US006099511A
`6,099,511
`[1] Patent Number:
`11»
`United States Patent
`Devosetal.
`[45] Date of Patent:
`Aug. 8, 2000
`
`
`[54] MANIFOLD WITH CHECK VALVE
`POSITIONED WITHIN MANIFOLD BODY
`
`[75]
`
`Inventors: Gilles J. Devos, Voisins le Bretonneux,
`France; William Padilla; Fred P.
`Lampropoulos, both of Sandy, Utah
`
`[73] Assignee: Merit Medical Systems, Inc., South
`Jordan, Utah
`
`[21] Appl. No.: 09/273,033
`[22]
`Filed:
`Mar. 19, 1999
`
`[SL] Unt, Cdn? ec
`cccceccssseecsssecssseeesssneeeees A61M 5/00
`[52] U.S. Che ce eeeeseeeeeee 604/246; 604/248; 604/30;
`604/82
`[58] Field of Search occ 604/246, 247,
`604/248, 30, 32, 82, 83, 236, 183, 184
`References Cited
`U.S. PATENT DOCUMENTS
`
`[56]
`
`5,356,375
`5,423,751
`5,533,978
`5,573,515
`5,618,268
`
`10/1994 Highey ......eeeseccssnsesseeseeeeeene 604/30
`6/1995 Harrisonetal. ...
`we 604/83
`
`7/1996 Teirstein oc
`eeeeeerceseeeeeeeeee 604/183
`
`11/1996 Wilson etal. .
`.. 604/236
`
`4/1997 Raines etal. ....ccsssscsssssessssssseee 604/82
`
`Primary Examiner—John D. Yasko
`Attorney, Agent, or Firm—Workman, Nydegger & Seeley
`
`[57]
`ABSTRACT
`A manifold has a manifold body defining a fluid flow
`pathway therethrough. The manifold body has a plurality of
`valves, at least one of which is a check valve. The manifold
`is coupled at one end to a syringe or other fluid delivery
`means and to an opposing end to a catheter or other fluid
`receiving means. By being positioned within the manifold
`body, the check valve is reinforced and stabilized within the
`manifold.
`
`5,158,539
`
`10/1992 Kolff et al. oiececcccessesseenees 604/31
`
`35 Claims, 8 Drawing Sheets
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`1
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`Sinclair Pharmaetal.
`EUNSUNG-1021
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`Sinclair Pharma et al.
`EUNSUNG-1021
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`1
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`U.S. Patent
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`Aug. 8
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`Sheet 1 of 8
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`U.S. Patent
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`Aug. 8, 2000
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`U.S. Patent
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`Aug.8, 2000
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`Sheet 4 of 8
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`U.S. Patent
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`Aug. 8, 2000
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`Sheet 5 of 8
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`U.S. Patent
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`Aug. 8, 2000
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`U.S. Patent
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`Aug. 8, 2000
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`Sheet 8 of 8
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`6,099,511
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`6,099,511
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`1
`MANIFOLD WITH CHECK VALVE
`POSITIONED WITHIN MANIFOLD BODY
`
`BACKGROUND OF THE INVENTION
`
`1. The Field of the Invention
`
`This invention relates to valves. More specifically, this
`invention relates to valves employed in manifolds used
`during administration of medical liquids to a patient.
`2. The Relevant Technology
`During angiography and angioplasty procedures
`(hereinafter, “angio procedures”), a fluids administrationset
`may be employed. During such an angio procedure, a
`femoral artery site or other site is prepared by a physician.
`Site preparation is typically performed by injecting a local
`anesthetic at the femoral artery penetration site to numb the
`area. An introducer is then used to puncture the epidermis
`and arterial wall thereunder so as to access the femoral
`artery. A guide wire is introduced into the artery, and the
`introducer is removed.
`
`After the removal of the introducer, a sheath is typically
`inserted into the area where the introducer was removed.
