WO2015117126A1

WO2015117126A1 - Medical valve

Info

Publication number: WO2015117126A1
Application number: PCT/US2015/014244
Authority: WO
Inventors: Jason A. WINE; Sean Carroll; Michael Lehmann; Chris J. OKOS; Dan HIPWOOD; Chris Miller; Mark Henault
Original assignee: Edwards Lifesciences Corporation
Priority date: 2014-02-03
Filing date: 2015-02-03
Publication date: 2015-08-06

Abstract

Disclosed is a valve that may be suitable as a sampling site for hemodynamic monitoring and blood sampling. The valve includes a housing with a cavity and conduits in fluidic communication with the cavity. The valve also includes an access port and a septum member that can transition between first and second states. In the first state, the septum member prevents flow through the access port. In second state, the septum member permits flow from one or more of the conduits through the access port. In some instances, the septum member may block flow from one of the conduits in the second state.

Description

MEDICAL VALVE

FIELD

[0001] Aspects of the disclosure generally relate to apparatus and methods for withdrawal of fluid from or injection of fluid into a medical line associated with a patient, and in particular may relate to a self-sealing, needleless, valved connection to the line, which may be, for example, a sampling site connecting to a catheter for hemodynamic monitoring and blood sampling, or an intravenous injection site.

BACKGROUND

[0002] In a hospital setting there is always the need to monitor patient health through the evaluation of the blood chemistry profile. The simplest method employed in the hospital is to use a syringe carrying a sharpened cannula at one end and insert that cannula into a vein or artery to extract a blood sample from the patient. Blood is drawn using a syringe or more easily into an evacuated vessel. Patients that are in the critical care units or the operating room sometimes require as many as twelve blood draws a day which can be quite uncomfortable. Moreover, such frequent sampling injections carry the risk to the clinician of needle sticks and blood exposure, and potentially subject the patient to airborne bacteria and viruses which can enter the bloodstream through the opening made by the sharpened cannula.

[0003] One way to obtain a blood sample is to draw the blood from a catheter that is already inserted in the patient, either in a central venous line, such as one placed in the right atrium, or in an arterial line. Typically, existing injection sites for arterial or venous drug infusion or pressure monitoring lines are used to take periodic blood samples from the patient. Conventional mechanisms for drawing blood from the lines used for infusion or pressure monitoring utilize a plurality of stopcock mechanisms that block flow from the infusion fluid supply or from the pressure column drip supply, while allowing blood to flow from the patient into a collecting syringe connected to a port formed in one of the stopcocks. Typically, a blunt cannula through a slit septum is used to remove the danger of sticking the nurse or clinician, in a so-called "needleless" system.

[0004] Most early systems required a two-step operation in which a first sample of fluid, typically between 2-12 ml in volume for intensive care environments, was withdrawn into the sampling syringe and discarded. This first sample potentially included some of the infusion fluid and thus could be an unreliable blood chemistry measurement sample. After the initial sample had been discharged, a second sample was pure blood from the artery or vein and was typically re-infused to the patient.

[0005] Because the possibility of discarding blood along with saline is a drawback of such early systems, especially for anemic patients, so-called closed systems that remain connected to the conduit line and preserve the initial fluid draw were developed. Closed systems include a dedicated syringe-like reservoir incorporated in the tubing line from the patient that can draw fluid past a sampling port. The line continues past the reservoir to a proximal source of flushing fluid and a pressure transducer. The clearing volume is held in the inline reservoir, and not set aside in a syringe for discard or re-infusion later. In reservoir systems the nurse or technician must manipulate the reservoir, then let go of it to take the blood sample, and then grasp it again to re-infuse the patient, all of which is relatively inconvenient. Furthermore the continuing presence of the reservoir dangling from the pressure monitoring line is undesirable as it is only infrequently used and can become tangled with bedding or with other equipment. Finally, because the reservoir remains in place and is used multiple times, it must include a contamination shield to isolate the reservoir plunger, and such a device is costly compared to a simple syringe.

[0006] A minimum quality of system frequency response in the blood

sampling/pressure monitoring systems described above is necessary for reliable blood pressure measurements. The pressure transducer typically includes a diaphragm exposed to the in-line fluid on one side and has a device for measuring deflection of the diaphragm on the other. Conventional sampling sites with elastomeric septums or a dedicated reservoir with a rubber-tipped plunger, however, may contribute to signal degradation.

[0007] In view of the foregoing, there is a need for a blood sampling system, especially used in conjunction with a pressure transducer, that is more convenient, provides an effective seal, keeps the valve clear, and maintains a quality of system frequency response adequate for reliable blood pressure measurements. SUMMARY

[0008] This application is directed to a medical valve that may be suitable as a sampling site for hemodynamic monitoring and blood sampling. The valve includes a housing with a cavity and conduits in fluidic communication with the cavity. The valve also includes an access port and a septum member that can transition between first and second states. In the first state, the septum member prevents flow through the access port. In the second state, the septum member permits flow from one or more of the conduits through the access port. In some embodiments, the septum member may block flow from one of the conduits in the second state.

[0009] A first exemplary embodiment provides a medical valve that includes: (i) a housing comprising: a body having a base surface and a peripheral wall defining a cavity; a first conduit having an associated first end in fluidic communication with the cavity; and a second conduit having an associated first end in fluidic communication with the cavity; (ii) a septum member comprising: a plug having an upper surface and a lower surface separated by a plug thickness; a slit extending at least partially through the plug thickness; and a skirt extending from the plug; and (iii) a cover member coupled with the body and positioned over the base surface, the cover member comprising an access port slidably receiving the plug, wherein the skirt is positioned over the base surface and the first ends associated with the first and second conduits.

[0010] In a first characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the skirt terminates in a continuous peripheral skirt edge forming a sealing relationship between the cover member and the housing.

[0011] In a second characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the lower surface of the plug is in fluidic communication with the cavity.

[0012] In a third characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, wherein the septum member is configured to transition from a first state to a second state, where in the first state, the first conduit and the second conduit are in fluidic communication, and fluidic communication through the slit is prevented; and where in the second state, the first conduit is in fluidic communication through the slit and wherein at least a portion of the septum member substantially blocks fluidic communication between the first conduit and the second conduit.

[0013] In a fourth characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the housing defines a first passage having a proximal end in the body and having a distal end terminating in the cavity, the first end of the first conduit terminating in the first passage.

[0014] In a fifth characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the distal end of the first passage terminates at the base surface and is aligned with the access port.

[0015] In a sixth characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the base surface defines an annular flange around the distal end of the first passage, the annular flange being configured to receive a portion of the septum member when the septum member is in the second state.

[0016] In a seventh characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the housing defines a second passage having a proximal end in the body and a distal end terminating in the cavity, the first end of the second conduit terminating in the second passage.

[0017] In an eighth characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the septum member is configured to transition from a first state to a second state, where in the first state, the first conduit and the second conduit are in fluidic communication, and fluidic communication through the slit is prevented; and where in the second state, the first conduit and the second conduit are in fluidic communication through the slit.

[0018] In a ninth characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the housing comprises a structural element extending from the base surface and terminating at a distal end, the structural element being aligned with the access port.

[0019] In a tenth characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the structural element defines a shape that is relatively narrower at its distal end and relatively wider at the base surface.

[0020] In a eleventh characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the distal end of the structural element at least partially penetrates the slit in the second state.

[0021] In a twelfth characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the first end of the first conduit terminates at the peripheral wall and proximate to the base surface; and the first end of the second conduit terminates at the peripheral wall and proximate to the base surface.

[0022] In a thirteenth characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the structural element defining a laterally open channel extending from the base surface to its distal end, the channel being laterally open towards the first end of the first conduit.

[0023] In a fourteenth characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the structural element comprises: a wall portion extending between a first portion of the peripheral wall and a second portion of the peripheral wall; and a penetrating member extending above the wall portion and being aligned with the access port, the penetrating member comprising the distal end of the structural element.

[0024] In a fifteenth characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the structural element comprises: a wall portion extending between a first portion of the peripheral wall and a second portion of the peripheral wall; and a penetrating member extending above the wall portion and being aligned with the access port, the penetrating member comprising the distal end of the structural element.

[0025] In a sixteenth characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the housing defines a first passage having a proximal end in the body and a distal end, the first end of the first conduit terminating in the first passage, the distal end of the first passage terminating vertically displaced from the base surface. [0026] In a seventeenth characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the housing defines a first passage having a proximal end in the body and having a distal end, the first end of the first conduit terminating in the first passage, the distal end of the first passage terminating flush with the base surface.

