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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-10265471-B2
Publication Date
2019-04-23
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 invention relates to a compact, high aspect ratio auto-injector for delivering a medicament dose subcutaneously or intramuscularly. A sealed housing is rotatably retained in a cover, and the sealed housing includes an interface to receive user input that facilitates manual rotation relative to the cover from a first locked position to a second unlocked position. A biasing member is operable such that when the sealed housing is rotated to the unlocked position, the sealed housing is automatically displaced axially relative to the cover, increasing a height of the auto-injector.
A medicament dispensing system is disposed within the sealed housing and includes a medicament reservoir adapted to contain the dose. The auto-injector further includes a needle extension mechanism coupled to the medicament reservoir, with a curved injection needle adapted to be straightened during deployment to facilitate dispensing of the dose by the auto-injector. The curved injection needle is deployed through an aperture in the cover so that the injection needle is straightened during the deployment of the distal end.
During operation, the medicament reservoir is pierced to provide fluidic communication between the reservoir and the injection needle, the dose is dispensed through the injection needle at a desired injection location, and thereafter the injection needle is retracted into the auto-injector. The needle extension mechanism comprises a needle barrel supporting the curved injection needle, and a spring coupled to the barrel for rotating the barrel to uncoil the curved injection needle, together with a barrel locking mechanism to prevent inadvertent rotation of the barrel. Safety behavior is provided by an interlock that prevents rotation and/or displacement relative to the cover unless removed, and further by post-use interlocking to prevent reuse and exposure of the distal end of the injection needle.
Claims Coverage
The independent claims cover two aspects of the same overall invention: a compact, high aspect ratio auto-injector for delivering a subcutaneous or intramuscular medicament dose, and a method of operating the auto-injector with deployment and straightening, reservoir piercing for fluidic communication, dose dispensing, and needle retraction. Across the independent claims, the core inventive set includes a rotatable sealed housing retained in a cover, axial displacement via a biasing member, a curved injection needle straightened during deployment, piercing of a medicament reservoir to establish fluidic communication, and a needle barrel uncoiling mechanism with barrel locking to prevent inadvertent rotation.
Compact high aspect ratio auto-injector with rotatable sealed housing
A compact, high aspect ratio auto-injector for delivering a medicament dose subcutaneously or intramuscularly comprising a sealed housing rotatably retained in a cover, where the sealed housing includes an interface to receive user input to facilitate a manual rotation of the sealed housing relative to the cover from a first locked position to a second unlocked position.
Axial displacement increasing injector height on unlocking
A biasing member operable such that when the sealed housing is rotated to the unlocked position, the sealed housing is automatically displaced axially relative to the cover, increasing a height of the auto-injector.
Curved injection needle straightened during deployment
A needle extension mechanism coupled to the medicament reservoir comprising a curved injection needle adapted to be straightened during deployment of the injection needle to facilitate dispensing of the dose by the auto-injector.
Needle deployment through cover aperture to straighten needle
Triggering deployment of a distal end of the injection needle through an aperture in the cover of the housing to straighten the injection needle.
Reservoir piercing to provide fluidic communication
Triggering piercing of the medicament reservoir to provide fluidic communication between the reservoir and the injection needle.
Dispensing dose then retracting injection needle
Dispensing the dose through the injection needle at a desired injection location; and thereafter, retracting a distal end of the injection needle into the auto-injector.
Needle barrel uncoiling with barrel spring and locking
A needle extension mechanism comprising a needle barrel for supporting the curved injection needle, a barrel spring coupled to the barrel for rotating the barrel to uncoil the injection needle, and a barrel locking mechanism to prevent inadvertent rotation of the barrel.
The independent claims collectively center on a compact, high aspect ratio auto-injector that uses a rotatable sealed housing retained in a cover to achieve axial displacement and needle deployment. A curved injection needle is straightened during deployment, while medicament reservoir piercing establishes fluidic communication for dose dispensing, followed by retraction of the injection needle. The needle straightening and deployment mechanism is driven by a barrel spring that uncoils a curved needle, and is stabilized by a barrel locking mechanism to prevent inadvertent rotation.
Stated Advantages
Increases a height of the auto-injector when the sealed housing is rotated to the unlocked position.
Prevents inadvertent rotation of the barrel via a barrel locking mechanism.
Provides fluidic communication between the medicament reservoir and the injection needle by piercing the medicament reservoir.
Prevents reuse of the auto-injector and exposure of the distal end of the injection needle by automatically interlocking after injection needle retraction.
Documented Applications
No documented applications found
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