Protective case for an auto-injector

Inventors

Kapas, Elijah • KANE, MATTHEW • Cullinane, Conor

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Assignees

Pirouette Pharma Inc

Member
Pirouette Pharma
Pirouette Pharma

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-11324882-B2

Patent

Publication Date

2022-05-10

Expiration Date


Abstract

The application describes a protective case for an auto-injector. The medicament contained within these auto-injectors can be susceptible to degradation due to exposure to extreme temperatures and light. Thus, one embodiment of the protective case reduces the rate of heat transfer between the internal storage compartment of the case and the external atmosphere by including particularly configured vacuum chambers. Additionally, as auto-injectors become smaller, portability can be desirable. Thus, another embodiment of the protective case includes low-profile cases that allow the user to keep the auto-injector with them, e.g., by attaching the case to a common everyday item.

Core Innovation

A protective auto-injector case is configured to form a close-fitting receiving portion for an auto-injector device such that an interface maintains constant and direct contact with at least a portion of the auto-injector when disposed in the receiving portion. The case securely supports and releasably receives the portion of the auto-injector device and fixedly holds the auto-injector device within the receiving portion. The protective case has a low-profile rigid form with an aspect ratio (width to height) of at least 1 and includes an attachment device directly coupled to the protective case.

The disclosed protective case thermally isolates a medicament dose from ambient conditions by forming vacuum-sealed chambers using an upper portion and a lower portion with overlapping sidewall flanges and sealed joints. The case further reduces heat transfer using internal insulation barriers formed by TP/TPE/foam layers and by reflective and/or polished vacuum-chamber surfaces. The vacuum sealed chamber and the insulation barrier arrangement are combined to limit heat transfer between the medicament and ambient conditions.

Portability and handling are addressed by providing low-profile case embodiments that are attachable to everyday objects using straps, clips, tethers, necklaces, pins, clamps, mounts, and/or adhesive layer attachment configurations. The external case includes ergonomic and textured external coatings and labeling. The case embodiments also provide rigidity and flexibility material options and can include damping via an insulating cradle or stabilizers to reduce vibration and relative motion, with optional configurations that hold one or multiple auto-injectors and provide optional power/IoT monitoring for temperature and location with remote monitoring alerts.

Claims Coverage

The independent claim set covers apparatus, method, and system for associating an auto-injector device with a user using a low-profile rigid protective case with an aspect ratio constraint and a directly coupled attachment device. Across the independent claims, three main inventive features are present: the close-fitting receiving portion with a constant direct-contact interface, the low-profile rigid aspect ratio of at least 1, and direct coupling of the attachment device to the protective case (with the system claim also requiring the auto-injector aspect ratio).

Close-fitting receiving portion with constant direct contact

A low-profile rigid protective case is configured to form a close-fitting receiving portion comprising an interface that maintains constant and direct contact with at least a portion of the auto-injector when disposed in the receiving portion, for securely supporting and releasably receiving the portion and fixedly holding the auto-injector device within the receiving portion.

Low-profile aspect ratio of at least 1

The protective case (and, in the system claim, the auto-injector device) has an aspect ratio (width to height) of at least 1.

Attachment device directly coupled to the protective case

An attachment device is provided that is directly coupled to the protective case.

The independent claims focus on associating an auto-injector with a user by using a low-profile rigid protective case that fixedly holds the auto-injector using an interface maintaining constant direct contact, imposing an aspect ratio (width to height) of at least 1, and coupling an attachment device directly to the case (with the system claim additionally requiring the auto-injector itself to have the aspect ratio constraint).

Stated Advantages

Improved thermal isolation of a medicament dose from ambient conditions by using vacuum-sealed chambers and insulation barrier arrangements.

Improved portability by using low-profile, attachable case configurations (e.g., straps/clips/tethers/pins/mounts/adhesives) and optionally configurations holding one or multiple auto-injectors.

Reduced vibration and relative motion through damping via insulating cradle/stabilizers.

Optional remote monitoring through IoT connectivity for temperature/location monitoring with alerts.

Documented Applications

Associating an auto-injector device with a user using an apparatus that includes a protective case and an attachment device.

Associating an auto-injector device with a user using a method that provides the protective case and the attachment device directly coupled to the protective case.

Associating an auto-injector device with a user using a system that includes the auto-injector device and an associating apparatus with the protective case and attachment device.

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