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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-12011569-B2
Publication Date
2024-06-18
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 auto-injector device component for delivering a medicament dose to a user, using a medicament reservoir containing the medicament dose and comprising a seal. A first sterile chamber is located proximate to the medicament reservoir and comprises a first protective barrier. The first sterile chamber contains a distal end of a dispensing needle that is configured to puncture the first protective barrier and the seal of the medicament reservoir to fluidically couple the medicament reservoir with the dispensing needle.
A second sterile chamber comprises a second protective barrier and is located remotely and non-contiguously with the first sterile chamber. The second sterile chamber contains a distal end of an injection needle fluidically coupled with the dispensing needle. This arrangement fluidically couples the injection needle with the medicament reservoir through the dispensing needle while keeping the second sterile chamber remotely and non-contiguously positioned from the first sterile chamber.
The invention further includes manufacturing and use aspects for the compact auto-injector device for delivering a medicament dose to a user. In manufacturing, the medicament reservoir, the first sterile chamber with the distal end of the dispensing needle configured to puncture the protective barrier and seal, and the second sterile chamber with the distal end of the injection needle fluidically coupled with the dispensing needle are formed. In use, a compact auto-injector device is obtained, disposed on a tissue surface of the user, and fired so that the injection needle is inserted into the tissue surface and the medicament dose is delivered therethrough to the user.
Claims Coverage
The independent claims identified are clm-00001, clm-00016, and clm-00019. Across these independent claims, three main inventive features are recited: the sealed medicament reservoir with a first sterile chamber for a dispensing needle puncture-coupling, the remotely and non-contiguously located second sterile chamber containing a distal injection needle fluidically coupled with the dispensing needle, and method-of-use steps for disposing on a tissue surface and firing to insert the injection needle and deliver the medicament dose.
Sealed medicament reservoir with puncture-coupled dispensing needle
A medicament reservoir containing the medicament dose and comprising a seal; a first sterile chamber comprising a first protective barrier located proximate to the medicament reservoir, containing a distal end of a dispensing needle configured to puncture the first protective barrier and the seal to fluidically couple the medicament reservoir with the dispensing needle.
Remote, non-contiguous second sterile chamber with injection needle coupling
A second sterile chamber comprising a second protective barrier, located remotely and non-contiguously with the first sterile chamber, containing a distal end of an injection needle fluidically coupled with the dispensing needle.
Tissue-surface disposal and firing for injection needle insertion and delivery
Obtaining an auto-injector device comprising the medicament reservoir and the first and second sterile chambers as defined; disposing the compact auto-injector on a tissue surface of the user; firing the compact auto-injector such that the injection needle is inserted into the tissue surface and the medicament dose is delivered therethrough to the user.
The independent claim set centers on a compact auto-injector arrangement in which a sealed medicament reservoir is coupled to a dispensing needle by puncturing a protective barrier in a first sterile chamber proximate to the reservoir, and the dispensing needle fluidically couples an injection needle located in a remotely and non-contiguously positioned second sterile chamber; the method-of-use further requires tissue-surface disposal and firing to deliver the medicament dose through the tissue.
Stated Advantages
Documented Applications
No documented applications found
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