Systems and methods for administering pharmaceutical compositions using intravenous tubing sets

Abstract

An intravenous tubing set for use in a system and method for administering a pharmaceutical composition includes a first spike for a pharmaceutical composition on a first line and a second spike for a solution on a second line, the first spike optionally mounted via a coupler. The first line and the second line are in fluid communication with a dual port chamber, which is in fluid communication with the coupler, which is capable of engaging an apparatus attached to a patient at an intravenous site. Where the pharmaceutical composition is a dose divided into multiple portions in multiple infusion vials, the first spike can be a vent spike that is reusable and insertable into each stopper of the multiple vials. The pharmaceutical composition can be administered via the intravenous tubing set using gravity infusion without leakage caused by the vent spike displacing the stopper of the infusion vials.

Description

[0001] Cross-references to related applications This application claims priority to U.S. Provisional Application Serial No. 63 / 558,017, filed February 26, 2024, pursuant to 35 USC §119(e). The entire disclosure of U.S. Provisional Application Serial No. 63 / 558,017 is incorporated herein by reference in its entirety. Technical Field

[0002] This disclosure relates to the administration of pharmaceutical compositions, and more particularly to a system and method for administering pharmaceutical compositions using an intravenous tubing assembly. Background Technology

[0003] The background description includes information that may help in understanding the subject matter of this disclosure. This does not mean that any information provided herein is prior art or related to the content of this disclosure.

[0004] The pharmaceutical composition can be stored in a container, such as an intravenous bag or infusion vial. One method of administering the pharmaceutical composition involves using gravity infusion, wherein the container is suspended above the intravenous injection site, and gravity causes the pharmaceutical composition to flow through the intravenous tubing assembly to the intravenous injection site. The dosage of the pharmaceutical composition can be administered as a single amount or multiple amounts. For example, depending on the volume of the container storing the pharmaceutical composition, the dosage of the pharmaceutical composition can be divided into multiple amounts stored in different containers.

[0005] In one example, a pharmaceutical composition containing at least one pharmaceutical substance may be stored in an infusion vial with a stopper. Engaging the stopper of the infusion vial with a needle in an intravenous tubing assembly can cause the stopper to shift. For example, while attempting to insert the needle into the stopper, the stopper may be pushed into the infusion vial. This can cause leakage of the infusion vial, especially when it is suspended upside down for gravity infusion (i.e., the stopper is facing down towards the ground). Additionally, this can cause the air filter within the needle to become wet or clogged, potentially preventing sufficient flow of the drug composition from the infusion vial to the injection site via gravity infusion. Where the dosage of the pharmaceutical composition is divided into multiple amounts in different containers, a wet or clogged air filter within the needle may necessitate the interchange of multiple needles between infusion vials containing the stored dosage in order to continue administering the pharmaceutical composition. Summary of the Invention

[0006] Therefore, there is a need for an improved intravenous tubing assembly that allows for the administration of a pharmaceutical composition via gravity infusion. The intravenous tubing assembly should be configured to administer a pharmaceutical composition in a single volume stored in a single container and in multiple volumes divided into different containers. In some embodiments, the intravenous tubing assembly should include a needle capable of being inserted into the stopper of an infusion vial (or, sequentially, multiple infusion vials during administration) without dislodging the stopper, thereby reducing the likelihood of vial leakage and / or the possibility of the air filter within the needle becoming wet or clogged, thus reducing the need to interchange multiple venting needles within the intravenous tubing assembly.

[0007] Embodiments of this disclosure relate to an intravenous catheter assembly having a first needle and a second needle. The first needle is insertable into a stopper of one or more infusion vials containing a pharmaceutical composition. The second needle is insertable into a container (i.e., an intravenous bag) containing another pharmaceutical composition. The first and second needles are located on respective lines in fluid communication with a two-port chamber. The two-port chamber is further in fluid communication with the patient at the site of intravenous injection. In some cases, the second needle on the second line includes a solution perfusing or flushing the two-port chamber prior to administration of the pharmaceutical composition via the first needle on the first line. In other cases, the second needle on the second line includes a solution configured to mix with the pharmaceutical composition provided by the first needle on the first line within the two-port chamber. In some embodiments, the first needle is a venting needle, including in cases where the container is a rigid infusion vial, to allow air to flow into the container as the stored pharmaceutical composition flows out and to maintain ambient pressure within the infusion vial. In these embodiments, the second needle is a non-venting needle.

[0008] Embodiments of this disclosure relate to a tube extending from a two-port chamber and in fluid communication with a connector capable of engaging a device attached to a patient at an intravenous injection site. The tube can be divided into multiple segments via a connector. In some cases, the connector is a branch connector, wherein the two-port chamber is in fluid communication with a first branch at a first end, and the connector is in fluid communication with a second end. A second branch at the first end (or along the length of the branch connector) can provide access to the tube (i.e., for communication with a needle-free injector via the second branch at the first end). Alternatively, the tube can be a continuous tubing. In some embodiments, the connector includes a coupling mechanism capable of engaging a device at an intravenous injection site, wherein the coupling mechanism includes, but is not limited to, a spinlock or Luer lock fitting.

[0009] Embodiments of this disclosure relate to clamps along the length of an intravenous tubing assembly on one or more sections of the tubing. The clamps may be sliding clamps or roller clamps.

[0010] Embodiments of this disclosure involve interchangeable infusion vials containing a pharmaceutical composition during administration without requiring replacement of the vent needle that engages the infusion vial stopper. Further embodiments of this disclosure involve interchangeable vent needles along with interchangeable infusion vials during administration of the pharmaceutical composition.

[0011] A first aspect of this disclosure is to provide an intravenous infusion tubing assembly. The intravenous infusion tubing assembly includes: a venting needle operable to be inserted into a stopper of an infusion vial; a first line having a first end in fluid communication with the venting needle; a non-venting needle operable to be inserted into an intravenous solution bag; a second line having a first end in fluid communication with the non-venting needle; and a two-port chamber. A second opposite end of the first line and a second opposite end of the second line are each in fluid communication with the first end of the two-port chamber.

[0012] The intravenous catheter assembly of the first aspect may optionally include: a first clamp operable to control fluid flow through a first line; and a second clamp operable to control fluid flow through a second line.

[0013] The intravenous catheter assembly of the first aspect may include one or more of the aforementioned embodiments, and optionally, at least one of the first clamp and the second clamp includes a sliding clamp or a roller clamp.

[0014] The first aspect of the intravenous infusion tubing assembly may include one or more of the aforementioned embodiments, and optionally include a third tubing in fluid communication with a second end of the two-port chamber and in fluid communication with a connector, wherein the connector is capable of engaging an instrument attached to the patient at the intravenous infusion site.

[0015] The intravenous infusion tubing assembly of the first aspect may include one or more of those described in the foregoing embodiments, and optionally includes a clamp operable to control fluid flow through the third tubing.

[0016] The intravenous catheter assembly of the first aspect may include one or more of the ones described in the foregoing embodiments, and optionally, the clamp includes a roller clamp.

[0017] The first aspect of the intravenous infusion tubing assembly may include one or more of the aforementioned embodiments, and optionally, the connector includes a coupling mechanism capable of engaging a device attached to the patient at the intravenous infusion site.

