DOSING SYSTEMS AND APPROACHES

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 upper, lower, first side, 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 positioned at the lower portion of the delivery container and has a first coupling mechanism. The at least one additional drug insertion port is also positioned at the lower portion of the delivery container, but includes a second coupling mechanism that is different than the first coupling mechanism. The IV connection port is positioned at the lower portion of the delivery container adjacent to a lower portion of the tapered region.

FIELD OF DISCLOSURE

The present disclosure generally relates to drug delivery systems and methods. More particularly, the present disclosure relates to improved approaches for preparing and delivering dosing systems.

BACKGROUND

Drugs are administered to treat a variety of conditions and diseases. Intravenous (“IV”) therapy is a drug dosing process that delivers drugs directly into a patient's vein using an infusion contained in a container (e.g., a pliable bag). These processes may be performed in a healthcare facility, or in some instances, at remote locations such as a patient's home. Oftentimes, a healthcare professional must prepare the drug by mixing numerous ingredients prior to administration of the drug. Existing systems typically involve a lengthy drug preparation process involving multiple steps. Further, in some environments where extended drug dosings are required involving sequential administration of drugs in multiple containers, it may be necessary to swap these containers while ensuring the entire contents of each container is administered to the patient.

As described in more detail below, the present disclosure sets forth systems and methods for patient monitoring and interventional dosing techniques embodying 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

In accordance with 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 upper, lower, first side, 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 positioned at the lower portion of the delivery container and has a first coupling mechanism. At least one additional drug insertion port is also positioned at the lower portion of the delivery container, but includes a second coupling mechanism that is different than the first coupling mechanism. The IV connection port is positioned at the lower portion of the delivery container adjacent to a lower portion of the tapered region.

In some examples, the first coupling mechanism is in the form of a luer lock mechanism. The second coupling mechanism may be a closed system transfer device (“CSTD”). In some examples, the CSTD is in the form of a standard 13 mm port that couples to at least one of a 2 R iso-vial or a 13 mm CTSD. In other examples, the CSTD is in the form of a standard 20 mm port that couples to at least one of an iso-vial or a 20 mm CSTD. Other examples are possible.

In some of these examples, the system further includes a rigid container that defines an inner volume. The rigid container has an upper portion and a lower portion that includes an opening to accommodate at least one of the IV connection port or an IV line. In some forms, the delivery container further includes at least one opening formed in the upper portion and the rigid container additionally includes at least one mounting post that is dimensioned to receive at least one opening to operably secure the delivery container within the inner volume of the rigid container. In some examples, the rigid container may include at least one securing strap member. In some approaches, the rigid container also includes an opening at the upper portion to accommodate a portion of the delivery container.

In some examples, the delivery container may be empty. In other approaches, the delivery container contains a saline solution and an intravenous stabilizing solution. In yet other examples, the delivery container contains the saline solution, an intravenous stabilizing solution, and a preservative.

In accordance with 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 upper, lower, first side, and second side portions, and additionally includes a tapered region extending between the first side portion and the second side portion and at least one opening formed in the upper portion thereof. The first drug insertion port is positioned at the lower portion of the delivery container and has a first coupling mechanism. At least one additional drug insertion port is also positioned at the lower portion of the delivery container, but includes a second coupling mechanism that is different than the first coupling mechanism. The IV connection port is positioned at the lower portion of the delivery container adjacent to a lower portion of the tapered region. The rigid container defines an inner volume and has upper and lower portions. The upper portion includes at least one mounting post that is dimensioned to receive the at least one opening of the delivery container to operably secure the delivery container within the inner volume of the rigid container. The lower portion of the rigid container includes an opening to accommodate at least one of the IV connection port or an IV line.

DETAILED DESCRIPTION

Turning to the figures, pursuant to these various embodiments, a drug delivery system100can include a delivery container110and a rigid container140, which could also be considered a case, a housing, a cover, etc. The system100may be used in intravenous, subcutaneous, intra-arterial, intramuscular, and/or epidural delivery approaches having delivery times between approximately five minutes and approximately eight hours. The delivery container110includes an upper portion110a,a lower portion110b,a first side portion110c,and a second side portion110d.The delivery container110further includes a tapered region112extending a distance between the first side portion110cand the second side portion110d.The delivery container is in the form of a flexible and/or pliable bag that includes an interior cavity111to accommodate a drug101contained therein to be delivered to a patient. In some versions, the interior cavity111is sterile. In some versions, the delivery container is constructed similar to a conventional IV bag, and can be formed from one or possibly two pieces of bag film bonded together at seams extending along its perimeter thereby defining the interior cavity111for material storage.

