US20020156431A1 - Multi-valve injection/aspiration manifold with needleless access connection - Google Patents

Abstract

An IV manifold includes a plurality of injection/aspiration ports including a needleless access port (NAC). A check valve included in the manifold is generally located at an upstream end of the manifold. However, the check valve may alternatively be located between injection ports. An aspiration port can be formed with a second seal disposed on the side of the valve element opposite a first seal. Two-way aspiration can be provided by a valve having a cage with or without compressible characteristics to accommodate low tolerance fittings. Alternatively, two way aspiration can be provided by the NAC having a single elongate valve element including a plug at one end. The elongate valve element has properties for resiliently and sealingly biasing the plug into an aperture of the NAC. In use the Plug is mechanically displaced by insertion of a male Luer for injection or aspiration.

Description

• This application is a continuation-in-part of co-pending application Ser. No. 09/154,939, filed on Sep. 17, 1998, which is hereby incorporated by reference in its entirety.[0001]
BACKGROUND OF THE INVENTION
• 1. Field of the Invention[0002]
• This invention relates generally to ports for injecting fluids into an intravenous (IV) line, and more specifically to injection manifolds including multiple injection ports.[0003]
• 2. Discussion of the Prior Art[0004]
• Patients are commonly injected with IV solutions which are initially provided in a bottle or bag and dripped into the vein of the patient through an IV line. Typically an injection port is provided along the line and adapted to function with a syringe to permit an injectate to be added to the IV solution. If a large quantity of injectate, or multiple injectates, are to be added to the IV solution, multiple ports may be required. In such a case, an injection manifold can be disposed in the IV line to provide multiple injection ports.[0005]
• A check valve is also commonly included in the IV line where it is disposed upstream from the injection manifold. It is the purpose of the check valve to permit fluid flow only in the direction of the patient. This ensures that the injectate flows downstream toward the patient, not upstream toward the IV reservoir.[0006]
• The prior art is deficient in that it does not adequately provide for check valves at locations than upstream of the ports. Doing so has its advantages in certain applications in which the prior art falls short.[0007]
• In the past, IV manifolds have been provided with an elongate and generally flat configuration in order to facilitate use of the multiple injection ports. The flow channel through the manifold has also had this elongate wide configuration, and consequently, has been susceptible to the formation of air pockets, and to generally uneven flow characteristics. In the vicinity of the injection ports, the manifolds of the past have also developed dead spaces where the injectate has tended to collect rather than mix with the IV solution. Other IV manifolds have been provided with a round tube defining the flow channel. Injection ports have been connected to this tube at a “T” junction. In this case, the flow channel has remained separate and the problems with dead spaces in the ports have been significant.[0008]
• Injection ports of the past have generally included only valves with a single valve seal. These seals have not been capable of withstanding high pressure such as those sometimes associated with an injection into an adjacent port. The resulting high back pressure has sometimes caused the valve element to deform and lodge in the lumen of the port, rendering the port inoperative.[0009]
• In the past, the ports associated with injection manifold have not been provided with characteristics permitting the aspiration of fluids from the flow channel. This is sometimes desirable in order to remove air from the manifold or withdraw a blood sample. In these cases, a separate aspiration port has been required in addition to the injection manifold.[0010]
• Even the three valve seat system provided by the embodiment having an apertured valve element of the instant invention has some drawbacks for certain applications. For example, this embodiment requires relatively high pressure for both aspiration and injection.[0011]
• Some injection ports have been provided with operative cages which mechanically open the valves. In this case a syringe having a male Luer fitting is relied on to push the cage against the valve element in order to open the valve. Due to wide tolerance variations in the plastic parts associated with the syringes, the male Luer fittings can sometimes extend into the injection port a distance greater than that required to open the valve. In many of these cases, damage to the injection port has resulted.[0012]
• Although the cage and valve element embodiment of the instant invention provides a means for permitting unimpeded aspiration, and although the cage of the instant invention provides for inserting a variety of male Luers without damaging the port or manifold, the cage adds a separate piece and increases the complexity of the overall device. With the cage embodiment, changes are also required in the port itself to accommodate the cage. For example, a large portion of the second seat must be removed in order to provide room for the cage.[0013]
SUMMARY OF THE INVENTION
