Patent Description:
Certain medical valves are used to permit fluid flow in either a first direction, such as for infusion through the valve, or a second direction, such as for aspiration through the valve. Known bidirectional medical valves, however, suffer from one or more drawbacks. Various limitations of such bidirectional medical valves can be resolved, remedied, ameliorated, or avoided by certain embodiments described herein. <CIT> ANGIODYNAMICS INC describes a pressure activated two-way slit valve assembly is designed to be used in combination with, but not limited to, a high flow rate catheter to prevent accidental ingestion of air or loss of blood if the closure cap comes off during non-use of the catheter. In addition, the potential for occlusion of the catheter due to blood clots in the catheter and catheter related infection is substantially reduced. The pressure activated two-way slit valve assembly includes a first end, a second end, a wall defining a dumbbell shaped channel, and a flexible, thin disk having a slit and positioned within the pressure activated two-way slit valve assembly to reside within the dumbbell shaped channel. The slit and the dumbbell shaped channel are sized to enable the slit to deform in response to a predetermined pressure differential across the slit to allow fluid to pass therethrough. <CIT> AMERICAN HOSPITAL SUPPLY CORP describes an administration set with a check valve above a side port where the side port is used for the introduction of a secondary liquid, and this check valve is extremely sensitive to minute pressure changes in the combined administration set. The valve includes a very light disk supported on a series of upstanding prongs that hold a sealing surface of the disk to within <NUM> to <NUM> inch of a valve seat when in open position. The highly sensitive valve is easy to manufacture, easy to prime, and resists malfunctioning due to sticking shut or open. The valve also permits high flow rates (up to <NUM>/hr. or more) commonly used in medical administration sets. <CIT> ANGIODYNAMICS INC describes a bi-directional, pressure-actuated medical valve assembly for improved control of fluids and related methods of use are described. The pressure-actuated, bi-directional valve includes a first flow control portion permitting fluid to flow in a first direction when subjected to a first pressure threshold and a second control flow portion for permitting fluid to flow in a second direction when subjected to a second pressure threshold. <CIT> DIKEMAN W. CARY & SPIKER KENY describes a pressure actuated flow control valve for an infusion catheter permits gravity flow of a liquid through the catheter and into a patient while resisting back flow of blood from the patient and into the catheter. The valve has a hemispherical body with an outstanding circumferential flange and a normally closed, diametric slit. The slit is longer on the convex outer surface than on the concave inner surface. Dome thickness diminishes in the area adjacent the slit, reducing total apical deflection upon collapse of the slit toward the concave surface. An inner orthogonal rib biases the slit closed. Upon application of a predetermined pressure, the slit opens toward the concave surface to permit forward fluid flow. At lower pressures, the slit closes to check fluid flow. Greater reverse pressure is required to collapse the slit toward the concave surface to permit reverse fluid flow.

The written disclosure herein describes illustrative embodiments that are nonlimiting and non-exhaustive. Reference is made to certain of such illustrative embodiments that are depicted in the figures, in which:.

The present disclosure relates generally to valves, and more particularly relates to bidirectional valves. Certain embodiments of valves disclosed herein can be particularly useful for a variety of medical applications. For example, embodiments of the valves may be particularly well suited for use in applications in which different cracking pressures in opposite directions of fluid flow are desired. In some instances, the valves can be used advantageously with catheters via which fluids are infused into a patient and/or via which blood is drawn or aspirated from the patient. Certain embodiments may perform well at flushing blood from the bidirectional valve after blood draws have been taken through the valve. In some embodiments, the valves may further be suitable for power injection. For example, certain valves may be used as proximal valves in PICC catheters, such as power injectable PICC catheters. These and other advantages will be evident from the present disclosure.

Proximal valves for PICC catheters are known in the art. Proximal valves generally are coupled to the proximal ends of catheter assemblies in which a catheter body is insertable into a body of a patient, and the valves remain at an exterior of the patient when the catheter body is in place within the patient to provide access to one or more lumens of the catheter. Such proximal valves generally can be used to infuse one or more fluids into a patient and/or to aspirate blood or other fluids from the patient. Known proximal valves, however, suffer from a variety of drawbacks.

For example, some known proximal valves include geometries, architectures, or internal configurations that inhibit blood and/or microbes from being flushed from the valves. In some instances, blood that is drawn into a proximal chamber of the valve during aspiration can enter between a shelf-like feature within a housing of the valve and a septum. Upon subsequent infusion through the valve, at least some of the blood can become trapped in this region, as fluid dynamics of the pressurized infusion fluid act to maintain at least some of the trapped blood in place, or push it further into crevices between adjacent surfaces, rather than clear the blood from this region. Stated otherwise, the shelf-like feature does not permit fluid to get in between the septum and the shelf-like feature, thereby trapping blood between these components. Similarly, microbes within the valve can be urged into such regions and permitted to colonize, rather than being flushed out.

In other or further instances, known proximal valves suffer from significant variation in one or more cracking pressures. The term "cracking pressure" is used herein in its ordinary sense, and includes, for example, a pressure differential across a feature at which a closure in that feature opens to permit fluid to flow through the closure. The term "closure" is used herein in its ordinary sense, and includes, for example, any suitable feature that can be closed and/or selectively opened. Thus, the term "closure" is not meant to imply a feature that is permanently closed, but rather, a feature that can be in a closed configuration to prevent fluid flow therethrough and may be transitioned to an open configuration to permit fluid flow therethrough. In some embodiments, a closure may be biased toward the closed configuration, and this bias may be overcome to open the closure. In other embodiments, the closure may be biased toward the open configuration, and this bias may be overcome to close the closure.

Certain known proximal valves may suffer from inconsistent infusion cracking pressures and/or inconsistent aspiration cracking pressures from one valve to the next, despite manufacturers' attempts to produce substantially identical or consistent valves. For example, one known bidirectional proximal valve includes an elastomeric septum that includes three closures. To permit fluid flow through the valve in one direction, a first of the three closures opens while the second and third closures remain closed, whereas to permit fluid flow through the valve in the opposite direction, the second and third closures open and the first valve closes. The cracking pressure of the first closure and/or the cracking pressure (or pressures) of the second and third closures can be widely inconsistent from one valve to the next. These inconsistencies may result, for example, from minor variations in the thickness of the septum and/or variations in the hardness of the material from which the septum is fabricated from one valve to the next and/or from one manufacturing lot to the next.

Often, such proximal valves may be incorporated into catheter assemblies prior to determining that one or more cracking pressures are outside of the manufacturer's tolerances, and the catheter assemblies must then be discarded. This can lead to significant material waste and heightened manufacturing costs.

Further, inconsistent cracking pressures, or even cracking pressures that vary within a large range of "acceptable" values (as determined by a manufacturer), can lead to unreliable tactile feedback during use of the catheter assemblies. For example, practitioners in many instances use tactile feedback to determine whether infusion and/or aspiration through a catheter assembly requires greater pressure than expected. Practitioners can develop a sense for whether or not a catheter is occluded based on how easy or difficult it is to infuse or aspirate through the catheter. Variation in cracking pressures in the proximal valve, however, can make it difficult for practitioners to gain an accurate sense for when occlusions may be present. For example, in many instances, practitioners may inaccurately conclude that a catheter is occluded when, in fact, the aspiration or infusion through a proximal valve is merely more difficult, as compared with the proximal valves of other catheter assemblies, due to variation in the cracking pressures of the proximal valves.

In other or further instances, inconsistent cracking pressures and/or valve degradation or failure of known proximal valves may result from the presence of stylets or guidewires within the valves. For example, in some instances, catheter assemblies may be prepackaged with a stylet extending through a proximal valve. In some instances, a proximal valve may include a slit through which the stylet passes. Over time, the presence of the stylet may deform one or more adjacent contact surfaces of the slit such that the contact surfaces may not align properly to seal the slit. Thus, the proximal valve may no longer operate as designed.

Certain embodiments described herein address, ameliorate, resolve, or avoid one or more of the foregoing disadvantages of known proximal valves. For example, various embodiments disclosed herein are configured to more effectively flush blood from a proximal chamber, to be manufactured with consistent and repeatable cracking pressures, and/or to be prepackaged with stylets extending therethrough or to permit guidewires to be passed therethrough without any degradation in valving performance. Various embodiments, can achieve one or more of these and/or other advantages, including those expressly discussed herein and those otherwise apparent from the present disclosure.

