MAAC ARIAACTATA
`
`US005163902A
`[11] Patent Number:
`[45] Date of Patent:
`
`5,163,902
`Nov. 17, 1992
`
`§/1990 Villaveces wi. eeeseeeee 248/314
`4,921,119
`4,966,582 10/1990. Sit et al. oe eeseeeseeeeeees 604/86
`
`FOREIGN PATENT DOCUMENTS
`
`1907296
`
`9/1969 Fed. Rep. of Germany ...... 604/258
`
`Primary Examiner—John D. Yasko
`Assistant Examiner—Adam J. Cermak
`Attorney, Agent, or Firm—Longacre & White
`
`ABSTRACT
`[57]
`A manifold for fluid connection ofa plurality of sources
`of fluid for a patient in which a numberofinlet ports on
`the upper surface of a housing communicate with a
`lower outlet port by passages or bores which merge to
`a single passages or bore. The ports are respectively
`occluded by elastomeric sealing members adaptedto be
`penetrated by a needle or cannula. Preferably, the inlet
`ports are symmetrical or coincident with an axis so the
`distance travelled by the fluid from each sourceis sub-
`stantially the same.
`
`United States Patent
`Lynnet al.
`
`1:9)
`
`[54] PATIENT FLUID MANIFOLD
`
`[75]
`
`Inventors: Lawrence A. Lynn, Columbus, Ohio;
`James R. Longacre, 3621 Littledale
`Rd., Kensington, Md. 20895
`
`~
`
`[73]
`
`Assignee:
`
`James R. Longacre, Arlington, Va.
`
`[21]
`
`[22]
`
`[51]
`[52]
`[58]
`
`[56]
`
`Appl. No.: 581,699
`
`Sep. 13, 1990
`Filed:
`Int, C15 oo. ececccecesseeerecenresseeesenens A61M 37/00
`ULS. Ch. ecccccccccccceceserssetereveneseeens 604/86; 604/283
`Field of Search ............ccccccccssessesesseees 604/80-88,
`604/192, 263, 258, 283; 28/DIG. 12, DIG. 15
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`1/1963 Myerson et al. 0... eee 206/43
`3,074,542
`3,834,386 9/1974 Sisley oe ws, 604/86 X
`4,048,995
`9/1977 Mittleman ...........cceeseeeeeeee 604/86
`4,121,585 10/1978 Becker,Jr.
`v 604/86
`4,252,117
`2/1981
`Sheehan.....
`w- 604/86
`4,560,378 12/1985 Weiland.....
`we 604/83
`4,915,688
`4/1990 Bischofet al. 0. 604/83
`
`
`
`31 Claims, 4 Drawing Sheets
`
`1
`
`Sinclair Pharmaetal.
`EUNSUNG-1022
`
`Sinclair Pharma et al.
`EUNSUNG-1022
`
`1
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`U.S. Patent
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`Nov, 17, 1992
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`Sheet1of4
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`FIG.
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`U.S. Patent
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`Noy. 17, 1992
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`U.S. Patent
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`Nov. 17, 1992
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`U.S. Patent
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`Nov. 17, 1992
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`1
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`PATIENT FLUID MANIFOLD
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`5,163,902
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`only easy to use andreliable, but also be inexpensive and
`simple to manufacture.
`The present invention relates to a unique disposable
`manifold which can be attachedas desired by the nurse
`at any convenient bedside location and therefore is
`universally adaptable to almost any bedside set up and
`any hospital bed. The manifold further can be posi-
`tioned at a height and at a position chosen by the nurse
`to suit her own height and work habits.
`Equally important, the manifold is simple, reliable
`and relatively inexpensive to manufacture.
`In the unique manifold of the present invention, a
`housing, preferably formed as a single moldedplastic,is
`provided on an upper extending surface with a plurality
`of separate inlet ports. These inlet ports communicate to
`internal passages or bores extending downward within
`the housing and merging within the housing into a sin-
`gle passage or bore communicating to a single outlet
`port. From the outlet port a tube extends to a catheter
`adapted for supplying thefluid exiting the outlet port to
`the patient.
`At least one and preferably all of the inlet ports are
`occluded by an elastomeric member such as a septum
`which can be penetrated by a needle or blunt cannula
`and which maintains the interior passages or bores ster-
`ile. The chances of backflow is also minimized because
`conditions creating backward flow through a needle
`penetrating a septum are unlikely to occur.
