United States Patent
`Oswald et al.
`
`[19
`
`LANAAAAA
`
`US005190525A
`(11] Patent Number:
`[45] Date of Patent:
`
`5,190,525
`Mar. 2, 1993
`
`[54] DRUG INFUSION MANIFOLD
`
`[75]
`
`Inventors: Timothy J. Oswald, Lincolnshire;
`Lois L. Caron, McHenry; Mark E.
`Larkin, Lindenhurst; William L.
`Rudzena, McHenry; EdwardS. Tripp,
`Park City, all of Ill.
`
`{73] Assignee: Abbott Laboratories, Abbott Park,
`Ill.
`
`[21] Appl. No.: 816,435
`
`(22} Filed:
`
`Dec. 31, 1991
`
`4,915,688 4/1990 Bischof ..sussssuesumanenene 604/83
`Primary Examiner—John D. Yasko
`Attorney, Agent, or Firm-—A. Nicholas Trausch
`[57]
`ABSTRACT
`A drug infusion manifold for controlling the infusion of
`drugs and/or other solutions into an intravenouspatient
`feed line. The manifold includes a housing defining an
`elongated in-line flow channel that communicates at
`one end with a carrier fluid inlet line and at the other
`end with the patient feed line. A plurality of spaced
`apart drug inlet openings are formed in the housing in
`communication with the flow channel. Eachoftheinlet
`openings is provided with a check valve assembly that
`Related U.S. Application Data
`includes a valve memberdefining an inlet socket por-
`[63].Continuation-in-part of Ser. No. 632,254, Dec. 21,
`tion and a valve stem portion that extends into the flow
`1990, abandoned.
`channel. The valve stem portion has a cylindrical side
`[ST] Unt, C15 occescceceseceeseneonenees AGIM 37/00
`wall that defines an inlet passage that communicates
`
`U.
`[52]
`with the socket portion. A plurality of lateral inlet ports
`[58] Field of Search .........:ceeee 604/80, 81, 82, 83,
`
`extend through the side wall. An elastic sleeve member
`604/169, 173, 905, 89, 90
`is received about the valve stem portion in covering
`relationship with the inlet ports. The valve stem portion
`is in-line with the flow ofcarrier fluid through the flow
`channel.-
`
`[56}
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`4,063,555 12/1977 Ullinder ....... cesssetesseseenaee 604/83
`4,795,441
`1/1989 Bhatt .........cccssesseteceseeee 604/80 X
`
`13 Claims, 3 Drawing Sheets
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`EUNSUNG-1023
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`Sinclair Pharma et al.
`EUNSUNG-1023
`
`1
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`Mar, 2
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`, 1993
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`5,190,525
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`Sheet 1 of 3
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`U.S. Patent
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`Mar. 2, 1993
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`Sheet 2 of 3
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`U.S. Patent
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`Mar.2, 1993
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`Sheet 30f3
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`1
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`DRUG INFUSION MANIFOLD
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`5,190,525
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`BACKGROUND OF THE INVENTION
`
`This application is a continuation in part of U.S. Pat.
`application Ser. No. 07/632,254 filed on Dec. 21, 1990
`now abandoned.
`1. Field Of The Invention
`This invention relates to a device for controlling the
`infusion of drugs and/or other solutions. More specifi-
`cally, the invention relates to an automatic drug infu-
`sion manifold that may be used to intravenously admin-
`ister drugs, such as anesthetic and cardiovascular drugs,
`without the use of manual switches and which permits
`gravity delivery of the carrier fluid.
`2. Description Of The Prior Art
`During surgery, and other medical procedures in the
`ICU, CCU,ER,it is necessary to deliver different drugs
`to a patient in a selected and controlled manner. One
`procedure currently being used to deliver such drugsis |
`by individual syringes. Each syringe is connected to a
`stopcock which in turn is used with a primary (or pa-
`tient) IV set. The doctor must manually rotate the knob,
`handle, control lever, etc. of the stopcock in order to
`deliver the selected drug to the patient. Depending on
`the positioning of the stopcocks’ knob, etc. and the
`inside diameter of the IV tubing, there may be a large
`volume in which different drug residuals may mix. De-
`pending on the particular drugs, such mixing may have
`adverse effects on the patient, particularly in cardiovas-
`cular drug infusion.
