Intravenous bag adapter for closed system transfer devices (CSTDS)

Abstract

The disclosure relates to secured closed system transfer devices (CSTDs) and their related components, and more particularly, to an intravenous (I.V.) bag adapter (IVBA) for a secured closed fluid transfer system component providing a universal spike port with improved force regulation (insertion and extraction) between the adapter and the IV Bag.

Description

INTRAVENOUS BAG ADAPTER FOR CLOSED SYSTEM TRANSFER DEVICES (CSTDS)Background

[0001] The disclosure is directed to secured closed system transfer devices (CSTDs) and their related components, and more particularly, to an intravenous (I.V.) bag adapter (IVBA) for a secured closed fluid transfer system component providing a universal spike port with improved force regulation (insertion and extraction) between the adapter and the IV Bag.

[0002] Hazardous medicines are frequently applied in the treatment of certain diseases, for example, in the treatment of cancer. Cytotoxic drugs have generally been used to kill cancer cells but present specific dangers to all cells, both in the patient and in healthcare providers. Although the exposure to a health care provider is normally very small for each cytotoxic drug dose administration, evidence suggests that chronic, low-dose exposure can produce significant health problems. Accordingly, it would be of great benefit to have a system that allows the safe handling of hazardous drugs while significantly reducing and / or eliminating the exposure to providers.

[0003] IV bag adapters are used in Closed System Transfer Devices (CSTDs) to connect IV bags to other components of the system, such as tubing sets - ensuring a closed environment for the safe transfer of drugs. These adapters are typical in maintaining a sealed system, preventing exposure to hazardous drugs and minimizing the risk of contamination and are typically used in conjunction with other CSTD components like syringe adapters and secondary IV sets to facilitate drug administration from the IV bag to the patient.

[0004] CSTDs are commonly used with medications such as neoplastic agents (e.g., bleomycin, cisplatin, methotrexate) where IV bag adapters would be used to connect the IV bag containing the medication to the rest of the CSTD system, ensuring a closed transfer process.

[0005] Common issues with spike ports such as those used with IV bag adapters, include the potential for leakage or disconnection during spiking, which can lead to drug exposure and contamination. Tubing spikes can be sharper than necessary, increasing the risk of puncturing the side of an IV bag, especially if not designed with safety features to prevent such incidents.Additionally, the process of spiking or unspiking can spread liquid droplets, posing a risk ofexposure to hazardous drugs. Furthermore, fragmentation of septa included in the spike port during the spiking process, may lead to serious injury if a fragment of the septa enters the bloodstream of the patient.

[0006] These and other shortcomings of the current components is addressed by the following description.Summary

[0007] Disclosed, in an exemplary implementation, is an intravenous (I.V.) bag adapter (IVBA) for a secured closed fluid transfer system, the IVBA comprising: a body portion having a proximal end and a distal end, a spike port adapted sized and configured to engage an external spike extending distally from the proximal end of the body portion, the spike port having a shaft spanning the length of the spike port, a spike extending distally from the distal end of the body portion, the spike having a distal end and an outer surface, the spike defining a longitudinal axis and having a first lumen extending axially therethrough, wherein: the first lumen is in fluid communication with the shaft defined in the spike port, and the outer surface of the spike having a roughened portion extending proximally from the distal end of the spike, and a smooth portion contiguously extending from the roughened portion to the distal end of the body.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The IVBA assembly for a closed and secure fluid transfer providing a universal spike port with improved force regulation (insertion and extraction) between the adapter and the IV Bag, will become apparent from the following detailed description when read in conjunction with the figures, which are exemplary, not limiting, and in which:

[0009] FIG. 1, illustrate a top rear perspective of the IVBA;

[0010] FIG. 2, illustrates a bottom front perspective of the IVBA;

[0011] Fig. 3, is a X-Z cross section of the IVBA;

[0012] FIG. 4, is an enlarged portion of the X-Z cross section of the IVBA illustrated in FIG.3;

[0013] FIG. 5, is a perspective view of a resilient cylindrical insert;

[0014] FIG.s 6, and 7 illustrate exemplary implementation of the roughened surface portions on the spike;

[0015] FIG. 8 is top perspective of a partially exploded view of the IVBA;

[0016] FIG. 9, is a bottom perspective view of the resilient cylindrical barrel; and

[0017] FIG. 10, is a perspective exploded view of the IVBA.

[0018] While the disclosure of the IVBA disclosed herein, is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be further described in detail hereinbelow. It should be understood, however, that the intention is not to limit the disclosure to the exemplary implementations described. On the contrary, the intention is to cover all modifications, equivalents, and alternative.DETAILED DESCRIPTION

[0019] In certain exemplary implementations, provided herein are intravenous (I.V.) bag adapters (IVBA) for a secured closed fluid transfer system component providing a universal spike port with improved force regulation (insertion and extraction) between the adapter and the IV Bag.