`Eachinlet port is preferably formed as an open ended
`tube extending upwardly from an upper surface which
`in a first embodimentis both circular and planar. The
`above described universal connector can readily and
`effectively connect to such an inlet port which can also
`receive a needle from a conventional syringe or other
`device. The connector, syringe or other device extends
`through the occluding elastomeric material so that the
`fluid passes downward throughtube into the associated
`bore and then into the merged bore, and ultimately to
`the patient via the outlet port. Preferably, flow takes
`places by gravity, but pumps can be employed ifde-
`sired.
`Preferably the distance travelled by the fluid from
`eachofthe inlet ports to the single outlet port is substan-
`tially the same. Thus, the size of the manifold is mini-
`mized, as is the tendency for backflow since each inlet
`tubeis closer to the outlet, and abovethe outlet, than to
`the otherinlet tubes. In one embodiment,theinlet ports
`are symmetrically disposed about an axis with one of
`the tubes coincident with that axis and the axis likewise
`defining the axis of the outlet tube.
`It is commonin the hospital environmentfor a fluid
`to be discontinued for some time and then reconnected.
`According to a further aspect to the present invention,
`a plurality of needle stations are provided on the exte-
`rior surface of the housing in which the needle or con-
`nector from a source can be temporarily stored for some
`time. Preferably,
`these stations are provided on the
`outside of the housing between theinlet and outlet ports
`so that they cannot be confused with inlets. Moreover,
`the housing is preferably transparent so it will be per-
`fectly apparent by visual inspection which aretheinlets
`and which are the “Needle Minding” stations. The
`stations can be given a color such as yellow, while
`remaining transparent,
`to visually differentiate them
`even more from the ports. This kind ofstation is further
`described in a co-pending application entitled, ““Needle
`Protection Station”, Ser. No. 07/515,466 filed Apr. 27,
`
`BACKGROUNDOF THE INVENTION
`The invention relates to a fluid manifold for coupling
`a plurality of fluid sources to a patient.
`In the hospital environment, particularly in intensive
`care, patients typically receive various kinds of fluids
`intravenously through a catheter. Some of the fluids
`provide nutrients, others replace blood and blood com-
`ponents, while yet others are drugs. Someofthe fluids
`may be supplied continuously for a matter of days while
`others may be supplied for only a short period oftime.
`Typically, all of the fluid sources are coupled to a
`single catheter by meansof various “Y” connectors and
`the like. Theresult is too often a tangle of tubing adja-
`cent and sometimes on or under the patient which is
`untidy, confusing and can even lead to error. Moreover,
`it
`is very easy for some of the sources to become
`pinched or even disconnected from the patient without
`the nurse or attending doctor immediately noticing and
`remedying the disconnection. Blood mayalso be with-
`drawn through the same catheterfor testing increasing
`the confusion and potential for error.
`This problem is to a considerable extent alleviated by
`a unique universal connectoras described in a co-pend-
`ing application entitled “Universal Intravenous Con-
`nector with Needle Protection”, Ser. No. 07/509,639,
`filed Apr. 17, 1990 now abandoned (the disclosure of
`which is hereby incorporated by reference). This con-
`nector permits by easy and reliable one handed motion
`any syringe or tubing to be coupled to virtually any
`junction whichis occluded by a septum orthelike. This
`universal connector thus provides greater security that
`inadvertent disconnection will not take place andat the
`same time provides protection for the nurse and others
`in the environment of the bedside from possible needle
`stick.
`.
`However, the universal connector doesnotby itself
`provide improved organization of the tubes supplying
`the fluid nor does it removethe possibility that some of
`the tubes may be pinched off to interrupt the supply of
`fluid, or may be inadvertently connected wrongly, or
`may even be disconnected.
`One approach which has been proposed to better
`organize the flow offluid from the various sources to
`the patient is to provide a manifold with input valves
`such as stopcocks, which must be manually operated in
`orderto interrupt and resumetheflow ofthe fluid. For
`example, the recently issued U.S. Pat. No. 4,915,688 to
`Bischof, describes a manifold arrangementof this type.
`The need for stopcocks and the bulky shaperesult in a
`device which is complex and expensive. For these rea-
`sons, previous manifolds have not been wholly satisfac-
`tory nor do they completely answer the problems de-
`scribed above.
`Such manifolds further are typically arranged with
`the stopcocksin a line. While this may makeit easier for
`the nurses to keep track of tubes, it also results in a
`bulky configuration which is difficult to mount. Fur-
`ther, should a source run dry and the nurse neglect to
`close the stopcock the tendency to backflow may be
`enhanced when the input from the empty source is
`immediately adjacent one whichis at full pressure.
`As a practical matter, such a manifold cannot be
`reused; it must be disposable. Further, in today’s hospi-
`tal environment, costis extremely important. Thus,it is
`vital that any manifold intended for general use be not
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`5,163,902
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`1990 (the disclosure of whichis incorporated herein by
`reference).