`Another system that has been used to deliver selected
`drugs to a patient includes a common manifold device
`having multiple inlet drug lines that are controlled by
`individual stopcocks. Similar type devices have been
`proposed that include various types of valve arrange-
`ments in the inlet drug lines to control the infusion of
`drugs through the inlet drug lines while preventing
`backflow therethrough. Examples of these types of
`drug infusion devices are disclosed in U.S. Pat. Nos.
`4,666,429, 4,819,684, 4,871,353, 4,908,018 and 4,915,688.
`In U.S. Pat. No. 4,346,704 a parenteral solution ad-
`ministration device is disclosed that includes an outer
`housing defining an outlet tube and an inner tubular
`support defining an inlet tube. The support has a closed
`forward end positioned within the outer housing and
`has lateral apertures through which the bore of the
`tubular support communicates with the outlet tube. An
`elastic tube or sleeve surrounds the tubular support in
`covering relationship with the lateral apertures. The
`inner tubular support is free of retaining structureat its
`closed end so as to permit the elastic tube to slide later-
`ally on the tubular support through a limited distance.
`Upon pressurized fluid flow through theinlet tube, the
`elastic tube is expanded by pressurized fluid passing
`through the apertures to permit fluid flow between the
`tube and tubular support out of both endsof the elastic
`tube.
`:
`In U.S. Pat. No. 4,063,555 a cannula assembly is dis-
`closed that includes a housing defining a fluid flow
`passage having twofluid inlets and one fluid outlet. One
`of the fluid inlets is shaped to receive the tip of an injec-
`tion syringe for introduction of fluid to the inlet. Fluid
`flow through the inlet is controlled by a check valve
`housing an elastic tubular valve member closing off
`outlet openings associated with the check valve. Under
`sufficient pressureofa fluid in the inlet the tubular valve
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`member deflects outwardly permitting flow through
`the outlet openings.
`There is a need for a drug infusion manifold for con-
`trolling the infusion of selected drugs that does not need
`to be manipulated by hand and does not require manual
`switching operation. There is a further need for such a
`device that permits the gravity delivery of the carrier
`solution. There is also a need for such a device that
`minimizes the volume of drug residual in the line and
`yet is still simple in design, reliable and inexpensive to
`manufacture.
`
`SUMMARYOF THE INVENTION
`
`A non-manual drug infusion manifold is provided
`that includes a housing defining an elongated in-line
`flow channel communicating at one end with a carrier
`fluid inlet line and at the other end with a patient pri-
`mary IV line. A plurality of spaced apart drug inlet
`openings are formed in the housing in communication
`with the flow channel. Each of the inlet openings is
`provided with a check valve assembly that extends
`therethrough and permits fluid flow directly into the
`flow channelof the carrierfluid while precluding fluid
`flow therefrom.
`In accordance with a unique feature of the invention,
`the check valve assembly includes a valve member
`defining an inlet socket portion for receipt of the tip
`portion of a drug-containing syringe, or other drug-con-
`taining pump means, thereinto and a generally hollow
`valve stem portion that extends directly into the flow
`channel. The valve stem portion is generally cylindrical
`and has a bore defining an inlet passage that is open at
`one end and communicates with the socket pocket por-
`tion and is closed at the other end and extendsinto the
`flow channel. A plurality of lateral inlet ports extend
`throughthe side wall defining the inlet passage. A valve
`sleeve memberis received about the valve stem portion
`in covering relationship with the inlet ports. When the
`pressure exerted by the fluid from the syringeis suffi-
`cient, the sleeve memberdeflects outwardly permitting
`fluid flow from the inlet passage of the valve stem por-
`tion into the flow channel. The valve stem portion of
`each of the check valvesis in-line with the flow of the
`carrier fluid through the flow channel.
