DOSING SYSTEMS AND APPROACHES
Patent Information
- Authority / Receiving Office
- MX · MX
- Patent Type
- Patents
- Current Assignee / Owner
- AMGEN INC
- Filing Date
- 2021-06-24
- Publication Date
- 2026-06-12
AI Technical Summary
Existing drug delivery systems require extensive preparation processes and may lead to incomplete drug administration due to container interchanges, especially in extended dosing scenarios.
A drug delivery system with a flexible supply container featuring multiple ports and a rigid container design that ensures complete drug delivery through a tapered region and various coupling mechanisms, allowing quick device changes and compatibility with different vial sizes.
Facilitates quick and complete drug administration by reducing drug retention and enabling seamless integration with different vial types, thus enhancing efficiency and reducing setup time.
Smart Images

Figure MX435101B0
Abstract
Description
DOSING SYSTEMS AND APPROACHES CROSS-REFERENCE TO RELATED REQUEST Priority is claimed for U.S. Provisional Patent Application No. e62 / 804,447, filed on February 12, 2019, the full content of which is hereby incorporated in this document by reference. FIELD OF DESCRIPTION This disclosure relates generally to drug delivery devices and methods. More specifically, this description relates to improved approaches for preparing and delivering dosage systems. BACKGROUND Drugs are administered to treat various conditions and diseases. Intravenous (IV) therapy is a drug dosing process that delivers medication directly into a patient's vein using an infusion contained in a container (e.g., a flexible bag). These procedures can be performed in a healthcare facility or, in some cases, in remote locations such as a patient's home. Often, a healthcare professional must prepare the drug by mixing several ingredients before administration. Existing systems generally involve an extensive drug preparation process with multiple steps.Additionally, in some settings where extended drug dosages are required involving sequential drug administration into multiple containers, it may be necessary to exchange these containers while ensuring that the entire contents of each container are administered to the patient. As described in more detail below, the present description sets out systems and methods for monitoring the patient and interventional dosing techniques that represent advantageous alternatives to existing systems and methods, and that may address one or more of the challenges or needs mentioned herein, as well as provide other benefits and advantages. SUMMARY According to a first aspect, a drug delivery system includes a delivery container, a first drug insertion port, at least one additional drug insertion port, and an IV connection port. The delivery container includes first top, bottom, and second side portions, and further includes a tapered region extending between the first side portion and the second side portion. The first drug insertion port is located at the bottom of the delivery container and has a first coupling mechanism. At least one additional drug insertion port is also located at the bottom of the delivery container, but includes a second coupling mechanism that differs from the first coupling mechanism. The IV connection port is located at the bottom of the delivery container adjacent to the bottom of the tapered region. In some examples, the first coupling mechanism is a Luer-lock mechanism. The second coupling mechanism may be a closed-system transfer device (CSTD). In some examples, the CSTD is a standard 13 mm port that couples to at least one 13 mm Iso 2R vial or CTSD. In other examples, the CSTD is a standard 20 mm port that couples to at least one 20 mm Iso vial or CTSD. Other examples are possible. In some of these examples, the system further includes a rigid container that defines an internal volume. The rigid container has a top and a bottom, including an opening to accommodate at least one IV connection port or IV way. In some forms, the delivery container further includes at least one opening formed in the top, and the rigid container additionally includes at least one mounting bolt sized to receive at least one opening for operationally securing the delivery container within the internal volume of the rigid container. In some examples, the rigid container may include at least one fastening strap member. In some approaches, the rigid container also includes an opening in the top to accommodate a portion of the delivery container. In some examples, the delivery container may be empty. In other approaches, the delivery container contains saline solution and an intravenous stabilizing solution. In still other examples, the delivery