[0027] In a eighteenth characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the housing comprises a structural element extending from the base surface and terminating at a distal end, the structural element being aligned with the access port.

[0028] In a nineteenth characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the structural element defines a shape that is relatively narrower at its distal end and relatively wider at the base surface.

[0029] In a twentieth characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the septum member is configured to transition from a first state to a second state, where in the first state, the first conduit and the second conduit are in fluidic communication, and fluidic communication through the slit is prevented, and where in the second state, the septum member provides fluidic communication from the first conduit through the slit and at least a portion of the septum member substantially blocks fluidic communication between the first conduit and the second conduit, the distal end of the structural element at least partially penetrating the slit in the second state.

[0030] In a twenty-first characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the housing defines a first passage having a proximal end in the body and a distal end, the first passage extending from its proximal end through the structural element with the distal end of the first passage terminating in the cavity at the distal end of the structural element, the first end of the first conduit terminating in the first passage.

[0031] In a twenty-second characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the housing defines a second passage having a proximal end in the body and a distal end terminating in the cavity, the first end of the second conduit terminating in the second passage.

[0032] In a twenty-third characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the second passage extends substantially vertically from the first end of the second conduit to the base surface.

[0033] In a twenty-fourth characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the structural element has a substantially cylindrical or frustoconical shape.

[0034] In a twenty-fifth characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the septum member is configured to transition from a first state to a second state, where in the first state, the first conduit and the second conduit are in fluidic communication, and fluidic communication through the slit is prevented, and where in the second state, the septum member provides fluidic communication from the first conduit through the slit and at least a portion of the septum member substantially blocks fluidic communication between the first conduit and the second conduit.

[0035] In a twenty-sixth characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the distal end of the structural element at least partially penetrates the slit in the second state.

[0036] In a twenty-seventh characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the housing defines a first passage having a proximal end in the body and a distal end terminating in the cavity, the distal end of the first passage being aligned with the access port, the first end of the first conduit terminating in the first passage; and the base surface defines a first channel therein, the first channel at least partially surrounding the distal end of the first passage, the first end of the second conduit terminating in the first channel.

[0037] In a twenty-eighth characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the septum member is configured to transition from a first state to a second state, where in the first state, the first conduit and the second conduit are in fluidic communication, and fluidic communication through the slit is prevented, and where in the second state, the septum member provides fluidic communication from the first conduit through the slit and at least a portion of the septum member substantially blocks fluidic communication between the first conduit and the second conduit.

[0038] In a twenty-ninth characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the first channel defines an arc-like shape at least partially surrounding the distal end of the first passage.

[0039] In a thirtieth characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the distal end of the first passage defines an elongated channel in the base surface.

[0040] In a thirty-first characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the housing comprises a structural element extending from the base surface and terminating at a distal end, the structural element being aligned with the access port, the first channel at least partially surrounding the structural element.

[0041] In a thirty-second characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the structural element defines a shape that is relatively wider at the base surface and relatively narrower at its distal end, the structural element defining a laterally open second channel extending from the base surface to its distal end, the distal end of the first passage terminating in the second channel.

[0042] In a thirty-third characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the septum member is configured to transition from a first state to a second state, where in the first state, the first conduit and the second conduit are in fluidic communication, and fluidic communication through the slit is prevented, and where in the second state, the septum member provides fluidic communication from the first conduit through the slit and at least a portion of the septum member substantially blocks fluidic communication between the first conduit and the second conduit, the distal end of the structural element at least partially penetrating the slit in the second state. [0043] In a thirty-fourth characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the first channel annularly surrounds the distal end of the first passage.

[0044] In a thirty-fifth characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the housing comprises a structural element extending from a bottom surface of the first channel to a distal end, the structural element being annularly surrounded by the first channel and aligned with the access port.

[0045] In a thirty-sixth characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the first passage extends through the structural element with the distal end of the first passage located at the distal end of the structural element.

[0046] In a thirty- seventh characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the structural element defines a shape that is relatively narrower at its distal end and relatively wider at the bottom of the first channel.

[0047] In a thirty-eighth characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the septum member is configured to transition from a first state to a second state, where in the first state, the first conduit and the second conduit are in fluidic communication, and fluidic communication through the slit is prevented, and where in the second state, the septum member provides fluidic communication from the first conduit through the slit and at least a portion of the septum member substantially blocks fluidic communication between the first conduit and the second conduit, the distal end of the structural element at least partially penetrating the slit in the second state.

[0048] In a thirty-ninth characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the housing defines a second passage having a proximal end in the body and a distal end terminating in the first channel, the first end of the second conduit terminating in the second passage. [0049] In a fortieth characteristic of the first embodiment, either alone or in combination with any other characteristic of the first embodiment, the cover member is integral with the housing.

[0050] In a second exemplary embodiment, the present invention embraces a medical valve that includes: (i) a housing comprising: a body defining a cavity; a first conduit having an associated first end in fluidic communication with the cavity; a second conduit having an associated first end in fluidic communication with the cavity; and an access port in fluidic communication with the cavity; and (ii) a septum member comprising a plug having an upper surface and a lower surface separated by a plug thickness, the plug being configured to be slidably positioned in the cavity, the septum member being configured to substantially block fluidic communication in the cavity between the upper surface and the lower surface of the plug.

[0051] In a first characteristic of the second embodiment, either alone or in combination with any other characteristic of the second embodiment, wherein the septum member is configured to transition from a first state to a second state, where in the first state, the first conduit and the second conduit are in fluidic communication and the plug substantially blocks fluidic communication between the access port and the first and second conduits; and where in the second state, the first conduit is in fluidic

communication with the access port and the septum member substantially blocks fluidic communication between the first conduit and the second conduit.

[0052] In a second characteristic of the second embodiment, either alone or in combination with any other characteristic of the second embodiment, the septum member comprises a skirt extending from the plug and attached to the housing, the skirt being configured to bias the septum member to the first state.

[0053] In a third characteristic of the second embodiment, either alone or in combination with any other characteristic of the second embodiment, where in the second state, the skirt substantially blocks fluidic communication between the first conduit and the second conduit.

[0054] In a fourth characteristic of the second embodiment, either alone or in combination with any other characteristic of the second embodiment, the medical valve comprises a biasing member connected to the housing and the septum member, the biasing member being configured to bias the septum member to the first state.

[0055] In a fifth characteristic of the second embodiment, either alone or in combination with any other characteristic of the second embodiment, the biasing member is a spring.

[0056] In a sixth characteristic of the second embodiment, either alone or in combination with any other characteristic of the second embodiment, where in the second state, the plug substantially blocks fluidic communication between the first conduit and the second conduit.

[0057] In a seventh characteristic of the second embodiment, either alone or in combination with any other characteristic of the second embodiment, the plug defines a lateral opening therethrough.

[0058] In an eighth characteristic of the second embodiment, either alone or in combination with any other characteristic of the second embodiment, the lateral opening provides fluidic communication between the first conduit and the second conduit in the first state.

[0059] In a ninth characteristic of the second embodiment, either alone or in combination with any other characteristic of the second embodiment, the plug comprises a body portion and a neck portion, the neck portion being configured to be slidably received by the access port, the body portion defining a lateral opening therethrough.

[0060] In a tenth characteristic of the second embodiment, either alone or in combination with any other characteristic of the second embodiment, the body defines an annular flange in the cavity, the annular flange being configured to slidably receive the body portion of the plug.

[0061] In a eleventh characteristic of the second embodiment, either alone or in combination with any other characteristic of the second embodiment, in the first state, the neck portion is positioned in the access port to substantially block fluidic communication between the access port and the first and second conduits, and the lateral opening is positioned at the annular flange to provide fluidic communication between the first conduit and the second conduit; and in the second state, the lateral opening is positioned below the annular flange, and the body portion of the plug substantially blocks fluidic communication between the first conduit and the second conduit.

[0062] In a twelfth characteristic of the second embodiment, either alone or in combination with any other characteristic of the second embodiment, the body portion of the plug defines a biasing portion, the biasing portion being configured to bias the septum member to the first state.