`The bottom portion of the valve stem portionispref-
`_erably located a short distance abovea flat bottom sur-
`face of the flow channel. The valve memberdefines a
`shoulder portion in the area where the socket portion
`meets the valve stem portion. The valve sleeve moves
`longitudinally along the valve stem during normaloper-
`ation of the check valve assembly. The movement of
`the valve sleeve is limited by its contact with the shoul-
`der portion and the bottom surface of the flow channel
`in a manner that always retains the valve sleeve on the
`valve stem portion in covering relationship with the
`inlet ports.
`In accordance with other features of the invention,
`the carrierfluid inlet line is provided with a check valve
`to preclude backflow of fluid from the flow channel
`into the carrier fluid inlet line while permitting gravity
`flow of carrier fluid therethrough. The socket portion
`of the check valve assembly is preferably configured to
`receive the male portion of the luer lock fitting. The
`manifold is preferably formed with an integral support
`bracket to facilitate gripping and clamping of the de-
`vice.
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`DESCRIPTION OF THE DRAWINGS
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`A better understanding of the drug infusion manifold
`of the invention will be had by reference to the draw-
`ings wherein:
`FIG.1 is an elevational view of a drug administration
`set utilizing a drug infusion manifold constructed in
`accordance with the invention;
`FIG. 2 is an enlarged longitudinalsectional view of
`the drug infusion manifold of the invention;
`FIG.3 is a top plan view of the drug infusion mani-
`‘fold shown in FIG.2;
`.
`FIG. 4 is a bottom plan view of the drug infusion
`manifold shown in FIG.2;
`FIG. 5 is an enlarged sectional view of one of the
`drug inlet openings;
`FIG.6 is an end view taken along the plane 6—6 in
`FIG.2 with the carrier fluid inlet line check valve being
`shown in phantom lines;
`FIG.7 is a sectional view taken along the plane 7—7
`in FIG.2.
`FIG.8 is an alternative embodiment similar to FIG.
`2; and
`FIG.9 is a sectional view along plane 9—9 in FIG.8.
`DESCRIPTION OF THE PREFERRED
`EMBODIMENT
`
`FIG. 1 illustrates a drug and/or solution infusion
`system 10 of the type used to administer intravenous
`anesthetic or cardiovascular drugs and/orsolutions into
`a patient during surgery, ICU, CCU or ER procedures
`that includes an automatic drug infusion manifold 12
`constructed in accordance with the present invention.
`System 10 includes a drug infusion manifold 12 that is
`connectedto a carrier fluid inlet line 14 having a spike/-
`sight chamber 16 for attachmentofthe carrier fluid inlet
`line to an IV set (not shown). A patient feed outlet line
`16 delivers the mixture of the carrier fluid and the drug
`to the patient through a conventional cannula (not
`shown). A syringe 18 is shown connected to one of the
`drug inlet. openings of the manifold 12. A Y site may be
`provided in carrier fluid inlet line 14 for infusion of a
`medicament into the carrier fluid inlet line in a well
`known manner.
`.
`Referring to FIGS. 2-7, a preferred embodiment of
`an automatic drug infusion manifold 12 incorporating
`features of the invention includes a housing 20 defining
`an elongated in-line flow channel 22. Flow channel 22 is
`generally rectangular in cross. section and is defined by
`a flat bottom wall portion 24, side wall portions 26 and
`28 and a top wail portion 30. Flow channel22 hasa first
`open end ‘portion 32 and a second open end portion 34.
`As best seen in FIG. 2, a plurality of spaced apart
`inlet openings. 36 extend through top wall portion 30.
`While the illustrated preferred embodiment has five
`such openings,it will be understood thatit is anticipated
`that alternative embodiments are envisioned that have
`either a fewer. or a greater numberof such openings.
