a2, United States Patent
`US 6,428,518 B1
`(10) Patent No.:
`Brengle et al.
`(45) Date of Patent:
`Aug.6, 2002
`
`
`US006428518B1
`
`(54) MEDICATION DELIVERY CONTAINER
`
`(75)
`
`Inventors: David R. Brengle, San Diego, CA
`(US); Michael W. Kleeman, Sudbury,
`.
`‘
`MA (US); Jeremy David Fennelly,
`Escondido; Douglas Everett Merritt,
`Oceanside, both of CA (US); Ronald
`Jay Forni, Littleton, MA (US)
`.
`:
`:
`(73) Assignee: Tandem Medical, San Diego, CA (US)
`
`(*) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`US.C. 154(b) by 0 days.
`
`(21) Appl. No.: 09/434,975
`
`(22)
`Filed:
`Nov. 5, 1999
`(SL) Ute C17 ee eeeeeccesessessessessesseeneeneseesess A61M 5/00
`(52) US. Ch. cece ccceccnesescenetecnenesenenenssenensseeees 604/191
`(58) Field of Search ....0.....ccccccceee 604/80, 83, 81,
`604/82, 84, 85, 410, 408, 411, 415, 191;
`206/219, 221, 438.
`
`(56)
`
`.
`References Cited
`U.S. PATENT DOCUMENTS
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`2,254,994 A *
`9/1941 Butland ....-ceeeeeeees 604/80
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`941,
`jietrich
`et al. we.
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`3/1985 Bohmanetal.
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`4/1985. Wunsch oesseesesscssceseeeoes 604/80
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`6/1985 Peery et al...
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`4,548,606 A * 10/1985 Larkin ..........
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`cece 604/81
`4,576,603 A
`3/1986 Moss.....
`we 604/410
`
`5/1988 Brown...
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`4,753,371 A
`11/1988 Halls et al.
`.......
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`4,784,157 A
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`4/1989 Hoganetal...
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`3/1991 Loretti et al.
`..
`... 206/219
`5,176,634 A
`1/1993 Smith et al. we. 604/87
`
`5,286,262 A *
`2/1994 Herwecket al... 604/80
`5,308,334 A
`. 604/131
`5/1994 Sancoff etal. ......
`
`5,318,515 A
`6/1994 Wilk wo...
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`oe A
`vyto0s thompson et al vesteee ot
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`3394,
`...
`cece
`jertman et al.
`5,431,496 A
`383/38
`......
`7/1995 Balteauet al.
`
`5,505,708 A
`4/1996. Atkinson .........
`.. 604/140
`5,509,898 A
`.-. 604/87
`4/1996.
`Isono etal. «....
`
`5,560,518 A
`10/1996 Cattrall etall.
`......
`.. 222/99
`
`5,578,005 A
`11/1996 Sancoff et al.
`...
`... 604/82
`5,643,205 A *
`7/1997 Utterberg .........
`... 604/80
`
`5,658,271 A *
`8/1997 Loubser .....
`ee 604/410
`5,853,388 A
`12/1998 Semel ou... ccceeeeeteeee 604/82
`OTHER PUBLICATIONS
`I-Flow VIVUS 50 and VIVUS 100, Data Sheets, 5 pages,
`Jun. 1993.
`
`* cited by examiner
`Primary Examiner—Manuel Mendez
`(74) Attorney, Agent, or Firm—Foley & Lardner; Stephen
`E. Reiter
`ABSTRACT
`«©?
`In accordance with the present invention, there is provided
`a medication delivery container that
`is preconfigured to
`administer an infusion therapy upon activation by a pump
`mechanism. The configuration of the bag can determine the
`sequence and amount of medication to be delivered. In one
`embodimentof the invention, the medication delivery con-
`tainer includes a multi-chamber bag, a manifold assembly
`_
`.
`:
`.
`_
`and nd administration
`ee maniioid assemblyis touj
`sured
`wilh
`interna’ conduits ane valves to
`direct Oulpu
`from each chamber of the bag to an output port in the
`manifold, and into the administration set.
`In additional
`embodiments,there are provided structures in the container
`to alleviate pressure drop during the application of pressure
`to the container. Invention containers provide improved
`infusion therapy administration whichis particularly advan-
`tageous for reducing errors, infections and other complica-
`tions associated with manual infusion techniques
`ques.