<FIG> depicts an embodiment of a catheter assembly <NUM> that includes a catheter body <NUM> (which may also be referred to as a catheter, catheter sheath, etc.), a junction <NUM>, a pair of extension legs <NUM>, <NUM>, and a pair of proximal valves <NUM>, <NUM> attached to the respective proximal ends of the extension legs <NUM>, <NUM>. The illustrated catheter body <NUM> includes two lumens (not shown), and each lumen is in fluid communication with a respective one of the extension legs <NUM>, <NUM> and a respective one of the proximal valves <NUM>, <NUM> via fluid channels (not shown) that extend through the junction <NUM>. The catheter assembly <NUM> can further include a pair of clamps <NUM>, <NUM>: one for each extension leg <NUM>, <NUM>, respectively. In the illustrated embodiment, the two lumens through the catheter body <NUM> extend fully from a proximal end of the catheter body <NUM> to a distal end thereof. The lumens thus may terminate at a distal tip of the catheter body <NUM>. Other suitable arrangements or configurations of the lumens are contemplated.

The catheter assembly <NUM> can be configured for any suitable use. In the illustrated embodiment, the catheter assembly <NUM> is suitable for use as a PICC. In some embodiments, the catheter assembly <NUM> and some or all components thereof, including the proximal valves <NUM>, <NUM>, may be suitable for power injections.

As used herein, the term "power injection" is consistent with the generally accepted definition of this term, and refers to pressurized infusions that occur at high flow rates, such as up to <NUM>/s or up to <NUM>/sec; that often involve injection of viscous materials, such as materials (e.g., contrast media) having a viscosity of <NUM> cP +/- <NUM> cP; and that take place at elevated pressures. In like manner, a "power injectable" catheter assembly is one that is capable of sustaining power injection without leaking, bursting, or swelling to a size that is not usable within the vasculature. For example, a power injectable catheter assembly may be one that complies with the power injection specifications of the International Standards Organization (ISO) standard ISO <NUM>-<NUM>. Thus, for example, a power injectable PICC is a PICC configured to sustain power injections. In some instances, power injectable PICCs can be and/or remain operable at pressures of up to about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or even <NUM> psi. In many instances, PICCs may also be used for other functions, such as intravenous therapy at lower pressures or standard infusion and aspiration or blood sampling.

In the illustrated embodiment, the proximal valves <NUM>, <NUM> are substantially identical to each other. In other embodiments, the proximal valves <NUM>, <NUM> may be different from each other. For example, the proximal valves <NUM>, <NUM> may have different performance characteristics, such as with respect to power injectability and/or with respect to cracking pressures. In some instances, one of the proximal valves <NUM>, <NUM> may be configured for power injections (e.g., can operate at and suffer little or no performance degradation due to elevated power injection pressures), whereas the other of the proximal valves <NUM>, <NUM> may only be configured for operation at lower pressures.

In some embodiments, the catheter assembly <NUM> may include a stylet (see <FIG>) that extends through the proximal valve <NUM>, the extension leg <NUM>, one of the fluid channels of the junction <NUM>, and one of the lumens of the catheter body <NUM>. In other or further embodiments, the stylet may instead extend through the other proximal valve <NUM> and its associated fluid path through the catheter assembly <NUM>. For example, in some embodiments, the stylet may be inserted just prior to introducing the catheter assembly <NUM> into a patient. In other embodiments, the stylet may be prepackaged with the catheter assembly <NUM> so as to extend through one of the fluid paths of the catheter assembly <NUM>. Embodiments of such catheter assemblies <NUM> that include a stylet can be used in manners known in the art, such as for stiffening the catheter body <NUM> for advancement through or otherwise positioning the catheter body <NUM> within the vasculature of a patient. Similarly, the catheter assembly <NUM> may be advanced over a guidewire in manners such as those known in the art.

In the illustrated embodiment, each proximal valve <NUM>, <NUM> is a bidirectional valve. Stated otherwise, each proximal valve <NUM>, <NUM> is configured to permit fluid to pass through the valve in each of a distal direction and a proximal direction. The direction of fluid flow may also be referred to as an ingress or infusion direction (e.g., toward or directed into the patient) or as an egress or aspiration direction (e.g., away from or directed out of the patient). As further discussed below, the bidirectional valves <NUM>, <NUM> can be asymmetrical, such that a cracking pressure in one direction is different from a cracking pressure in the opposite direction. Stated otherwise, each valve <NUM>, <NUM> is an asymmetric bidirectional valve. In the illustrated embodiment, the aspiration cracking pressure is higher than the infusion cracking pressure. It may be said that it is easier to introduce fluids into the patient through the proximal valves <NUM>, <NUM> than it is to remove fluids from the patient through the proximal valves <NUM>, <NUM>.

<FIG> and <FIG> depict an embodiment of the valve <NUM>, which can include a housing <NUM> and a septum <NUM>. The septum <NUM> may alternatively be referred to as a valve or as a valving member. In the illustrated embodiment, the housing <NUM> includes a plurality of pieces that are joined together. In particular, the housing <NUM> is a two-part housing that includes a first piece <NUM> and a second piece <NUM>. The first and second pieces <NUM>, <NUM> may also be referred to as separate housing members, elements, components, etc. In some embodiments (such as that depicted in <FIG>), the housing member <NUM> may also be referred to as a proximal housing member, and the housing member <NUM> may also be referred to as a distal housing member. Other orientations of the housing members <NUM>, <NUM> are contemplated, however, so the terms proximal and distal in this context is only illustrative and should not be construed as limiting. The housing members <NUM>, <NUM> may be joined together in any suitable fashion, including (without limitation) via one or more of adhesive bonding, solvent bonding, ultrasonic welding, etc..

The septum <NUM> can be fixedly secured to the housing <NUM>. For example, in the illustrated embodiment, the septum <NUM> is captured or held between the first and second housing member <NUM>, <NUM>, as further discussed below. In some instances, the septum <NUM> is gripped between the housing members <NUM>, <NUM> without either housing member <NUM>, <NUM> penetrating through the septum <NUM>. In other or further embodiments, one or more of the housing members <NUM>, <NUM> may pass through the septum <NUM> to retain or further retain the septum <NUM> in a desired position, such as discussed below, for example, with respect to <FIG>. Stated otherwise, the septum <NUM> may be anchored or otherwise securely attached to one or more of the housing members <NUM>, <NUM>, whether instead of or in addition to being gripped between the housing members <NUM>, <NUM>.

In the illustrated embodiment, each of the housing members <NUM>, <NUM> has a substantially oval-shaped profile. Stated otherwise, a perimeter or transverse cross-sectional shape of each housing member <NUM>, <NUM> is oval-shaped. The septum <NUM> likewise defines an oval-shaped profile or perimeter. Other shapes and configurations are contemplated.

The proximal housing member <NUM> can include a connection interface <NUM> that is configured to couple with one or more medical devices for infusion through the valve <NUM> in the ingress direction or for aspiration through the valve <NUM> in the egress direction. Stated otherwise, the connection interface <NUM> can permit infusion of fluid therethrough in the ingress direction and can permit aspiration of fluid therethrough in the egress direction. In the illustrated embodiment, the connection interface <NUM> comprises a Luer fitting <NUM>. For example, in some instances, a first medical device (e.g., a syringe, a gravity feed intravenous fluid bag, a power injector, or any other suitable medical fluid delivery device) may be coupled with the Luer fitting <NUM> for purposes of infusing a medical fluid through the valve <NUM> and into a patient. In further instances, the same medical device (e.g., the syringe) may be used to aspirate a fluid (e.g., blood) from the catheter body <NUM> and/or the vasculature of the patient. The first medical device may be decoupled from and recoupled to the Luer fitting <NUM> between aspiration and/or infusion events. In other or further instances, the first medical device is decoupled from the Luer fitting <NUM> and a second medical device different from the first medical device is coupled with the Luer fitting <NUM> for aspiration. Any suitable medical devices are contemplated.

The distal housing member <NUM> can similarly include a connection interface <NUM>. In the illustrated embodiment, the connection interface <NUM> comprises a protrusion or port <NUM> that is configured to be fixedly secured to a proximal end of an extension tube in any suitable manner, and generally in a fluid-tight manner. For example, in some embodiments, the distal housing member <NUM> can be overmolded onto an extension leg <NUM>, <NUM>. Other forms of attachment are also contemplated.

With reference to <FIG>, the proximal housing member <NUM> can include a sidewall <NUM> that defines a proximal chamber <NUM>. The sidewall <NUM> can terminate at a distal face <NUM>. The proximal housing member <NUM> can further include a plurality of support structures <NUM> that extend inwardly away from the sidewall <NUM> into the proximal chamber <NUM>. In the illustrated embodiment, the support structures <NUM> may also be referred to as fins, ribs, elongated protrusions, etc. More generally, the support structures <NUM> may be referred to as projections. In the illustrated embodiment, the proximal housing member <NUM> includes <NUM> support structures <NUM>.