[0063] The features, functions, and advantages that have been discussed may be achieved independently in various embodiments of the present invention or may be combined with yet other embodiments, further details of which can be seen with reference to the following description and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0064] For a more complete understanding, reference should now be had to the embodiments shown in the accompanying drawings and described below. In the drawings:

[0065] FIG. 1 is a perspective view of a closed blood sampling system, including an embodiment of a sampling site disclosed herein.

[0066] FIG. 2 is a perspective view of an embodiment of a sampling site of FIG. 1.

[0067] FIG. 3 is a top perspective view of the sampling site of FIG. 2 with the inside of the sampling site exposed.

[0068] FIG. 4 is a longitudinal section perspective view of the sampling site of

FIG. 3.

[0069] FIG. 5 is a longitudinal section view of the sampling site of FIG. 2 in an initial position.

[0070] FIG. 6 is a longitudinal section view of the sampling site of FIG. 2 in an actuated position, showing a male luer connected to the sampling site.

[0071] FIG. 7 is a cross-section view of the sampling site of FIG. 2.

[0072] FIGS. 8 and 9 are top and bottom perspective views of the septum member of the sampling site of FIG. 2, respectively.

[0073] FIG. 10 is a cross-section view of the septum member of the sampling site of FIG. 2. [0074] FIG. 11 is a perspective view of another embodiment of a sampling site of

FIG. 1.

[0075] FIG. 12 is a top perspective view of the sampling site of FIG. 11 with the inside of the sampling site exposed.

[0076] FIG. 13 is a longitudinal section perspective view of the sampling site of

FIG. 12.

[0077] FIG. 14 is a longitudinal section view of the sampling site of FIG. 11 in an initial position.

[0078] FIG. 15 is a longitudinal section view of the sampling site of FIG. 11 in an actuated position.

[0079] FIG. 16 is a cross-section view of the sampling site of FIG. 11.

[0080] FIGS. 17 and 18 are top and bottom perspective views of the septum member of the sampling site of FIG. 11 , respectively.

[0081] FIG. 19 is a cross-section view of the septum member of the sampling site of FIG. 11.

[0082] FIG. 20 is a perspective view of another embodiment of a sampling site of

FIG. 1.

[0083] FIG. 21 is a top perspective view of the sampling site of FIG. 20 with the inside of the sampling site exposed.

[0084] FIG. 22 is a longitudinal section perspective view of the sampling site of

FIG. 21.

[0085] FIG. 23 is a longitudinal section view of the sampling site of FIG. 20 in an initial position.

[0086] FIG. 24 is a cross-section view of the sampling site of FIG. 20 in the initial position.

[0087] FIG. 25 is a cross-section view of the sampling site of FIG. 20 in an actuated position.

[0088] FIGS. 26 and 27 are top and bottom perspective views of the septum member of the sampling site of FIG. 20, respectively.

[0089] FIG. 28 is a cross-section view of the septum member of the sampling site of FIG. 20. [0090] FIG. 29 is a perspective view of another embodiment of a sampling site of

FIG. 1.

[0091] FIG. 30 is a top perspective view of the sampling site of FIG. 29 with the inside of the sampling site exposed.

[0092] FIG. 31 is a longitudinal section perspective view of the sampling site of

FIG. 30.

[0093] FIG. 32 is a longitudinal section view of the sampling site of FIG. 29 in an initial position.

[0094] FIG. 33 is a longitudinal section view of the sampling site of FIG. 29 in an actuated position.

[0095] FIG. 34 is a cross-section view of the sampling site of FIG. 29.

[0096] FIGS. 35 and 36 are top and bottom perspective views of the septum member of the sampling site of FIG. 29, respectively.

[0097] FIG. 37 is a cross-section view of the septum member of the sampling site of FIG. 29.

[0098] FIG. 38 is a perspective view of another embodiment of a sampling site of

FIG. 1.

[0099] FIG. 39 is a top perspective view of the sampling site of FIG. 38 with the inside of the sampling site exposed.

[00100] FIG. 40 is a longitudinal section perspective view of the sampling site of FIG. 39.

[00101] FIG. 41 is a longitudinal section view of the sampling site of FIG. 38 in an initial position.

[00102] FIG. 42 is a longitudinal section view of the sampling site of FIG. 38 in an actuated position.

[00103] FIG. 43 is a cross-section view of the sampling site of FIG. 38.

[00104] FIGS. 44 and 45 are top and bottom perspective views of the septum member of the sampling site of FIG. 38, respectively.

[00105] FIG. 46 is a cross-section view of the septum member of the sampling site of FIG. 38. [00106] FIG. 47 is a perspective view of another embodiment of a sampling site of FIG. 1.

[00107] FIG. 48 is a top perspective view of the sampling site of FIG. 47 with the inside of the sampling site exposed.

[00108] FIG. 49 is a longitudinal section perspective view of the sampling site of FIG. 47.

[00109] FIG. 50 is a longitudinal section view of the sampling site of FIG. 47 in an initial position.

[00110] FIG. 51 is a longitudinal section view of the sampling site of FIG. 47 in an actuated position.

[00111] FIG. 52 is a cross-section view of the sampling site of FIG. 47.

[00112] FIGS. 53 and 54 are top and bottom perspective views of the septum member of the sampling site of FIG. 47, respectively.

[00113] FIG. 55 is a cross-section view of the septum member of the sampling site of FIG. 47.

DETAILED DESCRIPTION

[00114] The following detailed description of embodiments refers to the accompanying drawings, which illustrate specific embodiments. Other embodiments having different structures and operation may yet be within the scope of the present disclosure.

[00115] Embodiments of concepts disclosed herein are directed to apparatus and methods for hemodynamic monitoring and blood sampling from a patient, or for use in intravenous injection assemblies. Embodiments of valves disclosed may include, individually or in combination, an internal penetrating member or protruding member to create an opening in a slit septum when the septum is actuated, or a septum that is designed to collapse around certain points, resulting in the opening of a slit in a septum when the septum is actuated. Alternatively, some embodiments include a septum without a slit. All embodiments, by actuation of the septum, may open a flow path that permits flow in and out of the valve through a port. Some embodiments, when actuated to permit flow through the port, may concurrently prevent in-line flow through the valve.

[00116] Certain terminology is used herein for convenience only and is not to be taken as a limitation on the embodiments described. For example, words such as "top", "bottom", "upper," "lower," "left," "right," "horizontal," "vertical," "upward," and "downward" merely describe the configuration shown in the figures or the orientation of a part in the installed position. Indeed, the referenced components may be oriented in any direction and the terminology, therefore, should be understood as encompassing such variations unless specified otherwise. Throughout this disclosure, where a process or method is shown or described, the method may be performed in any order or

simultaneously, unless it is clear from the context that the method depends on certain actions being performed first.

[00117] Referring to the drawings, where like reference numerals refer to the same or similar parts, FIG. 1 depicts an exemplary closed blood sampling system 180. The system 180 includes a proximal connector 182 to connect to tubing, such as a catheter (not shown) that has an end inserted into a patient, and a distal connector 184 at the opposite end of tubing 186 to connect to adjacent tubing (not shown). Assuming flow is coming from the patient through the catheter and then the proximal connector 182, downstream flow is then to a sampling site 188, then through a shut-off or stopcock valve 190 to a reservoir 192, and to the distal connector 184. The system 180 may be similar to the VAMP® and VAMP Plus® Venous Arterial blood Management Protection systems of Edwards Lifesciences of Irvine, California. That said, instead of employing a

conventional sampling site, the sampling site is typically a valve as disclosed in more detail below.

[00118] When a blood sample is to be taken, the flow of flushing or infusion fluid typically is halted by turning the handle of the stopcock valve 190. The nurse or clinician then withdraws an amount of fluid into the reservoir 192 chamber sufficient to pull pure blood past the sampling site 188 and closes the stopcock valve 190. The flow line may also include a sampling site near the patient (not shown, more often used in the Intensive Care Unit). The stopcock valve 190 is then opened so that the volume within the reservoir 192 can be re-infused back into the patient, and the flushing drip and pressure monitoring resumes. The sampling site 188 is typically designed to ensure a complete flush after the sample is taken. Accordingly, opening the stopcock valve 190 may cause a clearing volume of saline to flow to the sampling site for flushing.

[00119] One criterion of interest in the sample taken may be a measurement of Arterial Blood Gases (ABG). Although the acceptable level of saline to avoid erroneous ABG readings is not known, it should ideally be close to zero. Accordingly, the sampling site 188 may include an automatic shut-off of the tubing to the reservoir 192 to help prevent saline from causing erroneous readings.

