Patent Description:
Biologic drugs continue to increase in their use to treat a variety of conditions such as autoimmune diseases such as Rheumatoid Arthritis (RA), Lupus, and Multiple Sclerosis (MS), cancers including lung cancer, breast cancer, leukemia and more, various cardiovascular diseases, and more. The most common type of biologic drug, monoclonal antibodies (mAbs) have increased in their use exponentially in recent years. Over <NUM>% of the total <NUM> mAbs ever approved for use on patients were launched within the last <NUM> years. In <NUM>, a record <NUM> new mAb drugs were introduced. Their revolutionary trend shows no signs of slowing down, with near <NUM>,<NUM> new biologic drugs currently in development, with most of these pipeline drugs requiring doses of greater than <NUM> of a viscous solution. Due to their greater volume and higher viscosity, traditional syringes or autoinjectors are not feasible or practical to deliver these medications. This presents a problem for pharmaceutical companies developing the drugs of having no good solution to get the drug into patients beyond the clinical setting.

A first problem is that syringes and autoinjectors are not suitable for many biologic medications/drugs, i.e., biologics. These drugs are typically injected. Most of the <NUM> biologic drugs in the current development pipeline are high volume dosage drugs (><NUM>). Biologics also can be highly viscous requiring excessive plunger force to dispense the drug through the injection needle within the relatively short injection time associated with the use of syringe or autoinjectors. The larger injection volumes and/or higher viscosity of the drug causes for syringes and autoinjectors to no longer meet the delivery needs of many biologic drugs.

A second problem is that cartridge- or syringe-based delivery devices introduce new factors to the drug-device development process creating additional challenges which must be overcome prior to moving forward with combination product commercialization. The traditional approach followed by biopharmaceutical companies is to use and/or develop high-volume cartridge- or syringe-based injection devices as the configuration for patient use beyond the clinical setting. Such devices require use of a rubber plunger and silicone oil lubricant which are in long term contact with the drug during product storage. For biologic drugs, these additional drug-contacting materials can introduce drug stability issues (i.e., drug degradation problems). Before the commercial application delivery device is adopted, biologic drugs are stored and developed in standard glass vials. Such containers involve no silicone oil lubricant or rubber plungers. Switching from the vial container into a cartridge or syringe container increases risk, as storing the newly developed drug in a different container may prove problematic. Additionally, new processes for washing, lubricating, sterilizing, and filling the different containers must be developed and implemented adding risk, time, and financial resources to development programs.

It is thus desirable to ensure that patients with chronic diseases have access to life changing drugs as early as possible by minimizing the drug development and regulatory approval timelines while also ensuring maximum patient compliance while on drug therapy. Several highly effective drugs for chronic diseases do not make it to market today as they are not formulated to fit in traditional drug delivery devices such as syringes or autoinjectors. With the rise in biologics, proteins and peptides, many drugs are highly viscous or have large delivery volumes making patient self-injection impractical or impossible. Delivery of these types of drugs therefore requires some form of a wearable injection system, which has created the unmet need in the marketplace. While some new wearable injector devices have entered the market, they all require cumbersome, time-consuming, and require error-prone steps to be performed by the user, drastically minimizing compliance. Addressing these two concerns of maximizing the likelihood of commercializing a drug (and doing so rapidly) while simultaneously enhancing patient compliance reduces the overall burden of healthcare costs on society and the economy by ensuring patients get access to drugs that would otherwise have not made it to market merely due to the absence of a suitable delivery mechanism. The need for better delivery devices is driven by factors such as, an increase in prevalence of chronic diseases (autoimmune diseases, cancers, etc.) due to increasing lifespan, a rise of biologics, proteins, peptides to treat these chronic diseases, and strong competition across pharma/biotech companies where competing drugs have similar dosing regimens and side effects thereby leading to the injection device becoming the differentiator and competitive advantage. Moreover, as more and more blockbuster drugs come off patent, the drug delivery device once again becomes the differentiator in competing against generics or biosimilars and preserving market share. Patient care is moving towards homecare with self-care/self-injection becoming common place. As patients become more educated and informed, the patient is viewed as the consumer and will ultimately be a key decision maker in his/her treatment regimens. As a result, a convenient drug delivery device is paramount.

Document <CIT> describes a rotational holster for holding a medical infusion pump and maintaining the electronic device in any one of a plurality of selectable rotational orientations.

The present invention is directed to a fully integrated wearable injector for automated delivery of biologic drugs. The inventive injector solves the problem of high volume and high viscosity drug administration by providing a device that can be worn by the patient through use of an adhesive patch to deliver the medication slowly over extended periods of time. Certain advantages of the inventive injector differentiate it from other injectors, including, by way of illustration and not limitation: <NUM>) its pre-filled and pre-assembled format improving acceptance and adoption; <NUM>) its vial-based design eliminates the need to switch drug storage into syringe or other custom container in late stage clinical trials avoiding additional drug stability studies, accelerating commercialization and reducing risks; and <NUM>) it provides important flexibility through clinical trials as doses, injection rates, injected volumes can change. Standard vials are also the ideal container for drug protection and stability. At least part of the innovation of the inventive injector is its novel design and engineering solutions which solve technical problems associated with an integrated vial approach for direct and automatic injection. This innovation greatly simplifies use for patients and makes adoption easier for pharmaceutical companies as it saves time in development and reduces commercialization cost.

The inventive injector may be used by pharmaceutical, biopharmaceutical, and similar companies that develop and manufacture biologic drugs. The inventive injector provides these companies with a solution for introducing/launching high volume and high viscosity drugs to market. The inventive injector is expected to accelerate the adoption of wearable injectors for broad impact in making treatment easier and more convenient for patients while reducing costs and increasing treatment accessibility.

The innovation of the present invention lies in its novel design which enables differentiating features such as its pre-filled and pre-assembled format making it simple and reliable for at home self-injection. Use of a standard glass vial, the most common, easiest to fill, and most compatible container for storage of biologic drugs, offers significant development and commercialization advantages for pharmaceutical companies.

The injector of the present invention provides a solution for administration of therapeutic drugs when dosage volumes and drug viscosity make use of a syringe or autoinjectors not possible or impractical. Additionally, when a given therapy could be administered at an infusion clinic, the present invention provides an alternative to this approach that enables the infusions to take place within the comfort of the patient's home. This translates to greater convenience for the patient, reduced cost to the healthcare system, and significantly increases the likelihood of patient compliance. Infusion clinics can also have limited capacity to provide treatment and in more remote parts of the world access to a clinic may not be available at all. The present invention can enable patients to receive medication that may otherwise not be accessible to them.