The proximal housing member <NUM> can be formed in any suitable manner. In the illustrated embodiment, the proximal housing member <NUM>, including the sidewall <NUM> and the support structures <NUM>, is integrally formed of a unitary piece of material (e.g., via injection molding).

In the illustrated embodiment, each fin <NUM> defines a contact or restriction surface <NUM> at a distal end thereof. Moreover, each pair or adjacent fins <NUM> defines a fluid channel <NUM> therebetween. As further discussed below, the fins <NUM> can constrain movement of the fluid through the channels <NUM>, or stated otherwise, can direct, channel, or guide fluid flow through the channels <NUM> toward the restriction surfaces <NUM>. Such constrained or directed fluid flow through the fluid channels <NUM> can assist in flushing all surfaces in or defining the proximal chamber <NUM>. The channels <NUM> may also be referred to as flushing channels. As shown in <FIG>, the illustrated embodiment of the proximal housing member <NUM> includes <NUM> fluid channels <NUM>. In particular, ten fluid channels <NUM> are shown as being elongated in the vertical direction, in the illustrated orientation, with five channels <NUM> being at the upper side of the housing member <NUM> and the other five channels <NUM> being at the lower side of the housing member <NUM>. In addition, one fluid channel <NUM> is positioned at the left side of the housing member <NUM> between two small fins <NUM>, and another fluid channel <NUM> is positioned at the right side of the housing member <NUM> between two small fins <NUM>.

As discussed further below, the restriction surfaces <NUM> can be configured to oppose movement or deformation of one or more specific regions of the septum <NUM> in the proximal direction. In the illustrated embodiment, each restriction surface <NUM> includes a curved or rounded surface at a distal end thereof. In particular, for the intermediate or centrally located fins <NUM>, the restriction surfaces <NUM> are each shaped substantially as hemicylinders of varying length, thus defining a substantially semicircular or U-shaped cross-section. For the four fins <NUM> located at each end of the two rows of fins <NUM>, a portion (e.g., a radially inner portion) of the restriction surface <NUM> is curved or rounded, whereas another portion (e.g., a radially outer portion) of the restriction surface <NUM> is flat so as to be flush with a distal face of the proximal housing member <NUM>.

Other shapes of the restriction surfaces are contemplated. For example, in some embodiments, each of at least some of the restriction surfaces <NUM> may be formed of two planar surfaces that meet at a line that extends along a lower edge of each surface. The restriction surfaces thus may be substantially V-shaped in cross-section.

With reference to <FIG>, in the illustrated embodiment, each restriction surface <NUM> extends inwardly from the sidewall <NUM> and terminates at one of two longitudinal planes <NUM>, <NUM>. The fins <NUM> likewise each terminate at an interior end thereof at one of the two longitudinal planes <NUM>, <NUM> (see <FIG>). In the illustrated embodiment, the longitudinal planes <NUM>, <NUM> are oriented parallel to each other. The planes <NUM>, <NUM> are positioned at opposite ends of a proximal opening <NUM> defined by the proximal housing member <NUM>. The longitudinal planes <NUM>, <NUM> can be separated from each other by a distance D. As further discussed below, the distance D by which the planes <NUM>, <NUM> are separated from each other can influence an aspiration cracking pressure of the valve <NUM>.

With reference to <FIG>, in the illustrated embodiment, each restriction surface <NUM> extends to and touches a lateral plane <NUM> that is orthogonal to the longitudinal planes <NUM>, <NUM>. Stated otherwise, only a distal end of each restriction surface <NUM> extends to the lateral plane <NUM>. The distal ends of the restriction surfaces <NUM> thus are all coplanar in the illustrated embodiment. Due to the rounded, hemicylindrical shape of many of the restriction surfaces <NUM>, the distal ends of these surfaces substantially define a straight line <NUM> along, or at the level of, the plane <NUM>, as shown in <FIG>. As further shown in <FIG>, these straight lines <NUM> can be oriented substantially orthogonal to the longitudinal planes <NUM>, <NUM>. In may also be said that adjacent lines <NUM> are parallel to each other. In other embodiments, adjacent lines <NUM> may angle toward or away from one another. In various of such embodiments, the lines <NUM> of adjacent restriction surfaces <NUM> do not physically touch, but extended projections of the lines may intersect at an angle that is no greater than <NUM>, <NUM>, <NUM>, or <NUM> degrees. Other arrangements are contemplated.

As further discussed below, a proximal surface of the septum <NUM> can be positioned substantially at the level of the transverse plane <NUM>. Stated otherwise, in embodiments where an upper or proximal surface of the septum <NUM> is substantially planar, the proximal surface can define the transverse plane <NUM> (see <FIG>).

With reference to <FIG>, the distal housing member <NUM> includes a sidewall <NUM> (e.g., an inner sidewall) that defines a distal chamber <NUM>. In the illustrated embodiment, the distal housing member <NUM> further includes an inner ridge or septum support <NUM> that extends about a full periphery of the distal chamber <NUM>. The septum support <NUM> may define at least an upper end of the sidewall <NUM>. A gripping and/or sealing rim <NUM> configured to engage the septum <NUM> can be positioned at the upper or proximal end of the septum support <NUM>. In the illustrated embodiment, the sealing rim <NUM> is substantially V-shaped in cross-section (see <FIG>).

The distal housing member <NUM> can include an outer sleeve <NUM> that can be positioned over and coupled with the proximal housing member <NUM>. Any suitable attachment mechanism is contemplated, and is desirably fluid tight. In some embodiments, the outer sleeve <NUM> can be adhered or solvent bonded to the proximal housing member <NUM>, and in further embodiments, the connection thus achieved can be fluid-tight, even at elevated pressures associated with power injections.

The distal housing member <NUM> can define a groove <NUM> or recess into which a downwardly projecting rim, lip, skirt, ring, edge, band, or flange of the septum <NUM> can be received, as discussed further below. An outer surface of the groove <NUM> can be defined by an inwardly facing surface of the outer sleeve <NUM>, and an inner surface of the groove <NUM> can be defined by an outwardly facing surface of the septum support <NUM>.

<FIG> illustrate an embodiment of the septum <NUM>, which can include a body <NUM> and a projecting rim, lip, skirt, ring, edge, band, or flange <NUM> that extends orthogonally from the body <NUM> around a full periphery thereof. In the illustrated embodiment, the flange <NUM> is sized to be received within the groove <NUM> of the distal housing member <NUM>.

The body <NUM> of the septum <NUM> can define an upper or proximal face <NUM> and a lower or distal face <NUM>. The upper and lower faces <NUM>, <NUM> can also be referred to as surfaces. In the illustrated embodiment, the upper and lower faces <NUM>, <NUM> face in opposite directions.

The septum <NUM> can further include a closure <NUM> that extends through a full thickness of the septum <NUM>. In the illustrated embodiment, the closure <NUM> is formed as a slit <NUM> that extends through the full thickness of the septum <NUM>. Stated otherwise, the closure <NUM> can extend fully between the upper and lower faces <NUM>, <NUM>. In the illustrated embodiment, the septum <NUM> is substantially oval shaped, or substantially ellipsoidal, and the slit <NUM> extends longitudinally along a major axis of the septum <NUM>. The slit <NUM> may be formed in any suitable manner. In the illustrated embodiment, the slit <NUM> extends through the full thickness of the septum <NUM> substantially along a vertically oriented plane (in the orientation depicted in <FIG>).

In the illustrated embodiment, the slit <NUM> is substantially defined by two opposing contact or sealing surfaces <NUM>, <NUM>. The sealing surfaces <NUM>, <NUM> abut one another to close the closure <NUM>. The sealing surfaces <NUM>, <NUM> can be forced apart to transition the opening <NUM> to an open configuration in which fluid can pass through the closure <NUM>. In some instances, a thickness T of septum <NUM> aids in ensuring that at least some portion of the sealing surfaces <NUM>, <NUM> abut one another to maintain the closure <NUM> in a closed configuration, when desired. In various embodiments, the thickness T is no less than about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> thousandths of an inch; is no greater than about <NUM>, <NUM>, <NUM>, or <NUM> thousandths of an inch; is within a range of from about <NUM> to about <NUM>, <NUM>, <NUM>, or <NUM> thousandths of an inch; or is about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> thousandths of an inch.