`
`The sheath protects the femoral artery site during the angio
`procedure. A guiding catheter is then slid through the sheath
`and femoral artery and the catheter is advanced to the heart
`of the patient. After the catheterization of the patient, a fluids
`administration set is attached to the guiding catheter for
`administration of fluids during the angio procedure.
`Fluids administration set 10 of FIG. 1 is a depiction of a
`fluids administration set which is typical in angio proce-
`dures. As to the typical aspect of such procedures, FIG. 1
`will now be explained. Fluids administration set 10 features
`a syringe 12 connected to a catheter manifold 14. Catheter
`manifold 14 has a manifold fluid tube 16 for moving a
`variety of pressure laden fluids through catheter manifold
`14.
`
`Manifold 14 has a proximal end 18 anda distal end 20. At
`distal end 20 of manifold 14, opposite syringe 12,
`is a
`rotating adaptor 22 which connects a catheter (not shown) to
`manifold 14 and through which various fluids pass intrac-
`orporeally to a patient undergoing an angio procedure.
`Saline solution occlusion stopcock 24 selectively directs
`fluid between manifold tube 16 andsaline solution port 26.
`Saline solution port 26 is in fluid communication with a
`saline solution container (not shown) such as a saline
`solution bag. Port 26 allows accessto saline for flushing the
`aforementioned catheter with saline so as to clear the
`
`catheter of any particulate or thrombosis. Pressure monitor
`occlusion stopcock 28 selectively directs fluid between
`manifold fluid tube 16 and pressure monitor port 30.
`Stopcocks 24, 28, each have a handle thereon which is
`rotated to direct the flow of pressure laden fluids through
`catheter manifold 14. In order to operate a stopcock to stop
`a fluid from passing through the stopcock, the associated
`handle is turned toward a fluid line so as to point at the fluid
`line. When so pointed, the stopcock valve closes and pre-
`vents fluid in the pointed at line from passing through the
`stopcock. In FIG. 1, each of the stopcock handles are pointed
`toward respective ports. This permits fluid traveling through
`manifold fluid tube 16 to pass through each of the two
`stopcocks, but not through ports 26 and 30.
`Pressure monitor port 30 is in fluid communication with
`a pressure monitor (not shown) which includes a transducer
`which measuresdifferent pressures in the catheterized heart.
`In order for this pressure measurement to take place, the
`handle 31 of pressure monitor occlusion stopcock 28 must
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`be turned to point toward syringe 12 so as to permit fluid to
`pass from the catheter through port 30 and on to the
`transducer for sensing and measurement of the heart pres-
`sures.
`
`At a proximal end 18 of manifold 14, a check valve 32 is
`coupled between syringe 12 and manifold 14. A tube (not
`shown) communicates contrast media from a contrast media
`fluid source (not shown), to port 34 of check valve 32. Upon
`retraction of plunger 36 of syringe 12, the contrast fluid
`selectively flows through valve 32, into syringe 12. Upon
`compression of syringe 12, the contrast fluid then flows
`through valve 32, manifold 14 and a catheter coupled to
`manifold 14 and then into the circulatory system of the
`patient. When contrast media is injected into the coronary
`arteries for fluoroscopy, the contrast is visible within the
`patient and aids in diagnostics.
`the
`In order to inject contrast media into the patient,
`handles of stopcocks 24, 28 should be pointed toward
`respective ports 26, 30 as illustrated in FIG. 1 so that
`contrast media ejected from syringe 12 will pass through
`both valve 32 and manifold 14. Upon compression of
`plunger 36 into fluid filled barrel 38, fluid is dispelled into
`the patient through manifold tube 16 and via the intracor-
`poreally inserted catheter (not shown).
`Check valve 32 has a main valve chamber40,a fluid inlet
`port 42 coupled to main valve chamber 40, and a fluid outlet
`port 44 coupled to main valve chamber 40. Fluid inlet port
`42 is coupled to syringe 12 through the use of interlocking
`male and female Luer lock members. Outlet port 44 is
`tapered so as to be pressed into inlet port 46 of fluid tube 16
`and secured thereto through the use of an adhesive.
