Clinical site medicine delivery device and method

Abstract

To provide a device and a method for clinical site medicine delivery.SOLUTION: A clinical site medicine delivery device 200 comprises a central connection member 210 functioning as a boundary part among, a physiologic saline source, a medicament source, and an injection line. The central connection member 210 facilitates priming of the injection line by physiologic saline from the physiologic saline source, injection of the medicament from the medicament source to a patient, and flushing of the injection line by the physiologic saline from the physiologic saline source. The central connection member 210 provides and / or forms a fluid connection part and / or a passage among various parts such as, the physiologic saline source, the medicament source and the injection line.SELECTED DRAWING: Figure 2A

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims priority to U.S. Provisional Application No. 63 / 235,060, titled "Point of Care Drug Delivery Apparatus and Method," filed on August 19, 2021, and U.S. Provisional Application No. 63 / 071,901, titled "Point of Care Drug Delivery Apparatus and Method," filed on August 28, 2020, the entire contents of each of which are incorporated herein by reference.

[0002] The present subject matter described herein generally relates to the delivery of pharmaceuticals from vials to patients. More specifically, the present subject matter relates to an apparatus for delivering pharmaceuticals from vials to patients at the point of care.

Background Art

[0003] To inject a patient with one or more pharmaceuticals, such as drugs, biopharmaceuticals, and / or biologicals, intravenous infusion of the pharmaceuticals may be required. One or more healthcare providers may be responsible for the intravenous administration, which may include, for example, procedures for preparing the dosage to be intravenously administered to the patient and procedures for facilitating the patient.

Summary of the Invention

[0004] Aspects of the present subject matter relate to a point - of - care pharmaceutical delivery apparatus and method. The point - of - care pharmaceutical delivery apparatus and method of the present invention, in accordance with embodiments of the present subject matter, provide a pharmaceutical delivery process to patients that reduces time and steps and is simplified compared to conventional methods.

[0005] The present invention provides a clinical drug delivery device and method that, according to the present aspect of the subject matter, provides a central component connecting a saline source, a drug source, and an infusion line for priming the infusion line with saline, injecting the drug into the patient, and flushing the infusion line with saline.

[0006] The present invention simplifies the healthcare provider's workflow by reducing preparation and infusion steps, thereby enabling intravenous (IV) infusion of liquid pharmaceuticals from a primary container. There is no need to dilute the IV bag before administration, and there is no need to switch IV bags between priming, dose administration, and flushing. This provides healthcare systems with a more convenient and faster IV administration option, while simultaneously improving the patient experience. The present invention enhances safety by being a closed system. The present invention eliminates the need for closed-system pharmaceutical delivery devices and reduces additional consumables that may normally be required, such as saline bags and secondary intravenous sets.

[0007] Apparatus provided in accordance with embodiments disclosed herein. The apparatus comprises: a central connecting member having a cavity enclosed by an outer wall, through which a plurality of access points are formed; an infusion port having a first end and a second end, the first end of which is connected to a first access point of the plurality of access points; a saline port having a first end and a second end, the second end of which is connected to a second access point of the plurality of access points such that a first passage is formed between the saline port and the infusion port through the cavity of the central connecting member; and a pharmaceutical port having a first end and a second end, the second end of which is connected to a third access point of the plurality of access points such that a second passage is formed between the pharmaceutical port and the infusion port through the cavity of the central connecting member.

[0008] In another related embodiment, a method is provided, which includes priming a first amount of saline through a saline port connected to an infusion port by a first passage formed in a cavity of a central connecting member to which a saline port and an infusion port are connected; injecting an infusion amount of a drug into a patient through a drug port connected to an infusion port by a second passage formed in a cavity of a central connecting member to which a drug port is connected; and injecting a second amount of saline into a patient through at least the saline port and the infusion port.

[0009] In another related embodiment, a device is provided, which has a connecting component and a port manifold. The connecting component has a central connecting member configured to connect to an infusion stand, and a first vial connecting member connected to a first support arm, the first support arm extending from the central connecting member, and the first vial connecting member configured to support a first vial adapter. The port manifold has a port configured to be inserted into a saline source, an infusion line configured to form a passage between the port and an intravenous administration set, and a first drug line configured to connect to a first vial adapter at its first end, the first drug line connected to the infusion line at its second end.

[0010] In another related embodiment, a method is provided, which includes priming an infusion line with a first volume of saline to prime the infusion line via an infusion line connected to a saline source, infusing an infusion volume of a drug into the patient from a first vial via a drug line connected to the infusion line, and flushing the patient's body with a second volume of saline via an infusion line connected to a saline source.

[0011] In another related embodiment, an apparatus is provided. The apparatus includes a central connecting member, an injection port, and a fluid port. The central connecting member may include a cavity enclosed by an outer wall and a plurality of access points formed through each surface of the outer wall. The injection port may be connected to a first access point among the plurality of access points. The injection port may be connected to a tube. The fluid port may be connected to a second access point among the plurality of access points. The fluid port may be positioned on the opposite side of the injection port such that a first passage is formed between the fluid port and the injection port through the cavity of the central connecting member. The fluid port may be connected to a pharmaceutical source. The injection port, the fluid port, the first access point, and the second access point may be aligned along the central longitudinal axis of the central connecting member.

[0012] In another related embodiment, a device is provided. The device includes a central connecting member, an infusion port, and a fluid port. The central connecting member may include a cavity surrounded by an outer wall and a plurality of access points formed through each surface of the outer wall. The infusion port may be connected to a first access point among the plurality of access points. The infusion port may be connected to an intravenous administration set. The fluid port may be located on the opposite side of the infusion port such that a first passage is formed between the fluid port and the infusion port through the cavity of the central connecting member. The fluid port may be connected non-simultaneously to a saline source and a drug source.

[0013] Details of one or more modifications of the subject matter described herein are shown in the accompanying drawings and the following description. Other features and advantages of the subject matter described herein will become apparent from the specification and drawings, as well as the claims. [Brief explanation of the drawing]

[0014] The accompanying drawings incorporated herein and constituting part thereof illustrate specific aspects of the subject matter disclosed herein and are useful in illustrating some of the principles relating to the disclosed embodiments, along with modes for carrying out the invention. Description of the drawings: [Figure 1A] This document illustrates embodiments of clinical-site drug delivery devices and methods consistent with the present subject matter. [Figure 1B] This document illustrates embodiments of clinical-site drug delivery devices and methods consistent with the present subject matter. [Figure 2A] This document describes embodiments of clinical site drug delivery devices and methods consistent with further embodiments of the present subject. [Figure 2B] This document describes embodiments of clinical site drug delivery devices and methods consistent with further embodiments of the present subject. [Figure 2C] This document describes embodiments of clinical site drug delivery devices and methods consistent with further embodiments of the present subject. [Figure 2D] This document describes embodiments of clinical site drug delivery devices and methods consistent with further embodiments of the present subject. [Figure 2E] This document describes embodiments of clinical site drug delivery devices and methods consistent with further embodiments of the present subject. [Figure 2F] This document describes embodiments of clinical site drug delivery devices and methods consistent with further embodiments of the present subject. [Figure 3A] This document describes embodiments of clinical site drug delivery devices and methods consistent with further embodiments of the present subject. [Figure 3B] This document describes embodiments of clinical site drug delivery devices and methods consistent with further embodiments of the present subject. [Figure 3C] This document describes embodiments of clinical site drug delivery devices and methods consistent with further embodiments of the present subject. [Figure 3D] This document describes embodiments of clinical site drug delivery devices and methods consistent with further embodiments of the present subject. [Figure 4A]Aspects of a clinical-site pharmaceutical delivery device and method consistent with further embodiments of the present subject matter are shown. [Figure 4B] Aspects of a clinical-site pharmaceutical delivery device and method consistent with further embodiments of the present subject matter are shown. [Figure 4C] Aspects of a clinical-site pharmaceutical delivery device and method consistent with further embodiments of the present subject matter are shown. [Figure 4D] Aspects of a clinical-site pharmaceutical delivery device and method consistent with further embodiments of the present subject matter are shown. [Figure 5A] Aspects of a clinical-site pharmaceutical delivery device and method consistent with further embodiments of the present subject matter are shown. [Figure 5B] Aspects of a clinical-site pharmaceutical delivery device and method consistent with further embodiments of the present subject matter are shown. [Figure 5C] Aspects of a clinical-site pharmaceutical delivery device and method consistent with further embodiments of the present subject matter are shown. [Figure 5D] Aspects of a clinical-site pharmaceutical delivery device and method consistent with further embodiments of the present subject matter are shown. [Figure 6A] Aspects of a clinical-site pharmaceutical delivery device and method consistent with embodiments of the present subject matter are shown. [Figure 6B] Aspects of a clinical-site pharmaceutical delivery device and method consistent with embodiments of the present subject matter are shown. [Figure 6C] Aspects of a clinical-site pharmaceutical delivery device and method consistent with embodiments of the present subject matter are shown. [Figure 6D] Aspects of a clinical-site pharmaceutical delivery device and method consistent with embodiments of the present subject matter are shown. [Figure 7] Aspects of a clinical-site pharmaceutical delivery device consistent with further embodiments of the present subject matter are shown. [Figure 8A] Aspects of a clinical-site pharmaceutical delivery device and method consistent with further embodiments of the present subject matter are shown. [Figure 8B]This document describes embodiments of clinical site drug delivery devices and methods consistent with further embodiments of the present subject. [Figure 8C] This document describes embodiments of clinical site drug delivery devices and methods consistent with further embodiments of the present subject. [Figure 9A] This book presents embodiments of clinical-site drug delivery devices and methods that are consistent with further embodiments of the subject matter. [Figure 9B] This book presents embodiments of clinical-site drug delivery devices and methods that are consistent with further embodiments of the subject matter. [Figure 9C] This book presents embodiments of clinical-site drug delivery devices and methods that are consistent with further embodiments of the subject matter. [Figure 9D] This book presents embodiments of clinical-site drug delivery devices and methods that are consistent with further embodiments of the subject matter. [Figure 9E] This book presents embodiments of clinical-site drug delivery devices and methods that are consistent with further embodiments of the subject matter. [Figure 9F] This book presents embodiments of clinical-site drug delivery devices and methods that are consistent with further embodiments of the subject matter. [Figure 9G] This book presents embodiments of clinical-site drug delivery devices and methods that are consistent with further embodiments of the subject matter. [Figure 10] This document includes graphs showing the concentration kinetics of drugs delivered using clinical-site drug delivery devices and methods consistent with further embodiments of the subject matter of this book. [Figure 11A] This book presents embodiments of clinical-site drug delivery devices and methods that are consistent with further embodiments of the subject matter. [Figure 11B] This book presents embodiments of clinical-site drug delivery devices and methods that are consistent with further embodiments of the subject matter. [Figure 11C] This book presents embodiments of clinical-site drug delivery devices and methods that are consistent with further embodiments of the subject matter. [Figure 11D] This book presents embodiments of clinical-site drug delivery devices and methods that are consistent with further embodiments of the subject matter. [Figure 11E] This book presents embodiments of clinical-site drug delivery devices and methods that are consistent with further embodiments of the subject matter. [Figure 11F] This book presents embodiments of clinical-site drug delivery devices and methods that are consistent with further embodiments of the subject matter. [Figure 12A] This book presents embodiments of clinical-site drug delivery devices and methods that are consistent with further embodiments of the subject matter. [Figure 12B] This book presents embodiments of clinical-site drug delivery devices and methods that are consistent with further embodiments of the subject matter. [Figure 12C] This book presents embodiments of clinical-site drug delivery devices and methods that are consistent with further embodiments of the subject matter. [Figure 13A] This book presents embodiments of clinical-site drug delivery devices and methods that are consistent with further embodiments of the subject matter. [Figure 13B] This book presents embodiments of clinical-site drug delivery devices and methods that are consistent with further embodiments of the subject matter. [Figure 13C] This book describes embodiments of clinical drug delivery devices and methods that are consistent with further embodiments of the subject matter. In practical use, similar reference numbers indicate similar structures, features, or elements. [Modes for carrying out the invention]

[0015] I. Definition "Patient" or "subject requiring it" means an organism suffering from or susceptible to a disease or condition that can be treated by administration of a pharmaceutical composition such as those provided herein. Non-limiting examples include humans, other mammals, cattle, rats, mice, dogs, cats, monkeys, goats, sheep, deer, and other non-mammals. In some embodiments, the patient is human.

[0016] Dosage may vary depending on the patient and the requirements of the compound being used. In the context of this disclosure, the dose administered to a patient should be sufficient to produce a beneficial therapeutic response in the patient over time. The magnitude of the dose is also determined by the presence, nature, and severity of side effects. Determining the appropriate dose for a particular situation is within the scope of the healthcare professional's skill. Dosage and intervals can be individually adjusted to provide an effective level of the administered compound for the specific clinical indication being treated. This allows for the provision of treatment commensurate with the severity of the individual's disease.

[0017] II. Pharmaceutical Compositions The term "pharmaceutical" is used in its simple, ordinary sense and refers to any pharmaceutical composition or preparation. A pharmaceutical may be a drug for the treatment and / or prevention of any disease. Preferably, a pharmaceutical is an aqueous composition or is diluted with an aqueous composition before being administered to a patient. A pharmaceutical may be, but is not limited to, an anticancer agent, an anti-inflammatory agent, a biopharmaceutical, a peptide, a small molecule, a nucleic acid, a lipid, etc.