[0018] The intravenous catheter assembly of the first aspect may include one or more of the aforementioned embodiments, and optionally, the coupling mechanism includes a spin lock or a Luer lock.

[0019] The intravenous catheter assembly of the first aspect may include one or more of the aforementioned embodiments, and optionally, the connector includes a cap operable to cover the distal end of the connector.

[0020] The intravenous catheter assembly of the first aspect may include one or more of the aforementioned embodiments, and optionally includes an additional connector that divides the third line into a first segment and a second segment. The first segment of the third line is in fluid communication with a second end of the two-port chamber and with a first end of the additional connector. The second segment of the third line is in fluid communication with a second end of the additional connector and with the additional connector.

[0021] The intravenous catheter assembly of the first aspect may include one or more of the aforementioned embodiments, and optionally, wherein the first end of the additional connector includes a first branch and a second branch, and wherein a first segment of the third line is in fluid communication with the first branch of the additional connector.

[0022] The intravenous catheter assembly of the first aspect may include one or more of those described in the foregoing embodiments, and optionally, a second branch of the additional connector is operable to provide access to a second segment of the third catheter.

[0023] The intravenous catheter assembly of the first aspect may include one or more of the aforementioned embodiments, and optionally, wherein the second end of the additional connector and the second branch of the first end of the additional connector are substantially collinear along a longitudinal axis passing through the additional connector, and wherein the first branch of the first end of the additional connector is configured to be at an angle to the longitudinal axis passing through the additional connector.

[0024] The intravenous infusion tubing assembly of the first aspect may include one or more of the aforementioned embodiments, and optionally, wherein the dual-port chamber includes a cap at the first end.

[0025] The intravenous infusion tubing assembly of the first aspect may include one or more of the aforementioned embodiments, and optionally, wherein the first line and the second line are respectively in fluid communication with the cap.

[0026] The intravenous catheter assembly of the first aspect may include one or more of those in the foregoing embodiments, and optionally, wherein the two-port chamber includes a port at a second end opposite to the first end of the two-port chamber.

[0027] A second aspect of this disclosure is to provide an intravenous injection tubing assembly. The intravenous injection tubing assembly includes: a tubing comprising a plurality of tubing lines; a non-ventilated needle connected to a first tubing line of the plurality of tubing lines; at least one second ventilated needle connected to at least one second tubing line of the plurality of tubing lines; and a two-port chamber, wherein the first tubing line and the at least one second tubing line are in fluid communication with a stopper at a first end of the two-port chamber.

[0028] The second aspect of the intravenous catheter assembly may optionally include, wherein the plurality of lines comprises: a first line having a first end in fluid communication with the at least one second ventilated needle; and a second line having a first end in fluid communication with a non-ventilated needle. A second opposite end of the first line and a second opposite end of the second line are each in fluid communication with a first end of a two-port chamber.

[0029] A third aspect of this disclosure is to provide a method for administering a pharmaceutical composition. The method may include, but is not limited to, connecting a first infusion vial and an intravenous solution bag to an intravenous tubing assembly to administer a first portion of the pharmaceutical composition. The intravenous tubing assembly includes: a venting needle operable to be inserted into a stopper of the first infusion vial; a first line having a first end in fluid communication with the venting needle; a non-venting needle operable to be inserted into the intravenous solution bag; a second line having a first end in fluid communication with the non-venting needle; and a two-port chamber. A second opposite end of the first line and the second opposite end of the second line are in fluid communication with the first end of the two-port chamber. The method may include, but is not limited to, disconnecting the first infusion vial from the intravenous tubing assembly. The method may include, but is not limited to, connecting a second infusion vial to the intravenous tubing assembly to administer a second portion of the pharmaceutical composition.

[0030] The third aspect of the method may include, optionally, a ventilator needle interchangeable with a second ventilator needle before connecting the second infusion vial to the intravenous tubing assembly, wherein the second ventilator needle is operable to be inserted into the stopper of the second infusion vial.

[0031] A fourth aspect of this disclosure is to provide an intravenous infusion tubing assembly. The intravenous infusion tubing assembly includes: a venting needle operable to be inserted into a stopper of an infusion vial; a first line having a first end in fluid communication with the venting needle; a non-venting needle operable to be inserted into an intravenous solution bag; a second line having a first end in fluid communication with the non-venting needle; and a two-port chamber. A second opposite end of the first line and a second opposite end of the second line are each in fluid communication with the first end of the two-port chamber.

[0032] The fourth aspect of the intravenous tubing assembly may optionally include: a first clamp operable to control fluid flow through the first tubing; and a second clamp operable to control fluid flow through the second tubing.

[0033] The fourth aspect of the intravenous infusion tubing may include one or more of the aforementioned embodiments, and optionally, wherein the first tubing is in fluid communication with a connector, wherein the connector is capable of engaging a ventilating needle.

[0034] The fourth aspect of the intravenous infusion tubing assembly may include one or more of the aforementioned embodiments, and optionally, the connector capable of engaging the ventilation needle includes a coupling mechanism comprising a spin lock or a Luer lock.

[0035] The fourth aspect of the intravenous catheter assembly may include one or more of the aforementioned embodiments, and optionally, wherein the connector capable of engaging the ventilator needle includes a cap operable to cover the distal end of the connector.

[0036] The fourth aspect of the intravenous infusion tubing may include one or more of the aforementioned embodiments, and optionally include a third tubing that is in fluid communication with a second end of the two-port chamber and with a connector capable of engaging an instrument attached to the patient at the intravenous infusion site.

[0037] The fourth aspect of the intravenous infusion tubing assembly may include one or more of the aforementioned embodiments and may optionally include a clamp operable to control fluid flow through the third tubing.

[0038] The fourth aspect of the intravenous infusion tubing assembly may include one or more of the aforementioned embodiments, and optionally, the connector capable of engaging the device includes a coupling mechanism comprising a spin lock or a Luer lock.

[0039] The fourth aspect of the intravenous catheter assembly may include one or more of the aforementioned embodiments, and optionally, the connector capable of engaging the device includes a cap operable to cover the distal end of the connector.

[0040] The fourth aspect of the intravenous catheter assembly may include one or more of the embodiments described above, and optionally includes an additional connector that divides the third line into a first segment and a second segment. The first segment of the third line is in fluid communication with a second end of the two-port chamber and with a first end of the additional connector. The second segment of the third line is in fluid communication with a second end of the additional connector and with the additional connector.

[0041] The fourth aspect of the intravenous catheter assembly may include one or more of the aforementioned embodiments, and optionally, wherein the first end of the additional connector includes a first branch and a second branch, and wherein a first segment of the third line is in fluid communication with the first branch of the additional connector.

[0042] The fourth aspect of the intravenous catheter assembly may include one or more of the aforementioned embodiments, and optionally, wherein a second branch of the additional connector is operable to provide access to a second segment of the third catheter.

[0043] The fourth aspect of the intravenous catheter assembly may include one or more of the aforementioned embodiments, and optionally, wherein the second end of the additional connector and the second branch of the first end of the additional connector are substantially collinear along a longitudinal axis passing through the additional connector, and wherein the first branch of the first end of the additional connector is configured to be at an angle to the longitudinal axis passing through the additional connector.