container contains saline solution, an intravenous stabilizing solution, and a preservative. According to another aspect, a drug delivery system includes a delivery container, a first drug insertion port, at least one additional drug insertion port, an IV connection port, and a rigid container. The delivery container includes first top, bottom, and second side portions, and further includes a tapered region extending between the first and second portions and at least one opening formed in the top portion thereof. The first drug insertion port is located in the bottom portion of the delivery container and has a first coupling mechanism. At least one additional drug insertion port is also located in the bottom portion of the delivery container, but includes a second coupling mechanism that differs from the first coupling mechanism. The IV connection port is located in the bottom portion of the delivery container adjacent to the bottom of the tapered region.The rigid container defines an internal volume and has a top and a bottom. The top includes at least one mounting bolt sized to receive at least one opening of the supply container to operatively secure the supply container within the internal volume of the rigid container. The bottom of the rigid container includes an opening to accommodate at least one IV connection port or IV way. BRIEF DESCRIPTION OF THE DRAWINGS The above needs are at least partially met by the provision of the drug delivery system described in the following detailed description, particularly when studied in conjunction with the drawings, where: Figure 1 illustrates an illustrative drug delivery system according to several embodiments; Figure 2 illustrates an exemplary delivery container for the drug delivery system of Figure 1 according to various embodiments; and Figure 3 illustrates an illustrative rigid container for the drug delivery system of Figures 1 and 2 according to various embodiments; Skilled workers will appreciate that elements in the figures are illustrated for simplicity and clarity and are not necessarily drawn to scale. For example, the dimensions and / or relative placement of some elements in the figures may be exaggerated in relation to other elements to aid in a better understanding of various embodiments of the present invention. Furthermore, common but well-understood elements that are useful or necessary in a commercially feasible embodiment are often omitted to facilitate a less obstructed view of these various embodiments. It will also be appreciated that certain actions and / or steps may be described or depicted in a particular order of occurrence, although skilled workers in the art will understand that such specificity with respect to sequence is not actually required.It shall also be understood that the terms and expressions used herein have the ordinary technical meaning agreed upon by persons skilled in the technical field as set forth above, except where different specific meanings have been established herein. DETAILED DESCRIPTION Returning to the figures, by virtue of these various embodiments, a drug delivery system 100 may include a delivery container 110 and a rigid container 140, which could also be considered a case, housing, cover, etc. The system 100 can be used in intravenous, subcutaneous, intra-arterial, intramuscular, and / or epidural delivery approaches with delivery times ranging from approximately five minutes to approximately eight hours. The delivery container 110 includes a top portion 110a, a bottom portion 110b, a first side portion 110c, and a second side portion 110d. The delivery container 110 further includes a conical region 112 extending a distance between the first portion 110c and the second portion 110d. The delivery container is in the form of a flexible and / or foldable bag that includes an inner cavity 111 to house a drug 101 contained therein to be delivered to a patient.In some versions, the internal cavity 111 is sterile. In some versions, the delivery container is constructed similarly to a conventional IV bag and may be formed from one or possibly two pieces of bag film joined at the seams that extend along its perimeter, thus defining the internal cavity 111 for material storage. In the illustrated example, the conical region 112 includes an upper portion 112a adjacent to the first side portion 110c of the supply vessel 110, and a lower portion 112b adjacent to both the second side portion 110d and the lower portion 110b of the supply vessel 110. From the lower portion 112b, the conical region 112 extends upward to the upper portion 112a adjacent to the first side portion 110c. The conical region 112 can form an angle α with respect to the lower portion 110b of the supply