[0018] 3-IAABU (cytoskeleton / Mount 3-IAABU (cytoskeleton / Mount Sinai School of Medicine, i.e., MF-569), narcosine (also known as NSC-5366), nascapine, D-24851 (Asta Medica), A-105972 (Abbott), Hemiastarlin, 3-BAABU (Cytoskeleton / Mount Sinai School of Medicine, i.e., MF-191), TMPN (Arizona State University), Vanadocene Acetylacetonate, T-138026 (Tularik), Monsatrol, Inanosin (i.e., NSC-698666), 3-IAABE (Cytoskeleton / Mount Sinai School of Medicine), A-204197 (Abbott), T-607 (Tuiarik, i.e., T-900607), RPR-115781 (Aventis), Eleuterobin (Desmethylleuterobin, Desaethylerutrobin, Isoeleterobin A, Z-Eleuterobin, etc.), Caribaeoside, Caribaeolin, Halichondrin B, D-64131 (Asta Medica), D-68144 (Asta Medica), Diazonamide A, A-293620 (Abbott), NPI-2350 (Nereus), Taccaronolide A, TUB-245 (Aventis), A-259754 (Abbott), Diozostatin, (-)-Phenylahistine (i.e., NSCL-96F037), D-68838 (Asta Medica), D-68836 (Asta Medica), Myoseberin B, D-43411 (Zentaris, i.e., D-81862), A-289099 (Abbott), A-318315 (Abbott), HTI-286 (i.e., SPA-110, trifluoroacetate) (Wyeth), D-82317 (Zentaris), D-82318 (Zentaris), SC-12983 (NCI), Resverastatin sodium phosphate, BPR-OY-007 (National Health Research Institutes), and SSR-250411 (Sanofi), Steroids (e.g., dexamethasone), Finasteride, Aromatase inhibitors, Gonadotropin-releasing hormone agonists (GnRH) such as goserelin or leuprolide, Adrenaline-corticosteroids (e.g., Prednisone),Progestins (e.g., hydroxyprogesterone caproate, megestrol acetate, medroxyprogesterone acetate), estrogens (e.g., dietristilbestrol, ethinylestradiol), anti-estrogens (e.g., tamoxifen), androgens (e.g., testosterone propionate, fluoxymesterone), anti-androgens), immunostimulants (e.g., Bacillus calmetgerin (BCG), Levamisosol, interleukin-2, alpha-interferon, etc.), monoclonal antibodies (e.g., anti- CD20, anti-HER2, anti-CD52, anti-HLA-DR, and anti-VEGF monoclonal antibodies), immunotoxins (e.g., anti-CD33 monoclonal antibody-calicheamicin conjugate, anti-CD22 monoclonal antibody-pseudomonas exotoxin conjugate, etc.), radioimmunotherapy (e.g., anti-CD20 monoclonal antibody conjugated to 111In, 90Y, or 131I, etc.), triptolide, homoharingtonin, dactinomycin, doxorubicin, epirubicin, topotecan, itraconazole, vindesine, cerivasta Tin, vincristine, deoxyadenosine, sertraline, pitavastatin, EGFR irinotecan, clofazimine, 5-nonyloxytryptamine, vemurafen, epidermal growth factor receptor (EGFR) targeted therapies or treatments (e.g., gefitinib (Iressa®), erlotinib (Tarceva®), cetuximab (Erbitux®), lapatinib (Tykerb®), panitumumab (Vectibix®), vandetanib (Caprelsa®), afatinib / BIBW2 992, CI-1033 / canertinib, neratinib / HKI-272, CP-724714, TAK-285, AST-1306, ARRY334543, ARRY-380, AG-1478, dacomitinib / PF299804, OSI-420 / desmethylerlotinib, AZD8931, AEE788, peritinib / EKB-569, CUDC-101, WZ8040, WZ4002, WZ3146, AG-490, XL647, PD153035, BMS-599626), sorafenib, imatinib, sunitinib, dasatinib, etc. In one embodiment, the anticancer drug is:These include immune checkpoint inhibitors (e.g., atezolizumab (Tecentriq®), pembrolizumab (Keytruda®), ipilimumab, nivolumab (Opdivo®), avelumab, durvalumab, semiprimab, or spartalizumab).

[0019] II.How to use As used herein, the term “administer” generally means intravenous administration unless otherwise indicated. Other forms of administration include, but are not limited to, suppositories, topical contact, oral administration, parenteral administration, intraperitoneal administration, intramuscular administration, intranasal administration, intrathecal administration, nasal administration, subcutaneous administration, sustained-release devices such as mini osmotic pumps, and transmucosal administration (e.g., buccal, sublingual, palate, gingival, nasal cavity, vagina, rectum, or transdermal). Parenteral administration includes, for example, intravenous, intramuscular, intra-arterial, intradermal, subcutaneous, intraperitoneal, intraperitoneal, and intracranial administration. Other modes of delivery include, but are not limited to, the use of liposomal drugs and transdermal patches.

[0020] It is understood that the examples and embodiments described herein are for illustrative purposes only, and that various modifications or changes taking them into account have been proposed to those skilled in the art and should be included in the spirit and scope of this specification and the appended claims.

[0021] III. Explanation The current subject matter relates to clinical site drug delivery devices and methods. The clinical site drug delivery devices and methods of the present invention, consistent with embodiments of the current subject matter, reduce time and steps and provide a simplified drug delivery process to patients compared to conventional methods.

[0022] The clinical drug delivery device and method of the present invention, according to the present aspect of the subject matter, incorporates a central component connecting a saline source, a drug source, and an infusion line for priming the infusion line with saline, injecting the drug into the patient, and flushing the infusion line with saline.

[0023] The present invention's in-situ drug delivery device and method, consistent with embodiments of the present subject matter, simplifies the healthcare provider's workflow by reducing preparation and infusion steps by enabling intravenous (IV) infusion of drugs from a primary container. Delivering drugs to patients using the in-situ drug delivery device and method eliminates the need for dilution in IV bags before administration and the need to switch IV bags between priming, dose administration, and flushing. Thus, the in-situ drug delivery device and method provides a more convenient and rapid IV administration option for healthcare systems while improving the patient experience. The present invention's in-situ drug delivery device and method enhances safety by being a closed system. The in-situ drug delivery device and method eliminates the need for closed-system drug delivery devices and reduces additional consumables such as saline bags and secondary intravenous sets that may normally be required.

[0024] Traditional drug infusion procedures may involve one or more healthcare providers administering medications intravenously, which may include, for example, dose preparation and patient preparation procedures to enable the drug to be administered to the patient intravenously. For example, dose preparation procedures may involve one or more healthcare providers diluting the drug in an infusion bag, which consumes valuable resources such as time (e.g., the time healthcare providers spend diluting the drug) and materials (e.g., infusion bags). Furthermore, dose preparation procedures must be performed in a sterile environment, consuming resources such as sterile equipment (e.g., healthcare provider gloves and masks) and hospital or clinic space. Moreover, such dose preparation procedures inherently carry a risk of error because they rely on human interaction in the dilution of the drug.

[0025] The clinical-stage drug delivery device and method consistent with the current subject matter simplifies conventional intravenous drug infusion procedures by injecting drugs into patients from vials or containers. This reduces the time, materials, and space resources required in conventional dosage preparation procedures.

[0026] According to the present aspect of the subject, the clinical drug delivery device (hereinafter also referred to as the drug delivery device) of the present invention has a central connecting member that functions as a connection between a saline source, a drug source, and an infusion line (e.g., an IV dosing set). The IV dosing set is configured to administer a liquid to a patient. For example, the IV dosing set can be connected to an infusion pump that operates to pump the fluid held in the IV dosing set at a predetermined rate. At the distal end of the infusion line is a single IV catheter or needle inserted to deliver the drug from the infusion line to the patient. The central connecting member facilitates priming of the infusion line with saline from the saline source, infusion of the drug from the drug source to the patient, and flushing of the infusion line with saline from the saline source.

[0027] In the present embodiment of the subject matter, as described below herein, the central connecting member connects and / or establishes and / or forms passages for fluids between various saline sources, drug sources, and infusion lines (e.g., IV dosing sets).

[0028] Figures 1A to 13C show various examples of drug delivery devices 100, 200, 300, 400, 700, 800, 900, 1100, and 1300 that are consistent with embodiments of the subject matter of this publication. Each of the features, characteristics, and / or components of the drug delivery devices 100, 200, 300, 400, 700, 800, 900, 1100, and 1300 described herein may be implemented in one or more of the other disclosed drug delivery devices 100, 200, 300, 400, 700, 800, 900, 1100, and 1300. For example, the features, characteristics, and / or components of drug delivery device 100 may be implemented in drug delivery devices 200, 300, 400, 700, 800, 900, 1100, and / or 1300. The features, characteristics, and / or components of the drug delivery device 200 may be implemented in drug delivery devices 100, 300, 400, 700, 800, 900, 1100, and / or 1300. The features, characteristics, and / or components of the drug delivery device 300 may be implemented in drug delivery devices 100, 200, 400, 700, 800, 900, 1100, and / or 1300. The features, characteristics, and / or components of the drug delivery device 400 may be implemented in drug delivery devices 100, 200, 300, 700, 800, 900, 1100, and / or 1300. The features, characteristics, and / or components of the drug delivery device 700 may be implemented in drug delivery devices 100, 200, 300, 400, 800, 900, 1100, and / or 1300. The features, characteristics, and / or components of the drug delivery device 800 may be implemented in drug delivery devices 100, 200, 300, 400, 700, 900, 1100, and / or 1300. The features, characteristics, and / or components of the drug delivery device 900 may be implemented in drug delivery devices 100, 200, 300, 400, 700, 800, 1100, and / or 1300. The features, characteristics, and / or components of the drug delivery device 1100 may be implemented in drug delivery devices 100, 200, 300, 400, 700, 800, 900, and / or 1300.The features, characteristics, and / or components of the drug delivery device 1300 may be implemented in drug delivery devices 100, 200, 300, 400, 700, 800, 900, and / or 1100.

[0029] Figure 1A shows an embodiment of a clinical-stage immediate drug delivery device and method consistent with the present subject. The drug delivery device 100 has a central connecting member 110. The central connecting member 110 has a cavity 112 surrounded by an outer wall 114 and a plurality of access points 116 formed through each surface of the outer wall 114. Figure 1A shows three access points: a first access point 116a, a second access point 116b, and a third access point 116c.

[0030] The drug delivery device 100 also has an infusion port 120, a saline port 130, and a drug port 140. According to the present embodiment of the subject, ports 120, 130, and 140 each have a first end and a second end, and ports 120, 130, and 140 are each connected at one end to the respective access points 116a, 116b, and 116c of the central connecting member 110.

[0031] The injection port 120 has a first end 121 connected to a first access point 116a of the central connecting member 110, and a second end 122. The second end 122 of the injection port 120 can be configured to connect to an IV dosing set for delivering fluid from the injection port 120.

[0032] The saline port 130 has a first end 131 and a second end 132. The second end 132 of the saline port 130 is connected to a second access point 116b of the central connecting member 110. This forms a first passage 150 between the saline port 130 and the infusion port 120 via the second access point 116b and the first access point 116a. The first passage 150 is a fluid connection through a cavity 112 of the central connecting member 110. The first end 131 of the saline port 130 is configured to be connected to a saline source, thereby allowing the saline port 130 to deliver saline from the saline source to the infusion port 120 through the cavity 112 of the central connecting member 110 (e.g., through the first passage 150). In some embodiments, the saline port 130 is terminated with a spike for connection to a saline source (e.g., a saline bag).

[0033] The drug port 140 of the drug delivery device 100 has a first end 141 and a second end 142. The second end 142 of the drug port 140 is connected to a third access point 116c of the central connecting member 110. This forms a second passage 160 between the drug port 140 and the infusion port 120 via the third access point 116c and the first access point 116a. The second passage 160 is a fluid connection that passes through the cavity 112 of the central connecting member 110. The first end 141 of the drug port 140 is configured to be connected to a drug source, thereby enabling the drug port 140 to deliver a drug from the drug source to the infusion port 120 through the cavity 112 of the central connecting member 110 (for example, through the second passage 160). The drug source may be, for example, a syringe. The drug source may be, for example, a vial or container. In one embodiment, the first end 141 of the drug port 140 may be a vial adapter configured to engage with a vial so that the drug flows through the vial and vial adapter through the drug port 140 to the cavity 112 of the central connecting member 110, or may engage with such a vial adapter.

[0034] As shown in Figure 1A, the drug delivery device 100 primes the IV dosing set with saline solution, flushes the IV dosing set with saline solution from a saline source, and establishes a fluid connection (e.g., a first passage 150) between the saline port 130 and the infusion port 120 via a central connecting member 110 and access points 116a, 116b, and 116c to deliver the drug from the drug source to the patient via the IV dosing set through the drug port 140 and the infusion port 120 (e.g., a second passage 160).

[0035] Figure 1B shows an operation of the drug delivery device 100 consistent with an embodiment of the present subject. Drug delivery using the drug delivery device 100, according to some embodiments, includes four steps, as shown in Figure 1B: priming 171, drug aspiration 172, drug infusion 173, and drug administration and flushing 174. Each step is achieved by pumping from an infusion pump connected to an IV dosing set coupled to the infusion port 120.

[0036] The priming step 171 includes injecting a first volume of saline solution from a saline source into the cavity 112 of the central connecting member 110 via the saline port 130. For example, the saline port 130 may be terminated with a spike or the like for connecting to a saline source such as a saline bag. Priming distributes the first volume of saline solution to the cavity 112 and the injection port 120 via the first passage 150.

[0037] The aspiration of pharmaceuticals 172 may also include, in accordance with the embodiments of the present subject matter, aspirating a certain amount (e.g., an injection amount) of pharmaceuticals from a pharmaceutical source such as a vial or container using a syringe or the like.

[0038] The drug injection 173 includes, for example, injecting an injection volume of drug contained in a syringe through the drug port 140 of the central connecting member 110. For example, the injection volume can be injected into the cavity 112 through the drug port 140.

[0039] The administration and flushing of the drug 174, according to the present embodiment of the subject, involves injecting the infusion volume of the drug and a second volume of saline into the patient via the infusion port 120 and the IV dosing set. For example, after priming with the first volume of saline 171 and injecting the infusion volume of the drug 173, the infusion volume and the second volume of saline may be flushed into the IV dosing set via the infusion port 120. The injection of the second volume of saline ensures that the infusion volume of the drug is delivered to the patient.

[0040] In a further embodiment of the present subject matter, a movable conduit may be provided inside the cavity of the central connecting member. The movable conduit may be a tube, pipe, etc., located within a cavity that connects to various access points, thereby forming a secure passage between various access points, and thereby a secure passage between saline ports, infusion ports, drug ports, and flushing ports (if incorporated as described below herein). Thus, the movable conduit becomes a passage (e.g., a fluid connection) that enables priming and flushing of saline, as well as delivery of drug. In an embodiment of the present subject matter, the central connecting member including the movable conduit is a type of valve for forming a fluid connection between various access points, as described below herein.

[0041] Figures 2A to 2C show embodiments of the drug delivery device 200 consistent with the present subject. Figure 2A is a perspective view, and Figures 2B and 2C are cross-sectional views of the drug delivery device 200.