`According to a further aspect of the present inven-
`tion, the housing is removably attachable, for example,
`by a hook and loop pile fastener such as VELCRO or
`the like, to any place in the bedside environment chosen
`by the nurse. Preferably, one patch of VELCRO is
`attached to a flat surface on the housing between the
`inlet ports and the outlet port. The VELCRO patch
`matches a similar patch which can be placed by the
`nurse anywherein the bedside environment most con-
`venient to the nurse. The second VELCROpatch is
`preferably supplied in a package with the manifold so
`the nurse can attach it whenever the nurse wants. A
`suitable adhesive is preferably provided on the back of 15
`this second patch for that purpose. The manifold may
`be attached to the patient under some circumstances.
`According to another embodiment the manifold is
`formed with the occluded tubesin line to serve nurses
`whoprefer and are accustomed to the linear manifolds
`now in use. Preferably, the outlet tube is arranged so
`that the distance from eachinlet tube to the outlet tube
`is substantially the same and the outlet tube is located
`below the inlet tubes.
`According to yet another embodiment a valve mem-
`ber is provided in at least one and preferably all of the
`inlet tubes which valve members can be manually ro-
`tated to open andclose anyinlet port without removing
`the connector or other device penetrating the septum.
`Onesuitable valve is formed by a hollow rotatable tube
`occluded by the elastomeric member with an openingat
`the bottom whichis alignable with the interior passage
`or bore and which can be rotated out of alignment.
`Many other objects and purposes of the invention
`will be clear from the following detailed description of 35
`the drawings.
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`22 and 24 are similarly hidden in FIG. 1. In the embodi-
`ment of FIG. 1, these bores are formed by molding, but
`alternatively, the housing may be hollow with separate
`flexible or inflexible elements therein forming the re-
`spective passages. The exterior surface of housing 12
`tapers inwardly in the direction of the outlet port 26.
`The molded plastic housing need not be, andis pref-
`erably not, solid in the regions between the internal
`bores and exterior surface. Much of the space can be
`open so long as the bores remain sealed from the atmo-
`sphere and the housing retains sufficient rigidity to
`avoid breakage.
`All the passages from the respective inlet ports be-
`tween housing surface 14 and outlet port 26 merge into
`a single bore 40 coincident with the above mentioned
`axis. Thus, the distance which the fluid travels from
`each of the respective inlet ports to the outlet port 26 is
`substantially the same.
`FIG.1 is not a cut away view, but rather the housing
`is preferably formed of transparent plastic so that the
`nurse can readily observe that the fluid is indeed flow-
`ing as desired through each ofthe respective passages
`and can see readily as well the difference between the
`stations at which needlesorthe like can be temporarily
`“minded”or stored and the respectiveinlet ports.
`In the embodiment of FIG. 2, a flexible line 42 is
`permanently connectedto outlet port 26 andbearsatits
`other end a catheter 44 for direct connection to a pa-
`tient. Thus, the manifold 10, line 42 and catheter 44 can
`be provided to the nurse asa single sterilized unit. Since
`the inlet ports are sealed by septums, the interior bores
`remainsterile after the manifold has been removed from
`the sterile packaging and until use. Alternatively, the
`catheter can be separately coupledto outlet port 26.
`A plurality of needle stations are preferably provided
`around the periphery of housing 12 between surface 14
`and outlet port 26. As can be seen in FIG. 2, in this
`embodiment,three stations 50, 52 and 54 are provided,
`each formed of an open ended tube extending outward
`and occluded by an elastomeric member which extends
`to its dead end. Thus,as shownin FIG. 2, a station 50 is
`formed of a tube 56 with an elastomeric member 58
`extending therein to its dead end and to a sufficient
`distance for fully receiving any needle to be used with
`the manifold.
`Ascan be seenin FIG.1,a flat surface 60 is provided
`between surface 14 and outlet port 26 and fixed to sur-
`face 60 is a conventional VELCROpatch 62 for engag-
`ing a similar VELCROpatch placedbythe nurse at any
`desired location in the bedside environment. Thus, the
`manifold of the present invention can be placed wher-
`ever the nurse desires and indeed easily moved by the
`nurse or by another nurse should the occasion warrant.
`FIG.3 showsa side view of an embodiment whichis
`similar to the embodiment of FIG. 1 and 2 except that
`the top surface 150 of manifold 152 is not circular, but
`linear. The tubes 154, 156, 158, 160 and 162 are arranged
`in a line rather than in a circle. The distance from each
`_ inlet tube to the outlet tube 164 is still substantially the
`same and the outlet tube is arranged to be below the
`inlet.
