Liquid transfer device with dual lumen iv spike

Abstract

A liquid delivery device comprises a monolithic three-pronged connector body that defines a barrel at its first end, defines a single intravenous (IV) spike at its second end, and defines a vial adapter lumen at its third end. The IV port is connected to the barrel. The single IV spike has a first IV spike lumen that is fluidly connected to the vial adapter lumen at its proximal end through the three-pronged connector body, and a second IV spike lumen that is fluidly connected to the IV port at its proximal end through the three-pronged connector body, thereby separating the fluid communication between the vial adapter and the single IV spike from the fluid communication between the IV port and the single IV spike.

Description

Technology Field

[0001] Cross-reference regarding related applications

[0002] This application claims the priority and benefit of U.S. Provisional Patent Application No. 62 / 840,620, filed on April 30, 2019, titled “Dual Lumen IV Spike,” the entire contents of which are incorporated herein by reference. Background Technology

[0003] The present invention generally relates to a liquid delivery device.

[0004] Conventional infusion liquid containers that hold the infusion liquid to be delivered to a patient generally take the form of infusion liquid bags or infusion liquid bottles. Pre-filled syringes or vials are typically used to form a diluted, medicated infusion liquid by adding a high concentration of drug to the contents of the infusion liquid via a liquid delivery device. Subsequently, an infusion set containing an intravenous (IV) spike can be inserted into the IV port of the liquid delivery device to administer the contents of the medicated infusion liquid to the patient. Minimizing the risk to the patient receiving a portion of a highly concentrated, undiluted drug is important for patient safety.

[0005] The present invention realizes an advantageous manufacture of a liquid delivery device having separate lumens, namely, a lumen for mixing the high-concentration drug with the infusion liquid and a lumen for delivering the diluted medicinal infusion liquid to the infusion set, as an additional measure to prevent a patient from receiving a portion of the undiluted high-concentration form of the drug. The present invention additionally or alternatively realizes an advantageous manufacture of a liquid delivery device capable of mixing fluids within a lumen between an IV port and a port connected to the medicinal infusion liquid contents before administering the medicinal infusion liquid contents to the patient.

[0006] Briefly, one aspect of the present invention relates to an infusion liquid container having an intravenous (IV) port for receiving and administering an infusion liquid, a vial containing a pharmaceutical additive sealed by a vial stopper, and a liquid delivery device configured for use with each of an infusion set, such as an infusion set, comprising an IV spike and a connector for sealing insertion into the IV port for the purpose of administration to a patient. The liquid delivery device comprises a monolithic trifurcated connector body that defines a barrel at its first end, defines a single IV spike at its second end, and defines a vial adapter lumen at its third end. The IV port is connected to the barrel and configured to sealably receive the IV spike of the infusion set. The vial adapter is configured to be permanently fixed to the vial adapter lumen and to be inserted and mounted onto the vial. The vial adapter includes a vial spike configured to flexibly connect with the vial adapter lumen and to puncture a vial stopper when the vial adapter is mounted on the vial to communicate fluidly with the vial. A single IV spike is configured to be inserted sealably into the IV port of the injection liquid container.A single IV spike has a first IV spike lumen fluidly connected to the vial adapter lumen at its proximal end through a triforked connector body, and a second IV spike lumen fluidly connected to the IV port at its proximal end through a triforked connector body, thereby enabling the initial introduction of a pharmaceutical additive from the vial into an infusion liquid container through the vial adapter and the first IV spike lumen to mix with the infusion liquid to form a medicinal infusion liquid, while separating the fluid communication between the vial adapter and the single IV spike from the fluid communication between the IV port and the single IV spike, and enabling the subsequent administration of the medicinal infusion liquid to a patient from the infusion liquid container to an infusion set through the second IV spike lumen and the IV port. The first IV spike lumen has a first distal opening positioned peripherally, and the second IV spike lumen has a second distal opening positioned peripherally.

[0007] Briefly, another aspect of the present invention relates to a method of using a liquid delivery device having a monolithic three-pronged connector body that defines a barrel at its first end, defines a single intravenous (IV) spike at its second end, and defines a vial adapter lumen at its third end. The method comprises the steps of: mounting a vial adapter, which is permanently fixed to the vial adapter lumen, onto a vial containing a pharmaceutical additive, and then perforating a stopper of the vial using a vial spike of the vial adapter that is flexibly connected to the vial adapter lumen; perforating an IV port of an infusion liquid container containing an infusion liquid using a single IV spike; and adding the pharmaceutical additive in the vial to the infusion liquid in the infusion liquid container (e.g., mixing the pharmaceutical and the infusion liquid) through the first IV spike lumen of the vial adapter lumen and the single IV spike to obtain a medicinal infusion liquid. The first IV spike lumen is fluidly connected to the vial adapter lumen at its proximal end through a three-pronged connector body and has a first distal opening positioned peripherally near the distal end of the single IV spike. The method also includes the step of inserting the IV spike of the infusion set into the IV port of the liquid delivery device, wherein the IV port of the liquid delivery device is fluidly connected to the second IV spike lumen of the single IV spike. The second IV spike lumen is fluidly connected to the IV port at its proximal end and has a second distal opening positioned peripherally near the distal end of the single IV spike, thereby fluidly connecting the infusion set to the infusion liquid container to administer a medicinal infusion liquid to a patient. Brief explanation of the drawing