`
`34 Claims, 9 Drawing Sheets
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`lie
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`ay
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`1
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`Sinclair Pharmaetal.
`EUNSUNG-1019
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`Sinclair Pharma et al.
`EUNSUNG-1019
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`1
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`U.S. Patent
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`Aug. 6, 2002
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`US 6,428,518 B1
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`1
`MEDICATION DELIVERY CONTAINER
`
`FIELD OF THE INVENTION
`
`The present invention generally relates to apparatus for
`the intravenous infusion of medication in accordance with a
`
`predetermined medical therapy. Medication delivery con-
`tainers of the invention are useful for improving the ease of
`administration of a variety of therapeutic agents.
`
`BACKGROUND OF THE INVENTION
`
`Intravenous medications including antibiotics and the like
`may be administered intermittently over an extended period
`of time. Each administration of an intravenous therapy
`generally follows a predefined procedure that often includes
`a series of manual steps. Such manual steps may include
`saline flushes and generally terminate with the application of
`anti-clotting medication. The manual steps in the therapy
`procedures are a principle source of error, infection, and
`other complications that may arise during intermittent infu-
`sion therapy.
`Accordingly, there is still a need in the art for a meansto
`improve the administration of intermittent medication infu-
`sion therapy. The present invention satisfies this and other
`needs in theart.
`
`BRIEF DESCRIPTION OF THE INVENTION
`
`The present invention overcomes manyof the problemsin
`the art by providing a medication delivery container
`designed to interface with a pump apparatus. The container
`comprises a multi-chamber bag and a manifold assembly for
`administering an infusion therapy upon activation by the
`pump mechanism. The multi-chamberbag hasa plurality of
`chambers that are configured to deliver a predetermined
`volume of each medication of an infusion therapy at a
`predetermined time, duration and interval. The medication
`delivery container may include an administration set for
`delivering the medications from the manifold assembly to an
`infusion site. The container provides improved infusion
`therapy administration over manual infusion techniques and
`reduces opportunities for error, infection or other complica-
`tions.
`
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`20
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`30
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`Alternatively, the invention may be embodied in a fluid
`delivery container including a bag having at least one fluid
`chamber. The container also includes structures for mini-
`
`45
`
`mizing pressure drop which may be associated with a
`chamber upon the application of pressure to the respective
`chamber, thereby allowing relatively unimpeded fluid flow
`from the respective chamberto an associated conduit during
`the entire period during which pressure is applied to the
`chamber.
`
`Another embodiment of the invention is a fluid delivery
`container for the automated infusion of a plurality of phar-
`macological agents. The container includes a plurality of
`chambers and a manifold assembly. Each chamber is con-
`figured with a respective geometry for controlling the
`administration of the plurality of pharmacological agents.
`Each chamber has a configuration that controls the volume
`of each pharmacological agent administered and the regimen
`by which said pharmacological agent is administered. The
`manifold assembly has a plurality of valves for controlling
`the administration of the plurality of pharmacological agents
`to an infusionsite.
`
`Alternatively, the invention may be embodied in a deliv-
`ery container to be filled with pharmacological fluids asso-
`ciated with a desired medical infusion therapy for treatment
`
`50
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`2
`of a patient. The container may include a plurality of
`chambers for containing the pharmacological fluids, and a
`manifold assembly for dispensing the pharmacological flu-
`ids. The manifold assembly is configured, and each chamber
`is sized and configured, to implement the desired medical
`therapy when the fluids are automatically infused into the
`patient.
`
`BRIEF DESCRIPTION OF THE FIGURES
`
`FIG. 1 is a perspective view of a medication delivery
`container according to the invention.
`FIG. 2 is a plan view of the medication delivery container
`of FIG. 1.
`
`FIG. 3 is a plan view of a multi-chamber bag of the
`medication delivery container of FIG. 1, showing the bag’s
`chambers and conduits and one embodiment of a chamber
`flex absorbing pattern.
`FIG. 4 is a cross-sectional view along line A—A of a
`multi-chamber bag of FIG. 3.
`FIG. 5 is a plan view of a multi-chamber bag of the
`medication delivery container of FIG. 1, showing analter-
`nate embodiment of the chamber flex absorbing pattern.