vessel 110. In some examples, the angle α can be between approximately 100° and approximately 150°. Other examples are possible. Furthermore, the conical region can extend any length of the first side portion 110c, such as, for example, approximately 25%. As a result, the supply vessel 110 is, in general, trapezoidal in shape.Although the illustrated exemplary supply container 110 includes a conical region 112 that terminates at a portion of the bottom 110b to create a generally flat surface, in other examples, the conical region 112 may extend its entire length between the first and second sides 110c, 110d. And while the conical region 112 described in this version extends entirely between the first and second side portions 110c, 110d, the conical region 112 in other versions may only extend partially between the first and second side portions 110c, 110d. Furthermore, although the conical region 112 is linear in shape, in other versions, other shapes are possible, including V-shaped or U-shaped shapes, for example. The upper portion 110a of the supply container 110 may include any number of mating members 114 (for example, holes) used to attach the supply container 110 to the rigid container 140 (as discussed in more detail below). In addition, the upper portion 110a of the supply container 110 may extend upward beyond the inner cavity 111. This region may include a gripping portion 115 of a seam that is textured relative to the supply container 110 to assist in safely handling the supply container 110. In some examples, the gripping portion 115 may also include a handle that enables the user to grasp and hold the supply container 110. Other examples are possible. The delivery container 110 further includes a first drug insertion port 116, at least one secondary drug insertion port 118, and an IV connection port 120 (e.g., delivery port), each of which is in fluid communication with the inner cavity 111 of the delivery container 110. The first drug insertion port 116 and the at least one secondary drug insertion port 118 are used by healthcare professionals to insert drug 101 into the inner cavity 111 of the delivery container 110 using a needle attached to a syringe or vial, for example. The IV connection port 120 is adapted to be coupled to a fluid line or tubing (not shown) for administering drug 101 to a user.In the illustrated example, ports 116, 118 are located on or near the bottom 110b of the supply vessel 110 (and specifically, along the tapered region 112), but in other examples, ports 116, 118 may be located anywhere on the supply vessel 110. The first drug insertion port 116 has a first coupling mechanism 116a for accommodating a vial, syringe, or other component used to insert drug 101 into cavity 111. In some examples, the first coupling mechanism 116a is in the form of a luer-lock mechanism. Similarly, the at least one secondary drug insertion port 118 has a second coupling mechanism 118a for accommodating a vial, syringe, or other component used to insert drug 101 into cavity 111. In some examples, the second coupling mechanism 118a is in the form of a closed system transfer device (CSTD) used to transfer drug 101 in a sterile environment. In the illustrated example, two secondary drug insertion ports 118 are provided, each of which includes a second coupling mechanism 118a having different dimensions to accommodate different sizes of vials, syringes, or containers.As a result, the 110 delivery container itself can be the CSTD, thereby providing compatibility across different vial types and coupling mechanisms. In some examples, the second coupling mechanism is a standard 13 mm port that couples to at least one ISO 2R vial or a 13 mm CSTD. In other examples, the second coupling mechanism may be a standard 20 mm port that couples to at least one ISO vial or a 20 mm CSTD. Other examples are possible. In some examples, the 110 delivery container is supplied to a healthcare professional in an empty state. In other examples, the 110 delivery container may be pre-filled with saline solution and / or an intravenous solution (IVSS). In still other examples, the 110 delivery container may additionally include a preservative besides the saline solution and IVSS. Other examples are possible that may reduce overall preparation time. As can be seen from Figure 2, the IV connection port 120 is located at the bottom 110b of the delivery container 110 and adjacent to part 112b of the conical region zz / ynn / Lznz / E / Yii 112, such that when the drug 101 within the delivery container 110 is administered to the patient, the entire contents of the delivery container 110 are delivered through the IV connection port 120. As a result, the delivery container 110 reduces