[00120] The embodiments of valves disclosed herein typically each include a housing. The exterior shape of the housing is not critical, and may vary from that shown. The housing may include a body and a cover mounted to the body. The cover may be attached to the body using a press fit, snap fit, ultrasonic welding, or another method known to one of ordinary skill in the art. Alternatively, the cover may be integral with the body. The cover may include a neck that provides a port as a connection for a sampling reservoir, such as a needleless syringe. Each port typically has a central axis passing through it. In the embodiments shown, the neck may be formed as a female luer with external, male threads, with the female luer being configured for receiving a male luer of a syringe having internal, female threads.

[00121] Within the valve, the housing typically has a round interior cavity with curved or rounded interior surfaces and edges. The rounded interior of the housing may help to prevent adhesion of liquid such as blood to the surface, and coagulation of the blood that may restrict flow to the sampling reservoir or negatively impact the sample and measurements taken from it.

[00122] The valves disclosed herein may include a septum (e.g., a septum member) that may be disposed in the port when in an unactuated position or a first state. Each septum of the may be a deformable, resilient member and material, and may have a slit extending through it that may be in a vertical orientation when the body is oriented horizontally. The septum may include a plug portion and skirt portion. The slit may extend less than completely across the width of the plug portion of septum. For example, the slit may be centered on the septum and extend two thirds to three quarters across the top of the plug portion or plug portion outer surface, leaving the portions of the plug portion at the outside edges intact. The slit typically extends between the plug portion outer surface and the plug portion inner surface. The slit is typically closed when the septum is in the first state, providing a seal that prevents flow of liquid out of the valve. In operation, the septum may be actuated to be depressed inward from the port to an actuated position or a second state in which the slit opens. In some embodiments, a structural element (e.g., a penetrating member) may help to open and extend through (e.g., to penetrate) the slit, and in other embodiments the septum may have a design that inherently causes the slit to open when the septum is actuated. When the slit is open, the liquid may flow out of the valve and through the slit, and into the lumen of a male luer.

[00123] FIGS. 2-10 show a first exemplary valve 200 in accordance with the present invention. Referring to FIG. 2, the valve 200 has a housing 202 that may include a body 204, hollow connection members 206, 208 extending from the body 204, a base 212, and a cover 210 that is typically positioned over the base. The exterior of the body 204 may have a cylindrical shape as shown, or otherwise. The connection members 206, 208 may be disposed on opposite sides of the body 204, or alternatively could be positioned around the body 204 in different locations, and are each configured to receive tubing 186 as shown in FIG. 1.

[00124] The cover 210 of the housing 202 may include an annular portion 214 with gripping members 216 on opposite sides of the cover 210 that provide a friction, snap, or other fit with the outside of the body 204 to connect the cover 210 to the body 204 of the housing 202. A central round opening in the cover 210 may be provided. In the embodiment shown here the cover 210 includes a neck 218 that extends upward from the annular portion 214 to provide a port 220 that is a connection for a sampling reservoir, such as a needleless syringe. As shown in FIG. 5, the port 220 has a central longitudinal axis Z— Z passing through it. In the embodiment shown, the neck 218 is formed as a female luer with external, male threads for receiving a male luer of a syringe having internal, female threads. A septum 230 may be disposed (e.g., slidably disposed) in the port 220 and may have a slit 232 extending through it. The base 212 may in some embodiments be integrally molded and seamless with the body 204, as shown.

[00125] FIGS. 3 and 4 show the interior of the housing 202, with the cover 210 and septum 230 removed from the body 204 of the housing 202. A base surface 213 and peripheral wall 215 of the housing 202 define a cavity 240 for receiving liquid from conduits 242, 244 that may be defined in the body 204. As shown in FIG. 4, the conduits 242, 244 may terminate at the peripheral wall 215 and proximate to the base surface (e.g., near the bottom of the cavity 240). The conduits 242, 244 may be in fluidic

communication with the tubing 186 (not shown) secured in the connection members 206, 208. For example, fluid flow of blood 250, may be through the tubing 186 in the first or upstream connection member 206, though the upstream or first conduit 242, through the cavity 240 of the housing 202, through the downstream or second conduit 244, and through the tubing 186 in the second or downstream connection member 208. Fluid flow of saline 252 may be in the opposite direction. As shown in FIG. 5, the first conduit 242 may have a central longitudinal axis XI— XI and the second conduit 244 may have a central longitudinal axis X2— X2. As shown, the axes XI— XI and X2— X2 may be in substantial alignment. Alternatively, the axes XI— XI and X2— X2 may be offset or at an angle to each other.

[00126] A structural element 260 may extend into the cavity 240 from the base surface 213 of the housing 202. The structural element 260 shown in this embodiment is wider at the base surface 213 and narrows as it extends upward, tapering to nearly a point at its distal end, and may be hollowed-out, creating a flow path upward in a laterally opened channel 262 along its length to receive flow from the conduit 244 that the channel 262 of the structural element 260 opens towards. The profile of the channel 262 may be helpful in directing saline solution to clear the seal of the slit after a blood sample is taken. As depicted in FIG 4, the structural element 260 may include a wall portion 261 extending between opposing sides of the peripheral wall 215 and a penetrating member 263 extending above the wall portion 261. The penetrating member 263 may be configured to extend through (e.g., penetrate) the slit 232 in the septum 230 when the septum 230 is depressed or actuated. Accordingly, the structural element 260 and the penetrating member 263 are typically aligned with the port 220 (e.g., so that the structural element 260 is positioned below the port 220 so that the penetrating member 263 penetrates the slit 232 when the septum 230 is in the second state).

[00127] The operation of the valve 200 is shown in FIGS. 5 and 6. The septum 230 may include a plug portion 270 and a skirt portion 272 depending from the plug portion 270. In this embodiment, an annular extension 274 may extend from the periphery of the skirt portion 272, and may be parallel to the central axis of the port 220. The slit 232 extends through the plug portion 270 from the top or outer surface 276 of the plug portion 270 to the bottom or inner surface 278 of the plug portion 270 (e.g., the slit extends through the thickness of the plug portion separating the top surface and the bottom surface). FIGS. 5 and 7 show the septum 230 in an initial, unactuated position or first state, in which the plug portion 270 is disposed in the port 220, spaced from the structural element 260, with the slit 232 closed, sealing off the cavity 240 defined by the housing 202 from the exterior of the valve 200. In other words, the slit, when closed, prevents fluidic communication between the bottom surface of the plug portion, which is in fluidic communication with the cavity, and the top surface of the plug portion. Although fluidic communication through the slit is prevented, the conduits 242, 244 remain in fluidic communication. The periphery (e.g., peripheral edge) of the skirt portion 272 and the annular extension 274 are secured between the cover 210 and the body 204, which also provides a sealing relationship.

[00128] FIG. 6 shows the male luer 280 of a needleless syringe inserted through the port 220 to actuate the septum 230. In doing do, the septum 230 may be depressed to an actuated position or second state. In the second state, the structural element 260 may extend through (e.g., penetrate) the slit 232 and the slit 232 opens, placing the channel 262 and the cavity 240 in fluidic communication with the lumen 282 of the male luer 280, allowing the liquid (e.g., liquid from both conduits 242, 244) to flow through the slit 232. Some flow may or may not occur through the slit 232 opening on the outside of the structural element 260 as well. The end of the male luer 280 may form a seal with the septum 230, preventing liquid from passing into the space 284 now formed by the inside surface of the cover 210 and the top surface of the septum 230. Liquid in this space 284 may, when the male luer 280 is withdrawn and the septum 230 returns to the first state, be directed to the port 220. Residual blood on top of the septum 230 may be minimized by the abutting contours of the components. This septum 230 and others disclosed herein may return to the first state in response to force applied by the structure of their design and the resiliency of the material used, and may or may not be assisted by the pressure of the fluid in the cavity 240 of the housing. Rather than the slightly countersunk port 220 and septum 230 relationship at the exterior surface, the valve 200 may be configured to present a flush or even slightly raised outer surface 276 of the top of the septum 230 relative to the port 220, making the septum 230 swab-able, permitting sanitary wiping and removal of any excess liquid.