`FIG. 6 is a plan view of a multi-chamber bag of the
`medication delivery container of FIG. 1, showing yet
`another embodiment of the e chamberflex absorbing pat-
`tern.
`
`FIG. 7 is a perspective view of a manifold assembly of the
`medication delivery container of FIG. 1.
`FIG. 8 is a perspective view of the manifold assembly of
`FIG. 7 from a reverse direction.
`
`FIG. 9 is an exploded perspective view of the manifold
`assembly of FIG. 7.
`FIG. 10 is a schematic diagram showing the internal
`conduit and valve configuration of the manifold assembly of
`FIGS. 7-9.
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`In accordance with the present invention, there is pro-
`vided a medication delivery container that is configured to
`administer an infusion therapy upon activation by a pump
`mechanism. The container is preferably further configured
`to interface with a pump apparatus in a mannerthat securely
`maintains the container in position during pumping.
`The invention container comprises a multi-chamber bag
`wherein the chambers are configured to deliver predeter-
`mined amounts of liquid medication at a predetermined rate
`and pressure. It is presently preferred that the container be
`formed of two sheets of flexible material. As will be appre-
`ciated by those of skill in the art, any suitable biocompatible
`flexible material may be employedin the construction of the
`bag, however, it is presently preferred that at least one side
`of the bag be transparent to facilitate viewing of the con-
`tents. For example, the flexible sheets may be ethyl vinyl
`acetate (EVA), polyvinyl chloride (PVC), polyolefin, or
`other suitable material. In one embodiment, thefirst sheet of
`flexible material has a relatively smooth inner surface and
`the second sheet of plastic has a texture, such as a taffeta
`texture, ribs, or the like, embossed on its inner surface.
`Alternatively, both sheets may have a patterned inner sur-
`face. The sheets are joined together around the perimeter of
`the container by any meanssuitable for forming an air and
`fluid-tight seal that can withstand the pressure generated by
`the pump apparatus. Fluid-tight seals are also formed
`11
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`11
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`

`US 6,428,518 B1
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`3
`between the individual chambers, and should have the same
`minimum pressure tolerances as the perimeter seals. Thus,
`the sheets are bonded together to create the patterns for the
`chambers, conduits, and ports. The materials may be bonded
`in a variety of ways, e.g., by a radio frequency (rf) seal, a
`sonication seal, a heat seal, adhesive, or the like, to form an
`air and fluid-tight seal as described herein.
`Each chamber has one or more associated conduits. The
`
`conduits provide a pathwayfor fluid to enter and/or exit each
`chamber. The conduits can be integrally formed during
`construction of the container, for example, by leaving chan-
`nels unbonded when the two sheets are fused together to
`form the container. Optionally, additional internal structure
`(e.g., rigid or semi-rigid tubing,or the like) may be provided
`to facilitate fluid flow to and from each chamber.
`It
`is
`
`presently preferred that the conduits through which medi-
`cation exits the chambers lie outside of the compression
`region (i.e., the region to which pressure is directly applied
`by contact with a pressure applying structure in the pump
`apparatus). In this manner, mixing of residual medications in
`the conduits with subsequently administered medications
`from other chambers is minimized. Alternatively, the con-
`duits may lie within the compression region, particularly if
`mixing is not a concern.
`If the conduits are constructed by leaving unbonded
`channels in the container, the conduit will have a generally
`flat shape but enlarges to have a more tubular shape upon the
`application of pressure to the corresponding chamber. The
`shape of the conduit depends on the strength of the materials
`used to construct
`the bag and the pressure of the fluid
`therein. Specifically, more rigid or thicker materials are
`more difficult
`to flex thus requiring greater pressure for
`enlarging the conduit. Advantageously, the textured inner
`surface of at least one side of the container provides flow
`channels that allow liquid pressure to act along the length of
`the conduit to assist in opening the conduit upon the appli-
`cation of pressure to the respective chamber. Otherwise,if
`both inner sides of the container are smooth, surface tension
`may hold them together and a greater amount of pressure
`may be required to open the conduits and initiate flow.