[0008] The following detailed description of embodiments of the present invention will be better understood when read together with the accompanying drawings. However, it should be understood that the present invention is not limited to the precise arrangements and means depicted. In the drawings, FIG. 1a is a front view of a bag-shaped injection liquid container that can be used with a liquid delivery device according to the present invention. FIG. 1b is a front view of an injection liquid container in the form of a flexible bottle that can be used with a liquid delivery device according to the present invention. FIG. 1c is a front view of a pre-filled needleless syringe and vial that can be used with a liquid delivery device according to the present invention. FIG. 1d is a front view of an injection set that can be used with a liquid delivery device according to the present invention. FIG. 2a is a perspective view of a liquid delivery device according to a first embodiment of the present invention in a compressed plunger configuration. FIG. 2b is a cross-sectional view of the liquid transfer device of FIG. 2a taken along the cross-sectional line 2B-2B of FIG. 2a. Figure 3 is a perspective view of the syringe plunger and IV port of the liquid delivery device of Figure 2a. FIG. 4a is a perspective view of a liquid delivery device according to the present invention in a drawn-out plunger configuration. FIG. 4b is a cross-sectional view of the liquid transfer device of FIG. 4a taken along the cross-sectional line 4B-4B of FIG. 4a. FIG. 5 is a cross-sectional view of another embodiment of a liquid delivery device having an alternatively configured IV spike. FIG. 6 is a cross-sectional view of the liquid delivery device of FIG. 2a taken along cross-sectional line 2B-2B of FIG. 2a, having another IV spike configured alternatively. FIG. 7a is an enlarged cross-sectional view of one configuration of the vial adapter of the liquid delivery device of FIG. 2a. FIG. 7b is an enlarged cross-sectional view of a different configuration of the vial adapter of the liquid delivery device of FIG. 2a. FIG. 8 is a perspective view of a liquid delivery device according to a second embodiment of the present invention. FIG. 9 is a cross-sectional view of the liquid transfer device of FIG. 8 taken along the cross-sectional line 9-9 of FIG. 8. FIG. 10 is an enlarged partial exploded perspective view of an alternative attachment between a three-branched connector body and an elongated connecting member, such as an IV port, of the liquid delivery device of FIG. 8. FIGS. 11a and FIGS. 11b are cross-sectional views of another embodiment of the liquid transfer device of FIG. 6 having an internal valve. Specific details for implementing the invention

[0009] For convenience only, certain terms are used in the following description and are not limiting. The words "lower," "bottom," "top," and "top" designate directions in the referenced drawings. The words "inward," "outward," "upward," and "downward" respectively designate directions toward the geometric center of the liquid delivery device and a designated part thereof, and directions away from it. Unless specifically stated herein, singular terms (“a,” “an,” and “the”) are not limited to a single element and should instead be read as meaning “at least one.” Terms include the words mentioned above, their derivatives, and words of similar meaning.

[0010] Furthermore, it should be understood that when referring to the dimensions or characteristics of the components of the present invention, terms used herein such as “about,” “approximately,” “generally,” “substantially,” and similar terms indicate that the described dimensions / characteristics are not strict boundaries or parameters and do not exclude small variations therefrom that are functionally similar. At a minimum, such references involving numerical parameters will include variations that do not alter the least significant figure by using mathematical and industrial principles accepted in the art (e.g., rounding, measurement or other systematic errors, manufacturing tolerances, etc.).

[0011] Referring in detail to drawings in which similar reference numerals indicate similar elements throughout, FIGS. 2a through 6 illustrate a liquid delivery device (30) according to a first embodiment of the present invention intended for use with a combination of an infusion liquid container that accommodates an infusion liquid and an additive delivery device. In the illustrated embodiment, the liquid delivery device (30) is intended for use with an infusion liquid container in the form of an infusion liquid bag (10) (Fig. 1a). As should be understood by those skilled in the art, a conventional infusion liquid bag (10) includes a reservoir (12) that accommodates an infusion liquid, which is in fluid communication with an intravenous administration port (14) and an additive port (16). The infusion liquid bag (10) can be folded when administering the infusion liquid therefrom. The liquid delivery device (30) may also be used with an infusion liquid container in the form of a flexible infusion liquid bottle (18) (Fig. 1b), etc. The liquid delivery device (30) of the illustrated embodiment is also intended to be used with an additive delivery device in the form of a sealed vial (20) (Fig. 1c). The vial (20) generally contains a highly concentrated liquid pharmaceutical additive or a lyophilized powder pharmaceutical that requires reconstitution before administration to a patient, that is, mixing with the infusion liquid in the bag (10) to form the medicinal infusion liquid to be administered to the patient. Thus, the contents of the vial (20) are introduced into the infusion liquid bag (10) through the liquid delivery device (30) (as described in more detail below). However, the liquid delivery device (30) may also take a different configuration intended to be used with a syringe (22) (Fig. 1c) that contains the liquid pharmaceutical additive.