[00129] FIGS. 8 and 9 show top and bottom of an embodiment of the septum 230, respectively, and FIG. 10 shows a cross-section, with the plug portion 270 having the vertical slit 232 through it across part of the width of the plug portion 270. The slit 232 may be closed when the septum 230 is not in the valve 200, such that pressure from the port 220 is not required to provide a seal at the slit 232. However, the port 220 may be configured to taper inward from the cavity 240 of the housing 202 toward the opening, such that the opening is narrower at the top, which may cause the port 220 to apply pressure to the plug portion 270 of the septum 230 to assist in maintaining the seal at the slit 232. The skirt portion 272 may extend downward from the plug portion 270 and then outward to the annular extension 274, may have walls of substantially constant thickness, and may form a convex shape relative to the cavity 240 of the housing. In this embodiment the skirt portion 272 substantially conforms to the shape of the inside of the cover 210, which may minimize open space between the inside of the cover 210 and the top side of the septum 230 to the benefit of frequency response and minimizing residual liquid at the exposed surfaces of the port 220 and septum 230.

[00130] FIGS. 11-19 show another embodiment of a valve 300. Similar features to the valve 200 of FIGS. 2-10 are numbered in the remaining figures similarly, and the operation of the valves shown in FIGS. 11-25 is similar to that described in FIGS. 5 and 6. Referring to FIG. 11, the valve 300 may have a cover 310 of the housing 202 that may include an annular portion 314. A flange 316 may extend from the annular portion 314, in this case in the downward direction. A central round opening in the cover 310 may be provided. In the embodiment shown the cover 310 includes a neck 218 that extends upward from the annular portion 314 to provide a port 220 that is a connection for a sampling reservoir, such as a needleless syringe. A septum 330 may be disposed (e.g., slidably disposed) in the port 220 and may have a slit 232 extending through it.

[00131] FIGS. 12 and 13 show the interior of the housing 202, with the cover 310 and septum 330 removed from the body 204 of the housing 202. A base surface 213 and peripheral wall 215 of the housing 202 define a cavity 240 for receiving liquid from conduits 242, 244 that may be defined in the body 204. As shown in FIG. 13, the conduits 242, 244 may terminate at the peripheral wall 215 and proximate to the base surface (e.g., near the bottom of the cavity 240). A structural element 360 (e.g., a penetrating member) may extend into the cavity 240 from the base surface 213 of the housing 202. The structural element 360 shown in this embodiment is wider at the base and narrows as it extends upward, tapering to nearly a point at its distal end. The structural element 360 may in one side define a channel 362 forming a flow path upward in its laterally opened channel 362 along its length to receive flow from the conduit 244 that the shape of the structural element 360 opens towards. The profile of the channel may be helpful in directing saline solution to clear the seal of the slit after a blood sample is taken. The structural element 360 may be configured to extend through (e.g., penetrate) the slit 232 in the septum 330 when the septum 330 is depressed or actuated. Accordingly, the structural element 360 is typically aligned with the port 220 (e.g., so that the structural element 360 is positioned below the port 220 so that the structural element 360 penetrates the slit 232 when the septum 230 is in the second state).

[00132] The operation of the valve 300 is shown in FIGS. 14 and 15. The septum 330 may include a plug portion 370 and a skirt portion 372 depending from the plug portion 370. In this embodiment, an annular extension 374 may extend from the periphery of the skirt portion 372, and may be generally distributed about a plane perpendicular to the central longitudinal axis Z— Z (e.g., as shown in FIG. 4) of the port 220. The slit 232 extends through the plug portion 370 from the top or outer surface 376 of the plug portion 370 to the bottom or inner surface 378 of the plug portion 370 (e.g., the slit extends through the thickness of the plug portion separating the top surface and the bottom surface). FIGS. 14 and 16 show the septum 330 in an initial, unactuated position or first state, in which the plug portion 370 is disposed in the port 220, spaced from the structural element 360, with the slit 232 closed, sealing off the cavity 240 defined by the housing 202 from the exterior of the valve 300. In other words, the slit, when closed, prevents fluidic communication between the bottom surface of the plug portion, which is in fluidic communication with the cavity, and the top surface of the plug portion. Although fluidic communication through the slit is prevented, the conduits 242, 244 remain in fluidic communication. The periphery (e.g., peripheral edge) of the skirt portion 372 and the annular extension 374 are secured between the cover 310 and the body 204, which also provides a seal.

[00133] FIG. 15 shows how the septum deviates when a male luer (not shown) of a needleless syringe is inserted through the port 220 to actuate the septum 330. In doing do, the septum 330 may be depressed to an actuated position or second state. In the second state, the structural element 360 may extend through (e.g., penetrate) the slit 232 and the slit 232 opens, placing the channel 362 and the cavity 240 in fluidic communication with the lumen 282 of the male luer, which allows the liquid (e.g., liquid from both conduits 242, 244) to flow through the slit 232. Some flow may or may not occur through the slit 232 opening on the outside of the structural element 360 as well. The end of the male luer may form a seal with the septum 330, preventing liquid from passing into the space 284 now formed by the inside surface of the cover 210 and the top surface of the septum 330.

[00134] FIGS. 17 and 18 show a top and a bottom of an embodiment of the septum 330, respectively, and FIG. 19 shows a cross-section, with the plug portion 370 having the vertical slit 232 through it across part of the width of the plug portion 370, as previously described. The skirt portion 372 may extend downward from the plug portion 370 and then outward to the annular extension 374, may have walls of substantially constant thickness, and may form a concave shape relative to the cavity 240 of the housing. In this embodiment the skirt portion 372 substantially conforms to the shape of the inside of the cover 310, which may minimize open space between the inside of the cover 310 and the top side of the septum 330 to the benefit of frequency response and minimizing residual liquid at the exposed surfaces of the port 220 and septum 330.

[00135] FIGS. 20-28 show another embodiment of a valve 400. Referring to FIG. 20, the valve 400 may have a cover 410 of the housing 202 that may include an annular portion 414. A central round opening in the cover 410 may be provided, and in the embodiment shown the cover 410 includes a neck 218 that extends upward from the annular portion 414 to provide a port 220 that is a connection for a sampling reservoir, such as a needleless syringe. A septum 430 may be disposed (e.g., slidably disposed) in the port 220 and may have a slit 232 extending through it. In this embodiment, the slit 232 may be aligned along the axes XI— XI and X2— X2 of the conduits 242, 244 as shown in FIG. 4.

[00136] FIGS. 21 and 22 show the interior of the housing 202, with the cover 410 and septum 430 removed from the body 204 of the housing 202. A base surface 213 and peripheral wall 215 of the housing 202 define a cavity 240 for receiving liquid from conduits 242, 244 that may be defined in the body 204. As shown in FIG. 22, the conduits 242, 244 may terminate at the peripheral wall 215 and proximate to the base surface (e.g., near the bottom of the cavity 240). A structural element 460 may extend into the cavity 240 from the base surface 213 of the housing 202. The structural element 460 shown in this embodiment is wider at the base and narrows as it extends upward. For example, the structural element may taper with curves on each of two edge faces to nearly a point at its distal end, and may be distributed about a plane that may be perpendicular to the direction of flow 250, 252, generally taking on the shape of a spade and having flat surfaces on opposite sides. The flat surfaces perpendicular to the direction of flow 250, 252 may help redirect flow 250, 252 upward to the port 220, as discussed below. As depicted in FIG 22, the structural element 460 may include a wall portion 461 extending between opposing sides of the peripheral wall 215 and a penetrating member 463 extending above the wall portion 461. The penetrating member 463 may be configured to extend through (e.g., penetrate) the slit 232 in the septum 430 when the septum 430 is depressed or actuated. Accordingly, the structural element 460 and the penetrating member 463 are typically aligned with the port 220 (e.g., so that the structural element 460 is positioned below the port 220 so that the penetrating member 463 penetrates the slit 232 when the septum 230 is in the second state). The plane of the structural element 460 may be perpendicular or substantially perpendicular to the slit 232, which may help the penetrating member 463 to open the slit 232.