`In one embodimentof the present invention, the chambers
`and corresponding conduits from each chamberare arranged
`in the bag so that when pressure is applied sequentially from
`one end ofthe bag to the opposite end, individual chambers
`are sequentially activated. It is presently preferred that the
`pressure be applied evenly. Even, sequential application of
`pressure can be accomplished by employing a constant force
`spring, a roller attached to a constant force spring, a motor-
`driven roller, or the like.
`It may be desirable to mix the contents of two or more
`chambers immediately prior to administration. Accordingly,
`in another embodiment of the present invention, frangible
`seals between two or more adjacent chambers may be
`formed. In this manner, upon application of pressure suffi-
`cient to rupture the seal, the contents of selected adjacent
`chambers will be mixed. The chambers may beside by side
`(i.e., configured so that pressure is applied to each substan-
`tially simultaneously), or in sequence.
`Chambers mayalso be configured to have a “blow down”
`period betweenactivation of one chamberand activation of
`the next chamber during an infusion sequence to prevent
`mixing of medications during the infusion. As described in
`greater detail below, this can be accomplished, for example,
`by providing a space between adjacent chambers,or the like.
`It has been observed that there can be a pressure drop
`between a chamber and its corresponding conduit when
`
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`pressure is applied to the contents of the bag. This is largely
`due to the formation of kinks in the bag whenpressure is
`applied to the contents of the bag. The region of primary
`concern is the interface between the chamberandits corre-
`sponding conduit. Thus in one embodiment of the present
`invention, structure is provided to alleviate pressure drop
`between each chamberandits corresponding conduit. This
`can be achieved by one or more of several methods, includ-
`ing quilting of the chamber, incorporation into the chamber
`of internalstructures (e.g., a stent, tubing, conduit bead(s),
`solid filament, or the like), or employing external structures
`(e.g., a source of pressure on the container, such as a
`protruding memberof the pump apparatus, or the like), and
`the like.
`
`As used herein, “quilting” means forming a structure in
`the interior of the chamber wherein the bottom and top sides
`of the bag are connected, preferably by fusing them together.
`It is presently preferred that quilting be employed to manage
`pressure drop, as the desired connection between first and
`second sides of the bag can be accomplished by the same
`methods used to form the perimeter seal of the container.
`Quilting may be at any region of the chamberthat provides
`a substantially reduced or eliminated pressure drop between
`the chamber and its corresponding conduit. It is presently
`preferred that the quilting be in the region of the chamber
`that is proximal to the conduit. In this region of the chamber,
`any one of a number of quilt shapes may be employed,
`including a T dot configuration, 55 and 56, as shownin FIG.
`2, a dash dot configuration, 155 and 156, as shown in FIG.
`5, bond blocks 255 and 256, as shownin FIG. 6, or the like.
`These types of quilting are discussed in greater detail below
`in reference to specific embodiments.
`Other features suitable for minimizing flow resistance
`(i.e., pressure drop) caused by kinks include thermoforming
`of the conduit, introduction of an internal conduit bead in the
`region where the conduit joins the chamber, coining, or the
`like. Thermoforming involves heating the bag materials in
`the region of the exit and associated conduit until
`the
`materials are softened slightly. Air pressure is applied to the
`chamber to open (or inflate) the exit and the conduit. The
`material is allowed to cool such that the exit and conduit
`retain a slightly circular opening or cross-section after the
`pressure is removed. For employing internal conduit bead
`(s), a portion of the bag adjacent the exit to the conduit is
`stamped with an offset bonding pattern or shim to provide a
`three-dimensional structure in the region of the exit. (See,
`e.g., structure 259, FIG. 6). This can be analogized to gluing
`two sheets of paper together at their perimeter and affixing
`a solid piece, like a bamboo skewer along the length of the
`seam between the two sheets. In this manner, even when the
`two sheets are pressed together, a channel will exist along
`the skewer wherethe sheets are prevented from meeting one
`another. Additionally, coining (i.e., forming a structured
`pattern in the bag material) may be appliedto the sides ofthe
`bag in the region of the exit to provide additional flow
`pathways not subject to greatly restricted flow by kinks.
`It is contemplated that each conduit will have an associ-
`ated port where, at a minimum,fluids exit the container.