• These problems with the injection ports and manifolds of the prior art are overcome with the present invention which provides for a generally U-shaped flow channel that extends axially of the manifold. By restricting the IV solution to this flow channel, the flow characteristics through the manifold are greatly enhanced. Importantly, there are no dead spots in the fluid flow through the manifold. Furthermore, the flow of fluid can be directed against the valve element of the injection port to avoid dead spots around the valve. A check valve can be included in this manifold and disposed at one end of the elongate housing. An infusion/aspiration port is preferably disposed upstream of the other injection ports and downstream of the check valve.[0014]
• Alternatively, the check valve may be located between an upstream injection/aspiration port and a downstream injection/aspiration port. In this way an injection/aspiration port may be advantageously located upstream of the check valve. As can be understood by those skilled in the art, locating the check valve downstream of at least one of the injection/aspiration ports enables either pulling IV fluid from the IV line into a syringe or reservoir of the port upstream of the check valve without pulling fluid from downstream of the check valve, or pulling of injectate from the at least one port into the IV line upstream of the manifold.[0015]
• A preferred injection port is provided with two seals, a line seal and a surface seal, which provide for low pressure and high pressure operation, respectively. When an injectate is being introduced into an adjacent port, the resulting high back pressure is resisted by the high pressure surface seal of the port.[0016]
• In an injection port embodiment including a cage, the cage can be configured to be axially compressible. These compressible characteristics accommodate the wide tolerance variations in the plastic parts which sometimes tend to cause a male Luer fitting to extend into the injection port a distance greater than that necessary to open the associated valve. By providing the cage with these compressible characteristics, the tolerance variations are accommodated without damaging the valve element.[0017]
• Alternatively, and perhaps preferably, a needleless access connection (NAC) can be included in the manifold. The NAC has the advantage of enabling the aspiration as well as the injection of fluids therethrough. This feature is achieved with a simple and reliable structure. In operation, a male Luer is inserted into a aperture of the NAC in order to open a NAC valve and permit aspiration or injection of fluids through the NAC. As can be appreciated, the aspiration and injection through the NAC requires very low pressures.[0018]
• In one aspect, the invention includes an injection port adapted for use with an IV line. The port includes a housing defining a flow channel and having an injection lumen. First portions of the housing define a first valve seat, while second portions of the housing define a second valve seat. A valve element, disposed to extend transverse to the injection lumen has properties for forming a first seal with the first valve seat at a first pressure, and a second seal with the second valve seat at a second pressure greater than the first pressure. The first valve seat, which forms part of the second valve seat, has the shape of a continuous line, while the second valve seat has the shape of a continuous surface.[0019]
• In another aspect, the invention includes a port for injecting an injectate into a flow channel for aspirating a fluid from the flow channel. The port includes a housing defining the flow channel and having a lumen disposed in fluid communication with the flow channel. First portions of the housing define a first valve seat while second portions of the housing define a second valve seat. A valve element has properties for forming a first seal with the first valve seat and a second seal with the second valve seat when the valve element is in a natural state. The valve element has properties for opening the first seal in response to a positive pressure in the lumen to facilitate flow of an injectate into the flow channel. The valve element also has properties for opening the second seal in response to a negative pressure in the lumen in order to facilitate flow of the fluid from the flow channel into the lumen of the port. The first valve seat is formed on the side of the valve element opposite the flow channel. The second valve seat is formed on the side of valve element opposite the first valve seat. This embodiment may include a post with the second seal being formed around the post.[0020]
• In an additional aspect of the invention an injection manifold includes a first body member and second body member forming a housing. First portions of the housing define a flow channel adapted to receive an IV solution flowing in an IV line. Second portions of the housing define at least one port with an injection lumen, the port having a outside diameter. The first portions of the housing have a width greater than the outside diameter of the port and define the flow channel with a width less than the diameter of the port. The flow channel will typically have a U-shaped configuration.[0021]
• In a further aspect of the invention an injection/aspiration port includes a housing with first portions defining a flow channel and second portions defining an injection/aspiration lumen. Third portions of the housing define a valve seat around the lumen. A valve element is biased toward the injection/aspiration lumen and forms a seal with the valve seat. A valve cage is disposed in the lumen and adapted to be moved by insertion of a male Luer fitting into the lumen against the valve element to open the seal and permit two-way flow between the lumen and the flow channel. The valve cage is axially compressible to accommodate slight variations in the size of the male Luer fitting.[0022]