In the illustrated example, the tapered region112includes a higher portion112aadjacent the first side portion110cof the delivery container110, and a lower portion112badjacent both the second side portion110dand the lower portion110bof the delivery container110. From the lower portion112b,the tapered region112extends upwardly to the upper portion112aadjacent the first side portion110c.The tapered region112may form an angle “α” relative to the lower portion110bof the delivery container110. In some examples, the angle α may be between approximately 100° and approximately 150°. Other examples are possible. Further, the tapered region may extend any length of the first side portion110csuch as, for example, approximately 25%. As a result, the delivery container110is generally trapezoidal in shape. While the illustrated example delivery container110includes a tapered region112that terminates at a portion of the lower portion110bto create a generally flat surface, in other examples, the tapered region112may extend the entire length between the first and second sides110c,110d.And while the tapered region112depicted in this version extends entirely between the first and second side portions110c,110d,the tapered region112in other versions may only extend partially between the first and second side portions110c,110d. Furthermore, while the tapered region112is linear in shape, in other versions, other shapes are possible, including V-shaped or U-shaped, for example.

The upper portion110aof the delivery container110may include any number of coupling members114(e.g., holes) used to secure the delivery container110to the rigid container140(as will be discussed in further detail below). Additionally, the upper portion110aof the delivery container110may extend a distance upwardly beyond the interior cavity111. This region may include a gripping portion115of a seam that is textured relative to the remainder of the delivery container110to assist in safely handling the delivery container110. In some examples, the gripping portion115may also include a handle that allows a user to grab and hold the delivery container110. Other examples are possible.

The delivery container110additionally includes a first drug insertion port116, at least one secondary drug insertion port118, and an IV connection port120(e.g., delivery port), each of which is in fluid communication with the interior cavity111of the delivery container110. The first drug insertion port116and the at least one secondary drug insertion port118are used by healthcare professionals to insert the drug101into the interior cavity111of the delivery container110with a needle attached to a syringe or a vial, for example. The IV connection port120is adapted to be coupled to a fluid line or tubing (not shown) to administer the drug101to a user. In the illustrated example, the ports116,118are positioned at or near the lower portion110bof the delivery container110(and specifically, along the tapered region112), but in other examples, the ports116,118may be positioned at any location on the delivery container110.

The first drug insertion port116has a first coupling mechanism116ato accommodate a vial, syringe, or other component used to insert the drug101into the cavity111. In some examples, the first coupling mechanism116ais in the form of a luer lock mechanism. Similarly, the at least one secondary drug insertion port118has a second coupling mechanism118ato accommodate a vial, syringe, or other component used to insert the drug101into the cavity111. In some examples, the second coupling mechanism118ais in the form of a closed system transfer device (“CSTD”) used to transfer the drug101in a sterile environment. In the illustrated example, two secondary drug insertion ports118are provided, each of which includes a second coupling mechanism118ahaving different dimensions to accommodate different sizes of vials, syringes, or containers. As a result, the delivery container110itself may be the CSTD, thereby providing compatibility across different types of vials and coupling mechanisms. In some examples, the second coupling mechanism is in the form of a standard 13 mm port that couples to at least one of a 2 R iso-vial or a 13 mm CSTD. In other examples, the second coupling mechanism may be in the form of a standard 20 mm port that couples to at least one of an iso-vial or a 20 mm CSTD. Other examples are possible.

In some examples, the delivery container110is delivered to a healthcare professional in an empty state. In other examples, the delivery container110may be pre-filled with a saline solution and/or an intravenous stabilizing solution (“IVSS”). In yet other examples, the delivery container110may additionally include a preservative in addition to the saline solution and IVSS. Other examples are possible that may reduce overall preparation time.

As can be seen inFIG. 2, the IV connection port120is positioned at the lower portion110bof the delivery container110and adjacent the lower portion112bof the tapered region112such that, when the drug101within the delivery container110is being administered to a patient, the entire contents of the delivery container110are delivered through the IV connection port120. As a result, the delivery container110reduces and/or eliminates the occurrence of drug hold up, and all of the contents of the delivery container110are administered to the user.

Turning now toFIGS. 1 and 3, the rigid container140includes an upper portion140aand a lower portion140b,and is the form of a shell having an inner volume141dimensioned to accommodate the delivery container110. As illustrated inFIG. 1, the rigid container140may be in the form of a hinged or clamshell member that opens to provide access to the inner volume141. The rigid container140is constructed from a rigid material such as a polymer, a metal, etc. that is sufficiently strong to protect the delivery container from damage. The lower portion140bof the rigid container140includes an opening142that accommodates a portion of the IV connection port120and/or an IV line that exits the IV connection port120. The rigid container140may additionally include padding144disposed within the shell to further protect the delivery container110. As a result the delivery container110is protected from the occurrence of punctures from occurring during drug administration.

