On body injector of liquid drugs

Abstract

An on-body wearable injector for delivery of liquid drugs that 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 and which simplifies development and commercialization of drug device combination products through its novel primary container and injection system design. The injector addresses challenges within the drug-device development and commercialization process through its innovative primary container design and delivery mechanisms.

Description

ON BODY INJECTOR OF LIQUID DRUGSFIELD OF THE DISCLOSURE[1] The present disclosure is directed to a drug injection device, and in particular, to a body -worn injection device.BACKGROUND OF THE DISCLOSURE[2] 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. Most of these pipeline drugs requiring doses of greater than ImL 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.[3] A first problem is that syringes and autoinjectors are not suitable for many biologic medications / drugs, i.e., biologies. These drugs are typically injected. Most biologic drugs in the current development pipeline are high volume dosage drugs (>lml). Biologies 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.[4] A second problem is that once a given biologic drug advances in its development to the point consideration of a suitable delivery device, new challenges arise resulting from having to switch from a standard vial container (in which the drug has been developed) to a different container used in traditional delivery devices e.g., syringes and penautoinjectors. This introduces new factors to the drug-device development process creating additional challenges which must be overcome prior to moving forward with combination product commercialization. Throughout the drug development process biologic drugs will be stored and developed in standard glass vials. Administration can be achieved using a syringe which is filled at the time of use manually before injection into a patient. However, the combination of high volume and high viscosity makes this approach impractical or in some cases not feasible at all. 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).[5] 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, increasing risk, time, and cost to bring to go to market. While following a method of syringe and vial is convenient and can avoid these challenges (from a drug development continuation and industrialization perspective), such an approach is not conducive to large scale commercial application.[6] It is thus desirable to find a solution that not only ensures patients with chronic diseases have access to life changing drugs as early as possible but also achieves this in a way which solves problems for both patients in terms of ease and convenience of administration and biopharma companies in terms of simplifying and streamlining the commercialization process. While some new wearable injector devices have entered the market, they fall short in solving the whole problem as they are either cumbersome to use and place too muchburden on the patient / user, or they utilize a design approach which adds too much complexity to the drug-device combination product development process. .[7] 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 biologies, 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.[8] Patient care is moving towards home care with self-care / self-inj ection 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.SUMMARY OF THE DISCLOSURE[9] The present disclosure is directed to a fully integrated wearable injector for automated delivery of biologic drugs. The disclosed 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 disclosed injector differentiate it from other injectors, including, by way of illustration and not limitation: 1) its pre-filled and preassembled container format improving acceptance and adoption; 2) its standard vial-like primary container design which offers many of the advantages of standard vial containers such as silicone free operation, filling on standard vial fill-finish lines, and use of standard elastomer components, accelerating commercialization and reducing risks; 3) its designwhich is insensitive to orientation allowing the pumping to function reliably regardless of the orientation of the device when placed on body or at any time during the injection process, and 4) its design architecture which provides important flexibility to accommodate changes in dose volume and injection rate within a single configuration.

[0010] Furthermore, the device design lends itself to either electro-mechanical drive operation where system properties such as injection rate can be altered via software program changes alone, or to purely mechanical drive operation requiring no on-board electronics or power sources. The embodiment using electric motor drive may be referred to as the “electric motor drive configuration” or “first embodiment injector” throughout this document and the embodiment using an all mechanical drive may be referred to as the “mechanical drive configuration” or “second embodiment injector” throughout this document. The disclosed injector is deliberately designed this way to offer flexibility in configuration to best meet the needs of the drug and biopharma customer.

[0011] Standard vials are also the ideal container for drug protection and stability, however they introduce challenges with respect to removal of the drug and transfer into the patient as orientation becomes a factor to successful draw the fluid out of the container. The novel design and engineering solutions associated with wearable injectors in accordance with the present disclosure maintains much of the value and benefit of using a full standard glass vial but also solves the fluid removal problem. This innovation greatly simplifies use for patients and makes adoption easier for pharmaceutical companies as it saves time in development and reduces commercialization cost.

[0012] The disclosed injector may be used by pharmaceutical, biopharmaceutical, and similar companies that develop and manufacture biologic drugs. The disclosed injector provides these companies with a solution for introducing / launching high volume and high viscosity drugs to market, or more generally an alternative to traditional syringes or auto-injectors where patient use anxiety or risk of non-compliance can be mitigated by a better delivery device The disclosed 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.

[0013] The innovation of wearable injectors in accordance with the present disclosure lies in part in its novel design which enables differentiating features such as its pre-filled and pre-assembled primary container format making it simple and reliable for at home selfinjection regardless of device orientation as well as use of a standard glass vial-like primary container which is fillable on standard glass vial filling lines and which requires no silicone lubrication, and furthermore is compatible with standard elastomer components which all combine to offer significant development and commercialization advantages for pharmaceutical companies.

[0014] The disclosed injector 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 disclosed wearable injector 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. Wearable injectors in accordance with the present disclosure can enable patients to receive medication that may otherwise not be accessible to them.

[0015] Embodiments of the disclosed wearable injector is provided with features and advantages not currently found in available devices. Possible embodiments of the disclosed injector use a standard vial -like container integrated into the device (or alternatively standardcartridge like or standard syringe like), is operatable without assistance of silicone oil or alternative lubricant, is orientation agnostic, and functions to continuously pump without disruption regardless of device orientation. The ability to function using a standard vial-like container leads to significant commercialization advantages, including reduced risk in drug stability studies, saving time, money, and resources, using the most economical and widely available filling equipment (vial filling, cartridge filling, or prefilled syringe (PFS) filling), accelerating advancement through clinical trials and simplifying commercial scale production, eliminating need for silicone oil lubricant (required for syringes standard cartridges, or other custom 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.

[0016] Embodiments of the disclosed injector is pre-filled which makes the injector 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.

[0017] In one embodiment, the disclosed 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 biologies 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.

[0018] In a further embodiment, the disclosed injector allows drug warming 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 injectiononset 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 predetermined 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.

[0019] Possible embodiments of the disclosed wearable injector further possess the capability to deliver variable volumes of viscous solutions, on the order of 1 mL - 20 mL or higher with viscosity levels anywhere between 1 and lOOcP, or higher depending on delivery time limitations. In addition, embodiments of the disclosed wearable injector may possesses electro-mechanical mechanisms for automatic fluid extraction from the vial and injection into subcutaneous tissue; with variable delivery rates achieved through software changes only.

[0020] Other possible embodiments of the disclosed injector alternatively permits use of a mechanical spring energy source to drive the pumping of the injector in lieu of an electro-mechanical motor drive approach if electronics are not desired for a given application, and while preserving use of approximately 80% of the components used throughout the rest of the system.