In accordance with embodiments of the present invention, a wearable injector is provided having a number of features and advantages not currently found in available devices. The inventive injector uses a standard vial, which leads to significant commercialization advantages, including transitioning from clinical to commercial device without the need for additional drug stability studies, saving time, money, and resources, using the most economical and widely available filling equipment (vial filling), accelerating advancement through clinical trials and simplifying commercial scale production, eliminating need for silicone oil lubricant (required for syringes, other non-vial containers) which can lead to protein aggregation, degrading the drug, eliminating the need for silicone oil lubricant avoiding need for specialized washing and siliconization equipment, eliminating the need for silicone oil lubricant enabling simpler sterilization processes to be used (e.g., steam auto-clave) for primary container sterilization over more complex and expensive methods such as ethylene oxide sterilization, eliminating the need for rubber plungers to expel the drug from a container reducing number of required components, simplifying commercialization, and eliminating the need for rubber plungers to expel the drug from a container avoiding any problems that could arise with drug contact with said rubber plungers during storage.

The inventive injector is pre-filled and pre-assembled, which makes device easier to use for patients as no filling of device or installation of drug container before use is required and reduces risk of user error increasing compliance to treatment.

The inventive injector is software configurable and controllable to accommodate high viscosity, variable dose volume, and variable rate control, which enables a single device configuration to work with many biologics that all have different viscosity, dose volume, and injection rate needs, and provides the flexibility needed to address changes in efficacious dose and target injection rate without the need to customize system hardware.

The inventive injector can warm drugs prior to injection reducing pain or discomfort or occurrence of injection site reaction, which can occur when the drug is injected cold. The warming is monitored such that the timing of injection onset can be informed by the drug temperature to provide benefit to the patient and/or device functionality, for example, permitting injection only after the drug has warmed to pre-determined temperature to ensure the patient realizes the benefit, and permitting injection only after the drug has warmed to a pre-determined temperature to ease mechanical stress on the pump mechanisms as warming of the drug reduces and stabilizes fluid viscosity.

The injector of the present invention further possesses the capability to deliver variable volumes of viscous solutions, on the order of <NUM> - <NUM> with viscosity levels anywhere between <NUM> and 100cP, or higher depending on delivery time limitations. In addition, the inventive injector possesses electro-mechanical mechanisms for automatic fluid extraction from the vial and injection into subcutaneous tissue; variable delivery rates achieved through software changes only.

An embodiment of the present invention is directed to a wearable injector for delivering a drug into a body part of a patient comprising, a housing, a base connected with the housing and releasably securable on the body part of the patient, a carrier rotatably arranged within the housing and base, and a delivery system on the carrier. The delivery system comprises a container sub-assembly for containing the drug, a drive control sub-assembly coupled with the container sub-assembly and configured for controlling delivery of the drug into the patient, a flow-path sub-assembly providing a fluid path with the container sub-assembly via which a fluid can be introduced into the container sub-assembly and via which the drug can be extracted from the container sub-assembly, wherein the drive control sub-assembly engages the flow-path sub-assembly to cause the fluid to be introduced into the container sub-assembly and to cause the drug to be extracted from the container and delivered into the patient, a sensor for detecting one of temperature of the body part, temperature of the drug in the container sub-assembly, and orientation of the container sub-assembly, and a controller receiving an input from the sensor and controlling the drive control sub-assembly based upon the input to set a state of the injector.

In a further embodiment of the present invention the drive control sub-assembly further comprises a peristaltic pump.

In a further embodiment of the present invention the peristaltic pump further comprises a drive motor and a pump wheel controllable by the drive motor.

In a further embodiment of the present invention the controller receives power from a power source and wherein the container sub-assembly further comprises a container for containing the drug, wherein the controller activates the drive control sub-assembly to pressurize the container when the controller receives power from the power source.

In a further embodiment of the present invention the controller activates the drive control sub-assembly to introduce air into the container via the flow-path sub-assembly when the controller receives power from the power source.

In a further embodiment of the present invention the controller activates the drive control sub-assembly to introduce a predetermined amount of air into the container.

In a further embodiment of the present invention the predetermined amount of air is based upon one of the volume of drug to be dispensed and the viscosity of the drug.

In a further embodiment of the present invention the container sub-assembly further comprises a container, and wherein the flow-path sub-assembly defines a fluid path with the container, wherein the drive control sub-assembly causes the injector to be primed by causing air to travel along the fluid path into the container, and wherein the drive control sub-assembly causes the injector to be extracted from the container for delivery into the patient by causing the drug to travel along the fluid path out of the container.

In a further embodiment of the present invention the drive control sub-assembly causes the fluid path to be primed with the drug prior to delivery of the drug into the patient.

In a further embodiment of the present invention the container sub-assembly further comprises a container, and wherein the flow-path sub-assembly defines a fluid path with the container, wherein the drive control sub-assembly causes the injector to be primed by causing air to travel along the fluid path into the container.

In a further embodiment of the present invention the flow-path sub-assembly further comprises an injection needle connected with the fluid path for delivering the drug into the patient, and wherein the drive control sub-assembly causes the drug to travel along the fluid path and through the injection needle into the patient when the injector is primed.

In a further embodiment of the present invention a bearing between the carrier and housing at least partially enables rotation of the carrier within the housing.

In a further embodiment of the present invention the bearing comprises at least one roller disposed in a recess defined in one of the carrier and housing, the roller being freely rotatable in the recess.

In a further embodiment of the present invention an adhesive on a part of the base releasably secures the base on the body part of the patient.

In a further embodiment of the present invention the adhesive comprises an annulus or partial annulus on a part of the base.

In a further embodiment of the present invention the container sub-assembly further comprises a container for the drug, and wherein the sensor further comprises an orientation sensor configured to determine an orientation of the container, the controller setting a state of the injector based up the orientation of the container.

In a further embodiment of the present invention the state of the injector comprises one of an injection state and a non-injection state, and wherein the controller is configured to toggle the state of the injector to/from the injection state from/to the non-injection state based upon an output from the orientation sensor.

In a further embodiment of the present invention the container sub-assembly further comprises a container for the drug, and wherein the sensor further comprises a first temperature sensor configured to determine a temperature of the drug in the container, wherein the controller is configured to control the drive control sub-assembly to cause the drug to be delivered into the patient when the temperature of the drug in the container is at least at a predetermined temperature.

In a further embodiment of the present invention the predetermined temperature is at least <NUM>° F.

In a further embodiment of the present invention the container sub-assembly further comprises a container for the drug, and wherein the sensor further comprises a second temperature sensor configured to determine whether the injector is on the patient's body.

In a further embodiment of the present invention the second temperature sensor is configured to determine a temperate of the patient at or near the body part, wherein the controller is configured to control the drive control sub-assembly to cause the drug to be delivered into the patient when the temperature of the patient at or near the body part is at least at a predetermined temperature.

In a further embodiment of the present invention the predetermined temperature is at least within <NUM>° F of <NUM>° F.

In a further embodiment of the present invention a lock prevents rotation of the carrier.

In a further embodiment of the present invention the flow-path sub-assembly further comprises an injection needle assembly comprising a needle carrier, an injection needle, and a needle position nub, and wherein the base further comprises at least one recess for receiving the needle position nub, wherein the injection needle assembly is movable from a first position in which the needle position nub and recess are in spaced apart relation to each other, and a second position in which the needle position nub is in the recess thereby preventing rotation of the carrier.