`Each of the inlet openings 36 is provided with a
`check valve assembly 38 for controlling the delivery of
`drugs into flow channel 22 and precluding the flow of
`carrier fluid and other drugs from the flow channel:
`Check valve 38 includes a valve member 40 defining an
`inlet portion 42 and a valve stem portion 44. Inlet por-
`tion 42 defines a socket 46 that is configured to form a
`female luer lock fitting for receipt ofa cooperating male
`luer lock fitting associated with a drug dispensing sy-
`ringe, pump, or other drug-containing pump means,in a
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`well known manner. The check valve is preferably
`formed with an annular flange portion 48 whichis re-
`ceived in a cooperating annual recess portion 50 formed
`in top wall portion 30 aroundinlet opening 36. Flange
`portion 48 is preferably ultrasonically welded to the
`recess portion 50.
`Valve stem portion 44 has a cylindrical side wall 52
`that defines an inlet passage 54 that is open at one end in
`communication with socket 46 and is closed at its other
`end. The valve stem portions 44 extend into flow chan-
`nel 22 andare in-line with the fluid flow therethrough.
`The portion of flow passage 22 into which valve stem
`portions 44 extend are configured to permitcarrier fluid
`flow around the valve stem portions. The bottom of the
`valve stem portion is positioned a short distance above
`the inner surface of bottom wall portion 24. A plurality
`of lateral inlet ports 56 extend through side wall 52
`through which the inlet passage 54 communicates with
`the flow channel 22.
`An elastomeric sleeve member 58 is positioned
`around valve stem portion 44 in covering relationship
`with ports 56. Sleeve. member 58 is preferably an ex-
`truded length of silicone tubing. The bottom of valve
`stem portion 44 is preferably chamberedsoas to facili-
`tate the assembly of sleeve member 58 around valve
`stem portion 44.It is anticipated that sleeve member 58
`may movelongitudinally along the length of valve stem
`portion 44 during operation of manifold 12. The upward
`longitudinal movementof the sleeve memberis limited
`as it contacts a shoulder portion 60 defined by flange
`portion 48 and the downward longitudinal movement
`thereof is limited as it contacts the inner surface of
`bottom wall portion 24. The shoulder portion and the
`inner surface are spaced apart so as to ensure that the
`sleeve member58 always remains on stem portion 44 in
`covering relationship with ports 56.
`An alternative embodimentis shownin FIG. 8 and 9.
`An oval shaped, hollow projection 24a is provided on
`the inner surface of the bottom wall portion 24 centered
`beneath each stem portion 44.
`Asseen in FIG.9, the major axis of the oval is greater
`than the diameter of the elastomeric sleeve member58.
`The minor axis of the oval is less than the diameter of
`the elastomeric sleeve member 58. Thus, should sleeve
`member58 migrate toward the bottom wall portion 24
`during use, the travel of the sleeve will be limited by
`‘ contact with the raised oval portion. Further, fluid flow.
`through the stem during use can exit the bottom of the
`sleeve and flow into the manifold flow passage 22
`through the uncovered ends 245 of the major axis of the
`oval. Additionally, fluid can flow through the open
`ends 24c of the sleeve 58 which do not overlap the
`minoraxis of the oval.
`This construction relaxes the manufacturing and as-
`sembly tolerances required between the shoulder por-
`tion and the inner surface of the bottom wall portion 24.
`Further, the raised oval may promote fluid turbulence
`and thus fluid mixing in the manifold flow passage dur-
`ing use.
`Endportion 32 of flow channel 22 is provided with a
`check valve 62 in fluid communication therewith to
`preclude the backflow of fluid from flow channel 22
`into a carrierinlet line 14 attached thereto while permit-
`ting the gravity flow ofcarrier liquid therethrough into
`channel 22. Check valve 62 is preferably. ultrasonically
`welded to housing 20 and includes a suitable female luer
`lock fitting 64 associated therewith for attachmentto a
`cooperating male luer lock fitting associated with the
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`carrier fluid inlet line. Check valve 62 is prefefably of
`the type having a normally closed biased diaphragm
`that will open with a pressure of 12 inches of water or
`less.