[0042] The pharmaceutical delivery device 200 has a central connecting member 210. The central connecting member 210 has a cavity 212 surrounded by an outer wall 214 and a plurality of access points 216 formed through each surface of the outer wall 214. Figures 2B and 2C show three access points: a first access point 216a, a second access point 216b, and a third access point 216c.

[0043] The pharmaceutical delivery device 200 has a movable conduit 270, as shown in the cross-sectional views of Figures 2B and 2C. The movable conduit 270 is located within a cavity 212 and is connected to a plurality of access points 216, as will be described later in this specification.

[0044] The drug delivery device 200 also has an infusion port 220, a saline port 230, and a drug port 240. According to the present embodiment of the subject, ports 220, 230, and 240 each have a first end and a second end, and ports 220, 230, and 240 each connect at one end to the respective access points 216a, 216b, and 216c of the central connecting member 210.

[0045] The injection port 220 has a first end 221 connected to a first access point 216a of the central connecting member 210, and a second end 222. The second end 222 of the injection port 220 can be configured to connect to an IV dosing set for delivering fluid from the injection port 220.

[0046] The saline port 230 has a first end 231 and a second end 232. The second end 232 of the saline port 230 is connected to the second access point 216b of the central connecting member 210.

[0047] In accordance with the current embodiment of the subject, the movable conduit 270 is configured to move between at least a first position and a second position. In the first position, the movable conduit 270 connects to a plurality of access points 216, with a first passage 250 set between a second access point 216b and a first access point 216a, forming a fluid connection between the saline port 230 and the injection port 220.

[0048] The first end 231 of the saline port 230 is configured to connect to a saline source, thereby allowing the saline port 230 to deliver saline from the saline source to the infusion port 220 through a first passage 250 formed by the movable conduit 270. In some embodiments, the saline port 230 is terminated with a spike for connection to a saline source (e.g., a saline bag).

[0049] The drug port 240 of the drug delivery device 200 has a first end 241 and a second end 242. The second end 242 of the drug port 240 is connected to a third access point 216c of the central connecting member 210.

[0050] In accordance with the current embodiment of the subject, in the second position, the movable conduit 270 is connected to a plurality of access points 216, and a second passage 260 is set between the third access point 216c and the first access point 216a, forming a fluid connection between the saline port 240 and the injection port 220.

[0051] The first end 241 of the drug port 240 is configured to be connected to a drug source, thereby enabling the drug port 240 to deliver a drug from the drug source to the infusion port 220 through a second passage 260.

[0052] As shown in Figures 2A to 2C, the first end 241 of the drug port 240 may be a vial adapter configured to engage with a vial and a vial adapter 280 so that the drug flows from the drug port 240 and the second passage 260 to the infusion port 220, or may engage with such a vial adapter.

[0053] In accordance with the embodiments of the present subject, the drug delivery device 200 may have a control member 290, as shown in Figure 2A. The control member 290 is connected to the movable conduit 270 to move the movable conduit 270 between a first position and a second position. For example, the control member 290 may be configured such that a movement of the control member 290, such as rotation of the control member 290, causes rotation of the movable conduit 270 within the cavity 212 of the central connecting member 210. The movement of the control member 290 causes alignment of the movable conduit 270 to form a first passage 250 and a second passage 260.

[0054] In the present embodiment of the subject, the first position and the second position of the movable conduit 270 do not occur simultaneously. That is, the first passage 250 is formed and opens between the second access point 216b and the first access point 216a, forming a fluid connection between the saline port 230 and the infusion port 220, but the second passage 260 is not formed (for example, the movable conduit 270 is positioned so that there is no fluid connection between the drug port 240 and the infusion port 220). If the second passage 260 is formed and opens between the third access point 216c and the first access point 216a, forming a fluid connection between the drug port 240 and the infusion port 220, then the first passage 250 is not formed (for example, the movable conduit 270 is positioned so that there is no fluid connection between the saline port 230 and the infusion port 220). This configuration allows priming and flushing with saline solution to occur between the saline port 230 and the infusion port 220, separate from the delivery of the drug from the drug port 240 to the infusion port 220.

[0055] Figures 2D and 2E show further embodiments of the drug delivery device 200 consistent with the embodiment of the present subject. Figure 2D is a perspective view of the drug delivery device 200 connected to a saline source 292 via a saline port 230 and to a vial 294 via a drug port 240, while Figure 2E is a cross-sectional view. An infusion port 220 is connected to an IV dosing set 296. As shown in the cross-sectional view of Figure 2E, the movable conduit 270 is positioned such that a first passage 250 opens between the saline port 230 and the infusion port 220. In the configuration shown in Figure 2E, a second passage 260 is not formed (for example, the movable conduit 270 is positioned such that there is no fluid connection between the drug port 240 and the infusion port 220).

[0056] Figure 2F shows an operation of the drug delivery device 200 consistent with the embodiment of the present subject. Drug delivery using the drug delivery device 200, according to some embodiments, includes three stages: priming 297, drug delivery 298, and flushing 299, as shown in Figure 2F. A cross-sectional view of the drug delivery device 200 is shown, illustrating the movable conduit 270, the first passage 250, and the second passage 260. A front view is also shown to indicate the corresponding position of the control member 290. Each stage is achieved by pumping from an infusion pump connected to an IV dosing set coupled to the infusion port 220.

[0057] In priming step 297, the movable conduit 270 is positioned in a first position such that a first passage 250 is formed between the saline port 230 and the infusion port 220, allowing saline from a saline source (e.g., a saline bag) to flow through the first passage 250 to the infusion port 220 (connected to an IV dosing set). Priming 297 includes injecting a first volume of saline into the drug delivery device 200 via the saline port 230. The saline port 230 may be terminated with a spike or the like for connection to a saline source such as a saline bag. Priming distributes the first volume of saline into the cavity 112 and the infusion port 220 via the first passage 250.

[0058] During the drug delivery stage 298, the movable conduit 270 is moved to a second position. For example, the control member 290 is rotated so that a second passage 260 is formed between the drug port 240 and the infusion port 220. This allows the drug to flow from the vial through the drug port 240 and through the second passage 260 to the infusion port 220 (which is connected to the IV administration set).

[0059] Following drug delivery 298, flushing 299 is the next operating step of the drug delivery device 200. The movable conduit 270 is returned to the first position so that a first passage 250 is formed. A second volume of saline solution is flushed through the first passage 250 to the infusion port 220. The infusion of the second volume of saline solution ensures that the infusion volume of drug is delivered to the patient.

[0060] Figures 3A to 3C show embodiments of the drug delivery device 300 consistent with the embodiment of the present subject. Figure 3A is a perspective view, and Figures 3B and 3C are cross-sectional views of the drug delivery device 300.

[0061] Similar to the drug delivery device 200, the drug delivery device 300 has a central connecting member 310 having a cavity 312 surrounded by an outer wall 314 and a plurality of access points 316 formed through each surface of the outer wall 314. Figures 3B and 3C show four access points: a first access point 316a, a second access point 316b, a third access point 316c, and a fourth access point 316d.

[0062] The pharmaceutical delivery device 300 has a movable conduit 370, as shown in the cross-sectional views of Figures 3B and 3C. The movable conduit 370 is located within a cavity 312 and is connected to a plurality of access points 316, as will be described later in this specification.

[0063] The drug delivery device 300 also has an infusion port 320, a saline port 330, a drug port 340, and a flushing port 345. According to the present embodiment of the subject, each of the ports 320, 330, 340, and 345 has a first end and a second end, and each of the ports 320, 330, 340, and 345 is connected at one end to the respective access points 316a, 316b, 316c, and 316d of the central connecting member 310.

[0064] The injection port 320 has a first end 321 connected to a first access point 316a of the central connecting member 310, and a second end 322. The second end 322 of the injection port 320 can be configured to connect to an IV dosing set for delivering fluid from the injection port 320.

[0065] The saline port 330 has a first end 331 and a second end 332. The second end 332 of the saline port 330 is connected to the second access point 316b of the central connecting member 310.

[0066] In accordance with the embodiment of the present subject, the movable conduit 370 is configured to move between at least a first position and a second position. In the first position, the movable conduit 370 is connected to a plurality of access points 316, with a first passage 350 set between a second access point 316b and a first access point 316a, forming a fluid connection between the saline port 330 and the injection port 320.

[0067] The first end 331 of the saline port 330 is configured to connect to a saline source, thereby enabling the saline port 330 to deliver saline from the saline source to the infusion port 320 through a first passage 350 formed by the movable conduit 370. In some embodiments, the saline port 330 is terminated with a spike for connection to a saline source (e.g., a saline bag).

[0068] The drug port 340 of the drug delivery device 300 has a first end 341 and a second end 342. The second end 342 of the drug port 340 is connected to a third access point 316c of the central connecting member 310.

[0069] The flushing port 345 has a first end 346 and a second end 347. The second end 347 of the flushing port 345 is connected to the fourth access point 316d of the central connecting member 310.

[0070] In accordance with the embodiment of the present subject, in the second position, the movable conduit 370 is connected to a plurality of access points 316, and a second passage 360 ​​is set between the third access point 316c and the first access point 316a, forming a fluid connection between the saline port 340 and the injection port 320. Furthermore, in the second position, the movable conduit 370 is connected to a plurality of access points 316, and a third passage 365 is set between the second access point 316b and the fourth access point 316d, forming a fluid connection between the saline port 330 and the flushing port 345.

[0071] The first end 341 of the drug port 340 is configured to be connected to a drug source, thereby enabling the drug port 340 to deliver a drug from the drug source to the infusion port 320 through a second passage 360.

[0072] The first end 346 of the flushing port 345 is configured to be connected to a drug source, thereby allowing saline to flow from the saline port 330 through the third passage 365 to the drug source. The third passage 365 allows flushing to occur within the drug source via the connection between the saline source and the drug source.

[0073] As shown in Figures 3A to 3C, the first end 341 of the drug port 340 and the first end 346 of the flushing port 345 may be terminated and / or engaged with a vial adapter 380 (not shown in Figures 3A to 3C) configured to engage with a vial. Consistent with the embodiment of the present subject, saline flows from a saline source through the vial adapter 380 into the vial, where it is mixed with the drug contained in the vial and flushed. Furthermore, the drug flows from the vial and vial adapter 380 through the drug port 340 and the second passage 360 ​​to the infusion port 320.

[0074] In accordance with the embodiments of the present subject, the drug delivery device 300 may have a control member 390, as shown in Figure 3A. The control member 390 is connected to the movable conduit 370 to move the movable conduit 370 between a first position and a second position. For example, the control member 390 may be configured such that a movement such as rotation of the control member 390 causes rotation of the movable conduit 370 within the cavity 312 of the central connecting member 310. The movement of the control member 390 then aligns the movable conduit 370 to form a first passage 350, a second passage 360, and a third passage 365.

[0075] According to the present embodiment of the subject, the first position and the second position of the movable conduit 370 do not occur simultaneously. That is, the first passage 350 is formed and open between the second access point 316b and the first access point 316a, forming a fluid connection between the saline port 330 and the infusion port 320, but the second passage 360 ​​and the third passage 365 are not formed. (For example, the movable conduit 370 is positioned so that there are no fluid connections between the drug port 340 and the infusion port 320 and between the saline port 330 and the flushing port 445). When the second passage 360 ​​and the third passage 365 are formed and open, the first passage 350 is not formed (for example, the movable conduit 370 is positioned so that there is no fluid connection between the saline port 330 and the infusion port 320). This arrangement allows saline priming to occur between the saline port 330 and the infusion port 320, separate from the delivery of the drug from the drug port 340 to the infusion port 320 and saline flushing to the drug source via the flushing port 345.

[0076] Figure 3D shows an operation of the drug delivery device 300 consistent with the embodiment of the present subject. Drug delivery using the drug delivery device 300, according to some embodiments, involves two stages: priming 392 and drug delivery 394, as shown in Figure 3D. The drug delivery device 300 is shown in a cross-sectional view, showing the movable conduit 370, the first passage 350, the second passage 360, and the third passage 365. Each stage is achieved by pumping from an infusion pump connected to an IV dosing set coupled to the infusion port 320.

[0077] In the priming stage 392, the movable conduit 370 is positioned in a first position such that a first passage 350 is formed between the saline port 330 and the infusion port 320, allowing saline from a saline source (e.g., a saline bag) to flow through the first passage 350 to the infusion port 320 (connected to an IV dosing set). Priming 392 includes injecting a first volume of saline into the drug delivery device 300 via the saline port 330. The saline port 330 may be terminated with a spike or the like for connection to a saline source such as a saline bag. Priming distributes the first volume of saline to the cavity 112 and the infusion port 320 via the first passage 350.

[0078] During the drug delivery stage 394, the movable conduit 370 is moved to a second position. For example, the control member 390 is rotated so that a second passage 360 ​​and a third passage 365 are formed. This allows the drug to flow from the vial through the drug port 340, through the second passage 360, to the infusion port 320 (connected to the IV administration set), and allows saline to flow from the saline port 330 through the third passage 365 to the flushing port 345 and the drug source.

[0079] Figures 4A to 4C show embodiments of the drug delivery device 400 consistent with the embodiment of the present subject. Figure 4A is a perspective view, and Figures 4B and 4C are cross-sectional views of the drug delivery device 400.

[0080] Similar to the drug delivery device 300, the drug delivery device 400 has a central connecting member 410 having a cavity 412 surrounded by an outer wall 414 and a plurality of access points 416 formed through each surface of the outer wall 414. Figures 4B and 4C show four access points: a first access point 416a, a second access point 416b, a third access point 416c, and a fourth access point 416d.

[0081] The pharmaceutical delivery device 400 has a movable conduit 470, as shown in the cross-sectional views of Figures 4B and 4C. The movable conduit 470 is located within a cavity 412 and is connected to a plurality of access points 416, as will be described later in this specification.

[0082] The drug delivery device 400 also has an infusion port 420, a saline port 430, a drug port 440, and a flushing port 445. According to the present embodiment of the subject, each of the ports 420, 430, 440, and 445 has a first end and a second end, and each of the ports 420, 430, 440, and 445 is connected at one end to the respective access points 416a, 416b, 416c, and 416d of the central connecting member 410.

[0083] The injection port 420 has a first end 421 connected to a first access point 416a of the central connecting member 410, and a second end 422. The second end 422 of the injection port 420 can be configured to connect to an IV dosing set for delivering fluid from the injection port 420.

