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WO2025165953A1 - Injecteur corporel de médicaments liquides - Google Patents

Injecteur corporel de médicaments liquides

Info

Publication number
WO2025165953A1
WO2025165953A1 PCT/US2025/013729 US2025013729W WO2025165953A1 WO 2025165953 A1 WO2025165953 A1 WO 2025165953A1 US 2025013729 W US2025013729 W US 2025013729W WO 2025165953 A1 WO2025165953 A1 WO 2025165953A1
Authority
WO
WIPO (PCT)
Prior art keywords
injector
assembly
drug
container
injection
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/013729
Other languages
English (en)
Inventor
Robert Scott RUSSO
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Synolus Medical Inc
Original Assignee
Synolus Medical Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Synolus Medical Inc filed Critical Synolus Medical Inc
Publication of WO2025165953A1 publication Critical patent/WO2025165953A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A61M2005/14252—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M2005/14268—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body with a reusable and a disposable component
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3368—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8206—Internal energy supply devices battery-operated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2209/00—Ancillary equipment
    • A61M2209/08—Supports for equipment
    • A61M2209/088—Supports for equipment on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/50—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically

Definitions

  • the present disclosure is directed to a drug injection device, and in particular, to a body -worn injection device.
  • 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.
  • 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.
  • 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.
  • 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 pen autoinjectors. 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.
  • 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.
  • 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.
  • these additional drug-contacting materials can introduce drug stability issues (i.e., drug degradation problems).
  • 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 design which 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 standard cartridge 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.
  • 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.
  • 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.
  • 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 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 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.
  • 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.
  • 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.
  • 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).
  • 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 interface with 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.
  • the drive control sub-assembly further comprises a peristaltic pump.
  • the peristaltic pump further comprises a drive motor and a pump wheel controllable by the drive motor or alternatively a coil drive spring.
  • 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.
  • 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.
  • 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 the container to the patient by causing by introducing negative pressure into the container resulting in extraction of liquid i.e., the drug from the container.
  • 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.
  • 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.
  • the drive control sub-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.
  • the drive control sub-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.
  • 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.
  • 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.
  • an adhesive on a part of the base releasably secures the base on the body part of the patient.
  • 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.
  • the predetermined temperature is at least 60° F.
  • 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.
  • 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.
  • the predetermined temperature is at least within 5° F of 98.6° F.
  • the injection subassembly further comprises a needle hub assembly comprising a needle carrier and injection needle.
  • 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.
  • 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.
  • 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.
  • a power source powers the injector, and a pull-tab that, when pulled enables the power source to power the injector.
  • the quasi -standard vial assembly further comprises a container for containing the drug
  • 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 automatically causes the drug to flow from the container.
  • an audible and/or visual indicator indicates a state of the injector.
  • a push-button is provided for user activation of the 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.
  • 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.
  • 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.
  • FIG. IB depicts a perspective top view of a second embodiment wearable injector in accordance with this disclosure that includes a mechanical drive configuration.
  • FIG. 2A is an exploded view of the first embodiment wearable injector shown in FIG. 1A.
  • FIG. 2B is an exploded view of the second embodiment wearable injector shown in FIG. IB.
  • FIG. 3A depicts the first embodiment wearable injector shown in FIG. 1A with the housing removed to show certain internal components.
  • FIG. 3B depicts the second embodiment wearable injector shown in FIG. IB with the housing removed to show certain internal components.
  • FIGS. 4A and 4B depict a quasi-standard vial assembly (QSVA) used with the first and second embodiments of the wearable injector.
  • QSVA quasi-standard vial assembly
  • 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.
  • QSVA quasi-standard vial assembly
  • ISA injection sub-assembly
  • DCS A drive control sub-assembly
  • FIG. 6 depicts an injection sub-assembly (ISA) of a wearable injector in accordance with this disclosure with some parts transparent.
  • ISA injection sub-assembly
  • 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.
  • QSVA quasi-standard vial assembly
  • FIG. 7B illustrates the delivery system shown in FIG. 7A but in a ready to begin injection state, the top cover removed for visibility.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • FIG. 13 depicts a flow diagram of a pre-injecting phase of a wearable injector in accordance with the present disclosure.
  • FIG. 14 depicts a flow diagram of an injecting phase of a wearable injector in accordance with the present disclosure.
  • 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.
  • 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.
  • 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).
  • QSVA quasi-standard vial assembly
  • ISA injection sub-assembly
  • MSA mechanical drive assembly
  • 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.
  • 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 .
  • possible embodiments of the disclosed wearable injector do not require the use of silicone lubrication as all other non-vial type glass containers require.
  • 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 second embodiment 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.
  • 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
  • the first embodiment injector 100 contains a primary container 222 for holding a drug 290, e.g. a liquid biologic drug.
  • 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.
  • the piston 236 and o-rings 250 may be replaced by a single all rubber component.
  • a piston 236 made from glass material can advantageously minimum the amount of drug 290 contacting non-glass material.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 for delivery of the drug 290 into the patient.
  • the drug 290 is extracted from the container 222 when the DCSA is activated.
  • the flow-path needle 284 and fluid transfer cannula 282 are each at least partially contained in the vial access manifold 262.
  • 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.
  • 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.
  • 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.
  • the drive motor 244 may comprise a DC motor or any other type of motor capable of providing the described functionality.
  • 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.
  • 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 integrated features 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.
  • 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.
  • control of the release clip 270 by the controller 400 may be affected by a one or more sensors in the injector 100 that monitor temperature 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.
  • the needle 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.
  • the injector 100 can be prevented from needle activation and/or commencing of fluid pumping until drug warming has been completed.
  • 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.
  • 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.
  • 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.
  • 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.
  • the release clip 270 becomes mechanically decoupled from the pump wheel 242, allowing the pump wheel 242 to continue its rotation to dispense the drug.
  • 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.
  • 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).
  • 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.
  • 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 tabs triggering 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the injection needle 278 remains inserted into the patient having pierced the patient’s skin in previous state.
  • the piston 236 has translated down the container 222 under negative 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.
  • 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.
  • a user of the injector 100 removes the injector 100 from its secondary packaging such as a blister pack.
  • secondary packaging such as a blister pack.
  • such removal will also remove the power-on pull tab 136, connecting the battery 402 with the controller 400 and initializing the injector 100.
  • 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.
  • 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.
  • a separate step may be required of the user to remove the adhesive backing 106.
  • 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 in the 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • a user/patient presses a push-button 104, at 1302.
  • 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.
  • 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.
  • a second outcome 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.
  • controller 400 does not cause the drive motor 244 to activate the needle 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.
  • 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.
  • 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.
  • the controller 400 receives input from at least the body temperature sensor 310 at 1404, and an end 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.
  • 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.
  • the end of dose sensor 340 detects and determines when delivery of the drug 290 is complete.
  • 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.
  • 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.
  • a second outcome 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.
  • 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.
  • 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.
  • the mechanical drive assembly 350 mounts to the base 120 in place of the DCSA 240.
  • 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.
  • 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 rotational force 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.
  • 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.
  • the MSA 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.

