subsequently, retract the needle while retaining the cannula in position for drug delivery to the body of the user.

As further discussed below, in some examples, the power and control system800and/or the drive control system820may control the needle insertion mechanism200via the multi-function drive mechanism100. Additionally, the power and control system800and/or the drive control system820may control the rate of drug delivery via the drive mechanism100and regulating mechanism500such as by metering, providing resistance, or otherwise preventing free axial translation of the plunger seal utilized to force a drug substance out of a drug container (thereby delivering drug substances at variable rates and/or delivery profiles).

Referring back toFIGS.2A-2E and3A-3D, the multi-function drive mechanisms100may concurrently or sequentially perform the steps of: triggering a needle insertion mechanism to provide a fluid pathway for drug delivery to a user; and connecting a sterile fluid pathway to a drug container to permit fluid flow from the drug container to the needle insertion mechanism for delivery to the user.

In at least one embodiment, as shown inFIGS.2A-2E and3A-3D, the control unit810may initiate motion of the actuator101of the drive control system820, which may cause rotation of the main/star gear102of the multi-function drive mechanism100. Main/star gear102is shown as a compound gear with aspects102A and102B (seeFIG.4). In one example, main/star gear102conveys motion to the regulating mechanism500through gear assembly516.

In another example, main/star gear102conveys motion to the needle insertion mechanism200through gear112. As gear112is rotated by main/star gear102, gear112engages the needle insertion mechanism200to initiate the fluid pathway connection into the user, as described in detail above. In one particular embodiment, needle insertion mechanism200is a rotational needle insertion mechanism. Accordingly, gear112is configured to engage a corresponding gear surface208of the needle insertion mechanism200(seeFIGS.2A and3B). Rotation of gear112causes rotation of needle insertion mechanism200through the gear interaction between gear112of the drive mechanism100and corresponding gear surface208of the needle insertion mechanism200. Once suitable rotation of the needle insertion mechanism200occurs, for example rotation along axis ‘R’ shown inFIG.2B-2C, the needle insertion mechanism may be initiated to create the fluid pathway connection into the user.

In an alternative embodiment, as shown inFIG.7A, the insertion mechanism200includes a rotationally biased member210which is initially held in an energized state. In one example, the rotationally biased member is a torsional spring. The drive control system820may actuate one or more components of the multi-function drive mechanism100, insertion mechanism200and/or the regulating mechanism500to prevent and/or control the rotation of the rotational biasing member210.

The gear112may be configured to engage a corresponding gear surface of a control arm202(visible inFIG.7B) that contacts or blocks the needle insertion mechanism200. Rotation of gear112causes movement of the control arm202, which may initiate or permit rotation of needle insertion mechanism200.

Moreover, the rotational biasing member may be prevented from de-energizing by contact of a component of the insertion mechanism with a rotation prevention feature, such as a blocking aspect of the control arm, of the drug pump. In one example, the rotational biasing member210may be prevented from de-energizing by interaction of gear surface208with gear112.

Additionally, or alternatively, the needle insertion mechanism may be mechanically activated. For example, the rotational biasing member210may be caused to de-energize upon depression of the activation button14. As described in more detail in International Patent Application Publication Number WO 2016/130679, which is incorporated herein by reference, depression of activation button14may allow rotation of NIM retainer610. This rotation of NIM retainer610allows de-energizing of biasing member210and insertion of a cannula into the patient. In addition, as shown inFIG.10, extension610C of NIM retainer610may contact status switch620, thereby providing a signal to power and control system800that needle insertion has been activated. This signal may, as described herein, trigger a number of functions of power and control system800, including the entering of a delay mode. Embodiments of the mechanical activation of the needle insertion may be found in International Patent Application Publication WO 2016/130679, which is incorporated herein by reference.

It is contemplated that, in one example, at least the prevention of the rotation of the rotational biasing member210may be implemented prior to the on-body sensing. As such, when the on-body sensor840senses skin portion of the user, and/or the power and control system800receives input for initiation of the drug delivery (e.g., via the activation button) and/or input for needle insertion, the power and control system800may command the drive control system820to permit the rotationally biased member210to, at least partially, de-energize. This may cause one or more components of the insertion mechanism200, drive control mechanism100and/or regulating mechanism500to rotate and, in turn, cause, or allow, the insertion of the needle into the patient. Furthermore, a cannula may be inserted into the patient as described above.

As detailed below, during the delivery of the drug, based on the interactions among the drive control system820, the drive mechanism100and the regulating mechanism500, the insertion mechanism may be further controlled. For example, when the control arm or another component of the drive control system820recognizes a slack in the tether, the rotationally biased member may be allowed to further de-energize, causing additional rotation of one or more components of the insertion mechanism200.

This rotation may cause, or allow, the drive control system820to retract the needle from the patient. The needle may be fully retracted in a single step or there may be multiple steps of retraction.

In at least one embodiment, the needle insertion mechanism200may be configured such that a particular degree of rotation upon rotational axis ‘R’ (shown inFIGS.2B-2C) enables the needle/trocar to retract as detailed above. Additionally or alternatively, such needle/trocar retraction may be configured to occur upon a user-activity or upon movement or function of another component of the drug pump. In at least one embodiment, needle/trocar retraction may be configured to occur upon end-of-drug-delivery, as triggered by, for example, the regulating mechanism500and/or one or more of the sensors (e.g., the tether sensor, pressure sensor, etc.) During these stages of operation, delivery of fluid substances from the drug chamber21may be initiated, on-going, and/or completed by the expansion of the biasing member122from its initial energized state acting upon the piston110and plunger seal60.

In one embodiment, translation of the activation mechanism may be a part of, or operate, a NIM activation mechanism. The NIM activation mechanism may include an enabling mechanism as shown inFIGS.17A-17B. In this embodiment, translation of the activation mechanism14may be directly or indirectly coupled to a slide602. In a first configuration, the enabling mechanism is configured such that translation of the activation mechanism and slide does not cause activation of the needle insertion mechanism200or sterile fluid pathway connection300.

FIGS.17A-17Billustrate the enabling mechanism configured such that translation of the activation mechanism14(SeeFIG.1A) and slide602causes activation of the needle insertion mechanism200. Transformation of the enabling mechanism from the first configuration to the second configuration may be initiated by, for example, triggering of an on-body sensor, or by the elapsing of a predetermined amount of time after power-on of the device. The transformation of the enabling mechanism from the first to the second configuration may be performed by rotation of the actuator101which may cause a selector member604to become aligned with an aspect of the slide602. The selector member604may include a ramped surface604A which is configured to contact a portion of the slide602upon translation of the activation mechanism14and slide602. The selector member604may be mounted to or be an integral portion of the gear interface such as key1101. Contact of the slide602with the selector member604may cause the slide602to be displaced such that a portion of the slide is aligned with a portion of a throw arm or control arm606, such as protrusion606A. In this configuration, translation of the activation mechanism14causes translation of the throw arm606. Translation of the throw arm606causes activation of the needle insertion mechanism200to insert the fluid path into the target. During manufacturing, transportation, and storage, the enabling mechanism is in the first configuration in which depression of the activation mechanism14does not activate the needle insertion mechanism200. In this way, the needle insertion mechanism is prevented from activating prematurely. Contact of the slide602with the selector member604may cause substantially rigid body displacement of the slide or, alternatively, the contact may cause a deformation of the slide. For example, the slide may include a deformable (i.e., less rigid) portion which may be displaced by the contact. At step930(seeFIG.9B) the enabling mechanism may be caused to enter this configuration, in order to allow NIM activation. With the enabling mechanism in this configuration, depression of activation button14may constitute step932.

One example of a NIM activation mechanism is shown inFIGS.11A-16B. For clarity, a number of components of the drug delivery device are hidden in these figures. The NIM activation mechanism includes: a slide602, a throw arm606, a NIM interlock608, and a NIM retainer610. Initially, as shown inFIGS.11A-12B, the NIM retainer610is positioned such that the NIM retainer610is in contact with a protrusion204of the NIM200such that the protrusion204is prevented from rotating about axis R (seeFIG.13B), thereby preventing activation of the NIM200. In the embodiment shown, the NIM retainer610is configured for rotational movement about axis B (seeFIG.15B). The NIM retainer610may, for example, be mounted to the housing12at the bore610A. For example, a pin or shaft may be disposed in bore610A around which the NIM retainer610may rotate. The pin or shaft may an integral portion of the housing12or, alternatively, may be a separate component. The NIM retainer610is prevented from rotating by contact between an arm610B of the NIM retainer610with the NIM interlock608. The NIM interlock608is disposed for translational motion (in the direction of the hatched arrow ofFIG.11B) and is initially held in position by a flex arm. The NIM interlock608is initially in a first position in which it is in contact with or adjacent to a lower surface606B of the throw arm606.

With the selector member604in the second configuration (shown inFIGS.17A-17B) depression of the activation mechanism14causes translation of the throw arm606as described above (in the direction of the solid arrow inFIG.11A). The ramped surface606C of the throw arm606contacts the NIM interlock608and causes the NIM interlock608to translate in a direction substantially orthogonal to the direction of translation of the throw arm606.FIGS.13A-14Bshow the position of the throw arm606and NIM interlock608after translation of the throw arm. As shown, in this configuration, the NIM interlock608is positioned adjacent to or in contact with an upper surface606D of the throw arm606. The window608A of the NIM interlock608is aligned with the arm610B of the NIM retainer610. Hence, as shown inFIGS.15A-16B, the NIM retainer610is able to rotate about axis B. The contact surfaces of protrusion204and retainer610may be configured such that the protrusion204applies a rotational force to NIM retainer610, thereby causing rotation of NIM retainer610about axis B. Alternatively, or additionally, the NIM retainer610may be biased to rotate by a biasing member. The biasing member may be, for example, a torsion spring. Rotation of the NIM retainer610causes the NIM retainer610to disengage the protrusion204of the NIM200. Hence, the NIM200is able to activate to insert a fluid path into a target.