[00137] The operation of the valve 400 is shown in FIGS. 23-25. The septum 430 may include a plug portion 470 and a skirt portion 472 depending from the plug portion 470. In this embodiment, an annular extension 474 may extend from the periphery of the skirt portion 472, and may generally be distributed about a plane perpendicular to the central longitudinal axis Z— Z of the port 220 shown in FIG. 5. The slit 232 extends through the plug portion 470 from the top or outer surface 476 of the plug portion 470 to the bottom or inner surface 478 of the plug portion 470 (e.g., the slit extends through the thickness of the plug portion separating the top surface and the bottom surface). FIGS. 23 and 24 show the septum 430 in an initial, unactuated position or first state, in which the plug portion 470 is disposed in the port 220, spaced from the structural element 460, with the slit 232 closed, sealing off the cavity 240 defined by the housing 202 from the exterior of the valve 400. In other words, the slit, when closed, prevents fluidic communication between the bottom surface of the plug portion, which is in fluidic communication with the cavity, and the top surface of the plug portion. Although fluidic communication through the slit is prevented, the conduits 242, 244 remain in fluidic communication. The periphery (e.g., peripheral edge) of the skirt portion 472 and the annular extension 474 are secured between the cover 410 and the body 204, which also provides a seal. To assist with the seal, an annular ridge 480, which in the embodiment shown is rounded, may extend upward from the body 204 of the housing 202 into the annular extension 474. In this embodiment of the valve 400 there may be a space 482 created between the inner surface of the cover 410 and the outer surface of the skirt portion 472.

[00138] FIG. 25 shows the deflection of the septum when a male luer (not shown) of a needleless syringe is inserted through the port 220 to actuate the septum 430. In doing do, the septum 430 may be depressed to an actuated position or second state. In the second state, the structural element 460 may extend through (e.g., penetrate) the slit 232 and the slit 232 opens, with the plane of the structural element 460 and the structural element 460 itself in a perpendicular or substantially perpendicular relationship with the alignment or plane of the slit 232. The structural element 460 extending through the slit 232 may allow the liquid (e.g., liquid from the conduits 242, 244) to flow through the slit 232. The opening in the slit 232 around the structural element 460 may have a larger area for flow 250, 252 than if the slit 232 and the structural element 460 were in parallel alignment. The end of the male luer may form a seal with the septum 430, preventing liquid from passing into the space 284 now formed by the inside surface of the cover 210 and the top surface of the septum 430.

[00139] FIGS. 26 and 27 show top and bottom of an embodiment of the septum 430, respectively, and FIG. 28 shows a cross-section, with the plug portion 470 having the vertical slit 232 through it across part of the width of the plug portion 470, as previously described. The skirt portion 472 may extend downward from the plug portion 470 and then outward to the annular extension 474. Rather than having walls of constant thickness, there may be at least one section with thinner walls, and this may be considered a collapse point 484. A collapse point is a relatively thinner section of the wall that encourages, through its consequently relatively weaker wall, the septum 430 to bend or deform at that location. It may be that the remainder of the walls of the skirt portion 472 has walls of substantially constant thickness as shown. In some embodiments, multiple collapse points trending outward may act to open the septum. In the compressed mode, the thicker sections contact may each other and contribute to a stiff er seal. The septum 430 may form, for example, a concave shape relative to the cavity 240 of the housing, or may form contiguous frustoconical shapes with its interior surface, as shown. As shown in FIGS. 23-25, an annular recess 486, which may be radially rounded, may be provided on the bottom or other surface of the annular extension 474 to receive a corresponding annular ridge such as annular ridge 480.

[00140] FIGS. 29-37 show another embodiment of a valve 500. This embodiment may be designed to provide an integral shut-off feature, in which the flow of saline or other fluid from the side of the valve opposite the patient is prevented when a sample is being taken from the port 220. Referring to FIG. 29, the valve 500 may have a cover 510 of the housing 202 that may include an annular portion 514. A central round opening in the cover 510 may be provided, and in the embodiment shown the cover 510 includes a neck 218 that extends upward from the annular portion 514 to provide a port 220 that is a connection for a sampling reservoir, such as a needleless syringe. A septum 530 may be disposed (e.g., slidably disposed) in the port 220 and may have a slit 232 extending through it.

[00141] FIGS. 30 and 31 show the interior of the housing 202, with the cover 510 and septum 530 removed from the body 204 of the housing 202. A base surface 582 and peripheral wall 515 of the housing 202 define a cavity 240 for receiving liquid from conduits 242, 244 that may be defined in the body 204. The conduit 244 may terminate in a channel 546 defined by the base surface 582 that may extend in a circular footprint at least partially around a portion of the base surface 582. As shown in FIGS. 30-31 the channel 546 may define an arc-like shape (e.g., in the shape of a horseshoe). The other conduit 242 may be in fluidic communication with the cavity 240 by terminating in a passage 548 (e.g., a vertical passage) that has a proximal end in the body and a distal end that terminates in the cavity 240. The channel 546 typically at least partially surrounds the distal end of the passage 548. As depicted in FIGS. 30-31, the passage 548 may have a slightly elongated cross section. A structural element 560 (e.g., penetrating member) may extend into the cavity 240 from the base surface 582 of the housing 202. The structural element 560 may define a channel 562 in which the passage 548 terminates. The structural element 560 shown in this embodiment is wider at the base and narrows as it extends upward, tapering to nearly a point at its distal end. The structural element 560 may in one side be hollowed-out to define the channel 562, forming a flow path upward in its laterally opened channel 562 along its length to receive flow from the conduit 242 via the passage 548 that the shape of the structural element 560 opens towards. The profile of the channel may be helpful in directing saline solution to clear the seal of the slit after a blood sample is taken. The structural element 560 may be configured to extend through (e.g., penetrate) the slit 232 in the septum 530 when the septum 530 is depressed or actuated. Accordingly, the structural element 560 is typically aligned with the port 220 (e.g., so that the structural element 560 is positioned below the port 220 so that the structural element 560 penetrates the slit 232 when the septum 530 is in the second state).

[00142] The operation of the valve 500 is shown in FIGS. 32 and 33. The septum 530 may include a plug portion 570 and a skirt portion 572 depending from the plug portion 570. In this embodiment, an annular extension 574 may extend from the periphery of the skirt portion 572, and may be generally distributed about a plane perpendicular to the central longitudinal axis Z— Z (e.g., as shown in FIG. 4) of the port 220. The slit 232 extends through the plug portion 570 from the top or outer surface 576 of the plug portion 570 to the bottom or inner surface 578 of the plug portion 570 (e.g., the slit extends through the thickness of the plug portion separating the top surface and the bottom surface). FIGS. 32 and 34 show the septum 530 in an initial, unactuated position or first state, in which the plug portion 570 is disposed in the port 220, spaced from the structural element 560, with the slit 232 closed, sealing off the cavity 240 defined by the housing 202 from the exterior of the valve 500. In other words, the slit, when closed, prevents fluidic communication between the bottom surface of the plug portion, which is in fluidic communication with the cavity, and the top surface of the plug portion. Although fluidic communication through the slit is prevented, the conduits 242, 244 remain in fluidic communication. The periphery (e.g., peripheral edge) of the skirt portion 572 and the annular extension 574 are secured between the cover 510 and the body 204, which also provides a seal. An annular ridge 580, which in this embodiment is shown to be asymmetrical and have sharp edges, may extend from the body 204 of the housing 202 to assist with the seal and securing the septum 530 in position. In this embodiment, there is a space 581 formed between the inner surface of the cover 510 and the outer surface of the septum, which may be used to control the performance of the valve 500.

[00143] FIG. 33 shows the deflection of the septum 530 when a male luer (not shown) of a needleless syringe is inserted through the port 220 to actuate the septum 530. In doing do, the septum 530 may be depressed to an actuated position or second state. In the second state, the structural element 560 may extend through (e.g., penetrate) the slit 232 and the slit 232 opens, placing the channel 562 and the cavity 240 in fluidic communication with the lumen 282 of the male luer, allowing the liquid to flow through the slit 232. Some flow may or may not occur through the slit 232 opening on the outside of the structural element 560 as well. The end of the male luer may form a seal with the septum 530, preventing liquid from passing into the space 284 now formed by the inside surface of the cover 210 and the top surface of the septum 530.

[00144] Concurrently, the septum 530 is lowered over the channel 546 and abuts the body 204 of the housing 202 at the base surface 582. The septum 530 may deform and deflect to form a seal with the base surface 582 to eliminate, temporarily, fluidic communication between the conduit 244 and the other conduit 242 and prevent fluidic communication from the conduit 244 through the slit 232, thereby creating an integral shut-off feature.