[0084] The saline port 430 has a first end 431 and a second end 432. The second end 432 of the saline port 430 is connected to the second access point 416b of the central connecting member 410.

[0085] In accordance with the embodiment of the present subject, the movable conduit 470 is configured to move between at least a first position and a second position. In the first position, the movable conduit 470 is connected to a plurality of access points 416, with a first passage 450 set between a second access point 416b and a first access point 416a, forming a fluid connection between the saline port 430 and the injection port 420.

[0086] The first end 431 of the saline port 430 is configured to connect to a saline source, thereby enabling the saline port 430 to deliver saline from the saline source to the infusion port 420 through a first passage 450 formed by the movable conduit 470. In some embodiments, the saline port 430 is terminated with a spike for connection to a saline source (e.g., a saline bag).

[0087] The drug delivery device 400's drug port 440 has a first end 441 and a second end 442. The second end 442 of the drug port 440 is connected to a third access point 416c of the central connecting member 410.

[0088] The flushing port 445 has a first end 446 and a second end 447. The second end 447 of the flushing port 445 is connected to a fourth access point 416d of the central connecting member 410.

[0089] In accordance with the embodiment of the present subject, in the second position, the movable conduit 470 is connected to a plurality of access points 416, and a second passage 460 is set between the third access point 416c and the first access point 416a, forming a fluid connection between the saline port 440 and the injection port 420. Furthermore, in the second position, the movable conduit 470 is connected to a plurality of access points 416, and a third passage 465 is set between the second access point 416b and the fourth access point 416d, forming a fluid connection between the saline port 430 and the flushing port 445.

[0090] The first end 441 of the drug port 440 is configured to connect to a drug supply source 444, thereby enabling the drug port 440 to deliver a drug from the drug supply source 444 to the infusion port 420 through a second passage 450. According to some embodiments of the present subject, the drug source 444 is a chamber containing an infusion volume of drug. For example, the drug source 444 may be connected to a vial or container via a vial adapter 480 (not shown in Figures 4A-4C) configured to engage with the vial or container. In some embodiments where the drug source 444 is a chamber, the chamber may be a compressible or flexible chamber that allows the drug to be transferred from the vial or container to the drug source via the vial adapter 480. The chamber may be a syringe, a flexible chamber, or a chamber with an extendable member configured to draw an infusion volume of drug from the vial or container. In some embodiments, the vial adapter 480 is not required.

[0091] The first end 446 of the flushing port 445 is configured to be connected to the drug source 444, thereby allowing saline to flow from the saline port 430 through the third passage 465 to the drug source 444. The third passage 465 allows flushing to occur within the drug source 444 via the connection between the saline source and the drug source 444.

[0092] In accordance with the embodiment of the present subject, the first end 446 of the flushing port 445 may be connected to the upper part of the drug source 444. The upper part may also refer to the portion of the drug source 444 that is above the midpoint of the length of the drug source 444. The upper part may also refer to the top surface of the drug source 444. The first end 441 of the drug port 440 may be connected to the lower part of the drug source 444. The lower part may also refer to the portion of the drug source 444 that is below the midpoint of the length of the drug source 444. The lower part may also refer to the top surface of the drug source 444. With the flushing port 445 connected to the upper part of the drug source 444 and the drug port 440 connected to the lower part, saline solution is added to the drug source 444 for automatic flushing. The drug flows from the vial and vial adapter 444 through the drug port 440 and the second passage 460 to the infusion port 420.

[0093] In accordance with the embodiments of the present subject, the drug delivery device 400 may have a control member 490, as shown in Figure 4A. The control member 490 is connected to the movable conduit 470 to move the movable conduit 470 between a first position and a second position. For example, the control member 490 may be configured such that a movement such as rotation of the control member 490 causes rotation of the movable conduit 470 within the cavity 412 of the central connecting member 410. The movement of the control member 490 then aligns the movable conduit 470 to form a first passage 450, a second passage 460, and a third passage 465.

[0094] According to the present embodiment of the subject, the first position and the second position of the movable conduit 470 do not occur simultaneously. That is, the first passage 450 is formed and opened between the second access point 416b and the first access point 416a, forming a fluid connection between the saline port 430 and the injection port 420, but the second passage 460 and the third passage 465 are not formed. (For example, the movable conduit 470 is positioned so that there are no fluid connections between the drug port 440 and the infusion port 420 and between the saline port 430 and the flushing port 445. When the second passage 460 and the third passage 465 are formed and open, the first passage 450 is not formed (for example, the movable conduit 470 is positioned so that there are no fluid connections between the saline port 430 and the infusion port 420). This arrangement allows saline priming to occur between the saline port 430 and the infusion port 420, apart from the delivery of the drug from the drug port 440 to the infusion port 420 and saline flushing to the drug source 444 via the flushing port 445.

[0095] Figure 4D shows an operation of the drug delivery device 400 consistent with the embodiment of the present subject. Drug delivery using the drug delivery device 400, according to some embodiments, includes three stages, as shown in Figure 4D: drug transfer 492, priming 494, and drug delivery and flushing 496. The drug delivery device 400 is shown in a cross-sectional view, showing the movable conduit 470, the first passage 450, the second passage 460, and the third passage 465. Each stage is achieved by pumping from an infusion pump connected to an IV dosing set coupled to an infusion port 420.

[0096] In the drug transfer stage 492, the drug is transferred from the vial to the drug source 444. Consistent with the embodiments of the present subject, the drug source 444 may be a flexible chamber that, when compressed, forces air from the chamber into the vial, creating a vacuum within the chamber. When the chamber is released, the drug is transferred to the chamber. The drug source 444 may be provided with a mechanism for transferring the appropriate amount, and may also be provided with a dose line or the like to ensure dosage accuracy.

[0097] In priming step 494, the movable conduit 470 is positioned in a first position such that a first passage 450 is formed between the saline port 430 and the infusion port 420, allowing saline from a saline source (e.g., a saline bag) to flow through the first passage 450 to the infusion port 420 (connected to an IV dosing set). Priming 492 includes injecting a first volume of saline into the drug delivery device 400 via the saline port 430. The saline port 430 may be terminated with a spike or the like for connection to a saline source such as a saline bag. Priming distributes the first volume of saline to the cavity 112 and the infusion port 420 via the first passage 450.

[0098] In the drug delivery stage 496, the movable conduit 470 is moved to a second position. For example, the control member 490 is rotated so that a second passage 460 and a third passage 465 are formed. This allows the drug to flow from the drug source 444 to the drug port 440, through the second passage 460 to the infusion port 420 (connected to the IV administration set), and saline solution to flow from the saline port 430 through the third passage 465 to the flushing port 445 and the drug source 444.

[0099] Figures 5A to 5C show further embodiments of the drug delivery device 400 consistent with the embodiment of the present subject. Figure 5A is a perspective view, and Figures 5B and 5C are cross-sectional views of the drug delivery device 400.

[0100] In accordance with some embodiments of the present subject, the drug delivery device 400 may have a control member 505. The extension member 505 may be, for example, a plunger connected to the drug source 444. For example, the extension member 505 may have a base from which an arm extends. The extension member 505 may be housed within the drug source 444 such that the base is securely but movable. For example, the diameter and circumference of the base may be slightly shorter than the inner diameter and circumference of the drug source 444, allowing the base to fit within the drug source 444 and move a suitable distance in the longitudinal direction by applying a suitable amount of force. The arm may extend from an opening at the lower end of the drug source 444. The base may be moved within the drug source 444 by moving the arm. For example, the arm can be extended downward to move the base downward, and the arm can be pushed in a certain direction to push the base upward.

[0101] When the drug source 444 is connected to a vial or container, for example, via a vial adapter 480 (not shown in Figures 5A-5C) configured to engage with the vial or container, the movement of the extension member 505 transfers the drug from the vial or container to the drug source 444. Downward movement of the extension member may cause aspiration of the drug from the vial or container.

[0102] Figure 5D shows an operation of the drug delivery device 400, including an extension member 505, consistent with the embodiment of the present subject. Drug delivery using the drug delivery device 400, according to some embodiments, includes three stages: drug transfer 510, priming 512, and drug delivery and flushing 514, as shown in Figure 5D. The drug delivery device 400 is shown in a cross-sectional view, showing the movable conduit 470, the first passage 450, the second passage 460, and the third passage 465. Each stage is achieved by pumping from an infusion pump connected to an IV dosing set coupled to an infusion port 420.

[0103] In the drug transfer stage 510, the drug is transferred from the vial to the drug supply source 444 via the movement of the extension member 505. The extension member 505 is initially positioned so that its base is located above the drug supply source 444. To transfer the drug from the vial, the extension member 505 is pulled downward through the drug supply source 444, drawing the drug from the vial into the drug supply source 444. The accuracy of the dosage may be ensured by providing a mechanism in the drug supply source 444, such as a dosage line, to indicate that the appropriate amount is being transferred.

[0104] In the priming stage 512, the movable conduit 470 is positioned in a first position such that a first passage 450 is formed between the saline port 430 and the infusion port 420, allowing saline from a saline source (e.g., a saline bag) to flow through the first passage 450 to the infusion port 420 (connected to an IV dosing set). Priming 492 includes injecting a first volume of saline into the drug delivery device 400 via the saline port 430. The saline port 430 may be terminated with a spike or the like for connection to a saline source such as a saline bag. Priming distributes the first volume of saline to the cavity 112 and the infusion port 420 via the first passage 450.

[0105] In the drug delivery stage 514, the movable conduit 470 is moved to a second position. For example, the control member 490 is rotated so that a second passage 460 and a third passage 465 are formed. This allows the drug to flow from the drug source 444 to the drug port 440, through the second passage 460 to the infusion port 420 (connected to the IV administration set), and saline solution to flow from the saline port 430 through the third passage 465 to the flushing port 445 and the drug source 444.

[0106] Figures 6A to 6C show further embodiments of the drug delivery device 400 consistent with the embodiment of the present subject. Figure 6A is a perspective view, and Figures 6B and 6C are cross-sectional views of the drug delivery device 400.

[0107] In some embodiments of the present subject, the drug delivery device 400 may have a double-lubricated spike 605 connecting a drug source 444 to a vial or container that engages with a vial adapter 480. The double-lubricated spike 605 has two lumens or pathways for the automatic transfer of the drug from the vial to the drug source 444. When the vial is connected to or inserted into the vial adapter 480, air flows from the drug source 444 or the surrounding atmosphere into one lumen, and the drug flows down the second lumen to the drug source 444.

[0108] Figure 6D shows an operation of the drug delivery device 400 having a double-lumen spike 605, consistent with the embodiment of the present subject. Drug delivery using the drug delivery device 400, according to some embodiments, includes three stages: drug transfer 610, priming 612, and drug delivery and flushing 614, as shown in Figure 6D. The drug delivery device 400 is shown in a cross-sectional view, showing the movable conduit 470, the first passage 450, the second passage 460, and the third passage 465. Each stage is achieved by pumping from an infusion pump connected to an IV dosing set coupled to an infusion port 420.

[0109] In the drug transfer phase 610, the drug is transferred from the vial to the drug source 444 via the double-lumen spike 605. When the vial is connected to or inserted into the vial adapter 480, air flows from the drug source 444 into one lumen, and the drug flows down the second lumen to the drug source 444.

[0110] In the priming step 612, the movable conduit 470 is positioned in a first position such that a first passage 450 is formed between the saline port 430 and the infusion port 420, allowing saline from a saline source (e.g., a saline bag) to flow through the first passage 450 to the infusion port 420 (connected to an IV dosing set). Priming 492 includes injecting a first volume of saline into the drug delivery device 400 via the saline port 430. The saline port 430 may be terminated with a spike or the like for connection to a saline source such as a saline bag. Priming distributes the first volume of saline to the cavity 112 and the infusion port 420 via the first passage 450.

[0111] In the drug delivery stage 614, the movable conduit 470 is moved to a second position. For example, the control member 490 is rotated so that a second passage 460 and a third passage 465 are formed. This allows the drug to flow from the drug source 444 to the drug port 440, through the second passage 460 to the infusion port 420 (connected to the IV administration set), and saline solution to flow from the saline port 430 through the third passage 465 to the flushing port 445 and the drug source 444.

[0112] In some configurations, the central connector, infusion port, saline port, drug port, and flushing port (if incorporated) are a single molded part formed from one or more elastic materials. In some configurations, one or more of the infusion port, saline port, drug port, and flushing port are separate components configured to securely connect to each of the access points. For example, one or more of the infusion port, saline port, drug port, and flushing port may be connected to each of the access points by snapping, screwing, or other means. In some configurations, the central connector may be an expandable and / or compressible chamber. In some embodiments, the central connector may be integrated with the saline source, drug source, and / or IV dosing set.

[0113] The drug source may have multiple vials, according to some embodiments of the present subject matter. Consistent with embodiments of the present subject matter, multiple vial adapters may be connected in sequence, each configured to engage with each of the multiple vials. For example, a first vial adapter may be connected to or positioned at a first end of a drug port. A second vial adapter may be connected to the first vial adapter. The first and second vial adapters may be connected so that the drug from the first vial engaging with the first vial adapter, and the drug from the second vial engaging with the second vial adapter, flow through the drug port into a cavity of a central connecting member.

[0114] Referring to Figure 7, an embodiment of the pharmaceutical delivery device 700 is shown. The pharmaceutical delivery device 700 has two separate pharmaceutical delivery devices, a first pharmaceutical delivery device 200 and a second pharmaceutical delivery device 200-2, which are interconnected for the delivery of two types of pharmaceuticals. The second central connecting member 210-2 has a second cavity 212-2 surrounded by a second outer wall 214-2 and a plurality of access points (not shown in Figure 7) formed through each surface of the second outer wall 214-2.

[0115] The second infusion port 220-2 has a first end and a second end, the first end being connected to the first access point of a plurality of second access points. The second end of the second infusion port 220-2 is connected to an IV dosing set (not shown) for delivering fluid to the patient.

[0116] The second saline port 230-2 has a first end and a second end. The second end of the second saline port 230-2 is connected to the second access point of a plurality of second access points. The first end of the second saline port 230-2 is connected to the second end of the infusion port 220, connecting the fluid of the infusion port 220 of the first drug delivery device 200 and the second saline port 230-2 of the second drug delivery device 200-2.