In a further embodiment of the present invention the container sub-assembly further comprises a container for containing the drug, the container having a pierceable seal, and wherein the flow-path sub-assembly further comprises a fluid path having a needle, the injector further comprising a spring for causing the container to move in a predetermined direction, and a removable barrier located between the pierceable seal and the needle maintain each in a sterile condition, wherein removal of the removable barrier causes the spring to cause the container to move in the predetermined direction in which the needle pierces the pierceable seal.

In a further embodiment of the present invention the injector is contained in a disposable package openable by a user of the injector, wherein the removable barrier is removed coincident with a user opening the package.

In a further embodiment of the present invention a collar is provided on the container and a container activator, wherein the spring engages the container activator to engage the collar to cause the container to move in a predetermined direction in which the needle pierces the pierceable seal.

In a further embodiment of the present invention a power source powers the injector, and a pull-tab that, when pulled enables the power source to power the injector.

In a further embodiment of the present invention the container sub-assembly further comprises a container for containing the drug, and wherein the drive control sub-assembly further comprises a pump operable to pressurize the container, and operable to cause the drug to flow from the container, upon the container being pressurized by the pump to a predetermined level, the pump automatically causes the drug to flow from the container.

In a further embodiment of the present invention an audible and/or visual indicator indicates a state of the injector.

In a further embodiment of the present invention the state is one of orientation and operational state of the injector.

In a further embodiment of the present invention a push-button is provided for user activation of the injector.

In a further embodiment of the present invention a needle is provided for delivering the drug into the patient, and wherein the container sub-assembly further comprises a container having a preferred orientation, wherein the carrier is configured to automatically orient the container in the preferred orientation, and wherein the injector is configured to automatically cause the needle to be inserted into the body part of the patient when the container is in the preferred orientation.

In a further embodiment of the present invention a needle is provided for delivering the drug into the patient and a user-depressible push-button, and wherein the container sub-assembly further comprises a container having a preferred orientation, wherein the carrier is configured to orient the container in the preferred orientation upon user first depression of the push-button, and wherein the injector is configured to cause the needle to be inserted into the body part of the patient when the container is in the preferred orientation upon user subsequent depression of the push-button.

In a further embodiment of the present invention the container sub-assembly further comprises a container having a preferred orientation, the injector further comprising a needle for delivering the drug into the patient and orientation means for changing the orientation of the container, wherein the container orientation is set by user use of the orientation means, and wherein the injector is configured to automatically cause the needle to be inserted into the body part of the patient when the container is in the preferred orientation by user use of the orientation means.

In a further embodiment of the present invention the orientation means comprises a tab connected with the carrier and that enables a user to cause the carrier to rotate within the housing.

In a further embodiment of the present invention a needle is provided for delivering the drug into the patient, orientation means for changing the orientation of the container, and a user-depressible push-button, wherein the container sub-assembly further comprises a container having a preferred orientation, wherein the container orientation is set by user use of the orientation means subsequent to user first depression of the push-button, and wherein the injector is configured to cause the needle to be inserted into the body part of the patient when the container is in the preferred orientation upon user subsequent depression of the push-button.

The present disclosure is also directed to a method for operating a wearable injector comprising a housing, a base connected with the housing and releasably securable on the body part of the patient, a carrier rotatably arranged within the housing and base, and a delivery system on the carrier comprising a container sub-assembly for containing the drug, a drive control sub-assembly coupled with the container sub-assembly and configured for controlling delivery of the drug into the patient, a flow-path sub-assembly providing a fluid path with the container sub-assembly via which a fluid can be introduced into the container sub-assembly and via which the drug can be extracted from the container sub-assembly, a sensor for detecting one of temperature of the body part, temperature of the drug in the container sub-assembly, and orientation of the container sub-assembly, and a controller receiving an input from the sensor. The method comprises the step of causing the drive control sub-assembly to engage the flow-path sub-assembly to cause the fluid to be introduced into the container sub-assembly and to cause the drug to be extracted from the container and delivered into the patient based upon the input from the sensor to set a state of the injector.

Embodiments of the present invention will now be described with reference to the following FIGS.

The present invention is directed to a fully integrated automated wearable injector for at home self-administration of drugs. The inventive injector includes a controller to control certain functions and aspects of the injector, effectively making the inventive injector a smart device. Advantageously, the inventive injector utilizes a standard glass vial as its primary container, an innovative aspect of which is that it enables differentiating features such as its pre-filled and pre-assembled format making it simple and reliable for at home self-injection. Use of a standard glass vial, the most common, easiest to fill, and most compatible container for storage of biologic drugs, offers significant development and commercialization advantages.

With reference next to the drawings, and in particular <FIG> and <FIG>, the present invention will now be discussed in detail. A first embodiment of the wearable injector <NUM> of the present invention is depicted in <FIG> and is an auto-orienting, user-activated device. A second embodiment of the wearable injector <NUM> of the present invention is depicted in <FIG> and is an auto-orienting, auto-activated device. A third embodiment of the wearable injector <NUM> of the present invention is depicted in <FIG> and is a user-orienting, user-activated device. A fourth embodiment of the wearable injector <NUM> of the present invention is depicted in <FIG> and is a user-orienting, auto-activated device. Each of these embodiments will be discussed in greater detail below.

The inventive injector <NUM> is depicted in exploded view in <FIG> and comprises a housing <NUM> and a base <NUM> that connect together and contain the other components of the injector <NUM>. A window <NUM> defined in the injector <NUM> enables a user of the injector <NUM> to see the container <NUM> and its contents. A delivery system carrier <NUM> is disposed within the housing <NUM> and on the base <NUM> and is rotatable with respect to both either by the user and one or more position tabs <NUM> on the housing cap <NUM> or, alternatively, the delivery system carrier <NUM> may self-orient by appropriately designed and placed mass within the injector <NUM>. In any case, a visual and/or audible indicator will indicate to the user when the injector <NUM> is properly orientated on the patient's body. Rotation of the carrier <NUM> while the housing <NUM> and base <NUM> remain fixed enables proper orientation of the container <NUM> for delivery of a drug <NUM> contained in the container <NUM>. In a preferred embodiment the container <NUM> comprises a vial. The injector <NUM> comprises a delivery system <NUM> (see also <FIG>) comprised of a vial container sub-assembly (VCSA) <NUM>, a drive control sub-assembly (DCSA) <NUM>, and a flow path sub-assembly (FSA) <NUM>. The delivery system <NUM> is mounted to and rotational with the carrier <NUM>. An adhesive <NUM> provided on the base <NUM> is preferable partially or completely annular and secures the injector <NUM> to a patient's body. A removable adhesive backing <NUM> covers an adhesive surface of the adhesive <NUM> prior to use, with the backing <NUM> being removed by a user prior to application to the patient's body.