[0012] The liquid delivery device (30) comprises a three-pronged connector body (32). In the exemplary embodiments of FIGS. 2a through 6, the three-pronged connector body (32) is a monolithic body that defines a barrel (34) at its first end, a single IV spike (36) at its second end, and a vial adapter (38) at its third end, but the invention is not so limited (as further described below). As best illustrated in FIGS. 2b, FIGS. 4b and FIGS. 5, the barrel (34) defines an inner chamber (34a) having an open proximal end (34b) for slidingly receiving a plunger (40) (as further described below). The IV spike (36) defining the second end of the three-branched body (32) enables the use of the liquid delivery device (30) with the injection liquid bag (10), that is, to seal the insertion of the IV spike (36) into the administration port (14) of the bag (10). The IV spike (36) may be constructed from a suitable rigid metal, such as a polymer or plastic material such as polycarbonate. A flange (33) extends laterally from the IV spike (36) near its proximal end to provide a gripping or supporting surface that allows the user to more easily insert the IV spike (36) into a liquid container such as the bag (10). The IV spike may optionally include a feature such as a raised step (35) around the circumferential surface of the IV spike (36) to limit the insertion depth into the administration port (14) of the bag (10). In one embodiment, the flange (33) may also be formed as an injection-molded monolithic structure having a connector body (32), but the invention is not so limited. A spike cap (not shown) may be removablely covered by the IV spike (36) when not in use.

[0013] As illustrated, the IV spike (36) is co-directional and / or coaxial with the barrel (34) and includes two internal lumens (36a, 36b). In the illustrated configuration, the lumens (36a, 36b) extend generally parallel to each other. The first IV spike lumen (36a) is fluidly connected at the proximal end to only the vial adapter lumen (37), which is located within the vial adapter (38) that branches diagonally from the IV spike (36). The first IV spike lumen (36a) includes a first distal opening (36c) positioned peripherally. As best illustrated in FIGS. 2b, 4b, and 5, the first IV spike lumen (36a) is not fluidly connected to the barrel chamber (34a) at its proximal end. The second IV spike lumen (36b) is only directly fluidly connected to the barrel chamber (34a) at the proximal end and includes a second distal opening (36d) positioned peripherally, which is distinct from the first distal opening (36c) of the first IV spike lumen (36a). The second IV spike lumen (36b) is not fluidly connected to the vial adapter lumen (37) at its proximal end or at any point along the length of the IV spike (36). In other words, the IV spike (36) includes two separate lumens (36a, 36b) extending through the IV spike (36) to provide separate fluid paths that are not connected within the IV spike (36). Thus, the fluid communication between the vial adapter (38) and the IV spike (36) is separated from the fluid communication between the barrel chamber (34a) and the IV spike (36).

[0014] The vial adapter (38) is configured to be mounted on the vial (20) to enable the use of the device (30) in conjunction with an additive delivery device in the form of a vial (20). In one configuration, the vial adapter (38) may be formed integrally with the third end of the connector body (32), that is, formed monolithically with the end end of the vial adapter lumen (37), or otherwise permanently fixed and sealed to the end end of the vial adapter lumen (37), but the invention is not so limited. As used herein throughout the specification and claims, "permanently fixed" means that it is not detachable / removable without causing damage to the device or any part thereof. As a non-limiting example, the vial adapter (38) may be ultrasonically welded to the vial adapter lumen (37).

[0015] Referring to FIG. 7a, the vial adapter (38) comprises an upper wall (38d), a flexible and / or flared skirt (38a) suspended therefrom for insertable snap-fit ​​mounting onto the vial (20) (in a standard manner), and a vial spike (38b) for perforating the vial (20), for example through its stopper, to fluidly communicate with the interior of the vial (20). The perforating vial spike (38b) comprises a lumen (38c) that fluidly communicates with the vial adapter lumen (37) and subsequently with the first IV spike lumen (36a). As should be understood by those skilled in the art, the inner diameter of the vial spike (38b), i.e. the diameter of the lumen (38c), and / or the outer diameter of the vial spike (38b) may have dimensions suitable for the intended use.

