Drug delivery device
Inventors
Müller, Matthias • Huber, Christian • BÜRLI, Fabian • Perrier, Alexandre
Assignees
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Publication Number
US-12059549-B2
Publication Date
2024-08-13
Expiration Date
Abstract
A drug delivery device (1) having a delivery unit (3) including a drug container (6), a liquid flow system (7), a pumping system (8), and a casing (9) enclosing therein the drug container, the pumping system and at least a part of the liquid flow system is disclosed. The drug container has a barrel portion (6a) and a plunger (12) slidably mounted within the barrel portion and sealing the drug (78) within the container at one end of the barrel portion. The drug container is contained within a container receiving cavity (75) of a container casing portion (38) and the container receiving cavity is fluidically interconnected to a fluid outlet (31) of the pumping system (8) in a gas tight manner. The pumping system pumps environmental air into the container receiving cavity (75) thus applying pressure on a back end (73) of the plunger for delivery of a liquid drug.
Core Innovation
The invention describes a drug delivery device that includes a delivery unit with a drug container for holding a liquid drug, a liquid flow system, a pumping system, and a casing. The casing encloses the drug container, the pumping system, and at least a part of the liquid flow system. The drug container includes a barrel portion with a plunger slidably mounted within the barrel portion, sealing the liquid drug within the container at one end of the barrel portion.
The drug container is contained in a hermetic manner within a container receiving cavity of a container casing portion of the casing. The container receiving cavity is fluidically interconnected to a fluid outlet of the pumping system in a gas tight manner. The pumping system includes a fluid inlet connected to environmental air, and is configured to pump environmental air into the container receiving cavity to generate gas pressure within the container casing portion, thus applying pressure on a back end of the plunger for delivery of the liquid drug.
The disclosed device further supports compact pumping and actuation hardware and closed-loop sensing. It includes pump engine structures and valving for pneumatic pumping and liquid delivery connection, and it enables detection of plunger position and operating states using pneumatic pressure sensing over time and/or optical time-of-flight sensing. In addition, the casing skin-contact wall can include a metal electrode for capacitive on-body skin contact detection.
The document also describes a container fluidic connection system for injection needle actuation using a septum needle that is moved from a retracted position to an actuated position to pierce a septum of the drug container, with a blocking organ and a spring. Manufacturing and sterilization concepts are disclosed to support hermetic sealing, including aseptic assembly and sealing membrane approaches, with sterilization options including gamma, ETO, steam, VHP, and other listed sterilization techniques.
Claims Coverage
The partial content identifies one independent claim, with claim 1 covering the overall hermetic, gas-tight pneumatic pressure delivery concept and including environmental air pumping and plunger actuation. Additional inventive features are provided in dependent claims 2, 4, 12, 13, and 14, which further refine the pumping hardware, needle-septum actuation, and sensing/feedback mechanisms. The coverage below reflects those inventive features explicitly present in the provided claim excerpts.
Hermetic, gas-tight pneumatic pressure actuation for liquid delivery
A drug container contained hermetically within a container receiving cavity of a container casing portion, where the cavity is fluidically interconnected to a fluid outlet of a pumping system in a gas tight manner; the pumping system pumps environmental air from a fluid inlet into the container receiving cavity to generate gas pressure within the container casing portion and apply pressure on a back end of a plunger for delivery of the liquid drug.
Dual-valve pump engine with stator and rotor channels
A pumping system with a pump engine including a stator and a rotor, where the rotor has first and second axially extending portions with different diameters, and the pump engine incorporates a first valve with a first valve seal on the stator and a corresponding first channel in the rotor, and a second valve with a second valve seal on the stator and a corresponding second channel in the rotor, with fluid communication when the respective valves are in an open position.
Septum needle piercing using blocking organ and spring
A container fluidic connection system having a movable septum needle and a spring, where the septum needle is held retracted by a blocking organ and upon actuation the blocking organ releases the septum needle support so the septum needle travels toward and pierces the septum of the drug container under the spring force.
Optical time-of-flight plunger position sensing
An optical plunger sensing system that transmits an optical signal to the plunger, receives reflected light from a back end of the plunger, measures a time of flight of the optical signal, and determines plunger position in a cylinder portion of the drug container.
Capacitive on-body skin contact detection via housing electrode
An on-body sensing system that includes an electrode formed in a skin contact wall of the housing and determines skin contact by measuring a capacitance value at the patient's skin using an on-body sensing control unit.
Pressure-over-time plunger position inference with occlusion and end-of-travel detection
A pressure sensor that measures pressure in a container casing portion over time and, from that pressure measurement history, determines plunger position over time, including detecting a plunger stop caused by occlusion in the drug delivery flow system or by the plunger reaching an end of travel corresponding to an empty container position.
Across the identified claims, the core coverage is a hermetically contained, gas-tight pneumatic pressure actuation of a plunger for liquid delivery using environmental air. Dependent features further specify a pump engine architecture with dual valves and rotor channels, a septum needle actuation mechanism using a blocking organ and spring, and feedback for plunger position and device state via optical time-of-flight and/or pressure-over-time inference and capacitive skin contact detection.
Stated Advantages
Pneumatic operation that avoids direct liquid connection/leakage risk, as stated in the provided description summary.
Provides compact pump engine structure for the pneumatic drive and actuation hardware, as stated in the provided description summary.
Enables plunger position and operating state detection using pressure-over-time sensing (including occlusion and end-of-travel) and/or optical time-of-flight sensing, as stated in the provided description summary.
Enables on-body determination of skin contact using capacitive measurement with a housing electrode, as stated in the provided description summary.
Supports long shelf life and sterility through hermetic sealing and disclosed aseptic assembly/manufacturing and sterilization options, as stated in the provided description summary.
Documented Applications
Subcutaneous administration using a subcutaneous patch drug delivery device, as stated in the provided description summary.
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