Referring next to <FIG> the vial container sub-assembly (VCSA) <NUM> will be discussed in greater detail. The injector <NUM> of the present invention contains a primary container <NUM> for holding a drug <NUM>, preferably a liquid biologic drug. In a preferred embodiment, the primary container <NUM> is a vial with a septum <NUM> secured in place over the vial opening by a crimp cap <NUM>. The present invention advantageously uses a standard vial as the primary container <NUM> which enables use of well-established and accepted filling, sterilization, storage, use, etc., processes for liquid biologic drugs and vials. As depicted in <FIG>, such a process for filling the vial <NUM> is depicted in which the drug <NUM> is introduced into the vial, a septum <NUM> is sealingly placed over an opening of the vial <NUM>, a crimp cap <NUM> is crimped in placed to sealingly secure the septum in place, and a sterile barrier tab <NUM> provided over the exposed septum surface <NUM>. The VCSA <NUM> is now ready for use in the injector <NUM> of the present invention. The VCSA <NUM> leverages well established standard components as well as drug filling and closure techniques which are compatible with existing fill-finish production lines. The sterile barrier tab <NUM> maintains the sterility of the septum surface <NUM> during storage. The sterile barrier tab <NUM> is designed to be removed at the time of use and serves the additional purpose of releasing a container stop <NUM>, enabling a spring-loaded mechanism to establish fluid connection between the VCSA <NUM> and FSA <NUM>, as described in more detail below.

With reference again to <FIG> and additional reference to <FIG>, the FSA <NUM> comprises a vial access manifold <NUM>, pump transfer block <NUM>, pump tube <NUM>, injection tube <NUM>, and release clip <NUM>. An access needle <NUM> preferably formed of steel provides a fluid path between the container <NUM> and the pump tube <NUM>. A fluid may be caused to travel through the access needle <NUM> and along the fluid path during preparation and use of the inventive injector <NUM>, as described in more detail below. A delivery cannula <NUM> preferably formed of steel provides a fluid path between the pump tube <NUM> and an injection needle <NUM>. A fluid may be caused to travel through the delivery cannula <NUM> and along the fluid path during preparation and use of the inventive injector <NUM>, as described in more detail below. In a preferred embodiment, the access needle <NUM> and delivery cannula <NUM> are each at least partially contained in the vial access manifold <NUM>.

The FSA <NUM> further comprises an injection needle assembly <NUM> comprising a needle carrier <NUM> for carrying an injection needle <NUM>, an injection spring <NUM> for causing the injection needle <NUM> to move to an injection position, and a needle shield <NUM> for covering and preferably maintaining the sterility of a sharp, patient end of the injection needle <NUM> prior to use. The FSA <NUM> is designed for interface with the VCSA <NUM> to establish fluid connection between the two sub-assemblies. The FSA <NUM> design provides a solution which allows its assembly and sterilization to occur separately from the VCSA <NUM>. This allows the vial sterilization and filling processes to remain standardized as opposed to having to introduce a new process that includes attachment of the connecting flow path components as part of the aseptic fill-finish process. Avoiding complexity within aseptic processing is of strategic importance to avoid manufacturing issues when scaling up. Additionally, keeping the FSA <NUM> separate from the VCSA <NUM> allows the FSA <NUM> to be sterilized using gamma sterilization methods, which provide the most economical bulk sterilization method and with fewer limitations on materials that can be used. By being able to go through gamma sterilization, as opposed to other more limiting methods such as Ethylene Oxide (ETO) sterilization, a broader range of materials can be used in the injector <NUM> as ETO permeability becomes a non-factor. Furthermore, this enables a design of flow passages that may not be sterilizable using ETO, as infiltration of the gas into these hard to reach areas is not a challenge for gamma sterilization. Additionally, the FSA <NUM> requires no physical contact of pump drive components with the drug. This means that the pump drive mechanisms do not have to be combined with fluid path mechanisms for sterilization. The pump drive mechanisms can be assembled separately and in septic environments without the need for any sterilization. This further simplifies manufacturing processes and keeps the task of validating sterilization processes much more manageable.

With continued reference to <FIG> and <FIG>, the DCSA <NUM> comprises a stepper drive motor <NUM> controlled by a controller <NUM> (see, e.g., <FIG>) for causing a roller carrier <NUM> having a plurality of rollers <NUM> to rotate in first and second directions. Alternatively the drive motor <NUM> may comprise a DC motor or any other type of motor capable of providing the described functionality. The rotation of the roller carrier <NUM> in the first and second directions creates a peristaltic pump that causes fluid to move along the fluid path defined by the access needle <NUM>, pump tube <NUM>, delivery cannula <NUM>, injection tube <NUM> and injection needle <NUM>. In a priming mode, prior to use of the injector <NUM> and injection of the drug <NUM>, the drive motor <NUM> causes air to be drawn into the injector <NUM> via the injection needle <NUM>, and further causes air to move along the fluid path into the container <NUM>, creating a positive pressure in the container <NUM> with respect to ambient. In a use or injection mode, the drive motor <NUM> causes the liquid drug <NUM> to move from the container <NUM> along the fluid path and exit the injection needle <NUM> into the patient. The roller carrier <NUM> may contain any means for multiple and localized contacting with the pump tube <NUM> to produce peristaltic pumping action, for example, fixed lobes which contact and slide against the pump tube <NUM>, a plurality of rollers <NUM> which spin freely about spindles of the roller carrier <NUM> while the rollers <NUM> roll in contact with the pump tube <NUM>, and quasi-fixed lobes which are integrated features of the roller carrier <NUM> and slide in contact against the pump tube <NUM> but experience flexion when under load from static and/or dynamic engagement with the pump tube <NUM>. The pump tube <NUM> with cross-sectional shape circular but may also be elliptical or other non-circular geometry to enhance resistance against tube kinking during assembly or during operation.

The present invention advantageously recognizes that application of a peristaltic method for administration of biologic drugs is uniquely well-suited for use with an integrated standard vial, as liquid cannot be pushed out (as in syringes or cartridges) and instead must be pulled out of the vial. The interface of the DCSA <NUM> with the FSA <NUM> enables the peristaltic pump to pressurize the vial by pulling air into the system first, before reversing to begin fluid extraction and injection into the patient. This aspect of the present invention was inspired by common syringe and vial delivery methods, where an empty syringe is used to fill the vial with a volume of air equal to dose volume to be taken from the vial, before extending the syringe plunger and pulling the drug out of the vial container. The air pulled into the injector <NUM> system can be from the ambient environment just as has been done for the long practiced syringe and vial method. This process prevents a vacuum from building inside the vial as its contents are extracted which can prevent full extraction of the drug. The injector <NUM> of the present invention accomplishes this same air pressurization step automatically avoiding the need for an additional vial venting mechanism.