[00145] FIGS. 35 and 36 show top and bottom of an embodiment of the septum 530, respectively, and FIG. 37 shows a cross-section, with the plug portion 570 having the vertical slit 232 through it across part of the width of the plug portion 570, as previously described. The skirt portion 572 may extend downward from the plug portion 570 and then outward to the annular extension 574, and may have a wall of varying thickness. For example, the wall may have a thinner section at a collapse point 584, and a thicker section 586 closer to the annular extension 574. The interior shape of the septum 530 may be, for example, a combination of substantially contiguous frustoconical shape, cylindrical shapes, convex shapes, concave shapes, or any combination thereof. In this embodiment the shape may be described as a combination of substantially frustoconical shapes with rounded intersecting transitions.

[00146] The valves depicted in FIGS. 38-113 also typically include an integral shut- off feature. In some embodiments, the valves include structural elements that engage the septum to assist with opening of the slit (e.g., by extending through or penetrating the slit). In other embodiments, the valves do not include a protrusion at all and may rely entirely on the configuration and materials of the septum to cause the slit to open when actuated.

[00147] FIGS. 38-46 show another embodiment of a valve 600 that may be provided with an integral shut-off feature, but this time may lack a penetrating structural element. Referring to FIG. 38, the valve 600 may have a cover 610 of the housing 202 that may include an annular portion 614. A central round opening in the cover 610 may be provided, and in the embodiment shown the cover 610 includes a neck 218 that extends upward from the annular portion 614 to provide a port 220 that is a connection for a sampling reservoir, such as a needleless syringe. A septum 630 may be disposed (e.g., slidably disposed) in the port 220 and may have a slit 232 extending through it.

[00148] FIGS. 39 and 40 show the interior of the housing 202, with the cover 610 and septum 630 removed from the body 204 of the housing 202. A base surface 682 and peripheral wall 615 of the housing 202 define a cavity 240 for receiving liquid from conduits 242, 244 that may be defined in the body 204. The conduit 244 may terminate in a channel 646 defined by the base surface 682 that may extend in a circular footprint at least partially around a portion of the base surface 682. As shown in FIGS. 39-40 the channel 646 may define an arc-like shape (e.g., in the shape of a horseshoe). The other conduit 242 may be in fluidic communication with the cavity 240 by terminating in a passage 648 (e.g., a vertical passage) that has a proximal end in the body and a distal end that terminates in the cavity 240 (e.g., at the base surface 682). The channel 646 typically at least partially surrounds the distal end of the passage 648. As depicted in FIGS. 39-40, the distal end of the passage 648 may define an elongated channel in the base surface 682. The distal end of the passage 648 is typically aligned with the port 220 (e.g., so that distal end of the passage 648 is positioned below the port 220 so that the passage is in fluidic communication through the slit 232 when the septum 630 is in the second state).

[00149] The operation of the valve 600 is shown in FIGS. 41 and 42. The septum 630 may include a plug portion 670 and a skirt portion 672 depending from the plug portion 670. In this embodiment, an annular extension 674 may extend from the periphery of the skirt portion 672, and may be generally distributed about a plane parallel to the central longitudinal axis Z— Z (e.g., as shown in FIG. 4) of the port 220 in both directions, upward and downward. The slit 232 extends through the plug portion 670 from the top or outer surface 676 of the plug portion 670 to the bottom or inner surface 678 of the plug portion 670 (e.g., the slit extends through the thickness of the plug portion separating the top surface and the bottom surface). FIGS. 41 and 43 show the septum 630 in an initial, unactuated position or first state, in which the plug portion 670 is disposed in the port 220 with the slit 232 closed, sealing off the cavity 240 defined by the housing 202 from the exterior of the valve 600. In other words, the slit, when closed, prevents fluidic communication between the bottom surface of the plug portion, which is in fluidic communication with the cavity, and the top surface of the plug portion. Although fluidic communication through the slit is prevented, the conduits 242, 244 remain in fluidic communication. The periphery (e.g., peripheral edge) of the skirt portion 672 and the annular extension 674 are secured between the cover 610 and the body 204, which also provides a seal. In this embodiment, there is no space between the inner surface of the cover 610 and the outer surface of the septum, which may eliminate or minimize residual liquid in that location.

[00150] FIG. 42 shows deflection of the septum when a male luer (not shown) of a needleless syringe is inserted through the port 220 to actuate the septum 630. In doing do, the septum 630 may be depressed to an actuated position or second state. In the second state, the depressed septum 630 is caused by its configuration and materials to open automatically as it is moved to the actuated position. In the actuated position, the slit 232 opens to place the passage 648 (and thus the conduit 242) in fluidic communication with the lumen 282 of the male luer, allowing the liquid to flow through the slit 232. As the septum 630 is lowered over the channel 646, it abuts the body 204 of the housing 202 at the base surface 682. The septum 630 may deform and deflect to form a seal with the base surface 682 to eliminate, temporarily, fluidic communication between the conduit 244 and the other conduit 242 and prevent fluidic communication from the conduit 244 through the slit 232, thereby creating an integral shut-off feature.

[00151] FIGS. 44 and 45 show top and bottom of an embodiment of the septum 630, respectively, and FIG. 46 shows a cross-section, with the plug portion 670 having the vertical slit 232 through it across part of the width of the plug portion 670, as previously described. The skirt portion 672 may extend downward from the plug portion 670 and then outward to the annular extension 674, and may have a wall of varying thickness. For example, the wall may have a thinner section at a collapse point 684, then a thicker section 686, and an angled section 688 of relatively constant wall thickness close to the annular extension 674. The interior shape of the septum 630 may be, for example, a combination of substantially contiguous frustoconical shape, cylindrical shapes, convex shapes, concave shapes, or any combination thereof. In this embodiment the interior of the skirt portion 672 may be described as a combination of substantially cylindrical and frustoconical shapes.

[00152] FIGS. 47-55 show another embodiment of a valve 700 that may be provided with an integral shut-off feature, again lacking a penetrating structural element. Referring to FIG. 38, the valve 700 may have a cover 710 of the housing 202 that may include an annular portion 714. A central round opening in the cover 710 may be provided, and in the embodiment shown the cover 710 includes a neck 218 that extends upward from the annular portion 714 to provide a port 220 that is a connection for a sampling reservoir, such as a needleless syringe. A septum 730 may be disposed (e.g., slidably disposed) in the port 220 and may have a slit 232 extending through it.

[00153] FIGS. 48 and 49 show the interior of the housing 202, with the cover 710 and septum 730 removed from the body 204 of the housing 202. A base surface 783 and peripheral wall 715 of the housing 202 define a cavity 240 for receiving liquid from conduits 242, 244 that may be defined in the body 204. The conduit 244 may terminate in a channel 746 defined by the base surface 783 that may extend in a circular footprint at least partially around a portion of the base surface 783. As shown in FIGS. 48-49 the channel 746 may define an arc-like shape (e.g., in the shape of a horseshoe). The other conduit 242 may be in fluidic communication with the cavity 240 by terminating in a passage 748 (e.g., a vertical passage) that has a proximal end in the body and a distal end that terminates in the cavity 240 (e.g., at the base surface 783). The channel 746 typically at least partially surrounds the distal end of the passage 748. As depicted in FIGS. 48-49, the distal end of the passage 748 may define a circular opening in the base surface 783. The distal end of the passage 748 is typically aligned with the port 220 (e.g., so that distal end of the passage 748 is positioned below the port 220 so that the passage is in fluidic communication through the slit 232 when the septum 730 is in the second state). The base surface 683 may define an annular flange 780 that extends around the distal end of the passage 748.

[00154] The operation of the valve 700 is shown in FIGS. 50 and 51. The septum 730 may include a plug portion 770 and a skirt portion 772 depending from the plug portion 770. In this embodiment, an annular extension 774 may extend from the periphery of the skirt portion 772, and may be generally distributed about a plane parallel to the central longitudinal axis Z— Z (e.g., as shown in FIG. 4) of the port 220, extending upward. The slit 232 extends through the plug portion 770 from the top or outer surface 776 of the plug portion 770 to the bottom or inner surface 778 of the plug portion 770 (e.g., the slit extends through the thickness of the plug portion separating the top surface and the bottom surface). FIGS. 50 and 52 show the septum 730 in an initial, unactuated position or first state, in which the plug portion 770 is disposed in the port 220 with the slit 232 closed, sealing off the cavity 240 defined by the housing 202 from the exterior of the valve 700. In other words, the slit, when closed, prevents fluidic communication between the bottom surface of the plug portion, which is in fluidic communication with the cavity, and the top surface of the plug portion. Although fluidic communication through the slit is prevented, the conduits 242, 244 remain in fluidic communication. The periphery (e.g., peripheral edge) of the skirt portion 772 and the annular extension 774 are secured between the cover 710 and the body 204, which also provides a seal. In this embodiment, there is a space 781 between the inner surface of the cover 710 and the outer surface of the septum 730, which may provide an effect on the response and performance of the valve 700.