`One advantage of check valve 32 is that the practitioner
`is not required to turn a stopcock in order to selectively
`allow fluid to flow therethrough. Instead, the practitioner is
`merely required to retract plunger 36 of syringe 12, thereby
`creating a negative pressure within barrel 38, which causes
`fluid to flow through port 34 from a source of contrast fluid,
`and into syringe 12. Then, also without turning a stopcock,
`the practitioner can compress plunger 36 into syringe 12,
`thereby releasing fluid into the circulatory system of the
`patient. Thus, contrast fluid can be injected into the patient’s
`circulatory system by retracting plunger, then compressing
`plunger, rather than requiring the opening of a stopcock to
`allow fluid into syringe 12 and turning a stopcock to deliver
`fluid to manifold 14.
`
`However, one difficulty with check valve 32, is that outlet
`port 44 of valve 32 is particularly susceptible to breakage
`and other damage during the use of system 10. As the
`practitioner manipulates syringe 12 in orderto fill syringe 12
`with fluid and dispel fluid therefrom, the practitioner must
`grip system 10 tightly and often push with significant force
`against plunger 36 of syringe 12 in order to force dispel
`within syringe 12 into the circulatory system of the patient.
`As the practitioner compresses fluid within syringe 12 by
`inserting plunger 36 with such force into barrel 38,
`the
`practitioner often holds manifold 14 in one hand. The
`practitioner thus presses against plunger 36 with one hand
`while holding manifold 14 in another hand. Consequently
`outlet port 44 of valve 32 presses with significant force
`againstinlet port 46 of manifold 14, stressing the connection
`between outlet port 44 and inlet port 46 and particularly
`stressing outlet port 44.
`In addition, as the practitioner presses against plunger 36
`with one hand while holding manifold 14 with another hand,
`it is not uncommonforthe practitioner to bend syringe 12 at
`least slightly with respect to manifold 14. This bending
`10
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`6,099,511
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`action places particular stress on outlet port 44 of valve 32,
`which is positioned between syringe 12 and manifold 14.
`The bending and compressive forces on outlet port 44 of
`valve 32 can break, crack or otherwise damage outlet port
`44. Such damage can result in the loss of fluid from system
`10 during an angioprocedure and may require replacement
`of valve 32 or both valve 32 and manifold 14 during such an
`angioprocedure. Suchloss offluid and replacementis incon-
`venient and time consuming and may require decoupling
`and recoupling of a variety of different fluid sources and
`systems before the procedure can be resumed.
`SUMMARY AND OBJECTS OF THE
`INVENTION
`
`10
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`It is an object of the invention to provide an improved
`manifold.
`
`15
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`It is another object of the invention to provide a manifold
`having a body with a check valve therein.
`It is another object of the invention to provide a catheter
`manifold in which a check valve is supported within a body
`of the catheter manifold.
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`a more particular description of the invention briefly
`described above will be rendered by reference to a specific
`embodiment thereof which is illustrated in the appended
`drawings. Understanding that these drawings depict only a
`typical embodimentof the invention and are not therefore to
`be considered to be limiting of its scope, the invention will
`be described and explained with additional specificity and
`detail through the use of the accompanying drawings in
`which:
`
`FIG. 1 is a side view of a priorart fluid administrationset.
`FIG. 2 is a side view of a fluid administration set of the
`
`present invention.
`FIG. 3 is a perspective view of the fluid administration set
`shown in FIG. 2.
`
`FIG. 4 is an exploded view of the manifold of the fluid
`administration set shown in FIG. 2.
`
`FIG. 5 is a cut away perspective view of the seat of the
`manifold body shown in FIG. 4.
`FIG. 6 is an end view of the seat of the manifold body
`shown in FIG. 5.
