United States Patent 15
`4,512,764
`[11] Patent Number:
`Wunsch
`
`[45] Date of Patent: Apr. 23, 1985
`
`[54]
`
`MANIFOLD FOR CONTROLLING
`ADMINISTRATION OF MULTIPLE
`INTRAVENOUS SOLUTIONS AND
`MEDICATIONS
`
`[76]
`
`Inventor:
`
`‘Richard E. Wunsch, 207 Circle Dr.,
`Traverse City, Mich. 49684
`
`[21]
`[22]
`
`[51]
`[52]
`
`[58]
`
`[56]
`
`Appl. No.: 423,978
`Filed:
`Sep. 27, 1982
`Tint, CLF ..cssescssessestscesesseeteseeteseenesenaeeeas AGIM 5/14
`DS. Clixcmanaasncnnasensios 604/80; 604/83;
`604/250; 138/118; 222/145
`Field of Search ..........sscsese0 604/34, 80, 86, 151,
`604/173, 250, 81, 284, 83; 138/118; 251/8;
`128/DIG. 12; 222/145, 330
`References Cited
`U.S. PATENT DOCUMENTS
`2,710,004
`6/1955
`
`
`- 604/66
`2,925,814 2/1960
`
`2,954,028
`9/1960
`--- 604/80
`
`604/81 X
`2,962,193 11/1960
`
`a 604/66
`3,043,303
`7/1962
`
`-- 604/81
`3,217,711 11/1965
`. 604/250 X
`
`3,411,534 11/1968
`am
`
`
`-» 604/81
`3,886,937 6/1975 Bobo etal. .
`3,941,126 3/1976 Dietrich et
`we 604/80
`
`3,982,534 9/1976 Buckman ...
`- 604/81
`3,993,054 11/1976 Newman «occ604/153 X
`
`we 604/81
`4,034,754 7/1977 Virag....
`eve 604/65
`
`4,094,318
`6/1978 Burke etal. ..
`
`4,184,815
`1/1980 Casson etal. .
`» 417/477
`
`+. 604/80
`4,191,183
`3/1980 Mendelson
`o- 604/81
`4,219,022
`8/1980 Genese......
`604/81
`-
`4,236,515 12/1980 Genese ..
`-. 604/58)
`4,237,880 12/1980 Genese......
`4,250,879 2/1981 Muetterties
`ve 604/81
`4,256,103
`3/1981 Mylrea oe...
`604/81
`4,256,104
`3/1981 Muetterties etal.
`604/81
`
`4,256,105
`3/1981 Leahey etal.
`.. 604/81
`4,258,712
`3/1981 Harmset al.
`ve 604/81
`.
`
`604/34 X
`4,312,993
`1/1982 Stauffer.....
`even 604/34 K
`4,425,113
`1/1984 Bilstad ..........
`
`
`
`Primary Examiner—Stephen C. Pellegrino
`Attorney, Agent, or Firm—Cullen, Sloman, Cantor,
`Grauer, Scott & Rutherford
`
`[57]
`
`ABSTRACT
`
`A manifold for sequentially dispensing a plurality of
`solutions through an intravenous supply catheter. The
`manifold includes a disposable tubing manifold that is
`connected to each of the solutions to be administered.
`Flow of solution through the branches of the tubing
`manifold can be stopped by valves which engage each
`branch. The quantity of solution dispensed is metered
`by a volumetric infusion pump and controlled by se-
`quentially opening and closing the valves individually.
`
`8 Claims, 3 Drawing Figures
`
`
`
`Sinclair Pharma etal.
`EUNSUNG-1009
`
`1
`
`Sinclair Pharma et al.
`EUNSUNG-1009
`
`

`

`U.S. Patent Apr. 23, 1985
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`U.S. Patent Apr. 23, 1985
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`4,512,764
`
`1
`
`MANIFOLD FOR CONTROLLING
`ADMINISTRATION OF MULTIPLE
`INTRAVENOUS SOLUTIONS AND
`MEDICATIONS
`
`BACKGROUNDOF THE INVENTION
`1. Technical Field
`Thepresent invention relates to a manifold for admin-
`istering intravenous solutions and medications. More
`particularly,
`the invention relates to a manifold for
`sequentially supplying a plurality of solutions to a single
`intravenous tube.
`2. Prior Art
`Medical treatmentfrequently requires the administra-
`tion of more than one solution or medication by intrave-
`nous injection.
`In many medical
`treatments several
`drugs are administered periodically.