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Abstract

L'invention concerne un injecteur pouvant être porté sur le corps pour l'administration de médicaments liquides qui résout le problème de volume élevé et d'administration de médicament à viscosité élevée par la fourniture d'un dispositif qui peut être porté par le patient à travers l'utilisation d'un timbre adhésif pour administrer le médicament lentement sur des périodes prolongées et qui simplifie le développement et la commercialisation de produits de combinaison de dispositifs médicamenteux par l'intermédiaire de sa conception de récipient primaire et de système d'injection innovante. L'injecteur répond aux défis liés au processus de développement et de commercialisation de dispositifs médicamenteux grâce à la conception innovante de son récipient primaire et de ses mécanismes d'administration.
PCT/US2025/013729 2024-01-30 2025-01-30 Injecteur corporel de médicaments liquides Pending WO2025165953A1 (fr)

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US63/626,563 2024-01-30

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140088508A1 (en) * 2012-09-24 2014-03-27 Patrick Ryan Drug-delivery devices with integrated needle-insertion mechanism
US20190167883A1 (en) * 2008-01-23 2019-06-06 Deka Products Limited Partnership Medical treatment system and methods using a plurality of fluid lines
US20220072230A1 (en) * 2016-07-14 2022-03-10 Sanofi Medicament delivery device
US20220143303A1 (en) * 2019-04-23 2022-05-12 Synolus Medical, Inc. Wearable Injector
US20230105585A1 (en) * 2017-05-05 2023-04-06 Regeneron Pharmaceuticals, Inc. Auto-injector and related methods of use
US20230201453A1 (en) * 2017-07-07 2023-06-29 Neuroderm, Ltd. Device for subcutaneous delivery of fluid medicament

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190167883A1 (en) * 2008-01-23 2019-06-06 Deka Products Limited Partnership Medical treatment system and methods using a plurality of fluid lines
US20140088508A1 (en) * 2012-09-24 2014-03-27 Patrick Ryan Drug-delivery devices with integrated needle-insertion mechanism
US20220072230A1 (en) * 2016-07-14 2022-03-10 Sanofi Medicament delivery device
US20230105585A1 (en) * 2017-05-05 2023-04-06 Regeneron Pharmaceuticals, Inc. Auto-injector and related methods of use
US20230201453A1 (en) * 2017-07-07 2023-06-29 Neuroderm, Ltd. Device for subcutaneous delivery of fluid medicament
US20220143303A1 (en) * 2019-04-23 2022-05-12 Synolus Medical, Inc. Wearable Injector

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