[0016] In the configuration of FIG. 7a, the vial spike (38b) includes a base section (39) that is generally concave with respect to the axis of the vial spike (38b). Alternatively, the vial adapter (38) may be configured to minimize / prevent leakage generated from a rupture formed within the stopper of the vial (20) as the vial adapter (38) is pressed downward onto the vial (20) and the vial spike (38b) advances through the stopper. As illustrated in the configuration of FIG. 7b, the extension direction of the base section (39') is generally convex with respect to the axis of the vial spike (38b), so that the base section (39') has a generally bulbous configuration. When the vial adapter (38) is pressed downward onto the vial (20) and the spike (38b) advances through the vial stopper, the base section (39') is compressed against the upper surface of the vial stopper, and the compressed material of the vial stopper surrounds the rupture formed within the vial stopper for its seal. The puncture of the vial stopper by the vial spike (38b) generally entails the formation of a depression within the upper surface of the vial stopper. The convex base section (39') is configured to fill the depression, thereby minimizing / preventing leakage. However, as should be understood by those skilled in the art, different sealing base sections / means, currently known or to be known later, may be employed to minimize leakage between the vial spike (38b) and the elastic stopper of the vial (20). Also, as should be understood, other vial adapter configurations, currently known or to be known later, may be alternatively employed.

[0017] Returning to the plunger (40), as best illustrated in FIGS. 2b, FIGS. 3, FIGS. 4b and FIGS. 5, the plunger (40) comprises an upright plunger tube (46) that encloses the plunger tube lumen (46a) internally. The plunger tube (46) is slidably engaged with the barrel (34) through a peripheral sealing member (42) interposed therein (e.g., made of an elastomer material, etc.) in a manner well understood by those skilled in the art, thereby allowing it to slide within the barrel (34) while creating a substantially hermetic seal between the plunger tube (46) and the inner side wall of the barrel (34). The plunger tube (46) and the sealing member (42), in combination with the barrel (34), define the sealed proximal end of the barrel chamber (34a). The plunger tube (46) includes a distal elongated neck portion (44) that terminates at the check valve (48). In the illustrated embodiment, the check valve (48) takes the form of a duckbill valve made of an elastomer material, but the invention is not so limited. For example, without limitation, the check valve (48) may take the form of several other types of one-way valves, such as a ball valve, silicone flapper valve, diaphragm-type valve, inline valve, stop-check valve, lift-check valve, etc., which can perform the function of the check valve (48) described herein.

[0018] As illustrated, the IV port (50) is flexibly connected to the proximal end of the plunger tube (46). The IV port (50) comprises a twist-off member (50a) located near the free proximal end of the periphery of the port (50), and an elongated connecting member (52) protruding distally from it, through which an inner lumen (52a) extends and terminates at an open end (the end opposite the twist-off member (50a)). The inner lumen (52a) of the IV port (50) extends co-directed and / or coaxially with the plunger lumen (46a). In one embodiment, the IV port (50) may be constructed of a suitable flexible polymer or plastic material, such as PVC, for example. In the illustrated embodiment, the elongated connecting member (52) is bonded to the plunger tube (46) by adhesive, i.e., adhesive, but the invention is not so limited. For example, without limitation, the slender connecting member (52) can be permanently fixed to and rotatably fixed to the plunger tube (46) (for example, as described in more detail below with respect to FIGS. 8 to 10).

[0019] The IV port (50) includes a septum (50b) positioned within an elongated connecting member (52) and sealing across an internal lumen (52a). Thus, the twist-off member (50a) can be removed without leading to a flow connection beyond the septum (50b). A flow connection beyond the septum (50b), i.e., the plunger lumen (46a) and beyond it, is achieved only when the septum (50b) is perforated (as described in more detail below). The twist-off member (50a) remains sterile until the IV port (50), and in particular the septum (50b), is used.

[0020] When in use, the liquid delivery device (30) can be coupled to the injection liquid bag (10) via the IV spike (36) (as previously described). Then, the user withdraws the plunger (40) in a proximal direction, that is, away from the IV spike (36) (Figs. 4a and 4b). Alternatively, a dedicated handle may be employed and attached to the plunger (40) for its translational movement. Withdrawal of the plunger (40) draws fluid from the bag (10), through the distal opening (36d), through the second IV spike lumen (36b), and into the barrel chamber (34a), with the distal opening (36d) immersed in the injection liquid within the bag (10). A duckbill valve (48) is configured to prevent fluid flow into the plunger tube lumen (46a) during withdrawal of the plunger (40). As should be understood by those skilled in the art, the withdrawal of the plunger (40) creates a vacuum within the barrel chamber (34a), causing a pressure difference with respect to the injection liquid bag (10), thereby drawing the fluid into the barrel chamber (34a). Also as should be understood, the injection liquid remains in the barrel chamber (34a) and the second IV spike lumen (36b) until it is manually discharged in a manner well understood by those skilled in the art, as described below.

[0021] Before or subsequently, the liquid delivery device (30) may be coupled to the vial (20) via the vial adapter (38) (as previously described). The user may mix / combine the contents of the vial (20) with the contents of the infusion liquid bag (10) through the vial adapter lumen (37) and the first IV spike lumen (36a) by inverting the infusion liquid bag (10) and the device (30) so that the contents of the vial (20) are discharged into the infusion liquid bag (10), i.e., by positioning the vial (20) over the bag (10). If the vial (20) contains a lyophilized powdered drug, the drug may be reconstituted in a similar manner. After the vial (20) is coupled to the liquid delivery device (30), the liquid bag (10) is held over the vial (20) so that the liquid from the liquid bag (10) is discharged into the vial (20) and the contents of the vial (20) are reconstituted. Subsequently, as previously described, the injection liquid bag (10) and the device (30) can be inverted to discharge the reconstituted contents of the vial (20) into the bag (10).