• These and other features and advantages of the present invention will be more apparent with a description of preferred embodiments and reference to the associated drawings.[0023]
DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a perspective view of an arm of a patient with an IV solution appropriately administered through an injection manifold of the present invention;[0024]
• FIG. 2A is a perspective view of the manifold having three injection ports and syringes of various sizes connected to the ports;[0025]
• FIG. 2B is a perspective view of an additional embodiment of the manifold having two injection ports and a NAC and syringes of various sizes connected to the port and NAC;[0026]
• FIG. 3A is an exploded view of the manifold of FIG. 2A illustrating first and second members forming a housing, and showing the interior of the first member and the exterior of the second member;[0027]
• FIG. 3B is an exploded view of the embodiment of FIG. 2B including the NAC;[0028]
• FIG. 3C is an exploded view of a further embodiment similar to FIG. 3A with the check valve disposed between two of the ports;[0029]
• FIG. 4A is an exploded view similar to FIG. 3A but showing the interior of the second member and the exterior of the first member;[0030]
• FIG. 4B is an exploded view similar to FIG. 4A of the embodiment of FIG. 3B including the NAC;[0031]
• FIG. 4C is an exploded view similar to FIG. 4B of the embodiment of FIG. 3C;[0032]
• FIG. 4D is an exploded perspective view of the embodiment of FIG. 3C with the check valve disposed between two ports;[0033]
• FIG. 5 is a side elevation view of the manifolds illustrated in FIGS.[0034]2A-4D;
• FIG. 6 is a top plan view of the manifolds illustrated in FIG. 5;[0035]
• FIG. 7A is a cross-section view taken along lines[0036]7-7 of FIG. 5;
• FIG. 7B is a cross-section view taken along lines[0037]7-7 of FIG. 5 and explicitly incorporating the NAC and the check valve, with the check valve disposed between two of injection ports;
• FIG. 8A is an axially cross-section view taken along lines[0038]8-8 of FIG. 6;
• FIG. 8B is an axial cross-section view taken along lines[0039]8-8 of FIG. 6 and explicitly showing the NAC and the check valve, with the check valve disposed between two of the injection ports;
• FIG. 9 is a cross-section view taken along lines[0040]9-9 of FIG. 6;
• FIG. 10 is a cross-section view similar to FIG. 9 and illustrating a further embodiment of the manifold;[0041]
• FIG. 11 is a radial cross-section view of an injection port taken along lines[0042]1111 of FIG. 6;
• FIG. 12 is a radial cross-section view of the injection port taken along lines[0043]1212 of FIG. 6;
• FIG. 13 is a cross-section view illustrating the port of FIG. 12 in a high pressure configuration;[0044]
• FIGS.[0045]14-16 are cross-section views similar to FIG. 12 illustrating operation of an injection port which also has aspiration characteristics;
• FIG. 14 is a cross-section view similar to FIG. 12 and showing a further embodiment of the invention with a valve in a normal state;[0046]
• FIG. 15 is a cross-section view similar to FIG. 14 and illustrating the valve in an injection state;[0047]
• FIG. 16 is a cross-section view similar to FIG. 14 and illustrating the valve in an aspiration state;[0048]
• FIGS. 17 and 18 are cross-section views similar to FIG. 12 and illustrating a further embodiment including a mechanical cage for actuating the valve element;[0049]
• FIG. 17 is a cross-section view similar to FIG. 12 and showing the valve in a normal sealed state;[0050]
• FIG. 18 is a cross-section view similar to FIG. 17 and illustrating the cage in a compressed configuration with the valve in an injection/aspiration state; and[0051]
• FIG. 19 is a section view of an end of the manifold of the second and third alternative embodiment similar to FIG. 8B.[0052]
DESCRIPTION OF THE PREFERRED EMBODIMENTS AND BEST MODE OF THE INVENTION
• The arm and hand of a patient are illustrated in FIG. 1 and designated generally by the[0053]reference numeral10. AnIV solution12 contained in a reservoir, such as a bottle orbag14, is appropriately communicated to the patient10 through anIV line16. Aninjection manifold18 of the present invention is connected in series with theline16 and provides a site where drugs and other fluids can be injected, typically through asyringe21, into the IV solution in theline16.
• The[0054]manifold18 of a preferred embodiment is illustrated in greater detail in FIG. 2. In this view it can be seen that the manifold18 has ahousing23 with an elongate configuration, and extends generally along anaxis25. Thehousing23 is connected in series with theIV line16, for example by a pair ofconnectors22 and24, so that the flow channel and theIV line16 also extends through thehousing23.
• A plurality of[0055]injection ports27,30 and32 can be molded integrally with thehousing23 and spaced along the length of thehousing23. In FIG. 2, a 60mm syringe34 is connected to theport32, while a 10mm syringe36 and a 5mm syringe38 are connected to theports30 and27, respectively. There will of course be situations requiring three syringes such as the 60cc syringe34 that must be coupled to the manifold18 at the same time. This will require that theports27,30 and32 be spaced sufficiently that theports27 and32 are separated by a distance equal to two times the diameter of the 60cc syringe34, and thecenter port30 disposed intermediate with theouter ports27 and32.