[0020] In the realm of secure fluid transfer for medications like chemotherapy, devices such as the IVBAs play significant roles. However, currently, regardless of the established standard length for the tubing set spike, manufacturers currently have shorter or longer piercing spikes when used with tubing sets, raising the risk of incomplete piercing of the spike port septa on the one hand, or fragmentation of the septa, leading to release of septum fragments into the IV bag on the other hand.

[0021] Additionally, partially rough surfaces of IV bag piercing spikes can provide more surface reduce piercing force on one hand if located towards the distal tip, while having a polished distal end is beneficial in maintaining a better seal between the spike and the bag. DETAILED DESCRIPTION

[0022] Provided herein are secured closed system transfer device (CSTD) components, specifically exemplary implementations of an intravenous (I.V.) bag adapter (IVBA) configured to interface an IV bag within a fluid transfer system while maintaining a sealed fluid pathway. As indicated, CSTDs are employed in the preparation and administration of hazardous drugs,including cytotoxic and antineoplastic agents, where maintaining containment integrity is critical to preventing occupational, and patient exposures. The IVBA addresses the need for controlled insertion force regulation during spiking events, dual independent fluid pathways for simultaneous drug withdrawal and venting, and a spike surface geometry that balances piercing force reduction with reliable sealing against the IV bag membrane.

[0023] Accordingly, and in an exemplary implementation, the IVBA can comprises body portion having a proximal end and a distal end. The body portion is adapted, sized and configured to serves as the primary structural chassis of the IVBA, integrating all functional sub-components into a unified assembly. In another exemplary implementations, the body portion is fabricated from a chemically resistant polymer such as, for example; polycarbonate or polypropylene, selected for resistance to the broad spectrum of antineoplastic agents encountered in oncology pharmacy practice. The body portion defines the geometric envelope within which the fluid pathway network, the male stem port, the spike port, and the IV bag piercing spike are coaxially and laterally organized.

[0024] The IVBA further comprises a spike port, adapted, sized, and configured to engage an external spike, the spike port extending distally from the proximal end of the body portion and having a lumen spanning its length. The spike port is designed to receive, for example, a piercing spike, such as, for example, that which is found on a secondary IV administration set, and which can also be configured to provide the conduit through which venting or fluid return flow is conducted during drug transfer operations. The shaft defined in the spike port can be configured to maintain fluid communication between the exterior connection interface at its proximal opening and the first lumen of the IV bag piercing spike at its distal terminus.

[0025] The IVBA can further comprise a spike extending distally from the distal end of the body portion, defining a longitudinal axis and is adapted, sized and configured to penetrate e.g., the resealable membrane or stopper portion of a standard IV bag upon application of a controlled axial insertion force. In yet another exemplary implementation, the spike can have an overall length e.g., between about 15 mm., and about 45 mm., and have an outer diameter ranging for example; between about 3 mm., and about 8 mm., at its proximal base, tapering to a sharpened distal end geometry engineered to facilitate clean, controlled septum penetration without fragmenting the IV bag membrane. The spike further defines a first lumen extending axially therethrough, the first lumen being in fluid communication with the shaft defined in the spikeport, and can be adapted, sized and configured to constitute the diluted drag withdrawal pathway, conducting liquid medicament drawn from the interior of the IV bag through the body of the spike and into another port for onward transfer to the administration set.

[0026] In certain exemplary implementations, the body portion can further comprise a male stem port extending laterally therefrom, at an angle, the male stem port having an axial lumen spanning its length. The male stem port can be oriented transverse to the longitudinal axis of the IV bag piercing spike and is adapted, sized and configured to establish e.g., a Luer-compatible, and / or proprietary- stem connection with a complementary female receptor on an associated CSTD component such as a syringe adapter. The axial lumen of the male stem port can be sized at a range of, for example, between about 1.0 millimeter (mm) and 3.0 mm., in internal diameter, while providing sufficient mechanical wall thickness for pressure containment.

[0027] The spike can further comprise a second lumen, maintaining fluid communications with the axial lumen defined in the male stem port. The second lumen can have an internal diameter between about 1.0 mm., and about 4.0 mm., sufficient to permit gravity and vacuum-assisted fluid transfer at clinically relevant flow rates without generating excessive resistance. The second lumen can be adapted, sized and configured to function as a dedicated venting and equalization pathway, or, alternatively, an inlet port for the concentrated medicament drawn from a vial adapter, or a syringe, permitting ingress of filtered air or fluid from the external spike engaged in the spike port to compensate for volumetric withdrawal from the IV bag and maintain pressure equilibrium.