The septum <NUM> can be formed of any suitable elastomeric material, such as, e.g., silicone. The closure <NUM> can be biased toward the closed configuration. For example, in the illustrated embodiment, a pressure differential across the septum body <NUM> can exceed a threshold, or cracking pressure, at which the body <NUM> is elastically deformed from its natural or resting configuration to urge the sealing surfaces <NUM>, <NUM> away from each other, thereby opening the closure <NUM>. When the pressure differential drops below the threshold, the sealing surfaces <NUM>, <NUM> can automatically come back into contact with each other as the body <NUM> returns to its natural state. As further discussed below, in the illustrated embodiment, the septum <NUM> exhibits a different cracking pressure in the ingress direction, as opposed to the egress direction, due to interactions between the septum <NUM> and the contact or restriction surfaces <NUM> of the fins <NUM>. It is again noted that the cracking pressures correspond to differential pressures across the septum <NUM>.

In some embodiments, a thickness of the septum body <NUM> is selected to ensure that the sealing surfaces <NUM>, <NUM> will maintain the closure <NUM> in the closed configuration under a variety of circumstances that would otherwise lead to premature cracking of the slit <NUM>, or stated otherwise, premature opening of the closure <NUM>. For example, a relatively thicker septum <NUM> can accommodate minor variations in thickness across the septum body <NUM> that might arise from manufacturing anomalies to ensure that at least some portion of the sealing surfaces <NUM>, <NUM> abut one another along the full length of the slit <NUM> to maintain the closure <NUM> in the closed orientation. In other or further instances, a relatively thicker septum <NUM> can accommodate minor deformations of the body <NUM> at both sides of the slit <NUM> that might arise from the long-term presence of a stylet or guidewire passing through the slit <NUM>, such as when the valve <NUM> is prepackaged with a stylet passing therethrough.

In some embodiments, it can be desirable to have a relatively compliant septum body <NUM>. For example, in some embodiments, the septum <NUM> is formed of a relatively soft silicone that can readily deform when a cracking pressure is reached. Further, in some instances, it may be relatively easier to control a thickness of the septum <NUM>-e.g., to ensure that variations in the septum thickness are minimal or negligible from one septum <NUM> to the next during manufacture-than it may be to control the hardness of the septum material (e.g., silicone) from one septum to the next, or even from one lot of septum material to the next. Accordingly, employing relatively softer septum materials <NUM> can render the septum <NUM> less dependent on the softness or compliance of the septum <NUM> and more controlled by the physical geometry of the septum <NUM>. This can lead to more predictable and repeatable cracking pressures. In various embodiments, the septum <NUM> is formed from a flexible silicone having a Shore A hardness of from about <NUM> to about <NUM>, about <NUM> to about <NUM>, about <NUM> to about <NUM>, about <NUM> to about <NUM>, about <NUM> to about <NUM>, about <NUM> to about <NUM>, about <NUM> to about <NUM>, about <NUM> to about <NUM>, about <NUM> to about <NUM>, about <NUM> to about <NUM>, about <NUM> to about <NUM>, about <NUM> to about <NUM>, about <NUM> to about <NUM>, about <NUM>, to about <NUM>, about <NUM> to about <NUM>, about <NUM> to about <NUM>, or of about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>.

In some embodiments, it can be advantageous to have a septum <NUM> that is both relatively thicker, for the reasons previously discussed, and relatively softer, for the reasons previously discussed. Further, in some instances, employing a relatively thicker septum <NUM> can accommodate relatively greater movement that may result from the material being more compliant.

In some instances, a relatively thinner septum <NUM> can be employed with a relatively smaller valve <NUM>. For example, in some instances, a relatively smaller distance D between opposing faces of the support structures <NUM>, as shown in <FIG>, can permit use of a relatively thinner septum <NUM> in order to achieve the same aspiration cracking pressure of a valve having a larger distance D and a thicker septum <NUM> (of the same hardness). In some instances, a relatively smaller valve <NUM> can be desirable. Smaller valves <NUM> can, in some instances, reduce material costs and/or be less bulky or easier for a practitioner to manipulate.

In various embodiments, the distance D (<FIG>) is no less than about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> thousandths of an inch; is no greater than about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> thousandths of an inch; is within a range of from about <NUM> to about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> thousandths of an inch; is within a range of from about <NUM> to about <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> thousandths of an inch; is within a range of from about <NUM> to about <NUM>, <NUM>, <NUM>, or <NUM> thousandths of an inch; is within a range of from about <NUM> to about <NUM>, <NUM>, or <NUM> thousandths of an inch; or is about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> thousandths of an inch. In various embodiments, the distance D is no less than about <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> times the thickness T (<FIG>) of the septum <NUM> , is no greater than about <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> times the thickness T; is within a range of from about <NUM> to about <NUM>, <NUM>, <NUM>, or <NUM> times the thickness T; is within a range of from about <NUM> to about <NUM>, <NUM>, or <NUM> times the thickness T; is within a range of from about <NUM> to about <NUM> or <NUM> times the thickness T; or is about <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> times the thickness T. For example, in some embodiments, the thickness T is approximately <NUM> thousandths of an inch and the distance D is about <NUM> thousandths of an inch.

<FIG> and <FIG> depict cross-sectional views of the valve <NUM> in the assembled state. The proximal and distal housing members <NUM>, <NUM> are joined together to form a housing <NUM> of the valve <NUM>. The housing <NUM> includes a chamber <NUM> therein, which includes both the proximal and distal chambers <NUM>, <NUM>. The valve <NUM> defines a longitudinal axis ALONG that extends substantially vertically in <FIG>, and is generally aligned with the direction of fluid flow through the valve <NUM> in each of the distal and proximal directions.

In the illustrated embodiment, the septum <NUM> is captured, trapped, or attached between the proximal housing member <NUM> and the distal housing member <NUM>. The housing members <NUM>, <NUM> can be formed of any suitable material, such as, e.g., any suitable polymeric material. In some embodiments, the polymeric material of at least the distal housing member <NUM> may be capable of forming a strong, fluid-tight bond with an extension leg <NUM>, <NUM> (see <FIG>). The housing members <NUM>, <NUM> can be joined together in any suitable manner to ensure the septum <NUM> forms a fluid tight seal with each of the housing members <NUM>, <NUM>, in manners such as described below. For example, in various embodiments, the housing members <NUM>, <NUM> are attached to each other via one or more of a friction fit, a snapping arrangement, one or more adhesives, solvent bonding, etc. For high-pressure applications, such as power injections, stronger attachment mechanisms, such as adhesives or solvent bonding, can be desirable.

In the illustrated embodiment, an active portion of the septum <NUM>, as discussed further below, is positioned within the chamber <NUM>, whereas immobilized portions along the periphery of the septum <NUM> are clamped between the housing members <NUM>, <NUM> at positions external to the chamber <NUM>. In many embodiments, only the active portion of the septum <NUM> is positioned within the chamber <NUM>. It may be said that a portion (e.g., the active portion) of the septum <NUM> is positioned within the chamber <NUM>.

The housing members <NUM>, <NUM> can be secured together in a fixed longitudinal approximation in which the sealing rim <NUM> atop the septum support <NUM> compresses a thin portion of the septum <NUM> against the distal face <NUM> of the sidewall <NUM> of the proximal housing member <NUM>. The gripped portion of the septum <NUM> can define a line (e.g., a line having a relatively small thickness) that extends about a full periphery of the septum body <NUM>. Accordingly, in the illustrated embodiment, the gripped portion of the septum <NUM> can substantially define a continuous oval shape. The compression can be sufficiently great such that the proximal and distal housing members <NUM>, <NUM> grip or tightly hold the septum <NUM> to prevent the entirety of the septum <NUM> from being pulled into either the proximal or distal chambers <NUM>, <NUM> during use of the valve <NUM>, or stated otherwise, can prevent the septum <NUM> from being disconnected from the housing, dislodged, ingested, or otherwise undesirably displaced into either the proximal or distal chambers <NUM>, <NUM>. Stated otherwise, advancement of the sealing rim <NUM> toward the distal face <NUM> of the sidewall <NUM> during assembly of the valve <NUM> can cause the sealing rim <NUM> to dig into or otherwise grip the septum <NUM>, which can inhibit the septum <NUM> from being pulled inwardly (e.g., radially inward, or inward toward the longitudinal axis of the valve) under the influence of pressurized fluid. Any other suitable gripping features are contemplated, and may or may not be continuous about a full periphery or perimeter of the housing.

In the illustrated embodiment, the continuous gripping arrangement that fully and continuously extends about a periphery of the septum support <NUM> can form a first, or proximal, fluid-tight seal between the proximal housing member <NUM> and the proximal face <NUM> of the septum <NUM> that prevents fluid from escaping from the proximal chamber <NUM> thereat, and can form a second, or distal, fluid-tight seal between the distal housing member <NUM> and the distal face <NUM> of the septum <NUM> that prevents fluid from escaping from the distal chamber <NUM> thereat. The first and second seals can form along the gripped portion of the septum <NUM> about a full periphery of the septum body <NUM>.