In other embodiments, the NIM interlock608may directly engage a portion of the NIM200, such as the protrusion204, to initially prevent activation of the NIM200. Translation of the NIM interlock608in the direction orthogonal to the translation of the throw arm606may cause the NIM interlock608to disengage the NIM200and allow the NIM200to activate. Also, while the slide602and the throw arm606are shown here as separate components, it is contemplated that these can be combined into a single, unified component. In such an embodiment, the selector member may initially be configured to prevent translation of the slide and/or throw arm.

In another embodiment, the throw arm606is engaged with a portion of the NIM whereby translation of the throw arm606allows activation of the NIM200.

Additionally or alternatively, the drive control system820may indirectly engage the needle insertion mechanism200in order to establish the sterile fluid connection sub-system300, as described below.

Fluid Pathway Connection

The power and control system800and/or drive control system820may additionally establish the fluid pathway connection or sub-system300by connecting the sterile fluid conduit to the drug container, to enable the fluid pathway connection.

The establishment of the fluid pathway connection300may be performed prior to, during, or after the wait time period. Additionally, the pathway connection300may be established prior to, or during the actuation of the insertion mechanism200. In some embodiments, the power and control system800may cause the establishment of the fluid pathway connection300via the multi-function drive mechanism100, and/or one of the other sub-systems such as the needle insertion mechanism or sub-system200. Generally, a suitable fluid pathway connection includes a sterile fluid conduit, a piercing member, and a sterile sleeve attached to a drug container or a sliding pierceable seal integrated within a drug container. The fluid pathway connection may further include one or more flow restrictors. Upon activation of the device10, the fluid pathway connection300is established to connect the sterile fluid conduit to the drug container of the drive mechanism100. Such connection may be facilitated by a piercing member, such as a needle, penetrating a pierceable seal of the drug container of the drive mechanism100. The sterility of this connection may be maintained by performing the connection within a flexible sterile sleeve. Upon substantially simultaneous activation of the insertion mechanism200, the fluid pathway between drug container and insertion mechanism is complete to permit drug delivery into the body of the user. In one such embodiment, the fluid pathway connection may be substantially similar to that described in International Patent Application No. PCT/US2012/054861, which is included by reference herein in its entirety for all purposes. In such an embodiment, a compressible sterile sleeve may be fixedly attached between the cap of the drug container and the connection hub of the fluid pathway connection. The piercing member may reside within the sterile sleeve until a connection between the fluid connection pathway and the drug container is desired. The sterile sleeve may be sterilized to ensure the sterility of the piercing member and the fluid pathway prior to activation.

Alternatively, the fluid pathway connection may be integrated into a drug container as described in International Patent Applications No. PCT/US2012/054861, PCT/US2013/030478, No. PCT/US2014/052329, or PCT/US2016/020486, for example, which are included by reference herein in their entirety for all purposes.

According to such an embodiment, a drug container50may have a drug chamber21within a barrel between a pierceable seal (not shown) and a plunger seal60. A drug fluid is contained in the drug chamber21. Upon activation of the device by the user, a drive mechanism (e.g., multi-function drive mechanism100) asserts a force on a plunger seal60contained in the drug container. As the plunger seal60asserts a force on the drug fluid and any air/gas gap or bubble, a combination of pneumatic and hydraulic pressure builds by compression of the air/gas and drug fluid and the force is relayed to the sliding pierceable seal. The pierceable seal is caused to slide towards the cap52, causing it to be pierced by the piercing member retained within the integrated sterile fluid pathway connection. Accordingly, the integrated sterile fluid pathway connection is connected (i.e., the fluid pathway is opened) by the combination pneumatic/hydraulic force of the air/gas and drug fluid within the drug chamber created by activation of a drive mechanism100. Once the integrated sterile fluid pathway connection is connected or opened, drug fluid is permitted to flow from the drug container50, through the integrated sterile fluid pathway connection300, sterile fluid conduit, and insertion mechanism200, and into the body of the user for drug delivery. In at least one embodiment, the fluid flows through only a manifold and a cannula and/or needle of the insertion mechanism, thereby maintaining the sterility of the fluid pathway before and during drug delivery.

In one embodiment, the power and control system800may command the drive control system820to establish or activate the sterile fluid pathway subsystem or connection300. For example, the connection300may be established via the needle insertion mechanism200which may be activated or controlled by the multi-function drive mechanism100.

Additionally or alternatively, the sterile fluid pathway connection300may be directly initiated by the multi-function drive mechanism100. For example, the control unit810may command the motor101to actuate a rotational gear, such as the star gear102described in detail herein, that may operate concurrently or sequentially to: (a) control the rate of drug delivery, (b) to actuate the needle insertion mechanism200, and/or (c) initiate the sterile fluid pathway connection300, based on various predetermined times (e.g., the wait time period, the drug delivery period) as provided by the power and control system800.

In one embodiment, shown inFIGS.1A-1C, the multi-function drive mechanism100performs all of these steps substantially concurrently. In that embodiment, the drive control system820causes the multi-function drive mechanism100to rotate a gear (e.g., star gear102) that acts upon several other components (e.g., other gear assemblies). For example, the gear acts on a gear assembly to control the rate of drug delivery, while also contacting a needle insertion mechanism200to introduce a fluid pathway connection200into the user. As the needle insertion mechanism200is initiated, the sterile fluid connection is made to permit drug fluid flow from the drug container50, through the fluid conduit, into the needle insertion mechanism200, for delivery into the patient as the gear and gear assembly of the multi-function drive mechanism control the rate of drug delivery.

It will be appreciated that, the drug pump device10is configured to deliver a range of drugs with different viscosities and volumes via the established sterile fluid pathway subsystem or connection300. In addition, the drug pump device10delivers a drug at a controlled flow rate (speed) and/or of a specified volume. In one embodiment, the drug delivery process is controlled by one or more flow restrictors (not shown) within the fluid pathway connection and/or the sterile fluid conduit. In other embodiments, other flow rates may be provided by varying the geometry of the fluid flow path or delivery conduit

As shown inFIGS.2A-2D and3A-3D, rotation of the needle insertion mechanism200in this manner may also cause a connection of a sterile fluid pathway to a drug container to permit fluid flow from the drug container to the needle insertion mechanism for delivery to the user. In such an example, the control unit810may command and control: (a) drive mechanism100, (b) the needle insertion mechanism200, and (c) the sterile fluid pathway connection300. For example, ramp aspect222of needle insertion mechanism200is caused to bear upon a movable connection hub322of the sterile fluid pathway connection300. As the needle insertion mechanism200is rotated by the multi-function drive mechanism100(based on the control unit810command), ramp aspect222of needle insertion mechanism200bears upon and translates movable connection hub322of the sterile fluid pathway connection300to facilitate a fluid connection therein.

Moreover, the drug pump device10may control the flow rate of the drug. In one example, the flow rate may be controlled by the drive control system820(e.g., the motor of the drive control system) by varying the speed at which one or more components of the drive mechanism100advances into the drug container50to dispense the drug. It is noted that, a combination of the different flow rate control methods may be implemented to control the flow of the drug via the sterile fluid pathway connection300.

The power and control system800(e.g., the control unit810) may send command signal to the drive control system820to control the flow rate control sub-system or regulating mechanism500via the multifunction drive mechanism100as discussed below. The rate of drug delivery as controlled by the drive control system820may be determined by: selection of the gear ratio of gear assembly516; selection of the main/star gear102; selection of the diameter of winding drum/gear520and further driving such elements by commanding the actuator101to control the rate of rotation of the main/star gear102; or any other method known to one skilled in the art. By using electromechanical actuator101to control and adjust the rate of rotation of the main/star gear102, it may be possible to configure the drug pump device10to provide a variable dose rate (i.e., the rate of drug delivery is varied during a treatment).

Additionally, the drive control system820may control the regulating mechanism or sub-system500which may include controlling the rate of drug delivery by metering, providing resistance, or otherwise preventing free axial translation of the plunger seal utilized to force a drug substance out of a drug container.

With references to the embodiments shown inFIGS.2A-2D and3A-3D, the power and control system820may control the drive mechanism100via the motor101. The drive mechanism100may include a gear assembly116including a main gear102, a drive housing130, and a drug container50having a cap52, a pierceable seal (not visible), a barrel58, and a plunger seal60. The main gear102may be, for example, a star gear disposed to contact multiple secondary gears or gear surfaces. A drug chamber21, located within the barrel58between the pierceable seal and the plunger seal60, may contain a drug fluid for delivery through the insertion mechanism and drug pump into the body of the user. The seals described herein may be comprised of a number of materials but are, in a preferred embodiment, comprised of one or more elastomers or rubbers. The drive mechanism100may further contain one or more drive biasing members, one or more release mechanisms, and one or more guides, as are described further herein. The components of the drive mechanism100function to force a fluid from the drug container out through the pierceable seal, or preferably through the piercing member of the fluid pathway connection300, for delivery through the fluid pathway connection, sterile fluid conduit, and insertion mechanism into the body of the user.

In one particular embodiment, the drive mechanism100employs one or more compression springs as the drive biasing member(s)122. In such embodiment, upon the activation of the drug pump by the user (e.g., via the activation button) the power and control system800may be configured to directly or indirectly (and electromechanically) release the drive biasing members122from an energized state. Upon release, the drive biasing members122may bear against and act upon the plunger seal60to force the fluid drug out of the drug container. The compression spring may bear against and act upon a piston which, in turn, acts upon the plunger seal60to force the fluid drug out of the drug container. In one example, one or more drive biasing members122may be compressed between the drive housing130and piston110, wherein the drive biasing members122may bear upon an interface surface of the piston110.

Optionally, a cover sleeve (not shown) may be utilized between the drive biasing members122and the interface surface of the piston110for example, to promote even distribution of force from the drive biasing member122to the piston110, prevent buckling of the drive biasing members122, and/or hide biasing members122from user view. Interface surface of piston110is caused to rest substantially adjacent to, or in contact with, a proximal end of seal60. Although the embodiments shown inFIGS.2A-2D and3A-3Dshow a singular biasing member it is also contemplated that one or more biasing members disposed to act in parallel may be used.