[0021] Embodiments of the disclosed injector may further utilize a design architecture which can be adapted to work with a primary container of any standard glass vial size (i.e., external dimensions).

[0022] Embodiments of the disclosed wearable injector for delivering a drug into a body part of a patient comprise a housing, a base connected with the housing and releasably securable on the body part of the patient, and a delivery system arranged within the housing and base. The delivery system comprises a quasi -standard vial assembly for containing the drug, a drive control sub-assembly coupled with the injection sub-assembly (or alternatively a mechanical drive assembly for the all mechanical embodiment) and configured to interfacewith the quasi-standard vial assembly for controlling delivery of the drug into the patient, where the injection sub-assembly provides a fluid path with the quasi-standard vial assembly, wherein the drive control sub-assembly (or alternatively a mechanical drive assembly) engages the injection sub-assembly to cause the drug to be extracted from the container and delivered into the patient, and in one embodiment a sensor for detecting one of temperature of the body part, temperature of the drug in the quasi-standard vial assembly, and in one embodiment a controller receiving an input from the sensor and controlling the drive control sub-assembly based upon the input to initiate an injector dosing state.

[0023] In a further possible embodiment of the disclosed wearable injector the drive control sub-assembly further comprises a peristaltic pump.

[0024] In a yet further possible embodiment of the disclosed wearable injector the peristaltic pump further comprises a drive motor and a pump wheel controllable by the drive motor or alternatively a coil drive spring.

[0025] In an additional further embodiment of the disclosed wearable injector the quasi-standard vial assembly further comprises a container wherein the drive control subassembly, or alternatively the mechanical drive assembly, causes the drug to be extracted from the container for delivery into the patient by causing the drug to travel along a fluid path out of the container.

[0026] In a yet additional further embodiment of the disclosed wearable injector the drive control sub-assembly, or alternatively the mechanical drive assembly, causes the fluid path to be primed with the drug prior to delivery of the drug into the patient.

[0027] In a yet other possible embodiment of the disclosed wearable injector the quasi-standard vial assembly further comprises a container, and wherein the injection subassembly defines a fluid path with the container, wherein the drive control sub-assembly, or alternatively the mechanical drive assembly, causes the injector to move drug from thecontainer to the patient by causing by introducing negative pressure into the container resulting in extraction of liquid i.e., the drug from the container.

[0028] In a further embodiment of the disclosed wearable injector a piston preferably made from glass material which translates along the container upon, and in response to, removal of the fluid from the container via operation of the drive control sub-assembly, or alternatively the mechanical drive assembly, and injection sub-assembly peristaltic pump, and without the assistance of any driving force acting from behind the piston.

[0029] In a further variant embodiment of the disclosed wearable injector the injection 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, or alternatively the mechanical drive assembly, causes the drug to travel along the fluid path and through the injection needle into the patient.

[0030] In a yet further variant embodiment of the disclosed wearable injector the drive control sub-assembly, or alternatively the mechanical drive assembly, causes for the injection needle of the injection sub-assembly to be released and inserted into the patient automatically before the start of drug injection.

[0031] In a yet further additional variant embodiment of the disclosed wearable injector the drive control sub-assembly, or alternatively the mechanical drive assembly, causes for the injection needle of the injection sub-assembly to be fully retracted back into the injector automatically after drug injection has fully completed thereby fully shielding the needle from the patient and preventing risk of injury due to accidental needle stick.

[0032] In a further embodiment of the disclosed wearable injector the needle insertion shroud of the injection sub-assembly automatically extends from the injector during retraction of the injection needle providing visual, tactile, and audible indication to the patient that the dosing session has concluded.

[0033] In a further embodiment of the disclosed wearable injector the drive control sub-assembly, or alternatively the mechanical drive assembly, serves as the single actuator causing for automatic injection needle insertion, extraction of the drug from the container and flow into the patient, and retraction of the injection needle.

[0034] In a further embodiment of the disclosed wearable injector an adhesive on a part of the base releasably secures the base on the body part of the patient.

[0035] In a further embodiment of the disclosed wearable injector the quasi -standard vial assembly further comprises a container for the drug, and wherein in one embodiment 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 subassembly 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.

[0036] In a further embodiment of the disclosed wearable injector the predetermined temperature is at least 60° F.

[0037] In a further embodiment of the disclosed wearable injector the quasi -standard vial 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.

[0038] In a further embodiment of the disclosed wearable injector the second temperature sensor is configured to determine a temperature 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.

[0039] In a further embodiment of the disclosed wearable injector the predetermined temperature is at least within 5° F of 98.6° F.

[0040] In a further embodiment of the disclosed wearable injector the injection subassembly further comprises a needle hub assembly comprising a needle carrier and injection needle.

[0041] In a further embodiment of the disclosed wearable injector the quasi -standard vial assembly further comprises a container for containing the drug, the container having a pierceable seal, and wherein the injection 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 maintained in a sterile condition, wherein removal of the removable barrier causes the spring to cause the container to move in a predetermined direction in which the needle pierces the pierceable seal.

[0042] In a further embodiment of the disclosed wearable injector 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.

[0043] In a further embodiment of the disclosed wearable injector 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.

[0044] In a further embodiment of the electric motor drive configuration of the disclosed wearable injector a power source powers the injector, and a pull-tab that, when pulled enables the power source to power the injector.

[0045] In a further embodiment of the electric motor drive configuration of the disclosed wearable injector the quasi -standard vial assembly further comprises a container for containing the drug, and wherein the drive control sub-assembly further comprises a pump operable to extract drug within the container, and operable to cause the drug to flowfrom the container, upon the attachment of the device to the patient, the pump automatically causes the drug to flow from the container.

[0046] In a further embodiment of the disclosed wearable injector an audible and / or visual indicator indicates a state of the injector.

[0047] In a further embodiment of the disclosed wearable injector a push-button is provided for user activation of the injector.

[0048] In a further embodiment of the electric motor drive configuration of the disclosed wearable injector a needle is provided for delivering the drug into the patient, and wherein the injector is configured to automatically cause the needle to be inserted into the body part of the patient via sensors on board the device.

[0049] Another embodiment of the electric motor drive configuration of the disclosed wearable injector is 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, and a delivery system on the base comprising a -quasi-standard vial assembly for containing the drug, a drive control sub-assembly coupled with the quasi-standard vial assembly and configured for controlling delivery of the drug into the patient, an injection sub-assembly providing a fluid path with the quasi-standard vial assembly via which the drug can be extracted from the quasi-standard vial assembly, a sensor for detecting one of temperature of the body part and temperature of the drug in the container sub-assembly, and a controller receiving an input from the sensor.BRIEF DESCRIPTION OF THE DRAWINGS

[0050] Embodiments of the disclosed wearable injector will now be described with reference to the following drawing figures.