[0022] After mixing / combining the contents of the injection liquid bag (10) and the vial (20) and orienting the liquid delivery device (30) so that the combined liquid flows into the injection liquid bag (10), the plunger (40) is pressed until at least a portion of the duckbill valve (48) engages with the proximal end / rim of the second IV spike lumen (36b). In the illustrated embodiment, at least one of the elastomeric lip / flap of the duckbill valve (48) comes into contact with the proximal end (41) of the second IV spike lumen (36b) and is displaced / compressed by it, thereby opening the duckbill valve (48) to allow fluid flow through it. That is, continuous pressure applied to at least one of the elastomeric lip / flap of the duckbill valve (48), caused by the plunger (40) being pressed to a position where the valve (48) engages with the proximal end / rim (41) of the second IV spike lumen (36b), displaces the elastomeric lip / flap of the valve (48) relative to one another, thereby destroying the seal between them and allowing fluid flow through it. Then, the twist-off member (50a) is removed (in a well-understood manner) to provide access to the inner lumen (52a). The IV port spike (96) of the infusion set (95) (Fig. 1d) is sealedly inserted into the inner lumen (52a) and completely penetrates the diaphragm (50b), thereby fluidly connecting the IV port spike (96) to any remaining portion of the inner lumen (52a) beyond the diaphragm (50b), and then fluidly connecting to the plunger lumen (46a) and the second IV spike lumen (36b) (via the open duckbill valve (48)) to administer a medicinal infusion liquid to the patient. The IV port spike (96) typically extends from the end of the drip chamber (97a) of the infusion set (95).Typically, the infusion set (95) additionally includes a roller clamp (97c) for controlling fluid administration to a patient, a male Luer connector (97d), and tubing (97b) for fluidly connecting the roller clamp (97c) to the drip chamber (97a).

[0023] Advantageously, the medicinal infusion liquid is fluidly connected to the infusion set (95) through the second IV spike lumen (36b) rather than the first IV spike lumen (36a), which is used only to mix the highly concentrated medicinal additive in the vial (20) with the infusion liquid in the bag (10). Thus, the possibility of administering a portion of the undiluted, high-concentration form of the medicinal additive to the patient is minimized. Furthermore, as the plunger (40) is pressed (as previously described), the infusion liquid in the barrel chamber (34a) is discharged through the second IV spike lumen (36b) and out of the distal opening (36d). Accordingly, after mixing the contents of the infusion liquid bag (10) and vial (20) using the liquid delivery device (30), the second IV spike lumen (36b) and its distal opening (36d) are not used for mixing, but nevertheless are flushed out before use to deliver the medicinal infusion liquid from the bag (10) to the infusion set (95), thereby further minimizing the possibility of administering a portion of the undiluted, high-concentration form of the pharmaceutical additive to the patient.

[0024] In an alternative configuration, as illustrated in FIG. 5, the distal end of the IV spike (36') is configured such that the first IV spike lumen (36a′) extends further distally than the second IV spike lumen (36b'). Thus, advantageously, the first distal opening (36c') is separated by a distance "d" from the distal opening (36d'), thereby further minimizing the opportunity for a portion of the undiluted, high-concentration form of the drug to exit the first distal opening (36c') and enter the distal opening (36d'). The distance "d" is preferably at least about 1.0 mm, more preferably at least about 2.5 mm, and most preferably at least about 4.0 mm.

[0025] In another alternative configuration, as illustrated in FIG. 6, the IV spike (36") may comprise a single lumen (36a") having a single distal opening (36c"). This configuration operates in a manner similar to that of the configurations illustrated in FIG. 2 through 4b, except that the fluid is drawn / released from or into the barrel chamber (34a) and the agent is mixed with the fluid is partially carried out through a common portion of the single lumen (36a"). As previously described, flushing of the lumen (36a") is performed between the step of mixing / combining the contents of the infusion liquid bag (10) and the vial (20) and the step of removing the twist-off member (50a) for connection of the infusion set (95).

[0026] In the preferred embodiment illustrated in FIG. 11a and FIG. 11b, a flow control valve (43) may be included within the device, and thus, rotation of the flow control valve (43) allows the user to selectively fluidly connect either the vial adapter lumen (37) or the barrel chamber (34a) with the single lumen (36a"). The valve (43) can prevent any highly concentrated pharmaceutical additive in the vial (20) from being aspirated into the barrel chamber (34a) when the plunger tube (46) is withdrawn, as illustrated in FIG. 11a. Before mixing the contents of the vial (20) into the bag (10), as illustrated in FIG. 11b, the valve (43) may be rotated to seal the barrel chamber (34a) as well as provide a fluid connection between the vial adapter lumen (37) and the single lumen (36a"). To flush the volume of liquid within a single lumen (36a "), the valve (43) can be rotated back to its original position in FIG. 11a before pressing the plunger tube (46).