As discussed below, in some embodiments, the drive control system820and/or the power and control system800may control the delivery rate of the drug via the drive mechanism100, insertion mechanism200and the regulating mechanism500.

As best shown inFIG.2DandFIG.3D, the piston110may be comprised of two components and have an interface surface to contact the plunger seal60.

Moreover, a tether, ribbon, string, or other retention strap (referred to herein as the “tether”525) may be connected at one end to the piston110. For example, the tether525may be connected to the piston110by retention between the two components of the piston110when assembled. The tether525is connected at another end to a winch drum/gear520(including a winch drum52013and a winch gear520A) of regulating control mechanism500. Through the use of the winch drum/gear520connected to one end of the tether525, and the tether525connected at another end to the piston110, the regulating mechanism500functions to control, meter, provide resistance, or otherwise prevent free axial translation of the piston110and plunger seal60utilized to force a drug substance out of a drug container50.

Accordingly, the power and control system800may control the regulating sub-system or mechanism500which may be a portion of the gear assembly116aspect of the multi-function drive mechanism, and which together may function to control the rate or profile of drug delivery to the user.

With reference toFIG.8C, the power and control system, via the drive control system820, may control the regulating mechanism500(e.g., via the drive control mechanism100). For example, the control unit810may drive the actuator or motor101to drive the gear assembly (e.g., gear assembly516) of the regulating mechanism500, by selecting appropriate configurations for the motor101and the gear assembly. Moreover, the driving of the regulating mechanism may be time-controlled, as discussed herein.

As shown inFIGS.2A-2D and3A-3D, and in isolation inFIGS.4and5A-5B, in the embodiments of the present disclosure, the regulating mechanism500is a gear assembly driven by an actuator101. Moreover, upon receiving command signals from the control unit810, the motor101may control the regulating mechanism500to retard or restrain the distribution of tether525, thus allowing the tether525to advance at a regulated or desired rate. This restricts movement of piston110within barrel58, which is pushed by one or more biasing members122, hence controlling the movement of plunger seal60and delivery of the drug contained in chamber21. As the plunger seal60advances in the drug container50, the drug substance is dispensed through the sterile pathway connection300, conduit, insertion mechanism200, and into the body of the user for drug delivery. In one example, the regulated motion of the tether525may be monitored by an optional tether sensor875which may provide status feedback to the control unit810of the power and control system800. The control unit810may process the feedback status information of the regulated motion of the tether525to further control the regulating mechanism500.

As discussed above, in at least one embodiment, the motor101may be a Pac-Man motor that has a gear interface within which one or more teeth of the main gear may partially reside during operation of the drug delivery pump device10. The operation of the Pac-Man motor may be controlled by the control unit810(seeFIGS.5A-5B).

In one example, when the gear interface101A of the Pac-Man motor101is in alignment with a tooth102A of the main gear102, rotational motion of the Pac-Man motor101causes gear interface rotation of the main gear102. When the Pac-Man motor101is between gear teeth of the main gear, it may act as a resistance for, for example, back-spinning or unwinding of the gear assembly116. In one particular embodiment, the Pac-Man motor101utilizes an alternating direction type motor to rotate the Pac-Man motor101backwards and forwards. This configuration aids in the prevention of a runaway condition, where the motor and the gears are freely permitted to rotate, by using the multi-direction of the motor to prevent continuous spin in one direction (as would be needed for a runaway condition). This bi-directional movement of the motor, coupled with the use of the gear interface cut within the Pac-Man motor, may provide suitable safety features to prevent a runaway condition that could potentially lead to over-delivery of drug to the user. Further detail about the gear assembly116, regulating mechanism500, and multi-function drive mechanism100are provided herein. In a particular embodiment shown inFIGS.5A-5B, the regulating mechanism500further includes one or more gears511,512,513,514, of a gear assembly516. One or more of the gears511,512,513,514may be, for example, compound gears having a small diameter gear attached at a shared center point to a large diameter gear. Gear513may be rotationally coupled to winch drum/gear520, for example by a keyed shaft, thereby coupling rotation of gear assembly516to winch drum/gear520. Compound gear512engages the small diameter gear513such that rotational movement of the compound gear aspect512B is conveyed by engagement of the gears (such as by engagement of corresponding gear teeth) to gear513. Compound gear aspect512A, the rotation of which is coupled to gear aspect512B, is caused to rotate by action of compound gear aspect102B of the main/star gear102. Compound gear aspect102B, the rotation of which is coupled to main/star gear102, is caused to rotate by interaction between main/star gear102A and interface101A of the actuator101. Thus, rotation of main/star gear102is conveyed to winch drum/gear520. Accordingly, rotation of the gear assembly516initiated by the actuator101(of the drive control system820) may be coupled to winch drum/gear520(i.e., through the gear assembly516), thereby controlling the distribution of tether525, and the rate of movement of plunger seal60within barrel58to force a fluid from drug chamber21. The rotational movement of the winch drum/gear520, and thus the axial translation of the piston110and plunger seal60, are metered, restrained, or otherwise prevented from free axial translation by other components of the regulating element500, as described herein. As described above, the actuator101may be a number of known power/motion sources including, for example, a motor (e.g., a DC motor, AC motor, or stepper motor) or a solenoid (e.g., linear solenoid, rotary solenoid).

As discussed above, the embodiments shown inFIGS.7A-7Bshow an actuator101that is driven by the control unit810, and is in horizontal alignment and indirect engagement with the main/star gear102. Such an embodiment may utilize a rack and pinion engagement, a drive screw, or a worm gear101W, as shown inFIGS.7A-7B, to change the direction of motion from horizontal to vertical (i.e., perpendicular interaction). Actuator101(based on command signals received from the control unit810) rotates worm gear101W, which engages gear101G and conveys the motion to the Pac-Man gear101A. The Pac-Man gear101A engages main/star gear102to enable operation of the drive mechanism and the drug delivery device, as described herein.

The control unit810controls main star gear102via the motor101. The main star gear102may then drive the gear assembly. For example, main/star gear102may drive operation of gear112to enable operation of the needle insertion mechanism200, as described herein.

In one embodiment, the control unit810provides command signals such that the actuator101rotate the worm gear101W, gear101G, and Pac-Man gear101A backwards and forwards. This configuration aids in the prevention of a runaway condition, where the motor and the gears are freely permitted to rotate, by using the multi-direction of the motor to prevent continuous spin in one direction (as would be needed for a runaway condition). This bi-directional movement of the actuator101, coupled with the use of the gear interface of the worm gear101W, gear101G, and Pac-Man gear101A with the main/star gear102, provide suitable safety features to prevent a runaway condition that could potentially lead to over-delivery of drug to the user.

Additionally, the motor101may include a stop member101B that stops the rotation of the Pac-Man gear101A against a stop block150. Stop block150further prevents over-rotation of the Pac-Man gear101A and, accordingly, the main/star gear102to prevent a runaway condition that could potentially lead to over-delivery of drug to the user. For the device to function in this configuration, the Pac-Man gear101A must be rotated backwards the other direction before rotating forwards again to progress the main/star gear102because the stop member101B prevents over rotation in one direction by interaction with the stop block150.

Additionally, the geometry of worm gear101W may be configured such that it is self-locking and/or cannot be back-driven by gear101G. This may be done by configuration of parameters such as: pitch, lead angle, pressure angle, and number of threads. In so doing, runaway conditions of the drive mechanism will be prevented by the worm gear's resistance to rotations that are not caused by actuator101. Alternatively or additionally, the control unit810may be configured to determine whether there is any feedback from the worm gear101W that is caused by the rotations of other gears (e.g., gear101G) and not by the motor101. If the control unit810determines or receives such feedback, the control unit810may terminate further operations.

It is noted that, the power and control system800does not control the regulating mechanisms500of the present invention to drive the delivery of fluid substances from the drug chamber21. The delivery of fluid substances from the drug chamber21is caused by the expansion of the biasing member122from its initial energized state acting upon the piston110and plunger seal60(which may be actuated by the control unit810via the motor101). The regulating mechanisms500instead function to provide resistance to the free motion of the piston110and plunger seal60as they are pushed by the expansion of the biasing member122from its initial energized state. The regulating mechanism500does not drive the delivery but only controls the delivery motion. The tether limits or otherwise restrains the motion of the piston110and plunger seal60, but does not apply the force for the delivery. According to a preferred embodiment, the controlled delivery drive mechanisms and drug pumps of the present invention include a regulating mechanism indirectly or directly connected to a tether metering the axial translation of the piston110and plunger seal60, which are being driven to axially translate by the biasing member122.

In one example, the power and control system800of the drug pump device10may be configured to receive one or more regulating parameters for controlling the regulating mechanism500. Alternatively, or additionally the power and control system800may receive sensor inputs (e.g., heart rate sensor, glucose monitor sensor information) and may then translate the sensor inputs into regulating parameters. The control unit810may then control the regulating mechanism500after a predetermined time (e.g., after the wait time period). Based on the inputs, the control unit810may meter the release of the tether525by the winch drum/gear520and thereby permit axial translation of the piston110by the biasing member122to translate a plunger seal60within a barrel58.

Based on the regulating parameters, the control unit810and motor101may additionally control the restraint provided by the tether525and winch drum/gear520on the free axial translation of the piston110upon which the biasing member122bears upon via the motor101. The control unit810may control such operations to provide a desired drug delivery rate or profile, to change the dose volume for delivery to the user, and/or to otherwise start, stop, or pause operation of the drive mechanism In one example, the control unit810may control the drug delivery rate in order to complete a drug delivery dose within a desired or a predetermined time. In one embodiment, the tether may be released and permitted to unwind unrestrained. This may provide a bolus delivery of the fluid.

