Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-12370324-B2
Publication Date
2025-07-29
Expiration Date
Abstract
A pen needle (10) includes a hub (12) supporting a needle (30), an inner shield (14) enclosing the distal end of the needle, and an outer cover (16). The outer surface of the hub can include ribs (66) that cooperate with ribs (72) on the inner surface of the outer cover to assist in attaching the pen needle to a delivery device while preventing over torqueing or over tightening. In one embodiment, the inner shield (14) has a dimension to attach to the distal end of the hub (12) after use to enclose the proximal, non-patent end of the needle. In another embodiment, the outer cover (16) includes a closure member that can be removed during use and re-attached after use to cover the proximal end of the needle.
Core Innovation
The invention provides a pen needle having a hub with a distal end and an open proximal end, where the hub includes an outer surface with a plurality of ribs extending longitudinally and projecting radially outward. The hub also includes side wall inner surfaces including threads configured for attachment to a delivery device. The ribs of the hub include a leading face at an incline and a trailing face oriented in a plane substantially parallel to the radius and parallel to the longitudinal axis, together with an outer radial face oriented in an inclined plane relative to an outer radial surface of the hub.
A needle is coupled to the hub such that the distal end of the needle extends from the distal end of the hub and a proximal end extends toward the open proximal end of the hub. A removable inner shield is coupled to the hub, with a side wall whose inner surface complements an outer surface of the hub, and where the inner shield is configured to couple to a distal end of the outer surface of the hub for covering the distal end of the needle. The inner shield has an outer surface dimension for coupling with an inner surface of the open proximal end of the hub for covering the proximal end of the needle.
An outer cover receives the hub and has a side wall with an inner surface having a plurality of ribs projecting radially inward, where each outer-cover rib engages a corresponding hub rib. The outer-cover ribs connect the hub to the delivery device by rotation of the outer cover in a first direction and separate the hub from the delivery device by rotation of the outer cover in a second direction, and the ribs on the outer cover engage the leading face of the hub ribs when rotating the outer cover in the first direction. The disclosed structure is further associated with limiting over-tightening/over-torqueing behavior during attachment and providing a tactile and/or audible indication of a correctly seated connection.
The described arrangement also includes coupling of the inner shield to cover the non-patient needle end after use, an outer-cover gripping and hub-separation assistance mechanism using a flexible hub portion and a cover projection/detent. Additionally, the pen needle assembly includes removable outer-cover closures/end caps with frangible and tamper-evident features to prevent or indicate reuse and needle stick.
Claims Coverage
The provided excerpt identifies one independent claim (clm-00001) covering the overall pen needle structure with thread attachment to a delivery device, removable inner shield, and an outer cover whose inward ribs engage corresponding hub ribs for rotational connect/separate behavior with leading-face engagement during connecting rotation. Dependent claims further refine the independent claim with additional geometric, coupling, and closure/tamper-evident limitations, including a tamper-evident closure cap and specific rib-face relationships.
Rib-and-thread hub configured for delivery-device attachment with leading/trailing rib faces
A hub having an outer surface with a plurality of ribs extending longitudinally projecting radially outward, a side wall including threads configured for attachment to a delivery device, wherein the ribs comprise a leading face at an incline relative to the longitudinal axis and relative to a radius, a trailing face oriented substantially parallel to the radius and parallel to the longitudinal axis, and an outer radial face oriented in an inclined plane relative to an outer radial surface of the hub.
Removable inner shield for covering the distal and proximal ends of the needle relative to the hub
A removable inner shield coupled to the hub, with a side wall whose inner surface complements an outer surface of the hub, configured for coupling to a distal end of the outer surface of the hub for covering the distal end of the needle and having an outer surface dimensioned for coupling with an inner surface of the open proximal end of the hub for covering the proximal end of the needle.
Outer cover with inward ribs that connect and separate the hub by rotation via leading-face engagement
An outer cover dimensioned to receive the hub, having a side wall with an inner surface having a plurality of ribs projecting radially inward, each outer-cover rib configured to engage a corresponding hub rib to connect the hub to the delivery device by rotation in a first direction and separating the hub from the delivery device by rotation in a second direction, where the ribs on the outer cover engage the leading face of the hub ribs when rotating the outer cover in the first direction.
Optional refinements in dependent claims: rib-face radial dimension relationship
The trailing face of the hub ribs has a greater radial dimension than the leading face of the hub ribs.
Optional refinements in dependent claims: rounded convex outer-cover rib shape
The ribs of the pen needle’s outer cover have a rounded convex shape.
Optional refinements in dependent claims: closure cap with tamper-evident member
A closure cap attached to an open end of the outer cover, where the closure cap has a tamper-evident member.
Optional refinements in dependent claims: friction-fit inner-shield coupling
The inner shield is attached to the inner surface of the hub’s open proximal end using a friction fit.
Optional refinements in dependent claims: flexible hub portion for separation
The hub side wall includes a flexible portion that flexes radially outward to separate the hub from the threaded end of the delivery device.
Across the provided independent claim and its listed dependent refinements, the inventive focus is the cooperation between hub ribs and outer-cover ribs that engage during rotational connecting and disengagement, together with a removable inner shield to cover both needle ends and additional constraints and features such as rib geometry, friction-fit coupling, separation assistance via flexibility, and tamper-evident/frangible closure characteristics.
Stated Advantages
Limits over-tightening/over-torqueing during attachment to the delivery device.
Provides tactile and/or audible indication of a correctly seated connection.
Helps prevent or indicate reuse and needle stick via frangible and tamper-evident features.
Documented Applications
Use in a medication pen/delivery device environment where the pen needle is attached to and detached from a delivery device via the outer cover rotational mechanism.
Post-use handling where the inner shield is used to cover the non-patient needle end after use.
Use with removable outer-cover closures/end caps having frangible and tamper-evident features intended to prevent or indicate reuse and needle stick.
Interested in licensing this patent?