[0028] Maintaining separate first and second lumens within the spike body is configured to prevent cross-contamination between the withdrawal and venting streams, or between diluted and concentrated medicine, a critical design requirement in closed system architectures for hazardous drug handling per NIOSH and USP Chapter 800 guidelines. The outer surface of the spike comprises a roughened portion extending proximally from the distal end of the spike, and a smooth portion contiguously extending from the roughened portion to the distal end of the body portion. The roughened portion is positioned at the distal zone of the spike to reduce the effective contact area and frictional resistance between the spike outer surface and the elastomeric IV bag membrane during insertion, thereby lowering the peak insertion force required to complete a spiking event. The smooth portion, occupying the proximal region of the spike, provides a continuous sealing contact surface against the elastomeric membrane once the spike is fullyseated, preserving system closure integrity and preventing fluid bypass along the outer surface of the spike during drug transfer operations.

[0029] In an exemplary implementation of the IVBA, the ratio between the roughened and smooth portions of the spike outer surface can be between about 1:1 and 9:1, establishing a zonal distribution that balances two competing functional requirements. The roughened distal portion reduces effective contact area between the spike and the IV bag membrane, decreasing insertion force consistent with tribological principles governing polymer-elastomer interfaces under axial compressive loading. The smooth proximal portion provides a continuous sealing interface once the spike is fully seated, preventing fluid bypass and preserving containment integrity. This ratio range accommodates typical spike lengths, while simultaneously maintaining adequate sealing contact across commercially available materials, such as, for example, polyvinyl chloride (PVC) and polyolefin IV bag membrane formulations.

[0030] Additionally, the mean root square roughness (Ra) of the roughened spike portion is at least 50% higher than the smooth portion, the smooth portion configured to have roughness of between about 0.025 pm and about 1.6 pm Ra. This quantified differential governs the tribological interaction between the spike outer surface and the IV bag membrane, or stopper. The smooth proximal portion being adapted, sized and configured to provide a near-mirror sealing surface ensuring conformal membrane contact and preventing fluid egress at full spike seating. The roughened distal portion reduces real contact area, decreasing peak insertion force through reduced adhesive and ploughing friction components. Surface roughness may be imparted by, e.g., abrasive finishing, laser texturing, injection molding, or knurling, verified for example, by contact profilometry and / or optical interferometry during quality control.

[0031] Additionally, the spike port defines a distally tapered opening and a cylindrical bore with an internal surface diameter larger than the shaft defined in the spike port. The tapered opening is configured to guide and centers an external spike during engagement, reducing misalignment-induced lateral loading in accordance with e.g., CSTD systems’ requirements. The transition into the enlarged bore creates an annular shoulder adapted to serve as a positive axial stop for housed retention components. The annular cavity between bore wall and lumen wall is adapted, sized and configured to provide the geometric envelope to accommodate the resilient sealing sub-assembly while maintaining the continuous fluid pathway. The taper angle may range between about 10° and about 45° relative to the spike port longitudinal axis.

[0032] In certain examples, the spike port further comprises a two-component sealing subassembly consisting of e.g., a resilient cylindrical barrel and a resilient cylindrical insert. The barrel, fabricated e.g., from bromobutyl, or chlorobutyl rubber, is adapted and configured to provide chemical resistance to e.g., antineoplastic agents and provide elastic recovery, with its outer diameter configured for close fit within the cylindrical bore. The insert, disposed within the barrel, is configured to be translated by the external spike distally, eventually passing through the slit(s) defined in the resilient cylindrical barrel. This dual-component architecture is configured to decouple sealing and retention functions, enabling independent optimization of material stiffness and bore taper, accommodating spike diameters between about 4 mm., and about 8 mm, with varying spike length as disclosed herein.

[0033] Consequently, and in an exemplary implementation, the resilient cylindrical insert is configured to translate axially, and distally from a first position, wherein its open proximal end is substantially planar with the proximal end of the barrel, to a second position where its sealed distal end abuts the upper surface partially sealed distal end of the barrel. This axial translation is configured to convert point-loading at the proximal face into distributed compressive stress across the insert body, reducing fracture risk during external spike engagement. In the first position, the flush proximal faces maintain a sealed interface preventing contaminant ingress. Abutment in the second position is configured to act as a spike extension and a cap, maintaining seal between the fluid inside the spike (and the first lumen). Translational travel may range between about 3 mm and about 15 mm, accommodating commercially available engagement depths of tubing set spike(s).