and / or eliminates the occurrence of drug retention, and the entire contents of the delivery container 110 are administered to the user. Returning now to Figures 1 and 3, the rigid container 140 includes a top portion 140a and a bottom portion 140b, and is in the form of a cover having an internal volume 141 sized to accommodate the supply container 110. As illustrated in Figure 1, the rigid container 140 may be in the form of a hinged member or a clamshell that opens to provide access to an internal volume 141. The rigid container 140 is constructed from a rigid material, such as a polymer, a metal, etc., that is strong enough to protect the supply container from damage. The bottom portion 140b of the rigid container 140 includes an opening 142 that accommodates a portion of the IV connection port 120 and / or a way IV extending from the IV connection port 120. The rigid container 140 may additionally include filler 144 arranged within the cover to further protect the supply container 110.As a result, the 110 delivery container is protected from punctures occurring during drug administration. Located on or near the top 140a of the rigid vessel 140 is at least one mounting portion 146 in the form of a mounting bolt. The mounting bolt 146 is sized to be inserted into the coupling member 114 of the delivery vessel 110, thereby further securing the delivery vessel 110 within the rigid vessel 140. The mounting bolt may extend upward from the front and / or rear of the rigid vessel 140 and may include a notched portion along its length that accommodates a coupling member 114 of the delivery vessel 110. In some instances, the mounting bolt may be in the form of two distinct sections, with one section attached to the front of the rigid vessel 140 and another section attached to the rear of the rigid vessel 140, which are mated together (e.g., by means of a friction connection, a snap fit, etc.).) to secure the coupling member 114 of the delivery vessel 110. In these examples, the coupling member 114 may simply be a part of the delivery vessel 110 held in place by two distinct sections. The two distinct sections may have mating end regions (for example, via a projection and corresponding socket) such that the coupling member 114 of the delivery vessel 110 is also pushed into the socket. In some examples, the rigid container 140 may also include a fastening strap member 148, which may be constructed from an elastic material. The supply container 110 may be inserted within the internal volume 141 of the rigid container 140 beneath the fastening strap member 148, such that the fastening strap member 148 holds the supply container 110 against the rear wall of the rigid container. In some examples, the rigid container 140 may further include a top opening 150 located in the top portion 140a to allow a portion of the top portion 110a of the delivery container 110 to pass through. The top opening 150 may be in the form of a slot that may include fastening features, such as teeth or pins, for securing the top portion 110a of the delivery container 110. In some approaches, the top opening 150 may also include a feeding mechanism, such as rollers, to advance the delivery container 110 upward. As a result, a user can grasp the gripping portion 115 of the delivery container instead of grasping the entire rigid container. In some examples, the rigid container 140 may additionally include any number of external fastening features.For example, an external strap (not shown) can function as an endless belt that secures the rigid container to a user's waist area. Other examples are possible. Configured in this way, the described drug delivery system 100 facilitates rapid changeover of delivery devices 110, while ensuring that all or most of the drug 101 is delivered to the patient because the shape and configuration of the container 110, including the tapered region 112, allows the drug to flow naturally into and out of the IV connection port 120. By including a number of different ports with different coupling mechanisms, healthcare professionals can also quickly and easily fill the delivery container 110 with the required drug and do not need to keep a large number of connection mechanisms (e.g., 10 to 15 conventional CSTD devices) in their inventory. The preceding description outlines various devices, assemblies, components, subsystems, and methods for use in connection with a drug delivery device. Drug delivery devices, assemblies, components, subsystems, methods, or devices may also include or be used with a drug, including, but not limited to, the drugs identified below, as well as their generic and biosimilar counterparts. The term "drug," as used herein, may be used interchangeably with