[0051] FIG. 1A depicts a perspective top view of a first embodiment wearable injector in accordance with this disclosure that includes an electric motor drive configuration.

[0052] FIG. IB depicts a perspective top view of a second embodiment wearable injector in accordance with this disclosure that includes a mechanical drive configuration.

[0053] FIG. 2A is an exploded view of the first embodiment wearable injector shown in FIG. 1A.

[0054] FIG. 2B is an exploded view of the second embodiment wearable injector shown in FIG. IB.

[0055] FIG. 3A depicts the first embodiment wearable injector shown in FIG. 1A with the housing removed to show certain internal components.

[0056] FIG. 3B depicts the second embodiment wearable injector shown in FIG. IB with the housing removed to show certain internal components.

[0057] FIGS. 4A and 4B depict a quasi-standard vial assembly (QSVA) used with the first and second embodiments of the wearable injector.

[0058] FIG. 5 depicts a delivery system including the quasi-standard vial assembly (QSVA), an injection sub-assembly (ISA), and a drive control sub-assembly (DCS A) used with the first embodiment wearable injector.

[0059] FIG. 6 depicts an injection sub-assembly (ISA) of a wearable injector in accordance with this disclosure with some parts transparent.

[0060] FIG. 7A depicts a delivery system used with the first and second embodiments of the wearable injector, the delivery system including a quasi-standard vial assembly (QSVA) and an injection sub-assembly mounted on a base with the quasi-standard vial assembly shown in a stored state.

[0061] FIG. 7B illustrates the delivery system shown in FIG. 7A but in a ready to begin injection state, the top cover removed for visibility.

[0062] FIGS. 8A - 8C depict respective views of the first embodiment wearable injector or the second embodiment wearable injector in a stored or pre-use state.

[0063] FIGS. 9A - 9C depict respective views of the first embodiment wearable injector or the second embodiment wearable injector in a ready -to-use state where the injector is ready to be placed onto the patient’s body.

[0064] FIGS. 10A - IOC depict respective views of the first embodiment wearable injector or the second embodiment wearable injector in a ready to start injection state with the needle inserted into the patient.

[0065] FIGS. 11A - 11C depict respective views of the first embodiment wearable injector or the second embodiment wearable injector in an injecting state approximately one- half completed.

[0066] FIGS. 12A - 12C depict respective views of he first embodiment wearable injector or the second embodiment wearable injector in an injection fully completed state with injection needle retracted.

[0067] FIG. 13 depicts a flow diagram of a pre-injecting phase of a wearable injector in accordance with the present disclosure.

[0068] FIG. 14 depicts a flow diagram of an injecting phase of a wearable injector in accordance with the present disclosure.

[0069] FIG. 15A and 15B depict a mechanical drive assembly used in the second embodiment wearable injector shown in FIG. 2B with the drive block removed for visibility and in a ready to start injection state and injection fully completed state, respectively.

[0070] FIG. 15C and 15D depict a mechanical drive assembly used in the second embodiment wearable injector shown in FIG. 2B and in a ready to start injection state and injecting state, respectively.

[0071] FIG. 16 depicts a delivery system used in the second embodiment wearable injector shown in FIG. 2B that includes a quasi-standard vial assembly (QSVA), an injection sub-assembly (ISA), and a mechanical drive assembly (MSA).DETAILED DESCRIPTION

[0072] The present disclosure is directed to an integrated automated wearable injector for at home self-administration of drugs. Two of the possible types of embodiments of the disclosed wearable injector includes a first embodiment wearable injector 100 (see FIG. 1A) that involves electro-mechanical functionality with embedded electronics and an electric motor for the systems drive system, and a second embodiment wearable injector 101 (see FIG. IB) which alternatively involves an all-mechanical solution for the device drive system.

[0073] For both electro-mechanical embodiments and all-mechanical embodiments of the disclosed wearable injector, and advantageously, injector embodiments may utilize a standard glass vial-like primary container, an innovative aspect of which is that it enables differentiating features such as its pre-filled and pre-assembled primary container format making it simple and reliable for at home self-inj ection. Use of a standard glass vial-like container described herein enables benefits including the ability to fill the container with drug using standard vial fill finish equipment, which is the most common, easiest to fill, and most compatible method of drug filling . Furthermore, possible embodiments of the disclosed wearable injector do not require the use of silicone lubrication as all other non-vial type glass containers require. These novel features combine to simplify the commercialization process to get to market faster and with less cost.

[0074] With reference next to the drawings, and in particular FIGS. 1 A and 2 A, a first embodiment integrated automated wearable injector 100 in accordance with this disclosure will now be discussed in detail. The first embodiment wearable injector 100 will be discussed in greater detail below, focusing on the first embodiment injector 100 comprehensively then on the distinct aspects of the second embodiment wearable injector 101, noting that most of the systems and therefore functionality is the same between the first and second embodiment injectors. The first embodiment injector 100 and the secondembodiment injector 101 differ primarily with the DCS A of the first embodiment injector being replaced by the MSA of the second embodiment injector to render the second embodiment injector all mechanical in its operation.

[0075] The first embodiment injector 100 is depicted in FIG. 1A and in an exploded view in FIG. 2A and comprises a housing 110 and a base 120 that connect together and contain the other components of the injector 100. A window 108 defined in the injector 100 enables a user of the injector 100 to see the container 222 and its contents. The injector 100 comprises a delivery system 200 (see also FIG. 5) comprised of a quasi -standard vial assembly (QSVA) 220 (shown assembled in FIG. 4A), a drive control sub-assembly (DCSA) 240 (shown assembled in FIG. 5) and an injection sub-assembly (ISA) 260 (shown assembled in FIG. 5). The delivery system 200 is mounted to the base 120. An adhesive 102 provided on the base 120 secures the injector 100 to a patient’s body. A removable adhesive backing 106 covers an adhesive surface of the adhesive 102 prior to use, with the backing 106 being removed by a user prior to application to the patient’s body.

[0076] Referring next to FIG. 4A and FIG. 4B, the quasi -standard vial assembly (QSVA) 220 will be discussed in greater detail. The first embodiment injector 100 contains a primary container 222 for holding a drug 290, e.g. a liquid biologic drug. In a preferred embodiment, the primary container 222 is a vial-like glass container design which mimics the external geometry of existing standard glass vials. A piston 236, preferably made of glass, is inserted into an open bottom of the container with a seal between the piston 236 and container 222 established via one or more piston o-rings 250 with the o-rings preferably made of a flouroelastomer e.g., Teflon coated material.

[0077] Alternatively, the piston 236 and o-rings 250 may be replaced by a single all rubber component. However, a piston 236 made from glass material can advantageously minimum the amount of drug 290 contacting non-glass material.