`These conduits may serve the dual purpose of providing a
`channel for both the introduction of fluids into the chamber
`(s) and exit of fluids from the chambers. The container may
`have one or more ports for introduction of fluids into one or
`more of the individual chambers of the container. In one
`
`embodiment, these ports have associated conduits, separate
`from the exit conduits. The ports are configured to allow
`regulated, sterile introduction of fluids. This can be accom-
`plished byfitting the ports with injection ports, or the like.
`12
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`ports can only exit the manifold through the output port
`Because the container is to be subject to the sequential
`without returning to the bag by way of any other chamber
`application of pressure, it is desirable for the container to be
`
`anchored inside the pump apparatus in a mannerthat pre- port. This is accomplished by interposingafirst check valve
`vents the pressure application device from merely moving
`in a first conduit between each chamberport and the output
`the container ahead ofit as the pressure is applied from one
`port. The check valve only allowsfluid to flow from the bag
`side of the manifold towards the infusion side where the
`end of the bag to the other. Accordingly,
`it is presently
`preferred that
`the container be anchorable to the pump
`output port is located.
`apparatus. This can be accomplished in a variety of ways,
`It is important to note that someorall of the bag chambers
`including the use of fasteners secured to the bag that will
`may be individually filled by way of optional separate fill
`mate with counterpart fasteners in the pump apparatus. Such
`ports on the bag rather than by way of the optional bulk fill
`fasteners include hook and loop fasteners, snaps, buttons,
`port of the manifold. In an embodiment of the present
`zippers, and the like. In a presently preferred embodiment,
`invention, when a bulk fill port is to be used, fluid flow in the
`the container is anchored by forming holes in a non-fluid
`manifoldis further regulated so that fluid introduced through
`containing portion of the bag, and mating these holes with
`the bulk fill port can access one or more of the chamberports
`corresponding protrusions such as pins, or the like, in the
`for filling of chambers in the bag. Accordingly, chamber
`pump housing. These anchoring structures can serve the dual
`ports to be used for both filling and dispensing fluids will
`have two manifold conduits associated therewith: a first
`purposeof securing the bag and positioning it properly in the
`pump apparatus. This latter purpose can be accomplished by
`manifold conduit, as described above, for directing fluids
`orienting the attachmentstructures so that there is only one
`from the chamber port(s) to the output port; and a second
`orientation with which the bag can be positioned in the pump
`manifold conduit branchingoff of thefirst at a point between
`apparatus.
`each chamber port and the first check valve.
`In this
`embodiment, a second check valveis located on each second
`In another embodimentof the present invention, contain-
`ers further comprise a manifold to regulate delivery of the
`manifold conduit between the chamberport and the bulkfill
`medication from the bag port of the conduits to an admin-
`port. The second check valve only allowsfluid to flow from
`istration tube set (“administration set”), and also optionally
`the bulk fill port towards the chamberport. A schematic of
`provides a structure forfilling the container. As used herein,
`one example of this embodimentis provided in FIG. 10, as
`further described below.
`“bag port of the conduit” and “bag port” refer to the terminal
`portion of each conduit leading to/from a chamber in the
`Anytype of check valve can be employedin the practice
`bag. The bag ports may have an adapter affixed thereto for
`of the present
`invention,
`including ball check valves,
`mating the bag ports with the manifold, or the manifold may
`umbrella check valves, and the like. In a presently preferred
`be attached directly to the bag ports. The manifold can be
`embodiment of the present invention, an umbrella check
`any structure that is attachable to the bag ports (or adapters)
`valve is employed. Umbrella valves are inexpensive, simple
`in a fluid-tight manner while providing a commonoutlet for
`in their operation and easy to install. Because umbrella
`all bag ports to the administration set.
`valves are held in place byfriction, it is presently preferred
`that the interior of the manifold be configured so that, upon
`In describing the manifold, reference will be madeto the
`assembly of the manifold,
`the umbrella valves are held
`bag side, where the manifold attaches to the bag ports, and
`the infusion side, where the manifold attaches to the admin-
`securely in place by the internal structure of the manifold.
`
`istration set. Further reference will be made to chamberports This can be accomplished simply by havingastructure that
`of the manifold, where the manifold attaches to and is in
`contacts the center of the umbrella portion(i.e., the dome of
`the umbrella) to bias the valve towards its associated pas-
`fluid communication with the bag ports. Accordingly, the
`chamber ports are on the bag side of the manifold. Addi-
`sageway. In this manner, the force of liquid flowing past the
`tional reference will be made to an output port of the
`valve will open but not unseat the valve.