• The[0056]manifold18 is further illustrated in the exploded views of FIGS. 3 and 4. In these views, the housing of a preferred embodiment is illustrated to include afirst housing member41 and asecond housing member43. Thefirst housing member41 has ininner side45 illustrated in FIG. 3 and anouter side47 illustrated in FIG. 4. Similarly, thesecond housing member43 has aninner side46 and anouter side48. From these views it can be seen that each ofports27,30 and32 includes acylinder50,52 and54, respectively, which projects from theouter surface47 of thefirst housing member41. Thesecylinders50,52 and54 in turn definelumen56,58 and61, respectively, which are in fluid communication with theflow channel49. Thecylinders50,52 and54 also form with the first housing member41 a plurality ofcavities63,65 and67, respectively, which are adapted to receive associatedvalve elements70,72 and74. The operation of theseports27,30 and32 will be discussed in greater detail below.
• In this particular embodiment, a[0057]check valve76 is provided at one end of the manifold18. In this case, thecheck valve76 is formed with a plurality ofpins78 which extend from theinner side45 in a generally circular configuration. Thesepins78 are adapted to receive avalve element81. The manifold18 is intended to be connected in theIV line16 and oriented with thecheck valve76 connected to the upstream side of theline16.
• Perhaps best illustrated in FIG. 4 are a plurality of[0058]protrusions83,85 and87 which interrupt theflow channel49 at each of the associatedports27,30 and32, respectively. Theseprotrusions83,85 and87, which are also illustrated in the assembled view of FIG. 7 and the cross-section view of FIG. 8, are of particular advantage to the present invention as they disrupt the flow of theIV solution12 along thechannel49 and direct that flow into the associatedcavities63. With this directed fluid flow, thecavities63,65 and67, and particularly thevalve elements70,72 and74, are constantly washed so that there are substantially no dead spots associated with theinjection ports27,30 and32. In the past, these dead spots have been particularly common in the concave area beneath thevalve70,72 and74. With the fluid flow directed specifically onto the concave side of eachelement70,72 and74, the dead spots are greatly minimized. This diverted flow is illustrated in greater detail in FIG. 11 where thecavity63 andvalve element70 of theinjection port27 are washed by the IV solution flow which is illustrated byarrows89.
• In relation to this washing effect, FIGS.[0059]7A-8B illustrate how the valve cavities associated withports27,30 and32 have a height less than each of a width and a length. In this way, a flow path is formed such that a liquid passing through the manifold, readily impinges on an underside of the valve elements in the cavities. Thus the structural relationship of height to width and length reduces stagnation. Flow is further enhanced by structural details in the cavities. Specifically, the portion of the cavities forming valve the valve seats and thevalve elements70,72,74 themselves form a concave surface on a side of thevalve elements70,72,74 opposite to the valve seats.
• With reference to FIG. 9, it can be seen that a preferred embodiment of the manifold[0060]18 provides aflow channel49 with a U-shaped configuration. This shape is generated by providing theinner surface45 of thefirst housing member41 with a generally planar configuration. When thesecond housing member43 is mated to thefirst housing member41, aU-shaped cavity90 in thesurface48 automatically provides theflow channel49 with the U-shape desired. In this particular embodiment, the generally planar inner surface of thehousing member41 makes it possible to also provide theouter surface47 with a planar configuration. This shape greatly facilitates wiping the manifold18 between theadjacent ports27 and30, and theports30 and32.
• In an alternative embodiment illustrated in FIG. 10, the[0061]flow channel49 is defined by theU-shaped cavity90 formed in thefirst housing member41, and by a secondU-shaped cavity92 formed in thesecond housing member43. When these parts are joined, the twocavities90 and92 provide theflow channel49 with the shape of an oval. The views presented by FIGS. 9 and 10 also are best suited to illustrate the mating relationship of thefirst housing member41 and thesecond housing member43. Thesemembers41 and43 are operatively positioned with theirrespective surfaces45 and46 in close proximity so that these surfaces do not form any part of theflow channel49. This contributes greatly to the flow characteristics within thechannel49 and avoids many of the air pockets and dead spots associated with the full-width flow channels of the prior art. Thesecond housing member43 can be fixed to thefirst housing member41 in this operative position by means of adhesive or by heat seals94.
• Operation of the[0062]injection port27 is best described with reference to FIGS. 12 and 13. In these views, it will be noted that theport27 includesportions96 which define a first valve seat andportions98 which define a second valve seat. Thefirst valve seat96 forms a slight annulus above thevalve element70. In its normal configuration, thevalve element70, which has elastomeric properties, is biased by theprotrusion83 beneath theelement70 to form a seal with thefirst valve seat96.
• When an injectate is introduced through one of the adjacent ports, such as[0063]port30 or32, a relatively high pressure occurs in theflow channel49. By operation of thecheck valve76, this pressure is exerted against the underside of thevalve element70 of theport27. In the manifold18, the higher pressure will cause thevalve element70 to deform as illustrated in FIG. 13 until it comes into contact with thesecond valve seat98 as illustrated in FIG. 13. With thissecond valve seat98 providing surface contact with thevalve element70, a high pressure seal is formed without radical deformation or damage to thevalve element70.