[00155] FIG. 51 shows the male luer 280 of a needleless syringe inserted through the port 220 to actuate the septum 730. In doing do, the septum 730 may be depressed to an actuated position or second state. In the second state, the depressed septum 730 is caused by its configuration and materials to open automatically as it is moved to the actuated position. In the actuated position, the slit 232 opens to place the passage 748 (and thus the conduit 242) in fluidic communication with the lumen 282 of the male luer 280, allowing the liquid to flow through the slit 232. As the septum 730 is lowered over the vertical, circular channel 746, it abuts the body 204 of the housing 202 at the annular flange 780 that extends around the distal end of the passage 748. The septum 730 may deform and deflect to form a seal with this annular flange 780 to eliminate, temporarily, fluidic communication between the conduit 244 and the other conduit 242 and prevent fluidic communication from the conduit 244 through the slit 232, thereby creating an integral shut-off feature.

[00156] FIGS. 53 and 54 show top and bottom of an embodiment of the septum 730, respectively, and FIG. 55 shows a cross-section, with the plug portion 770 having the vertical slit 232 through it across part of the width of the plug portion 770, as previously described. The skirt portion 772 may extend downward from the plug portion 770 and then outward to the annular extension 774, and may have a wall of varying thickness. For example, the wall may have a thinner section at a collapse point 782, then a thicker section 784, and an angled, stepped section 786 close to the annular extension 774. The interior shape of the septum 730 may again be, for example, a combination of substantially contiguous frustoconical shape, cylindrical shapes, convex shapes, concave shapes, or any combination thereof. In this embodiment the interior of the skirt portion 772 may be described as a combination of substantially frustoconical and flared shapes.

Claims

What is claimed is:

1. A medical valve comprising:

a housing comprising:

a body having a base surface and a peripheral wall defining a cavity;

a first conduit having an associated first end in fluidic communication with the cavity; and

a second conduit having an associated first end in fluidic communication with the cavity;

a septum member comprising:

a plug having an upper surface and a lower surface separated by a plug thickness;

a slit extending at least partially through the plug thickness; and a skirt extending from the plug; and

a cover member coupled with the body and positioned over the base surface, the cover member comprising an access port slidably receiving the plug, wherein the skirt is positioned over the base surface and the first ends associated with the first and second conduits.

2. The medical valve of claim 1 , wherein the skirt terminates in a continuous peripheral skirt edge forming a sealing relationship between the cover member and the housing.

3. The medical valve of claim 2, wherein the lower surface of the plug is in fluidic communication with the cavity.

4. The medical valve of claim 1 , wherein the septum member is configured to transition from a first state to a second state,

where in the first state, the first conduit and the second conduit are in fluidic communication, and fluidic communication through the slit is prevented; and where in the second state, the first conduit is in fluidic communication through the slit and wherein at least a portion of the septum member substantially blocks fluidic communication between the first conduit and the second conduit.

5. The medical valve of claim 4, wherein the housing defines a first passage having a proximal end in the body and having a distal end terminating in the cavity, the first end of the first conduit terminating in the first passage.

6. The medical valve of claim 5, wherein the distal end of the first passage terminates at the base surface and is aligned with the access port.

7. The medical valve of claim 6, wherein the base surface defines an annular flange around the distal end of the first passage, the annular flange being configured to receive a portion of the septum member when the septum member is in the second state.

8. The medical valve of claim 5, wherein the housing defines a second passage having a proximal end in the body and a distal end terminating in the cavity, the first end of the second conduit terminating in the second passage.

9. The medical valve of claim 1, wherein the septum member is configured to transition from a first state to a second state,

where in the first state, the first conduit and the second conduit are in fluidic communication, and fluidic communication through the slit is prevented; and

where in the second state, the first conduit and the second conduit are in fluidic communication through the slit.

10. The medical valve of claim 9, wherein the housing comprises a structural element extending from the base surface and terminating at a distal end, the structural element being aligned with the access port.

11. The medical valve of claim 10, wherein the structural element defines a shape that is relatively narrower at its distal end and relatively wider at the base surface.

12. The medical valve of claim 10, wherein the distal end of the structural element at least partially penetrates the slit in the second state.

13. The medical valve of claim 10, wherein:

the first end of the first conduit terminates at the peripheral wall and proximate to the base surface; and

the first end of the second conduit terminates at the peripheral wall and proximate to the base surface.

14 The medical valve of claim 10, wherein the structural element defining a laterally open channel extending from the base surface to its distal end, the channel being laterally open towards the first end of the first conduit.

15. The medical valve of claim 14, wherein the structural element comprises:

a wall portion extending between a first portion of the peripheral wall and a second portion of the peripheral wall; and

a penetrating member extending above the wall portion and being aligned with the access port, the penetrating member comprising the distal end of the structural element.

16. The medical valve of claim 10, wherein the structural element comprises:

17. The medical valve of claim 1, wherein the housing defines a first passage having a proximal end in the body and a distal end, the first end of the first conduit terminating in the first passage, the distal end of the first passage terminating vertically displaced from the base surface.

18. The medical valve of claim 1, wherein the housing defines a first passage having a proximal end in the body and having a distal end, the first end of the first conduit terminating in the first passage, the distal end of the first passage terminating flush with the base surface.

19. The medical valve of claim 1, wherein the housing comprises a structural element extending from the base surface and terminating at a distal end, the structural element being aligned with the access port.

20. The medical valve of claim 19, wherein the structural element defines a shape that is relatively narrower at its distal end and relatively wider at the base surface.

21. The medical valve of claim 19, wherein the septum member is configured to transition from a first state to a second state,

where in the first state, the first conduit and the second conduit are in fluidic communication, and fluidic communication through the slit is prevented, and

where in the second state, the septum member provides fluidic communication from the first conduit through the slit and at least a portion of the septum member substantially blocks fluidic communication between the first conduit and the second conduit, the distal end of the structural element at least partially penetrating the slit in the second state.

22. The medical valve of claim 19, wherein the housing defines a first passage having a proximal end in the body and a distal end, the first passage extending from its proximal end through the structural element with the distal end of the first passage terminating in the cavity at the distal end of the structural element, the first end of the first conduit terminating in the first passage.

23. The medical valve of claim 22, wherein the housing defines a second passage having a proximal end in the body and a distal end terminating in the cavity, the first end of the second conduit terminating in the second passage.

24. The medical valve of claim 23, wherein the second passage extends substantially vertically from the first end of the second conduit to the base surface.

25. The medical valve of claim 22, wherein the structural element has a substantially cylindrical or frustoconical shape.

26. The medical valve of claim 22, wherein the septum member is configured to transition from a first state to a second state,

where in the second state, the septum member provides fluidic communication from the first conduit through the slit and at least a portion of the septum member substantially blocks fluidic communication between the first conduit and the second conduit.

27. The medical valve of claim 26, wherein the distal end of the structural element at least partially penetrates the slit in the second state.

28. The medical valve of claim 1, wherein:

the housing defines a first passage having a proximal end in the body and a distal end terminating in the cavity, the distal end of the first passage being aligned with the access port, the first end of the first conduit terminating in the first passage; and

the base surface defines a first channel therein, the first channel at least partially surrounding the distal end of the first passage, the first end of the second conduit terminating in the first channel.

29. The medical valve of claim 28, wherein the septum member is configured to transition from a first state to a second state,

30. The medical valve of claim 28, wherein the first channel defines an arc-like shape at least partially surrounding the distal end of the first passage.

31. The medical valve of claim 30, wherein the distal end of the first passage defines an elongated channel in the base surface.

32. The medical valve of claim 30, wherein the housing comprises a structural element extending from the base surface and terminating at a distal end, the structural element being aligned with the access port, the first channel at least partially surrounding the structural element.

33. The medical valve of claim 32, wherein the structural element defines a shape that is relatively wider at the base surface and relatively narrower at its distal end, the structural element defining a laterally open second channel extending from the base surface to its distal end, the distal end of the first passage terminating in the second channel.

34. The medical valve of claim 33, wherein the septum member is configured to transition from a first state to a second state, where in the first state, the first conduit and the second conduit are in fluidic communication, and fluidic communication through the slit is prevented, and