`Reference is now made to FIG. 4 which shows a
`further embodimentin which the inlet tubes are formed
`as a separate part from the housing and function as a
`valve. Thus, the connection between a given source and
`the patient can be interrupted by manual operation of
`the valve and without disconnecting the source. Al-
`though improvedin design and function, the valve op-
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`FIG. 1 showsa side view ofa first embodimentofthe
`drawing in which a tube and catheter are permanently
`fixed to the output port.
`FIG. 2 showsa top view of the embodiment of FIG.
`
`1.
`
`FIG. 3 showsa side view of a second embodimentin
`which the inlet tubes extend in a line.
`FIG. 4 shows a view of a third embodiment in which
`the inlet tube operates as a manually operable, rotatable
`valve.
`
`DETAILED DESCRIPTION OF THE
`DRAWINGS
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`Reference is now made in FIGS.1 and 2 whichillus-
`trate a first embodimentof the present invention. Mani-
`fold 10 is formed of a housing 12 which is of a clear
`single moldedplastic. On an upper extending surface 14
`of housing 12 are providedfive inlet ports 16, 18, 20, 22
`and 24. Only inlet ports 16, 18 and 20 can be seen in
`FIG.2 since ports 22 and 24 are hidden behind port 18
`in that view. The inlet ports 16, 18, 20 and 24 are sym-
`metrical about an axis which also coincides with the axis
`ofinlet port 22. Each of the ports is formed by an open
`ended tube extending upward from the surface 14.
`The respective inlet ports each communicate to an
`internal passage or bore extending within housing 12 to
`an outlet port 26 opposite surface 14. As can be seen in
`FIG. 1,
`inlet port 16 connects to a internal bore or
`passage 28, inlet port 18 to a passage 30 and inlet port 20
`to a passage 32. The passages connectingto inlet ports
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`5,163,902
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`erates like a stopcock. Obviously such a manifold is
`more complex and expensive that
`the embodiments
`described about but the additional capability of inter-
`ruption may be worth the additional expense,at least for
`some health care providers.
`In the drawing only one tube and theassociated part
`of the housing are shown. The other tubes are prefera-
`bly arranged in the same way,and the housing generally
`configured as described above.
`Tube 200 is preferably a hollow tube of transparent
`plastic. The open end 202 is occluded by a conventional
`elastomeric member 204 which can be penetrated by a
`needle or cannula as described above. Integral portions
`206 and 208 extend outwardly from tube 200 near open
`end 202 to form a handle for rotating tube 200.
`Tube 200 is mounted in housing 210 to extend into a
`bore 212. Tube 200 is easily rotatable within bore 212
`but cannot be easily removed. Adjacent the opposite
`end 214 of tube 200 is an opening 216 communicating to
`the hollow interior of tube 200. An interior passage of
`bore 216 has a similar opening 220 into bore 212 so that
`whenopenings 220 and 216 arealigned fluid passes from
`passage 216 into passage 220 which ultimately merges
`with other passages and conveysfluid to an outlet port
`as described above. When the openingsare not aligned
`passageis blocked. Detents or stops may be provided if
`desired to indicate when the connection is open or
`closed.
`Various proposals have been made to incorporate
`anti-viral or anti-bacterial compositions into elastomers
`which are then formed as septums. Incorporating such
`materials into the members occludingtheinlet and out-
`let tubes, and in the needle stations may be desirable.
`Many changes and modifications in the above de-
`scribed embodimentofthe invention can, of course, be
`carried out without departing from the scope thereof.
`For example, provision can be made for withdrawing
`blood from the patient through the manifold or by an
`alternative path within the manifold adjacent the outlet
`port. While the simplicity and ease of manufacture of
`this manifold militate in favor ofsingle use, the present
`invention can be reusable, at least for certain applica-
`tions. Accordingly, that scope is intended to be limited
`only by the scope of the appended claims.
`Whatis claimed:
`1. A manifold for fluid connection of a plurality of
`sources offluid for a patient comprising:
`a housing having an upper extended surface with a
`plurality of inlet ports each adapted for connection
`to one of said sources, a lower outlet port and
`conduit means including a plurality of passages
`each having a centerline, said centerlines intersect
`at a common point, each ofsaid plurality of pas-
`sages adapted to carry fluid from oneofsaid input
`ports to said outlet port; and
`elastomeric sealing means occluding at least one of
`said inlet ports and adapted to be penetrated by a
`needle or cannula to supply fluid tothat inlet port.