`
`It is another object of the invention to provide a manifold
`having a manifold body with a check valve integrally
`coupled to at least one other valve of the manifold.
`A manifold of the present invention features a manifold
`body having a proximal end and a distal end. The manifold
`body defines a fluid flow pathway extending between the
`proximal and distal ends thereof. The manifold body
`includes a plurality of valves, including a check valve and
`one or more additional valves. The additional valves may be
`stopcock-actuated valves, for example. The manifold is
`selectively coupled to a catheter or other fluid receiving
`means and to a syringe or other fluid delivery means.
`The positioning of the check valve within the body of the
`manifold significantly reduces the potential for damage to
`the check valve during use. The connection between the
`check valves andthe other structures on the manifold body
`is reinforced against damage caused during compression of
`the syringe plunger and during bending of the syringe with
`respect to the manifold.
`The check valve comprises a main valve chamber and a
`plurality of ports coupled to the main valve chamber. In
`order to further prevent damage to the check valve,
`the
`With reference now to FIGS. 2 and 3, a medical fluid
`invention further comprises support means coupled to the
`administration set 100 of the present invention is shown.
`main valve chamberof the check valve for supporting the
`Medical fluid administration set 100 comprises (i) a syringe
`main valve chamber. A variety of different examples of such
`102, and (ii) a manifold 104. Manifold 104 comprises(i) a
`support meansare available.
`manifold body 108 having a proximal end 122 andadistal
`In one embodiment,
`the support means comprises the
`end 124; (ii) means for coupling the proximal end 122 of
`manifold body including a seat coupled to the main chamber
`manifold body 108 in fluid communication with fluid deliv-
`of the valve. The seat is configured to receive the main
`ery means for delivering fluid to manifold body 108 (e.g.,
`chamber of the valve in a mating relationship. In another
`syringe 102); and (iii) means for coupling distal end 124 of
`embodiment, the support means comprises a rigid support
`manifold body 108 in fluid communication with means for
`plate coupled to the manifold body.
`receiving fluid from manifold body 108, such as a catheter
`Bypositioning the check valve within the manifold body,
`(not shown) to be placed into the circulatory system of the
`the connection between the check valve and additional
`patient.
`Manifold body 108 defines a fluid flow pathway extend-
`ing between proximal and distal ends 122, 124 of manifold
`body 108. Manifold body 108 also includes a check valve
`106, and one or more valves 110, 112 coupled thereto.
`Manifold body 108 comprises means for coupling check
`valve 106 to second valve 110 such that check valve 106 is
`in fluid communication with second valve 110. Manifold
`
`FIG. 7 is an exploded view of the embodiment of the
`valve shown in FIG. 4.
`FIG. 8 is a cross-sectional view of the valve shown in
`FIG. 7.
`FIG. 9 is a cross-sectional view of the valve shown in
`
`FIG. 7 showing the fluid input path from a contrast fluid
`source to a syringe.
`FIG. 10 is a cross-sectional view of the valve shown in
`
`FIG. 9 demonstrating the fluid output path from a syringe
`through the manifold.
`FIG. 11 is a perspective view of another manifold of the
`present invention,
`the manifold having an integral check
`valve.
`FIG. 12 is a side view of a fluid administration set
`employing the manifold of FIG. 11.
`FIG. 13 is a cross-sectional cutaway view of the proximal
`end of the manifold shown in FIGS. 11 and 12.
`
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS
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`body 108 further comprises means for coupling second
`valve 110 in fluid communication with third valve 112.
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`An example of such means for coupling check valve 106
`to second valve 110 shown in FIGS. 2 and 3 includesa first
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`11
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`valves within the manifold is strengthened significantly. In
`addition, the seat and/or rigid plate coupled to the main
`chamberof the check valve provides significant stability and
`reinforcement.
`
`These and other objects and features of the present
`invention will become more fully apparent from the follow-
`ing description and appended claims, or may be learned by
`the practice of the invention as set forth hereinafter.