`To minimize the numberofinjections given to a pa-
`tient
`it
`is common practice to inject medications
`througha single intravenous tubing by meansof one or
`more Y-connectors. The normal procedure is for a
`member of a hospital staff to unsheath a needle and
`insert it ina Y-connectorat time periods and in quanti-
`ties specified by the treating physician. When a given
`medication has been administered the needle is removed
`from the Y-connector, resheathed and stored next to the
`patient’s bed until the next treatmentinterval. This pro-
`cedure is subject to contamination due to the repeated
`sheathing and unsheathing of the needle. While this
`procedure is acceptable when a limited number of medi-
`cations are administered,as the frequency ofadministra-
`tion increases the amountofstaff time expended, diffi-
`culty ofkeeping the needle and Y-connectorsterile, and
`chance of error in administering a medication likewise
`increase.
`This procedure for periodically administering medi-
`cation to patients is time consuming for hospital staff
`and requires detailed instructions because medicationis
`often prescribed around the clock. In medical treat-
`ments requiring a large numberofsolutions each having
`a loosely hanging tube, a member of the hospital staff
`could conceivably be confused and dispense the wrong
`solution.
`Frequently, tubes are left dangling loosely around the
`patient’s bed, instead of being tied out of the way, be-
`cause the tubes must be free for connection to the Y-
`connector. The tubes can be caughtin the side rails of
`the bed and damaged. During administration ofa solu-
`tion one of the tubes may be pinched off inadvertently
`resulting in insufficient medication being dispensed.
`Various types of manifolding apparatus have been
`developed to meet the problems posed by supplying
`multiple medications
`to a patient. U.S. Pat. No.
`2,954,028 to Smith discloses such an apparatus for ad-
`ministering parenteral fluids through the use of a mani-
`fold. While the Smith manifold allows a large number of
`medications to be administered simultaneously,
`it
`is
`bulky and time consumingto set up. The different medi-
`cations in the various passages of the manifold may
`intermix and if not compatible could interact deleteri-
`ously with each other. Different branches of the mani-
`fold open into the central tube at directly opposite loca-
`tions which allows the fluids to flow from one branch
`into another.
`
`Reuse of the Smith manifold is subject to several
`drawbacks.
`It is well known that some medications,
`while theraputic for some, are toxic to otherpatients. If
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`a patient receives medication through a manifold resid-
`ual deposits of a previously administered medication
`maybe present in the manifold. If the residual deposit is
`a substance thatis toxic to the patient it is possible that
`the patient could be harmed. Therefore, unless the man-
`ifold is cleaned and sterilized between each patient,
`there is a danger that a patient may inadvertently re-
`ceive residue from a medication administered to a prior
`patient. Cleaning andsterilizing the manifold between
`uses is laborious and requires valuable staff time.
`In addition, prior art devices have failed to disclose
`an accurate method for sequentially metering several
`different medications through a common catheter that
`is both inexpensive and simple to use. While visual sight
`glass drop counters have been used with Y-connectors,
`as shownin U.S. Pat. No. 3,886,937 to Boboet al and in
`the Smith manifold described above, such devices are
`time consuming to use and must be visually monitored
`for accuracy. Electronic drop counters as disclosed in
`U.S. Pat. No. 4,094,318 to Burke offer improved accu-
`racy but are extremely expensive, especially if more
`than one or two solutions are to be administered.
`These and other problems are solved simply and
`efficiently by the present invention.
`SUMMARYOF THE INVENTION
`
`The multiple intravenous solution manifold of the
`present
`invention comprises a three-piece manifold
`valve assembly having a disposable tubing manifold that
`assures sterility and purity in medications dispensed to a
`patient. The three part manifold apparatusis simple to
`disassemble for removing the disposable tubing mani-
`fold andreplacing it with a newsterile tubing manifold.
`The remainder of the manifold valve assembly does
`not contact any medication and therefore may be safely
`used repeatedly by different patients. Since the only
`portion of the valve manifold assembly that contacts
`more than one medication is the tubing manifold, there
`is no hazard of residual medication being administered
`to subsequent patients.
`The manifold plate has a plurality of valves with each
`valve being operative to close off the flow of a solution
`through a branch ofthe tubing manifold to control the
`flow ofthe solutions to the patients. The use of a mani-
`fold valve apparatus eliminates the need to sheath and
`unsheath medication needles from individual solutions
`to connect them to Y-tubing connectors. Therefore, the
`present invention offers improved sterility because the
`tubing is handled only when a solution bottle is re-
`placed.