• Under some circumstances, it is desirable to have an injection port, such as the[0064]port32, function not only to receive injectate into theflow channel49, but also to aspirate or withdraw fluid from theflow channel49. When an injection/aspiration port, such as theport32, is included in the manifold18, it is preferably disposed on the upstream side of the other ports so that injectate introduced in the other ports is not aspirated from the manifold18. Since thecheck valve76 is also to be positioned upstream of the ports27-32, it is desirable that the injection/aspiration port32 be positioned next to thecheck valve76.
• A preferred configuration for the injection/[0065]aspiration port32 is illustrated in FIGS.14-16. In this embodiment, theprojection87 is configured with ashoulder101 which forms athird valve seat103, and a post extending toward thelumen61 of theport32. In this case, thevalve element74 is provided with a central aperture orhole107 which is sized to receive thepost105. In the manner previously discussed with reference to the FIG. 12 embodiment, afirst valve seat110 can be formed above thevalve elements74 with thethird valve seat103 formed beneath thevalve element74. In its normal state, theport32 is positioned with thevalve element74 biased to form a first seal with thefirst valve seat110 and a second seal with athird valve seat103 as illustrated in FIG. 14. Under the fluid pressure of an injectate, as illustrated by anarrow112 in FIG. 15, thevalve element74 is bent downwardly opening the first seal at thefirst valve seat110. The second seal with thevalve seat103 is strengthened by this downward pressure against thevalve element74. Nevertheless, theinjectate112 flows through the first valve and into theflow channel49.
• Aspiration is accommodated by applying a suction to the[0066]lumen61 as illustrated by anarrow114 in FIG. 16. This causes thevalve element74 to raise off of theshoulder103 which form the second valve seat. Fluid within theflow channel49 is thereby permitted to pass between thevalve element74 and thepost105 into thelumen61. In all cases, thehole107 in thevalve element74, and thepost105, maintain thevalve element74 centered with respect to the valve seats110 and103, respectively.
• A further embodiment of the injection/[0067]aspiration port32 is illustrated in FIGS. 17 and 18. In this case, theport32 is operated not by fluid pressure, but rather mechanically by the force of thesyringe38 acting upon acage121. In this case, thecylinder54 defining thelumen61 is provided with an interior shoulder which faces downwardly and prevents thecage121 from moving upwardly within thelumen61. In this embodiment, thecage121 fits between theshoulder123 of thecylinder54 and the upper surface of thevalve element74. Thecage121 can be formed of wire or other resilient material and provided with a configuration which is axially compressible. The advantage of thisport32 is that it does not rely upon fluid pressure to open, but rather the mechanical force of a male Luer fitting123 associated with thesyringe38.
• With the tolerances accommodated in forming the Luer fitting[0068]123 and in forming thelumen61, it can be appreciated that thesyringe38 can extend a variable distance into thecylinder54. If thecage121 is provided only as a rigid element, damage to thevalve element74 can result when the male Luer fitting123 extends too far into thelumen61. In the illustrated embodiment, wherein thecage121 is axially compressible, this great variation in distance of insertion can be accommodated by thecage121 so that thevalve element74 is not radically deformed. When thevalve element74 is opened by thecage121, two-way flow through theport32 can be accommodated as illustrated by thearrows125 in FIG. 18. Thus, thevalve element74 is separated from thevalve seat110 opening the valve to either receive injectate into theflow channel49 or remove fluid from theflow channel49.
• FIG. 2B illustrates a modified[0069]manifold130. The modifiedmanifold130 differs from the embodiment of FIG. 2A in that aport27 has been replaced by a needleless access connection (NAC)132. All other aspects of the manifold remain the same. However, the NAC has several details that are unique and important.
• The NAC is made up of a[0070]body portion133 having atop piece134 thereon. The top piece has anaperture135 therethrough forming part of a conduit through theNAC body133. Thetop piece134 is also provided with a fastening means136. A bottom end137 of theNAC132 is connected to thehousing23. In this embodiment, the NAC can be rigidly connected to or formed integrally with thehousing23.
• FIG. 3B perhaps best illustrates an aspect of the NAC bottom end[0071]137. This aspect is agrate138 integrally formed with the bottom end137.Grate138 provides an opening141 through which fluid may flow. At the same time,grate138 retains anelongate valve element143 within theNAC132. The elongate valve element is further retained by a shoulder144 formed on the interior oftop piece134. In this way, theelongate valve element143 is captured in theNAC132 and extends between thegrate138 and thetop piece134.
• As can be seen from FIG. 4C, the[0072]grate138 may be replaced by a grate means145. In this embodiment the grate means145 is not formed integrally with theNAC body portion133. Rather the grate means145 is formed separately as a part ofhousing member43. In this way, it can be appreciated that theelongate valve element143 will be captured in theNAC132 when thehousing members41 and43 are assembled together. Importantly, grate means145 still provides an opening at a bottom end of theNAC132. This opening is provided byslot147 and other structure that permits fluid to flow in and out of a bottom end137 ofNAC132.