other similar terms and may refer to any type of medicinal product or therapeutic material, including traditional and non-traditional drugs, nutraceuticals, supplements, biological products, biologically active agents and compositions, macromolecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, low molecular weight molecules, and generics.Non-therapeutic injectable materials are also included. The drug may be in liquid form, a lyophilized form, or a form reconstituted from a lyophilized form. The following list of example drugs should not be considered exhaustive or limiting. The drug will be contained in a reservoir. In some cases, the reservoir is a master container that is filled or pre-filled for treatment with the drug. The master container may be a vial, a cartridge, or a pre-filled syringe. In some embodiments, the reservoir of the drug delivery device can be filled with, or the device can be used with, colony-stimulating factors, such as granulocyte colony-stimulating factor (G-CSF). Such G-CSF agents include, but are not limited to, Neulasta® (pegfilgrastim, pegylated filgrastim, pegylated G-CSF, pegylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-Met-G-CSF). In other embodiments, the drug delivery device may contain or be used with an erythropoiesis-stimulating drug (ESD), which may be in liquid or lyophilized form. An ESD is any molecule that stimulates erythropoiesis. In some embodiments, an ESD is an erythropoiesis-stimulating protein. As used herein, “erythropoiesis-stimulating protein” means any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to and causing dimerization of the receptor. Erythropoiesis-stimulating proteins include erythropoietin and variants, analogues, or derivatives thereof that bind to and activate the erythropoietin receptor; antibodies that bind to and activate the erythropoietin receptor; or peptides that bind to and activate the erythropoietin receptor.Erythropoiesis-stimulating proteins include, but are not limited to, Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methioxypolyethylene glycol-epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alfa), epoetin alfa Hexal, Abseamed® (epoetin alfa), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alfa, epoetin beta, epoetin ¡ota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta and epoetin delta, pegylated erythropoietin, carbamylated erythropoietin, as well as molecules or variants or analogues of these. Particularly illustrative proteins include the specific proteins described below, which include fusions, fragments, analogues, variants, or derivatives thereof: OPGL-specific antibodies, peptibodies, related proteins, and the like (also referred to as RANKL-specific antibodies, peptibodies, and the like), including fully humanized and human OPGL-specific antibodies, particularly fully humanized monoclonal antibodies; myostatin-binding proteins, related proteins, and the like, including myostatin-specific peptibodies; IL-4 receptor-specific antibodies, peptibodies, related proteins, and the like, particularly those that inhibit activities mediated by the binding of IL-4 and / or IL-13 to the receptor; interleukin-1 receptor 1-specific antibodies (ILI-RTj, peptibodies, related proteins, and the like);Ang2-specific antibodies, peptibodies, related proteins and the like; NGF-specific antibodies, peptibodies, related proteins and the like; CD22-specific antibodies, peptibodies, related proteins and the like, in particular human CD22-specific antibodies, such as, but not limited to, humanized and fully human antibodies, including, but not limited to, humanized and fully human monoclonal antibodies, in particular, including, but not limited to, human CD22-specific IgG antibodies, such as, a dimer of a mouse monoclonal hLL2 gamma chain disulfide linked to a human-mouse monoclonal hLL2 kappa chain, e.g., the humanized fully human CD22-specific antibody in Epratuzumab, CAS Registry Number 501423-23-0;IGF-1 receptor-specific antibodies, peptibodies, and related and similar proteins, including, but not limited to, anti-IGF-1R antibodies; B-7-related protein 1-specific antibodies, peptibodies, related and similar proteins (B7RP-1 and also in relation to B7H2, ICOSL, B7h and CD275), including, but not limited to, B7RP-specific fully human monoclonal IgG2 antibodies, including, but not limited to, the fully human IgG2 monoclonal antibody that binds to an epitope in the first immunoglobulin-like domain of B7RP-1, including, but not limited to, those that inhibit the interaction of B7RP-1 with its natural receptor, ICOS, on activated T cells; IL-15-specific antibodies, peptibodies, related proteins and the like, such as, in particular, humanized monoclonal