`End portion 34 of flow channel 22 is provided with a
`male luer lock fitting 66 associated therewith for attach-
`ment to a female luer lock fitting associated with the
`patient inlet feed line 16.
`In orderto facilitate use of manifold 12 it is provided
`with a generally flat support bracket member 70 formed
`integrally with housing 20 for suitably gripping or
`clamping the manifold in place during use.
`The brief discussion of the operation of the above-
`described preferred embodiment of the invention that
`follows sets forth the cooperation between the above
`disclosed structural elements.
`In use, the drug infusion system 10 is assembled in
`such a mannerthat one endofthe carrier fluid inlet line
`14 communicates with a supply of carrier fluid, which is
`typically an IV set having a carrier solution-containing
`bag elevated on a support pole. Manifold 12 is attached
`to the other end ofthe carrier fluid inlet line at fitting
`64. The patient feed outlet line 16 is attached to the
`manifold 12 atfitting 66. Syringes 18 containing prese-
`lected drugs and/or solutions are attached to a corre-
`sponding socket 46 of a valve assembly 38.
`Thecarrierfluid flows into manifold 12 through open
`end 32 into flow passage 22, flows around the valve
`stem portions 44 of the check valves 38, leaves the
`manifold through open end 34, and is directed through
`feed line 16 into the patient. At such time as it is neces-
`sary to infuse a particular drug or drugs into thepatient,
`the particular drug containing syringe or syringes 18 are
`depressed directing the drug solution into a passage 54.
`When the pressure of the drug solution exceeds the
`cracking pressure ofthe valve 38, the sleeve member 58
`deflects outwardly communicating passage 54 with
`flow channel 22 throughports 56. In accordance with a
`preferred embodiment of the invention,
`the opening
`pressure required to maintain flow through the valve 38
`is preferably from about 1.0 psig to about 8.0 psig, most
`preferably about 3.0 psig. The flow of drug solution
`mixes with the carrier solution in channel 22 and the
`mixture is directed to the patient through line 16. When
`the pressure of the drug solutionis less than the opening
`pressure of the valve 38, the sleeve member 58 returns
`to its original position in covering relationship with -
`ports 56 and the flow of drug solution into flow channel
`22 is terminated.
`—
`After termination of the flow of a particular drug
`through a corresponding valve 38 into flow channel 22,
`the residual of that particular drug in the commonvol-
`ume of flow channel 22 is quite minimal and therefore
`not likely to mix with subsequently added drugs. The
`in-line flow of carrier liquid around the valve stem
`portion 44 serves to flush drug residuals therefrom and
`delivering a total dose of the drugto the patient.
`As can be appreciated from the above description of
`the invention, manifold 12 controls the infusion of se-
`lected drugs and does not require a manual switching
`operation. The manifold 12 also permits the gravity
`delivery of the carrier solution. The manifold is acti-
`vated by syringe pressure requiring no manual manipu-
`lation,
`thereby permitting one hand operation. The
`drugs exit the valve directly into the primary flow line
`resulting in no pockets of unmixed drugs. The residual
`volumeof drugs abovethe valves is minimal and there
`is no flow into pockets associated with adjacent valves.
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`The check valve prevents retrograde of drug up line of
`the manifold. The use of the sleeve valves also mini-
`mizes contamination associated with manual switches.
`The manifold also permits use of multiple .drug sources
`such as syringes and IV fluids infused via a positive
`pressure device, while permitting these drug sources to
`remain attached without dilution or wicking of drug if
`no pressureis applied. These advantages are achieved in
`a mannerthat is simple in design, reliable in operation,
`and inexpensive to manufacture.
`The foregoing invention can now be practiced by
`those skilled in the art. Such skilled persons will appre-
`ciate that the drug infusion manifold of the present
`invention is not necessarily restricted to the particular
`preferred embodiments presented herein. The scope of
`the inventionis to be defined by the termsofthe follow-
`ing claims in the spirit and meaning of the preceding
`description.