`BRIEF DESCRIPTION OF THE DRAWINGS
`In order that the manner in which the above-recited and
`
`other advantages and objects of the invention are obtained,
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`tube 116 coupled between second valve 110 and check valve
`106. As an example of means for coupling valves 110, 112,
`a second tube 114 is coupled between second valve 110 and
`third valve 112. In the embodiment of FIGS. 2 and 3, second
`and third valve 110, 112 comprise stopcock-actuated valves,
`although a variety of different valves are available within
`body 108. By selectively opening second valve 110, check
`valve 106 is in fluid communication with third valve 112.
`
`the fluid flow
`In the embodiment of FIGS. 2 and 3,
`pathway of manifold body 108 is defined by (i) valves 106,
`110, 112; (ii) tube 116; (ii) tube 114; and third tube 118
`coupled to second valve 112 and a rotating adaptor 126, or
`other meansfor selectively coupling manifold 104 in fluid
`communication with a catheter. However,
`the fluid flow
`pathway can be defined by a variety of different members
`such as through the use of a check valve and another valve,
`or through the use of four or more valves.
`Eachof tubes 114, 116, 118 can havea variety of different
`cross sectional shapes,
`including circular, rectangular,
`square and a variety of other shapes. In one embodiment,
`check valve is selectively coupled to a fluid delivery means,
`e.g., syringe 102 and to a source of contrast fluid, while
`second valve 110 is selectively coupled to a source of saline
`solution, and third valve 112 is selectively coupled to a
`pressure monitor, for example. Upon orienting the handles
`of the stopcocks of valves 110, 112 upwardly as shown in
`FIGS. 2 and 3, fluid dispelled from syringe 102 flows
`through tubes 116, 114 and 118 and into a catheter coupled
`to distal end 124.
`
`The orientation of check valve 106 within manifold body
`108 fosters an improved, reinforced connection between
`check valve 106 and the remaining structures of manifold
`body 108. In light of the positioning of check valve 106
`within body 108, check valve 106 is protected from damage
`during bending of syringe 102 and compression of the
`syringe plunger.
`The connection between check valve 106 and such struc-
`
`tures within body 108 is also reinforced by providing
`support means coupledto first tube 116 and check valve 106
`for supporting check valve 106. Check valve 106 comprises
`a housing having a main valve chamber 120 anda plurality
`of ports coupled to main valve chamber 120. A variety of
`different examples of support meansare available for sup-
`porting check valve 106, including for example, a seat 132
`coupled to main chamber 120 and tube 116.
`Seat 132 is configured to receive a portion of valve 106 in
`mating relationship. Tube 116 includes a collar 128 sized to
`receive an exit port 156 (FIG. 3) of valve 106. Seat 132 is
`coupled to collar 128 and is configured to receive a portion
`of main chamber 120 of valve 106 in mating relationship.
`Another example of a support means includes a support
`member 121 coupled to check valve main chamber 120. In
`the embodiment of FIGS. 2 and 3, support member 121 is
`coupled to seat 132. Support member 121 of FIGS. 2 and 3
`is also coupled to tubes 114, 116, 118 andto valves 106, 110,
`and 112 of manifold body 108.
`It will be appreciated,
`however, that support member 121 may be merely coupled
`to one or more tubes, and/or one or more valves, depending
`on the embodiment of the manifold desired.
`
`A first end 134 of support member 121 is coupled along
`the longitudinal length of the manifold body 108 while a
`second end 136 thereof is free. Proximal terminus 138 of
`support member 121 is coupled to the lower surface 140 of
`seat 132 of manifold body 108, thereby providing support to
`seat 132 and main chamber 120 of valve 106. A distal
`terminus 142 of support member 121 is coupledto distal end
`124 of manifold body 108.
