Safe auto-needle device

Inventors

Lewkonya, GadCarmel, EhoudDaily, DavidRaday, LiorDrori, Hagay

Assignees

Dali Medical Devices Ltd

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Publication Number

US-10850044-B2

Patent

Publication Date

2020-12-01

Expiration Date


Abstract

The invention provides a safe auto-needle device for injection, comprising: a main housing and a syringe-support receiving a disposable prefilled syringe terminating in a needle covered by a needle sheath (NS). The speed of depressing of the syringe plunger is manually controllable by a user. In a first embodiment, a locking mechanism is present, for preventing premature advancement of the needle. A second embodiment comprises an interlock, for preventing depressing of a plunger, prior to advancement of the syringe-support to a needle penetration location. Additional components include a drive mechanism; and a needle shield moveable between: a needle covered position; a partially exposed position, to a fully extended needle safe position. The invention also discloses a needle sheath (NS) remover.

Core Innovation

The invention relates to a disposable safe auto-needle device for injection that uses a main housing and a drive mechanism to advance a syringe-support distally toward an injection site. The device receives a disposable prefilled syringe having a piston, a proximal end including a flange, and a distal end terminating in a needle covered by a needle sheath (NS). A generally tubular needle shield concentric to the main housing is moveable through positions in which the needle is covered, at least partially exposed, and then in a third fully extended position the needle is irreversibly concealed.

The generally tubular needle shield includes a distal end for contacting an injection site and a proximal end, with a spring urging distal movement and a needle shield spring seat. A needle sheath (NS) remover is designed to mate with and irreversibly grip the needle sheath (NS), for removal of the needle sheath prior to injection. The device includes a locking mechanism for preventing premature advancement of the needle, where depressing upon the distal end of the needle shield results in release of the locking mechanism, and the tubular needle shield cannot be depressed prior to removal of the needle sheath (NS).

User safety is reinforced by a user-manually controllable plunger speed and by an interlock that prevents depressing of a plunger before the syringe-support reaches a needle penetration location. Prematurity during storage is addressed by engagement of locking face protrusions located upon an anterior plunger pusher within appropriate grooves of locking faces of a rear cap. Further features include interlock behavior that prevents inward bending of the protrusions and release of the locking mechanism via lifting of the T-shaped locking arms radially outwards by proximal movement of the needle shield after sheath removal.

An NS remover embodiment is also described in which an external part transfers impact forces upon dropping to a stopper on the main housing, with ratchet teeth configured to allow tolerance in the position of the needle sheath (NS) during storage.

Claims Coverage

The independent claims are clm-00001, clm-00002, and clm-00027. Across these claims, the coverage centers on six inventive features: a movable tubular needle shield, a needle sheath remover, a needle advancement lock released by needle shield depression after sheath removal, manually controllable plunger speed, an interlock preventing premature plunger depression, and an NS remover that transfers drop impact forces with ratchet teeth storage tolerance.

Movable tubular needle shield for irreversibly concealing the needle

A generally tubular needle shield concentric to a main housing that is moveable from a first position where the needle is covered, to a second position where the needle is at least partially exposed, to a third fully extended position in which the needle is irreversibly concealed; the needle shield includes a distal end for contacting an injection site and a proximal end, and a spring urging distal movement with a needle shield spring seat.

Needle sheath remover that irreversibly grips and enables sheath removal prior to injection

A needle sheath (NS) remover designed to mate with and irreversibly grip the needle sheath (NS), for removal of the needle sheath prior to injection.

Locking mechanism releasing based on needle shield depression after sheath removal

A locking mechanism for preventing premature advancement of the needle, constructed such that depressing upon the distal end of the generally tubular needle shield results in release of the locking mechanism, and the tubular needle shield cannot be depressed prior to removal of the needle sheath (NS); the locking mechanism comprises T-shaped locking arms of the main housing opposing and pressing on the syringe-support, where release comprises lifting of the T-shaped locking arms radially outwards by proximal movement of the needle shield.

Manually controllable plunger speed

A plunger rod for engaging a piston of the prefilled syringe in which the speed of depressing of the plunger is manually controllable by a user.

Interlock preventing plunger depressing prior to needle penetration location

An interlock for preventing depressing of a plunger prior to advancement of the syringe-support to a needle penetration location, where the interlock comprises an outwardly facing locking face; movement of the interlock and premature pressing of the plunger are prevented during storage by engagement of locking face protrusions located upon an anterior plunger pusher within appropriate grooves of locking faces of a rear cap, and the outwardly facing locking face prevents the locking face protrusions from bending inwardly.

NS remover transferring drop impact forces and allowing storage tolerance via ratchet teeth

An NS remover for use with an injection device having a syringe, a needle and a needle sheath (NS), comprising an internal part for mating with the needle sheath and an external part for transferring impact forces upon dropping of the injection device to a stopper on a main housing; ratchet teeth are present on one of the internal part and the external part for engaging flexible teeth upon the other part, with the ratchet teeth allowing tolerance in a position of the needle sheath (NS) during storage.

Across clm-00001 and clm-00002, the claim coverage includes a movable tubular needle shield that ends in an irreversibly concealed state, a needle sheath remover that irreversibly grips and must be removed before the needle shield can release the needle-advance lock, and plunger safety via user-manually controllable plunger speed and an interlock preventing premature plunger depression until a needle penetration position. clm-00027 additionally covers an NS remover configuration that transfers drop impact forces to a stopper and uses ratchet teeth engagement to allow tolerance of the needle sheath position during storage.

Stated Advantages

User safety is reinforced by a user-manually controllable plunger speed and by an interlock that prevents depressing of a plunger before the syringe-support reaches a needle penetration location.

Prematurity during storage is addressed by engagement of locking face protrusions located upon an anterior plunger pusher within appropriate grooves of locking faces of a rear cap.

The ratchet teeth allow tolerance in the position of the needle sheath (NS) during storage.

Documented Applications

A disposable safe auto-needle device for injection.

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