`Whatis claimedis:
`1. A drug infusion manifold for use in intravenous
`administration of drugs and/or solutions to a patient,
`said drug infusion manifold comprising:
`(a) a housing defining an elongated in-line flow chan-
`nel, said flow channel having a first open end por-
`tion for receipt of carrier fluid thereinto and a
`second open end portion for directing patient feed
`fluid therefrom;
`(b) a plurality of spaced apart inlet openings formed
`in said housing in fluid communication with said
`flow channel; and
`(c) check valve means extending through each ofsaid
`inlet openings and into said flow channelfor direct-
`ing drugs and/orsolutions into said flow channel
`and precluding fluid flow from said flow channel,
`said check valve means including a valve member
`defining an inlet portion for receipt of a drug and-
`/or solution thereinto under pressure and a valve
`stem portion that extends into said flow channel,
`said valve stem portion having a side wall that
`defines an inlet passage that is open at one end in
`communication with said inlet portion andis closed
`at the other end, said side wall having at least one
`lateral inlet port extending therethrough communi-
`cating said inlet passage with said flow channel,
`said valve stem portion having an elastomeric
`sleeve member received in covering relationship
`with said inlet port such that when the pressure of
`the drug and/or solution in said inlet passage ex-
`ceeds a predetermined level said sleeve member
`deflects outwardly directing fluid flow from said
`inlet passage into said flow channel to be trans-
`ferred to the patient by flow of the carrier fluid.
`2. The invention as defined in claim 1 wherein said
`inlet portion of said valve member defines a socket for
`receipt of the tip of a drug and/or solution-containing
`syringe thereinto.
`|
`3. The invention as defined in claim 2 wherein said
`inlet portion defines a female luerfitting for receipt of a
`cooperating male luer fitting associated with the sy-
`ringe.
`4. The invention as defined in claim 1 wherein said
`valve member defines a shoulder portion extending
`outwardly from an upper portion of said valve stem
`portion and the bottom of said valve stem portion is
`located a short distance above a bottom surface of said
`flow channel so as to limit longitudinal movement of
`said sleeve memberon said valve stem portion between
`said shoulder portion and said bottom surface so as to
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`retain said sleeve memberon said valve stem portion in
`covering relationship with said inlet port.
`5. The invention as defined in claim 4 wherein said
`bottom surface of said flow channelis substantially flat.
`6. The invention as defined in claim 1 wherein said
`first open end portion of said flow channel has a check
`valve associated therewith to preclude the backflow of
`fluid from said flow channel therethrough while permit-
`ting the gravity flow of carrier fluid therethrough.
`7. The invention as defined in claim 1 further includ-
`ing a generally flat support bracket member formed
`integrally with said housing.
`8. The invention as defined in claim 6 wherein said
`check valve attached to said first open end portion of
`said flow channel has a female luer fitting associated
`therewith for attachment to a male luer fitting associ-
`ated with a carrier fluid inlet line.
`9. The invention as defined in claim 1 wherein said
`second open end portion ofsaid flow channel has a male
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`luer fitting associated therewith for attachment to a
`female luerfitting associated with a patient feed outlet
`catheter.
`10. The invention as defined in claim 1 wherein said
`sleeve memberis an extruded length ofsilicone tubing.
`11. The invention as defined in claim 1 wherein the
`bottom endof said valve stem portion is chamfered to
`facilitate positioning of said sleeve member thereon.
`12. The invention as defined in claim 1 wherein said
`check valve means has an opening pressure in the range
`from about 1.0 psig to about 8.0 psig.
`13. The invention as defined in claim 4 wherein said
`bottom surface of said flow channel further includes a
`raised oval portion centered beneath each valve stem
`portion and having a major axis greater than the diame-
`ter of said elastomeric sleeve member and a minoraxis
`less. than or equal to the diameter of said elastomeric
`sleeve portion.
`*
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