`The manifold valve assembly also eliminates the un-
`sightly and confusing loosely dangling tubes of the prior
`art by allowing the solution tubes to remain attached to
`the apparatus when notin use. Instructions from physi-
`cians to hospital staff can be simplified since each chan-
`nel of the apparatus can be clearly identified. The tub-
`ing may be conveniently tied together out of the way of
`the hospital staff and the patient because the tubes do
`not need to be handled as often.
`The dispensing tube of the valve manifold is prefera-
`bly connected to an infusion pump that in turn pumps
`the intravenous solution at a measureable rate into a
`patient by means of an intravenous needle or catheter.
`At any onetimeit is preferred that only one valve will
`be open to allow the solution to be accurately measured
`as it is dispersed. The infusion pump draws solution at a
`known flow rate for a prescribed period of time,
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`4,512,764
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`3
`whereby the medication dose may be easily and accu-
`rately measured. A tube for a keep open solution, or
`base solution, is connected to one end of the valve mani-
`fold for use when no medication is being dispensed to
`prevent the formation of clots in the catheter or in the
`patient’s vein at the injection point.
`The present invention will be better understood after
`studying the attached drawings in view of the following
`detailed description of the invention.
`BRIEF DESCRIPTION OF THE DRAWINGS
`FIG. 1 is an elevational view of the manifold con-
`nected to several solution containers and an infusion
`pump.
`FIG.2 is a sectional view of the manifold taken along
`the line 2—2 in FIG.1.
`FIG. 3 is an exploded perspective view of the three
`part valve manifold assembly.
`DETAILED DESCRIPTION
`
`Referring now to FIG. 1, the multiple intravenous
`solution manifold assembly is generally indicated by the
`reference numeral £0. The manifold 10 is used to intra-
`venously dispense a plurality of medications and solu-
`tions to a patient. The intravenous solutions are con-
`tained in a plurality of bottles 13 that are connected to
`the manifold 10 by means of supply tubes 14. Solutions
`passing through the manifold 10 are sequentially admin-
`istered by means of the dispensing tube 16 which is
`poweredand controlled by an infusion pump 17. Medi-
`cation is injected into a patient by means of a catheter or
`intraveousneedle 19.
`The intravenous solution manifold assembly 10 of the
`present invention is described in detail with reference to
`FIGS. 2 and 3. The manifold assembly 10 includes a
`manifold plate, generally indicated by the numeral 21,
`whichreceives the tubing manifold 22 and is covered by
`the valve plate 23. The entire manifold assembly 10 is
`secured together by meansofa plurality of bolts 24 that
`are removably received within threaded openings 25
`formed in the manifold plate 21. If desired, the threaded
`openings 25 may include a nut or other threaded rein-
`forcement member.
`The manifoldplate 21 is a rigid memberand has a pair
`of generally flat
`inner and outer surfaces 11 and 12
`respectively and a pair of side surfaces 15. Inner surface
`11 has a vertical slot 26 running the length of the mani-
`fold plate 21 from the top or end surface 27 to the bot-
`tom or end surface 28. The vertical slot 26 is a U-shaped
`channel opening on the face or inner surface 11 of the
`manifold plate 21. Branch slots 29 are formed in the
`manifold plate 21 to extend from the vertical slot 26 to
`the lateral sides 30 of the manifold plate 21. The branch
`slots 29 are U-shaped channels that open onto the face
`of the manifold plate 21. The branch slots 29 extend
`from the vertical slot 26 at a slightly acute angle relative
`to the portion of the vertical slot extending toward the
`top 27 of the manifold plate 21.
`The tubing manifold 22 is made up of the trunk tube
`32 that extends from the top 27 to the bottom 28 of the
`manifold plate 21. The trunk tube 32 includes a female
`connector 33 on its top end and a male connector 34 on
`its bottom end. A plurality of branch tubes 37 extend
`from opposite sides of the trunk tube 32 from longitudi-
`nally spaced openings 38 formed in the trunk tube. The
`branch tubes open into the trunk tube 32 to permit fluid
`flow from the branch tubes 37 to the trunk tube 32. The
`branch tubes 37 intersect the trunk tube 32 at spaced
`
`4
`locations so that fluid flow is directed into the trunk
`tube 32 and not into another branch tube 37.