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`Support member 121 comprises a rigid plate 144 having
`a first end 146 coupled along the longitudinal length of
`manifold body 108. A second end 148 of plate 144 has a
`beam 150 coupled along the longitudinal axis thereof. Beam
`150 assists plate 144 in strengthening the connection
`between valve and manifold body.
`With reference now to FIG. 4, an exploded view of
`manifold body 104 is shown. As mentioned, check valve 106
`has a housing 151 comprising: (i) a main valve chamber 120,
`(ii) a first port 152 coupled to main valve chamber 120;(iii)
`a second port 154 coupled to main valve chamber 120, and
`(iv) a third port 156 coupled to main valve chamber 120. As
`will be discussed in additional detail below, housing 151 is
`an example of housing meansfor defining first, second and
`third fluid flow passageways.
`Collar 128 of tube 116 receives and surroundsthird port
`156 of valve 106 while seat 132 coupled to collar 128
`receives a lower portion of main valve chamber 120 in
`mating relationship. This aligns valve 106 such that port 152
`is in alignment with ports 158, 160 of body 108.
`Ports 152, 154 have male Luer lock components or female
`Luer lock components thereon or other meansfor selectively
`coupling ports 152, 154 to desired structures. Preferably port
`154 is configured to be selectively coupled in fluid commu-
`nication with a fluid delivery means, such as syringe 102,
`port 152 is configured to be selectively coupled in fluid
`communication with a contrast fluid source, and port 156 is
`configured to be coupled to seat 132 and collar 128 of
`manifold body 108. In one embodiment, port 156 and collar
`128 are joined permanently through the use of an adhesive,
`such as chemical adhesives, or by friction welding, ultra-
`sonic welding, or other means knowninthe art. Port 156 and
`collar 128 can also be integrally formed.
`FIG. 4 also demonstrates the valve casings 162, 164 of
`manifold body 108 which receive respective stopcocks 166,
`168 of valves 110, 112. Manifold 104 further comprises
`means on manifold body 108 for coupling a catheter in fluid
`communication with manifold body 108. Adaptor 126 hav-
`ing a male or female Luer lock componentor other suitable
`connector may be employed as an example of means on the
`manifold body for selectively coupling a catheter to mani-
`fold body 108.
`FIGS. 5 and 6 provide additional views of seat 132 and
`collar 128 of manifold body 108 and of the support member
`121 coupled thereto. As shown in FIG. 5,
`in one
`embodiment, the support member 121 has a beam 150, the
`sides of which extend on opposingsides of free end 148 of
`support plate 144, thereby providing support and reinforce-
`ment to support plate 144.
`FIG. 6 demonstrates support member 121 being disposed
`below receiving seat 132, thereby providing support and
`reinforcement to main valve chamber 120 of valve 106.
`
`Each of FIGS. 4, 5, and 6 demonstrate the support provided
`to main valve chamber 120 by support plate 144, seat 132,
`and collar 128. This support reinforces the connection
`between valve 106 and the remainder of manifold body 108.
`While a variety of different check valves may be
`employed in the present invention, the check valves having
`a variety of different components andfluid flow paths, check
`valve 106 of FIGS. 2-10, will now be described in additional
`detail by way of example. With reference now to FIGS. 7
`and 8, check valve 106 is shown in exploded and cross
`sectional views.
`
`Main chamber 120 of valve 106 includes a body portion
`170 and a cap 172. Cap 172 hasfirst port 152 coupled thereto
`while body 170 has a second port 154 and a third port 156
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`6,099,511
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`7
`coupled thereto. Second and third ports 154, 156 are each
`coupled on opposing sides of body 170 of valve 106. Each
`of said first, second, and third ports 152, 154, 156 define a
`fluid passageway therethrough. Thus, as mentioned, check
`valve housing 151 is an example of housing means for
`defining first, second and third fluid flow passageways.
`Check valve 106 further comprises valving means for
`responding to a pressure laden fluid within one passageway
`to open another passageway and simultaneously close yet
`another passageway. As shown,the valving means of FIGS.