Positioned at or near the upper portion140aof the rigid container140is at least one mounting portion146in the form of a mounting post. The mounting post146is dimensioned to be inserted into the coupling member114of the delivery container110, thereby further securing the delivery container110within the rigid container140. The mounting post may extend upwardly from the front and/or the rear portion of the rigid container140, and may include a notched portion along its length that accommodates the coupling member114of the delivery container110. In some examples, the mounting post may be in the form of two distinct sections with one section being coupled to the front portion of the rigid container140and another section being coupled to the rear portion of the rigid container140that couple together (e.g., via a frictional connection, a snap fit, etc.) to secure to the coupling member114of the delivery container110. In these examples, the coupling member114may simply be a portion of the delivery container110that is held in place by the two distinct sections. The two distinct sections may have end regions that mate together (e.g., via a protrusion and corresponding socket) in a way that the coupling member114of the delivery container110is also urged into the socket.

In some examples, the rigid container140may also include a securing strap member148which may be constructed from an elastic material. The delivery container110may be inserted into the inner volume141of the rigid container140below the securing strap member148such that the securing strap member148maintains the delivery container110against the rear wall thereof.

In some examples, the rigid container140may additionally include an upper opening150positioned at the upper portion140ato allow a portion of the upper portion110aof the delivery container110to pass through. The upper opening150may be in the form of a slot that may include securement features such as teeth or prongs to secure the upper portion110aof the delivery container110. In some approaches, the upper opening150may also include a feeding mechanism such as rollers to advance the delivery container110upwards. As a result, a user may grasp the gripping portion115of the delivery container instead of grasping the entire rigid container. In some examples, the rigid container140may additionally include any number of external securement features. For example, an external strap (not shown) may act as a belt loop that secures the rigid container to a user's waist region. Other examples are possible.

So configured, the described drug delivery system100makes it easier to change out delivery containers110quickly, along with ensuring that all or most of drug101is actually delivered to the patient because the shape and configuration of the container110including the tapered region112allows the drug to naturally flow to and out of the IV connection port120. By including a number of different ports having different coupling mechanisms, healthcare professionals can also quickly and easily fill the delivery container110with the required drug, and needn't keep a large number of connection mechanisms (e.g.,10-15conventional CSTD devices) in stock.

The above description describes various devices, assemblies, components, subsystems and methods for use related to a drug delivery device. The devices, assemblies, components, subsystems, methods or drug delivery devices can further comprise or be used with a drug including but not limited to those drugs identified below as well as their generic and biosimilar counterparts. The term drug, as used herein, can be used interchangeably with other similar terms and can be used to refer to any type of medicament or therapeutic material including traditional and non-traditional pharmaceuticals, nutraceuticals, supplements, biologics, biologically active agents and compositions, large molecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules and generics. Non-therapeutic injectable materials are also encompassed. The drug may be in liquid form, a lyophilized form, or in a reconstituted from lyophilized form. The following example list of drugs should not be considered as all-inclusive or limiting.

The drug will be contained in a reservoir. In some instances, the reservoir is a primary container that is either filled or pre-filled for treatment with the drug. The primary container can be a vial, a cartridge or a pre-filled syringe.

In some embodiments, the reservoir of the drug delivery device may 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 filgastrim, pegylated G-CSF, pegylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-MetG-CSF).

In other embodiments, the drug delivery device may contain or be used with an erythropoiesis stimulating agent (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoiesis. In some embodiments, an ESA 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, analogs, or derivatives thereof that bind to and activate erythropoietin receptor; antibodies that bind to erythropoietin receptor and activate the receptor; or peptides that bind to and activate erythropoietin receptor. Erythropoiesis stimulating proteins include, but are not limited to, Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methyoxy polyethylene 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 iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta, and epoetin delta, pegylated erythropoietin, carbamylated erythropoietin, as well as the molecules or variants or analogs thereof.

In some embodiments, the drug delivery device may contain or be used with a sclerostin antibody, such as but not limited to romosozumab, blosozumab, or BPS 804 (Novartis) and in other embodiments, a monoclonal antibody (IgG) that binds 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 reservoir of the drug delivery device may be filled with or the device can be used with IMLYGIC® (talimogene laherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers including but are not limited to OncoVEXGALV/CD; OrienX010; G207, 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device may contain or be used with endogenous tissue inhibitors of metalloproteinases (TIMPs) such as but not limited to TIMP-3. Antagonistic antibodies for human calcitonin gene-related peptide (CGRP) receptor such as but not limited to erenumab and bispecific antibody molecules that target the CGRP receptor and other headache targets may also be delivered with a drug delivery device of the present disclosure. Additionally, bispecific T cell engager (BiTE®) antibodies such as but not limited to BLINCYTO® (blinatumomab) can be used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device may contain or be used with an APJ large molecule agonist such as but not limited to apelin or analogues thereof. In some embodiments, a therapeutically effective amount of an anti-thymic stromal lymphopoietin (TSLP) or TSLP receptor antibody is used in or with the drug delivery device of the present disclosure.

Although the drug delivery devices, assemblies, components, subsystems and methods have been described in terms of exemplary embodiments, they are not limited thereto. The detailed description is to be construed as exemplary only and does not describe every possible embodiment 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(s) disclosed herein.