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Assignees
Member
Pirouette PharmaPirouette Pharma is a clinical-stage pharmaceutical company focused on simplifying chronic injectable care with the development of a patient-centric, hidden-needle auto-injector platform for self-administration of essential medicines at home or in high-stress settings. Leveraging engineering, automation, and regulatory expertise, the company’s mission is to improve adherence, persistence, and comfort for chronic and rescue therapies while enabling scalable manufacturing in the United States. Pirouette partners with pharmaceutical companies for the co-development and distribution of both novel and established injectables using abbreviated FDA regulatory pathways.
Pirouette Pharma is a clinical-stage pharmaceutical company focused on simplifying chronic injectable care with the development of a patient-centric, hidden-needle auto-injector platform for self-administration of essential medicines at home or in high-stress settings. Leveraging engineering, automation, and regulatory expertise, the company’s mission is to improve adherence, persistence, and comfort for chronic and rescue therapies while enabling scalable manufacturing in the United States. Pirouette partners with pharmaceutical companies for the co-development and distribution of both novel and established injectables using abbreviated FDA regulatory pathways.
Publication Number
US-10449296-B2
Publication Date
2019-10-22
Expiration Date
Abstract
A novel single use auto-injector for delivering a fixed amount of medicament is described. The auto-injector may include a sealed housing rotatably held in a cover. Once the auto-injector is positioned at the injection location, the user can transition the housing from a locked to an armed position. The user can then compress the sealed housing into the cover, triggering activation mechanisms that initiate the injection. A first activation mechanism engages an interlock to prevent reuse of the auto-injector. A second activation mechanism straightens and extends a curved needle to a set the exposed needle length. A third activation mechanism pierces a sealed reservoir allowing the medicament to be forced through the injection needle. Following the injection, the auto-injector expands and interlocks, retracting the needle into the auto-injector and preventing reuse.
Core Innovation
The disclosed invention relates to a compact, high aspect ratio auto-injector for delivering a medicament dose subcutaneously or intramuscularly. The auto-injector includes a housing and a medicament dispensing system disposed within the housing, where the medicament dispensing system comprises a medicament reservoir adapted to contain the dose. A needle extension mechanism is coupled to the medicament reservoir, including a curved injection needle and a needle guide.
The curved injection needle is non-self-straightening and is straightened by the needle guide during deployment. Deployment includes directing a distal end of the curved injection needle through an aperture in a cover aligned with the needle guide, such that straightening is facilitated to support dispensing of the dose. After dispensing, the distal end of the curved injection needle is retracted into the auto-injector.
The medicament dispensing system drives dispensing of a fixed dose from the medicament reservoir via a dispensing needle and fluidic communication to the curved injection needle. A spring/retainer/locking mechanism is arranged to release and drive a plunger to pierce a sealed medicament reservoir and establish the fluidic communication for dispensing. The housing and cover provide user orientation aids and protective features including a needle sheath/shroud and barriers/seals for cleanliness and hermetic internal storage, and the device includes interlocks that render the auto-injector single-use and control sharps exposure.
Activation and post-injection sequencing are governed by interlocks and biasing members, including a workflow in which the sealed housing is rotatably retained in a cover and is manually rotated from a locked to an unlocked/armed position. Axial expansion increases the height of the auto-injector during arming, and after compression release the biasing springs expand the housing while interlocks engage and the needle retracts into the injector to prevent further deployment. Optional connectivity and audible instructions are also discussed, along with indicia for determining locked, unlocked, and armed positions.
Claims Coverage
Two independent claims are identified: one for the auto-injector apparatus and one for operating the auto-injector method. Across these independent claims, the core inventive features focus on a compact, high aspect ratio auto-injector with a curved, non-self-straightening injection needle straightened by a needle guide during deployment, combined with medicament reservoir piercing for fluidic communication, dose dispensing, and post-dispensing needle retraction, together with an interlock-driven operational workflow that supports single-use and controlled sequencing.
Compact, high aspect ratio auto-injector with medicament reservoir
A compact, high aspect ratio auto-injector comprising a housing; a medicament dispensing system disposed within the housing and comprising a medicament reservoir adapted to contain the dose; and a needle extension mechanism coupled to the medicament reservoir.
Non-self-straightening curved injection needle straightened by needle guide
A needle extension mechanism comprising a curved injection needle and a needle guide adapted to straighten the curved injection needle during deployment through the needle guide, such that the curved injection needle is non-self-straightening and is straightened by the needle guide, to facilitate dispensing of the dose by the auto-injector.
Deploy curved injection needle through cover aperture to straighten
Triggering deployment of a distal end of the curved injection needle through an aperture in a cover of the housing aligned with the needle guide to straighten the curved injection needle, wherein the curved injection needle is non-self-straightening and is straightened by the needle guide.
Pierce medicament reservoir to provide fluidic communication, dispense dose, retract needle
Triggering piercing of the medicament reservoir to provide fluidic communication between the medicament reservoir and the curved injection needle; dispensing the dose through the curved injection needle at a desired injection location; and thereafter, retracting the distal end of the curved injection needle into the auto-injector.
The apparatus claim centers on a compact, high aspect ratio auto-injector with a medicament reservoir and a curved, non-self-straightening injection needle straightened by a needle guide during deployment. The method claim mirrors this by specifying deployment through a cover aperture aligned with the needle guide, piercing of the medicament reservoir to establish fluidic communication for dose dispensing, and subsequent retraction of the needle into the auto-injector.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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