`Whenthe tubing manifold 22 is placed in the mani-
`fold plate 21 the branch tubes 37arefit into the branch
`slots 29 while the trunk tube 32 fits into the vertical slot
`26. The branch tubes 37 in their free state extend per-
`pendicularly from the trunk tube 32. However, when
`the tubing manifold 22 is placed in the manifold plate
`21, the branch tubes 37 are bent into the inclination of
`the branch slots 29. By so doing, fluid flow in the
`branch tubes from thelateral sides 30 to the trunk tube
`32 is encouraged by gravity while fluid flow in the
`opposite direction is resisted by gravity.
`The valve plate 23 has a pair of generally flat inner
`and outer surfaces 18 and 20 respectively and includes a
`plurality of valves 40 which are used to selectively stop
`fluid flow through the branch tubes 37 and the trunk
`tube 32. The valves 40 includes a wedge 41 which is
`positioned to bear upon one of the branch tubes 37 or
`the trunk tube 32. The wedge 41 is connected to inter-
`nally threaded valve stem 42 that is retained in the valve
`plate by means of a packing nut 43. The valve stem
`receives a valve shaft 44 whichis attached to the wedge
`41 for moving the wedge 41 longitudinally relative to
`the internally threaded valve stem 42. A knob 45 is
`provided on the internally threaded valve stem 42 to
`permit operation of the valve 40.
`Each of the valves 40 has an open position in which
`fluid flow is permitted through the tube 37 and a closed
`position in which the wedge 41 is pressed against the
`tube 37 to prevent fluid flow through the branch tube
`37, A valve 40 is also provided on the trunk tube 32 for
`shutting off the keep open solution. The valve 40 engag-
`ing the trunk tube 32 operates in the same manner as
`each of the valves 40 engaging the branch tubes 37.
`In operation, the solution bottles 13 are hung above
`the valve manifold apparatus 10 so that solution flows
`from the bottles 13 to the apparatus 10 through the
`supply tubes 14. The supply tubes 14 are received
`within the female connectors 33 that extend from the
`top 27 of the manifold plate 21 in fluid flow connection
`with the trunk tube 32. Other supply tubes 14 are re-
`ceived within female connectors 33 that are attached to
`each of the branch tubes 37 and extend from thelateral
`sides 30 of the manifold plate 21. Each LV. solution
`flows from the bottles 13 to the apparatus 10. The flow
`of the LV. solution into the dispensing tube 16 is con-
`trolled by meansofthe valves 40. Each ofthe valves 40
`has an open position in which fluid is permitted to flow
`from the supply tubes 14 into the dispensing tube 16 and
`a closed position in which the branch tube 37is pinched
`off to prevent fluid flow therethrough.
`Fluid volume through the dispensing tube is con-
`trolled by means of a volumetric infusion pump 17. The
`volumetric infusion pump 17 accurately maintains con-
`stant flow through the dispensing tube 16 and can regu-
`late the amount of fluid administered. By controlling
`the amountoffluid administered while the appropriate
`valve is open the volume ofsolution dispensed is auto-
`matically controlled.
`Accurate control of fluid administration may be as-
`sured by sequentially opening and closing the valves 40
`so that a single volumetric infusion pump may be used
`to draw fluids from each of the solution bottles sequen-
`tially. A volumetric infusion pumpis capable of meter-
`ing the amount of solution administered to a patient.
`Whennoneof the medications are required the valve 40
`controlling the trunk tube 32 is opened to permit the
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`to the number of branch slots disposed in said
`keep opensolution or base solution to flow, thereby
`branchslots, with one branch tube in a branchslot,
`keeping the intravenous needle openandfreeof clots.
`each branch tube being connectedto the trunk tube
`The valve 40 for the keep open solution is preferably
`on a first end and extending from the trunk tube
`opened for a short period between changes in medica-
`towards one or the other side surface, said branch
`tion to flush out the manifold, thereby preventing inter-
`tubes being connected to said trunk tube to permit
`mixing of different solutions.
`fluid flow from the branch tubes to the trunk tube;
`The present invention may also be used with a hepa-
`female tubing connector means attached to one end
`rin lock unit by semi-ambulantpatients.
`of said trunk tube and a second end of each branch
`Since the supply tubes 14 of the present invention are
`tube for attachment with a male connector of a
`hooked up to the apparatus 10 and do not need to be
`solution supply tube;
`sheathed and unsheathed periodically to administer
`meansattached to the other endofsaid trunk tube for
`medication, the supply tubes 14 may be tied together
`attaching the manifold to an intravenous solution
`out of the way of the hospital staff and the patient.