The DCSA <NUM> not only provides the pumping action, but also the means for releasing the injection needle <NUM> from a stored position to an injection position, as can be seen in <FIG> and <FIG> (see also <FIG> and <FIG>). A release clip <NUM> has arms 270a, 270b that are sized and shaped to engage a part of the needle carrier <NUM> and maintain the needle carrier <NUM> and needle <NUM> fixed in place prior to use. More importantly, the release clip <NUM> is controlled by the controller <NUM> to ensure that the needle carrier <NUM> and needle <NUM> are only released, enabling injection of the needle <NUM> into the patient's skin, when predetermined conditions of the injector <NUM> are satisfied. The release clip <NUM> thus locks the needle carrier <NUM> and needle <NUM> to prevent untimely or accidental activation.

Control of the release clip <NUM> by the controller <NUM> is effected by a plurality of sensors in the injector <NUM> that monitor spatial orientation of the container <NUM>, temperature of the drug <NUM> contained within the container <NUM>, and temperature of the base <NUM>, i.e., temperature of the patient at the injection site. After placement on the patient's body, the container <NUM> must be properly oriented with respect to gravity to allow proper uptake of the liquid drug <NUM> by the delivery system <NUM>. Or alternatively, the injector <NUM> may be configured to not permit rotation of the system carrier <NUM> relative to the housing <NUM> and base <NUM>, where in such configuration the injector <NUM> is oriented properly by the user before placement on patient's body. With the needle insertion activated electromechanically, the needle can be locked out from activation until proper orientation of the container <NUM> is detected through integration of an orientation sensor <NUM> to determine orientation of the container <NUM>. Additionally, it is desirable to allow the drug <NUM> to warm prior to beginning injection into the patient, which is monitored by a container temperature sensor <NUM>. Through integration of thermal sensors, the injector <NUM> can be prevented from needle activation and/or commencing of fluid pumping until drug warming has been completed. Furthermore, a body temperature sensor <NUM> detects when the injector <NUM> has been placed on the patient's body to further restrict injector activation until properly affixed to a patient's skin.

The controller <NUM> receives input from at least one of the orientation sensor <NUM>, container temperature sensor <NUM>, and body temperature sensor <NUM>, and controls movement of the release clip <NUM> by the drive motor <NUM> through a threaded interface between them via the pump wheel <NUM>. Preferably the drive motor <NUM> causes the release clip <NUM> to move in a direction transverse to the longitudinal axis of the injection needle <NUM> and away from the drive motor <NUM> to release the injection needle <NUM>. Such movement causes arms 270a, 270b of the release clip <NUM> to be displaced with respect to the needle carrier <NUM>, thereby presenting an opening to the needle carrier <NUM>, allowing it to be displaced by the insertion spring <NUM>, causing the injection needle <NUM> to enter the patient's skin.

The threaded engagement between the drive motor <NUM> and the release clip <NUM> via the pump wheel <NUM> allows the rotation of the pump wheel <NUM> to occur in the direction needed to introduce air into the container <NUM> without disrupting retention of the injection needle <NUM>. Only once the pump wheel <NUM> is reversed will the release clip <NUM> translate forward to release the injection needle <NUM>. Once the injection needle <NUM> releases, the release clip <NUM> becomes mechanically decoupled from the pump wheel <NUM>, allowing the pump wheel <NUM> to continue its rotation to dispense the drug.

The present invention advantageously coordinates a plurality of mechanical systems of the inventive injector <NUM> so that the retention clip is timed to translate to the point of needle release into the patient only after flow-path priming has completed. A retention clip to pump wheel threaded interface enables air injection via one direction of motor rotation without disrupting needle retention, whereas only upon reversal of the motor does the release clip begin to translate forward to trigger needle insertion into the patient. An integrated wave spring feature of the retention clip provides the necessary mechanical bias for thread engagement between the pump wheel and retention clip to occur upon motor reversal following completion of the air injection step.

The VCSA <NUM>, FSA <NUM> and DCSA <NUM> sub-systems previously described are assembled in, into or on the delivery system carrier <NUM>, as depicted in <FIG>. The delivery system carrier <NUM> is sized, shaped and configured to rotate relative to the housing <NUM> and base <NUM> to allow the VCSA <NUM>, FSA <NUM>, and DCSA <NUM> to all rotate together as one unit to properly orient the container <NUM> for drug delivery. Additionally, the base <NUM> includes one or more openings for the sterile barrier tab <NUM> to pass through, see, e.g., <FIG>, <FIG> and <FIG>. In a preferred embodiment, the sterile barrier tab <NUM> comprises two release tabs, as depicted in <FIG>, one of which provides a sterile barrier for the exposed end of the access needle <NUM>, and the other of which provides a sterile barrier for the exposed surface <NUM> of the septum <NUM>. A container stop <NUM> is secured to an end of the septum surface sterile barrier tab <NUM> that is removed coincident with removal of that sterile barrier tab <NUM>. Removal of the container stop <NUM> enables the container <NUM> to be moved causing the exposed sharp tip of the access needle <NUM> to pierce the septum <NUM>, establishing a fluid path from the container <NUM> to the injection needle <NUM>. The two sterile barrier tabs <NUM> are configured such that one removal action peels both tabs triggering fluid connection between the container <NUM> and the FSA <NUM>. This sequence of functions is intended to occur in rapid succession upon removal of the injector <NUM> from its secondary packaging, or alternatively upon removal of the adhesive backing <NUM>, such that certain pre-injection steps are completed passively to the user. More specifically, a user removes the injector <NUM> from its secondary packaging in preparation for use, which may simultaneously remove the sterile barrier tabs <NUM> and container stop <NUM>. The user next removes the adhesive backing <NUM> which may simultaneously remove the sterile barrier tabs <NUM> and container stop <NUM> (if not achieved during the removal from packaging step) or, alternatively, the adhesive backing <NUM> and sterile barrier tabs <NUM> may be removed via discrete, separate actions. In either case, once the container stop <NUM> is removed, the container <NUM> is caused to move from its storage position, depicted in <FIG>, for example, to its ready position, depicted in <FIG>, for example, in which a tip of the access needle <NUM> pierces the septum <NUM> connecting the interior chamber of the container <NUM> with the fluid path. Such movement of the container <NUM> is caused by a pair of springs <NUM> provided in channels defined in each side of a container cradle <NUM>, that act upon a vial activator <NUM> (see, e.g., <FIG>). Advantageously, the vial activator <NUM> engages the crimp cap <NUM> of the VCSA <NUM> which reduces the stress imposed in the container <NUM> by the springs <NUM> and reduces the risk of container breakage.

A further improvement of the present invention is directed to system power-on and priming/arming for injection. The present invention is thus further directed to an injector <NUM> having a power-on pull tab <NUM> as an integral part of removing the device from its packaging, or alternatively upon removal of the adhesive backing <NUM>.