In the illustrated embodiment, the peripheral configuration of the septum <NUM> can further ensure that the septum <NUM> will not be entrained into, ingested, pushed or forced into, or otherwise undesirably displaced into the distal chamber <NUM> and potentially plug the valve <NUM> during infusion events. For example, it can be desirable to ensure that the septum <NUM> is not forced distally into the distal chamber <NUM> by high pressure fluid flow during power injections. In the illustrated embodiment, the septum flange <NUM> extends proximally into the groove <NUM>, which can assist in maintaining the septum <NUM> in place. For example, in some instances when high pressure fluid is being passed distally through the valve, the flange <NUM> can grip the septum support <NUM> to prevent entrainment or ingestion of the septum <NUM>.

With continued reference to <FIG> and <FIG>, in the illustrated embodiment, the fins <NUM> are arranged in two distinct groups that are positioned at opposite sides of the closure <NUM>. Only one of the two sets is shown in <FIG>; the other is shown, e.g., in <FIG> and <FIG>. In the illustrated embodiment, each set includes six fins <NUM>. Other numbers of fins are contemplated. The fins <NUM> are arranged symmetrically relative to the closure. Moreover, in the illustrated embodiment, the two sets of fins <NUM> are mirror images of one another across a plane that passes through the closure <NUM>, which corresponds to the plane of the cross-section in <FIG>. In some instances, symmetrical arrangements can inhibit or prevent asymmetrical distortion of the closure <NUM>, which can, in some instances, lead to unpredictability, variability, or non-repeatability of cracking pressures.

With continued reference to <FIG>, the distal ends of the restriction surfaces <NUM> can contact or be in close proximity to the proximal face <NUM> of the septum <NUM> when the septum <NUM> is in a natural or relaxed state. Moreover, as previously discussed, in the illustrated embodiment, the restriction surfaces <NUM> are curved or rounded convexly, such that only a small portion thereof contacts the proximal face <NUM>, whereas the vast majority of the restriction surfaces <NUM>, as well as the remainder of the fins <NUM>, is exposed to fluid within the proximal chamber <NUM>. Thus, in certain embodiments, in circumstances in which there is substantially no pressure differential across the septum <NUM>, a substantial majority of the restriction surfaces <NUM> can be exposed, or stated otherwise, can be separate from or not contact the septum <NUM>. This can enable fluid to contact all or substantially all interior surfaces of the proximal housing member <NUM>, when the proximal chamber <NUM> is filled with fluid. Stated otherwise, regions in which blood and/or microbes can become stagnant, stuck, and/or isolated from fluid flow can be reduced, minimized, or eliminated.

Moreover, during a flushing event, fluid (e.g., saline) is forced distally through the proximal housing member <NUM> at an elevated pressure. This pressure can cause the septum <NUM> to deform or bend away from the fins <NUM> in the distal direction, thereby exposing any portions of the restriction surfaces <NUM> that previously may have been in contact with the septum <NUM>. Fluid is thus permitted to readily flow between the restriction surfaces <NUM> and the septum <NUM>, thus flushing these regions.

For example, in some instances, a practitioner may couple a syringe or other device to the valve <NUM> to withdraw blood through the valve <NUM> in the proximal (e.g., aspiration) direction, such that blood may remain within the proximal chamber <NUM> at the end of the aspiration event. Thereafter, the practitioner may replace the syringe or other medical device with a separate medical device-e.g., a saline-filled syringe-to flush the valve <NUM>, or more generally, to flush a full fluid path of the catheter assembly <NUM>. The practitioner thus may depress the plunger of the syringe to pressurize the saline and force open the closure <NUM>. As the pressurized saline is forced into and through the proximal chamber <NUM>, the fins <NUM> direct the fluid to flow through the channels <NUM> and under the restriction surfaces <NUM>, or stated otherwise, between the restriction surfaces <NUM> and the septum <NUM>. Accordingly, the valve <NUM> reduces the amount of blood that could get trapped between the restriction surfaces <NUM> and the septum <NUM>. Microbes and/or other undesirable materials may similarly be flushed from all or substantially all portions of the proximal chamber <NUM>.

In the illustrated embodiment, the flushing channels <NUM> are oriented substantially longitudinally. That is, the flushing channels <NUM> extend in directions that are substantially parallel to the longitudinal axis ALONG of the valve <NUM> (see <FIG>). Moreover, in the illustrated embodiment, the flushing channels <NUM> are defined, in part, by opposing faces of adjacent fins <NUM>. In the illustrated embodiment, the opposing faces of adjacent fins <NUM> are substantially planar. In various embodiments, the planar opposing faces are substantially parallel to each other, and each smoothly transitions to the rounded distal ends. In some instances, such an arrangement of the flushing channels <NUM> can promote longitudinal fluid flow along the surface of the fins <NUM> and enhance flushing at the distal ends of the fins, such as to disrupt biofilm, clear out blood and/or microbes, etc. Other configurations of the fins <NUM> are contemplated.

The fins <NUM> can provide sufficient columnar strength in the longitudinal direction to resist any longitudinal deformation when the septum <NUM> is urged proximally during aspiration. For example, in some instances, longitudinal elongation of the fins <NUM> or ribs can enhance their longitudinal strength and support of the septum <NUM> as it is urged proximally.

<FIG> is a proximally directed cross-sectional view of the assembled valve <NUM>, which depicts portions of the proximal housing member <NUM> and the distal housing member <NUM> at a position just above the septum. An oval-shaped sealing region inner limit <NUM>, depicted in broken lines, identifies an inner edge of a region of pressure provided by the sealing rim <NUM> of the distal housing member <NUM> (see <FIG> and <FIG>). That is, as can be seen in <FIG>, the sealing rim <NUM> presses the septum <NUM> against the distal face <NUM> of the sidewall <NUM> of the proximal housing member <NUM> to form the first and second (proximal and distal) seals, as previously discussed, and the sealing region inner limit <NUM> shown in <FIG> represents the inner limit of the proximal seal.

The portion of the septum <NUM> along which the proximal and distal seals are formed can correspond to an immobilized region of the septum <NUM>. That is, the compressive grip provided by the proximal and distal housing members <NUM>, <NUM> can provide seals between the housing members <NUM>, <NUM> and the septum <NUM> and can also substantially fix a thin region of the septum <NUM> along a fully periphery of the septum <NUM>. This sealing and immobilization region can demarcate an outer edge of an active region <NUM> of the septum <NUM> (see <FIG>), or stated otherwise, can serve as a fixed outer boundary <NUM> to a portion of the septum <NUM> that is permitted to move in at least one direction (i.e., distally and, in some areas, proximally as well).

Stated in yet another manner, the sealing region inner limit <NUM> previously identified can have an identical or substantially identical footprint to that of the sealing rim <NUM>-for example, an inner periphery of the sealing region inner limit <NUM> may correspond to an inner edge of the sealing rim <NUM> (see <FIG>). This inner periphery of the sealing region can correspond to an outer perimeter <NUM> of the active region <NUM> of the septum body <NUM> (see <FIG>), as discussed further below. Note that the septum <NUM> is not shown in either <FIG>, but is instead shown and discussed with respect to <FIG>.

In <FIG>, the distal ends of the fins <NUM> are also shown. As previously discussed, these distal ends correspond to the restriction surfaces <NUM>, which interact with the septum <NUM> to inhibit, restrict, delimit, or prevent proximal movement of specific regions of the septum <NUM>. As previously mentioned, in many instances, only a small portion of the restriction surfaces <NUM> (e.g., the linear regions <NUM>, which are oriented vertically in the present view) interact with-e.g., contact to resist or oppose proximal movement of-the septum <NUM>. In some instances, the septum <NUM> may contact greater portions of the restriction surfaces <NUM> due to pressure-induced deformation during aspiration.

With reference to <FIG>, the inner edge of the rim <NUM> of the distal housing member <NUM> is shown. As previously discussed the illustrated embodiment, this inner edge can correspond to the sealing region inner limit <NUM> and the outer peripheral limit or outer perimeter <NUM> of the active region <NUM> of the septum body <NUM> (see <FIG>).

<FIG> is a top plan view of the septum <NUM>, with the outer perimeter <NUM> of the active region <NUM> shown as a broken line. As previously mentioned, the outer perimeter <NUM> of the active region <NUM> can correspond to the inner edges of the sealing regions that result from clamping the septum <NUM> between the proximal and distal housing members <NUM>, <NUM>. The outer perimeter <NUM> of the active region <NUM> is shown in a first style of broken lines.