[0117] The second drug port 240-2 has a first end and a second end. The second end of the second drug port 240-2 is connected to a third access point of a plurality of second access points to connect the fluids of the second drug port 240-2 and the second infusion port 220-2. The first end of the second drug port 240-2 is either a second vial adapter 280-2 configured to engage with a second vial (not shown in Figure 7) or may be engaged with such a second vial adapter 280-2, so that the second drug flows from the second vial and the second vial adapter 280-2 through the second drug port 240-2 to the second infusion port 220-2.

[0118] In accordance with the embodiments of the present subject, the second drug delivery device 200-2 may have a control member 290-2, as shown in Figure 7. The second control member 290-2 is connected to a movable conduit in the second cavity 212-2 to form a passage between the second ports (220-2, 230-2, and 240-2) in a manner equivalent to that described with reference to the drug delivery device 200. In accordance with the embodiments of the present subject, priming, drug delivery of the drug and the second drug, and flushing conditions may be performed by controlling the movement of the control member 290 and the second control member 290-2. For example, the drug in the vial connected to the drug delivery device 200 may be delivered first, followed by the delivery of the second drug product in the second vial connected to the second drug delivery device 200-2, or in the reverse order. In some embodiments, the drug and the second drug may be delivered simultaneously. In some embodiments, the flushing step may be incorporated between the delivery of the first drug and the delivery of the second drug, or between the delivery of the second drug and the delivery of the first drug.

[0119] Figures 8A and 8B show embodiments of the drug delivery device 800 consistent with further embodiments of the present subject. Figure 8A is a perspective view of the drug delivery device 800, and Figure 8B is a cross-sectional view of the drug delivery device 800.

[0120] According to the current implementation of the subject, the drug delivery device 800 comprises a connector 810 and a port manifold 850. In an upright configuration, the connector 810 supports a saline source containing saline solution and one or more vials containing one or more drugs to be administered to the patient. The port manifold 850 connects the saline source to the one or more vials supported by the connector 810 and the IV administration set, as described later herein.

[0121] The connecting component 810 has a central connecting member 812 configured to connect to an IV stand or the like. The central connecting member 812 may be, for example, hook-shaped or ring-shaped. The central connecting member 812 may have a mounting structure having at least a partial opening from which one or more support arms extend. The mounting structure is oriented such that at least the partial opening is generally aligned with the vertical axis.

[0122] The connecting component 810 further has a first vial connecting member 816a connected to a first support arm 814a. According to some embodiments of the present subject, the first support arm 814a extends from a central connecting member 812. The first vial connecting member 816a is configured to support a first vial adapter 818a for engaging with a first vial. In some embodiments, the first vial connecting member 816a may support the first vial directly or indirectly without using a vial adapter. In some embodiments, the first vial adapter 818a may be incorporated within the first vial connecting member 816a. The first vial connecting member 816a may have a ring structure into which the first vial adapter 818a is fitted or attached, the ring structure being oriented such that its opening is generally aligned with a horizontal axis.

[0123] Figures 8A and 8B show a second vial connector 816b, a second support arm 814b, and a second vial adapter 818b. However, embodiments of the present subject are not limited to two sets of support arms / vial connectors / vial adapters. Rather, some embodiments may incorporate one support arm, one vial connector, and one vial adapter, and some embodiments may incorporate two or more. The central connector 812 and the support arms may be mounted to accommodate any number of sets of support arms / vial connectors / vial adapters. For example, in the case of three sets, the support arms may be positioned 120 degrees apart around the central connector 812. In the case of a single set, the support arms may extend longitudinally and vertically downward from the central connector. Other possible adaptations are also within the scope of the present embodiments of the drug delivery device 800.

[0124] The connecting component 810 further includes a saline source connecting member 820 connected to a support arm 822. The support arm 822 extends from the central connecting member 812 and is configured to support a saline source, such as a saline bag. For example, the distal end portion of the saline source connecting member 820 may have a hook or a similar shape to securely hold the saline source during infusion.

[0125] In accordance with the current embodiment of the subject, when the first vial is connected to and / or engaged with the first vial adapter 818a (and the second vial, if included, is connected to and / or engaged with the second vial adapter 818b), and when the saline source is connected to the saline source connecting member 820, the configuration of the connecting component 810 is such that the first vial (and the second vial, if included) is positioned above the saline source with respect to the vertical axis. That is, the first vial (and the second vial, if included) is positioned higher than the saline source. This arrangement facilitates the injection of the pharmaceutical product contained in the first vial (and the second vial, if included).

[0126] As described above, the drug delivery device 800 also has a saline source and a port manifold 850 for connecting one or more vials to the IV administration set. The port manifold 850 has a port 852 configured to be inserted into the saline source (connected to the saline source connecting member 820). The port 852 can be terminated with a spike for connection to the saline source. The infusion line 854 is configured to form a passage between the port 852 and the IV administration set. Furthermore, a first drug line 856a is provided. The first drug line 856a is configured to connect to the first vial adapter 818a at a first end and to the infusion line 854 at a second end. In embodiments using a second vial adapter 818b, a second drug line 856b is provided, configured to connect to the second vial adapter 818b at a first end and to the infusion line 854 at a second end.

[0127] In accordance with the embodiments of the present subject, the infusion line 854 may be closed from the first pharmaceutical line 856a via a valve located at the interface between the first pharmaceutical line 856a and the infusion line 854. The valve may be movable by a rotating member between a first position in which the infusion line 854 is closed from the first pharmaceutical line 856a and a second position in which the infusion line 854 is open to the first pharmaceutical line 856a. The valve or a separate valve may also be connected to the second pharmaceutical line 856b at the junction with the infusion line 854, and the valve functions to open and close the infusion line 854 with respect to the second pharmaceutical line 856b.

[0128] The port manifold 850 may further have a removable mounting member at the end of the infusion line 854. Removal of the removable mounting member may constitute attachment of the infusion line 854 to the IV administration set.

[0129] Figure 8C shows an operation of the drug delivery device 800 consistent with the embodiment of the present subject. Drug delivery using the drug delivery device 800, according to some embodiments, includes two stages: priming 860 and drug delivery and flushing 862, as shown in Figure 8C. Each stage is achieved, for example, by pumping from an infusion pump connected to an IV dosing set coupled to an infusion line. As shown in Figure 8C, the drug delivery device 800 is prepared using a saline bag supported by a saline source connecting member 820, with two vials, namely a first vial and a second vial, engaged with a first vial adapter 818a and a second vial adapter 818b, respectively.

[0130] The priming step 860 includes injecting a first volume of saline from a saline source into the infusion line 854. The drug delivery and flushing step 862 includes opening the connection (e.g., via a valve) between the first drug line 856a and / or the second drug line 856b and the infusion line 854 to allow the flow of the first drug. The product and / or the second drug reaches the IV dosing set via the first drug line 856a and / or the second drug line 856b and the infusion line 854. Since the first vial and / or the second vial are in a vertical position higher than the saline source, the first drug and / or the second drug flow through the infusion line 854 and become empty, at which point saline from the saline source flows and flushes the infusion line 854.

[0131] Figures 9A to 9G show embodiments of the drug delivery device 900 consistent with the embodiment of the subject matter of this book. Figure 9A is a perspective view of the drug delivery device 900 in a first position, and Figures 9B and 9C are cross-sectional views of the drug delivery device 900 in a first position. Figure 9D is a perspective view of the drug delivery device 900 in a second position, and Figures 9E and 9F are cross-sectional views of the drug delivery device 900 in a second position. Figures 9C and 9F show the drug delivery device 900 connected to a saline supply source 992 and a vial 994 containing the drug.

[0132] The pharmaceutical delivery device 900 includes a central connecting member 910. The central connecting member 910 includes a cavity 912 surrounded by an outer wall 914 and a plurality of access points formed through each surface of the outer wall 914. For example, the plurality of access points may include one, two, three, four, or more access points. Referring to Figures 9B, 9C, 9E, and 9F, the central connecting member 910 may include at least three access points, such as a first access point 916a, a second access point 916b, and a third access point 916c. The access points can provide access to the cavity 912 and can allow fluid to enter and exit the cavity 912 of the central connecting member 910.

[0133] The drug delivery device 900 also includes an infusion port 920, a saline port 930, and a drug port 940. According to the aspects of the subject matter of this book, each of the ports 920, 930, and 940 has a first end and a second end, and each of the ports 920, 930, and 940 is connected at one end to the respective access points 916a, 916b, and 916c of the central connecting member 910.

[0134] The infusion port 920 has a first end 921 connected to a first access point 916a of the central connecting member 910, and a second end 922. The second end 922 may be on the opposite side of the first end 921. The second end 922 of the infusion port 920 can be connected to an IV dosing set 996 for delivering fluid from the infusion port 920. For example, fluid passing through the cavity 912 of the central connecting member 910 can be delivered to the IV dosing set 996 via the infusion port 920. The infusion port 920 may be connected to a Luer lock or other connector which is connected to a tube or another delivery mechanism for delivering fluid to the patient.

[0135] The saline port 930 has a first end 931 and a second end 932. The second end 932 may be on the opposite side of the first end 931. The second end 932 of the saline port 930 is connected to a second access point 916b of the central connecting member 910. The first end 931 of the saline port 930 is configured to be connected to a saline supply source. Thus, saline from the saline source passes through the saline port 930, enters and passes through the cavity 912, passes through the infusion port 920, and is delivered to the IV dosing set 996, which can then be primed and / or flushed. In some embodiments, the saline port 930 is terminated with a spike for connection to a saline supply source (e.g., a saline bag).

[0136] The saline port 930 may be aligned perpendicularly to the infusion port 920. For example, the saline port 930 and the infusion port 920 can be aligned along the central vertical axis 903 of the central connecting member 910. In some embodiments, the saline port 930 and the infusion port 920 are positioned opposite each other with the central connecting member 910 in between. Such a configuration allows saline to flow easily between the saline port 930 and the infusion port 920.

[0137] The drug port 940 of the drug delivery device 900 has a first end 941 and a second end 942. The second end 942 of the drug port 940 is connected to a third access point 916c of the central connecting member 910. In some embodiments, the second end 942 and the first end 941 are arranged along a single axis.

[0138] In some embodiments, such as those shown in Figures 9A to 9F, the first end 941 is positioned perpendicular to the second end 942. For example, the drug port 940 may include a first drug channel 943 and a second drug channel 945. The first drug channel 943 and the second drug channel 945 may be fluidly connected and / or integrally formed to define the drug port 940. The first drug channel 943 may extend between the first end 941 and the second drug channel 945. The second drug channel 945 may extend between the first drug channel 943 and the second end 942. The second drug channel 945 may extend laterally from the central connecting member 910, such as along the lateral axis 901 of the central connecting member 910 perpendicular to the longitudinal axis 903 of the central connecting member 910. In some embodiments, such as the exemplary drug delivery device 200 shown in Figures 2B and 2C, the second drug channel 945 may extend at an angle with respect to the longitudinal axis 903 and / or the first drug channel 943 of the central connecting member 910. The first drug channel 943 may extend perpendicular to the transverse axis 901 and / or the second drug channel 945, but other angles are possible that are consistent with the embodiments of the subject matter of this publication.

[0139] Referring again to Figures 9A to 9F, the first end 941 of the drug port 940 is configured to connect to a drug source, thus allowing the drug port 940 to deliver the drug from the drug source through the second passage 960 to the infusion port 920. The first end 941 of the drug port 940 may be, or may engage with, a vial adapter 980 configured to engage with a vial 994 (shown in Figures 9C and 9F) so that the drug flows from the vial and vial adapter 980 through the drug port 940 to the cavity 912 of the central connecting member 910 and the infusion port 920.

[0140] The pharmaceutical delivery device 900 may include a movable conduit 970, as shown in the cross-sectional views of Figures 9B, 9C, 9E, and 9F. The movable conduit 970 is located within the cavity 912 and is connected by connections to a plurality of access points, such as the first, second, and third access points 916a, 916b, 916c. The movable conduit 970 may include one, two, three, four, five, or more movable conduits 970. For example, as shown in Figures 9B, 9C, 9E, and 9F, the movable conduit 970 includes a first movable conduit 971 and a second movable conduit 973. Each movable conduit 970 may be separated from each other so that each movable conduit is not in fluid communication with the others. In other embodiments, one or more of the movable conduits 970 may be fluidly connected to each other.

[0141] In accordance with the embodiments of the subject matter of this book, the movable conduit 970 is configured to move between at least a first position (see Figures 9A–9C) and a second position (see Figures 9D–9F). In the first position, saline solution can pass from the saline supply source 992 through a central connecting member 910, such as an IV administration set 996. In the first position, pharmaceuticals cannot pass through the central connecting member 910. For example, in the first position, the opening providing access to the second movable conduit 973 does not have to be fluidly connected to the first, second, and / or third access points 916a, 916b, 916c. Instead, the opening to the second movable conduit 973 may be blocked by an outer wall 914 surrounding the cavity 912.

[0142] In the second position, the drug can pass through the central connector 910, such as from vial 994 to IV dosing set 996. In the second position, saline solution cannot pass through the central connector 910. For example, in the second position, the opening providing access to the first movable conduit 973 does not have to be fluid-connected to the first, second, and / or third access points 916a, 916b, 916c. Instead, the opening to the first movable conduit 971 may be blocked by the outer wall 914 surrounding the cavity 912.

[0143] In other words, the first position of the movable conduit and the second position of the movable conduit 970 do not occur simultaneously. That is, a first passage 950 is formed and open between the second access point 916b and the first access point 916a to provide a fluid connection between the saline port 930 and the infusion port 920, but a second passage 960 is not formed (for example, the movable conduit 970 is positioned so that there is no fluid connection between the drug port 940 and the infusion port 920). When a second passage 960 is formed and opens between the third access point 916c and the first access point 916a to provide a fluid connection between the drug port 940 and the infusion port 920, the first passage 950 is not formed (for example, the movable conduit 970 is positioned so that there is no fluid connection between the saline port 930 and the infusion port 920). This configuration allows for priming and flushing of saline solution between the saline port 940 and the infusion port 920, separate from the delivery of the drug from the drug port 930 to the infusion port 920.

[0144] In accordance with the embodiments of the subject matter of this book, in the first position, the movable conduit 970 is connected to a plurality of access points by connections, defining a first passage 950 between the second access point 916b and the first access point 916a, providing a fluid connection between the saline port 930 and the infusion port 920. In this configuration, the first movable conduit 971 defines the first passage 950. The first movable conduit 971 may form a straight (e.g., non-bent) channel extending between the first access point 916a and the second access point 916b. As described above, the first end 931 of the saline port 930 is configured to be connected to a saline source, so that the saline port 930 can deliver saline from the saline source to the infusion port 920 through the first passage 950 formed by the first movable conduit 971.