During the drug delivery process, and after a predetermined wait time period, the power and control system may provide delivery instructions to the drive control system820. Based on the instructions, the drive control system may control the components of the drive mechanism100, to axially translate the plunger seal60of the drug container50in the distal direction. Optionally, the drive mechanism100and/or the regulating mechanism500may include one or more compliance features which enable additional axial translation of the plunger seal60to, for example, ensure that substantially the entire drug dose has been delivered to the user. For example, the plunger seal60, itself, may have some compressibility permitting a compliance push of drug fluid from the drug container.

For example, the controlled delivery drive mechanisms and/or drug pumps of the present invention may additionally enable a compliance push to ensure that substantially all of the drug substance has been pushed out of the drug chamber21. The plunger seal60, itself, may have some compressibility permitting a compliance push of drug fluid from the drug container. For example, when a pop-out plunger seal is employed, i.e., a plunger seal that is deformable from an initial state, the plunger seal may be caused to deform or “pop-out” to provide a compliance push of drug fluid from the drug container. Additionally or alternatively, an electromechanical status switch may be utilized to contact, connect, or otherwise enable a transmission to the control unit810of the power and control system800to signal end-of-dose to the user. This configuration may further enable true end-of-dose indication to the user.

As discussed with reference toFIG.8B, the drive control system820may include various sensors (e.g., the tether sensor875, valve sensor877, pressure sensor870) that may be coupled to the control unit810and/or to the motor101. The sensors may be configured to provide signal or status information for various elements of the systems and sub-systems of the drug pump device10. In one example, the control unit810may process the feedback signals or the status information received from the sensors to control the sub-systems, such as the regulating sub-system or mechanism500.

Additionally, the power and control system800may provide notification to the user based on the feedback provided by the sensors to the control unit. The notification may be tactile, visual, and/or auditory, as described above, and may be redundant such that more than one signal or type of notification is provided to the user during use of the device. For example, the user may be provided an initial notification to indicate that the drug pump device10is operational and ready for drug delivery and may further provide an end-of-dose notification, based on the feedback signal provided, for example, by one or more sensors. In one example, pressure sensor870and/or a valve sensor877, positioned at appropriate location in the drug pump device10, may sense the end-of-dose when the piston reaches the end of its axial translation. Accordingly, the control unit810may then provide an end-of-dose notification based on the sensor signals received from the sensors.

Additionally or alternatively, tether525may have one or more sensor triggers such as electrical contacts, optical markings, and/or electromechanical pins or recesses that are configured to provide status feedback to the tether sensors875, and in turn, to the control unit820. In at least one embodiment, an end-of-dose status notification may be provided to the user once the tether sensor875detects that the final status trigger positioned on the tether525has reached a final position upon the end of axial travel of the piston110and plunger60within the barrel58of the drug container50. The tether sensor875may be, for example, an electrical switch reader to contact the corresponding electrical contacts, an optical reader to recognize the corresponding optical markings, or a mechanical or electromechanical reader configured to contact corresponding pins, holes, or similar aspects on the tether525.

In one example, the status triggers (not shown) may be positioned along the tether525to be read or detected at positions which correspond with the beginning and end of drug delivery, as well as at desired increments during drug delivery.

In some examples, the drive control system820initiates the drug delivery (upon actuation of the drive mechanism100) by release of the biasing member122and the resulting force applied to the piston110and plunger seal60. The power and control system800further instructs the drive control system820to control the rate or profile of drug delivery to the user by controlling the regulating mechanism500, gear assembly516, winch drum/gear520, releasing the tether525and permitting expansion of the biasing member122and axial translation of the piston110and plunger seal60. As this occurs, the status triggers of the tether525are contacted or recognized by the tether sensor and the status of the drive mechanism before, during, and after operation can then be relayed to the control unit810of the power and control system800to provide feedback to the user. Depending on the number of status triggers located on the tether525, the frequency of the incremental status indication may be varied as desired. As described above, a range of tether sensors may be utilized depending on the status triggers utilized.

In some embodiments, the tether sensor may include one or more sensors of similar type, and/or a combination of different types of sensors. In one example, a tension force may be applied to the tether525(e.g., according to one or more command signals from the control unit810). When the drug pump device10reaches the end-of-dose, the tether525goes slack which may be detected by a tether sensor875such as an electrical or electromechanical switch. The tether sensor875may signal a slack in the tether525to the control unit810of the power and control system800.

Additionally, gear511A and/or gear511B, or any other gear of gear assembly516may be configured as an encoder along with a sensor. For example, the sensor/encoder combination873may be configured to provide feedback of gear assembly rotation. In one example, the encoder/sensor873may be calibrated to an initial position of the piston (e.g., the position of piston110when there is no slack in the tether525). Moreover, this positional information may be recorded or stored in the control unit810. As such, the control unit810or the power and control system800may receive positional feedback, end-of-dose signal, and error indication, such as an occlusion, for example, due to a slack in the tether525prior to reaching the expected number of motor rotations as counted by the sensor/encoder873c. Alternatively or additionally, the drive control system820may control the rate of flow of drug via the tether525in combination with the regulating mechanism500.

It will be appreciated that, additional and/or alternative means may be implemented for terminating or restraining the flow of the medicament in the case of slack in, or failure of, the tether525(e.g., during a breakage of the tether). For example, International Patent Application Publication Number WO 2016/130679, which is incorporated herein by reference, describes a number of such safety mechanisms.

FIGS.6A-6Bshows one such embodiment for a safety-stop during a failure of the tether525. Disposed within barrel58are brake64, sleeve62, and plug68, and optionally retainer66. Biasing member122bears against sleeve62. Initially, the tether525is engaged with plug68, thereby allowing tether525to restrain the motion of sleeve62. This restraint controls the rate of expansion or de-energizing of biasing member122. When tether525is under tension, plug68bears against distal face64A of brake64, causing proximal face64B of brake64to bear against sleeve62. Due to this contact, and the profile of the distal end62A of sleeve62, brake64is maintained in a substantially conical configuration as shown inFIG.6A. In this configuration, expansion or de-energizing of biasing member122is restrained. Also, in this conical configuration, the outer diameter of brake64is less than the inner diameter of barrel58, thus translation of the brake is not restrained by contact with the inner wall of the drug container. Also, a portion of brake64is in contact with retainer66. Because brake64is maintained in this configuration by plug68and sleeve62, translation of sleeve62, caused by decompression of biasing member122, is transferred to retainer66. Likewise, contact of retainer66with plunger seal60causes translation of plunger seal60.

As shown inFIG.6B, in the event of slack in, or failure of, tether525, plug68is no longer held in position by tether525and, therefore, no longer restrains motion of sleeve62. As biasing member122decompresses or de-energizes, brake64transforms to a relatively less conical or flatter configuration. This may be caused by a natural bias of brake64to transform to this configuration or, alternatively, may be caused by contact of brake64with both retainer66and sleeve62. As the brake is transformed, it comes into contact with the inner wall of barrel58. The brake thus acts as a wedge to restrict translation of sleeve62. This may prevent further translation or may act to restrict the rate of translation. Optionally, restoring tension in the tether may cause the plug to contact the brake and to transform the brake back to its conical configuration and thus restore normal operation of the drug pump.

FIGS.6A-6Bshows the plug as having a spherical shape and the brake as having a conical shape. Such shapes are used herein merely for exemplary purposes and other shapes or configurations could readily be utilized to achieve the same or similar functionality. For example, the plug may itself be conical in shape and, in one embodiment, be shaped to interface the brake when the brake is in a conical shape. In such a configuration, the conical shape of the plug assists in maintaining the conical shape of the brake, thereby preventing contact between the outer diameter of the brake with the inner diameter of the barrel in order to restrict the axial translation of the sleeve62(i.e., applying a braking force). In another embodiment, the brake64could employ a star-shaped or other configuration when in a substantially flattened position so as to make contact with the inner diameter of the barrel58to prevent or restrict further axial translation of sleeve62. Without further translation of sleeve62, biasing member122cannot expand or de-energize further which, in turn, prevents or restricts further drug delivery to the user. This provides a necessary and useful safety measure for drug delivery, to prevent over-delivery or accelerated delivery of drug to the user.

Moreover, as discussed above, the control of the tether525may be provided by the control unit810. Additionally, any feedback related to slack or failure of the tether525may be provided to the drive control system820and/or to the power and control system800.

As described above, the regulating mechanisms500provide resistance to the free motion of the piston110and plunger seal60as they are pushed by the expansion of the biasing member122from its initial energized state. The regulating mechanism500may not drive the delivery but may only control the delivery motion.

It is noted that, the tether may limit or restrain the motion of the piston110and plunger seal60, but may not apply the force for the delivery (seeFIGS.2A-2D and3A-3D). The motion of the piston110and plunger seal60as they are pushed by the expansion of the biasing member122from its initial energized state are shown in the direction of the solid arrow along axis ‘A’ from proximal or first position ‘ID’ to the distal or second position ‘D’, as shown in the transition ofFIGS.2A-2D and3A-3D.

Control of the tether525is further described with reference toFIG.4andFIGS.5A-5B.

FIG.4shows a perspective view of the multi-function drive mechanism, according to at least a first embodiment, during its initial locked stage. Initially, the tether525may retain the biasing member122in an initial energized position within piston110. When the power and control system800receives inputs for activation, it commands the drive control system to initiate the multi-function drive mechanism100. In one example, the drive mechanism100may cause the biasing member to impart a force to piston110and therefore to tether525. This force on tether525imparts a torque on winding drum520which causes the gear assembly516and regulating mechanism500to begin motion.

Moreover, as shown inFIG.3C, the piston110and biasing member122are both initially in a compressed, energized state behind the plunger seal60. The biasing member122may be maintained in this state until activation of the device between internal features of drive housing130and interface surface of piston110. As the drug pump10is activated and the drive mechanism100is triggered to operate, biasing member122is permitted to expand (i.e., decompress) axially in the distal direction (i.e., in the direction of the solid arrow shown inFIGS.2A-2DandFIGS.3A-3D). Such expansion causes the biasing member122to act upon and distally translate interface surface and piston110, thereby distally translating plunger seal60to push drug fluid out of the drug chamber21of barrel58.