[0044] The fourth aspect of the intravenous infusion tubing assembly may include one or more of the aforementioned embodiments, and optionally, the dual-port chamber includes a cap at the first end.

[0045] The fourth aspect of the intravenous infusion tubing may include one or more of the tubing described in the foregoing embodiments, and optionally, wherein the first tubing and the second tubing are respectively in fluid communication with the cap.

[0046] The fourth aspect of the intravenous infusion tubing assembly may include one or more of the aforementioned embodiments, and optionally, wherein the dual-port chamber includes a port at a second end opposite to the first end of the dual-port chamber.

[0047] These and other advantages will become apparent from the disclosure contained herein. The above embodiments, objects, and configurations are neither complete nor exhaustive. The summary is neither intended nor should be construed as representing the full breadth and scope of this disclosure. Furthermore, references herein to "this disclosure" or aspects thereof should be understood as referring to certain embodiments of this disclosure and not necessarily as limiting all embodiments to the specific description. This disclosure has been set forth in various degrees of detail in the summary, the accompanying drawings, and the detailed description, and the inclusion or exclusion of certain elements, components, etc., in the summary is not intended to limit the scope of this disclosure. Other aspects of this disclosure will become clearer from the detailed description, particularly when understood in conjunction with the accompanying drawings. Attached Figure Description

[0048] Those skilled in the art will recognize that the following description is merely illustrative of the principles of this disclosure, and that many different alternative embodiments can be provided by applying the principles of the invention in various ways. This description is made to illustrate the general principles of the teachings of this disclosure and is not intended to limit the conception of the disclosure herein.

[0049] Embodiments are illustrated in conjunction with the accompanying drawings, which form part of the specification, and together with the general description of the disclosure given above and the detailed description of the drawings given below, are used to explain the principles of the disclosure.

[0050] Figure 1A An intravenous infusion tubing assembly according to one or more embodiments of this disclosure is shown; Figure 1B Showing Figure 1A The dual-port chamber of the intravenous infusion tubing assembly; Figure 1C Showing Figure 1A The intravenous injection tubing set; Figure 1D Showing Figure 1C It is part of an intravenous injection tubing assembly, which is in fluid communication with a first container containing a drug composition and a second container containing a solution; Figure 1E Showing Figure 1A Another embodiment of the intravenous infusion tubing assembly; Figure 1F Showing Figure 1A Another embodiment of the intravenous infusion tubing assembly; Figure 2 One or more embodiments based on this disclosure are shown. Figure 1A The first variant of the intravenous infusion tubing set; Figure 3 One or more embodiments based on this disclosure are shown. Figure 1A The second variant of the intravenous infusion tubing set; Figure 4 One or more embodiments based on this disclosure are shown. Figure 1A The third variant of the intravenous infusion tubing set; Figure 5 One or more embodiments based on this disclosure are shown. Figure 1A The fourth variant of the intravenous injection tubing set; Figure 6A One or more embodiments based on this disclosure are shown. Figure 1A The fifth variant of the intravenous injection tubing set; Figure 6B Showing Figure 6AThe first part of the intravenous injection tubing assembly is in fluid communication with a first container containing a drug composition and a second container containing a solution; Figure 6C Showing Figure 6B The second part of the intravenous injection tubing assembly is in fluid communication with a first container containing a drug composition and a second container containing a solution; Figure 6D Showing Figure 6A The intravenous injection tubing set; and Figure 7 A flowchart is shown for methods or procedures for operating and using an intravenous catheter assembly as described throughout this disclosure.

[0051] It should be understood that the accompanying drawings are not necessarily drawn to scale and may vary in size. In some cases, details that are not essential for understanding this disclosure or that would make other details difficult to understand have been omitted. Of course, it should be understood that this disclosure is not limited to the specific embodiments shown herein. Detailed Implementation

[0052] While the following text sets forth detailed descriptions of many different embodiments, it should be understood that the legal scope of the description is defined by the words of the claims set forth at the end of this disclosure. The detailed descriptions are to be interpreted as exemplary only, and not every possible embodiment is described, as describing every possible embodiment of the intravenous tubing assembly would be impractical, if not impossible. Many alternative embodiments can be implemented using current technology or technology developed after the filing date of this patent, and these alternative embodiments will still fall within the scope of the claims. Furthermore, any combination of features shown in the various figures can be used to form additional embodiments of this disclosure. Thus, the dimensions, aspects, and features of one embodiment of the intravenous tubing assembly can be combined with the dimensions, aspects, and features of another embodiment of the intravenous tubing assembly to produce the claimed embodiment.

[0053] Generally, embodiments of this disclosure relate to a system and method for administering a pharmaceutical composition using an intravenous tubing assembly. The intravenous tubing assembly includes a first needle on a first line for the pharmaceutical composition and a second needle on a second line for the solution. The first and second lines are in fluid communication with a two-port chamber in fluid communication with a connector capable of engaging a device attached to a patient at an intravenous injection site. In some embodiments, the pharmaceutical composition is administered via gravity infusion through the intravenous tubing assembly. In some embodiments, the first needle is a ventilated needle and the second needle is a non-ventilated needle.

[0054] Embodiments of this disclosure also relate to an intravenous tubing assembly capable of administering a dose of a pharmaceutical composition dispensed into different infusion vials. The intravenous tubing assembly should include a venting needle that can be inserted into the different infusion vials. It is not necessary to replace the venting needle between infusion vials because the pharmaceutical composition from the first infusion vial may clog or wet the filter within the venting needle. The venting needle can be inserted into the stopper of the infusion vial without dislodging or shifting the stopper, which could lead to leakage of the infusion vial (i.e., due to the infusion vial being suspended for gravity infusion purposes via the intravenous tubing assembly).

[0055] Figures 1A to 1F An intravenous injection tube assembly 100 according to one or more embodiments of this disclosure is generally shown. It should be noted that, for the purposes of this disclosure, "intravenous injection tube" and "IV tube" (along with other variations of "intravenous injection" and "IV") may be considered equivalent.

[0056] The intravenous infusion tubing assembly 100 includes a needle 102 in fluid communication with a tubing 104. The needle 102 can be inserted into a container 156 operable to store a pharmaceutical composition. For example, the needle 102 can be a venting needle operable to allow airflow into the container 156, allowing air to enter the container 156 while the pharmaceutical composition stored within it flows through the tubing 104. This may be advantageous, for example, if the container 156 includes rigid or non-deformable sidewalls (i.e., such as glass or rigid plastic infusion vials). In this example, the needle 102 may include a filter 106 for filtering the airflow entering the needle 102.

[0057] It should be noted throughout this document that the pharmaceutical compositions described herein may include, but are not limited to, 100 mL doses containing natural killer (NK) cell products (e.g., including but not limited to PD-L1 t-haNK or CD19 t-haNK), wherein the 100 mL dose is aliquoted into two 50 mL infusion vials 156. Typically, the pharmaceutical composition may be any investigational product or other solution comprising a pharmaceutical substance that can be supplied via gravity infusion from the container 156 (e.g., which may be rigid, such as an infusion vial). In an embodiment, the needle 102 includes a cap 108 to help ensure that the tip 110 of the needle 102 remains sterile or otherwise uncontaminated (i.e., unblocked and / or dry) before insertion into the container 156.