`7 and 8 includes a valve head 174. Valve head 174 is
`preferably a flexible, elastomeric membrane, which
`respondsto pressure laden fluid flowing through ports 152,
`154, 156. Valve head 174 is preferably a hexagonal shaped
`member. This shape is preferred in orderto allow valve head
`174 to be properly oriented within main chamber 120 such
`that valve head 174 seals a desired fluid pathway, but also
`such that fluid flows past the sides of valve head 174 when
`desired.
`
`Oncevalve head 174is placed within body 170, body 170
`and valve cap 172 are joined together by mutually accom-
`modating ridges and grooves by application of an adhesive,
`such as chemical adhesives, or by friction welding, ultra-
`sonic welding, or other means knownintheart.
`With reference now to FIGS. 9 and 10, in the embodiment
`shown, check valve housing 151 further defines a common
`passageway intersection cavity 176 within main chamber
`120 in whichfirst, second, and third passageways 178, 180,
`182 intersect. Valve head 174 responds to a pressure laden
`fluid within first passageway 178 to selectively open second
`passageway 180 and simultaneously close third passageway
`182. Thus, fluid in the first passageway 178 flows from first
`passageway 178, through the intersection cavity 176, and
`into the second passageway 180 without entering third
`passageway 182. Valve head 174 also respondsto a pressure
`laden fluid flowing into the intersection cavity 176 from
`second passageway 180 to seal first passageway 178 and to
`open third passageway 182.
`In the embodiment of FIGS. 9 and 10, the valving means
`further comprises first and second valve seat means for
`providing first and second sealing surfaces. By way of
`example, the first and second valve seat means shown for
`providing first and second sealing surfaces are respectively
`depicted as circular first valve seat 184 and circular second
`valve seat 186. Upon flow offluid through valve, valve head
`174 contacts either the first or second sealing surface so as
`to seal or open a selected passageway.
`The valving meansis situated in intersection cavity 176.
`As shown,third port 156 of check valve 106 is coupled to
`collar 128 of tube 116 such that third passageway 182 is in
`fluid communication with second valve 110. Tube 116 is an
`example of means for coupling the check valve 106 to
`second valve 110 such that third passageway 182 of check
`valve 106 is in fluid communication with second valve 110.
`
`In order for valve head 174 to be positioned soas to allow
`a pressure laden fluid to flow from one passageway through
`the common channel
`intersection cavity 176 and into
`another passageway, a predetermined crack pressure must be
`realized in the pressure laden fluid so as to break the seal
`between valve head 174 and the corresponding valveseat.
`To better increase the crack pressure needed to deform
`valve head 174 in such a manner, in one embodiment,first
`valve seat 184 is beveled with respect to the longitudinal
`axis of valve 106, such as by being beveled 12° with respect
`to the longitudinal axis of valve 106. Similarly,
`in one
`embodiment, second valve seat 186 is beveled with respect
`
`8
`to the longitudinal axis of valve 106, such as by being
`beveled 15° with respect to the longitudinal axis of valve
`106. Thus, valve head 174 is contacted by the beveled part
`of the respective valve seat. These beveled surfaces serve to
`better seal the channels and to increase the resultant crack
`
`pressure of valve head 174.
`The pressure required to deform valve head 174 so as to
`allow fluid to flow past valve head 174 must be both a
`pressure to overcome opposing fluid pressures in other
`channels plus the predetermined crack pressure applicable
`thereto. For example, valve head 174 seals third passageway
`182 whenthe pressure in first passageway 178is greater than
`the pressure in second passageway 180 or third passageway
`182 (or is greater than the pressure in second passageway
`180 and the pressure in third passageway 182 is not greater
`than ambient), whereby the fluid flows from first passage-
`way 178 through the intersection cavity 176 of the three
`passagewaysand into second passageway 180 withoutenter-
`ing third passageway 182. Also, valve head 174 sealsfirst
`passageway 178 whenthe pressure in second passageway
`180 is greater than the pressure in either first passageway
`178 or third passageway 182 (oris greater than the pressure
`in first passageway 178 andthe pressure in third passageway
`182 is not greater than ambient). Then, the fluid in second
`passageway 180 flows therefrom through the intersection
`cavity 176 of the three passagewaysand into third passage-
`way 182 without entering first passageway 178, which has
`been sealed off by valve head 174.