[0034] Moreover, the resilient cylindrical barrel further defines a flange extending radially from its open proximal end, sized and configured to be accommodated within a complementary radial groove in the proximal end of the spike port. This mechanism provides positive axial retention without adhesive bonding or mechanical fasteners, preserving chemical resistance and enabling disassembly during manufacturing inspection. The flange is configured to resist proximal ejection forces during spike withdrawal, preventing barrel extraction. Flanged outer diameter may exceed the bore diameter for example, by between about 0.5 mm and about 2.0 mm, with flange thickness ranging between about 0.5 mm and about 1.5 mm. Discrete radial tabs may alternatively replace the continuous annular flange, providing equivalent retention with reduced assembly insertion force.

[0035] Furthermore, the outer surface of the resilient cylindrical barrel defines a plurality of axial rails extending radially therefrom, each is adapted, sized and configured to provide engage complementary grooves in the internal surface of the cylindrical shaft defined in the spike port, thereby rotationally constraining the barrel against torsional displacement during repeated spike insertion and extraction cycles, preventing angular misalignment of the coaxial slit relative to the spike first lumen. Each rail may have a radial height ranging between about 0.3 mm and about 1.0 mm, and axial length equal to the bore engagement zone. Between about 2 and about 6 rails, can be circumferentially distributed at equal angular intervals, provide balanced radial loading and prevent eccentric barrel deflection under asymmetric spiking force vectors.

[0036] In an exemplary implementation, the partially sealed distal end of the resilient cylindrical barrel defines a coaxial slit having an upper surface, configurable, for example: as a single linear slit, a cross-shaped pattern, or other multi-arm geometries. The coaxial slit is a prescored stress-relief feature directing deformation during external spike perforation, enabling controlled barrel opening, allowing for passage of the resilient cylindrical insert that reduces the risk of elastomeric fragmentation, a major CSTD safety requirement consistent with USP Chapter 1 standards, since particulates entering the IV fluid pathway could cause patient embolism. Slit amt length may range for example, between about 30% and about 80% of the distal end radius, with nominally zero (0) slit width in the unloaded state, providing substantially resealable closure upon spike withdrawal and preserving spike port hermetic integrity.

[0037] Also, the outer cylindrical surface of the resilient cylindrical insert can be coated with a friction modifier configured to reduce friction between the insert and slitted floor of the resilient cylindrical barrel. The friction modifier maintains can be configured to affect consistent axial sliding resistance throughout the insert translational stroke, ensuring spike engagement force remains within acceptable CSTD insertion force windows without excessive operator effort. Suitable compositions can be, for example; medical-grade silicone oil, polytetrafluoroethylene (PTFE) dispersion, or parylene-C, selected for biocompatibility and chemical resistance to antineoplastic agents. Coating thickness may range between about 1 pm and about 25 pm, reducing dynamic coefficient of friction from between about 0.5 and about 1.2 to between about 0.1 and about 0.3.

[0038] A more complete understanding of the IVBA component for a closed and secure fluid transfer providing a generic spike port with improved force regulation (insertion and extraction)between the adapter and the IV Bag, can be obtained by reference to the accompanying drawings. These figures (also referred to herein as “FIG.”) are merely schematic representations based on convenience and the ease of demonstrating the present disclosure, and are, therefore, not intended to indicate relative size, scale and dimensions of the devices or components thereof, and / or to define or limit the scope of the exemplary implementations. Although specific terms are used in the following description for the sake of clarity, these terms are intended to refer only to the particular structure of the exemplary implementations selected for illustration in the drawings, and are not intended to define or limit the scope of the disclosure. In the drawings and the following description below, it is to be understood that like numeric designations refer to components of like function.

[0039] Turning now to FIG.s 1-10. illustrating an exemplary implementation of an intravenous (I.V.) bag adapter (IVBA) 10 for a secured closed fluid transfer system, IVBA 10 comprising: body portion 100 having proximal end 101 and distal end 102, body portion 100 having male stem port 210 extending laterally therefrom. It is contemplated, that male stem portion 210 may not always be present. Male stem port 210 further having axial lumen 220 (see e.g., FIG. 3) spanning length of male stem port 210; spike port 106 adapted sized and configured to engage external spike 750 (not shown, referring for example, to a piercing spike connected e.g., to a tubing set) extending distally from proximal end 101 of body portion 100, spike port 106 having shaft 250 (see e.g.. FIG.s 3, 4) defined therein, spanning length of spike port 110. Also illustrated is (IV bag piercing) spike 400 extending distally from basal surface 105 of distal end 102 of body 100 portion defining rim 104, and grasp ribs 103, spike 400 having distal end 401 and outer surface 4000. defining longitudinal axis and having first lumen 251 and second lumen 221 (when present), extending axially therethrough, wherein: first lumen 251 of spike 400 is in fluid communication with lumen 250 defined in spike port 106; first lumen 251 is in fluid communication with shaft 250 defined in spike port 110; and outer surface 4000 having roughened portion 403 extending proximally from distal end 401 of spike, and smooth portion 404 contiguously extending from roughened portion 403 to basal surface 105 of distal end 102 of body 100 portion.