<FIG> also depicts contact regions <NUM> at which the septum <NUM> contacts the restriction surfaces <NUM> of the fins <NUM>. The contact regions <NUM> are shown in a second style of broken lines. Most of the contact regions <NUM> are substantially rectilinear and are oriented orthogonally relative to a major axis of the septum <NUM>, which major axis is aligned with the slit <NUM> in the illustrated embodiment. Four substantially triangular contact regions <NUM> are also present: one at each end of the two rows of substantially rectilinear contact regions <NUM>.

The contact regions <NUM> can define a restricted portion <NUM> of the active region <NUM> of the septum <NUM>. The restricted portion <NUM> represents one or more regions of the septum <NUM> that are inhibited from moving proximally. In the illustrated embodiment, this inhibition is provided by the restriction surfaces <NUM> of the fins <NUM>. Further, in the illustrated embodiment, the restricted portion <NUM> includes two separate, distinct restricted regions <NUM>, <NUM> at opposite sides of the septum <NUM>. The inner edges of the restricted regions <NUM>, <NUM> are shown in a third style of broken lines. In the illustrated embodiment, these inner edges are aligned with the longitudinal planes <NUM>, <NUM> discussed previously (see <FIG>).

As can be seen in <FIG>, the outer perimeter <NUM> of the active region <NUM> can substantially correspond with an inner perimeter defined by the sidewall <NUM>, and in particular, an inner perimeter defined by the septum support <NUM> portion of the sidewall <NUM>. In the illustrated embodiment, the outer perimeter <NUM> is substantially oval. The outer perimeter <NUM> may be said to define a continuously curved shape. The active region <NUM> can further include an inner perimeter <NUM> that is at least partially defined (i.e., at its rounded ends) by the septum support <NUM>, and is otherwise bounded by the restricted regions <NUM>, <NUM>. In the illustrated embodiment, the restricted regions <NUM>, <NUM> provide substantially rectilinear boundaries to the inner perimeter <NUM>. The inner perimeter <NUM> is thus substantially shaped as a stadium in the illustrated embodiment, with rectilinear sides and rounded opposing ends. The portion of the active region <NUM> that is interior to the inner perimeter <NUM> may be termed as a secondary active region <NUM>. The full active region <NUM> may also be referred to as the primary active region <NUM>.

In certain embodiments, the septum <NUM> can bend or pivot along the various boundaries just described-specifically, the outer perimeter <NUM> and the inner perimeter <NUM>. For example, in some embodiments, during an infusion event, distal movement of the full active region <NUM> can be unopposed, and the septum <NUM> may thus bend or pivot distally along the outer perimeter <NUM>. Similarly, during an aspiration event, proximal movement of the restricted regions <NUM>, <NUM> can be opposed by the fins <NUM>, such that only the secondary active region <NUM> may move unopposed in the proximal direction. In such instances, the septum <NUM> may bend or pivot proximally along the inner perimeter <NUM>.

In use, an entirety of the active region <NUM> is capable of moving in the distal direction unopposed by any portion of the fins <NUM>. That is, both the secondary active region <NUM> and the restricted regions <NUM>, <NUM> of the septum <NUM> can move distally without any opposition from the fins <NUM>. However, the restricted regions <NUM>, <NUM> of the septum <NUM> are inhibited from proximal movement by the fins <NUM> in manners such as previously discussed. As a result, a greater portion of the septum <NUM> is permitted to move in the proximal direction or stated otherwise, fluid pressure can act, unopposed, on a greater portion of the septum <NUM>. Accordingly, the slit <NUM> can open at a lower pressure differential, or cracking pressure, in the distal or ingress direction than it does in the proximal or egress direction. Stated otherwise, during infusion, the full, oval-shaped primary active region <NUM> of the septum <NUM> can be acted on and urged distally such that a lower cracking pressure of the slit <NUM> can be achieved, as compared with an aspiration event, in which only the stadium-shaped, smaller, secondary active region <NUM> can be acted on unopposed by the fins <NUM> such that the slit <NUM> is more difficult to open in the proximal direction and such that a higher cracking pressure of the slit <NUM> is exhibited. Stated in yet another way, the fins <NUM> permit free movement of the septum <NUM>, including the restricted portion <NUM> of the septum <NUM>, in the distal or ingress direction; and oppose or inhibit movement of the septum <NUM>, and in particular the restricted portion <NUM> of the septum <NUM>, in the proximal or egress direction, thus resulting in a higher cracking pressure of the septum in the proximal or egress direction.

In various embodiments, an area of the primary active region <NUM> is no less than about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>; is no more than about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>; or is within a range of from about <NUM> to about <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>; from about <NUM> to about <NUM>, <NUM>, <NUM>, or <NUM>; from about <NUM> to about <NUM>, <NUM>, or <NUM>; from about <NUM> to about <NUM> or <NUM>; or from about <NUM> to about <NUM> times greater than an area of the secondary active region <NUM>.

In various embodiments, the cracking pressure in the proximal direction is no less than <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> times; no greater than <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> times; within a range of from <NUM> to <NUM>, <NUM> to <NUM>, <NUM> to <NUM>, <NUM> to <NUM>, <NUM> to <NUM>, <NUM> to <NUM>, <NUM> to <NUM>, <NUM> to <NUM>, <NUM> to <NUM>, or <NUM> to <NUM> times; or is about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> times the cracking pressure in the distal direction. In some embodiments, the cracking pressure in the distal direction, or the infusion cracking pressure, is no less than about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> psig; is no greater than about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> psig; is within a range of from about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> to about <NUM> psig; is within a range of from about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> to about <NUM> psig; is within a range of from about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> to about <NUM> psig; is within a range of from about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> to about <NUM> psig; is within a range of from about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>, to about <NUM> psig; or is about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> psig. In these or in further embodiments, the cracking pressure in the proximal direction, or the aspiration cracking pressure, is no less than about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> psig; is no greater than about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> psig; is within a range of from about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> to about <NUM> psig; is within a range of from about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> to about <NUM> psig; is within a range of from about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or <NUM> to about <NUM> psig; is within a range of from about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> to about <NUM> psig; or is about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> psig. In various embodiments, precise cracking pressures are achievable from one valve to the next, or stated otherwise, the valves can be produced with tight tolerances. In various embodiments, each of the distal and proximal cracking pressures for a manufacturing lot of valves can fall within a tolerance range of no more than ± <NUM> psi or ± <NUM> psi. In further instances, the same tolerances are possible from one manufacturing lot to the next, even when different lots of septum materials are used. Stated otherwise, the cracking pressures can be relatively unaffected by minor differences material hardness from one lot of manufacturing materials to the next. In various embodiments, the foregoing cracking pressures can be achieved in embodiments of valves for which the septum <NUM> satisfies the hardness conditions previously described and/or that meets the septum thickness T and/or the support structure separation distance D criteria previous described.

As previously discussed, in some instances, it can be advantageous for only a small portion of the restriction surfaces <NUM> to come into contact with the septum <NUM>, as this can reduce the area in which blood or pathogens could become trapped between the proximal housing member <NUM> and the septum <NUM>. Thus, it can be advantageous for the contact regions <NUM> of the septum <NUM> to represent only a small portion of the total area of the restricted portion <NUM> of the septum <NUM> that is effectively inhibited from proximal movement by the fins <NUM>. In various embodiments, a collective total area of the contact regions <NUM> of the septum <NUM> is no greater than <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> percent of the area of the restricted portion <NUM>.

<FIG> depict another embodiment of a bidirectional valve <NUM> that can resemble embodiments of the valve <NUM> previously discussed in certain respects. Accordingly, like features are designated with like reference numerals, with the leading digits incremented to "<NUM>. " Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the valve <NUM> that correspond to features of the valve <NUM> may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and/or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the system <NUM> and components thereof. Any suitable combination of the features and variations of the same described with respect to the valve <NUM> can be employed with the valve <NUM>, and vice versa. This pattern of disclosure applies equally to further embodiments depicted in subsequent figures and described hereafter, wherein the leading digits may be further incremented.