As discussed above, an end-of-dose status indication may also be provided to the user once one or more sensors contacts or detects the end of axial travel of the piston110and plunger seal60within the barrel58of the drug container50(e.g., based on a status trigger positioned on the tether525). The status triggers may be positioned along the tether525at various increments, such as increments which correspond to certain volume measurement, to provide incremental status indication to the user. In at least one embodiment, the sensor is an optical status reader configured to recognize the corresponding optical status triggers on the tether. As would be understood by an ordinarily skilled artisan, such optical status triggers may be markings which are recognizable by the optical status reader. In another embodiment, the status reader is a mechanical or electromechanical reader configured to physically contact corresponding pins, holes, or similar aspects on the tether. Electrical contacts could similarly be utilized on the tether as status triggers which contact or are otherwise recognized by the corresponding electrical sensors. The status triggers may be positioned along the tether525to be read or recognized at positions which correspond with the beginning and end of drug delivery, as well as at desired increments during drug delivery. As shown, tether525passes substantially axially through the drive mechanism housing130, the biasing member122, and connects to the piston110to restrict the axial translation of the piston110and the plunger seal60that resides adjacent thereto. The sensors may communicate the detected information (e.g., the end of dose information, incremental motion, restricted motion, etc.) to the drive control system820and/or to the power and control system800to notify or provide feedback of the controlled motion of the various components.

As mentioned above various sensors may be coupled directly to the power and control system800or via the drive control system820, and may be configured to provide the incremental status indication. A user may then be notified of such indication based on, for example, the detection of the rotational movement of one or more gears of gear assembly516. For example, as the gear assembly516rotates, a sensor may read or detect one or more corresponding status triggers on one of the gears in the gear assembly to provide incremental status indication before, during, and after operation of the variable rate controlled delivery drive mechanism. A number of sensors may be utilized within the embodiments of the present invention.

In one example, the drive mechanism100may utilize an electro-mechanical sensor which may be physically in contact with the gear teeth of one of the gears of the gear assembly. As the sensor is contacted by the status or sensor trigger(s), which in this exemplary embodiment may be the gear teeth of one of the gears (or holes, pins, ridges, markings, electrical contacts, or the like, upon the gear), the sensor measures or detects the rotational position of the gear and transmits a signal to the power and control system800for status indication or notification to the user.

Additionally or alternatively, the drive mechanism100may utilize an electro-optical sensor. The optical sensor may include a light beam that may be configured detect a motion and transmit a status signal to the power and control system. For example, the optical sensor may be configured to detect motion of the gear teeth of one of the gears in the gear assembly (or holes, pins, ridges, markings, electrical contacts, or the like, upon the gear). In another embodiment, the sensor may be an electrical switch configured to recognize electrical contacts on the gear. In any of these embodiments, the sensor may be utilized to then transmit a signal to the power and control system to provide notification feedback to the user about the controlled motion and/or the delivery of the drug.

As would be appreciated by one having ordinary skill in the art, electro-optical sensors and corresponding triggers, electromechanical sensors and corresponding triggers, and/or electrical or mechanical sensor and corresponding triggers may all be implemented by the embodiments of the present invention to provide incremental status indication to the user power and control system800. While the drive mechanisms of the present invention are described with reference to the gear assembly and regulating mechanism, a range of configurations may be acceptable and capable of being employed within the embodiments of the present invention, as would readily be appreciated by an ordinarily skilled artisan. Accordingly, the embodiments of the present invention are not limited to the specific gear assembly and regulating mechanism described herein, which is provided as an exemplary embodiment of such mechanisms for employment within the controlled delivery drive mechanisms and drug delivery pumps.

Moreover, in at least one embodiment of the present invention, the delivery profile of the medicament is adjustable. For example, it may be desirable to deliver a bolus injection of medicament before, during, or subsequent to certain activities such as eating, exercising, sleeping, etc. A “bolus injection” is any measured drug volume that is delivered often irrespective of the delivery time or duration. Conversely, a “basal injection” is often a controlled rate of delivery and/or a drug delivery profile having various rates of delivery at different time intervals. Similarly, the user may desire to increase or decrease the basal delivery rate of the medicament at these or other times. In at least one embodiment, the delivery profile may be adjustable by the user to achieve this desired drug delivery. The user may adjust the delivery profile by interacting with the drug delivery device itself or, alternatively, may use an external device, such as a smart-phone, to do so. For example, the user may adjust the delivery profile by displacing the activation mechanism or may engage a separate device-integrated or external delivery control mechanism.

In another embodiment of the present invention, the delivery profile may be adjusted automatically based on one or more inputs. For example, the delivery profile may be adjusted based on the patient's activity level, heart rate, blood sugar level, blood pressure, etc. As above, these measurements may be used to determine the need for a bolus injection or for the increase or decrease of the basal injection delivery rate or adjustment to the basal injection delivery profile. In at least one embodiment, these input measurements may be monitored by the device itself. Additionally, or alternatively, they may be monitored by a secondary device such as a smart-phone, smart watch, heart rate monitor, glucose monitor, blood pressure monitor, or the like. In some embodiments, the delivery profile may be adjusted based on these measurements with no required user intervention. In the case of monitoring and/or control by a secondary device, the secondary device and drug delivery device may be in wireless or wired communication with one another. This communication may be through Bluetooth, near field communication, Wi-Fi, or any other method known to one having ordinary skill in the relevant art of device interconnectivity.

In a preferred embodiment, however, the monitoring/adjustment mechanism may alert and make recommendations to the user and the user may have active control to initiate/authorize or disregard the recommendation made by the monitoring/adjustment mechanism. For example, if one or more of the measurements is above or below a specified threshold value the device may emit an audible, visual, or tactile alert to the user. In one example, the alert is provided by a vibration of the device, thereby providing a discrete alert to the user. Additionally or alternatively, the alert may be provided by the user's smart-phone or other secondary device. The user may be able to view the current status of the measurements in a computer program or web interface on the device itself, a computer, smart-phone, or other device. The computer program or web interface may provide a recommended adjustment to the delivery profile. Based on this information, the user may adjust the delivery rate of the drug delivery device. As above, the user may adjust the delivery profile by displacing the activation mechanism or engaging a separate device-integrated or external delivery control mechanism.

In one embodiment, in response to a signal to adjust the delivery profile, either based on user input or based on the measurements described above, the power and control system may cause a change in the rate of movement of actuator101. The change in the rate of movement of actuator101causes a change in the rotation rate of regulating mechanism500which, in turn, controls the rate of drug delivery to the user. Alternatively, the delivery profile may be altered by a change in the characteristics of the flow path of medicament through the conduit connecting the drug container and insertion mechanism. The change may be caused by the introduction, removal, or modification of a flow restrictor which restricts flow of medicament from the drug container to the insertion mechanism. For example, a flow restrictor may have multiple flow paths which may be selectively placed in fluid communication with an input and an output of the flow restrictor. By providing flow paths which are of different length or cross-section the rate of delivery may be controlled. In other embodiments, the delivery profile may be altered by the introduction or removal of an impingement of the conduit. An impingement of the flow path may interrupt or slow flow of medicament through the conduit, thereby controlling the rate of delivery to the user. Accordingly, one or more embodiments of the present invention are capable of producing a change to the rate of medicament delivery from the drug container thereby providing a dynamic control capability to the multi-function drive mechanism and/or the drug delivery device.

Details of an exemplary method associated with drug delivery in a predetermined time are now provided with references toFIG.9A. One or more steps of the method900may be executed during active power mode or non-active power mode of the power and control system800. The method900, for example, includes steps related to initiating and delivering drug at an adjusted rate to a user by a drug pump device10after a predetermined wait time period. The method may include steps of communication between the drug pump device10and a mobile device11. The method may optionally monitor and receive information (e.g., heart rate of the user, glucose/insulin information, etc.) related to the health of the patient during the monitoring period. Particularly, the method requests a user of the drug pump device10to activate the needle insertion (i.e., initiate NIM200), after the device has been activated. Upon activation, by the user, of the needle insertion mechanism, a status switch may be activated, indicating to the power and control system that needle insertion has been completed. When the needle insertion has been actuated, the drug pump device10may then initiate a timer to track delay time period. Alternatively, a timer may be initiated by the activation of the device.

Furthermore, the method determines whether the predetermined wait time period has elapsed, and based on the determination may notify the user accordingly about the initiation of the drug delivery process. Optionally, the power and control system may regulate the delivery rate of the drug based on information received from sensors (e.g., temperature sensor, heart rate sensor, glucose monitor sensor). Regulation of the delivery rate may be based on optimization of the effectiveness of the drug. Alternatively, or additionally, the delivery rate may be regulated to reduce and/or minimize the user's discomfort. For example, delivery of a relatively cold drug may cause pain to the user. Hence, if the temperature sensor provides a signal to the control unit that the drug and/or drug container is low, the delivery rate may be reduced.

The method may further determine whether the drug delivery has ended, and based on the determination, in one example may further transmit the end of drug delivery information to the mobile device or cause an audible or visual indication to be emitted from the drug delivery device. The mobile device may further provide the received information to a remote server (e.g., a cloud server). Other parameters may be regulated based on the inputs from the sensors. For example, the delay between activation of an end-of-dose sensor and notification, to the user, that drug delivery has completed. The viscosity of the drug may be dependent on the temperature of the drug and a more viscous drug may require additional time to be fully delivered to the user. Hence, the control unit may use the input from the temperature sensor to determine how long to delay notification to the user of completion of delivery. The control unit may, for example, compare the input from the temperature sensor to a look-up table which is either stored locally or is accessed remotely. Alternatively, the control unit may use the input from the temperature sensor as an input in an equation used to calculate the delay.