`Referring to FIG. 9, as the practitioner retracts the plunger
`of syringe 102, fluid from the contrast fluid source or other
`fluid source flows through first port 152 into syringe 102
`along ingress path 188. With reference now to FIG. 10, upon
`then desiring to insert contrast dye fluid into the circulatory
`system ofthe patient, the practitioner inserts the plungerinto
`the syringe barrel, thereby forcing fluid from syringe 102
`into manifold along egress path 190.
`Although these fluid paths have been shown by way of
`example in FIGS. 9 and 10, it will be appreciated that a
`variety of different fluid paths may be employed and a
`variety of different configurations of a check valve and
`valving means (including more than one valve head for
`example) may be employed in the present invention.
`Referring now to FIGS. 11 and 12,in another embodiment
`of a manifold 200, manifold body 202 features a check valve
`204 integrally coupled to a first tube 210. Tube 210 is
`integrally coupled between check valve 202 and second
`valve 206, while a second tube 212 is integrally coupled
`between second valve 206 and third valve 208. A support
`plate 218 is coupled integrally to the main valve chamber
`219 of check valve 204, and to second valve 206, third valve
`208, first tube 210, second tube 212 and third tube 216. A
`cross sectional view of the integrally coupled check valve
`204 is featured within FIG. 13.
`
`Fluid flows through manifold 200 in the same or similar
`manner as discussed above with respect to manifold 104.
`This embodiment is advantageous because the connection
`between check valve 204 and the remainder of manifold
`
`10
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`15
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`20
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`25
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`30
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`35
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`40
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`45
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`50
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`55
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`60
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`body 202 and support plate 218 is an integral connection,
`further preventing damage through breaking or cracking of
`the connection between valve 204 and the remainder of
`
`65
`
`manifold body 202 during use.
`Valve head 174 should be comprised of materials which
`function equally well with saline, contrast media, heparin-
`ized saline, or with whole blood. Valve head 174 preferably
`has low or nolipid interaction and is transparent and either
`light or clear in color. The materials from which manifold
`13
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`13
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`

`

`6,099,511
`
`9
`104 and manifold 200 are constructed are preferably
`polyvinylchloride, polycarbonate, or other suitable medical
`grade plastic.
`The present invention may be embodied in other specific
`forms without departing from its spirit or essential charac-
`teristics. The described embodiments are to be considered in
`all respects only as illustrative and notrestrictive. The scope
`of the invention is, therefore, indicated by the appended
`claims rather than by the foregoing description. All changes
`which come within the meaning and range of equivalency of
`the claims are to be embraced within their scope.
`What is claimed and desired to be secured by United
`States Letters Patent is:
`
`1. A manifold, comprising:
`a manifold body having a proximal end and a distal end,
`the manifold body defining a fluid flow pathway
`extending between the proximal and distal ends of the
`manifold body, the manifold body including a plurality
`of valves, at least one valve having (i) housing means
`for defining first, second and third fluid flow
`passageways, each of said passagewaysintersecting in
`a common passageway intersection cavity; and (ii)
`valving means situated within the intersection cavity
`for responding to a pressure laden fluid within one
`passageway to open another passageway and simulta-
`neously close yet another passageway;
`meansfor coupling the proximal end of the manifold body
`in fluid communication with fluid delivery means for
`delivering fluid to the manifold body; and
`means for coupling the distal end of the manifold body in
`fluid communication wi