[0040] As further illustrated second lumen 221 can be adapted to maintain fluid communication with axial lumen 220 defined in the male stem port 210.

[0041] Also shown is protective cap 450 having distal end 451. As illustrated (IV bag piercing) spike 400 further having neck portion 405, and openings 402’ and 402, leading to second lumen 221 and first lumen 251 respectively (see e.g.. FIG. 2, FIG. 3).

[0042] In another exemplary implementation, illustrated e.g., in FIG.s 6, and 7, the ratio between roughened portion 403 of spike 400 and smooth portion 404 of the spike is between about 1:1 and about 9:1. For example, the mean root square roughness (Ra) of roughened portion 403 of spike 400 is at least 50% higher than smooth portion 404 of spike 400, for example, smooth portion 403 of spike having roughness of between about 0.025 pm to about 1.0 pm Ra, where the roughened portion, having a roughness that is at least 50% higher, for example, between about 0.4 pm and about 1.6 pm.

[0043] Turning now to FIG.s 3, 4, 5. and 8, illustrating spike port 106 defining distally tapered opening 1101 and cylindrical bore 1110 (see e.g., FIG. 8) having internal surface with internal diameter IDmo that is larger than the internal diameter of shaft 250 («ODi2i) defined in spike port 110. Moreover, spike port 106 further comprises: a resilient cylindrical barrel 120 having open proximal end 121, and partially sealed distal end 123 having internal cylindrical volume 122, resilient cylindrical barrel 120 having outer diameter (OD120) configured to be accommodated within cylindrical bore 1110 of spike port 110; and a resilient cylindrical insert 130 having outer cylindrical surface 134, open proximal end 132 (see e.g., FIG. 5) and sealed distal end 133, located in internal cylindrical volume 122 of resilient cylindrical barrel 120, wherein resilient cylindrical insert 130 is configured to be translated distally by external spike 750 (not shown), and wherein resilient cylindrical insert 130 further defines distally tapered bore 135, sized adapted and configured to engage at least portion of external spike 750.

[0044] In another exemplary implementation, resilient cylindrical insert 130 is configured to translate distally from first position wherein open proximal end 132 of resilient cylindrical insert 130 is substantially planar with open proximal end 121 of resilient cylindrical barrel 120, to second position where sealed distal end 133 of resilient cylindrical insert 130 passes through partially sealed distal end 133 of resilient cylindrical barrel 130, and abuts floor 253 of shaft 250. or wherein open proximal end 132 is distal to partially sealed distal end 133 of resilient cylindrical barrel 130, within shaft 250.

[0045] Additionally, resilient cylindrical barrel 120 further defines flange 1210 extending radially from open proximal end 121 of resilient cylindrical barrel 120, flange 1210 sizedadapted and configured to be accommodated within radial groove 1111 defined in proximal end 101 of spike port 106, while outer surface 124 of resilient cylindrical barrel 120 (see e.g., FIG.s 8, 9) further defines plurality of axial rails 1200p extending radially from outer surface 124 of resilient cylindrical barrel 120, plurality of axial rails 1240 are each sized and configured to be accommodated within plurality of complementary grooves 1102q defined in internal surface of cylindrical bore 1110 of spike port 106 having floor 1105 (see e.g., FIG.s 3, 8). As further illustrated in FIG. 9, partially sealed distal end 123 of the resilient cylindrical barrel 120 defines a coaxial slit 125, illustrated as a cross, however, different slits can be defined, including a single slit. Incorporating the slit 125 inhibits fragmentation of resilient cylindrical barrel 120 upon insertion of external spike 750.

[0046] In yet another exemplary implementation, outer cylindrical surface 134 of the resilient cylindrical insert 130 is further coated with friction modifier, configured to reduce friction between outer surface 134 of resilient cylindrical insert 130 (FIG. 5), and internal cylindrical volume 122 of resilient cylindrical barrel 120 (FIG. 8).Definitions

[0047] In the context of the disclosure, the term "Roughened portion" means an axial zone of the spike outer surface, positioned at the distal region of the spike, having a mean arithmetic surface roughness (Ra) at least 50% greater than the Ra of the smooth portion, with the boundary between the two zones being a defined transition point on the spike's axial length rather than a gradual blend. "Smooth portion" means the contiguous proximal axial zone of the spike outer surface having an Ra of between about 0.25 pm and about 0.8 pm as recited in the specification, configured to provide a sealing interface against the IV bag membrane when the spike is fully seated.