Referring now toFIG.9A, the process flows depicted are merely embodiments of the invention and are not intended to limit the scope of the invention. For example, the steps recited in any of the method or process descriptions may be executed in any order and are not limited to the order presented. Furthermore, it will be appreciated that the following description makes appropriate references not only to the steps depicted inFIG.9A, but also to the various system components as described with reference to the present invention.

Referring now toFIG.9A, at step901, the pump device10is activated. The drug pump device10may be configured with an activation mechanism that may include receiving a trigger signal from the user to power the power and control system800. In one example, a user may activate the drug pump device10by pressing a start button that may be an on/off switch, and/or a toggle switch. The activation button or the switch may be located through the pump housing12, such as through an aperture between upper housing and lower housing, and which contacts either directly or indirectly the power and control system800(e.g., a via electrical contacts). The user may press the activation button or the switch a predetermined number of times (e.g., one single press) to initially activate the drug pump device10. Alternatively, pump device10may be activated by actuation of an on-body sensor. For example, pump device10may include a mechanical or electrical on-body sensor, such as those described in PCT/US2016/021585. In at least one embodiment, actuation of the on-body sensor completes a connection to provide power to the power and control system. Alternatively, the pump device10may be configured such that it is activated upon removal from a portion of its packaging. The pump device10may include one or more packaging status sensors that are configured to detect the removal of the pump device from a portion of the packaging. The packaging status sensor may take any form capable of detecting a removal of the pump device from a portion of the packaging. For example, the packaging status sensor may be in the form of a pin interconnect on the power and control system800that is either connected or disconnected when packaged. Removal from the packaging may cause the pin interconnect to change state from connected to disconnected or vice versa. This change of state may cause initiation of the timer. Alternatively, the packaging status sensor may consist of an optical sensor which is configured to detect a change in lighting conditions caused by a removal of the pump device10from a portion of the packaging.

In one example, upon receiving the activation input, a short-range wireless communication link may be initiated between the drug pump device10and the mobile device11. In one example, the wireless communication link may be established based on a Bluetooth pairing between the mobile device11and the drug pump device10.

In one example, during and/or upon the activation, the drug pump device10may be in a discovery mode, during which the mobile device11may discover the drug pump device10, and establish the wireless communication with the drug pump device10. Alternatively, the drug pump device10may initiate and establish the wireless communication with the mobile device11by sending short-burst signals or pings to the mobile device11.

Upon receiving the activation signal, the pump device10may provide notification or feedback to the user to indicate that the device10has been activated. For example, notification signals, such as audible tones, and/or visual notification such as LED lights, may be provided by the power and control system800.

It is contemplated that, in one example, a user may use the mobile device11to activate the drug pump device10. In such an example, prior to activation, the drug pump device10may be in communication only mode during which the drug pump device10may be configured to establish a communication link with the mobile device11(e.g., Bluetooth pairing). Upon establishing the communication link between the two devices, the user may select or press activation/start button10bto activate the drug pump device10.

In one example, the housing12may include one or more status indicators (e.g., light emitting diodes (LEDs) and/or speakers) and windows that may provide indication of the activation of the drug pump device10. The activation mechanism, the status indicator, the window, and combinations thereof may be provided on the upper housing or the lower housing such as, for example, on a side visible to the user when the drug pump10is placed on the body of the user. Housing12is described in further detail hereinafter with reference to other components and embodiments of the present invention.

Additionally or alternatively, the drug pump device10may push the activation notification to the mobile device11. In this example, the mobile app10amay cause the mobile device11to provide the notification via speakers or LED lights (not shown) of the mobile device11. Alternatively, the user may select the notification/data button10dto receive the notification of the activation.

When the drug pump device10and the mobile device11are linked via the short range wireless communication based on the device activation, the mobile device11may provide notification and guidance related to the operation of the drug pump device10. In one example, the mobile device11may provide instruction to place the drug pump device10on the body of the user.

It is noted that, during the device activation step, the drug pump device10may be in the non-active power mode (i.e., the power and control system800may be receiving power from the power source and the drive control system820(i.e., motor101) may not be receiving power from the power source).

Optionally, at step903, if on-body sensor840is not used to activate drug pump device10, after the drug pump device10has been activated, the control unit810may determine the status of the on-body skin sensor840. For example, the control unit810may monitor signals from the on-body skin sensor840and/or the electro-mechanical skin sensor to determine whether the drug pump device10is in contact with the user's skin or body. When the control unit810determines that the on-body skin sensor840is in contact with the skin of the user for a predetermined amount of time (e.g., 2 minutes), the control unit810may set a flag to “on”. In some embodiments, activation of the needle insertion mechanism is only possible when the on-body sensor flag is “on”. This may be the case whether or not on-body sensor840is used to activate drug pump device10.

It will be appreciated that, the status check of the on-body sensor provides safety measure for the drug pump device10. Specifically, because the control unit810monitors the on-body sensor indication signal for substantial amount of time prior to setting the flag to “on”, any quick contact (for a few seconds) or touch (e.g., by mistake) between the drug pump device10and the skin of the user may be disregarded by the control unit810and/or not allow activation of the needle insertion mechanism. Moreover, any subsequent activation button press by the user for various operations of the drug pump device10may only be recognized by the control unit, upon determining that the on-body sensor840is on.

At step904, the drug pump device10may provide notification to terminate the drug delivery process if the control unit810determines that the drug pump device10is not in contact with the body of the user for the predetermined amount of time. Additionally or alternatively, the drug pump device10may notify the user of the termination of the drug delivery process or to properly position the drug pump device10via the mobile app10a.

At step905, the drug pump device10provides a NIM request notification to the user to activate the needle insertion. For example, as described above, the request notification may be provided via audible tones (continuous or variable tones) and/or via LED lights of the drug pump device10to press the activation button a predetermined number of times (e.g., two times) to activate the needle insertion. In at least one embodiment, the request notification is only provided if needle insertion is not activated within a given time period. For example, the request notification may initially be provided two minutes after activation of the device. If needle insertion is performed prior to the expiration of this period, no request notification will be provided.

In another example, the request notification may be provided via the mobile device11after control unit810determines that the “on” status of the on-body skin sensor840. In that example, the drug pump mobile app10amay cause the mobile device11to provide the request notification for activation of the needle insertion. In one example, the mobile device may provide the user with a request notification to press the activation button (e.g., two times) to activate the needle insertion. For example, the request and/or notification may be provided via a text message. In another example, the user may receive an indication of the notification of the request message via the notification button10d. Upon selecting the button10d, the user may be provided with the request notification message.

At step907, the control unit810may determine whether the user has provided the appropriate input for the activation of the needle insertion (e.g., press of the activation button).

At step908, when the control unit810determines that the needle activation has not been activated within a predetermined amount of time, the method may notify the user to terminate the drug delivery process. In such an example, the control unit810may wait for the predetermined amount of time, prior to providing the termination notification. Optionally, in such an embodiment, subsequent initiation of needle insertion may be ineffective.

At step907, the control unit may determine that the user has responded to the request notification by executing the needle insertion activation (e.g., by pressing the activation button according to the request message). For example, activation of needle insertion may cause a NIM status switch to be activated. The NIM status switch may be activated by contact with a portion of the needle insertion mechanism while inserting the needle or cannula into the target. For example, as shown inFIG.10, extension610C of NIM retainer610may contact status switch620as NIM retainer610rotates to allow operation of needle insertion mechanism200. The method then proceeds to step909.

It is noted that, the user initiated needle insertion activation is beneficial, as this makes the user aware of the activation of the needle insertion into the body of the user and/or initiation of the drug delivery process.

At step909, the power and control system800, may prepare or prime the drug pump device10. In one example, the power and control system800may activate the needle insertion mechanism200, upon receiving user activation at step907.

Additionally, the power and control system may prime or initiate the SFPC sub-system300. It is contemplated that, in some embodiments, the SFPC may be initiated when the drug is being delivered (e.g., at step921), or concurrently with the needle insertion activation. In one example, during the priming of the device, the piston may be controlled to fill the fluid conduit with fluid drug, thereby displacing any air originally present therein.

It is noted that, during the steps901,903,904,907and908the power and control system may be in non-active power mode (i.e., the drive control system820or motor101may not be receiving any power from the power source).

At step911, timer unit812may be initiated automatically. For example, the control unit810may initialize the timer unit812which may start the wait time period. Optionally, the wait time period may be monitored by the mobile device11. For example, upon the initiation of the timer unit812, the control unit810may communicate the timing information (e.g., when the timer was initiated, the amount of time left before the drug delivery, etc.) to the mobile device11. The user may receive such timing information via app11a(e.g., by pressing timer button10c).

It is noted that, the control unit810may access or consult the timer unit812to monitor a wait time period or a delay period. The wait time period may correspond to a time period that needs to be elapsed prior to the initiation of the drug delivery. In one example, the wait time period may be pre-programmed in the power and control system800. In one example, the wait time period may be 27 hours. Alternatively, the wait time period may be any other suitable time period for the drug delivery process.

Moreover, during the wait time period, the drug pump device10may be in the non-active power mode or delay mode. In such embodiments, during the wait time period, the drug pump device may intermittently enter a communication mode in which notifications may be provided to the user and the status of the timer may be monitored. In one example, the drug pump device10may communicate with the mobile device11intermittently during the wait time period. For example, the control unit810via the communication unit830of the drug pump device10may send a status signal (e.g., a ping signal) to the mobile device11to indicate that the drug pump device10is operational. Additionally, the drug pump device10may send information related to timing information (as discussed above) to the mobile device11. Additionally, or alternatively, during the wait time period drug pump device10may intermittently provide a delay mode indicator, such as an audible or visual notification, to the user.