[0078] An end cap 238 may be attached to the bottom of container 222 and is of a geometry which mimics the bottom design of existing standard glass vials. The container 222 together with end cap 238 matches the external geometry of existing standard glass vials enabling the quasi-standard vial assembly (QSVA) 220 to be fillable on standard vial filling lines. Alternatively, the end cap 238 can be left out of the QVSA 220 if not required to facilitate drug filling on a standard vial filling line. The container is closed with a septum 224 secured in place over the container opening by a crimp cap 228. Wearable injectors in accordance with the present disclosure advantageously may use a standard vial-like design for the primary container 222 which enables use of well-established and accepted filling, sterilization, storage, use, etc., processes for liquid biologic drugs and vials.

[0079] As depicted sequentially in FIG. 4B, such a process for filling the vial 222 is depicted in which the drug 290 is introduced into the container opening, a septum 224 is sealingly placed over an opening of the container 222, and a crimp cap 228 is crimped in placed to sealingly secure the septum in place. A sterile barrier 230 with integrated container retention clip 234 is attached to the crimp cap 228 to maintain sterility of the septum 224 during storage. The QSVA 220 is now ready for use in the injector 100. The QSVA 220 leverages well established standard components as well as drug filling and closure techniques which are compatible with existing fill-finish production lines. The QSVA 220 containing the drug 290 is able to insert into the injector 100 to establish fluid connection between the QSVA 220 and ISA 260, as described in more detail below.

[0080] With reference again to FIG. 5 and additional reference to FIG. 6, the ISA 260 includes a vial access manifold 262, pump transfer block 264 (see also FIG. 3), pump tube 266, injection tube 268, and release clip 270. A flow-path needle 284 provides a fluid path between the QVSA 220 and pump tube 266. A fluid transfer cannula 282 extends the fluid path from the pump tube 266 to the injection tube 268 and then to the injection needle 278 fordelivery of the drug 290 into the patient. The drug 290 is extracted from the container 222 when the DCSA is activated. In a preferred embodiment, the flow-path needle 284 and fluid transfer cannula 282 are each at least partially contained in the vial access manifold 262.

[0081] With continued reference to FIG. 5 and FIG. 6, the ISA 260 further comprises a needle hub assembly 272 comprising a needle carrier 280 for carrying an injection needle 278, an injection spring 274 nested inside a needle hub shroud 302 for causing the injection needle 278 to move to an injection position, a retraction spring 298 for causing the injection needle 278 to move to a retracted position, and a needle shield 276 for covering and maintaining the sterility of a sharp, patient end of the injection needle 278 prior to use. A sterile barrier 232 is attached to the vial access manifold 262 to maintain sterility of the flowpath needle during storage. The ISA 260 is designed for interface with the QSVA 220 to establish fluid connection between the two sub-assemblies.

[0082] The ISA 260 design provides a solution which allows its assembly and sterilization to occur separately from the QSVA 220. This allows the container 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 fillfinish process.

[0083] Avoiding complexity within aseptic processing is of strategic importance to avoid manufacturing issues when scaling up. Additionally, keeping the ISA 260 separate from the QSVA 220 allows the ISA 260 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 100 as ETO permeability becomes a non-factor.

[0084] 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 ISA 260 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.

[0085] With continued reference to FIGS. 5 and 6, the DC SA 240 comprises a stepper drive motor 244 controlled by a controller 400 (see also FIG. 2A) for causing a roller carrier 248 having a plurality of rollers 246 to rotate in first and second directions. Alternatively, the drive motor 244 may comprise a DC motor or any other type of motor capable of providing the described functionality. Alternatively, the drive motor 244 may comprise an allmechanical means or generating rotational energy such as a clock spring coil (see FIG 3B) which is further described in detail later in this document. The rotation of the roller carrier 248 creates a peristaltic pump that causes the drug 290 to move along the fluid path defined by the flow-path needle 284, pump tube 266, fluid transfer cannula 282, injection tube 268, and injection needle 278.

[0086] In a use or injection mode, the drive motor 244 causes the liquid drug 290 to be extracted from the container 222 and move along a fluid path eventually exiting the injection needle 278 into the patient. The roller carrier 248 may contain any means for multiple and localized contacting with the pump tube 266 to produce peristaltic pumping action, for example, fixed lobes which contact and slide against the pump tube 266, a plurality of rollers 246 which spin freely about spindles of the roller carrier 248 while the rollers 246 roll in contact with the pump tube 266, and quasi-fixed lobes which are integratedfeatures of the roller carrier 248 and slide in contact against the pump tube 266 but experience flexion when under load from static and / or dynamic engagement with the pump tube 266. The pump tube 266 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, or to achieve a predetermined volume of pumped fluid per revolution of the pump wheel 242 or a preferred mechanical compression profile of the pump tube 266 during operation.

[0087] The DCSA 240 not only provides the pumping action, but also the means for releasing the injection needle 278 from a stored position (see FIGS. 5 and 6 and 8C) to an injection position (see FIG. 10C) under power of the injection spring 274. A release clip 270 has arms 270a, 270b that are sized and shaped to engage a part of the needle carrier 280 and maintain the needle carrier 280 and injection needle 278 fixed in place prior to use. More importantly, the release clip 270 is controlled by the controller 400 to ensure that the needle carrier 280 and injection needle 278 are only released, enabling insertion of the injection needle 278 into the patient’s skin, when predetermined conditions of the injector 100 are satisfied. The release clip 270 thus locks the needle carrier 280 and injection needle 278 to prevent untimely or accidental activation. Furthermore, with continued reference to FIGS. 5 and 6 (see also FIGS. 11C and 12C) the DCSA 240 provides the means for triggering the retraction of the injection needle 278 from the injection position (see FIG. 11C) after the drug has been delivered into the patient to a retracted position (see FIG. 12C). The release clip 270 further has a tab 270c which engages the needle hub shroud 302 upon reversal of the drive motor 244 causing it to rotate and release the needle carrier 280 and injection needle 278 to retract back up into the injector 100 under power of the retraction spring 298.

[0088] For the first embodiment injector 100, control of the release clip 270 by the controller 400 may be affected by a one or more sensors in the injector 100 that monitortemperature of the drug 290 contained within the container 222 and temperature of the base 120, i.e., temperature of the patient at the injection site. With the needle insertion activated electromechanically ,the needle can be locked out from activation until the drug 290 has warmed prior to beginning injection which is monitored by a container temperature sensor 330. Through integration of thermal sensors, the injector 100 can be prevented from needle activation and / or commencing of fluid pumping until drug warming has been completed. Furthermore, a body temperature sensor 310 can be used to detect when the injector 100 has been placed on the patient’s body to further restrict injector activation until properly affixed to a patient’s skin.