[0027] In another alternative embodiment, the vial adapter (38) may be detachable. For example, the device may be provided with a valve such as the needleless additive control valve disclosed in U.S. Patent No. 8,551,067, the contents of which are incorporated herein by reference. The valve will cause the vial adapter (38) to be detachable before the plunger tube (46) is withdrawn. Subsequently, the vial adapter (38) and the vial (20) are connected through the valve to empty the highly concentrated contents of the vial (20) into the bag (20), followed by the compression of the plunger tube (46) to flush a single lumen (36a).

[0028] FIGS. 8 through 10 illustrate a second embodiment of a liquid delivery device (130). The reference numerals of the second embodiment may be distinguished from those of the first embodiment configuration (Figs. 2a through 7b) described above by a factor of one hundred (100), but represent the same elements as those shown above differently, except as otherwise specified. The liquid delivery device (130) of this embodiment is similar to that of the first embodiment configuration. Accordingly, descriptions of certain similarities and modes of operation between embodiments may be omitted from this specification for brevity and convenience and are therefore not limited.

[0029] One difference between the liquid delivery device (30) and the liquid delivery device (130) relates to the configuration of the first end of the connector body (132). As shown in FIGS. 8 and 9, the plunger (40) is removed and the IV port (150) is directly and permanently fixed and sealed to the barrel (134), that is, it cannot be disconnected / removed without causing damage to at least one of the IV port (150) or the barrel (134) or otherwise the device (130). Thus, the second IV spike lumen (136b) of the single IV spike (136) remains in direct and continuous fluid communication with only the inner lumen (152a) of the elongated connecting member (152) of the IV port (150) at the proximal end, while remaining unfluidly connected to the vial adapter lumen (137) at its proximal end. The first IV spike lumen (136a) of the single IV spike (136) is also maintained in a state of continuous and direct fluid connection with only the vial adapter lumen (137) at the proximal end, and is not fluidly connected with the inner lumen (152a) of the elongated connecting member (152) at its proximal end.

[0030] In the exemplary embodiments of FIGS. 8 and 9, the elongated connecting member (152) is bonded to the barrel (134) by adhesive, i.e., adhesive. As previously mentioned, the elongated connecting member (152) may be attached to the barrel (134) in a permanently fixed state. For example, as shown in FIG. 10, the barrel (134) may be terminated at a barbed fitting member (154) having an open end (154a). The barbed fitting member (154) may be configured in relation to the inner diameter and material of the elongated connecting member (152), i.e., size, dimensions, and material, so as to advance into the inner lumen (152a) and form a barbed, frictional, i.e., interference fit between them. As should be understood by those skilled in the art, the orientation of the barb-shaped fitting member (154) causes it to advance into the inner lumen (152a) so that the IV port (150) is sealed and securely mounted in a co-direction on the barrel (134) of the connector body (132), and also substantially prevents the barb-shaped fitting member (154) from being pulled out without damaging at least one of the elongated connecting member (152) and the barb-shaped fitting member (154).

[0031] As described, the barb-shaped fitting member (154) is shaped into a truncated cone having a diameter that gradually increases in the direction away from the open end (154a). The opposite end of the barb-shaped fitting member (154) defines a larger diameter from the lower part of the barrel (134), consequently creating an annular rib (156) that provides an interference fit with the inner side wall of the elongated connecting member (152) when attempting to pull the barb-shaped fitting member (154) out of the elongated connecting member (152). Thus, the barb-shaped fitting member (154) can advance into the inner lumen (152a) of the elongated connecting member (152) during assembly, and then cannot be easily pulled out without causing damage.

[0032] Additionally, the rim of the elongated connecting member (152) defining the open end (152b) of the elongated connecting member (152) includes at least one cutout (158a), and the barrel (134) includes at least one corresponding radial tab (158b) that protrudes from the barrel (134) and is configured to align with at least one cutout (158a). In the illustrated embodiment, the elongated connecting member (152) includes a plurality of cutouts (158a) spaced apart in each direction, and the barrel (134) includes a plurality of tabs (158b) spaced apart in each direction. The tab(s) (158b) align with the cutout(s) (158a) while the IV port (150) is mounted on the barb-shaped fitting member (154) of the barrel (134), thereby rotatably securing the IV port (150) to the remainder of the liquid delivery device (130). The tab(s) (158b) also prevent relative rotation between the barrel (134) and the elongated connecting member (152), and allow the twist-off member (150a) to be removed before connection to the injection set (95), as described below.

[0033] When in use, the liquid delivery device (130) can be coupled to the vial (20) via the vial adapter (138), and the user can mix / combine the contents of the vial (20) with the contents of the injection liquid bag (10) via the vial adapter lumen (137) and the first IV spike lumen (136a). After mixing / combining the contents of the infusion liquid bag (10) and vial (20) and orienting the liquid delivery device (130) so that the combined liquid flows into the infusion liquid bag (10), the twist-off member (150a) is removed (in a well-understood manner) to provide access to the inner lumen (152a), and the IV port spike (96) (Fig. 1d) of the infusion set (95) is sealedly inserted into the inner lumen (152a) and completely penetrates the diaphragm (150b), thereby fluidly connecting the IV port spike (96) to any remaining portion of the inner lumen (152a) beyond the diaphragm (150b), and then fluidly connecting it to the second IV spike lumen (136b) to administer the medicinal infusion liquid to the patient.