• As can be seen in the Figures, the NAC has a diameter of width greater than the other injection valves, yet narrower than the housing of the[0073]manifold132. The bottom end137 of theNAC132 is rigidly connected to the manifold housing. Furthermore, the bottom end137 of theNAC132 has an opening for placing the conduit or interior of theNAC132 in fluid communication with theflow channel49 of themanifold132
• A second alternative embodiment or modified[0074]manifold152 is perhaps best illustrated in FIG. 3C. The second modifiedmanifold152 is different from the manifold18 in that the locations of theinjection port32 and thecheck valve76 have been interchanged. All other aspects remain substantially the same. However,additional flow channel154 best illustrated in FIG. 4A and FIG. 19 have a different and significant relationship to other elements of the invention in this embodiment. Theadditional flow channel154 of the previously described embodiments normally defines a flow between an IV fluid inlet and afirst port32. However, in the second modifiedmanifold152 theadditional flow channel154 now defines a flow path for the IV fluid between theinjection port32 andflow channel49. In this caseadditional flow channel154 is in direct fluid communication withflow channel49.
• FIG. 19 illustrates how the second modified manifold advantageously functions. As shown, injection flow through[0075]port32 and indicated byarrows156 can be caused by a net negative pressure in the upstream portion of the IV line. Of course, if the net negative pressure is in a downstream portion of the IV line relative to thecheck valve76, then flow156 will move through thecheck valve76 and downstream. However, as can be appreciated, by manipulating the pressure upstream of the manifold in the IV line between a negative net pressure and a positive net pressure, the flow may be alternated between aninjection flow156 and a downstream throughflow158. By thus cycling negative and positive pressures upstream in the IV line, a repeated draw of fluid from a reservoir connected to port32 and a forcing through of the fluid through the manifold may be achieved. Of course, a single cycle or a half cycle may be implemented as well.
• A third alternative embodiment or alternatively modified[0076]manifold165 is depicted in FIG. 5. As shown in dashed lines the manifold of this embodiment incorporates theNAC132 in place ofport27 and interchanged locations ofinjection port32 and thecheck valve76. All other aspects of the manifold are substantially the same.
• FIG. 7B is a sectional view along lines[0077]7-7 of FIG. 5 and explicitly showing the third alternatively modifiedmanifold165. Likewise, FIG. 8B is a sectional view taken along lines8-8 of FIG. 6 and also shows the third alternatively modifiedmanifold165.
• FIG. 8B best illustrates the[0078]elongate valve element143 of the first and third alternative embodiments. Theelongate valve element143 has a plug170 at its upper end and an elastomeric shaft172 extending downwardly and engaging thegrate138. As can be appreciated, the elastomeric shaft resiliently biases the plug170 into theaperture135 of theNAC132.
• In use, when a male Luer is forced into the[0079]aperture135 of the NAC and seals the NAC against fluid passage or reflux in and out of the top of the NAC. The plug170 is resiliently displaced downwardly into theNAC132. The elastomeric shaft172 cants and permits this displacement, and fluid communication is thereby established between the Luer tip and the NAC. The elastomeric shaft172 may include structural features that enhance canting such as, for example, recesses in the elastomeric shaft172. It can also be appreciated that the height of the NAC and the resiliency of theelongate valve element143 accommodate a wide range of male Luer lengths without harming or adversely affecting the manifold.
• The NAC of the instant invention has an advantage over many of the injection ports described above in that the NAC may be used for aspiration as well as for injection of fluids therethrough. Furthermore, the NAC is capable of operating at lower pressures. For example, the NAC may be operated at pressures of 1.5 psi or less depending on other relative pressures in the system. On the other hand the injection ports of the previously described embodiments operate at higher pressures. That is, for example, in the range of 2-6 psi. As can be appreciated by those skilled in the art the NAC therefore can be appropriately used to inject fluids therethrough from an IV bottle or bag source.[0080]
• It will be appreciated that many variations of these embodiments will now be apparent to those skilled in the art. Certainly, the configuration of the[0081]flow channel49 can be varied widely to accommodate and improve fluid flow through the manifold18. Also, the shape of theprojections83,85 and87 can be varied considerably as long as the fluid flow is directed into the cavities containing the valve elements. Other embodiments providing multiple valve seats to accommodate high and low pressures will also be apparent. In addition, other ports facilitating aspiration from theflow channel49 will also be apparent to either provide two-way fluid communication or alternatively to otherwise direct the fluid flow as illustrated in the Figures.
• Based on these and many other variation which will now be apparent, one is cautioned not to determine the extent of the concept only with reference to the disclosed and illustrated embodiments, but rather to determine the scope of the invention only with reference to the following claims.[0082]

