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Abstract
A needle-based medical device and method of manufacturing the same are disclosed. A needle device includes a hub having a longitudinal axis; a needle having a sharp distal tip; and a needle shield assembly associated with the needle and moveable from a non-shielding position to a shielding position. In the shielding position, the sharp distal tip is covered by at least part of the needle shield assembly. A bushing disposed about the needle, and a latch for engaging with the hub when the needle shield assembly is in the non-shielding position are further provided.
Core Innovation
The invention relates to a passive needle-shielding medical device including a needle having a longitudinal axis, a proximal end, and a sharp distal tip. A needle shield assembly includes a needle blocker and a bushing disposed about the needle having an inner surface and proximal and distal ends.
In a non-shielding position, the needle blocker is biased radially inward against a radially outward-facing surface of the bushing between the proximal end and the distal end of the bushing. In a shielding position, the sharp distal tip is positioned within the bushing, and the needle blocker lies at least partially across a distal opening of an axial lumen of the bushing, blocking distal movement of the sharp distal tip.
The device also includes hub and latch engagement that holds the needle shield assembly in a non-shielding position until the needle is withdrawn, and prevents disengagement prior to shielding. Alternate embodiments include a clip needle guard having axially extending arms with a radially extending member that blocks distal movement of the sharp distal tip of the needle, optionally in combination with a latch and housing that maintain hub features while minimizing interference.
Claims Coverage
This document includes two independent claims, each centered on a passive needle-shielding needle device with distinct structural guard/latch architectures. Across the independent claims, the inventive coverage includes a bushing with a radially inward biased needle blocker and a hub-engaged latch with a movable clip needle guard.
Radially inward biased needle blocker with bushing distal opening
In a non-shielding position, a needle blocker is biased radially inward against a radially outward-facing surface of a bushing between the proximal end and the distal end of the bushing, and in a shielding position the sharp distal tip is positioned within the bushing and the needle blocker lies at least partially across a distal opening of an axial lumen of the bushing to block distal movement of the sharp distal tip.
Hub-engaging latch and movable clip needle guard with radially extending block
A hub has an engaging member on an exterior thereof, a latch includes a housing and a hooked latch member disposed at a distal end of the housing, and a clip needle guard is disposed at least partially within the hub and at least partially within the housing of the latch and is movable between a non-shielding position and a shielding position, where in the non-shielding position the hooked latch member engages the engaging member and in the shielding position the radially extending member blocks distal movement of the sharp distal tip of the needle.
Claim coverage is grounded in two main passive architectures: a bushing-based radially inward biased needle blocker that crosses a distal opening to prevent distal movement of the sharp distal tip, and a hub and hooked latch that retain a clip needle guard until transitioning to a shielding position where a radially extending portion blocks distal tip movement.
Stated Advantages
Documented Applications
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