[0089] Additionally for the first embodiment injector 100, the controller 400 receives input from at least one of the container temperature sensor 320 and body temperature sensor 310, and controls movement of the release clip 270 by the drive motor 244 through a threaded interface between them via the pump wheel 242. Preferably the drive motor 244 causes the release clip 270 to move in a direction transverse to the longitudinal axis of the injection needle 278 and toward the drive motor 244 to release the injection needle 278. Such movement causes arms 270a and 270b of the release clip 270 to be displaced with respect to the needle carrier 280, thereby presenting an opening to the needle carrier 280, allowing it to be displaced by the insertion spring 274, causing the injection needle 278 to enter the patient’s skin.

[0090] The threaded engagement between the pump wheel 242 and the release clip 270 allows the rotation of the pump wheel 242 to occur in the direction causing for drug 290 to begin moving along the fluid path into the injection needle 278 either before or after release of the injection needle 278, and furthermore is manipulated via the thread design of the pump wheel 242 and release clip 270. Once the injection needle 278 releases, the releaseclip 270 becomes mechanically decoupled from the pump wheel 242, allowing the pump wheel 242 to continue its rotation to dispense the drug.

[0091] Integrated automated wearable injectors in accordance with this disclosure such as the first embodiment injector 100 and the second embodiment injector 101 advantageously coordinates a plurality of mechanical systems of so that the retention clip is timed to translate to the point of needle release into the patient only after fluid path priming has completed. Furthermore, 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 injection to move the retention clip in a direction away from the drive motor. Movement of the retention clip away from the drive motor causes a tab 270c of the retention clip to engage an arm 302a of the needle hub shroud 302 thereby rotating the needle hub shroud to release the retraction spring 298 and move the injection needle 278 back up into the injector 100.

[0092] The QSVA 220, ISA 260 and DCSA 240 sub-systems previously described are assembled onto a base 120 as depicted in FIG. 3A. The base 120 includes one or more openings for the power-on pull tab 136 (applicable to embodiment one only), the needle shield 276, and the sterile barrier tabs 230 and 232 to pass through (see FIGS. 7A and 8A). In a preferred embodiment, the sterile barrier tab 230 provides a sterile barrier for the exposed end of the flow-path needle 284, and the sterile barrier tab 232 provides a sterile barrier for the septum 224. A container stop 234 is secured to an end of the septum surface sterile barrier tab 230 and is removed coincident with removal of that sterile barrier tab 230.

[0093] Removal of the container stop 234 enables the container 222 to be moved causing the exposed sharp tip of the flow-path needle 284 to pierce the septum 224, establishing a fluid path from the container 222 to the injection needle 278. The two sterile barrier tabs 230 and 232 are configured such that one removal action peels both tabstriggering fluid connection between the container 222 and the ISA 260. This sequence of functions is intended to occur in rapid succession upon removal of the injector 100 from its secondary packaging, or alternatively upon removal of the adhesive backing 106, such that certain pre-inj ection steps are completed passively to the user. More specifically, a user removes the injector 100 from its secondary packaging in preparation for use, which may simultaneously remove the sterile barrier tabs 230 and 232 and container stop 234.

[0094] The user next removes the adhesive backing 106 which may simultaneously remove the sterile barrier tabs 230 and 232 and container stop 234 (if not achieved during the removal from packaging step) or, alternatively, the adhesive backing 106 and sterile barrier tabs 230 and 232 may be removed via discrete, separate actions. In either case, once the container stop 234 is removed, the container 222 is caused to move from its storage position, depicted in FIG. 7A, to its ready position, depicted in FIG. 7B, in which a tip of the flow-path needle 284 pierces the septum 224 connecting the interior chamber of the container 222 with the fluid path. Such movement of the container 222 is caused by a pair of springs 252 provided in channels defined in each side of a container cradle 254, that act upon a vial activator 112 (see Fig. 2). Advantageously, the vial activator 112 engages the crimp cap 228 of the QSVA 220 which reduces the stress imposed in the container 222 by the springs 252 and reduces the risk of container breakage.

[0095] A further improvement of the first embodiment injector 100 is directed to system power-on and priming / arming for injection. Wearable injectors in accordance with the present disclosure may thus further be directed to an injector such as the first embodiment injector 100 having a power-on pull tab 136 as an integral part of removing the device from its packaging, or alternatively upon removal of the adhesive backing 106.

[0096] An exemplary, illustrative and non-limiting use of a wearable injector in accordance with the present disclosure will now be discussed with reference to FIGS. 8Athrough 8C. In general, FIGS. 8A-8C depict the first embodiment injector 100 in a storage state prior to use. This can be the state of the injector 100 when it is contained in its secondary packaging or after it is removed from that packaging. In the stored state the adhesive backing 106, power-on pull tab 136 (applicable to first embodiment injectors having electro-mechanical functionality), and needle shield 276 are in place. The QVSA 220 resides inside the injector 100 along with the ISA 260. The fluid path components of the QVSA 220, which includes the septum 224, and all components of the ISA 260 which includes all drug contacting parts are maintained in a sterile state in the storage state.

[0097] FIGS. 9A-9C generally depict the injector 100 in a ready to use state but prior to placement on the patient’s body. The adhesive backing 106, and needle shield 276 are removed, which can occur simultaneously with removal of the injector 100 from its secondary packaging, or via separate discrete steps carried-out by the user. In this state the fluid path between the QVSA 220 and ISA 260 connecting the container 220 to the injection needle 278 has been established wherein the drug 290 is now able to flow from the container 222 depending at least in part upon operation of the DCSA 240.

[0098] FIGS. 10A-10C generally depict the injector 100 in an injection state at the onset of injection that occurs when the injector 100 is in place on the patient’s body. In this state the injection needle 278 has pierced the patient’s skin. These conditions occur only upon satisfaction of certain criteria regarding temperature of the drug 290 in the container 222 (applicable to embodiment one only) and presence of the injector 100 on the patient’s body.

[0099] FIGS. 11A - 11C generally depict the injector 100 in an injection state and approximately one-half of the drug 290 extracted from the container 222. In this state the injection needle 278 remains inserted into the patient having pierced the patient’s skin in previous state. In this state the piston 236 has translated down the container 222 undernegative pressure resulting from activation of the DCSA 240, and in response to the drug 290 exiting the container, and represents a state when the injector is actively dosing.

[0100] FIGS. 12A -12C generally depict the injector 100 in state of injection completion with the drug 290 fully expelled from the container 222 and with the injection needle 278 retracted back inside the injector 100. In this state the needle hub shroud 302 is protruding from the top of the housing 110.