[0048] The term "Substantially planar" refers in an exemplary implementation, to the open proximal end of the resilient cylindrical insert and the open proximal end of the resilient cylindrical barrel lying in the same plane or in planes sufficiently close together that the sealed interface between them prevents contaminant ingress in the first (pre-insertion) position, consistent with the specification's functional requirement of maintaining a sealed interface before external spike engagement. Minor manufacturing deviations that do not compromise this sealed interface are encompassed.

[0049] The term “Partially sealed distal end" indicates a distal end of the resilient cylindrical barrel that is closed by an elastomeric membrane across all but one or more pre-formed stressrelief features, which may have, but are not limited to, a coaxial slit as recited herein, such that the distal end remains closed and fluid-impermeable in the absence of applied spike insertion force, but permits controlled, directed perforation and opening upon axial insertion of an external spike, and substantially reseals upon spike withdrawal to maintain containment integrity.

[0050] Furthermore, the term "Coaxial slit" means a pre-formed stress-relief feature defined in the partially sealed distal end of the resilient cylindrical barrel, centered on and aligned with the longitudinal axis of the barrel, configured to direct and control elastomeric deformation during perforation by an external spike. The term encompasses a single linear slit, a cross-shaped pattern, or other multi-arm geometries, as expressly described in the specification, provided that each geometry is centered on the barrel's longitudinal axis; off-center or asymmetrically positioned slits are excluded.

[0051] In the context of the disclosure, language referring to "Adapted, sized and configured to" means that the recited structural element is dimensioned and physically arranged to be capable of performing the specified function, engaging an external spike (as to the spike port) or frictionally engaging at least a portion of an external spike (as to the resilient cylindrical insert's tapered bore) based on its structural characteristics alone, without requiring proof of actual use or activation in any particular instance. The recited structures (lumen, tapered bore, cylindrical bore) are sufficient to define the structural class of each element.

[0052] As used herein, the term "Distally tapered bore" means an internal bore of the resilient cylindrical insert whose inner diameter decreases progressively in the distal direction along a meaningful axial extent, sufficient to generate graduated, increasing compressive gripping force on an inserted external spike shaft as insertion depth increases, rather than a merely nominal or incidental diameter reduction. The taper may be linear or curvilinear in cross-section and is sized to engage external spikes having outer diameters in the range described in the specification, without requiring the taper to extend the full axial length of the bore.

[0053] The term "about" means that amounts, sizes, formulations, parameters, and other quantities and characteristics are not and need not be exact, but may be approximate and / or larger or smaller, as desired, reflecting tolerances, conversion factors, rounding off, measurement error and the like, and other factors known to those of skill in the art. In general, amount, size,formulation, parameter or other quantity or characteristic is "about" or "approximate" whether or not expressly stated to be such.

[0054] For example, "About," means that the recited numerical values, including the 1:1 to 4:1 rough to Smooth ratio range and the Ra values of between 0.25 pm and 0.8 pm, are not exact and may vary within the range of manufacturing tolerances, measurement error (including profilometry instrument calibration uncertainty), rounding conventions, and conversion factors as recognized by a person of ordinary skill in the medical device manufacturing arts, but does not extend the range so broadly as to encompass values that a person of ordinary skill in the art would recognize as outside the tolerance band for the recited parameter.

[0055] The term “abut” refers to items that are in direct physical contact with each other, although the items may (not) be attached, secured, fused, or welded together. The term “accommodate” includes both a case in which the whole of object to be accommodated is positioned inside the housing and a case in which a part of the object to be accommodated is positioned inside the housing.

[0056] Terms "bottom", "below", "top" and "above" as used herein do not necessarily indicate that a "bottom" component is below a "top" component, or that a component that is "below" is indeed "below" another component or that a component that is "above" is indeed "above" another component. As such, directions, components or both may be flipped, rotated, moved in space, placed in a diagonal orientation or position, placed horizontally or vertically, or similarly modified. Accordingly, it will be appreciated that the terms "bottom", "below", "top" and "above" may be used herein for exemplary purposes only, to illustrate the relative positioning or placement of certain components, to indicate a first and a second component or to do both.

[0057] "Communicate" (and its derivatives e.g., a first component "communicates with" or "is in communication with" a second component) and grammatical variations thereof are used to indicate a structural, functional, mechanical, electrical, optical, liquid, or fluidic relationship, or any combination thereof, between two or more components or elements. As such, the fact that one component is said to communicate with a second component is not intended to exclude the possibility that additional components can be present between, and / or operatively associated or engaged with, the first and second components.

[0058] Similarly, the term "Fluid communication" means a continuous fluid pathway through which liquid medicament or gas may flow, in either direction as dictated by pressure differentialor clinical operation, between two identified structural elements, specifically the first lumen and the male stem port lumen (drug withdrawal pathway) and the first lumen and the shaft defined in spike port (venting pathway), without requiring a straight-line path but requiring that no valve, sealed interface, or barrier interrupts flow in the operative, fully assembled state of the IVBA.