With reference to <FIG>, the valve <NUM> is shown incorporated into a catheter assembly <NUM>, which can include an additional valve <NUM>. The catheter assembly <NUM> can resemble the catheter assembly <NUM> in many respects, and can include a catheter shaft <NUM>, a junction <NUM>, a pair of extension legs <NUM>, <NUM>, and a pair of clamps <NUM>, <NUM>. In the illustrated embodiment, the catheter assembly <NUM> further includes a stylet <NUM> that extends through the valve <NUM>, the extension leg <NUM>, the junction <NUM>, and a lumen defined by the catheter shaft <NUM>. In some embodiments, the stylet <NUM> is prepackaged with the catheter assembly <NUM> in the depicted orientation. In other embodiments, a user may insert the stylet <NUM> as shown prior to using the assembly <NUM>. Use of the stylet for insertion and/or positioning of the catheter shaft <NUM> within the vasculature of the patient can proceed in any suitable manner, including those known in the art. In other embodiments, the stylet <NUM> may be omitted.

With reference to <FIG> and <FIG>, the valve <NUM> can include a housing <NUM> and a septum <NUM>. The housing <NUM> may include proximal and distal housing members <NUM>, <NUM> that are fixedly secured to each other in any suitable manner. The housing members <NUM>, <NUM> can be fixedly secured to the septum <NUM>, as discussed further below.

The proximal housing member <NUM> can include a connection interface <NUM> that is configured to couple with one or more medical devices for infusion through the valve <NUM> in the ingress direction or for aspiration through the valve <NUM> in the egress direction. In the illustrated embodiment, the connection interface <NUM> comprises a Luer fitting <NUM>. The distal housing member <NUM> can similarly include a connection interface <NUM>. In the illustrated embodiment, the connection interface <NUM> comprises a protrusion or port <NUM> that is configured to be fixedly secured to a proximal end of an extension tube in any suitable manner, and generally in a fluid-tight manner. For example, in some embodiments, the distal housing member <NUM> can be overmolded onto an extension leg <NUM>, <NUM>. Other forms of attachment are also contemplated.

With reference to <FIG>, the proximal housing member <NUM> can include a sidewall <NUM> that defines a proximal chamber <NUM>. The sidewall <NUM> can terminate at a distal face <NUM>. In the illustrated embodiment, a sealing rim or gripping rim <NUM> is positioned at an interior edge of the sidewall <NUM> and extends distally relative to the sidewall <NUM>. As discussed below, the gripping rim <NUM> can cooperate with the septum <NUM> to generate proximal and distal seals and can assist in gripping the septum <NUM> to inhibit or prevent ingestion of the septum <NUM> in manners similar to those discussed above with respect to the sealing or gripping rim <NUM>.

The proximal housing member <NUM> can further include a plurality of support structures <NUM> that extend inwardly away from the sidewall <NUM> into the proximal chamber <NUM>. Each fin <NUM> defines a contact or restriction surface <NUM> at a distal end thereof. Moreover, each pair or adjacent fins <NUM> defines a fluid channel <NUM> therebetween. The illustrated embodiment includes eight total fins <NUM>, which are arranged in two symmetrical groups of four fins <NUM> mirrored across a longitudinal plane through the proximal housing member <NUM> (i.e., the plane of the cross-section of <FIG>).

With reference to <FIG>, in the illustrated embodiment, each restriction surface <NUM> extends to and touches a lateral plane <NUM>. The gripping rim <NUM> projects distally past this plane <NUM>.

With reference to <FIG>, in the illustrated embodiment, each restriction surface <NUM> extends inwardly from the sidewall <NUM> and terminates at one of two longitudinal planes <NUM>, <NUM>. The fins <NUM> likewise each terminate at an interior end thereof at a planner surface, which is coplanar with one of two longitudinal planes <NUM>, <NUM>. In the illustrated embodiment, the planes <NUM>, <NUM> each extend through a proximal opening <NUM>. This arrangement can be relatively more compact than the more spaced-apart arrangement of the proximal housing member <NUM> depicted in <FIG>. In such a compact arrangement, the fins <NUM> extend into a flow path of fluid that enters into the valve <NUM> through the proximal opening <NUM>. In some embodiments, as shown in <FIG>, angled surfaces or ramps <NUM> can be positioned at upper ends of one or more of the fins <NUM> to reduce or avoid disruption of the fluid flow, such as the formation of turbulence, eddies, etc..

With reference to <FIG>, the distal housing member <NUM> includes a sidewall <NUM> that defines a distal chamber <NUM>. In the illustrated embodiment, the distal housing member <NUM> further includes a plurality of retention members, anchors, or posts <NUM> that extend proximally from a proximal surface <NUM> of the sidewall <NUM>. The illustrated embodiment includes six posts <NUM>. In the illustrated embodiment, the posts <NUM> are shaped substantially as frustocones, although other shapes and configurations are contemplated (e.g., cylindrical). In some instances, the frustoconical shape can assist in an assembly process, as the shape can facilitate placement of the septum <NUM> onto the posts, as further discussed below. In the illustrated embodiment, the posts <NUM> are regularly spaced about a full periphery of the distal chamber <NUM>.

In some embodiments, the distal housing member <NUM> includes an outer sleeve <NUM> that can be positioned over and coupled with the proximal housing member <NUM>. Any suitable attachment mechanism is contemplated, and is desirably fluid tight. In some embodiments, the outer sleeve <NUM> can be adhered or solvent bonded to the proximal housing member <NUM>, and in further embodiments, the connection thus achieved can be fluid-tight, even at elevated pressures associated with power injections.

In some embodiments, the outer sleeve <NUM> includes a groove <NUM> which, in cooperation with the proximal housing member <NUM>, can define a port or solvent vent <NUM>, as shown in <FIG>. In the illustrated embodiment, the groove <NUM> and the solvent vent <NUM> extend about a full periphery of the assembled valve <NUM>. During manufacture of the valve <NUM>, an appropriate solvent can be provided to an outer surface of the sidewall <NUM> of the proximal housing member <NUM> and/or an inner surface of the outer sleeve <NUM> of the distal housing member <NUM>. As the housing members <NUM>, <NUM> are subsequently advanced together, liquified portions of these members may be forced into at least a portion of the vent <NUM>. In other or further instances, once the housing members <NUM>, <NUM> are fully coupled together, the vent <NUM> may provide an egress port the which the solvent can evaporate. In the illustrated embodiment, the distal housing member <NUM> defines the groove <NUM>. In other embodiments, the proximal housing member <NUM> may additionally or alternatively define the groove.

With reference again to <FIG>, in certain embodiments, the protrusion <NUM> can be attached to the proximal end of an extension leg in any suitable manner, as previously mentioned. In some instances, the protrusion <NUM> defines a lumen that receives the extension leg, and an opening at the proximal end of the lumen can, in some instances, be sized to be substantially identical to an inner diameter of the extension leg.

<FIG> depict an embodiment of the septum <NUM>, which includes a main septum body <NUM> and a closure <NUM>. In the illustrated embodiment, the septum <NUM> further includes a plurality of openings, apertures, or channels <NUM> that fully extend through the body <NUM>. The channels <NUM> can extend about a periphery of the septum <NUM>. In the illustrated embodiment, the septum <NUM> includes six channels that are regularly spaced around a periphery thereof. Other arrangements and orientations are contemplated.

The channels <NUM> can be formed in any suitable manner. In some embodiments, the channels <NUM> are cut or stamped from the body <NUM>. In other embodiments, the septum <NUM> is molded to include the channels <NUM>.

In the illustrated embodiment, the septum <NUM> defines a uniform thickness T<NUM>. The septum <NUM> is devoid of peripheral flanges, such as discussed above with respect to the septum <NUM>.

With reference again to <FIG> and with additional reference to <FIG>, when the valve <NUM> is in its assembled state, each post <NUM> of the distal housing member <NUM> extends through a separate channel <NUM> of the septum <NUM>. A proximal surface of each post <NUM> can contact or abut against the distal face <NUM> of the sidewall <NUM> of the proximal housing member <NUM>. The housing members <NUM>, <NUM> can be securely attached together, such that each post <NUM> remains approximated to the sidewall <NUM> in this manner. A portion of the septum <NUM> thus is trapped between the housing members <NUM>, <NUM> at an outward (e.g., radially or laterally outward) position relative to each post <NUM>. These trapped portions of the septum <NUM> are incapable of moving around or in inwardly past the posts <NUM> when inwardly directed forces are applied to the septum <NUM> during infusion or aspiration. The posts <NUM> can cooperate with the channels <NUM> to secure the septum <NUM> relative to the housing. Stated otherwise, the posts <NUM> can prevent the septum <NUM> from being pulled fully into either of the chambers <NUM>, <NUM> during aspiration or infusion, respectively, or stated otherwise, under the influence of pressurized fluid.