[0058] The intravenous tubing assembly 100 includes a needle 112 in fluid communication with tubing 114. For example, the needle 112 may be a non-ventilated needle. The needle 112 can be inserted into a container 160 (e.g., an IV bag, infusion vial, etc.) operable to store a solution. For example, the solution may include, but is not limited to, saline solution or other solutions that (a) perfuse or flush the intravenous tubing assembly, (b) combine with a pharmaceutical composition in container 156, or (c) are other pharmaceutical compositions. In an embodiment, the needle 112 includes a cap 116 to help keep the needle tip 118 sterile before insertion into container 160.

[0059] In some configurations of the intravenous tubing assembly 100, the needle 102 is shorter than the needle 112. For example, the needle 102 may have an inner diameter of 0.162 inches, an outer diameter of 0.303 inches, and a length of 2.36 inches. By another example, the needle 112 may have an inner diameter of 0.162 inches, an outer diameter of 0.232 inches, and a length of 3.27 inches. It should be noted herein that the longer needle 112 may be used to supply solution from container 160 to perfuse the intravenous tubing assembly 100 before administering the drug composition from container 156 via the needle 102 (i.e., perfusing with solution from container 160). Additionally, it should be noted herein that the longer needle 112 may be used to supply solution from container 160 to flush the intravenous tubing assembly 100 after administering the drug composition from container 156 via the needle 102 (i.e., flushing with solution from container 160).

[0060] In this embodiment, lines 104 and 114 are each in fluid communication with the two-port chamber 120. For example, as... Figure 1BAs shown, the dual-port chamber 120 may include a cover 122 at a first end of the dual-port chamber 120, wherein the cover 122 includes one or more openings into which conduits 104 and 114 are inserted. By another example, the dual-port chamber 120 may include one or more ports into which conduits 104 and / or 114 are coupled (e.g., internally or externally coupled, in the case of internal coupling, the conduit is inserted into the port, and in the case of external coupling, the port is inserted into the conduit). It should be noted herein that, without departing from the scope of this disclosure, conduits 104 and 114 may be in fluid communication with the same opening or the same port of the cover 122, or alternatively may be in fluid communication with different openings or ports of the cover 122. Furthermore, it is conceivable that the cover 122 can receive (or include) a connector to which conduits 104 and 114 are respectively connected, such that conduit 104 is connected to a first branch of the connector, conduit 114 is connected to a second branch of the connector, and a third branch of the connector is connected to the cover 122. The dual-port chamber 120 further includes a housing 124 to which the cover 122 is connected.

[0061] Fluid flow (including its rate) from the needle 102 through line 104 to the two-port chamber 120 can be controlled via clamp 126. For example, clamp 126 can be a sliding clamp that can be used to start or stop fluid flow through line 104. By another example, clamp 126 can be a roller clamp that can be used to control the rate of fluid flow through line 104. It should be noted herein that reducing the flow rate to 0 (or allowing a flow rate greater than 0) via roller clamp effectively stops or starts fluid flow within line 104.

[0062] Fluid flow (including its rate) from the needle 112 through line 114 to the two-port chamber 120 can be controlled via clamp 128. For example, clamp 128 can be a sliding clamp that can be used to start or stop fluid flow through line 114. By another example, clamp 128 can be a roller clamp that can be used to control the rate of fluid flow through line 114. It should be noted herein that reducing the flow rate to 0 (or allowing a flow rate greater than 0) via roller clamp effectively stops or starts fluid flow within line 114.

[0063] In one embodiment, the conduit 130 is in fluid communication with port 132 at the second end of the two-port chamber 120. For example, the conduit 130 may be internally connected to port 132, in which case the conduit 130 is inserted into port 132. By another example, the conduit 130 may be externally connected to port 132, in which case port 132 is inserted into the conduit 130. Fluid passing through the housing 124 can exit through port 132 and enter the conduit 130.

[0064] It should be understood that, for the purposes of this disclosure, cover 122 may include a set of openings or ports for the dual-port chamber 120, and housing 124 may include a second set of openings or ports (i.e., port 132) for the dual-port chamber 120. However, it is contemplated that, without departing from the scope of this disclosure, the dual-port chamber 120 may be a sealed unit having openings and / or ports at a first end and a second opposite end of housing 124, thus eliminating the need for cover 122.

[0065] In some non-limiting embodiments, housing 124 may optionally include filter 134, such that the two-port chamber 120 is a filter chamber. For example, a pharmaceutical composition supplied from container 156 by line 104 and / or a solution supplied from container 160 by line 114 to the two-port chamber 120 may pass through filter 134 before the fluid exits the two-port chamber 120 via port 132 and line 130. It should be noted that filter 134 may include a blood filter in the range of 170 micrometers to 260 micrometers. For example, filter 134 may be a 200-micrometer blood filter.

[0066] It should be noted herein that one or more of tubing 104, tubing 114, tubing 130, and the two-port chamber 120 may be transparent or translucent to allow visualization of the pharmaceutical composition and / or solution passing through the intravenous injection tubing assembly 100. However, it should be understood that one or more of tubing 104, tubing 114, tubing 130, and the two-port chamber 120 may be partially or substantially opaque without departing from the scope of this disclosure.

[0067] In one embodiment, line 130 is in fluid communication with connector 136. For example, connector 136 can engage a device (i.e., a needle or other port) attached to the patient at an intravenous injection site.

[0068] In some embodiments, connector 136 includes a coupling mechanism capable of engaging a device attached to a patient at an intravenous injection site. For example, the coupling mechanism may include, but is not limited to, a set of interlocking components, such as complementary threads, spin locks, or Luer locks. It should be noted that the coupling mechanism should be sealed and / or leak-proof. Additionally, it should be noted that the coupling mechanism may be a one-way coupling mechanism to prevent connector 136 from disengaging from the device attached to the intravenous injection site. However, it should be noted herein that, without departing from the scope of this disclosure, tubing may be directly coupled to connector 136, either internally or externally, with tubing 130 inserted into connector 136 in the case of internal coupling and connector 136 inserted into tubing 130 in the case of external coupling.

[0069] In some embodiments, the connector 136 includes a cap 138 that helps maintain the sterility of the distal end of the connector 136 before being attached to a device that is attached to the patient at an intravenous injection site. For example, the cap 138 may be a ventilator.

[0070] Fluid flow (including its rate) from the two-port chamber 120 through line 130 to connector 136 can be controlled via clamp 140. For example, clamp 140 may be a roller clamp that can be used to control the rate of fluid flow through line 130. It should be noted herein that reducing the flow rate to 0 (or allowing a flow rate greater than 0) via roller clamp effectively stops or starts fluid flow within line 130. By another example, clamp 140 may be a sliding clamp that can be used to start or stop fluid flow through line 130.

[0071] In some embodiments, the dual-port chamber 120 is in direct fluid communication with the connector 136 via a conduit 130. In other embodiments, the conduit 130 is divided into multiple segments, which are connected together via at least one connector.