`supply tube;
`According to the present invention the tubing mani-
`a valve plate having a pair of generally flat inner and
`fold 22 is disposable thereby eliminating the need to
`outer surfaces, with the inner surfaces of the mani-
`clean andsterilize the manifold apparatus between uses
`fold and vaive plates abutting and attached to-
`on different patients. The valve plate 23 is easily disas-
`gether thereby enclosing said elongated slot and
`sembled from the manifold plate 20 and the tubing man-
`branchslots;
`ifold may be simply disconnected from the supply tubes
`a plurality of valves mounted in said valve plate, with
`14 and removed from the manifold plate 21. The tubing
`each ofsaid valves having a clamp means movable
`manifold 22 is then replaced when a new patientis to be
`towards and away from said tubing manifold for
`hooked up to the manifold unit. This procedure assures
`selectively engaging and thereby closing said
`that a patient will not
`inadvertently receive residue
`branch tubes and said trunk tube to prevent fluid
`from inside a manifold as was possible with prior art
`flow therethrough;
`manifold units. The branch tubes 37 are received in the
`and means for releasing said clamp means to selec-
`trunk tube at a slight angle whichinhibits solutions from
`tively permit fluid flow therethrough.
`intermixing in the branch tubes 37 and supply tubes 14.
`2. In the manifold assembly of claim 1, wherein said
`In the disclosed embodiment of the invention, up to
`valve plate and said manifold plate are separable,
`to
`eight solutions may be accommodated bya single mani-
`permit said tubing manifold to be removed from the
`fold apparatus 10. It should be understood that the num-
`manifold plate and replaced.
`ber of branches and valves provided can be changed
`3. In the manifold assembly of claim 1, wherein the
`without departing from the scope of the invention.
`branch slots in said manifold plate extend from said
`Each ofthefluids is introduced into the trunk tube at a
`elongated slot to define an acute angle between the
`location spaced from the other openings 38 in the trunk
`portion of the elongated slot extending towardssaid one
`tube 32. In this way the fluids are introduced into the
`end surface and each branchslot.
`trunk tube and begin flowing toward the bottom 28 of
`4. In the manifold assembly of claim 1, wherein said
`the manifold plate 21 before encountering the next
`control meansis a threaded shaft having a wedgeat a
`opening 38 in the trunk tube 32. This arrangement pre-
`first end for engaging said tubing and a knobat a second
`vents the fluids from intermixing and contaminating one
`another.
`end for turning the shaft to move the shaft relative to a
`fixed threaded packing nut.
`The invention has been described with reference to
`5. In the manifold assembly of claim 1, wherein said
`two preferred embodiments and it is to be understood
`intravenoussolution supply tube is connected to a volu-
`that the foregoing description is intended to be exem-
`metric infusion pump which urges said solutions into a
`plary. Various modifications are possible within the
`patient.
`spirit and scope ofthe invention. The scopeofthe pres-
`6. In the manifold assembly of claim 1, wherein said
`ent invention should be determined by reference to the
`releasing means permits fluid flow through only one of
`appended claims.
`I claim:
`said valves at a time to permit accurate measuring of
`fluid flow therethrough.
`1. A manifold assembly adapted for administering a
`7. A disposable plastic tubing manifold comprising:
`plurality of different intravenous solutions comprising:
`an elongated and flexible trunk tube having on one
`a manifold plate having a pair of generally flat inner
`end a female connector and on the other end a male
`and outer surfaces, a pair of side surfaces and a pair
`connector;
`of end surfaces, an elongated slot provided in said
`a plurality offlexible branch tubes connected on their
`inner surface and extending from one end surface
`inner ends to opposing surfaces of said elongated
`to the other end surface,said slot being of generally
`trunk tube for fluid flow, said branch tubes being of
`U-shape configuration;
`generally equal length and extending in a direction
`a plurality of branch slots providedin said inner sur-
`away from the trunk tube, parallel to one another
`face and extending from said elongated slot to said
`eachofsaid branch tubes extending from said trunk
`side surfaces of the manifold plate; some of said
`tube in longitudinally spaced relationship from the
`branch slots extending to one side surface and the
`other of said branch tubes; and
`remaining branchslots extending to the other side
`each of said branch tubes having a female tubing
`surface;
`connector on the outer end thereof.
`said branchslots being of generally U-shape configu-
`8. In the tubing manifold of claim 7, wherein said
`ration;
`a disposable tubing manifold made offlexible tubing 65 branch tubes extend perpendicularly away from said
`elongated tube.
`*
`*
`*
`*
`*
`and havinga trunk tube disposed in said elongated
`slot and a plurality of branch tubes equal in number
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