Needle free hypodermic injector and ampule for intradermal, subcutaneous and intramuscular injection

Abstract

A needle free hypodermic injector comprising a hand manipulatable elongate housing, an impact impulse injection mechanism within the housing, a suction generating means within the housing and cooperable with the impact impulse injection mechanism, a safety interlock mechanism, at least one medicament containing ampule cooperable with the impact impulse injection mechanism and the suction generating means and having a jet orifice through which medicament is injectable through a skin surface in response to an impulse placed on the medicament by the impact impulse injection mechanism, and means to receive and hold the ampule on the injector in registration with the impact impulse injection mechanism and in communication with the suction generating means; whereby the injector is adapted to expel the medicament from the ampule in a jet stream of sufficient velocity to penetrate skin tissue held against the orifice by the suction generating means and to deposit the medicament intradermally, subcutaneously or intramuscularly based on the position and angle of the jet orifice.

Description

FIELD OF THE INVENTION [0001] This invention relates to a needle free, impact impulse injector device and disposable, single use, fillable or pre-filled, ampules therefor that are capable of delivering intradermal, (ID), subcutaneous (SUB-Q) and intramuscular (IM) injections in human or animal tissue by means of a thin high pressure liquid jet stream of sufficient velocity to penetrate the tissue of the recipient. The injector deposits medicament intradermally, or subcutaneously, or intramuscularly, utilizing the single use, disposable, medicament ampules that are designed to provide interfaces to the activation device, allowing easy installation by hand or mechanically from a multiple ampule dispensing apparatus, and providing exact positioning and sealing to the activation device structure. The ampules further contain features that induce a vacuum to stretch the skin, keeping the skin precisely aligned with the jet orifice for the short duration of the injection. The ampule's orif...

AI Technical Summary

Benefits of technology

The solution provides precise and reliable delivery of medicaments to specific tissue layers, reducing pain and infection risk by spreading the injection area, minimizing tissue damage, and ensuring proper skin alignment, while preventing accidental activation and leakage.

Problems solved by technology

Present state of the art attempts to inject medications intradermally have met with only limited success due to the inherent difficulty associated with accurate positioning of the skin relative to the injector jet opening and the lack of precise control of the jet pressure vs. skin penetration when the injection is performed normal to the skin surface.

In addition, present systems lack precise control and repeatability of the injection jet velocity due to mechanical equipment tolerance variations within the pressure / force generators utilized.

Some present devices present safety concerns due to the lack of safety interlocks to prevent the device from being activated when not in proper contact with the skin, and catastrophic failures have been observed in the injector bodies in part caused by the lack of pressure control inherent in the device designs.

Such prior art devices result in substandard and painful injections because of this blasting action and the inability to address the variables of flow control once the skin is penetrated.

They are also deficient with respect to being able to provide the force necessary to penetrate the stratum corneum while restricting medicament delivery to the intradermal area generally and, specifically, the upper layers of the skin.

Typically, the use of existing devices results in loss of medicament at the nozzle entry point, poor injections on account of the recipient's movements or the operator's inexperience and receipt of the injection at an angle that either does not penetrate or penetrates too much for placement and dispersal of the medicament at the correct depth and layer of tissue.

In addition, premature operations are common, as well as relative movement between the epidermis and orifice which can cause tearing of the skin during injection, resulting in pain and poor transfer of the medicament to the recipient.

The need for medicament supply and personnel skill have produced problems for using these devices, for example, precisely measuring and controlling of the quantity of medicament administered and ensuring that the injector delivers the correct amount of medicament into the proper tissue.

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