[0072] For example, the conduit 130 may be divided into a first conduit section 142 and a second conduit section 144. The first conduit section 142 and the second conduit section 144 may be in fluid communication with the connector 146. For example, the first conduit section 142 of the third conduit 130 may be in fluid communication with the second end of the two-port chamber 120 and with the first end 148 of the connector 146. Additionally, the second conduit section 144 of the third conduit 130 may be in fluid communication with the second end 150 of the connector 146 and with the connector 136. In some embodiments, the connector 146 is a pinless connector.

[0073] It should be noted herein that connector 146 may include one or more branches on the first end 148 and / or the second end 150. In a non-limiting example, connector 146 may include a first branch 152 and a second branch 154 on the first end 148. In this non-limiting example, connector 146 may be a Y-connector or a T-connector. When connector 146 is a Y-connector or a T-connector, the second branch 154 may be aligned with the second end 150 by being coaxial with or sharing the longitudinal axis passing through connector 146, such that connector 146 provides access to a second tube segment 144 of tubing 130 for medical professionals (i.e., technicians, nurses, doctors, etc.), while the first branch 152 is angled relative to the longitudinal axis. However, it should be noted herein that, without departing from the scope of this disclosure, both the first branch 152 and the second branch 154 may be angled relative to the longitudinal axis passing through the second end 150 of connector 146, and the respective angles may be substantially the same or may be different.

[0074] It should be noted in this document that, without departing from the scope of this disclosure, the clamp 140 may be positioned on the first pipe section 142 or the second pipe section 144 (or generally on any section of the pipe 130).

[0075] like Figure 1D As shown, in some embodiments, the needle 102 can be used to administer a dose of a pharmaceutical composition, wherein the dose is dispensed into one or more containers. In the case that container 156 is an infusion vial, the needle 102 can be inserted into the stopper 158 of container 156. Alternatively, in the case that container 160 is an IV bag, the needle 112 can be inserted into the port 162 of container 160.

[0076] In one non-limiting example, the dosage of the pharmaceutical composition may be in a single container 156. In another non-limiting example, the dosage of the pharmaceutical composition may be in multiple containers 156 (e.g., due to size limitations, time intervals for the administration of portions of the dosage, or other reasons specific to the pharmaceutical composition). It is conceivable that during administration, the same needle 102 may be sequentially connected to multiple containers 156. For example, a medical professional may remove the first container 156 and sterilize the needle 102 (i.e., by performing hand hygiene, wearing clean gloves, and applying alcohol at least to the tip 110 of the needle 102), and then immediately insert the tip 110 into the second container 156 using aseptic non-contact techniques (i.e., such that once the tip 110 is cleaned, the stopper 158 of the container 156 is not touched). In this respect, the administration of each portion of the dosage of the pharmaceutical composition can be controlled by a medical professional.

[0077] although Figure 1A A single tube 104 and a needle 102 were shown, but Figure 1E A single tubing 104 is shown to branch further to include multiple needles 102. For example, tubing 104 may include a connector and a first portion in fluid communication with a two-port chamber 120. The connector is in fluid communication via connector 164 with two branch tubings, each including a needle 102. Each branch tubing with a corresponding needle 102 is used to contain a container 156 for a portion of a dose of the drug composition. It should be noted that each branch tubing of tubing 104 may additionally or alternatively include a clamp 126. In this respect, multiple portions of the drug composition can be coupled to the intravenous tubing assembly at any time during administration. Additionally, with clamps 126 included on each branch tubing, the administration of each portion of the drug composition dose can be controlled by a medical professional.

[0078] In addition, although Figure 1A A single tube 104 and a needle 102 were shown, but Figure 1F Multiple individual sub-assemblies (each including a line 104 and a needle 102) for administering a drug composition are shown to alternatively be in fluid communication with a two-port chamber 120. For example, an intravenous tubing assembly 100 may include two sub-assemblies, each including a line 104 and a needle 102. Each sub-assembly is used to contain a portion of the drug composition dose in a container 156. It should be noted that each branch of the line 104 may additionally include a clamp 126. In this respect, multiple portions of the drug composition can be coupled to the intravenous tubing assembly at any time during administration. Furthermore, with the clamp 126 included on each sub-assembly, the administration of each portion of the drug composition dose can be controlled by a medical professional.

[0079] Figure 2 One or more embodiments based on this disclosure are shown. Figure 1A The intravenous tubing assembly 100 may be a variant of the intravenous tubing assembly 100 or the intravenous tubing assembly 200. It should be understood that, without departing from the scope of this disclosure, unless otherwise stated, aspects and / or components of the intravenous tubing assembly 100 may be shared with and / or combined with one or more aspects and / or components of the intravenous tubing assembly 200. In particular, it should be understood that, without departing from the scope of this disclosure, the intravenous tubing assembly 200 may include variations similar to... Figure 1E and Figure 1F The alternative construction for the intravenous injection tubing assembly 100 is shown in the image.

[0080] like Figure 2As shown, the intravenous catheter assembly 200 includes a needle 202 connected to a tube 204 and having a filter 206. The needle 202 includes a cap 208 and a sterile tip 210, which is more than... Figure 1A The needle 102 is shorter and has a smaller diameter. For example, the needle 202 could be a venting needle. However, testing has determined that a sterile tip 210 that is too short and / or too small in diameter can easily be pulled out or displaced from the stopper 158 of the infusion vial 156, creating the possibility of leakage from the stopper 158 (i.e., from the hole formed in the stopper 158 by the sterile tip 210). In some cases, leakage from the stopper 158 can clog the filter 206 and / or make the filter 206 wet. Therefore, as Figure 1A The length and diameter of the needle 102 shown were determined to be more conducive to the operation of the intravenous infusion tubing 100.

[0081] Figure 3 One or more embodiments based on this disclosure are shown. Figure 1A The intravenous tubing assembly 100 may be a variant of the intravenous tubing assembly 100 or the intravenous tubing assembly 300. It should be understood that, without departing from the scope of this disclosure, unless otherwise stated, aspects and / or components of the intravenous tubing assembly 300 may be shared with and / or combined with one or more aspects and / or components of the intravenous tubing assemblies 100 and / or 200. In particular, it should be understood that, without departing from the scope of this disclosure, the intravenous tubing assembly 300 may include variations similar to... Figure 1E and Figure 1F The alternative construction for the intravenous injection tubing assembly 100 is shown in the image.

[0082] like Figure 3 As shown, the intravenous catheter assembly 300 includes a needle 302 connected to a tube 304 and having a filter 306. The needle 302 includes a cap 308 and a sterile tip 310, which is more than... Figure 1A The needle 102 is shorter and has a larger diameter. For example, the needle 302 can be a ventilation needle. The needle 302 includes a chamber 312.

[0083] However, testing determined that a sterile tip 310 that is too short and / or too large in diameter would fail to effectively push the stopper 158 through the infusion vial 156, potentially causing the stopper 158 to be pushed into the infusion vial 156 and creating the possibility of leakage from the needle 302. Additionally, inappropriate contamination of the filter 306 could occur. Furthermore, the chamber 312 was determined not to be a necessary part of the ventilation needle 302. Therefore, as... Figure 1A The length and diameter of the needle 102 shown were determined to be more conducive to the operation of the intravenous infusion tubing assembly 100.