Claims (23)

We claim:

1. An injection port adapted for use with an intravenous line, comprising:

a housing defining a flow channel and having an injection lumen extending in fluid communication with the flow channel;

first portions of the housing defining a first valve seat around the injection lumen;

second portions of the housing defining a second valve seat around the injection lumen;

a valve element disposed to extend transverse to the injection lumen;

the valve element having properties for forming a first seal with the first valve seat at a first pressure;

the valve element having properties for forming a second seal with the second valve seat in response to a second pressure greater than the first pressure of the fluid in the flow channel, and

the valve element having properties for forming an open configuration between said lumen and said flow channel in response to a third pressure in said lumen greater than one of said first pressure and said second pressure.

2. The injection port recited inclaim 1, further comprising:

third portions of the housing defining a third valve seat on the side of the valve element opposite the first and second valve seats; and

the valve element having properties for forming a third seal with the third valve seat.

3. The injection port recited inclaim 2, wherein the valve element has properties for opening at least the first seal for said open configuration under the pressure of an injectate in the injection lumen to create a flow path around the valve element between the injection lumen and the flow channel; and

the valve element has properties for opening the third seal in response to a partial vacuum in the injection lumen to aspirate a portion of the fluid in the flow channel through an aperture in the valve element and into the injection lumen.

4. An injection manifold adapted to be disposed in an intravenous line extending from an intravenous reservoir to a patient, the manifold comprising:

a first body member;

a second body member forming with the first body member a housing;

first portions of the housing defining a flow channel to receive the IV solution flowing in the IV line;

second portions of the housing defining at least one port with an injection lumen, the port having an outside diameter;

third portions of the housing defining at least one cavity interconnecting in fluid communication said flow channel and said at least one port, said at least one cavity having a plurality of valve seats, and

the first portions of the housing having a width greater than a width of the cavity and the width of the cavity being greater than the diameter of the port.

5. The injection manifold recited inclaim 4, wherein said third portion defines said cavity having a height less than each of a width and a length of said cavity such that the flow of a liquid passing through the manifold readily impinges on an underside of a valve element in said cavity and thereby reduces stagnation.

6. The injection manifold recited inclaim 5, wherein said third portion and said valve element form a concave surface on a side of the valve element opposite from the valve seats.

7. An injection/aspiration port adapted for operation with a male Luer fitting, comprising:

a housing;

first portions of the housing defining a flow channel;

second portions of the housing defining an injection/aspiration lumen;

third portions of the housing defining a valve seat around the injection/aspiration lumen;

a valve element biased toward the injection/aspiration lumen and forming a seal with the valve seat;

a valve cage disposed in the lumen and adapted to be moved by insertion of the male Luer fitting into the lumen against the valve element to open the seal and permit two-way flow between the lumen and the flow channel;

a first body member comprising the second portions and third portions and defining the lumen and the valve seat, the lumen having an enlarged portion defining a shoulder against which the valve cage is biased when no male Luer is inserted; and

a second body member comprising the first portions and forming the housing with the first body member, said second body member including portions contacting the valve element on the side of the valve element opposite the valve seat to bias the valve element against the valve seat to form the seal.

8. The injection/aspiration port recited inclaim 7, wherein the valve cage is resilient, is biased to an expanded state, and is adapted to be compressed by the insertion of the male Luer, wherein the cage has properties for moving the valve only a small distance in response to the male Luer being inserted to any of a range of predetermined depths greater than said small distance.

9. A manifold for placement in an IV line and for sealingly connecting said IV line between an upstream portion and a downstream portion thereof, said manifold comprising:

a housing defining flow volume including a volume in a flow channel;

a plurality of fluid injection ports in said housing in fluidic communication with said flow channel;

at least one of the injection ports having at least one valve,

said at least one valve having a first valve seat, a second valve seat, and a valve element;

said valve element having properties that cause the valve element to engage said first valve seat at a first fluid pressure and to engage said second valve seat at a second fluid pressure; and

said plurality of fluid injection ports further comprising at least another injection port comprising an injection and aspiration port in the form of a needleless access connector (NAC); and

at least one check valve in the flow volume for limiting flow in at least one direction through the manifold.

10. The manifold ofclaim 9, wherein said check valve is located upstream of said at least one fluid injection port.

11. The manifold ofclaim 9, further comprising:

said check valve located downstream of said at least one fluid injection port, wherein:

suctioning upstream of said fluid injection valve pulls fluid from a reservoir feeding the fluid injection port and into the manifold, and

forcing IV fluid into the manifold from upstream closes the fluid injection valve and opens the check valve;

whereby repetitions of said suctioning and forcing cause a cyclical pumping of the fluid from said reservoir feeding the fluid injection port.