antibodies, including, but not limited to, IL-15 HuMax antibodies and related proteins, such as, for example, 146B7;IFN-gamma-specific antibodies, peptibodies, related proteins, and the like, including, but not limited to, human IFN-gamma-specific antibodies, and including, but not limited to, fully human anti-IFN-gamma antibodies; TALL-1-specific antibodies, peptibodies, related proteins, and the like, and other TALL-specific binding proteins; parathyroid hormone (PTH)-specific antibodies, peptibodies, related proteins, and the like; thrombopoietin receptor (TPO-R)-specific antibodies, peptibodies, related proteins, and the like; hepatocyte growth factor (HGF'j)-specific antibodies, peptibodies, related proteins, and the like, including those directed against the HGF / SF:cMet axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize hepatocyte growth factor / dispersion factor (HGF / SF);TRAIL-R2 specific antibodies, peptibodies, related proteins, and the like; divin A specific antibodies, peptibodies, proteins, and the like; TGF-beta specific antibodies, peptibodies, related proteins, and the like; zz / ynn / Lznz / E / Yii specific antibodies for amyloid beta protein, peptibodies, related proteins, and the like; c-Kit specific antibodies, peptibodies, related proteins, and the like, including, but not limited to, proteins that bind to c-Kit and / or other stem cell factor receptors; OX40L specific antibodies, peptibodies, related proteins, and the like, including, but not limited to, proteins that bind to OX40L and / or other OX40 receptor ligands; Activasa® (alteplase, tPA); Aranesp® (darbepoetin alfa); Epogen® (epoetin alfa, or erythropoietin); GLP-1, Avonex® (interferon beta-1a); Bexxar® (tositumomab, antimonoclonal antibody CD22); Betaseron® (interferon beta);Campath® (alemtuzumab, antimonoclonal CD52 antibody); Dynepo® (epoetinadelta); Velcade® (bortezomib); MLN0002 (antia4B7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb); Enbrel® (etanercept, TNF receptor / Fe fusion protein, TNF blocker); Eprex® (epoetin alfa); Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1); Genotropin® (somatropin, human growth hormone); Herceptin® (trastuzumab, anti-HER2 / neu receptor mAb (erbB2)); Humatrope® (somatropin, human growth hormone); Humira® (adalimumab); Vectibix® (panitumumab), Xgeva® (denosumab), Prolia® (denosumab), Enbrel® (etanercept, TNF receptor / Fe fusion protein, TNF blocker), Nplate® (romiplostim), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution; Infergen® (alfacon interferon-1); Natrecor® (nesiritide; recombinant human b-type natriuretic peptide (hBNP); Kineret® (anakinra); Leukine® (sargamostim, rhuGM-CSF); LymphoCide® (epratuzumab, anti-CD22 mAb);Benlysta™ (lymphostat B, belimumab, anti-BlyS mAb); Metalyse® (tenecteplase, t-PA analog); Mircera® (methoxy polyethylene glycol-epoetin beta); Mylotarg® (gemtuzumab ozogamicin); Raptiva® (efalizumab); Cimzia® (certolizumab pegol, CDP 870); Soliris™ (eculizumab); pexelizumab (ant¡-C5 complement); Numax® (MEDI-524); Lucentis® (ranibizumab); Panorex® (17-1A, edrecolomab); Trabio® (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (vicilizumab); cantuzumab mertansine (huC242-DM1); NeoRecormon® (beta poison); Neumega® (oprelvekin, human interleukin 11); Orthoclone OKT3® (muromonab-CD3, anti-CD3 monoclonal antibody); Procrit® (epoetinalpha); Remicade® (infliximab, anti-TNFa monoclonal antibody); Reopro® (abciximab, anti-GP receptor monoclonal antibody llb / llia); Actemra® (anti-IL6 mAb receptor); Avastin® (bevacizumab), HuMax-CD4 (zanolimumab); Rituxan® (rituximab, anti-CD20 anti-IL6 mAb); Tarceva® (erlotinib);RoferonA®-(interferon alpha-2a); Simulect® (basiliximab); Prexige® (lumiracoxib); Synagis® (palivizumab); 146B7-CHO (anti-IL15 antibody, see U.S. Patent No. 7,153,507); Tysabri® (natalizumab, anti-a4¡nteghna mAb); Valortim® (MDX-1303, anti-B. anthracis protective antigen mAb); ABthrax™; Xolair® (omalizumab); ETI211 (anti-MRSA mAb); IL1 trap (the Fe part of human IgG 1 and the extracellular domains of both components of the IL-1 receptor zz / ynn / Lznz / E / Yii (the type I receptor and the receptor accessory protein)); VEGF trap (VEGFR1 Ig domains fused to lgG1 Fe); Zenapax® (daclizumab); Zenapax® (daclizumab, anti-IL-2Ra mAb); Zevalin® (ibritumomab tiuxetan); Zetia® (ezetimibe); Orencia® (atacicept, TACI-lg); anti-CD80 monoclonal antibody (galiximab); anti-CD23 mAb (lumiliximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNFa mAb); HGS-ETR1 (mapatumumab; human anti-TRAIL receptor-1 mAb);HuMax-CD20 (ocrelizumab, mAb humano anti-CD20); HuMax-EGFR (zalutumumab); M200 (volociximab, anti-a5p1 mAb); MDX-010 (ipilimumab, mAb anti-CTLA-4 y VEGFR-1 (IMC-18F1); mAb anti-BR3; anti-C. difficile Toxina A