[0084] Figure 4 One or more embodiments based on this disclosure are shown. Figure 1A The intravenous tubing assembly 100 may be a variant of the intravenous tubing assembly 100 or the intravenous tubing assembly 400. It should be understood that, without departing from the scope of this disclosure, unless otherwise stated, aspects and / or components of the intravenous tubing assembly 400 may be shared with and / or combined with one or more aspects and / or components of the intravenous tubing assemblies 100, 200, and / or 300. In particular, it should be understood that, without departing from the scope of this disclosure, the intravenous tubing assembly 400 may include variations similar to... Figure 1E and Figure 1F The alternative construction for the intravenous injection tubing assembly 100 is shown in the image.

[0085] like Figure 4 As shown, the intravenous catheter assembly 400 includes a needle 402 connected to a tube 404 and having a filter 406. The needle 402 includes a cap 408 and a sterile tip 410, which is more than... Figure 1A The needle 102 is shorter and has a smaller diameter. For example, the needle 402 can be a non-ventilated needle.

[0086] In one embodiment, the needle 402 is separate from the intravenous tubing assembly 400 and is connectable to a connector 412 on the tubing 404. In some embodiments, the needle 402 is connected to the connector 412 via a coupling mechanism capable of receiving and engaging the needle 402. For example, the coupling mechanism may include, but is not limited to, a set of interlocking components, such as complementary threads, spin locks, or Luer locks. It should be noted that the coupling mechanism may be sealing and / or leak-proof. Additionally, it should be noted that the coupling mechanism may be a one-way connection to prevent the needle 402 from disengaging from the tubing 604.

[0087] In some embodiments, connector 412 may include a cap 414 to help maintain the sterility of connector 412 (e.g., when needle 402 is not attached to connector 412).

[0088] Figure 5 One or more embodiments based on this disclosure are shown. Figure 1A The intravenous tubing assembly 100 may be a variant of the intravenous tubing assembly 100 or the intravenous tubing assembly 500. It should be understood that, without departing from the scope of this disclosure, unless otherwise stated, aspects and / or components of the intravenous tubing assembly 500 may be shared with and / or combined with one or more aspects and / or components of the intravenous tubing assemblies 100, 200, 300, and / or 400. In particular, it should be understood that, without departing from the scope of this disclosure, the intravenous tubing assembly 500 may include variations similar to... Figure 1E and Figure 1FThe alternative construction for the intravenous injection tubing assembly 100 is shown in the image.

[0089] like Figure 5 As shown, the intravenous catheter assembly 500 includes a needle 502 connected to a tube 504 and having a filter 506. The needle 502 includes a cap 508 and a sterile tip 510, which is more than... Figure 1A The needle 102 is shorter and has a smaller diameter. For example, the needle 502 could be a ventilator needle. However, testing has shown that sterilizing the tip 510 is difficult. Therefore, as... Figure 1A The length and diameter of the needle 102 shown were determined to be more conducive to the operation of the intravenous infusion tubing assembly 100.

[0090] Figures 6A to 6D One or more embodiments based on this disclosure are shown in general. Figure 1A The intravenous tubing assembly 100 may be a variant of the intravenous tubing assembly 100 or the intravenous tubing assembly 600. It should be understood that, without departing from the scope of this disclosure, unless otherwise stated, aspects and / or components of the intravenous tubing assembly 600 may be shared with and / or combined with one or more aspects and / or components of the intravenous tubing assemblies 100, 200, 300, 400, and / or 500. In particular, it should be understood that, without departing from the scope of this disclosure, the intravenous tubing assembly 600 may include variations similar to... Figure 1E and Figure 1F The alternative construction for the intravenous injection tubing assembly 100 is shown in the image.

[0091] like Figures 6A to 6D As shown, the intravenous catheter assembly 600 includes a needle 602 connected to a tube 604 and having a filter 606. The needle 602 includes a cap 608 and a sterile end 610. For example, the needle 602 could be a ventilation needle.

[0092] Testing determined that needle 102 (e.g., during ventilation) can only operate under pressures not exceeding a predetermined threshold (e.g., up to approximately 2.9 pounds per square inch (PSI)). In contrast, needle 602 (e.g., during ventilation) can handle increased pressure volumes compared to needle 102. This ability of needle 602 to handle increased pressure volumes compared to needle 102 of the intravenous tubing assembly 600 was identified as potentially more beneficial for the operation of the intravenous tubing assembly 600.

[0093] In one embodiment, the needle 602 is separate from the intravenous tubing assembly 600 and is connectable to a connector 612 on the tubing 104. In some embodiments, the needle 602 is connected to the connector 612 via a coupling mechanism capable of receiving and engaging the needle 602. For example, the coupling mechanism may include, but is not limited to, a set of interlocking components, such as complementary threads, spin locks, or Luer locks. It should be noted that the coupling mechanism may be sealing and / or leak-proof. Additionally, it should be noted that the coupling mechanism may be a one-way connection to prevent the needle 602 from disengaging from the tubing 604.

[0094] In some embodiments, connector 612 may include a cap 614 to help maintain the sterility of connector 612 (e.g., when needle 602 is not attached to connector 612).

[0095] Therefore, as by comparison Figures 1A to 6D The intravenous tubing assembly shown in the diagram demonstrates that testing and experimentation were necessary to determine the appropriate combination of needles. These tests and experiments determined that, compared to known intravenous tubing assemblies, the venting needle does not become wet or clogged and is therefore reusable with multiple infusion vials, and does not dislodge or displace the stoppers in the infusion vials, which is a beneficial configuration for the intravenous tubing assembly of this application. Because the venting needle is reusable, the intravenous tubing assembly of this application is more cost-effective than previously known solutions (i.e., such as disposable intravenous tubing assemblies). Furthermore, because the venting needle can be interchanged with another venting needle, the intravenous tubing assembly of this application is more cost-effective than previously known solutions, as only the individual venting needle needs to be interchanged (i.e., compared to a disposable, fully constructed intravenous tubing assembly).

[0096] In some embodiments, the length of the corresponding tubing 104, 204, 304, 404, 504, and 604 of the intravenous tubing assemblies 100, 200, 300, 400, 500, and 600 may be approximately 10 inches. Additionally, the length of tubing 114 may be approximately 10 inches. Further, the length of the first tubing segment 142 of tubing 130 may be approximately 60 inches, and the length of the second tubing segment 144 of tubing 130 may be approximately 10 inches. Therefore, the intravenous tubing assemblies 100, 200, 300, 400, 500, and 600 may each have tubing with a total length of approximately 80 inches (e.g., tubing 114 is connected in series with tubing 130 having segments 142 and 144, and tubing 114 is connected in parallel with the corresponding tubing 104, 204, 304, 404, 504, and 604, as shown in the various figures). However, it should be understood that the lengths of tubes 104, 204, 304, 404, 504, 604, 114 and tube 130 with segments 142 and 144, and / or the total lengths of the intravenous tubing groups 100, 200, 300, 400, 500, 600 are not limited to the examples above. More precisely, without departing from the scope of this disclosure, the corresponding lengths of tubes 104, 204, 304, 404, 504, 604, 114 and tube 130 with segments 142 and 144, and / or the total lengths of the intravenous tubing groups 100, 200, 300, 400, 500, 600 may be shorter or longer than those in the examples above.