`manifold, where the manifold attaches to and is fluid com-
`The ports, valves and conduits of the manifold may be
`munication with the administration set. Although optional,it
`configured in any manner that permits the desired flow of
`is presently preferred that the manifold also have a bulk fill
`fluid through the manifold. It is presently preferred that the
`port, where the manifold can be attached to, and be in fluid
`conduits and output port be configured so that fluid exiting
`communication with, a source of fluid medications for
`each sequentially activated bag chamber flows through its
`introduction into the bag.
`associated first check valve and then past all conduits
`Manifolds contemplated for use in the practice of the
`leading from previously emptied bag chambers, before the
`present invention will have manifold conduits for directing
`output port is encountered. In this manner, residual fluid
`fluid from chamber ports to the output port for exit to the
`output from each bag chamberis pushed through the mani-
`administration set, and from the bulk fill port, when
`fold and out through the output port by fluid from subse-
`employed, to the chamber ports. These manifold conduits
`quently emptied bag chambers.
`can be isolated from one anotherin a fluid-tight manner and
`In order for the fluid flow to be further regulated (e.g., to
`can comprise internally molded chambers connecting the
`prevent unintentional fluid flow from the bag through to the
`desired portions of the manifold, or they may comprise
`output port), it is desirable that the check valves be control-
`internally mounted tubing connecting the appropriate por-
`lable as to when flow is permitted therethrough. This can be
`tions of the manifold, combinations thereof, or the like.
`accomplished in a number of ways, depending on the type
`In order to regulate the flow of fluid through the manifold
`of check valve employed. For example, a valve can be
`employed having a threshold operating pressure (i.e., a
`and to prevent backflow from the output port to the chamber
`cracking pressure) that opens the valve. The cracking pres-
`ports, it is presently preferred that the manifold have check
`valves therein. Check valves can be configured in a variety
`sure of the valve may be any pressure suitable for the
`of manners to regulate fluid flow as desired; all such
`intended application. Suitable cracking pressures should be
`configurations are contemplated as being within the scope of
`no higher, obviously, than the pressure generated by the
`the present invention. In one embodiment of the present
`pump apparatus, yet high enough to prevent unintentional
`invention, fluid flow is regulated so that fluid exiting the
`flow through the manifold. Cracking pressures can be in the
`container and entering the manifold through the chamber
`range of about 0.25 Ibs per square inch up to about 2 lbs per
`13
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`45
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`50
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`55
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`60
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`65
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`13
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`

`

`US 6,428,518 B1
`
`8
`7
`infections and other complications associated with manual
`the cracking
`is presently preferred that
`It
`square inch.
`infusion techniques.
`pressures be in the range of about 0.50 lbs per square inch
`up to about 1 lbs per square inch. In a most preferred
`The multi-chamber bag, as shown in FIGS. 3 and 4, may
`embodiment,
`the cracking pressure is about 0.75 lbs per
`include four chambers18, 20, 22 and 24,six ports 26, 28, 30,
`square inch. The cracking pressures should be consistent in
`32, 34 and 35, and six conduits 36, 38, 40, 42, 44 and 46 for
`a given direction of fluid flow. Thus,
`the check valves
`coupling each of the respective ports to a chamber. The
`associated with the chamber ports and the output port can
`multi-chamber bag may have other chamber, port and con-
`have one cracking pressure while the check valve(s) asso-
`duit configurations of varying number, sizes, and shapes in
`ciated with the bulk fill port has a different cracking pres-
`accordance with the invention. The ports maylie at the end
`sure. Due to economiesof scale, it presently preferred that
`48 or along one or more edges of the bag. The chambers
`the valve types and cracking pressures be consistent
`comprise a relatively large area of the bag in a central
`throughout the manifold.
