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Abstract
A needle-free injector includes a housing, a cartridge positioned within the housing, and a plunger slidably coupled to and disposed within the chamber, a motor operatively coupled to the plunger, the motor operable to actuate the plunger in the chamber, and a controller operatively coupled to the motor. The controller is operable to selectively operate the plunger according to any of a first delivery profile, a second delivery profile, and a third delivery profile. The controller may transition from the first delivery profile to the second delivery profile responsive to compression of a gas in the chamber, e.g., upon detecting a spike in a measured current applied to the motor. The controller may transition from the second delivery profile to the third delivery profile responsive to detecting a steady state condition between the measured current and a velocity of the plunger. Methods of delivering an injectate using the needle-free injectors are provided. Methods of facilitating needle-free injection of an injectate using the needle-free injectors are also provided.
Core Innovation
The invention provides a needle-free injector that includes a plunger positioned to pressurize a fluid and a gas in a cartridge having an exit port. A motor is operatively coupled to the plunger to actuate the plunger in linear motion along an axis of the cartridge to direct the fluid from the cartridge. A controller operates the plunger responsive to an injection initiation signal using delivery profiles.
The controller operates the plunger according to a first delivery profile to compress the gas within the cartridge, and then transitions to a second delivery profile responsive to detecting compression of the gas above a predetermined threshold. Detecting gas compression comprises detecting a concurrent decrease in velocity of the plunger and an increase in drive current to the motor, or detecting a deviation between a model-predicted free-running motor drive current and a measured motor current.
The control framework uses delivery profiles to manage motion and injection phases while accounting for a free-running model of motor drive current and plunger velocity. The described rationale is to avoid overshoot and integrator windup from trapped gas bubbles by switching profiles based on sensed compression and reaching a steady-state condition between measured motor current and plunger velocity. Injection continues until a target volume is dispensed, and the second delivery profile can be biphasic including a piercing phase followed by a delivery phase.
Claims Coverage
The provided independent claim coverage describes 5 inventive features for a needle-free injector that switches from a first to a second delivery profile based on detected gas compression. The coverage includes two alternative compression-detection criteria, profile velocity relationships, a biphasic second delivery profile, and fluid category limits.
Concurrent decrease in plunger velocity and increase in drive current for switching profiles
Operate the plunger according to a first delivery profile to compress gas within the cartridge, and switch to a second delivery profile responsive to detecting compression of the gas above a predetermined threshold, where detecting the compression comprises detecting a concurrent decrease in velocity of the plunger and increase in drive current to the motor.
Deviation between model-predicted free-running motor drive current and measured motor current
Detect gas compression by detecting a deviation between a model-predicted free-running motor drive current and a measured motor current supplied to the motor.
First target velocity greater than second target velocity between delivery profiles
The first delivery profile has a first target velocity greater than a second target velocity of the second delivery profile.
Biphasic second delivery profile with piercing phase followed by delivery phase
The second delivery profile is biphasic, including a piercing phase followed by a delivery phase.
Fluid limited to injectable pharmaceutical, injectable nutraceutical formulation, or high viscosity biologic formulation
A needle-free injector is configured for use with a fluid comprising at least one of an injectable pharmaceutical, an injectable nutraceutical formulation, and a high viscosity biologic formulation.
Overall, the claims coverage focuses on switching delivery profiles in a needle-free injector based on detected gas compression in a cartridge, using sensor signals derived from plunger velocity and motor drive current and, in refinements, using deviation from a free-running model. Additional claim coverage structures the relationship between target velocities of profiles and the biphasic piercing-then-delivery nature of the second delivery profile, and constrains the intended fluid categories.
Stated Advantages
Documented Applications
Not explicitly described in patent.
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