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-12048829-B2
Publication Date
2024-07-30
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 for transferring a drug therethrough, comprising a housing with at least two housing portions connected by a snap-fit connection. At least a first housing portion is made from at least one first thermoplastic material that is a drug-incompatible material. At least one element arranged inside the housing is configured for passing the drug through the medical device and is held by the snap-fit connection.
The at least one internal element is made from at least one second thermoplastic material that is drug-compatible. The second thermoplastic material is characterized by at least one of the following properties: having a lower stiffness than the first thermoplastic material and being chemically inert.
The disclosure further emphasizes spike adaptor/ports for drug delivery with a spike-locking mechanism that automatically switches from an unlocking state to a locking state upon initiation of spike extraction to prevent accidental extraction. The spike adaptor/ports also address reduced insertion force and maintained extraction resistance by minimizing friction/contact and optionally using lubricious materials, while ensuring a force relationship where the second minimal force is at least about three times the first minimal force.
The disclosure additionally includes spike sealing elements that seal against leakage during ISO-compliant hold/pressure testing, with separation between sealing functions and spike stabilization functions. A drug-transfer housing is joined by snap-fit connections using drug-incompatible and drug-compatible thermoplastic selections to support mechanical integrity while enabling drug transfer through the device.
Claims Coverage
Independent claim clm-00001 is directed to a drug-transfer medical device with a snap-fit housing and a two-thermoplastic-material arrangement, with the internal element further defined by lower stiffness and/or chemical inertness. The claim set includes 1 independent claim and multiple dependent claim refinements, focusing on mechanical coupling via snap-fit and material compatibility for drug contact.
Snap-fit housing with drug-incompatible thermoplastic first housing portion
A housing comprising at least two housing portions connected to each other by a snap-fit connection, where at least a first housing portion is made from at least one first thermoplastic material that is a drug-incompatible material.
Drug-passing element held in the snap-fit housing with drug-compatible thermoplastic
At least one element at least partially arranged inside the housing and configured for passing the drug through the medical device, held by the snap-fit connection, wherein the at least one element is made from at least one second thermoplastic material that is drug-compatible and has at least one of: lower stiffness than the first thermoplastic material and chemically inert.
Protruding arms and snap-in portions in the snap-fit connection
The snap-fit connection comprises protruding arms that engage corresponding snap-in portions on another housing portion.
Acetal as the drug-incompatible first thermoplastic material
At least one of the first thermoplastic materials comprises Acetal.
PVC-free material and/or polypropylene as the drug-compatible second thermoplastic material
The second thermoplastic material comprises at least one of a PVC-free material or polypropylene.
Injection inlet port configured to connect to a fluid transfer device
A first housing portion defines an injection inlet port configured to connect to a fluid transfer device to receive the drug.
The claims cover a drug-transfer medical device where mechanical assembly is implemented via a snap-fit housing, with drug-incompatible thermoplastic material used for at least one outer housing portion and drug-compatible thermoplastic material used for the internal drug-passing element. The internal element is further defined by lower stiffness relative to the first thermoplastic material and/or chemical inertness, with additional refinements to snap-fit engagement geometry, specific thermoplastic material examples, and an injection inlet port interface for connecting to a fluid transfer device.
Stated Advantages
Automatically switching from an unlocking state to a locking state upon initiation of spike extraction to prevent accidental extraction.
Reduced insertion force by minimizing friction/contact and optionally using lubricious materials.
Maintaining high extraction resistance via a force relationship where the extraction force is at least about three times the insertion force.
Sealing against leakage during ISO-compliant hold/pressure testing, while separating sealing functions from spike stabilization functions.
Improved compatibility and integrity by using drug-incompatible high-stiffness thermoplastics for outer rigid portions and drug-compatible lower-stiffness/chemically inert elements for internal parts.
Documented Applications
Spike adaptor/ports for drug delivery, including spike insertion/extraction behavior and spike sealing during ISO-compliant hold/pressure testing.
Drug transfer medical devices using a housing and drug-transfer element arrangement, including an injection inlet port configured to connect to a fluid transfer device to receive the drug.
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