[0101] In use, a user of the injector 100 removes the injector 100 from its secondary packaging such as a blister pack. In possible embodiments of injectors in accordance with this disclosure, including the first embodiment injector 100, such removal will also remove the power-on pull tab 136, connecting the battery 402 with the controller 400 and initializing the injector 100. Alternatively, a separate step may be required of the user to remove the power-on pull tab 136. Removal of the injector 100 from the blister pack may also cause removal of the adhesive backing 106, exposing the adhesive 102. In such an embodiment, removal of the injector 100 from the blister pack renders the injector 100 ready to place on the patient’s skin and further ready to use. Alternatively, a separate step may be required of the user to remove the adhesive backing 106.

[0102] Once the injector is removed from its secondary packaging and the power-on pull tab 136 and adhesive backing 106 are removed, the injector 100 is ready for placement on the patient’s body and use. Activation of the injector 100 by the controller 400 depends upon the signals received by the controller 400 from the body temperature sensor 310 and container temperature sensor 320. The body temperature sensor 310 can determine if the injector 100 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 100 is on body will the body temperature sensor 310 send an activation signal to the controller 400. The container temperature sensor 320 can determine the temperature of the drug 290 inthe container 222 to ensure that it is within a desired temperature range before the injector 100 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 320 sends a signal to the controller 400 when the sensor 320 detects that the temperature of the drug 290 is at a desired level or within a desired range.

[0103] Referring next to FIGS. 13 and 14, which are applicable to first embodiment injectors and variants thereof in accordance with this disclosure, certain aspects of operation will now be discussed in greater detail. FIG. 13 discloses certain steps carried-out by the controller 400 in a pre-injecting or pre-injection phase of operation of the injector 100. For this phase the controller 400 receives input from at least body temperature sensor 310 at 1308, and container temperature sensor 320 at 1310. These sensors monitor and detect various conditions the drug 290 contained in the container 222 and the patient, as illustrative, non-limiting examples, to ensure that the injector 100 is activated only under certain conditions, e.g., temperature.. The controller 400 enables operation of the injector 100 (at 1304) based upon the patient’s body temperature and temperature of the drug to be injected.

[0104] The body temperature sensor 310 detects the patient’s body temperature to determine when the injector 100 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 or possibly 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 5 degrees F of human body temperature would be sufficient. In terms of accuracy of the sensor, + / - 2 degrees F with 0.5 degree resolution is preferable.

[0105] The container temperature sensor 320 detects the temperature of the container 222 (and drug 290) 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 60 degrees F should be the minimum temperature of the drug before the injector 100 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.

[0106] To further activate the injector 100, a user / patient presses a push-button 104, at 1302.

[0107] Thereafter for electro-mechanical embodiments of the disclosed injector, such as the injector 100, there may be five possible outcomes of the pre-injecting phases indicated by references 1312, 1314, 1316, 1318 and 1320 of FIG. 13. A first outcome, indicated by 1312, occurs when the body temperature sensor 310 and container temperature sensor 320 both detect levels or values that are within their respective predetermined values or ranges. Under these conditions and upon depression of the push-button 104, the controller 400 causes the drive motor 244 to actuate the needle 278 to insert into the patient’s skin. The controller 400 then causes the injector 100 to operate in the injection or injecting phase, as depicted in FIG. 14 and discussed below.

[0108] A second outcome, indicated by 1314, occurs when the body temperature sensor 310 determines that the temperature of the delivery system base 120 is not at a predetermined value, the container temperature sensor 320 determines that the container temperature is not at or near room temperature, and the push-button 104 is not pressed.Under these conditions the controller 400 does not cause the drive motor 244 to activate theneedle hub assembly 272, and an audible and / or visual indicator indicates that pre-inj ection steps have not completed and the injector 100 will not inject.

[0109] A third outcome, indicated by 1316, occurs when the body temperature sensor310 and container temperature sensor 320 both detect levels or values that are within their respective predetermined values or ranges but the push-button 104 is not pressed after a predetermined amount of time. Under these conditions the controller 400 causes the drive motor 244 to actuate the needle hub assembly 272 to insert the needle into the patient’s skin. The controller 400 then causes the injector 100 to operate in the injection or injecting phase, as depicted in FIG. 14 and discussed below.[HO] A fourth outcome, indicated by 1318, occurs when the body temperature sensor 310 detects levels or values that are within a predetermined value or range, but the container temperature sensor 320 does not. Under these conditions and upon depression of the push-button 104, the controller 400 causes the drive motor 244 to actuate the needle hub assembly 272 to insert into the patient’s skin. The controller 400 then causes the injector 100 to operate in the injection or injecting phase, as depicted in FIG. 14 and discussed below.[Hl] A fifth outcome, indicated by 1320, occurs when the body temperature sensor310 detects levels or values that are within a predetermined value or range, but the container temperature sensor 320 does not, and the push-button 104 is not pressed after a predetermined amount of time. Under these conditions the controller 400 causes the drive motor 244 to actuate the needle hub assembly 272 to insert the needle into the patient’s skin. The controller 400 then causes the injector 100 to operate in the injection or injecting phase, as depicted in FIG. 14 and discussed below.

[0112] Referring next to FIG. 14, an injection or injecting phase of the first embodiment injector 100 will now be discussed in greater detail. For this phase the controller 400 receives input from at least the body temperature sensor 310 at 1404, and anend of dose sensing at 1406. End of dose sensing is provided by logic programmed into the controller 400 that enables monitoring drive motor 244 current draw for current draw rise or drop to a predetermined level resulting from the mechanical resistance change experienced by the drive motor 244 when no more liquid is being pumped and / or when the displacer balloon has maximally expanded. Thus, end of dose sensing is done indirectly and is part of the logic programmed into the controller 400. These sensors monitor and detect various conditions of the injector 100, the drug 290 contained in the container 222, and the patient, as illustrative, non-limiting examples, to ensure that the injector 100 is activated only under certain conditions, e.g., temperature, and that the injector 100 stops injecting once the container 222 is empty. The controller 400 enables operation of the injector 100 (at 1408) based upon the patient’s body temperature and temperature of the drug to be injected.

[0113] The body temperature sensor 310 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. One 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 5 degrees F of human body temperature would be sufficient. In terms of accuracy of the sensor, + / - 2 degrees F with 0.5 degree resolution should suffice.

[0114] The end of dose sensor 340 detects and determines when delivery of the drug 290 is complete.

[0115] For first embodiment injectors having electro-mechanical functionality such as the injector 100, three possible outcomes of the injecting phase may be provided inaccordance with this disclosure, as indicated by references 1410, 1414 and 1416 of FIG. 14. A first outcome, indicated by 1410, occurs when the body temperature sensor 310 detects levels or values that are within a predetermined value or range, and the end of dose sensor 340 does not indicate that delivery of the drug 290 is complete. Under these conditions the drive motor 244 will activate injection of the drug 290 from the container 222, through the injection needle 278 and into the patient until the end of dose sensor 340 indicates completion of delivery of the drug 290 after which the DCSA will reverse direction to move the needle clip 270 toward the needle hub assembly 272 engaging the needle hub shroud 302 at its release tab 302a and causing for the injection needle 278 to be retracted back into the injector 100.