At step913, the power and control system800may monitor sensor signals from the various internal and/or external sensors. For example, the control unit810may monitor signals from the temperature sensor880to determine the temperature of the drug. In one example, the control unit810may process the detected temperature values to determine that the drug has reached predetermined optimal temperature for drug delivery. The drug pump device10may send the temperature information of the drug to the mobile device11, during the wait time period. The mobile device11may process such received data to provide further notification to the user during the wait time period. Step913may also include the continuous monitoring of the on-body sensor by the control unit. In the event that the on-body sensor indicates to the control system800that the pump device10is not in contact with the patient's skin, the control system may provide a notification to the user.

Optionally, the control unit810may request the mobile device11to monitor signals or data from external sensors such as the glucose rate monitor11band the heart rate monitor11a, and further process the captured data.

In one example, based on the request signal from the drug pump device10, the mobile app10amay process the data received from the external sensors to determine various operations of the drug delivery process. For example, based on the data received from the external sensors, the mobile app10amay determine an adjusted drug delivery rate of the drug that may be delivered to the patient.

In one example, a user may work-out during the wait time period, during which, the mobile app10amay monitor the heart rate of the user by communicating with the heart rate monitor11a. The mobile app10amay execute an algorithm to determine and adjust the drug delivery rate based on the change in the heart rate of the user. Additionally, or alternatively, the mobile app10amay communicate with the glucose rate monitor11bto determine and adjust the drug delivery rate based on the change in the glucose rate of the user. Accordingly, the mobile app11amay provide notification and instruction that provides information as to how to deliver the drug at the adjusted rate. In one example, the user may access such information via the notification button10d. For example, the notification may include the number of times the user needs to press the activation button on the drug pump device10to deliver the drug at the adjusted rate. During the drug delivery period, the control unit810of drug pump device10, upon receiving such specified activation signal (e.g., the number of the press of activation button), may consult the storage unit813to translate the adjusted delivery rate information into the drive mechanism information (e.g., gear ratio of various gear assemblies, rate of rotation of the motor101, etc.) in order to deliver the drug at the adjusted delivery rate. For example, the control unit810may control the regulating mechanism500or the flow-rate control sub-system825via the drive control system820.

Optionally, in another example, the mobile device11may wirelessly communicate the adjusted drug delivery rate to the drug pump device10, and the drug pump device10may automatically deliver the drug at the adjusted rate when the predetermined wait time period expires. In that example, the user may not need to press the activation button to adjust the delivery rate of the drug.

Yet in another example, for a bolus delivery of the drug, the drug pump device10may not adjust the delivery rate. In that example, the control unit810may optionally monitor the temperature of the drug during the wait time period, and deliver the drug to the user after the wait time period elapses. Optionally, after the wait time period has elapsed, drug delivery may be further delayed if the temperature of the drug and/or drug container is below a predefined value. Additionally, the mobile app11amay provide notification to the user prior to the delivery of the drug.

At step915, the drug pump device10may determine whether the wait time period has elapsed and/or nearing the end of the wait time period. For example, the control unit810, upon consulting the timer unit812, may perform the determination.

In one example, the control unit810may determine that the wait time period has elapsed and/or nearing the end of the wait time period. The method may then proceed to step917.

However, if it is determined that the wait time period has not elapsed and/or not near the wait time period (e.g., if the control unit810performs the check 4 hours prior to the end of the wait time period), the method goes back to step913.

In one example, for a bolus delivery process, at step917, the drug pump device10provides notification to the user to indicate that the wait time period has elapsed and/or the end of the wait time period is approaching. The notification may further indicate that the drug delivery will be initiated. For example, as described above, the notification may be provided via audible tones (continuous or variable tones) and/or via LED lights of the drug pump device10. In another example, the notification may be provided via the mobile device11. As described above, the mobile device10may receive indication signal from the drug pump device10, or alternatively, may determine that the drug is to be delivered. Accordingly, the mobile device11may then provide the appropriate notification to the user.

In another example, as shown inFIG.9B, the drug device may be configured such that the user has the option of initiating drug delivery near to the completion of the wait time, or soon thereafter. In such a scenario, the notification may be provided just before the predetermined time has elapsed (e.g., about 5 minutes before the 27 hour wait period). This may provide the user with sufficient time to prepare and initiate the drug delivery process. For example, the user may be in an office meeting when the predetermined wait time period is about to elapse, and may not be aware of the wait time period. As such, if the user receives the alarm or notification alert prior to end of the wait time period, the user may have sufficient time to step out of the office meeting to initiate the drug delivery, or simply initiate the drug delivery while at the meeting. As shown inFIG.9B, at step940the pump device monitors whether the user has activated delivery of the fluid at step942. If the user does not activate within the initiation time, the power and control system may automatically initiate delivery.

In another example, the notification may be provided via the pump device10or mobile device11after or near the wait time period expiration. In that example, the drug pump mobile app10amay cause the mobile device11to provide notification, as described above. In one example, the mobile app10amay further provide the user with a request message to prepare to initiate the drug delivery (based on the monitored external sensor data). For example, the request and/or notification may be provided via a text message. In another example, the user may receive an indication of the notification of the request message via the notification button10d. Upon selecting the button10d, the user may be provided with the request and/or the notification message. Alternatively, or in addition, the pump device may provide notification to the user of the expiration of the wait time period through audible tones, visual indications, or other means.

It is contemplated that, the mobile drug pump app10amay track the wait time period. For example, the user may select the timer button10cto gather information such as how much time is left or how much time has elapsed in the wait time period prior to the drug delivery. In some examples, based on the information, the user may terminate the drug delivery process, or send information to the drug pump device10.

As described above, the notification may further provide instruction related to the delivery of adjusted drug delivery rate to the user. The power and control system800may determine if the user has activated the initiation of the drug delivery within a predetermined time. For example, the control unit810may determine whether the activation button has been pressed (e.g., within about 2 minutes), after the notification.

If the drug pump device10determines that the user has not provided any input to initiate the drug delivery process within the predetermined time at the adjusted rate, the control unit810may terminate the drug delivery process. However, if the user provides the input for activation within the predetermined time upon receiving the notification, the method then proceeds to step919and enter a delivery mode. In another embodiment, drug pump device10automatically proceeds to step919at the completion of the predetermined time with or without providing notification to the user. While in the delivery mode, the power and control system may provide one or more delivery mode indicators, such as an audible or visual indicator, to notify the user that delivery of the drug is in progress.

Optionally, as shown inFIG.9B, the pump device10may be configured such that, the user has the option to initiate drug delivery within some predetermined time after completion of the wait time period. If the user does not initiate drug delivery within this predetermined time, the pump device may automatically initiate drug delivery at the expiration of the predetermined time.

At step919, the power and control system800may provide instructions to the drive control system820to control the various drive mechanisms of the drug pump device10to deliver the drug after the predetermined wait time period.

For example, the control unit of the power and control system800may translate the delivery rate information to the settings and configurations for the various components of the drive control system to enable the delivery of the drug according to the determined delivery rate. As described above, the translation may include consulting lookup tables and/or databases stored in the storage units. Alternatively, the power and control system810may send the delivery rate information to the drive control system820, and another controller (not shown) of the drive control system may perform the translation to enable the delivery of the drug according to the determined delivery rate, as described above.

Optionally, at step919, the power and control system800may appropriately change (e.g., increase or decrease) the drug delivery rate, based on the processed data received from the external sensors (e.g., based on the heart rate and/or the glucose rate information of the user, as described at step913).

Accordingly, the control unit810may instruct the drive control system820to initiate the drug delivery process (irrespective of the user activation). The drive control system may then deliver the drug by controlling via the drive mechanism100.

It is contemplated that, in some examples, the power and control system800may instruct the drive control system to initiate the insertion mechanism200and create the connection between the drug container and the sterile pathway during the drug delivery, after the predetermined wait time period has elapsed. In such a scenario, the user may provide the input for the NIM activation after the predetermined time has elapsed. In another embodiment, the NIM is activated by the power and control system800prior to initiation of drug delivery.

At step921, the power and control system810may determine whether the delivery of the drug has ended. For example, motor101may receive signal from the tether sensor875, a valve sensor877and/or pressure sensor870that indicates an end-of-dose of the drug. Accordingly, the drive control system820may then communicate the end-of-dose information to the control unit810. The method then proceeds to step923to provide an end-of-delivery indicator to the user.

When the drug pump device10determines that the drug has been delivered, the power and control system800may provide notification via audible tones and/or LED lights as described above. Additionally and/or alternatively, notification of the end-of-dose information may be provided by the drug pump device10via the drug pump mobile app10a.

In one example, the drug pump device10may determine that the drug has not been delivered or the end-of-dose did not occur in a predetermined amount of time. In such a case, the drug pump device10may provide error notification (e.g., via the LED lights and/or via the drug pump mobile app10a), and the method may then go back to step919. Alternatively, the power and control system800may terminate drug delivery and/or activate retraction of the NIM if an end-of-dose signal is not received within the expected delivery time.

At step923, upon the determination that the end-of-dose of the drug has occurred (i.e., the drug has been delivered in a predetermined time and/or according to a desired rate of delivery), the drug pump device10may communicate various end-of delivery information to the drug pump mobile app10a. The mobile app10amay then cause the mobile device11to transmit such information to one or more remote servers or storage11cof various entities (e.g., healthcare provider, health insurance provider, drug manufacturer, etc.). In one example, data stored in the drug pump app10arelated to the end of delivery information may be transmitted to the cloud server11cvia cellular network interface. Moreover, the end of delivery information may include, but is not limited to, validation of the end-of-dose, total time period of the drug delivery, delivery rate information, etc. In one example, a user may select the button10dof the mobile app10ato transfer such information. In one example, the mobile app10amay be configured to selectively transfer the end of delivery information to the various entities. It is contemplated that, the end of delivery information, and/or any other information related to the drug delivery may not be stored permanently upon transfer of such information to the cloud server11c.

