Devices for use in drug delivery systems
Inventors
Kriheli, Marino • TAVOR, Raanan • SHEM-TOV, Eric • DACH, Shlomi
Assignees
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Publication Number
US-11925785-B2
Publication Date
2024-03-12
Expiration Date
Abstract
Some embodiments are directed to a medical device for fluidly connecting to a medical spike, including a spike port configured to receive therein the medical spike and establish fluid communication between the medical spike and the medical device. The spike-locking mechanism can be configured to resist extraction of the medical spike from the spike port.
Core Innovation
The invention relates to a medical device configured for fluidly connecting to a medical spike. The spike port is configured to receive the medical spike with a first minimal force for insertion within the spike port and to resist extraction of the medical spike by a second minimal force that is at least three times greater than the first minimal force.
The spike port comprises at least one spike sealing element, where the port inner surface faces an interior of the spike port. The spike sealing element is a resilient element formed as a ring-shaped protrusion extending from the port inner surface towards a port longitudinal axis, providing a resilient sealing interaction during insertion and connection of the medical spike.
The disclosed spike-port structures further include a spike-locking mechanism and specific spike-locking element structures configured to switch from an unlocking state to an automatic locking state upon initiation of extraction. A resilient sealing element is combined with geometry that reduces friction between the spike port and the medical spike while preventing leakage, including compliance with ISO 8536-4 test conditions described as resulting in no leakage under specified dwell and gauge pressure.
Claims Coverage
The partial content provides one independent claim (clm-00001). Across the included family members, the coverage is refined with dependent claims that add quantitative force multiples, numeric force thresholds, and specified ISO 8536-4 test measurement conditions and rates, plus specific force thresholds for extraction relative to insertion.
Spike-port with insertion and extraction force ratio
A spike port configured to receive the medical spike upon insertion within the spike port with a first minimal force and configured to resist extraction of the medical spike from the spike port by a second minimal force at least three times greater than the first minimal force.
Resilient ring-shaped protrusion sealing element
The spike port has a port inner surface facing an interior of the spike port, and the spike sealing element is a resilient element formed as a ring-shaped protrusion extending from the port inner surface towards a port longitudinal axis.
Extraction force at least four times insertion force
The second minimal force is at least four times greater than the first minimal force.
Insertion minimal force threshold under ISO 8536-4
The first minimal force is no more than 40 N at an insertion rate of 500 mm·min−1 when tested using a test spike according to ISO 8536-4.
Second minimal force threshold under ISO 8536-4
The second minimal force is at least 120 N under the same test spike and at a removal speed of 100 mm·min−1 when measured relative to the first minimal force.
Extraction force at least five times insertion force
The second minimal force is at least five times greater than the first minimal force.
Overall claim coverage centers on a spike port that enables fluid connection using a first minimal insertion force while requiring a second minimal extraction force at least three times greater, with a resilient ring-shaped protrusion sealing element extending toward the port longitudinal axis, and dependent limitations that tighten the force ratio and specify ISO 8536-4-based insertion and extraction measurement thresholds and rates.
Stated Advantages
Resists extraction of the medical spike with a second minimal force at least three times greater than the first minimal insertion force.
Provides a resilient ring-shaped protrusion sealing element in the spike port.
Prevents leakage as described by an ISO 8536-4 test result of no leakage under specified dwell and gauge pressure.
Documented Applications
Drug-delivery device use as a medical device configured for fluidly connecting to a medical spike via a spike port.
Contamination-free drug injection/transfer housing using snap-fit thermoplastic materials combining rigid and drug-compatible, lower-stiffness inert components without glue.
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