12. The manifold ofclaim 9, further comprising:

said check valve located downstream of said at least one fluid injection port, wherein:

suctioning from said at least one fluid injection port pulls fluid from upstream in the IV line, through a portion of the manifold, and into a reservoir connected to the at least one port, and

forcing fluid through said at least one port into the manifold from the reservoir sends said fluid downstream through said check valve;

whereby repetitions of said suctioning and forcing cause a cyclical pumping of the fluid from upstream in said IV line into said reservoir and downstream through said check valve.

13. The manifold ofclaim 9, said needleless access connector comprising:

a body having an end piece at a first end of said body, said end piece having an aperture therethrough, said body forming a conduit, said conduit extending in fluid communication with said aperture, an opening in a second end of said body, said second end of said body connected to said manifold with said conduit in fluid communication through said opening with said flow channel; and

an elongate valve element disposed in said conduit and comprising:

a plug at one end sealingly disposed in said aperture to prevent reflux through the aperture, and

an elastomeric shaft to resiliently bias the plug into said aperture.

14. The manifold ofclaim 13, wherein said needleless access connector is connected to the manifold downstream of the check valve.

15. The manifold ofclaim 9, wherein said at least one fluid injection port is an injection/aspiration port and is the next port downstream of the check valve.

16. A manifold for placement in an IV line in order to facilitate injecting fluids into and withdrawing fluids from said IV line, said manifold comprising:

an upstream connection at an upstream end, a downstream connection at a downstream end;

a first body member between said upstream connection and said downstream connection and defining a first portion of a housing;

a second body member defining a plurality of fluid injection ports and a second portion of said housing;

a plurality of cavities formed by said first portion and said second portion between said fluid injection ports and said first portion of said housing;

at least one valve in one of said cavities, said valve comprising at least one valve member, said valve member dividing said cavity into first and second parts generally adjacent to said first and second portions of said housing respectively;

said housing forming a fluidic communication therethrough between said upstream connection and said downstream connection;

said first housing member and said second housing member defining at least one flow channel between said first housing member and said second housing member and fluidically connecting said cavities; and

said manifold defining a flow volume comprising a volume in said upstream connection, a volume in said downstream connection, a volume in said second part of said cavities, and a volume defined by said flow channel;

wherein all of the flow volume is substantially in a flow path such that substantially none of the flow volume becomes stagnant.

17. The manifold ofclaim 16, further comprising a needleless access port (NAC) connected to the housing in addition to said plurality of ports.

18. The manifold ofclaim 16, further comprising a check valve in said housing between at least one upstream and one downstream fluid injection port.

19. The manifold ofclaim 17, further comprising a check valve in said housing between the upstream connection and at least one downstream fluid injection port.

20. A needleless access connection (NAC) in combination with a manifold having at least one injection port and adapted for use with an intravenous line, said combination comprising:

a housing with an upstream connection and a downstream connection, said housing having a first portion defining a flow channel between said upstream connection and said downstream connection;

said housing comprising a second portion integrally providing said NAC, said NAC having structure defining an injection and aspiration conduit, said second portion further providing an injection and aspiration aperture at one end of said NAC in fluid communication with the conduit;

said housing comprising a third portion integrally defining a grate having at least one opening at another end of said NAC and extending in fluid communication with said conduit and said flow channel for fluid injection into and aspiration from said flow channel;

an elongate valve element disposed in said second portion of said housing and naturally biased into engagement with the injection and aspiration aperture;

the elongate valve element having properties for naturally forming a first seal with the injection aperture; and

the valve element having properties for moving out of said aperture in response to insertion of a male Luer into said aperture, and for resiliently moving back into said aperture of said NAC when said male Luer is removed; and

said housing further comprising said at least one injection port in fluid communication with said flow channel.

21. The combination ofclaim 20, wherein said elongate valve element disposed in said second portion is also in abutting relation to said third portion.

22. An injection manifold adapted to be disposed in an intravenous line extending from an intravenous reservoir to a patient, the manifold comprising:

a first body member;

a second body member forming with the first body member a housing;

first portions of the housing defining a flow channel to receive the IV solution flowing in the IV line;

second portions of the housing defining at least one injection port with an injection lumen extending in fluid communication with said flow channel; and

third portions of the housing defining at least one injection and aspiration needleless access connection (NAC), said NAC having a housing defining a conduit in fluid communication with said flow channel at a proximal end and having a plugged aperture at a distal end.

23. The manifold ofclaim 22, further comprising:

said at least on injection port having a first outside diameter;

said at least one NAC having at least a second outside diameter; and

the first portions of the housing having a width greater than the second diameter, and the second diameter having a width greater than the first diameter.

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