[0059] Furthermore, the term "Contiguously extending" means that the smooth portion of the spike outer surface is spatially continuous with, i.e„ directly adjoins without interruption by any intervening distinct surface feature, groove, step, or zone of differing texture, the roughened portion at one boundary and the distal end of the body portion at the other boundary, such that the transition between the two surface zones is unbroken along the axial length of the spike.

[0060] "comprising" and its derivatives, as used herein, are intended to be open ended terms that specify the presence of the stated features, elements, components, groups, integers, and / or steps, but do not exclude the presence of other unstated features, elements, components, groups, integers and / or steps. The foregoing also applies to words having similar meanings such as the terms, "including", "having" and their derivatives. Also, the terms "member" or "element" when used in the singular refers to a single integrated part that moves as a unit and does not include a plurality of parts with independent and separate movement between. In other words, as used herein, the terms "member" or "element" can be made of several pieces to foam integral unit, but does not include two or more parts with a first part that moves relative to a second part.

[0061] The term “coupled”, including its various forms such as ’’operably coupling”, "coupling" or "couplable", refers to and comprises any direct or indirect, structural coupling, connection or attachment, or adaptation or capability for such a direct or indirect structural or operational coupling, connection or attachment, including integrally formed components and components which are coupled via or through another component or by the forming process. Indirect coupling may involve coupling through intermediary member or adhesive, or abutting and otherwise resting against, whether frictionally or by separate means without any physical connection.

[0062] The term “resilient” generally refers to a rubberlike material (e.g., a material which can experience deformation and return to the undeformed configuration). In addition, the term "Resilient," refers to a material capable of undergoing elastic deformation upon application of a compressive or axial load and returning to its undeformed configuration upon removal of that load, such as, for example; bromobutyl rubber and chlorobutyl rubber as exemplified in thespecification, and encompassing other elastomeric materials capable of equivalent elastic recovery and chemical resistance to antineoplastic agents encountered in CSTD applications.

[0063] Accordingly, provided herein is an intravenous (I.V.) bag adapter (IVBA) for a secured closed fluid transfer system, the IVBA comprising: a body portion having a proximal end and a distal end, a spike port adapted sized and configured to engage an external spike extending distally from the proximal end of the body portion, the spike port having a shaft spanning the length of the spike port, a spike extending distally from the distal end of the body portion, the spike having a distal end and an outer surface, the spike defining a longitudinal axis and having a first lumen extending axially therethrough, wherein: the first lumen is in fluid communication with the shaft defined in the spike port, and the outer surface of the spike having a roughened portion extending proximally from the distal end of the spike, and a smooth portion contiguously extending from the roughened portion to the distal end of the body, wherein (i) the ratio between the roughened portion of the spike and the smooth portion of the spike is between about 1:1 and about 9:1, (ii) the spike port defines distally tapered opening and a cylindrical bore having an internal surface with a diameter that is larger than the shaft defined in the spike port, and (iii) further comprises: a resilient cylindrical barrel having an open proximal end, and a partially sealed distal end having an internal cylindrical volume, the resilient cylindrical barrel having an outer diameter configured to be accommodated within the cylindrical bore of the spike port, and a resilient cylindrical insert having an outer cylindrical surface, an open proximal end and a sealed distal end, located in the internal cylindrical volume of the resilient cylindrical barrel, wherein the resilient cylindrical insert is configured to translate distally by the external spike, and wherein the resilient cylindrical insert further defines a distally tapered bore, sized adapted and configured to engage at least a portion of the external spike, wherein (iv) the resilient cylindrical insert is configured to translate distally from a first position wherein the open proximal end of the resilient cylindrical insert is substantially planar with the open proximal end of the resilient cylindrical barrel, to a second position where the sealed proximal end of the resilient cylindrical insert distally traverses through the partially sealed distal end of the resilient cylindrical barrel, (v) and further defines a flange extending radially from the open proximal end of the resilient cylindrical barrel, the flange sized adapted and configured to be accommodated within a radial groove defined in the proximal end of the spike port, (vi) wherein an outer surface of the resilient cylindrical barrel further defines a plurality of axial rails extending radially fromthe outer surface of the resilient cylindrical barrel, the plurality of rails are each sized and configured to be accommodated within a plurality of complementary grooves defined in the internal surface of the cylindrical bore of the spike port, wherein (vii) the partially sealed distal end of the resilient cylindrical barrel defines a coaxial slit, (viii) wherein the outer cylindrical surface of the resilient cylindrical insert is further coated with a friction modifier, configured to reduce friction between the outer surface of the resilient cylindrical insert, and the internal cylindrical volume of the resilient cylindrical barrel, (ix) wherein the mean root square roughness (Ra) of the roughened portion of the spike is at least 50% higher than the smooth portion of the spike, the smooth portion of the spike having roughness of between about 0.025 pm to about 1.0 pm Ra, (x) wherein the body portion further having a male stem port extending laterally therefrom, the male stem port further having an axial lumen spanning the length of the male stem portion, (xi) wherein the spike is further comprising a second lumen, the second lumen of the spike being in fluid communication with a venting aperture, or (xii) the second lumen of the spike being in fluid communication with the axial lumen defined in the male stem port.