[0097] In a non-limiting example, tubes 104, 204, 304, 404, 504, 604, and 114 of the intravenous tubing assemblies 100, 200, 300, 400, 500, and 600, and tube 130 having segments 142 and 144, respectively, have an inner diameter of approximately 0.110 inches (2.79 mm) and an outer diameter of approximately 0.162 inches (4.11 mm). However, it is conceivable that at least some of the tubes 104, 204, 304, 404, 504, 604, and 114 of the intravenous tubing assemblies 100, 200, 300, 400, 500, and 600, and tube 130 having segments 142 and 144, may have different inner diameters and / or outer diameters, respectively.

[0098] Figure 7 This is a flowchart 700 illustrating a method or process for administering a pharmaceutical composition using assemblies of intravenous tubing 100, 200, 300, 400, 500, and 600 according to one or more embodiments of this disclosure. Although Figure 7 The general sequence of steps in the method or process is shown, but the method or process may include more or fewer steps, or may be combined with... Figure 7The steps shown are arranged in different (including simultaneously, substantially simultaneously, or sequentially) orders. It should be noted that... Figure 7 The methods or processes should be referenced and combined Figures 1A to 6D The description refers to components, equipment, sub-components, environments, etc. For example, it should be noted that, without departing from the scope of this disclosure, one should not refer to the descriptions of other materials or equipment. Figure 7 When describing the embodiments, it should be understood that... Figures 1A to 6D The illustrated embodiments are, in reverse order.

[0099] In an embodiment, a first infusion vial and an intravenous solution bag are connected 702 to an intravenous tubing assembly to administer a first portion of the pharmaceutical composition. For example, as described throughout this disclosure, the first infusion vial 156 may be connected to needles 102, 202, 302, 402, 502, and 602, and the intravenous solution bag may be connected to needles 112 of intravenous tubing assemblies 100, 200, 300, 400, 500, and 600.

[0100] In this embodiment, the first infusion vial is disconnected from the intravenous tubing assembly 704. For example, the first infusion vial 156 can be disconnected from or removed from the needles 102, 202, 302, 402, 502, and 602.

[0101] In one embodiment, a second infusion vial 706 is connected to an intravenous tubing assembly to administer a second portion of the pharmaceutical composition. For example, the first infusion vial 156 can be disconnected from or removed from needles 102, 202, 302, 402, 502, 602, after which the second infusion vial 156 can be connected to needles 102, 202, 302, 402, 502, 602 and its contents administered. By another example, the second infusion vial 156 can be connected to the second needles 102, 202, 302, 402, 502, 602 of the respective intravenous tubing assemblies 100, 200, 300, 400, 500, 600, simultaneously with or after connecting the first infusion vial 156 and administering its contents. For example, the second needles 102, 202, 302, 402, 502, and 602 can be located on separate conduits 104, 204, 304, 404, 504, and 604, just like the first needles 102, 202, 302, 402, 502, and 602. Alternatively, the conduits 104, 204, 304, 404, 504, and 604 can be branched and in fluid communication with both needles 102, 202, 302, 402, 502, and 602.

[0102] In an embodiment, any one of the needles 102, 202, 302, 402, 502, and 602 may optionally be interchanged with another needle 102, 202, 302, 402, 502, and 602, and then, with or without tubing 104, 204, 304, 404, 504, and 604 of the corresponding length, the second infusion vial is connected to the corresponding intravenous tubing assembly 100, 200, 300, 400, 500, and 600. It should also be noted that, without departing from the scope of this disclosure, the needle 112 for the intravenous solution bag may similarly be interchanged with another needle 112.

[0103] Although the embodiments of this disclosure involve one or more of the needles 102, 202, 302, 402, 502, 602 being ventilated, for example at the location where a particular needle 102, 202, 302, 402, 502, 602 is inserted into the stopper 158 of the infusion vial 156, it should be understood that non-ventilated needles may be used without departing from the scope of this disclosure when using an infusion bag with a non-rigid side.

[0104] Although method or process 700 is described as having two parts that can be used to produce a dosage of a pharmaceutical composition, it should be understood that this disclosure is not limited to a two-part dosage. Rather, without departing from the scope of this disclosure, method or process 700 (and the intravenous tubing assemblies 100, 200, 300, 400, 500, 600 that can be used in method or process 700) can be modified to be used to produce a pharmaceutical composition having any number of parts constituting a dosage.

[0105] In this respect, the advantages of this disclosure include, but are not limited to, a system and method for administering a pharmaceutical composition using an intravenous tubing assembly. The intravenous tubing assembly includes a first ventilated needle for the pharmaceutical composition on a first line and a second non-ventilated needle for the solution on a second line. The first and second lines are in fluid communication with a two-port chamber in fluid communication with a connector capable of engaging an instrument attached to a patient at the intravenous injection site.

[0106] The advantages of this disclosure also include, but are not limited to, a tubing assembly capable of administering a dose of a pharmaceutical composition dispensed into different infusion vials. The tubing assembly includes a venting needle that can be inserted into the different infusion vials. There is no need to change the venting needle between infusion vials because the filter within the venting needle may become clogged or wetted by the pharmaceutical composition from the first infusion vial. The venting needle can be inserted into the stopper of the infusion vial without dislodging or shifting the stopper, which could lead to leakage of the infusion vial (i.e., due to the infusion vial being suspended for gravity infusion purposes).

[0107] As used herein, the phrases “at least one,” “one or more,” and “and / or” are open-ended expressions that act as both conjunctions and adversative conjunctions in operation. For example, each of the expressions “at least one of A, B, and C,” “at least one of A, B, or C,” “one or more of A, B, and C,” “one or more of A, B, or C,” and “A, B, and / or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B, and C together.

[0108] Unless otherwise stated, all figures representing quantities, dimensions, conditions, etc., used in the specification and claims shall be understood to be modified by the term “about” in all cases.

[0109] When referring to measurable quantities (e.g., diameter or other distances) and used for comparative purposes, the use of “substantially” in this disclosure is intended to mean within 5% of the quantity being compared. As used herein, the terms “substantially similar,” “substantially the same as,” and “substantially equal” should be interpreted as if explicitly stated and covering the specific cases in which the comparative items are “similar,” “the same,” and “equal,” respectively.

[0110] As used herein, unless otherwise stated, the terms “about,” “approximately,” etc., when used with respect to numerical limits or ranges, mean that the listed limits or ranges can vary by up to 10%. As a non-limiting example, “about 750” can mean as little as 675 or as much as 825, or any value in between. When used with respect to a ratio or relationship between two or more numerical limits or ranges, the terms “about,” “approximately,” etc., mean that each of the limits or ranges can vary by up to 10%; as a non-limiting example, a statement that two quantities are “approximately equal” can mean that the ratio between the two quantities is as low as 0.9:1.1 or as high as 1.1:0.9 (or any value in between), and a statement of a ratio of “about 5:3:1:1” for four quantities can mean that the first value in the ratio can be any value that is at least 4.5 and no more than 5.5, the second value in the ratio can be any value that is at least 2.7 and no more than 3.3, and so on.