`2. A manifold as in claim 1 wherein said inlet ports
`include at least three ports and wherein the distance
`travelled by fluid from each ofsaid inlet ports to the
`outlet port is substantially the same.
`3. A manifold as in claim 1 wherein said upper surface
`is bounded by a edge whichis closed.
`4. A manifold as in claim 3 wherein said upper surface
`is planar.
`5. A manifold as in claim 4 wherein said upper surface
`is circular.
`
`6
`6. A manifold as in claim 1 wherein the exterior sur-
`face of said housing tapers inwardly in the direction of
`said outlet port.
`7. A manifold as in claim 1 wherein said housingis a
`unitary plastic molding.
`8. A manifold as in claim 1 whereinsaid inlet ports are
`each an open ended tube extending upwardly from said
`surface and communicating each with oneofsaid plu-
`rality of passages.
`9. A manifold as in claim 1 including a plurality of
`closed end bores extending into said housing and each
`occluded by as elastomeric memberto providea station
`for temporarily storing a needle or cannula.
`10. A manifold as in claim 9 wherein said stations are
`provided on the exterior of said housing between said
`extended surface and said outlet port.
`11. A manifold as in claim 1 further including means
`for temporarily attaching said manifold to a bedside
`location.
`12. A manifold as in claim 11 wherein said attaching
`meansincludes a patch of VELCROfixed to said mani-
`fold for engaging a similar VELCROpatchat a bedside
`location.
`13. A manifold as in claim 12 wherein said housingis
`provided with a flattened surface between said ex-
`tended surface and said outlet port to which said VEL-
`CROpatch is fixed.
`14. A manifold as in claim 1 further including a cathe-
`ter and a tube connecting said outlet port to said cathe-
`ter.
`15. A manifold as in claim 1 wherein said housing is
`transparent.
`16. A manifoldas in claim 1 wherein positions of each
`of said inlet ports are selected from the group consisting
`of symmetrical abouta centerlineofsaid outlet port and
`substantially coincident with said centerline of said
`outlet port.
`17. A manifold as in claim 1 wherein each ofsaid
`ports is occluded by an elastomeric memberadapted to
`be penetrated by a needle or cannula.
`18. A molded manifold for connection between a
`plurality of fluid sources and a patient comprising a
`housing having a plurality of inlet tubes extending from
`an exterior surface of said housing, each adapted to be
`occluded by a septum, an outlet tube extending from
`said surface and a plurality of internal passages each
`having a centerline, said centerlines intersect at a com-
`mon point, and said internal passages extending within
`said housing from oneofsaid inlet tubes to said outlet
`tube.
`19. A manifold as in claim 18 wherein said manifold is
`further provided with a plurality of dead end bores
`extending into said manifold and each adapted to be
`occluded by an elastomeric member.
`20. A manifold as in claim 18 wherein said inlet tubes
`extend from an uppersurface and wherein said manifold
`tapers inwardly from said upper surface to said outlet
`tube.
`21. A manifold as in claim 18 wherein the surface of
`said manifold between said inlet tubes and said outlet
`tube is adapted for attaching said manifold to a surface.
`22. A manifold as in claim 18 wherein said manifold is
`molded ofclear plastic.
`23. A manifold as in claim 18 wherein said inlet tubes
`are integral with said housing.
`24. A manifold as in claim 18 wherein said housing
`and inlet tubes are separate.
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`25. A manifold as in claim 18 wherein said inlet tubes
`extend from an upper, planar, substantially circular
`surface.
`26. A manifold as in claim 18 wherein the distance
`fluid travels from each ofsaid inlet tubesto said. outlet
`tube is substantially the same.
`27. A manifold as in claim 18 wherein said inlet tubes
`are symmetrical about an axis and said outlet tube is
`coincident with said axis.
`28. A manifold for coupling a plurality of fluid
`sources to a patient comprising:
`a housing having a plurality of inlet ports, an outlet
`port, and a plurality of passage means each having
`a centerline, said centerlines intersect at a common
`point for connecting said inlet ports to said outlet
`port; and
`
`8
`elastomeric means sealing each ofsaid inlet ports and
`adapted to be pierced bya needle or blunt cannula
`and meanssealingsaid outlet port so that passage of
`contaminants into said passages from the ambient
`environment is blocked.
`29. A manifold as in claim 28 wherein said inlet ports
`are defined by tubes upwardly extending from an upper
`surface andsaid outlet port is defined by a downwardly
`extending tube.
`30. A manifold as in claim 28 wherein said housingis
`further provided with a plurality of dead end bores
`extending into said manifold and each adapted to be
`occluded by an elastomeric member.
`31. A manifold as in claim 28 including means for
`attaching said manifold to an external surface.
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