[0145] In the second position, the movable conduit 970 connects to a plurality of access points such that a second passage 960 is defined between a third access point 916c and a first access point 916a to provide a fluid connection between the drug port 940 and the infusion port 920. In this configuration, the second movable conduit 973 defines the second passage 960. The second movable conduit 973 may be bent and / or may form an open space within the central connecting member 910 that allows the drug to pass between the third access point 916c and the first access point 916a. As described herein, the first end 941 of the drug port 940 may be, or may engage with, a vial adapter 980 configured to engage with a vial 994 so that the drug flows from the drug port 940 and through the second passage 960 formed by the second movable conduit 973 to the infusion port 920.

[0146] In accordance with the embodiments of the subject matter of this book, the drug delivery device 900 may include a control member 990, as shown in Figures 9A and 9D. The control member 990 is connected to the movable conduit 970 to move the movable conduit 970 between a first position and a second position. For example, the control member 990 may be configured such that movement, such as rotation of the control member 990, causes the movable conduit 970 to rotate within the cavity 912 of the central connecting member 910. Thus, the movement of the control member 990 aligns the movable conduit 970 to form the first passage 950 and the second passage 960.

[0147] In some embodiments, the control member 990 is located on the first side of the central connecting member 910. As shown in Figures 9A to 9F, when facing the control member 990, the drug port 940 is located to the left of the saline port 930. Such a configuration may help improve the ergonomics of the drug delivery device 900 and the user experience of using the drug delivery device 900.

[0148] Figure 9G shows an operation of the drug delivery device 900 consistent with an embodiment of the subject matter of this book. Drug delivery using the drug delivery device 900 includes one or more stages, such as one-stage, two-stage, three-stage, or more, according to some embodiments. For example, the stages of drug delivery using the drug delivery device 900 may include three stages. Although this example is shown as having three stages, other numbers of stages may be performed, and in some cases, only one or two of the three stages shown may be performed. As shown in Figure 9G, drug delivery using the drug delivery device 900 may include priming 997, drug delivery 998, and flushing 999. The drug delivery device 900 is shown in a cross-sectional view to show an embodiment of the movable conduit 970 (e.g., a first movable conduit 971 defining a first flow path 950 and a second movable conduit 973 defining a second flow path 960). A front view is also provided to show the corresponding positions of the control member 990. Each stage is achieved by pumping from an infusion pump interacting with an IV dosing set connected to the infusion port 920. Additionally or alternatively, the infusion pump can be controlled by a control member 990 to move the movable conduit 970 from a first position to a second position and / or from a second position to a first position (for example, automatically, after receiving input).

[0149] In the priming stage 997, the movable conduit 970 is positioned in a first location such that a first passage 950 is formed between the saline port 930 and the infusion port 920, allowing saline to flow from a saline source (e.g., a saline bag) through the first passage 950 to the infusion port 920 (connected to an IV dosing set). Priming 997 includes injecting a first volume of saline into the drug delivery device 900 via the saline port 930. The saline port 930 may be terminated with a spike or the like for connection to a saline source such as a saline bag. Priming allows the first volume of saline to be distributed through the first passage 950 to the infusion port 920.

[0150] During the drug delivery stage 998, the movable conduit 970 is moved to a second position. For example, the control member 990 is rotated so that a second passage 960 is formed between the drug port 940 and the infusion port 920. This allows the drug to flow from the vial to the drug port 940 and through the second passage 960 to the infusion port 920 (which is connected to the IV dosing set).

[0151] Following drug delivery 998, flushing 999 is the next step in the operation of the drug delivery device 900. The movable conduit 970 is returned to the first position so that a first flow path 950 is formed. A second volume of saline solution is flowed through the first passage 950 to the infusion port 920. The infusion of the second volume of saline solution ensures that the amount of drug delivered is delivered to the patient.

[0152] Therefore, the drug delivery device 900 provides a more convenient and rapid IV administration option for healthcare systems while improving patient experience and patient safety.

[0153] Figure 10 shows an exemplary graph 1000 illustrating the concentration dynamics of a drug during delivery using a drug delivery device 900, consistent with the embodiment of the subject matter of this book. In other words, graph 1000 shows a comparison between the protein concentration in the drug and the volume of the drug injected. In this example, the concentration dynamics were recorded for the delivery of 20 mL of drug. The drug used was tiragolumab with a protein concentration of 120 mg / mL. For example, the drug concentration based on the volume of fluid injected via an IV dosing set such as IV dosing set 996 was compared over various flow rates, including a minimum flow rate (1 mL / min) 1002, a target flow rate (6 mL / min) 1004, a maximum flow rate (10 mL / min) 1006, and a control flow rate 1008. As shown in Graph 1000, the protein concentration of pharmaceuticals in the collected fluid solutions (including physiological saline and / or pharmaceuticals) was measured at eight data collection points for each flow rate, namely: (1) after collecting 20 mL of fluid solution; (2) after collecting 60 mL of solution; (3) after collecting 80 mL of solution; (4) after collecting 100 mL of solution; (5) after collecting 120 mL of solution; (6) after collecting 140 mL of solution; (7) after collecting 160 mL of solution; and (8) after collecting 180 mL of fluid solution.

[0154] Graph 1000 shows that the delivery of a drug at a desired concentration using the drug delivery device 1100 (or any of the drug delivery devices described herein) can be advantageously achieved with a smaller amount of drug and therefore in a shorter time. Thus, such embodiments may be more convenient for patients because they spend less time in a chair, less time waiting for a chair to become available, and less time waiting for the drug to be prepared. Such configurations can also reduce the time nurses or other healthcare professionals spend managing each patient and / or reduce the workload of the pharmacy.

[0155] During drug concentration testing using each flow rate (e.g., minimum flow rate (1 mL / min) 1002, target flow rate (6 mL / min) 1004, maximum flow rate (10 mL / min) 1006, and control flow rate 1008), the method shown in Figure 9G was performed, including priming 997, drug delivery 998, and flushing 999 steps.

[0156] First, the priming step 997 involved injecting a first volume of saline solution into the drug delivery device 900 via the saline port 930. During the injection of the first volume of saline solution, the movable conduit 970 was positioned in a first location such that a first passage 950 was formed between the saline port 930 and the infusion port 920, allowing saline solution to flow from a saline source (e.g., a saline bag) through the first passage 950 to the infusion port 920 (connected to an IV dosing set). After the priming step 997, at least some saline solution remained in the drug delivery device 900.

[0157] After priming 997, the control member 990 was rotated so that a second passage 960 was formed between the drug port 940 and the infusion port 920. This allowed the drug to flow from the vial to the drug port 940 and through the second passage 960 to the infusion port 920 (connected to the IV dosing set). Thus, the movable conduit 970 was moved to the second position.

[0158] The infusion pump connected to the drug delivery device 900 was switched on, and the flow rate was set to one of the following, depending on the flow rate being tested: minimum flow rate (1 mL / min) 1002, target flow rate (6 mL / min) 1004, maximum flow rate (10 mL / min) 1006, or control flow rate 1008.

[0159] Next, during drug delivery 998, the drug was taken from the drug source (e.g., vial) by the drug delivery device 900, and the fluid solution of the fluid drawn through the drug delivery device 900 was collected in a beaker. The fluid solution contained saline and the drug. At each data collection point (e.g., 20 mL, 60 mL, 80 mL, 100 mL, 120 mL, 140 mL, 160 mL, and 180 mL of solution were collected), the protein concentration of the collected solution was measured. At each data collection point, the infusion pump was automatically stopped (or switched off) to allow measurement of the protein concentration. As shown in graph 1000, at the first data collection point (e.g., with 20 mL of fluid solution collected), the protein concentration was low because most of the collected fluid solution contained saline present in the tube as a result of priming 997. After the first data collection point (e.g., with 20 mL of fluid solution collected), the drug source was emptied.

[0160] Next, in the flushing stage 999, the control member 990 was rotated so that the movable conduit 970 was returned to the first position to form the first flow path 950. The infusion pump was switched on to continue drawing the drug solution through the drug delivery device 900 and collecting it in a beaker. After the first data acquisition point, an additional 40 mL of fluid solution was collected in the beaker, and the infusion pump automatically stopped working for the protein concentration of the collected fluid solution to be measured. At the second data acquisition point (e.g., with 60 mL of fluid solution collected), the protein concentration was higher than at the first data acquisition point because most of the fluid solution collected at this point contained the drug. The flushing stage 999 continued in 20 mL increments until a total of 180 mL of fluid solution had been recovered.

[0161] Figures 11A to 11G show embodiments of the drug delivery device 1100 consistent with the embodiment of the subject matter of this book. Figure 11A is a perspective view of the drug delivery device 1100 in a first position, and Figures 11B and 11C are cross-sectional views of the drug delivery device 1100 in a first position. Figure 11D is a perspective view of the drug delivery device 1100 in a second position, and Figures 11E and 11F are cross-sectional views of the drug delivery device 1100 in a second position. Figures 11C and 11F show the drug delivery device 1100 connected to a saline supply source 1192 and a vial 1194 containing the drug.

[0162] The pharmaceutical delivery device 1100 includes a central connecting member 1110. The central connecting member 1110 includes a cavity 1112 surrounded by an outer wall 1114 and a plurality of access points formed through each surface of the outer wall 1114. For example, the plurality of access points may include one, two, three, four, or more access points. Referring to Figures 11B, 11C, 11E, and 11F, the central connecting member 1110 may include at least three access points, such as a first access point 1116a, a second access point 1116b, and a third access point 1116c. The access points can provide access to the cavity 1112 and can allow fluid to enter and exit the cavity 1112 of the central connecting member 1110.

[0163] The drug delivery device 1100 also includes an infusion port 1120, a saline port 1130, and a drug port 1140. According to the aspects of the subject matter of this book, each of the ports 1120, 1130, and 1140 has a first end and a second end, and each of the ports 1120, 1130, and 1140 is connected at one end to the respective access points 1116a, 1116b, and 1116c of the central connecting member 1110.

[0164] The infusion port 1120 has a first end 1121 connected to a first access point 1116a of the central connecting member 1110, and a second end 1122. The second end 1122 may be on the opposite side of the first end 1121. The second end 1122 of the infusion port 1120 can be connected to an IV dosing set 1196 for delivering fluid from the infusion port 1120. For example, fluid passing through the cavity 1112 of the central connecting member 1110 can be delivered to the IV dosing set 1196 via the infusion port 1120. The infusion port 1120 may be connected to a Luer lock or other connector which is connected to a tube or another delivery mechanism for delivering fluid to the patient.

[0165] The saline port 1130 of the drug delivery device 1100 has a first end 1131 and a second end 1132. The second end 1132 of the saline port 1130 is connected to a third access point 1116c of the central connecting member 1110. In some embodiments, the second end 1132 and the first end 1131 are arranged along a single axis.

[0166] In some embodiments, such as those shown in Figures 11A to 11F, the first end 1131 is positioned perpendicular to the second end 1132. For example, the saline port 1130 may include a first saline passage 1133 and a second saline passage 1135. The first saline passage 1133 and the second saline passage 1135 may be fluid-connected and / or integrally formed to define the saline port 1130. The first saline passage 1133 may extend between the first end 1131 and the second saline passage 1135. The second saline passage 1135 may extend between the first saline passage 1133 and the second end 1132. The second saline passage 1135 may extend laterally from the central connecting member 1110, such as along the transverse axis 1101 of the central connecting member 1110, which is perpendicular to the longitudinal axis 1103 of the central connecting member 1110. The first saline passage 1133 may extend in a direction perpendicular to the transverse axis 1101 and / or the second saline passage 1135, but other angles are also possible that are consistent with the embodiments of the subject matter of this book.

[0167] Referring again to Figures 11A to 11F, the first end 1131 of the saline port 1130 is configured to be connected to a saline source. Thus, saline from the saline source passes through the saline port 1130, enters and passes through the cavity 1112, passes through the infusion port 1120, and is delivered to the IV administration set 1196, which can then be primed and / or flushed. In some embodiments, the saline port 1130 is terminated with a spike for connection to a saline source (e.g., a saline bag).

[0168] The drug port 1140 has a first end 1141 and a second end 1142. The second end 1142 may be on the opposite side of the first end 1141. The second end 1142 of the drug port 1140 is connected to a second access point 1116b of the central connecting member 1110. The first end 1141 of the drug port 1140 is configured to be connected to a drug source, thus enabling the drug port 1140 to deliver a drug from the drug source to the infusion port 1120 through the second passage 1160. The first end 1141 of the drug port 1140 may be, or may engage with, a vial adapter 1180 configured to engage with a vial 1194 (shown in Figures 11C and 11F) so that the drug flows from the vial and vial adapter 1180 through the drug port 1140 to the cavity 1112 and injection port 1120 of the central connecting member 1110.

[0169] The drug port 1140 can be aligned perpendicularly to the infusion port 1120. For example, the drug port 1140 and the infusion port 1120 can be aligned along the central longitudinal axis 1103 of the central connecting member 1110. In some embodiments, the drug port 1140 and the infusion port 1120 are positioned opposite each other with the central connecting member 1110 in between. Such a configuration allows saline solution to flow easily between the drug port 1140 and the infusion port 1120. Such a configuration can additionally or alternatively reduce the volume of drug remaining in the drug port 1140 after the drug has been delivered to the IV dosing set 1196. For example, in some examples, if the drug port 1140 includes a bend and / or otherwise includes multiple passages, a small amount of drug may remain in the drug port 1140 after the drug has been delivered to the IV dosing set for delivery to the patient. A drug delivery device 1100 consistent with the embodiment of the subject matter of this book may help reduce or eliminate the volume of drug remaining in the drug port 1140 or another part of the drug delivery device 1100. For example, the drug port 1140 does not have to include a bend, and the entire passage of the drug port 1140 may be longitudinally aligned with the infusion port 1120 along the longitudinal axis 1103, so that the drug can flow easily between the drug port 1140 and the infusion port 1120. Thus, the drug delivery device 1100 can reduce the amount of drug wasted and help ensure that the correct amount of drug is delivered to the patient.