[0064] While in the foregoing specification the intravenous (I.V.) bag adapter (IVBA) for a secured closed fluid transfer system component providing a universal spike port with improved force regulation (insertion and extraction) between the adapter and the IV Bag, have been described in relation to certain preferred exemplary implementations, and many details are set forth for purpose of illustration, it will be apparent to those skilled in the art that the disclosure is susceptible to additional exemplary implementations and that certain of the details described in this specification and as are more fully delineated in the following claims can be varied considerably without departing from the basic principles of this disclosure.

Claims

What is Claimed:

1. An intravenous (I.V.) bag adapter (IVBA) for a secured closed fluid transfer system, the IVBA comprising:a) a body portion having a proximal end and a distal end;b) a spike port adapted sized and configured to engage an external spike extending distally from the proximal end of the body portion, the spike port having a shaft spanning the length of the spike port; andc) a spike extending distally from the distal end of the body portion, the spike having a distal end and an outer surface, the spike defining a longitudinal axis and having a first lumen extending axially therethrough, wherein:i. the first lumen is in fluid communication with the shaft defined in the spike port; andii. the outer surface of the spike having a roughened portion extending proximally from the distal end of the spike, and a smooth portion contiguously extending from the roughened portion to the distal end of the body.

2. The IVBA of claim 1, wherein the ratio between the roughened portion of the spike and the smooth portion of the spike is between about 1:1 and about 9:1.

3. The IVBA of claim 1, wherein the spike port defines distally tapered opening and a cylindrical bore having an internal surface with a diameter that is larger than the shaft defined in the spike port.

4. The IVBA of claim 3, wherein the spike port further comprises:a) a resilient cylindrical barrel having an open proximal end, and a partially sealed distal end having an internal cylindrical volume, the resilient cylindrical barrel having an outer diameter configured to be accommodated within the cylindrical bore of the spike port; andb) a resilient cylindrical insert having an outer cylindrical surface, an open proximal end and a sealed distal end, located in the internal cylindrical volume of the resilient cylindrical barrel, wherein the resilient cylindrical insert is configured to translate distally by the external spike, and wherein the resilient cylindrical insert further defines a distally tapered bore, sized adapted and configured to engage at least a portion of the external spike.

5. The TVBA of claim 4, wherein the resilient cylindrical insert is configured to translate distally from a first position wherein the open proximal end of the resilient cylindrical insert is substantially planar with the open proximal end of the resilient cylindrical barrel, to a second position where the sealed proximal end of the resilient cylindrical insert distally traverses through the partially sealed distal end of the resilient cylindrical barrel.

6. The IVBA of claim 4, wherein the resilient cylindrical barrel further defines a flange extending radially from the open proximal end of the resilient cylindrical barrel, the flange sized adapted and configured to be accommodated within a radial groove defined in the proximal end of the spike port.

7. The IVBA of claim 6, wherein an outer surface of the resilient cylindrical barrel further defines a plurality of axial rails extending radially from the outer surface of the resilient cylindrical barrel, the plurality of rails are each sized and configured to be accommodated within a plurality of complementary grooves defined in the internal surface of the cylindrical bore of the spike port.

8. The IVBA of claim 4, wherein the partially sealed distal end of the resilient cylindrical barrel defines a coaxial slit.

9. The IVBA of claim 5, wherein the outer cylindrical surface of the resilient cylindrical insert is further coated with a friction modifier, configured to reduce friction between the outer surface of the resilient cylindrical insert, and the internal cylindrical volume of the resilient cylindrical barrel.

10. The IVBA of claim 2, wherein the mean root square roughness (Ra) of the roughened portion of the spike is at least 50% higher than the smooth portion of the spike, the smooth portion of the spike having roughness of between about 0.025 pm to about 1.0 pm Ra.

11. The IVBA of claim 1, wherein the body portion further having a male stem port extending laterally therefrom, the male stem port further having an axial lumen spanning the length of the male stem portion.

12. The IVBA of claim 1, wherein the spike further comprises a second lumen, the second lumen of the spike being in fluid communication with a venting aperture.

13. The IVBA of claim 11, wherein the spike further comprises a second lumen, the second lumen of the spike is in fluid communication with the axial lumen defined in the male stem port.

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