y Toxina BC mAbs MDX-066 (CDA-1) y MDX-1388); conjugados dsFv-PE38 anti-CD22 (CAT-3888 and CAT-8015); mAb antiCD25 (HuMax-TAC); anti-CD3 mAb (NI-0401); adecatumumab; mAb anti-CD30 (MDX-060); MDX-1333 (anti-IFNAR); mAb anti-CD38 (HuMax CD38); mAb anti-CD40L; mAb anti-Cripto; fibrógeno de phase 1 de fibrosis pulmonar idiopática anti-CTGF (FG-3019); mAb anti-CTLA4; mAb anti-eotaxina 1 (CAT-213); mAb anti-FGF8; mAb anti-gangliósido GD2; mAb antigangliósido GM2; mAb anti-GDF-8 humano (MYO-029); mAb del receptor anti-GM-CSF (CAM-3001); mAb anti-HepC (HuMax HepC); mAb anti-IFNa (MEDI-545, MDX-1103); mAb anti-IGF1R; mAb antiIGF-1 R (HuMax-Inflam); mAb anti-IL12 (ABT-874); mAb anti-IL12 / IL23 (CNTO 1275); mAb antiIL13 (CAT-354); mAb anti-IL2Ra (HuMax-TAC);anti-IL5 receptor mAb; anti-integrin receptor mAb (MDX-018, CNTO 95); anti-IP10 ulcerative colitis mAb (MDX-1100); BMS66513; anti-mannose / hCGp receptor mAb (MDX-1307); antimesothelin dsFv-PE38 conjugate (CAT-5001); anti-PD1 mAb (MDX-1106 (ONO-4538)); anti-PDGFRa antibody (IMC-3G3); anti-TGFB mAb (GC-1008); human anti-TRAIL receptor-2 mAb (HGS-ETR2); anti-TWEAK mAb; anti-VEGFR / Flt-1 mAb; and anti-ZP3 mAb (HuMax-ZP3).; In some embodiments, the drug delivery device may contain or be used with an anti-sclerostin antibody, such as, but not limited to, romosozumab, blosozumab, or BPS 804 (Novartis), and in other embodiments, a monoclonal antibody (IgG) that binds to human proprotein convertase subtilisin / kexin type 9 (PCSK9). Such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may contain or be used with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, or panitumumab.In some embodiments, the drug delivery device reservoir may be filled with, or the device may be used with, IMLYGIC® (thalimogen laherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers, including, but not limited to, OncoVEXGALV / CD; OrienXOI 0; G207,1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device may contain, or may be used with, tissue inhibitors of endogenous metalloproteinases (TIMPs) such as, but not limited to, TIMP-3. Antibodies antagonistic to the calcitonin gene-related peptide receptor (CGRP), such as, but not limited to, erenumab and bispecific antibody molecules that act on the CGRP receptor and other headache targets, may also be delivered with a drug delivery device of the present disclosure.Additionally, bispecific T-cell binding antibodies (BiTE®) such as, but not limited to, BLINCYTO® (blinatumomab) may be used in or with the drug delivery device described herein. In some embodiments, the drug delivery device may contain or be used with an APJ agonist macromolecule such as, but not limited to, apelin or its analogues. In some embodiments, a therapeutically effective amount of an anti-thymic stromal lymphopoietin (TSLP) antibody or TSLP receptor is used in or with the drug delivery device described herein. Although the drug delivery devices, assemblies, components, subsystems, and methods have been described in terms of exemplary embodiments, they are not limited to these. The detailed description is to be interpreted as an example only and does not describe all possible embodiments of the present disclosure. Numerous alternative embodiments could be implemented, using either current technology or technology developed after the filing date of this patent, that would still fall within the scope of the claims defining the invention or inventions disclosed herein. Skilled professionals will recognize that a wide variety of modifications, alterations, and combinations can be made to the embodiments described above without departing from the spirit and scope of the invention(s), and that such modifications, alterations, and combinations should be viewed as being within the scope of the inventive concept(s). zz / ynn / Lznz / E / Yu NOVELTY OF THE INVENTION Having described the present invention as above, it is considered novel and, therefore, the contents contained in the following are claimed as property:
Claims
1. A drug delivery system comprising: a delivery container including a top portion, a bottom portion, a first side portion, a second side portion, and a tapered region extending between the first side portion and the second side portion; a first drug insertion port located at the bottom of the delivery container, the first drug insertion port having a first coupling mechanism; at least one additional drug insertion port located at the bottom of the delivery container, the at least one additional drug insertion port having a second coupling mechanism that differs from the first coupling mechanism; and an IV connection port located at the bottom of the delivery container adjacent to the bottom of the tapered region.