[0170] The pharmaceutical delivery device 1100 may include a movable conduit 1170, as shown in the cross-sectional views of Figures 11B, 11C, 11E, and 11F. The movable conduit 1170 is located within the cavity 1112 and connects to multiple access points, such as the first, second, and third access points 1116a, 1116b, 1116c. The movable conduit 1170 may include one, two, three, four, five, or more movable conduits 1170. For example, as shown in Figures 11B, 11C, 11E, and 11F, the movable conduit 1170 includes a first movable conduit 1171 and a second movable conduit 1173. Each movable conduit 1170 may be separated from each other so that each movable conduit is not in fluid communication with the others. In other embodiments, one or more of the movable conduits 1170 may be fluidly connected to each other.

[0171] In accordance with the embodiments of the subject matter of this book, the movable conduit 1170 is configured to move between at least a first position (see Figures 11A–1C) and a second position (see Figures 11D–11F). In the first position, saline solution can pass from the saline supply source 1192 through a central connecting member 1110, such as an IV administration set 1196. In the first position, pharmaceuticals cannot pass through the central connecting member 1110. For example, in the first position, the opening providing access to the second movable conduit 1173 does not have to be fluidly connected to the first, second, and / or third access points 1116a, 1116b, 1116c. Instead, the opening to the second movable conduit 1173 may be blocked by an outer wall 1114 surrounding the cavity 1112.

[0172] In the second position, the drug can pass through the central connecting member 1110, such as from vial 1194 to IV dosing set 1196. In the second position, saline solution cannot pass through the central connecting member 1110. For example, in the second position, the opening providing access to the first movable conduit 1173 does not have to be fluid-connected to the first, second, and / or third access points 1116a, 1116b, 1116c. Instead, the opening to the first movable conduit 1171 may be blocked by the outer wall 1114 surrounding the cavity 1112.

[0173] In other words, the first position of the movable conduit and the second position of the movable conduit 1170 do not occur simultaneously. That is, a first passage 1150 is formed and opens between the third access point 1116c and the first access point 1116a to provide a fluid connection between the saline port 1130 and the infusion port 1120, but a second passage 1160 is not formed (for example, the movable conduit 1170 is positioned so that there is no fluid connection between the drug port 1140 and the infusion port 1120). When a second passage 1160 is formed and opens between the second access point 1116b and the first access point 1116a to provide a fluid connection between the drug port 1140 and the infusion port 1120, the first passage 1150 is not formed (for example, the movable conduit 1170 is positioned so that there is no fluid connection between the saline port 1130 and the infusion port 1120). This configuration allows for priming and flushing of saline solution between the saline port 1140 and the infusion port 1120, separate from the delivery of the drug from the drug port 1130 to the infusion port 1120.

[0174] In accordance with the embodiments of the subject matter of this book, in the first position, the movable conduit 1170 connects to a plurality of access points, defining a first passage 1150 between the third access point 1116c and the first access point 1116a, and providing a fluid connection between the saline port 1130 and the injection port 1120. In this configuration, the first movable conduit 1171 defines the first passage 1150. The first movable conduit 1171 may be bent and / or an open space may be formed within the central connecting member 1110 that allows saline to pass between the third access point 1116c and the first access point 1116a. As described above, the first end 1131 of the saline port 1130 is configured to be connected to a saline supply source, so that the saline port 1130 can deliver saline from the saline supply source to the infusion port 1120 through the first passage 1150 formed by the first movable conduit 1171.

[0175] In the second position, the movable conduit 1170 connects to multiple access points such that a second passage 1160 is defined between a third access point 1116b and a first access point 1116a, providing a fluid connection between the drug port 1140 and the injection port 1120. In this configuration, the second movable conduit 1173 defines the second passage 1160. The second movable conduit 1173 may form a straight (e.g., non-bent) channel extending between the first access point 1116a and the second access point 1116b. As described herein, the first end 1141 of the drug port 1140 may be or may engage with a vial adapter 1180 configured to engage with a vial 1194 so that the drug flows from the vial and vial adapter 1180 through a second passage 1160 formed by the drug port 1140 and a second movable conduit 1173 to the injection port 1120.

[0176] In accordance with the embodiments of the subject matter of this book, the drug delivery device 1100 may include a control member 1190, as shown in Figures 11A and 11D. The control member 1190 is connected to the movable conduit 1170 to move the movable conduit 1170 between a first position and a second position. For example, the control member 1190 may be configured such that movement, such as rotation of the control member 1190, causes the movable conduit 1170 to rotate within the cavity 1112 of the central connecting member 1110. Thus, the movement of the control member 1190 aligns the movable conduit 1170 to form the first passage 1150 and the second passage 1160.

[0177] In some embodiments, the control member 1190 is located on the first side of the central connecting member 1110. As shown in Figures 11A to 11F, when facing the control member 1190, the saline port 1130 is located to the left of the drug port 1140. Such a configuration may help improve the ergonomics of the drug delivery device 1100 and the user experience of using the drug delivery device 1100.

[0178] In some embodiments, as shown in Figures 11A–11F, the drug port 1140 is connected to the central connecting member 1110 via a lock nut. Figures 12A, 12B, and 12C show another example of a drug delivery device 1110 in which the drug port 1140 is directly connected to the central connecting member 1110. For example, the drug port 1140 may be formed integrally with the central connecting member 1110, the drug port 1140 and the central connecting member 1110 may be molded as a single component, and / or the drug port 1140 may be connected to the central connecting member 1110 (e.g., solvent connection). Such a configuration may help reduce the amount of drug remaining in the drug port 1140 after the drug has been delivered to the IV dosing set, for example, via the infusion port 1120.

[0179] In accordance with the embodiments of the subject matter of this book, drug delivery using the drug delivery device 1100 includes one or more steps, such as one, two, three, or more, according to some embodiments. For example, the steps of drug delivery using the drug delivery device 1100 may include three steps. Although this example is described as having three steps, other numbers of steps may be performed, and in some cases, only one or two of the three steps may be performed. For example, drug delivery using the drug delivery device 1100 may include priming, drug delivery, and flushing. Each step is achieved by pumping from an infusion pump interacting with an IV dose set connected to the infusion port 1120. Additionally or alternatively, the infusion pump may cause a control member 1190 to move the movable conduit 1170 from a first position to a second position and / or from a second position to a first position (e.g., automatically, after receiving input).

[0180] In the priming phase, the movable conduit 1170 is positioned in a first location such that a first passage 1150 is formed between the saline port 1130 and the infusion port 1120, allowing saline to flow from a saline source (e.g., a saline bag) through the first passage 1150 to the infusion port 1120 (connected to an IV dosing set). Priming 1197 includes injecting a first volume of saline into the drug delivery device 1100 via the saline port 1130. The saline port 1130 may be terminated with a spike or the like for connection to a saline source such as a saline bag. Priming allows the first volume of saline to be distributed through the first passage 1150 to the infusion port 1120.

[0181] During the drug delivery phase, the movable conduit 1170 is moved to a second position. For example, the control member 1190 is rotated so that a second passage 1160 is formed between the drug port 1140 and the infusion port 1120. This allows the drug to flow from the vial to the drug port 1140 and through the second passage 1160 to the infusion port 1120 (which is connected to the IV dosing set).

[0182] After drug delivery, flushing is the next step in the operation of the drug delivery device 1100. The movable conduit 1170 is returned to its first position so that a first flow path 1150 is formed. A second volume of saline solution is flowed through the first passage 1150 to the infusion port 1120. The infusion of the second volume of saline solution ensures that the amount of drug delivered is reliably delivered to the patient.

[0183] Therefore, the drug delivery device 1100 provides a more convenient and rapid IV administration option for healthcare systems while improving patient experience and patient safety.

[0184] Figures 13A to 13C show embodiments of the drug delivery device 1300 consistent with the embodiment of the subject matter of this book. Figure 13A is a perspective view of the drug delivery device 1300, Figure 13B is a cross-sectional view of the drug delivery device 1300, and Figure 13C is a cross-sectional view of the drug delivery device 1300 connected to a vial 1394 containing a drug.

[0185] The drug delivery device 1300 includes a central connecting member 1310. The central connecting member 1310 includes a cavity 1312 surrounded by an outer wall 1314 and a plurality of access points 1316 formed through each surface of the outer wall 1314. The drug delivery device 1300 may also include two access points: a first access point 1316a and a second access point 1316b.

[0186] The drug delivery device 1300 also includes an infusion port 1320 and a fluid port 1325. The fluid port 1325 can define both a saline port and a drug port. However, the fluid port 1325 may define only a drug port, and the drug delivery device 1300 may not use saline. For example, the drug delivery device 1300 may beneficially enable the infusion of an appropriate amount of drug without using saline to flush the drug delivery device 1300. Each of the ports 1320, 1325 is connected to and / or defines the respective access points 1316a, 1316b of the central connecting member 1310. For example, the infusion port 1320 may be connected to and / or defined to the first access point 1316a of the central connecting member 1310. In other words, the infusion port 1320 may be an opening in the central connecting member 1310.

[0187] The first access point 1316a and the second access point 1316b may be aligned along the central longitudinal axis 1399 of the central connecting member 1310. The first access point 1316a and the second access point 1316b may also be aligned with the center of the fluid port 1325 and / or the center of the injection port 1320. Thus, in some embodiments, the first access point 1316a, the second access point 1316b, the fluid port 1325, and the injection port 1320 may be aligned along the central longitudinal axis 1399 of the central connecting member 1310. Such a configuration may help to deliver the drug more quickly through the drug delivery device 1300 while minimizing the amount of drug remaining in the drug delivery device 1300 after injection. In some embodiments, the center of the drug source, such as a vial, is also aligned along the central longitudinal axis 1399.

[0188] In some embodiments, the drug delivery device 1300 functions as an IV dosing set so that additional IV dosing sets are not connected to the drug delivery device. Alternatively, the drug delivery device 1300 may deliver the drug directly to the patient via the tube 1396. In other embodiments, the infusion port 1320 may be configured to connect to an IV dosing set for delivering fluid from the infusion port 120. In some embodiments, a flow stopper 1398 or other mechanism controls the flow of fluid from within the cavity 1312 through the tube 1396 to the patient (or a separate IV dosing set). The tube 1396 can include various lengths ranging from a few inches to a few feet, depending on the implementation.

[0189] The fluid port 1325 may be connected to and / or defined to a second access point 1316b of the central connecting member 1310. Thus, a first passage 1350 is formed between the fluid port 1325 and the injection port 1320 via the second access point 116b and the first access point 116a. The first passage 1350 is a fluid connection portion passing through the cavity 1312 of the central connecting member 1310.

[0190] The fluid port 1325 is configured to connect to a drug source, and thus allows the fluid port 1325 to deliver the drug from the drug source to the infusion port 1320 through the cavity 1312 of the central connecting member 1310 (e.g., through the first passage 1350). The drug source may be, for example, a syringe. The source of the drug may be, for example, a vial or container. In some embodiments, the fluid port 1325 may be a vial adapter configured to engage with a vial so that the drug flows from the vial and vial adapter through the fluid port 1325 to the cavity 1312 of the central connecting member 1310. As a result, the fluid port 1325 may be a single port configured to connect to one or more drug sources. In other embodiments, the fluid port is configured to connect to a saline source and a drug source non-simultaneously.

[0191] As described above, in some embodiments, the drug delivery device 1300 may not be used with saline solution for priming and / or flushing. Therefore, drug delivery using the drug delivery device 1300, according to some embodiments, includes two steps: drug retrieval and drug administration. Although described as two steps in this example, there may be other numbers of steps (e.g., one, two, three, four, five, or more). For example, in some examples where the drug delivery device 1300 is used with saline solution, the drug delivery device 1300 may be primed before drug retrieval and / or drug administration, and / or the drug delivery device 1300 may be flushed after drug retrieval and / or drug administration.

[0192] Drug recovery consistent with the embodiments of the subject matter of this book may include recovering a certain amount (e.g., an injection volume) of drug from a drug source such as a vial or container using a syringe or the like. In other embodiments, the drug source may be directly connected to the fluid port 1325, and the drug may be removed from the drug source.

[0193] A drug injection involves injecting an injection volume of a drug contained in a drug source such as a syringe and / or vial through a fluid port 1325. For example, the injection volume may be injected into a cavity 1312 through the fluid port 1325 and then into a tube 1396 for delivery to the patient.

[0194] V. Administration Method In one embodiment, a method for administering a drug to a patient by intravenous infusion is provided. The method of the present invention may be performed using a clinical drug delivery device described herein.

[0195] The method of the present invention may include priming the infusion line with a first volume of saline solution (or other suitable liquid). For example, the first volume of saline solution may be supplied to a saline bag or container (e.g., containing 0.9% NaCl) and then introduced into the infusion line (via pump operation). This may be done so as to remove air from the infusion line before the drug is administered to the patient (and before the IV catheter is inserted into the patient).

[0196] The medication may be administered using an infusion pump. After the infusion volume of medication being administered to the patient has been completed, a second medication may be administered to the patient using the same or similar procedure. The second medication may be of the same type as the first medication administered, or it may be of a different type. When the infusion of the currently administered medication volume is complete, or after the administration of the second medication, the infusion line may be flushed with a second volume of saline solution.

[0197] In accordance with further embodiments of the subject matter of the present invention, the steps for administering a drug to a patient may include injecting a first volume of saline solution into the patient via an infusion line, and then injecting an infusion volume of the drug from a vial into the patient via the infusion line for a first period of time. The drug may be administered in a fixed dose (e.g., the same dose regardless of the patient's age and / or weight).

[0198] In some embodiments, the initial volume of the drug in the vial is approximately 100 mL, approximately 90 mL, approximately 80 mL, approximately 70 mL, approximately 60 mL, approximately 50 mL, approximately 40 mL, approximately 30 mL, approximately 20 mL, approximately 10 mL, or approximately 5 mL or less. In some embodiments, the initial volume of the drug in the vial is between approximately 1 mL and approximately 30 mL. In some embodiments, the initial volume of the drug in the vial is between approximately 1 mL and approximately 20 mL. In some embodiments, the initial volume of the drug in the vial is between approximately 1 mL and approximately 15 mL. In some embodiments, the initial volume of the drug in the vial is between approximately 5 mL and approximately 30 mL. In some embodiments, the initial volume of the drug in the vial is between approximately 10 mL and approximately 30 mL. In some embodiments, the initial volume of the drug in the vial is between approximately 15 mL and approximately 30 mL. In some embodiments, the initial volume of the drug in the vial is between approximately 5 mL and approximately 25 mL. In some embodiments, the initial volume of the drug in the vial is between approximately 5 mL and approximately 20 mL. In some embodiments, the initial volume of the drug in the vial is between approximately 5 mL and approximately 15 mL. The volume may be any value or sub-range within the cited range, including the endpoint.