[0034] It will be understood by those skilled in the art that modifications to the embodiments described above may be made without departing from the broad inventive concept of the invention. For example, instead of a vial adapter, the three-pronged connector body (32, 134) may include a normally closed (NC) needleless additive port (not shown) at its third end (allowing for the choice of use with a syringe (22) or a vial (20)). As another example, the vial adapter (38, 138) may be replaced with a manually operated stop cock, etc. As yet another example, the liquid delivery device (30) may include a locking mechanism for stabilizing and / or locking the plunger (40) at its different positions. Accordingly, it is understood that the invention is not limited to the specific embodiments disclosed, but is intended to cover variations within the spirit and scope of the invention as described in the appended claims.

Claims

Claim 1 A vial adapter configured to receive a vial and including a vial spike—the vial spike being configured to puncture the vial stopper of the vial and defining the vial spike lumen—; an intravenous (IV) port configured to receive a port spike of an infusion set; A liquid delivery device comprising a connector body, wherein the connector body comprises a vial adapter lumen that is fluidly in communication with the vial spike lumen - the vial adapter being permanently fixed to the vial adapter lumen - a barrel connected to the IV port, and an IV spike comprising a central wall, wherein the IV spike comprises a first IV spike lumen that is fluidly in communication with the vial adapter lumen and has a distal opposing opening and a second IV spike lumen that is fluidly in communication with the IV port and has a lateral opposing opening, wherein the first IV spike lumen and the second IV spike lumen are separated by the central wall, and the central wall has a transverse protrusion forming the distal surface of the second IV spike lumen. Claim 2 A liquid delivery device according to claim 1, wherein the distal opposing opening is aligned with the longitudinal axis of the first IV spike lumen. Claim 3 A liquid delivery device according to claim 1 or 2, wherein the IV spike has a tapered distal tip, and the distal opposing opening extends through the tapered distal tip. Claim 4 A liquid delivery device according to claim 1 or 2, wherein the lateral opposing opening is positioned next to the longitudinal axis of the second IV spike lumen. Claim 5 A liquid delivery device according to claim 1 or 2, wherein the lateral opposing opening is defined between the distal surface formed by the transverse protrusion and the proximal surface on the outer wall of the IV spike, and the proximal surface is inclined with respect to the distal surface. Claim 6 A liquid delivery device according to claim 1 or 2, wherein the vial adapter comprises a skirt configured to receive the vial in a tucked-in manner, and the skirt comprises at least two inward protrusions for snap-fitting under the flange of the vial. Claim 7 A liquid delivery device according to claim 1 or 2, wherein the IV port comprises: a connecting member comprising an internal lumen and a diaphragm configured to be perforated by the port spike of the injection set; and a twist-off member attached to the connecting member in a ruptureable manner and configured to be removed from the connecting member to allow access to the diaphragm to be perforated by the port spike of the injection set. Claim 8 A liquid delivery device according to claim 1 or 2, wherein the barrel is aligned with the longitudinal axis of the IV spike and the vial adapter lumen is positioned at an angle with respect to the longitudinal axis of the IV spike. Claim 9 A liquid delivery device according to claim 1 or 2, wherein the connector body has a flange extending laterally for gripping. Claim 10 In claim 9, the liquid transfer device, wherein the flange extends laterally along the longitudinal axis of the barrel. Claim 11 A vial adapter configured to receive a vial and including a vial spike—the vial spike being configured to puncture the vial stopper of the vial and defining the vial spike lumen—; an IV port configured to receive a port spike of an infusion set; A liquid delivery device comprising a connector body, wherein the connector body comprises a vial adapter lumen flexibly communicating with the vial spike lumen - the vial adapter is permanently fixed to the vial adapter lumen - a barrel connected to the IV port, and an IV spike comprising a central wall, wherein the IV spike comprises a first IV spike lumen flexibly communicating with the vial adapter lumen - the first IV spike lumen comprises a first opening aligned with the longitudinal axis of the first IV spike lumen - and a second IV spike lumen flexibly communicating with the IV port - the second IV spike lumen comprises a second opening adjacent to the longitudinal axis of the second IV spike lumen - and wherein the first IV spike lumen and the second IV spike lumen are separated by the central wall, and the central wall has a transverse protrusion forming the distal surface of the second IV spike lumen. Claim 12 A liquid delivery device according to claim 11, wherein the first opening is distal-opposite and the second opening is lateral-opposite. Claim 13 A liquid delivery device according to claim 11 or 12, wherein the IV spike has a tapered distal tip and the second opening extends through the tapered distal tip. Claim 14 A liquid delivery device according to claim 11 or 12, wherein the vial adapter comprises a skirt configured to receive the vial in a tucked-in manner, and the skirt comprises at least two inward protrusions for snap-fitting under the flange of the vial. Claim 15 A liquid delivery device according to claim 11 or 12, wherein the IV port comprises: a