`portion of the bag and are configured to be filled with
`medication fluids or pharmacological agents. The central
`is optionally provided in one
`An administration set
`chamber portion of the bag maybe referred to as a com-
`embodimentof the present invention. The administration set
`pression region which is sequentially compressed by appli-
`comprises a length of medical grade tubing, such as a
`micro-bore tube, or the like, with structures at each end: at
`cation of an external force to drive liquid from the chambers
`through the respective conduits and out the ports in accor-
`one end (proximal end) for connecting the tubing to the
`dance with the infusion therapy. The conduits generally lie
`output port of the manifold and at the opposite (distal) end
`outside of the compression region to avoid residual medi-
`for connection to a standard intravenous-type needle. Stan-
`cations in the conduits from mixing with subsequently
`dard luer connectors, or the like may be used in the practice
`administered medications from other chambers. The con-
`of the present invention.
`duits may lie within the compression region particularly if
`The administration set may be further configured to
`mixing is not a concern.
`regulate the rate of fluid administration to the patient. It is
`The multi-chamber bag 12 is formed of two flexible
`necessary to know the pressure generated by the pump/
`sheets 50 and 52, of material and has a generally rectangular
`manifold combination in order to calibrate the delivery rate
`flat shape. The flexible sheets may be ethyl vinyl acetate
`of the administration set. The pump apparatus generates
`(EVA), polyvinyl chloride (PVC), polyolefin or othersuit-
`predictable fluid pressures based on the volumeof solution
`able material. One sheet may havea relatively smooth inner
`in each chamber. Using the predictable fluid pressures, the
`surface and the other sheet may haveataffeta texture (or
`flow rate from the bag may be selectable using administra-
`30
`similar pattern that is not smooth, such as ribs) embossed on
`tion sets having predetermined tubing lengths and inner
`its inner surface. Alternatively, both sheets may have an
`diameters. The flow rate through the administration set is
`inner surface that is not smooth. The sheets are bonded
`selected by varying the microbore tubing’s inner diameter
`and length. The relationship is approximated by Poiseulle’s
`equation:
`
`10
`
`15
`
`20
`
`25
`
`Ap-x-D*
`O= Teak
`
`Equation 1
`
`Where Q is the flow rate, Ap is the pressure drop across
`a flow controlling orifice, D is the inside diameter of the
`orifice, 4 is the dynamic viscosity of the fluid and L is the
`length of the orifice. Thus, any structures included in the
`administration set will effect the flow rate in a predictable
`and calculable manner. Structures contemplated for optional
`incorporation into the administration set include particulate
`filters, air elimination filters, fluid flow restrictors, and the
`like. The administration set may further comprise a clamp,
`or the like, for stopping fluid flow, as desired.
`In another embodiment of the present invention there is
`provided a restrictor set for attachment to the distal end of
`the administration set. In this manner, the rate of fluid flow
`can be altered with the simple addition of a restrictor set,
`rather than by re-engineering the administration set. Of
`course, the maximum fluid flow rate will be determined by
`the configuration of the administration set, with fine-tuning
`to slower rates provided by the restrictorset.
`The invention will now be described in greater detail by
`reference to specific, non-limiting embodiments. Moreover,
`each of the embodiments of the various components
`described below need not necessarily be used in conjunction
`with the other specific embodiments shown.
`With reference to FIGS. 1 and 2, the medication delivery
`container 10 of the invention includes a multi-chamber bag
`12, a manifold assembly 14 and a tube assembly 16. The
`container provides improved infusion therapy administra-
`tion whichis particularly advantageous for reducing errors,
`
`35
`
`together to create the patterns for the chambers, conduits,
`and ports. The materials may be bonded by suitable means,
`e.g., by a radio frequency (rf) seal, sonication, by heatseal,
`adhesive, or the like, to form an air and fluid tight seal
`between the chambers and the conduits. When filled with
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`medication fluids, the chambers bulge creating a “pillow-
`like” shape (FIG. 4).
`The first chamber 18 is furthest from the port side 48 of
`the bag and may contain a first medication fluid of an
`infusion therapy sequence. The first chamberis coupled to a
`first bag port 26 by a first conduit 36. The first chamberis
`filled with fluid through the first bag port.
`The spacings 60, 62 and 64 between the chambers advan-
`tageously provides a “blow-down”period during an infusion
`sequence to prevent mixing of medications during the infu-
`sion. The spacing 62 between the second chamber 20 and the
`third chamber 22 is sized based on the time needed for the
`chamber and conduit to “blow down”, or flow until the
`residual pressure is below the c