[0116] A second outcome, indicated by 1414, occurs when the body temperature sensor 310 determines that the internal base temperature is not at its predetermined value. The controller 400 interprets these conditions as an indication that the injector 100 has been removed from the patient’s skin, and permanently stops delivery of the drug 290 after which the DCSA will reverse direction to move the needle clip 270 toward the needle hub assembly 272 engaging the needle hub shroud 302 and causing for the injection needle 278 to be retracted back into the injector 100. The controller 400 also preferably provides an audible and / or visual indicator of this condition.

[0117] A third outcome, indicated by 1416, occurs when the end of dose sensor 340 indicates to the controller 400 the delivery of the drug 290 is complete. The controller 400 causes the drive motor 244 to stop after which the DCSA will reverse direction to move the needle clip 270 toward needle hub assembly 272 engaging the needle hub shroud 302 and causing for the injection needle 278 to be retracted back into the injector 100. The controller 400 also preferably provides an audible and / or visual indicator that delivery of the drug 290 is complete.

[0118] The alternative mechanical drive system (MSA) 350 previously introduced for use in the second embodiment wearable injector 101 will now be discussed with reference to FIGS. 15 and 16. A mechanical drive assembly (MDA) 350 of the injector 101 operates in place of the previously described DCSA 240 of the first embodiment wearable injector 100. The mechanical drive assembly 350 comprises a drive block 352 (see also FIG. 2B and 3B) within which a center drive shaft 354, a transfer gear 356, a pinion gear 358, a coil drive spring 360, a retraction release slide 362, and a driveshaft bushing 364 are housed. A drive release sleeve 366 is attached to one end of the center drive shaft 354 with the pump wheel 242 (used also in embodiment one where instead is attached to the motor 244) attached to the other end. In embodiment two the mechanical drive assembly 350 mounts to the base 120 in place of the DCSA 240.

[0119] Referring next to FIGS. 15A - 15D, the center driver shaft 354 operates to transfer rotational force to the pump wheel 242 under power from the coil drive spring 360. The coil drive spring 360 attaches to the center drive shaft 354 and the drive block 352 (see also FIG. 3B). The coil drive spring is energized and locked in a stored state against the drive block by the drive release sleeve 366 (reference FIG. 15 A). The drive release sleeve 366 is attached to an activation button 368 (see FIG. 2B and 3B) via which the user can initiate release of the mechanical drive assembly thereby activating the injector.

[0120] Injectors in accordance with this disclosure may advantageously utilize most of the same parts for first embodiment injectors having electro-mechanical functionality (for example, the injector 100 shown in FIG. 2 A) and for second embodiment injectors having an all-mechanical solution for the device drive system (for example, the second embodiment wearable injector 101 (reference FIG. 2B) with primarily the DCSA 240 of the first embodiment wearable injector 100 being replaced by the MDA 350 as described illustratively through comparison of FIG. 5 and FIG. 16 where a coil drive spring 360 generates rotationalforce instead of the electric motor 244. All sterile barrier and fluid path systems remain identical between the first embodiment wearable injector 100 and the second embodiment wearable inj ector 101.

[0121] Operation of the second embodiment wearable injector 101 is described next. The user steps leading up to the point of placement onto the patient’s body remain the same as described previously for the first embodiment wearable injector 100. After placement on the patient’s body, and again with reference to FIGS. 15A - 15D, the user then depresses the activation button 368 (see also FIG. IB) which acts on the drive release sleeve 366 causing it to move from a first position (reference FIG. 15A and 15C) to a second position (reference FIG. 15B and 15D) whereas once the second position is reached the center drive shaft 354 is released and able to rotate in a predetermined direction. The coil drive spring 360 applies rotational force to the center drive shaft 354 which in turn rotates the pump wheel 244 causing for the drug 290 to move from the container 222 along a fluid path for injection into the patient through the same means as described previously for embodiment one. Furthermore, rotation of the center drive shaft 354 causes for the retraction release slide 362 to translate toward the needle hub shroud 302 and eventually trigger retraction of the injection needle 278 via contact between a release tab of the needle retraction release slide 362a and release tab of the needle hub shroud 302a (see also FIG. 6). The distance the retraction release slide 362 translates before triggering retraction of the injection needle is predetermined via manipulation of gearing ratios between the center drive shaft 354, transfer gear 356, and pinion gear 358, and furthermore is timed to occur only after the predetermined number of revolutions needed to fully deliver the drug has been reached as described in more detail below.

[0122] With the second embodiment injector 101, flow of the drug 290 from the container 222 commences coincident with the user depressing the activation button 368. TheMSA 350 is configured to cause the center driveshaft 354 to rotate a predetermined number of revolutions based on the volume of drug to be delivered, and furthermore wherein the amount of drug dispensed into the patient for each turn of the pump wheel 242 is a known quantity based on prescribed dimensional attributes of the pumping mechanism. The MSA is therefore configured to generate a sufficient number of turns in one predetermined direction to cause for, in sequence, priming of the drug into the fluid path, release of the injection needle 278 into the patient, delivery of the full dose of drug, and release of retraction of the injection needle back into the injector.

[0123] Modifications to embodiments of wearable injectors in accordance with this disclosure are possible without departing from the scope and teachings of the disclosure and as defined by the accompanying claims. Expressions such as “including,” “comprising,” “incorporating,” “consisting of,” “have,” “is,” used to describe and claim the disclosed wearable injector 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.

[0124] Although specific example embodiments of the disclosed injector have been described, it will be evident that various modifications and changes may be made to these embodiments without departing from the broader scope of the disclosed subject matter described herein. Accordingly, the specification and drawings are to be regarded in an illustrative rather than a restrictive sense. The accompanying drawings that form a part hereof, show by way of illustration, and not of limitation, specific embodiments in which the subject matter may be practiced. The embodiments illustrated are described in sufficient detail to enable those skilled in the art to practice the teachings disclosed herein. Other embodiments may be utilized and derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure.This description, therefore, is not to be taken in a limiting sense, and the scope of various embodiments is defined only by the appended claims, along with the full range of equivalents to which such claims are entitled.

Claims

CLAIMS1. 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, and a delivery system arranged within the housing and base; the delivery system comprising a quasi-standard vial assembly for containing the drug, an injection drive sub-assembly, and a drive control sub-assembly coupled with the injection drive sub-assembly, the injection drive sub-assembly and the drive control sub-assembly being configured to interface with the quasi-standard vial assembly for controlling delivery of the drug into the patient; the injection sub-assembly providing a fluid path with the quasi-standard vial assembly, wherein the drive control sub-assembly engaging the injection sub-assembly to cause the drug to be extracted from the quasi-standard vial assembly and delivered into the patient.