connecting member comprising an internal lumen and a diaphragm configured to be perforated by the port spike of the injection set; and a twist-off member attached to the connecting member in a ruptureable manner and configured to be removed from the connecting member to allow access to the diaphragm to be perforated by the port spike of the injection set. Claim 16 A liquid delivery device according to claim 11 or 12, wherein the barrel is aligned with the longitudinal axis of the IV spike and the vial adapter lumen is positioned at an angle with respect to the longitudinal axis of the IV spike. Claim 17 A liquid delivery device according to claim 11 or 12, wherein the connector body has a flange at the proximal end of the IV spike. Claim 18 A liquid delivery device comprising: a vial adapter configured to receive a vial and including a vial spike, wherein the vial spike is configured to puncture a vial stopper of the vial and defines a vial spike lumen; an IV port configured to receive a port spike of an infusion set; and a connector body, wherein the connector body includes a vial adapter lumen that is fluidly in communication with the vial spike lumen, wherein the vial adapter is permanently fixed to the vial adapter lumen, a barrel connected to the IV port, and an IV spike including a central wall, wherein the IV spike defines a first IV spike lumen that is linear and fluidly in communication with the vial adapter lumen and a second IV spike lumen that is L-shaped and fluidly in communication with the IV port, wherein the first IV spike lumen and the second IV spike lumen are separated by the central wall, and the central wall has a transverse protrusion forming a distal surface of the second IV spike lumen. Claim 19 A liquid delivery device according to claim 18, wherein the first IV spike lumen comprises a distal opposing opening aligned with the longitudinal axis of the first IV spike lumen. Claim 20 A liquid delivery device according to claim 18 or 19, wherein the second IV spike lumen comprises a lateral opposing opening located adjacent to the longitudinal axis of the second IV spike lumen. Claim 21 A liquid delivery device according to claim 18 or 19, wherein the vial adapter comprises a skirt configured to receive the vial in a tucked-in manner, and the skirt comprises at least two inward protrusions for snap-fitting under the flange of the vial. Claim 22 A liquid delivery device according to claim 18 or 19, wherein the IV port comprises: a connecting member comprising an internal lumen and a diaphragm configured to be perforated by the port spike of the injection set; and a twist-off member attached to the connecting member in a ruptureable manner and configured to be removed from the connecting member to allow access to the diaphragm to be perforated by the port spike of the injection set. Claim 23 A liquid delivery device according to claim 18 or 19, wherein the barrel is aligned with the longitudinal axis of the IV spike and the vial adapter lumen is positioned at an angle with respect to the longitudinal axis of the IV spike. Claim 24 A liquid delivery device according to claim 18 or 19, wherein the connector body has a flange at the proximal end of the IV spike. Claim 25 A receptacle comprising a skirt and a vial spike configured to engage with a medicinal vial—the vial spike being configured to penetrate a stopper on the medicinal vial—; an IV connector configured for inline connection with a patient IV line; A medicinal vial reconstitution and administration device comprising: a branch body extending from the IV connector and having an IV bag spike with a tapered end; wherein the branch body surrounds a first channel and a second channel, and the receptacle is permanently fixed to the branch body; wherein the first channel is configured for fluid communication from the receptacle to the IV bag through a first orifice of the IV bag spike, and the second channel is configured for delivering liquid from the IV bag to the IV connector through a second orifice on the IV bag spike, and wherein the first orifice and the second orifice each define a fluid connection to the receptacle and the patient IV line, and the central wall between the first channel and the second channel has a transverse protrusion forming the distal surface of the second channel. Claim 26 In paragraph 25, the first orifice extends through the tapered end, and the second orifice is located on the side of the IV back spike, a medicinal vial reconstitution and administration device. Claim 27 A medicinal vial reconstitution and administration device according to claim 25 or 26, wherein the first orifice is aligned with the longitudinal axis of the first channel, the second orifice is aligned with the longitudinal axis of the second channel, and the first orifice is spaced distally from the second orifice. Claim 28 A medicinal vial reconstitution and administration device according to claim 25 or 26, wherein the first orifice is aligned with the longitudinal axis of the first channel and the second orifice is positioned adjacent to the longitudinal axis of the second channel. Claim 29 A medicinal vial reconstitution and administration device according to claim 25 or 26, wherein the IV connector comprises: a connecting member comprising an inner lumen and a diaphragm configured to be perforated by a port spike of the patient IV line; and a twist-off member attached to the connecting member in a ruptureable manner and configured to be removed from the connecting member so as to allow access to the diaphragm to be perforated by the port spike of the patient IV line. Claim 30 A medicinal vial reconstitution and administration device according to claim 25 or 26, wherein the branch body has a flange at the proximal end of the IV back spike.

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