With reference next to <FIG>, <FIG> and <FIG>, the DCSA <NUM> and FSA <NUM> function as a peristaltic pump mechanism capable of injecting air into the container <NUM> and extracting the drug <NUM> from the container <NUM> along the same fluid path. In an air injection or priming state, air injection preferably occurs automatically after injector <NUM> is powered on by removal of the power-on pull tab <NUM>. Advantageously, the controller <NUM> enables the injector <NUM> of the present invention to control the volume of air injected into the container <NUM> to a pre-set amount that is proportional to volume of drug <NUM> in the container <NUM>. Preferably, the drive motor <NUM> causes the pump wheel <NUM> to rotate in a counter-clockwise direction, as indicated by arrow "C" of <FIG>. Such rotation draws air into the needle <NUM> and causes the air to flow along the fluid path comprised of the access needle <NUM>, pump tube <NUM>, delivery cannula <NUM>, injection tube <NUM> and injection needle <NUM>, and into the container <NUM>, as indicated by arrows "B" and "A" in <FIG>. This step avoids the need for separate venting of the container <NUM> and overcomes vacuum effects which would otherwise resist fluid extraction from the container <NUM> by establishing and maintaining upstream positive pressure throughout injection. The inventive injector <NUM> further provides a system with which, immediately following completion of the air injection step, the injector <NUM> automatically reverses the drive motor <NUM> direction (i.e., reverses the pump direction) and begins to prime the fluid path. This continues after the injector <NUM> is placed on the patient's body and properly oriented to deliver the entire drug volume contained within the container <NUM>.

After placement on body, the present invention is designed and configured to self-orient (<FIG>) or permit manual orienting (<FIG>), to position the container <NUM> into the proper orientation for drug extraction and injection. As depicted in <FIG> and <FIG> the adhesive <NUM> is generally annular or partially annular and secures the housing <NUM> to the patient. Once in place on the patient movement of the injector <NUM>, specifically movement of the housing <NUM> and the base <NUM>, rotational or otherwise, is prevented by the adhesive <NUM>. The delivery system carrier <NUM> is contained within the housing <NUM> but free to rotate with respect thereto until needle activation is triggered at which point the delivery system carrier <NUM> and housing <NUM> are locked in position.

Rotation of the delivery system carrier <NUM> with respect to the housing <NUM> and base <NUM> is prevented or permitted based upon certain criteria of the injection device <NUM>, as determined by the controller <NUM>. Such rotation is prevented or permitted by a rotational lockout <NUM> (see, e.g., <FIG>) comprised of a first part defined on the needle carrier <NUM> as a semi-spherical needle position nub <NUM> (see, e.g., <FIG> and <FIG>) that is selectively positionable into and out of a second part comprised of any one of a plurality of recesses <NUM> defined in the base <NUM> (see, e.g., <FIG>). The rotational lockout <NUM> is engaged upon insertion of the injection needle <NUM> into the patient thereby rotationally locking the delivery system carrier <NUM> relative to the housing <NUM> and base <NUM>, thus preventing lateral motion of the needle <NUM> after insertion into the patient's skin. An orientation sensor <NUM>, preferably an accelerometer, monitors the orientation of the delivery system carrier <NUM>, and consequently the orientation of the container <NUM> before and after on-body placement. Such monitoring enables the controller <NUM> to control the rotational lockout <NUM> to provide means of electro-mechanical interlocking of FSA <NUM> (and the needle <NUM>) and the DCSA <NUM> based upon the orientation of the container <NUM> such that needle insertion after placement on-body can only occur when the container <NUM> is properly oriented and such that pumping is only engaged during times when the container <NUM> is properly oriented.

In addition to the positional control provided by the rotational lockout <NUM>, the orientation sensor <NUM> also enables the controller <NUM> to control the drive motor <NUM> of the DCSA <NUM> to toggle the DCSA <NUM> on and off depending upon the orientational position of the injector <NUM>. The present invention thus provides a system capable of on/off pumping toggling where pauses in pumping occurs in response to patient movement if such movement causes moments when the container <NUM> in not oriented properly or stable. In an embodiment, the controller <NUM> activates an audible and/or visual signal to alert the patient of the temporary state of improper container orientation.

As previously noted, the delivery system carrier <NUM> is rotatable within the housing <NUM> and base <NUM>. The rotation may be user or gravity controlled and can ensure that the container <NUM> is properly oriented to facilitate delivery of the drug <NUM>. With reference to <FIG>, rotation of the delivery system carrier <NUM> is facilitated by a bearing defined by a plurality of rollers <NUM> disposed between a surface of the delivery system carrier <NUM> and surfaces of the base <NUM> and housing <NUM>. Preferably, a plurality of rollers <NUM> are circumferentially and equidistantly displaced about an outer surface <NUM> of the delivery system carrier <NUM>. A recess <NUM> is defined in the outer surface <NUM> of the delivery system carrier <NUM> to receive each of the plurality of rollers <NUM>, with the rollers being freely rotatable in the recess <NUM>. A part of each roller <NUM> engages an inner surface <NUM> of the base <NUM>, and a part engages an inner surface <NUM> of the housing <NUM> acting as a bearing that provides means for the container <NUM> to self-orient to enable proper uptake and extraction of the drug <NUM> from the container <NUM>. The rollers <NUM> thus enable rotational movement of the delivery system carrier <NUM> with respect to the housing <NUM> and base <NUM>, facilitating proper positioning of the delivery system carrier <NUM> and the container <NUM>. A guide <NUM> comprised of a guide pin <NUM> defined on the outer surface <NUM> of the delivery system carrier <NUM> and a track <NUM> defined in the inner surface <NUM> of the housing <NUM> further facilitates rotational movement of the delivery system carrier <NUM> and maintains it in a desired position with respect to the housing <NUM> and base <NUM>. These features of the present invention are directed to container orientation control and pump feedback sensing aspects of the inventive injector <NUM>. The annular or partially annular shape of the adhesive <NUM> enables the base <NUM> to still rotate freely after placement of the injector <NUM> on body, and furthermore to provide a clear unobstructed path for needle insertion into patient tissue.

An exemplary, illustrative and non-limiting use of the present invention will now be discussed with reference to <FIG>, <FIG> and <FIG>. In general, <FIG> depict the injector <NUM> of the present invention in a storage state prior to use. This can be the state of the injector <NUM> when it is contained in its secondary packaging or after it is removed from that packaging. In the stored state the adhesive backing <NUM>, sterile barrier tab <NUM>, power-on pull tab <NUM> and needle shield <NUM> are in place. The container <NUM> is in a first position in which it is not in fluid communication with the fluid path and in which the septum surface <NUM> and the access needle <NUM> are each maintained in a sterile state by the presence of the sterile barrier tab <NUM>. The injection needle <NUM> is also maintained in a sterile state by the needle shield <NUM>.

<FIG> generally depict the inventive injector <NUM> in a ready to use state but prior to placement on the patient's body. The adhesive backing <NUM>, sterile barrier tab <NUM>, power-on pull tab <NUM> and needle shield <NUM> are removed, which can occur simultaneously with removal of the injector <NUM> from its secondary packaging, or via separate discrete steps carried-out by the user. Removal of the sterile barrier tab <NUM> also causes removal of the container stop <NUM>, releasing the container <NUM> for movement in the container cradle <NUM> by the container drive springs <NUM> acting upon the container activator <NUM> (see, e.g., <FIG>), which acts upon the crimp cap <NUM>. Such movement causes a point tip of the access needle <NUM> to pierce the septum <NUM> and fluidly connect the interior chamber of the container <NUM> with the fluid path. In this state a fluid can be introduced into or extracted from the chamber of the container <NUM>, depending at least in part upon operation of the DCSA <NUM>.