[0199] In some embodiments, the initial amount of drug in the vial is approximately 30 mL, approximately 29 mL, approximately 28 mL, approximately 27 mL, approximately 26 mL, approximately 25 mL, approximately 24 mL, approximately 22 mL, or approximately 21 mL or less. In some embodiments, the initial amount of drug in the vial is approximately 20 mL or less. In some embodiments, the initial amount of drug in the vial is approximately 19 mL or less. In some embodiments, the initial amount of drug in the vial is approximately 18 mL or less. In some embodiments, the initial amount of drug in the vial is approximately 17 mL or less. In some embodiments, the initial amount of drug in the vial is approximately 16 mL or less. In some embodiments, the initial amount of drug in the vial is approximately 15 mL or less. In some embodiments, the initial amount of drug in the vial is approximately 14 mL or less. In some embodiments, the initial amount of drug in the vial is approximately 13 mL or less. In some embodiments, the initial amount of drug in the vial is approximately 12 mL or less. In some embodiments, the initial amount of drug in the vial is approximately 11 mL or less. In some embodiments, the initial amount of drug in the vial is approximately 10 mL or less. In some embodiments, the initial amount of drug in the vial is approximately 5 mL or less.

[0200] The amount of medication to be injected may be between approximately 10 mL and 30 mL, and the second amount of physiological saline may be between approximately 25 mL and 90 mL.

[0201] In embodiments, the second amount of saline may be between about 20 mL and about 100 mL. In embodiments, the second amount of saline may be between about 25 mL and about 90 mL. In embodiments, the second amount of saline may be between about 25 mL and about 80 mL. In embodiments, the second amount of saline may be between about 25 mL and about 70 mL. In embodiments, the second amount of saline may be between about 25 mL and about 60 mL. In embodiments, the second amount of saline may be between about 25 mL and about 50 mL. In embodiments, the second amount of saline may be between about 25 mL and about 40 mL. In embodiments, the second amount of saline may be between about 25 mL and about 30 mL. The amount may be any value or sub-range within the cited range, including the endpoint.

[0202] The drug and / or a second volume of saline may be infused into the patient at an infusion rate between approximately 1 mL / min and approximately 10 mL / min. The drug and / or a second volume of saline may be infused into the patient at an infusion rate between approximately 3 mL / min and approximately 10 mL / min. The drug and / or a third volume of saline may be infused into the patient at an infusion rate between approximately 3 mL / min and approximately 10 mL / min. The drug and / or a second volume of saline may be infused into the patient at an infusion rate between approximately 1 mL / min and approximately 8 mL / min. The drug and / or a second volume of saline may be infused into the patient at an infusion rate between approximately 1 mL / min and approximately 6 mL / min. The drug and / or a second volume of saline may be infused into the patient at an infusion rate of approximately 1 mL / min. The drug and / or a second volume of saline may be infused into the patient at an infusion rate of approximately 2 mL / min. The drug and / or a second volume of saline may be infused into the patient at an infusion rate of approximately 3 mL / min. The drug and / or a second volume of saline may be administered to the patient at an infusion rate of approximately 4 mL / min. The drug and / or a second volume of saline may be administered to the patient at an infusion rate of approximately 5 mL / min. The drug and / or a second volume of saline may be administered to the patient at an infusion rate of approximately 6 mL / min. The drug and / or a second volume of saline may be administered to the patient at an infusion rate of approximately 7 mL / min. The drug and / or a second volume of saline may be administered to the patient at an infusion rate of approximately 8 mL / min. The drug and / or a second volume of saline may be administered to the patient at an infusion rate of approximately 9 mL / min. The drug and / or a second volume of saline may be administered to the patient at an infusion rate of approximately 10 mL / min. The volume may be any value or sub-range within the listed range, may be greater than the listed range, and / or less than the listed range, including the endpoints.

[0203] The disclosures described herein, including the figures, may describe and / or illustrate different variations separately, but it should be understood that all or some of these variations, or combinations thereof, may be used.

[0204] While various exemplary embodiments are described above, any number of modifications may be made to these embodiments. For example, the order in which the steps of the various methods described above are performed can often be changed in alternative embodiments, and in other alternative embodiments, it may be possible to completely skip one or more steps of the method. Any feature of the embodiments of the various devices and systems may be included in some embodiments but not in others. Therefore, the above description is provided primarily for illustrative purposes and should not be construed as limiting the scope of the claims.

[0205] Where a feature or element is referred to herein as being "on top of" another feature or element, it may be directly on top of the other feature or element, or there may be intervening features and / or elements. In contrast, where a feature or element is referred to as being "directly" on another feature or element, there are no intervening features or elements. Where a feature or element is referred to as being "connected," "attached," or "linked" to another feature or element, it will also be understood that it may be directly connected, attached, or linked to the other feature or element, or there may be intervening features or elements. In contrast, where a feature or element is referred to as being "directly connected," "directly linked," or "directly linked" to another feature or element, there are no intervening features or elements. Features and elements described or shown in relation to one embodiment may be applicable to other embodiments. A reference to a structure or feature positioned "adjacent" to another feature may have a portion that overlaps with or underlies the adjacent feature.

[0206] The terms used herein are intended solely to describe and not to limit specific embodiments. For example, as used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms unless the context clearly indicates otherwise. As used herein, the terms “comprises” and / or “comprising” specify the presence of the described features, steps, actions, elements, and / or components, but are not intended to exclude the presence or addition of one or more other features, steps, actions, elements, components, and / or groups thereof. As used herein, the terms “and / or” include any combination of one or more of the listed items relating and may be abbreviated as “ / ”.

[0207] Terms expressing spatial relativity, such as “downward,” “below,” “further down,” “upward,” and “further up,” may be used herein to facilitate explanation and to describe the relationship between one element or feature and another, as illustrated. It will be understood that spatially relative terms are intended to encompass different orientations of the apparatus in use or operation, in addition to the orientation shown in the figure. For example, if the apparatus in the figure is turned upside down, an element described as “below” or “below” another element or feature becomes “above” or “further up” the other element or feature. Thus, the exemplary term “downward” can encompass both upward and downward directions. The apparatus may be oriented in other ways (e.g., rotated 90 degrees or in other directions), and the spatially relative descriptors used herein may be interpreted accordingly. Similarly, terms such as “upward,” “downward,” “vertical,” and “horizontal” are used herein for illustrative purposes only, unless otherwise specified.

[0208] The terms “first” and “second” may be used herein to describe various features / elements (including steps), but unless the context indicates otherwise, these features / elements should not be limited by these terms. These terms may be used to distinguish one feature / element from another. Thus, the first feature / element described below may be called the second feature / element, and similarly, the second feature / element described below may be called the first feature / element without departing from the teachings provided herein.

[0209] Throughout this specification and the following claims, unless otherwise specified in the context, the word “comprise,” and variations such as “comprises” and “comprising,” are to be used jointly in methods and articles (e.g., compositions and apparatus and methods). For example, the term “comprising” would be understood to mean the inclusion of the element or step described, but not the exclusion of other elements or steps.

[0210] Where used herein and in the claims, including as used in the examples, all numbers, unless otherwise expressly specified, can be read as if they begin with the word “about” or “approximately,” even if the term is not expressly indicated. The phrase “about” or “approximately” is used when describing size and / or location and may be used to indicate that the number and / or location described is within a reasonably expected range of the value and / or location. For example, a number may have values ​​such as ±0.1% of the stated value (or range of value), ±1% of the stated value (or range of value), ±2% of the stated value (or range of value), ±5% of the stated value (or range of value), ±10% of the stated value (or range of value), etc. In the examples, “about” means less than or equal to ±10% of the stated value (or range of value). Numbers given herein should also be understood to be about or approximately that value unless the context indicates otherwise.

[0211] The examples and figures included herein illustrate, not limiting, specific embodiments in which the subject matter can be implemented. As stated above, other embodiments can be utilized and derived therefrom, and as a result, structural and logical substitutions and modifications can be made without departing from the scope of this disclosure. While specific embodiments are illustrated and described herein, any arrangement calculated to achieve the same objective may be substituted for the specific embodiments shown. This disclosure is intended to cover all possible adaptations or variations of various embodiments. Combinations of the embodiments described above, and other embodiments not specifically described herein, are possible.

[0212] In the above description and claims, phrases such as “at least one” or “one or more” may appear following a list of elements or features. The term “and / or” may also occur with lists of two or more elements or features. Unless implicitly or explicitly contradicted by the context in which it is used, such phrases are intended to mean any of the enumerated elements or features individually, or any of the enumerated elements or features in combination with any of the other enumerated elements or features. For example, the expressions “at least one of A and B,” “one or more of A and B,” and “A and / or B” are intended to mean “A alone, B alone, or A and B together,” respectively. A similar interpretation is intended for lists containing three or more items. For example, the expressions "at least one of A, B, and C," "one or more of A, B, and C," and "A, B, and / or C" are intended to mean "A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B, and C together," respectively. The use of the term "based on" in the above and in the claims is intended to mean "based on at least a part of," so as to allow for undescribed features or elements as well.

[0213] The embodiments described herein do not represent all embodiments that are consistent with the subject matter described herein. Rather, they are merely examples that are consistent with aspects related to the described subject matter. While several variations are described in detail herein, other modifications or additions are possible. In particular, further features and / or variations can be provided in addition to those described herein. For example, the embodiments described above can be directed to various combinations and subcombinations of the disclosed features, and / or combinations and subcombinations of one or more further features of the features disclosed herein. Furthermore, the logical flows depicted in the accompanying figures and / or the logical flows described herein do not necessarily require a specific order or sequential order to achieve the desired result. The following claims may include other embodiments or practices.

Claims

1. a central connecting member having a cavity surrounded by outer walls, the central connecting member having a plurality of access points formed through each surface of the outer walls; an injection port having a first end and a second end, the first end coupled to a first access point of the plurality of access points; a saline port having a first end and a second end, the second end of the saline port being coupled to a second access point of the plurality of access points such that a first passageway is formed between the saline port and the injection port through a cavity in the central connecting member; and a medication port having a first end and a second end, the first end of the medication port being coupled to terminate at a medication source, and the second end of the medication port being coupled to a third access point of the plurality of access points such that a second passageway is formed between the medication port and the injection port through a cavity in a central connecting member; The device wherein the cavity of the central connecting member is capable of holding saline or a pharmaceutical agent.

2. 10. The device of claim 1, wherein the central connecting member, the injection port, the saline port, and the medication port comprise a single molded part.

3. 3. The device of claim 1 or 2, wherein the second end of the injection port is configured to connect to an intravenous administration set.

4. 4. The device of claim 3, wherein the injection port is configured to deliver saline and medication to a patient through the intravenous administration set.

5. 5. The device of claim 1, wherein a first end of the saline port is configured to be coupled to a saline source, and the saline port is configured to deliver saline from the saline source to the injection port through a cavity in the central connecting member.

6. The device of claim 5 , wherein the saline port is terminated in a spike.

7. 7. The device of claim 1, wherein a first end of the medication port is configured to be coupled to a medication source, and the medication port is configured to deliver medication from the medication source to the injection port through the cavity of the central connecting member.

8. a second central connecting member comprising a second cavity surrounded by a second outer wall, a plurality of second access points formed through each surface of the second outer wall; a second injection port having a first end and a second end, the first end of the second injection port coupled to a first access point of a plurality of second access points; a second saline port having a first end and a second end, the second end of the second saline port coupled to a second access point of a plurality of second access points and the first end of the second saline port coupled to the second end of the injection port to fluidly connect the injection port and the second saline port; and a second medication port having a first end and a second end, the second end of the second medication port coupled to a third access point of the plurality of second access points to fluidly connect the second medication port to a second injection port via a second cavity of a second central connecting member; The apparatus of any one of claims 1 to 7, further comprising:

9. The device of claim 7 , wherein the source of medication comprises a syringe.

10. 8. The device of claim 7, wherein the source of medication comprises at least one vial, and wherein the first end of the medication port comprises at least one vial adapter configured to engage with each of the at least one vial, and wherein medication flows from the at least one vial and the at least one vial adapter into the cavity of the central connecting member.

11. The device of any one of claims 1 to 10, wherein the central connecting member comprises an expandable chamber.

12. 12. The device of claim 1, wherein the medication port and the injection port are aligned along a longitudinal axis of the central connecting member, and at least a portion of the saline port is aligned along a lateral axis of the central connecting member, the lateral axis being perpendicular to the longitudinal axis.

13. 13. The device of claim 12, wherein the medication port and the injection port are vertically aligned along the longitudinal axis.

14. 13. The device of claim 12, wherein the saline port includes a first saline passageway and a second saline passageway, the first saline passageway being disposed perpendicular to the second saline passageway, and the second saline passageway extending along the transverse axis.

15. 12. The device of any one of claims 1-11, wherein the saline port and the injection port are aligned along a longitudinal axis of the central connecting member, and at least a portion of the medication port is aligned along a lateral axis of the central connecting member, the lateral axis being perpendicular to the longitudinal axis.

16. 16. The device of claim 15, wherein the saline port and the injection port are aligned vertically along the longitudinal axis.

17. 16. The device of claim 15, wherein the medication port includes a first medication passageway and a second medication passageway, the first medication passageway being disposed perpendicular to the second medication passageway and the second medication passageway extending along the transverse axis.

18. A central connection structure connected to an IV stand; a first support arm extending from the central connecting structure; a first vial connecting member coupled to the first support arm and supporting a first vial adapter; the saline port configured to have a first end inserted into a source of saline; 10. The device of claim 1, wherein a first end of the medication port is connected to the first vial adapter.

19. The injection port is connected to a tube; the medication port is located opposite the injection port; The device of claim 1 , wherein the injection port, the medication port, the first access point, and the second access point are aligned along a longitudinal axis of the central connecting member.

20. The injection port is configured to be connected to an intravenous administration set; the medication port is located opposite the injection port; The device of claim 1 , wherein the injection port is configured to be non-simultaneously connected to a source of saline and a source of medication.

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