Release mechanism for use with needle shielding devices
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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 latch is further provided for engaging with the hub when the needle shield assembly is in the non-shielding position; as well as a locking member operably connected to the needle shield assembly, and located at least partially within the hub when the needle shield assembly is in the non-shielding position. The latch and locking member lock the latch to the hub, such that when the needle shield assembly moves into the shielding position, the locking member moves generally proximally, unlocking the latch.
Core Innovation
The disclosure describes a passive needle safety shield for a catheter introducer-type needle device. The needle shield assembly is moveable between a non-shielding position and a shielding position in which the sharp distal tip is covered by at least part of the needle shield assembly. A spring-biased needle blocking object advances into an axial lumen and blocks the sharp tip from emerging.
In the non-shielding position, a latch engages with a radially outer surface of the hub, or engages with the luer thread or luer connector of the hub. A locking member operably connected to the needle shield assembly is located at least partially within the hub or at least partially in the luer connector, thereby locking the latch to the hub or luer connector. When the needle shield assembly moves into the shielding position, the locking member moves generally proximally or moves axially, thereby unlocking the latch.
The disclosed structure coordinates the movement of the needle blocking object with the latch and locking member to prevent premature release. Geometric features include a hooked latch member and an angled restraining surface, openings in the shroud and latch, and carrier/spring/channel structures that establish a force/friction relationship via protrusions so that a pull-out force is greater than a frictional force. The arrangement includes hub flange/luer components and engagement relationships intended to limit wedging and premature unlocking while transitioning the shield assembly to cover the needle tip.
Claims Coverage
The document provides four independent claims, each directed to a needle device with a moveable needle shield assembly and a latch/locking member arrangement that transitions from a non-shielding position to a shielding position. Across the independent claims, inventive features include a locking member within the hub that unlocks a latch as the shield moves, latch engagement with luer thread/luer connector, and manufacturing of a needle assembly using a carrier, shroud, housing openings, and hooked-member/flange engagement.
Passive needle shield with hub latch unlocking by proximal locking member movement
A needle device comprising a hub with a longitudinal axis; a needle with a sharp distal tip; a needle shield assembly moveable from a non-shielding position to a shielding position covering the sharp distal tip; a latch engaging a radially outer surface of the hub when the needle shield assembly is in the non-shielding position; and a locking member operably connected to the needle shield assembly and located at least partially within the hub when the needle shield assembly is in the non-shielding position to lock the latch to the hub, wherein when the needle shield assembly moves into the shielding position the locking member moves generally proximally, thereby unlocking the latch.
Luer connector latch engagement with axially moving locking member
A needle device comprising a hub comprising a luer connector with a luer thread and having a longitudinal axis; a needle having a sharp distal tip; a needle shield assembly moveable from a non-shielding position to a shielding position covering the sharp distal tip; a latch engaging with the luer thread of the hub when the needle shield assembly is in the non-shielding position; and a locking member operably connected to the needle shield assembly and located at least partially in the luer connector when the needle shield assembly is in the non-shielding position thereby locking the latch to the hub, such that when the needle shield assembly moves into the shielding position the locking member moves axially.
Shielding transition permitting radial latch movement relative to longitudinal axis
A needle device comprising a hub comprising a luer connector with a luer thread and having a longitudinal axis; a needle having a sharp distal tip; and a housing comprising a needle shield assembly associated with the needle and operably connected to the housing, moveable from a non-shielding position to a shielding position covering the sharp distal tip; a latch engaging with the luer connector of the hub when the needle shield assembly is in a non-shielding position; and the needle shield assembly further comprising a locking member located at least partially in the hub when the needle shield assembly is in the non-shielding position thereby locking the latch to the luer connector, and such that when the needle shield assembly moves into the shielding position the locking member moves axially thereby allowing the latch to move radially relative to the longitudinal axis.
Manufacturing needle assembly using carrier/flange, shroud and housing openings, and hooked-member engagement
A method of manufacturing a needle assembly comprising placing a blocking object in a carrier including a flange on a distal end; inserting the carrier into a shroud; inserting the shroud into a housing until a proximal end of the shroud abuts a reduced diameter portion of the housing, the housing having a hooked member circumferentially extending from a portion of a distal end and first distal opening and second proximal opening through a wall; inserting a proximal end of a needle into an axial lumen of the carrier thereby displacing the blocking object so it protrudes at least partially through the proximal second opening; affixing the proximal end of the needle to a needle hub; engaging the hooked member with a flanged proximal end of a hub; threading the hub and a cannula over a distal end of the needle; and inserting the housing into the needle hub, wherein the engaging and inserting causes the blocking object to move distally so it protrudes from the first distal opening in the housing.
Across the independent claims, the coverage centers on a passive needle shield assembly that transitions from a non-shielding position to a shielding position covering a sharp distal tip, with a latch locked by a locking member located in the hub or luer connector and unlocked when the shield moves. The independent claim set also covers luer connector/luer thread-specific latch engagement and a manufacturing method coordinated around carrier/shroud/housing openings and hooked-member/flange engagement.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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