<FIG> generally depict the inventive injector <NUM> in an injection state that occurs when the injector <NUM> is in place on the patient's body. In this state the injection needle <NUM> has pierced the patient's skin, and rotation of the delivery system carrier <NUM> and injection needle <NUM> are prevented by the rotation lockout <NUM> comprised of the needle position nub <NUM> and at least one recess <NUM> in the base <NUM>. These conditions occur only upon satisfaction of certain criteria regarding orientation of the container <NUM>, temperature of the drug <NUM> in the container <NUM> and presence of the injector <NUM> on the patient's body.

The In use, a user of the injector <NUM> of the present invention removes the injector <NUM> from its secondary packaging such as a blister pack. In an embodiment of the present invention, such removal will also remove the power-on pull tab <NUM>, connecting the battery <NUM> with the controller <NUM> and initializing the injector <NUM>. Alternatively, a separate step may be required of the user to remove the power-on pull tab <NUM>. Removal of the injector <NUM> from the blister pack may also cause removal of the adhesive backing <NUM>, exposing the adhesive <NUM>. In such an embodiment, removal of the injector <NUM> from the blister pack renders the injector <NUM> ready to place on the patient's skin and further ready to use. Alternatively, a separate step may be required of the user to remover the adhesive backing <NUM>. Once the injector is removed from its secondary packaging and the power-on pull tab <NUM> and adhesive backing <NUM> are removed, the injector <NUM> is ready for placement on the patient's body and use. Activation of the injector <NUM> by the controller <NUM> depends upon the signals received by the controller <NUM> from the body temperature sensor <NUM>, container temperature sensor <NUM> and orientation sensor <NUM>. The body temperature sensor <NUM> is able to determine if the injector <NUM> is on body by detecting a temperature rising, and eventually reaching, the range of human body temperature (or other animal body temperature). Only when the injector <NUM> is on body will the body temperature sensor <NUM> send an activation signal to the controller <NUM>. The container temperature sensor <NUM> can determine the temperature of the drug <NUM> in the container <NUM> to ensure that it is within a desired temperature range before the injector <NUM> begins an injection. Certain drugs are stored refrigerated and thus benefit from being brought to a warmer temperature before they are injected. The container temperature sensor <NUM> sends a signal to the controller <NUM> when the sensor <NUM> detects that the temperature of the drug <NUM> is at a desired level or within a desired range. The orientation sensor <NUM> determines the position of the container <NUM> with respect to a predetermined desired position that facilitates operation of the injector <NUM> to ensure proper and complete delivery of the drug <NUM>. As noted, the delivery system carrier <NUM> can be configured to auto-orient, or for user orientation. In both cases a light bar <NUM> in the housing <NUM> indicates when the delivery system carrier <NUM> is properly oriented. The orientation sensor <NUM> sends a signal to the controller <NUM> when the delivery system carrier <NUM> is properly oriented.

Referring next to <FIG> and <FIG>, certain aspects of the present invention and its operation will now be discussed in greater detail. <FIG> discloses certain steps carried-out by the controller <NUM> in a pre-injecting or pre-injection phase of operation of the injector <NUM> of the present invention. For this phase the controller <NUM> receives input from at least the orientation sensor <NUM> at <NUM>, the body temperature sensor <NUM> at <NUM>, and container temperature sensor <NUM> at <NUM>. These sensors monitor and detect various conditions of the injector <NUM>, the drug <NUM> contained in the container <NUM>, and the patient, as illustrative, non-limiting examples, to ensure that the injector <NUM> is activated only under certain conditions, e.g., temperature and orientational. The controller <NUM> enables operation of the injector <NUM> (at <NUM>) based upon the orientation of the injector <NUM>, patient's body temperature, and temperature of the drug to be injected.

The orientation sensor <NUM> detects and determines the orientation of the delivery system carrier <NUM>, as its orientation is important to ensure proper operation of the injector <NUM> and delivery of the drug <NUM>.

The body temperature sensor <NUM> detects the patient's body temperature to determine when the injector <NUM> is on-body. The way in which it is concluded that the device has been placed on the patient's body from a temperature sensor may not alone, or at all, be based on reaching a preset temperature level. The best way is likely to monitor the rate of temperature rise to differentiate between a rise due to the device sitting within a room temperature environment versus it being placed on the patient's body, with the rate of rise being much steeper for the latter. The rate of rise in addition to the temperature magnitude may both be needed where a temperature level within <NUM> degrees F of human body temperature would be sufficient. In terms of accuracy of the sensor, +/- <NUM> degrees F with <NUM> degree resolution is preferable.

The container temperature sensor <NUM> detects the temperature of the container <NUM> (and drug <NUM>) to determine whether it is near room temperature. It is preferred that drugs reach room temperature before injection. In a preferred embodiment, a drug temperature around <NUM> degrees F should be the minimum temperature of the drug before the injector <NUM> will initiate an injection. Given the drug will still be able to be injected and work properly even if injected colder, significant tolerance is acceptable in terms of the temperature of the drug and room temperature, with accuracy and resolution needed no tighter than as indicated for the on-body detection.

To further activate the injector <NUM>, a user/patient presses a push-button <NUM>, at <NUM>.

Thereafter, there are five possible outcomes of the pre-injecting phase in accordance with embodiments of the present invention, as indicated by references <NUM>, <NUM>, <NUM>, <NUM> and <NUM> of <FIG>. A first outcome, indicated by <NUM>, occurs when the orientation sensor <NUM>, body temperature sensor <NUM> and container temperature sensor <NUM> all detect levels or values that are within their respective predetermined values or ranges. Under these conditions and upon depression of the push-button <NUM>, the controller <NUM> causes the drive motor <NUM> to actuate the needle <NUM> to insert into the patient's skin. The controller <NUM> then causes the injector <NUM> to operate in the injection or injecting phase, as depicted in <FIG> and discussed below.

A second outcome, indicated by <NUM>, occurs when the orientation sensor <NUM> and body temperature sensor <NUM> each determine that the orientation and temperature of the delivery system carrier <NUM> are not at their respective predetermined values, the container temperature sensor <NUM> determines that the container temperature is not at or near room temperature, and the push-button <NUM> is not pressed. Under these conditions the controller <NUM> does not cause the drive motor <NUM> to activate the needle assembly <NUM>, and an audible and/or visual indicator indicates that pre-injection steps have not completed and the injector <NUM> will not inject.