[0111] As used herein, the term “a” or “an” entity refers to one or more of that entity. Therefore, the terms “a” (or “an”), “one or more”, and “at least one” are used interchangeably herein.

[0112] The use of “comprising,” “including,” or “having,” and variations thereof herein means to cover the items listed below and their equivalents, as well as additional items. Therefore, the terms “comprising,” “including,” or “having,” and variations thereof are used interchangeably herein. The use of “joining with,” and variations thereof herein is intended to cover any direct or indirect connection between components.

[0113] It should be understood that, as used herein, the term "device" should be given its broadest possible interpretation in accordance with 35 USC § 112(f). Therefore, claims containing the term "device" should cover all structures, materials, or actions set forth herein and all their equivalents. Furthermore, structures, materials, or actions and their equivalents should include all that is described in the summary of this disclosure, the description of the drawings, the detailed description, the abstract, and the claims themselves.

[0114] Whether explicitly stated or not, all external references are incorporated herein by reference in their entirety.

[0115] It should be understood that any embodiment, feature, or aspect described herein may be claimed in combination with any other embodiment(s), feature(s), or aspect(s) described herein, regardless of whether such features or aspects derive from the same embodiment described. For example, any one or more aspects described herein may be combined with any other one or more aspects described herein. Additionally, any one or more features described herein may be combined with any other one or more features described herein. Furthermore, any one or more embodiments described herein may be combined with any other one or more embodiments described herein.

[0116] While various embodiments of this disclosure have been described in detail, it should be clear that those skilled in the art will be able to conceive of various modifications and variations to those embodiments. However, it should be understood that such modifications and variations are within the scope and spirit of this disclosure as set forth in the following claims. Furthermore, the disclosure described herein can have other embodiments and can be practiced or implemented in a variety of different ways. It should be understood that the wording and terminology used herein are for illustrative purposes and should not be considered restrictive.

Claims

1. An intravenous injection tubing assembly, comprising: A venting needle that is operable to be inserted into the stopper of an infusion vial; A first conduit having a first end in fluid communication with the ventilated needle; A non-ventilated needle that is operable to be inserted into an intravenous solution bag; A second conduit having a first end in fluid communication with the non-ventilated needle; as well as A two-port chamber, wherein the second opposite end of the first pipeline and the second opposite end of the second pipeline are each in fluid communication with the first end of the two-port chamber.

2. The intravenous infusion tubing assembly as claimed in claim 1, further comprising: A first clamp, which is operable to control the flow of fluid through the first pipeline; as well as A second clamp, which is operable to control the flow of fluid through the second pipeline.

3. The intravenous infusion tubing assembly as described in claim 1, wherein, The first line is in fluid communication with a connector, which is capable of engaging the ventilating needle.

4. The intravenous infusion tubing assembly as described in claim 3, wherein, The connector capable of engaging the ventilating needle includes a coupling mechanism, which includes a spin lock or a Luer lock.

5. The intravenous infusion tubing assembly as described in claim 3, wherein, The connector capable of engaging the ventilating needle includes a cap that is operable to cover the distal end of the connector.

6. The intravenous infusion tubing assembly as claimed in claim 1, further comprising: A third line is in fluid communication with the second end of the two-port chamber and with a connector capable of engaging an instrument attached to the patient at an intravenous injection site.

7. The intravenous infusion tubing assembly of claim 6, further comprising: A clamp that can be operated to control the flow of fluid through the third pipeline.

8. The intravenous infusion tubing assembly as described in claim 6, wherein, The connector capable of engaging the device includes a coupling mechanism, which includes a spin lock or a Luer lock.

9. The intravenous infusion tubing assembly as described in claim 6, wherein, The connector capable of engaging the device includes a cover operable to cover the distal end of the connector.

10. The intravenous infusion tubing assembly of claim 6, further comprising: An additional connector that divides the third pipeline into a first section and a second section. The first section of the third pipeline is in fluid communication with the second end of the dual-port chamber and with the first end of the additional connector. The second section of the third pipeline is in fluid communication with the second end of the additional connector and is in fluid communication with the additional connector.

11. The intravenous infusion tubing assembly as claimed in claim 10, wherein, The first end of the additional connector includes a first branch and a second branch, wherein a first section of the third pipeline is in fluid communication with the first branch of the additional connector.

12. The intravenous infusion tubing assembly as claimed in claim 11, wherein, The second branch of the additional connector is operable to provide access to a second section of the third pipeline.

13. The intravenous infusion tubing assembly as claimed in claim 11, wherein, The second end of the additional connector and the second branch of the first end of the additional connector are substantially collinear along the longitudinal axis passing through the additional connector, and wherein the first branch of the first end of the additional connector is configured to be at an angle to the longitudinal axis passing through the additional connector.

14. The intravenous infusion tubing assembly as claimed in claim 1, wherein, The two-port chamber includes a cover at the first end.

15. The intravenous infusion tubing assembly as claimed in claim 14, wherein, The first pipeline and the second pipeline are respectively in fluid communication with the cover.

16. The intravenous infusion tubing assembly as claimed in claim 1, wherein, The dual-port chamber includes a port at a second end opposite to the first end of the dual-port chamber.

17. An intravenous injection tubing assembly, comprising: The pipe, which includes multiple pipelines; A non-ventilated needle, which is connected to the first of the multiple lines; At least one second venting needle, which is connected to at least one of the plurality of tubing lines; as well as A two-port chamber, wherein the first pipeline and the at least one second pipeline of the plurality of pipelines are in fluid communication with a plug at the first end of the two-port chamber.

18. The intravenous infusion tubing assembly as claimed in claim 17, wherein, These pipelines include: A first conduit having a first end in fluid communication with the at least one second ventilated needle; and The second conduit has a first end that is in fluid communication with the non-ventilated needle. The second opposite end of the first pipeline and the second opposite end of the second pipeline are respectively in fluid communication with the first end of the dual-port chamber.

19. A method for administering a pharmaceutical composition, comprising: A first infusion vial and an intravenous solution bag are connected to an intravenous tubing assembly for administering a first portion of the pharmaceutical composition, the intravenous tubing assembly comprising: A venting needle, operable to be inserted into the stopper of the first infusion vial; A first conduit having a first end in fluid communication with the ventilated needle; A non-ventilated needle that is operable to be inserted into the intravenous solution bag; A second conduit having a first end in fluid communication with the non-ventilated needle; and A two-port chamber, wherein the second opposite end of the first pipeline and the second opposite end of the second pipeline are in fluid communication with the first end of the two-port chamber; Disconnect the first infusion vial from the intravenous tubing assembly; and Connect the second infusion vial to the intravenous tubing assembly to administer the second portion of the drug composition.

20. The method of claim 19, wherein, Before connecting the second infusion vial to the intravenous tubing assembly, the venting needle is interchangeable with the second venting needle, which is operable to be inserted into the stopper of the second infusion vial.

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