Medicament delivery device and methods for delivering drugs to infants and children

Inventors

Edwards, Eric S. • Edwards, Evan T. • Kelley, Glen L. • Meyers, Paul F.

Assignees

kaleo Inc

Abstract

A method of delivering epinephrine includes placing a distal end surface of a medical injector into contact with a target location of a patient. The medical injector includes a housing, an energy storage member, and a medicament container containing a dose of epinephrine effective for administration to the patient experiencing anaphylaxis and having a weight of less than 15 kg. The medicament container is coupled to a needle. The medical injector is actuated such that the energy storage member produces a force to move the needle from a first needle position to a second needle position. A distal tip of the needle extends from the distal end surface by a distance of between 7 millimeters and 8 millimeters when the needle is in the second needle position. A portion of the force is exerted to expel the dose of epinephrine when the needle is in the second position.

Core Innovation

The invention relates to medicament delivery devices and methods that deliver epinephrine to a patient experiencing anaphylaxis, including infants and small children. The device includes a housing with a contact surface configured to contact a target location of a patient, and the medicament container contains an epinephrine dose effective for administration.

Actuation is produced by an energy storage member that produces an actuation force to move a needle from a first needle position to a second needle position and to move the medicament container from a first container position to a second container position. The needle distal tip extends from the distal end surface by at least 6.35 millimeters when the needle is in the second needle position, and the actuation force expels the dose of epinephrine from the medicament container when the needle is in the second position.

The carrier retains the medicament container so that a distal end portion of the medicament container is fluidically isolated from a proximal tip of the needle in the first container position. When the medicament container moves to the second container position, the distal end portion becomes fluidically coupled to the proximal tip of the needle so that the epinephrine dose is delivered through the needle, and the carrier retention portion includes an annular protrusion defining a bleed passageway from the coupling volume towards a proximal end portion of the carrier.

Claims Coverage

The partial content includes three independent claims that share a common needle/energy-storage actuation architecture and a carrier that fluidically isolates and then fluidically couples the medicament container to the needle tip. Across the independent claims, the coverage focuses on placement of the injector contact surface onto a patient target location, energy-stored actuation that moves the needle to a specified second position, carrier-driven fluidic isolation-to-coupling using a coupling volume and retention portion, and needle distal tip extension at least 6.35 millimeters in the second needle position.

Across the independent claims, the inventive coverage centers on an injector/auto-injector architecture in which energy-stored actuation moves a needle to a second position with distal tip extension of at least 6.35 millimeters, while a carrier retains a medicament container to fluidically isolate the distal end from the needle tip in a first container position and fluidically couple it in a second container position, with an annular protrusion bleed passageway. One apparatus claim further includes a plunger-driven expulsion relationship and a carrier release member configured to release a portion of the actuation force after plunger movement.

Stated Advantages

Documented Applications