2. The drug delivery system of claim 1, wherein the first coupling mechanism comprises a luer-lock.
3. The drug delivery system of claim 1 or 2, wherein the second coupling mechanism comprises a closed system transfer device (“CSTD”).
4. The drug delivery system of claim 3, wherein the CSTD comprises at least one of: a 13 mm standard port adapted to couple to at least one of an iso 2R vial or a 13 mm CSTD; or a 20 mm standard port adapted to couple to at least one of an iso vial or a 20 mm CSTD.
5. The drug delivery system of any of claims 1 to 4, further comprising a rigid container defining an internal volume, the rigid container having a top and a bottom portion, the bottom portion of the rigid container including an opening to accommodate at least one IV connection port or IV line.
6. The drug delivery system of claim 5, wherein the delivery container further includes at least one opening formed in its upper portion, and the rigid container further includes at least one mounting bolt sized to receive the at least one opening of the delivery container for operatively securing the delivery container within the internal volume of the rigid container. zz / ynn / Lznz / E / Yii 7. The drug delivery system of claim 5 or 6, wherein the rigid container further includes at least one safety strap member.
8. The drug delivery system of any of claims 5 to 7, wherein the rigid container includes an opening in the top thereof to accommodate a portion of the delivery container.
9. The drug delivery system of any of claims 1 to 8, wherein the delivery container is empty.
10. The drug delivery system of any of claims 1 to 8, wherein the delivery container contains a saline solution and an intravenous stabilizing solution.
11. The drug delivery system of claim 10, wherein the delivery container further contains a preservative.
12. A drug delivery system comprising: a delivery container including a top portion, a bottom portion, a first side portion, a second side portion, and a tapered region extending between the first side portion and the second side portion, the delivery container including at least one opening formed in the top portion thereof; a first drug insertion port located in the bottom of the delivery container, the first drug insertion port having a first coupling mechanism; at least one additional drug insertion port located in the bottom of the delivery container, the at least one additional drug insertion port having a second coupling mechanism that differs from the first coupling mechanism; an IV connection port located in the bottom of the delivery container adjacent to the bottom of the tapered region;and a rigid container defining an internal volume, the rigid container having a top and a bottom, the top including at least one mounting bolt sized to receive the at least one opening of the supply container to operatively fix the supply container within the internal volume of the rigid container, the bottom of the rigid container including an opening to accommodate at least one IV connection port or IV way.; 13. The drug delivery system of claim 12, wherein the first coupling mechanism comprises a luer-lock.
14. The drug delivery system of claim 12 or 13, wherein the second coupling mechanism comprises a closed-system transfer device (“CSTD’j. zz / ynn / Lznz / E / Yii 15. The drug delivery system of claim 14, wherein the CSTD comprises at least one of: a 13 mm standard port adapted to couple to at least one of a 2R vial or a 13 mm CSTD; or a 20 mm standard port adapted to couple to at least one of a 20 mm vial or a 20 mm CSTD.
16. The drug delivery system of any of claims 12 to 15, wherein the rigid container further includes at least one safety strap member.
17. The drug delivery system of any of claims 12 to 16, wherein the rigid container includes an opening in the upper portion thereof to accommodate a portion of the delivery container.
18. The drug delivery system of any of claims 12 to 17, wherein the delivery container is empty.
19. The drug delivery system of any of claims 12 to 17, wherein the delivery container contains a saline solution and an intravenous stabilizing solution.
20. The drug delivery system of claim 19, wherein the delivery container further contains a preservative.