2. The wearable injector of claim 1 wherein the drive control sub-assembly comprises an electrically driven motor that drives the injection drive sub-assembly.

3. The wearable injector of claim 1 wherein the drive control sub-assembly comprises a non-electrically driven motor that drives the injection drive sub-assembly.

4. The wearable injector of claim 1 comprising: a sensor for detecting at least one of: (a) a temperature of the body part, (b) a temperature of a drug in the quasi-standard vial assembly.

5. The wearable injector of claim 4 comprising: a controller receiving an input from the sensor, the input representing the temperature of the body part and / or the temperature of the drug in the quasi-standard vial assembly, the controller being operatively connected to the drive control sub-assembly and being configured to control operation of the drive control sub-assembly based upon the input to initiate an injector dosing state.

6. The wearable injector of claim 1 wherein the drive control sub-assembly comprises a peristaltic pump.

7. The wearable injector of claim 6 wherein the peristaltic pump comprises one of (a) and (b):(a) a pump wheel controllable by a drive motor; and(b) a coil drive spring.

8. The wearable injector of claim 1 wherein: the quasi -standard vial assembly further comprises a container; and the drive control sub-assembly causes the drug to be extracted from the container for delivery into the patient by causing the drug to travel along a fluid path out of the container.

9. The wearable injector of claim 1 wherein the drive control sub-assembly causes the fluid path to be primed with the drug prior to delivery of the drug into the patient.

10. The wearable injector of claim 1 wherein the quasi-standard vial assembly comprises a container; the injection sub-assembly defines a fluid path with the container; the drive control sub-assembly causes an injector of the injection sub-assembly to move drug from the container to the patient by introducing negative pressure into the container resulting in extraction of the drug from the container.

11. The wearable injector of claim 10 wherein the drive control sub-assembly comprises a peristaltic pump; the injection sub-assembly comprises a piston which translates along the container upon, and in response to, removal of the drug from the container via operation of the drive control subassembly and the injection sub-assembly peristaltic pump, and the piston translation is accomplished without the assistance of any driving force acting from behind the piston urging the piston to translate along the container.

12. The wearable injector of claim 1 wherein the injection sub-assembly 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.

13. The wearable injector of claim 12 wherein the drive control sub-assembly causes the injection needle of the injection sub-assembly to be released and inserted into the patient automatically before the start of drug injection.

14. The wearable injector of claim 12 wherein the drive control sub-assembly causes the injection needle of the injection sub-assembly to be fully retracted back into the housing automatically after drug injection has fully completed, the housing fully shielding the injector needle from the patient and reducing the risk of injury from an accidental needle stick.

15. The wearable injector of claim 14 wherein the injection sub-assembly comprises a needle shroud; the needle insertion shroud of the injection sub-assembly automatically extends from the injector during retraction of the injection needle, thereby providing visual, tactile, and audible indication to the patient that the dosing session has concluded.

16. The wearable injector of claim 12 wherein the drive control sub-assembly serves as a single actuator of the injector causing for automatic injection needle insertion, extraction of the drug from the container and flow into the patient, and retraction of the injection needle.

17. The wearable injector of claim 1 comprising an adhesive on at least a part of the base, the adhesive being capable of releasably securing the base onto the body part of the patient.

18. The wearable injector of claim 1 comprising: the quasi -standard vial assembly comprising a container; a temperature sensor being configured to determine a temperature of the drug in the container;a controller receiving an input from the temperature sensor, the input representing the temperature of the drug in the container; and the controller being configured to control the drive control sub-assembly in response to the input 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.

19. The wearable injector of claim 18 wherein the drive control sub-assembly causes the drug to be delivered when the temperature of the drug is at least 60aF.

20. The wearable injector of claim 1 comprising: the quasi -standard vial assembly comprising a container for the drug; a temperature sensor being configured to determine whether the injector is on the patient’s body.

21. The wearable injector of claim 1 comprising: a temperature sensor being configured to determine a temperature of the patient at or near the body part; a controller receiving an input from the temperature sensor, the input representing the temperature of the patient at or near the body part; and the controller being configured to control the drive control sub-assembly in response to the input to cause the drug to be delivered into the patient when the temperature of the patient at or near the drug in the container is at least at a predetermined temperature.

22. The wearable injector of claim 21 wherein the predetermined temperature is at least within 5aF of 98.6aF.

23. The wearable injector of claim 1 wherein the injection sub-assembly comprises a needle hub assembly comprising a needle carrier and an injection needle.

24. The wearable injector of claim 1 comprising: the quasi-standard vial assembly further comprising a container for containing the drug, the container having a pierceable seal;the injection sub-assembly further comprises a fluid path having a needle; a spring for causing the container to move in a predetermined direction and a removable barrier located between the pierceable seal and the needle maintained in a sterile condition; and wherein removal of the removable barrier causes the spring to cause the container to move in a predetermined direction in which the needle pierces the pierceable seal.

25. The wearable injector of claim 24 wherein 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.

26. The wearable injector of claim 25 comprising: a collar being provided on the container and a container activator; and 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.

27. The wearable injector of claim 26 comprising: a source of electrical power and a pull tab extending outwardly from the injector housing; the source of electrical power capable of powering the injector; and the pull-tab when pulled away from the injector causing the power source to power the injector.

28. The wearable injector of claim 1 comprising: the drive control sub-assembly comprising an electrically driven motor that drives the injection drive sub-assembly; the quasi -standard vial assembly comprising a container for containing the drug; and the drive control sub-assembly further comprises a pump operable to extract drug within the container, and operable to cause the drug to flow from the container, upon the attachment of the device to the patient, the pump in response to attachment automatically causing the drug to flow from the container.

29. The wearable injector of claim 1 comprising an audible and / or visual indicator being configured to indicate a state of the injector.

30. The wearable injector of claim 1 comprising a push-button operable to activate the injector.

31. The wearable injector of claim 1 wherein a needle is provided for delivering the drug into the patient, and wherein the injector is configured to automatically cause the needle to be inserted into the body part of the patient in response to input from at least one sensor on board the device.

32. A method for operating a wearable injector, said injector comprising a housing, a base connected with the housing and releasably securable on the body part of a patient, and a delivery system on the base comprising a quasi-standard vial assembly for containing the drug, a drive control sub-assembly coupled with the quasi-standard vial assembly and configured for controlling delivery of the drug into the patient, an injection sub-assembly providing a fluid path with the quasi-standard vial assembly via which the drug can be extracted from the quasi- standard vial assembly, a sensor for detecting one of temperature of the body part and temperature of the drug in the container sub-assembly, and a controller receiving an input from the sensor representing the temperature of the body part of the temperature of the drug in the container.

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