FIGS.9B and9Cshow alternative methods of operation of the pump device10and/or mobile device11. In the methods illustrated inFIGS.9B and9C, activation of the device initiates the timer to mark the beginning of the predetermined wait time. Additionally, device activation also initiates the first step in the NIM activation process. As shown in the figures, the first step in the NIM activation process may be to determine if the on-body sensor detects the presence of a target. If the target is detected for the required time period, the device may be prepared for NIM activation, at step930. The preparation of the device for NIM activation may include configuring one or more of the drive mechanism, regulating mechanism, and actuation mechanism such that the user may activate the NIM. After the device is prepared for NIM activation, the user may be notified to activate the NIM. The notification may be in the form of audible, visual, or tactile feedback from the pump device. Alternatively, or additionally, the notification may be provided by the mobile device.

After notification, the user may activate the NIM to insert the fluid path into the target. For example, the user may activate the NIM by depressing or actuating the actuation mechanism or another mechanism of the pump device. The activation of the NIM may initiate the timer to begin monitoring the predetermined wait time, as described herein.

As shown inFIG.9B, after the predetermined wait time has elapsed, the user may be notified that the pump device may be activated to begin drug delivery. The user may be able to initiate drug delivery within a predetermined “user initiation time.” After the user initiation time has elapsed, the pump device may automatically initiate drug delivery. The user may, optionally, be notified upon initiation of drug delivery. The notification may in the form of visual, audible, or tactile indication by the pump device or, alternatively, by notification by the mobile device.

In the method shown inFIG.9C, the pump device10is configured such that drug delivery is automatically initiated after the wait time elapses. At step944, the user may be notified that drug delivery will be, or has been, initiated. The user may be notified by an audible, visual, or tactile notification from the pump device. Alternatively, the user may be notified by the mobile device.

Assembly and/or manufacturing of controlled delivery drive mechanism100, drug delivery pump10, or any of the individual components may utilize a number of known materials and methodologies in the art. For example, a number of known cleaning fluids such as isopropyl alcohol and hexane may be used to clean the components and/or the devices. A number of known adhesives or glues may similarly be employed in the manufacturing process. Additionally, known siliconization and/or lubrication fluids and processes may be employed during the manufacture of the components and devices. Furthermore, known sterilization processes may be employed at one or more of the manufacturing or assembly stages to ensure the sterility of the final product.

The drive mechanism may be assembled in a number of methodologies. In one method of assembly, the drug container50may first be assembled and filled with a fluid for delivery to the user. The drug container50includes a cap52, a pierceable seal56, a barrel58, and a plunger seal60. The pierceable seal56may be fixedly engaged between the cap52and the barrel58, at a distal end of the barrel58. The barrel58may be filled with a drug fluid through the open proximal end prior to insertion of the plunger seal60from the proximal end of the barrel58. An optional connection mount54may be mounted to a distal end of the pierceable seal56. The connection mount54may guide the insertion of the piercing member of the fluid pathway connection into the barrel58of the drug container50. The drug container50may then be mounted to a distal end of drive housing130.

One or more drive biasing members122may be inserted into a distal end of the drive housing130. Optionally, a cover sleeve140may be inserted into a distal end of the drive housing130to substantially cover biasing member122. A piston may be inserted into the distal end of the drive housing130such that it resides at least partially within an axial pass-through of the biasing member122and the biasing member122is permitted to contact a piston interface surface of piston110at the distal end of the biasing member122. An optional cover sleeve140may be utilized to enclose the biasing member122and contact the piston interface surface of piston110. The piston110and drive biasing member122, and optional cover sleeve140, may be compressed into drive housing130. Such assembly positions the drive biasing member122in an initial compressed, energized state and preferably places a piston interface surface in contact with the proximal surface of the plunger seal60within the proximal end of barrel58. The piston, piston biasing member, contact sleeve, and optional components, may be compressed and locked into the ready-to-actuate state within the drive housing130prior to attachment or mounting of the drug container50. The tether525is pre-connected to the proximal end of the piston110and passed through the axial aperture of the biasing member122and drive mechanism130, and then wound through the interior of the drug pump with the other end of the tether525wrapped around the winch drum/gear520of the regulating mechanism500.

A fluid pathway connection, and specifically a sterile sleeve of the fluid pathway connection, may be connected to the cap and/or pierceable seal of the drug container. A fluid conduit may be connected to the other end of the fluid pathway connection which itself is connected to the insertion mechanism such that the fluid pathway, when opened, connected, or otherwise enabled travels directly from the drug container, fluid pathway connection, fluid conduit, insertion mechanism, and through the cannula for drug delivery into the body of a user. The components which constitute the pathway for fluid flow are now assembled. These components may be sterilized, by a number of known methods, and then mounted either fixedly or removably to an assembly platform or housing of the drug pump, as shown inFIG.1B.

Certain optional standard components or variations of drive mechanism100or drug pump10are contemplated while remaining within the breadth and scope of the present invention. For example, the embodiments may include one or more batteries utilized to power a motor or solenoid, drive mechanisms, and drug pumps of the present invention. A range of batteries known in the art may be utilized for this purpose. Additionally, upper or lower housings may optionally contain one or more transparent or translucent windows18to enable the user to view the operation of the drug pump10or verify that drug dose has completed. Similarly, the drug pump10may contain an adhesive patch and a patch liner on the bottom surface of the housing12. The adhesive patch26may be utilized to adhere the drug pump10to the body of the user for delivery of the drug dose. As would be readily understood by one having ordinary skill in the art, the adhesive patch may have an adhesive surface for adhesion of the drug pump to the body of the user. The adhesive surface of the adhesive patch may initially be covered by a non-adhesive patch liner, which is removed from the adhesive patch prior to placement of the drug pump10in contact with the body of the user. Removal of the patch liner may further remove the sealing membrane of the insertion mechanism200, opening the insertion mechanism to the body of the user for drug delivery (as shown inFIG.1C).

Similarly, one or more of the components of controlled delivery drive mechanism100and drug pump10may be modified while remaining functionally within the breadth and scope of the present invention. For example, as described above, while the housing of drug pump10is shown as two separate components upper housing12A and lower housing12B, these components may be a single unified component. As discussed above, a glue, adhesive, or other known materials or methods may be utilized to affix one or more components of the controlled delivery drive mechanism and/or drug pump to each other. Alternatively, one or more components of the controlled delivery drive mechanism and/or drug pump may be a unified component. For example, the upper housing and lower housing may be separate components affixed together by a glue or adhesive, a screw fit connection, an interference fit, fusion joining, welding, ultrasonic welding, and the like; or the upper housing and lower housing may be a single unified component. Such standard components and functional variations would be appreciated by one having ordinary skill in the art and are, accordingly, within the breadth and scope of the present invention.

It will be appreciated from the above description that the controlled delivery drive mechanisms and drug pumps disclosed herein provide an efficient and easily-operated system for automated drug delivery from a drug container. The embodiments described herein provide drive mechanisms for the controlled delivery of drug substances and drug delivery pumps which incorporate such controlled delivery drive mechanisms. The drive mechanisms of the present invention control the rate of drug delivery by metering, providing resistance, or otherwise preventing free axial translation of the plunger seal utilized to force a drug substance out of a drug container and, thus, are capable of delivering drug substances at variable rates and/or delivery profiles. Additionally, the drive mechanisms of the present invention may provide integrated status indication features which provide feedback to the user before, during, and after drug delivery. For example, the user may be provided an initial feedback to identify that the system is operational and ready for drug delivery. Upon activation, the system may then provide one or more drug delivery status indications to the user. At completion of drug delivery, the drive mechanism and drug pump may provide an end-of-dose indication. The controlled delivery drive mechanisms of the present invention may be directly or indirectly activated by the user. Furthermore, the configurations of the controlled delivery drive mechanism and drug pumps of the present invention maintain the sterility of the fluid pathway during storage, transportation, and through operation of the device. Because the path that the drug fluid travels within the device is entirely maintained in a sterile condition, only these components need be sterilized during the manufacturing process. Such components include the drug container of the drive mechanism, the fluid pathway connection, the sterile fluid conduit, and the insertion mechanism. In at least one embodiment of the present invention, the power and control system, the assembly platform, the control arm, the activation mechanism, the housing, and other components of the drug pump do not need to be sterilized. This greatly improves the manufacturability of the device and reduces associated assembly costs. Accordingly, the devices of the present invention do not require terminal sterilization upon completion of assembly.

Manufacturing of a drug pump includes the step of attaching both the controlled delivery drive mechanism and drug container, either separately or as a combined component, to an assembly platform or housing of the drug pump. The method of manufacturing further includes attachment of the fluid pathway connection, drug container, and insertion mechanism to the assembly platform or housing. The additional components of the drug pump, as described above, including the power and control system, the activation mechanism, and the control arm may be attached, preformed, or pre-assembled to the assembly platform or housing. An adhesive patch and patch liner may be attached to the housing surface of the drug pump that contacts the user during operation of the device.

A method of operating the drug pump includes the steps of: activating, by a user, the activation mechanism; displacing a control arm to actuate an insertion mechanism; and actuating a power and control system to activate a controlled delivery drive mechanism to drive fluid drug flow through the drug pump according to a controlled rate or drug delivery profile. The method may further include the step of: engaging an optional on-body sensor prior to activating the activation mechanism. The method similarly may include the step of: establishing a connection between a fluid pathway connection to a drug container. Furthermore, the method of operation may include translating a plunger seal within the controlled delivery drive mechanism by the expansion of the biasing member acting upon a piston within a drug container to force fluid drug flow through the drug container, the fluid pathway connection, a sterile fluid conduit, and the insertion mechanism for delivery of the fluid drug to the body of a user, wherein a regulating mechanism acting to restrain the distribution of a tether is utilized to meter the free axial translation of the piston. The method of operation of the drive mechanism and the drug pump may be better appreciated with reference toFIGS.2A-2DandFIGS.3A-3D, as described above.

Throughout the specification, the aim has been to describe the preferred embodiments of the invention without limiting the invention to any one embodiment or specific collection of features. Various changes and modifications may be made to the embodiments described and illustrated without departing from the present invention. The disclosure of each patent and scientific document, computer program and algorithm referred to in this specification is incorporated by reference in its entirety.