A third outcome, indicated by <NUM>, occurs when the orientation sensor <NUM>, body temperature sensor <NUM> and container temperature sensor <NUM> all detect levels or values that are within their respective predetermined values or ranges but the push-button <NUM> is not pressed after a predetermined amount of time. Under these conditions the controller <NUM> causes the drive motor <NUM> to actuate the needle assembly <NUM> to insert the needle into the patient's skin. The controller <NUM> then causes the injector <NUM> to operate in the injection or injecting phase, as depicted in <FIG> and discussed below.

A fourth outcome, indicated by <NUM>, occurs when the orientation sensor <NUM> and body temperature sensor <NUM> each detect levels or values that are within their respective predetermined values or ranges, but the container temperature sensor <NUM> does not. Under these conditions and upon depression of the push-button <NUM>, the controller <NUM> causes the drive motor <NUM> to actuate the needle assembly <NUM> to insert into the patient's skin. The controller <NUM> then causes the injector <NUM> to operate in the injection or injecting phase, as depicted in <FIG> and discussed below.

A fifth outcome, indicated by <NUM>, occurs when the orientation sensor <NUM> and body temperature sensor <NUM> each detect levels or values that are within their respective predetermined values or ranges, but the container temperature sensor <NUM> does not, and the push-button <NUM> is not pressed after a predetermined amount of time. Under these conditions the controller <NUM> causes the drive motor <NUM> to actuate the needle assembly <NUM> to insert the needle into the patient's skin. The controller <NUM> then causes the injector <NUM> to operate in the injection or injecting phase, as depicted in <FIG> and discussed below.

Referring next to <FIG>, an injection or injecting phase of the injector <NUM> of the present invention will now be discussed in greater detail. For this phase the controller <NUM> receives input from at least the orientation sensor <NUM> at <NUM>, the body temperature sensor <NUM> at <NUM>, and an end of dose sensing at <NUM>. End of dose sensing is provided by logic programmed into the controller <NUM> that enables monitoring drive motor <NUM> current draw such a current draw drop to a predetermined level resulting from the mechanical resistance experienced by the drive motor <NUM> being reduced indicates that no more liquid is being pumped. Thus end of dose sensing is done indirectly and is part of the logic programmed into the controller <NUM>. These sensors monitor and detect various conditions of the injector <NUM>, the drug <NUM> contained in the container <NUM>, and the patient, as illustrative, non-limiting examples, to ensure that the injector <NUM> is activated only under certain conditions, e.g., temperature and orientational, and that the injector <NUM> stops injecting once the container <NUM> is empty. The controller <NUM> enables operation of the injector <NUM> (at <NUM>) based upon the orientation of the injector <NUM>, patient's body temperature, and temperature of the drug to be injected.

The body temperature sensor <NUM> detects the patient's body temperature to determine whether the internal base temperature is near the patient's body temperature. The way in which it is concluded that the device has been placed on body from a temperature sensor may not alone, or at all, be based on reaching a preset temperature level. The best way is likely to monitor the rate of temperature rise to differentiate between a rise due to the device sitting within a room temperature environment versus it being placed on the patient's body, with the rate of rise being much steeper for the latter. The rate of rise in addition to the temperature magnitude may both be needed where a temperature level within <NUM> degrees F of human body temperature would be sufficient. In terms of accuracy of the sensor, +/- <NUM> degrees F with <NUM> degree resolution should suffice.

The end of dose sensor <NUM> detects and determines when delivery of the drug <NUM> is complete.

Four possible outcomes of the injecting phase are provided in accordance with embodiments of the present invention, as indicated by references <NUM>, <NUM>, <NUM> and <NUM> of <FIG>. A first outcome, indicated by <NUM>, occurs when the orientation sensor <NUM> and body temperature sensor <NUM> each detect levels or values that are within their respective predetermined values or ranges, and the end of dose sensor <NUM> does not indicate that delivery of the drug <NUM> is complete. Under these conditions the drive motor <NUM> will activate injection of the drug <NUM> from the container <NUM>, through the needle <NUM> and into the patient until the end of dose sensor <NUM> indicates completion of delivery of the drug <NUM>.

A second outcome, indicated by <NUM>, occurs when the orientation sensor <NUM> determines that the orientation of the delivery system carrier <NUM> is not at its predetermined value, but the body temperature sensor <NUM> indicates that the internal base temperature is. Provided the end of dose sensor <NUM> has not indicated an end of dose condition, the controller <NUM> will cause the drive motor <NUM> to pause injection of the drug <NUM>, preferably also providing an audible and/or visual indicator, until the orientation sensor <NUM> detects that the delivery system carrier <NUM> is properly oriented, at which time the controller <NUM> will cause the drive motor <NUM> to resume the injection until the end of dose indicator <NUM> indicates that delivery of the drug <NUM> is complete.

A third outcome, indicated by <NUM>, occurs when the orientation sensor <NUM> determines that the orientation of the delivery system carrier <NUM> is not at its predetermined value and the body temperature sensor <NUM> determines that the internal base temperature is not at its predetermined value. The controller <NUM> interprets these conditions as an indication that the injector <NUM> has been removed from the patient's skin, and permanently stops delivery of the drug <NUM>. The controller <NUM> also preferably provides an audible and/or visual indicator of this condition.

A fourth outcome, indicated by <NUM>, occurs when the end of dose sensor <NUM> indicates to the controller <NUM> the delivery of the drug <NUM> is complete. The controller <NUM> causes the drive motor <NUM> to stop and provides an audible and/or visual indicator that delivery of the drug <NUM> is complete.

Modifications to embodiments of the present invention are possible without departing from the scope of the invention as defined by the accompanying claims. Expressions such as "including," "comprising," "incorporating," "consisting of," "have," "is," used to describe and claim the present invention are intended to be construed in a non-exclusive manner, namely allowing for articles, components or elements not explicitly described herein also to be present. Reference to the singular is to be construed to relate to the plural, where applicable.

Claim 1:
A wearable injector for delivering a drug into a body part of a patient comprising:
a housing (<NUM>);
a base (<NUM>) connected with the housing and releasably securable on the body part of the patient; and
a delivery system comprising:
a container sub-assembly (<NUM>) for containing the drug;
a drive control sub-assembly (<NUM>) coupled with the container sub-assembly and configured for controlling delivery of the drug into the patient;
a flow-path sub-assembly (<NUM>) providing a fluid path with the container sub-assembly via which a fluid can be introduced into the container sub-assembly and via which the drug can be extracted from the container sub-assembly, wherein the drive control sub-assembly engages the flow-path sub-assembly to cause the fluid to be introduced into the container sub-assembly and to cause the drug to be extracted from the container and delivered into the patient; and
a sensor (<NUM>; <NUM>; <NUM>) for detecting one of temperature of the body part, temperature of the drug in the container subassembly, and orientation of the container sub-assembly; and a controller (<NUM>) receiving an input from the sensor and controlling the drive control sub-assembly based upon the input to set a state of the injector;
characterized by
a carrier (<NUM>) rotatably arranged within the housing and base, the delivery system on the carrier.