Alternative arrangements of the posts <NUM> are contemplated. For example, in other embodiments, the proximal housing member <NUM> can define the posts <NUM>. In still other embodiments, each of the housing members <NUM>, <NUM> can define one or more of the posts <NUM>, such that some posts may project proximally while others may project distally. Such an arrangement could be advantageous from the perspective of tolerancing. For example, in the event that variations among the components were to yield gaps between one or more of the posts and an opposing housing surface, by having the posts <NUM> alternatively project proximally and distally, the septum <NUM> would still be unlikely to be both pulled over the top of one post and pulled under the bottom of an adjacent post. In still other embodiments, one housing member <NUM>, <NUM> may include a post, and the opposing housing member <NUM>, <NUM> can include a recess or a channel into which the post is receive.

With continued reference to <FIG> and <FIG>, the gripping rim <NUM> can impinge upon, embed in, or otherwise grip the septum <NUM>, which opposition forces being provided by the opposing face <NUM> of the distal housing member <NUM>. The gripping rim <NUM> can form the proximal and distal seals, as previously discussed, and can assist in preventing the septum <NUM> from being ingested into either of the chambers <NUM>, <NUM>. As shown in <FIG>, the posts <NUM> can function as standoffs to ensure a desired spacing between the gripping rim <NUM> and the proximal face <NUM> is maintained. Stated otherwise, the posts <NUM> can prevent the housing members <NUM>, <NUM> from being over-approximated to each other during manufacture. This can prevent over-compression of the septum <NUM>, which could result in weakening, cutting, or tearing of the septum.

<FIG> depict proximal and distal housing members <NUM>, <NUM>, respectively, of another embodiment of a bi-directional valve <NUM> (see <FIG>). As shown in <FIG>, the proximal housing member <NUM> can include a sidewall <NUM> that defines a distal face <NUM> at an end thereof. The proximal housing member <NUM> can further define a groove <NUM> and a gripping rim <NUM>. In the illustrated embodiment, the gripping rim <NUM> is shaped, in cross-section, substantially as an elongated trapezoid.

With reference to <FIG>, the distal housing member <NUM> can include a groove <NUM> and a gripping rim <NUM>. In the illustrated embodiment, the gripping rim <NUM> is shaped, in cross-section, substantially as an elongated trapezoid. The distal housing member <NUM> can further include a standoff or ledge <NUM>, which extends about a full periphery of the housing member <NUM> in the illustrated embodiment. In other embodiments the ledge <NUM> can be discontinuous, or stated otherwise, a plurality of standoffs (e.g., ledges) may be distributed around the periphery of the housing member <NUM>.

With reference to <FIG>, in some embodiments, a septum <NUM> includes a main body <NUM> through which a selectively openable and closable, or sealable, closure <NUM> extends. As with the septum <NUM>, the septum <NUM> includes a flange <NUM> that extends distally from the body <NUM>. In the illustrated embodiment, the septum <NUM> further includes a second flange <NUM> that extends proximally from the body <NUM>. The flanges <NUM>, <NUM> may alternatively be considered as a single flange that extends about the full periphery of the body <NUM> in both the proximal and distal directions.

As shown in <FIG>, the septum <NUM> can be captured between the proximal and distal housing members <NUM>, <NUM> and thereby secured to the housing member <NUM>, <NUM>. In the illustrated embodiment, the proximal and distal gripping rims <NUM>, <NUM> are aligned with each other and impinge on the body <NUM> of the septum <NUM> in opposite directions so as to squeeze the septum <NUM> therebetween. The proximal flange <NUM> of the septum <NUM> is received within the groove <NUM> and the distal flange <NUM> of the septum <NUM> is received within the groove <NUM>. The flanges <NUM>, <NUM> and the grooves <NUM>, <NUM> can cooperate with each other to prevent ingestion of the septum <NUM> during aspiration or infusion. For example, when pressurized fluids act on the septum <NUM> to pull the periphery of the septum <NUM> inward, the flanges <NUM>, <NUM> can abut against the outer surfaces of the gripping rims <NUM>, <NUM>, respectively. The gap between the gripping rims <NUM>, <NUM> can be sufficiently small the prevent the flanges <NUM>, <NUM> from passing therethrough, even when the septum <NUM> is stretched and/or distorted under the influence of pressurized fluids flowing through the septum <NUM>.

<FIG> depict an embodiment of a projection plate <NUM> that can be incorporated into certain embodiments of bi-directional valves. For example, the projection plate <NUM> can be incorporated into embodiments of the valves <NUM>, <NUM>, <NUM>.

The projection plate <NUM> can comprise a body <NUM> from which a plurality of projections <NUM> extend inwardly into an opening <NUM>. The opening <NUM> can extend fully through the body <NUM>. The projections <NUM> can define a profile similar to the plan-view profile of other embodiments. For example, the projection plate <NUM> can have a similar profile to the bottom plan view of the proximal housing member <NUM>, as depicted in <FIG>.

The projections <NUM> can replace other projection features previously disclosed. By way of example, in some embodiments, the fins <NUM> of the proximal housing member <NUM> (e.g., of <FIG>) can be omitted, and the projection plate <NUM> can instead be incorporated into the valve <NUM> by being placed between the proximal surface of the septum <NUM> and the distal face <NUM> of the proximal housing member <NUM>.

Stated otherwise, in some embodiments of the valves <NUM>, <NUM>, <NUM>, the illustrated fins can be omitted and replaced with the projection plate <NUM>. The projections <NUM> can function substantially in the same manner as the bottom ends of the fins, as previously disclosed. In some embodiments, the plate <NUM> can be securely attached to the proximal housing member in an early stage of assembly-e.g., prior to coupling the proximal housing member to the septum and the distal housing member.

As shown in <FIG>, in some embodiments, the projection plate <NUM> defines a thickness T<NUM>. In various embodiments, composition of the projection plate <NUM> and/or the thickness T<NUM> may be sufficient to prevent or inhibit the projections <NUM> from bending, either distally or proximally, during infusion or aspiration, respectively. In various embodiments, the projection plate <NUM> includes one or more of metallic or polymeric materials. In some embodiments, the projection plate <NUM> is formed of a sheet metal, such as a sheet of stainless steel. In other embodiments, the projection plate <NUM> comprises a metalized plastic (e.g., a plastic sheet coated in metal). In some instances, inclusion of a metallic material may provide advantageous antimicrobial properties.

In the illustrated embodiment, the tips of the projections <NUM> have a rectangular profile. In other embodiments, the tips of one or more of the projections <NUM> may have a rounded or smooth profile. In some embodiments, all edges of the projection plate may be smoothed.

Although the foregoing detailed description contains many specifics for the purpose of illustration, a person of ordinary skill in the art will appreciate that many variations and alterations to the following details can be made and are considered to be included herein. Accordingly, the foregoing embodiments are set forth without any loss of generality to, and without imposing limitations upon, any claims set forth. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs.

Any methods disclosed herein comprise one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified.

As used in this specification and the appended claims, the singular forms "a," "an" and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a layer" includes a plurality of such layers.

In this disclosure, "comprises," "comprising," "containing" and "having" and the like can have the meaning ascribed to them in U. patent law and can mean "includes," "including," and the like, and are generally interpreted to be open ended terms. The terms "consisting of" or "consists of" are closed terms, and include only the component structures, steps, or the like specifically listed in conjunction with such terms, as well as that which is in accordance with U. patent law.

The terms "first," "second," "third," "fourth," and the like in the description and in the claims, if any, are used for distinguishing between similar elements and not necessarily for describing a particular sequential or chronological order. It is to be understood that the terms so used are interchangeable under appropriate circumstances such that the embodiments described herein are, for example, capable of operation in sequences other than those illustrated or otherwise described herein. Similarly, if a method is described herein as comprising a series of steps, the order of such steps as presented herein is not necessarily the only order in which such steps may be performed, and certain of the stated steps may possibly be omitted and/or certain other steps not described herein may possibly be added to the method.

It is to be understood that the terms so used are interchangeable under appropriate circumstances such that the embodiments described herein are, for example, capable of operation in other orientations than those illustrated or otherwise described herein. For example, although <FIG> and <FIG> have been referred to as bottom and top views, respectively, these orientations are merely expressed with respect to the orientation of the valve depicted in <FIG>. In various embodiments, the valve may be operated with the valve in any orientation (e.g., independent of whether the Luer fitting is "up" or "down" relative to a gravitational influences). The term "coupled," as used herein, is defined as directly or indirectly connected in any suitable manner. Objects described herein as being "adjacent to" each other may be in physical contact with each other, in close proximity to each other, or in the same general region or area as each other, as appropriate for the context in which the phrase is used. Occurrences of the phrase "in one embodiment," or "in one aspect," herein do not necessarily all refer to the same embodiment or aspect.

As used herein, the term "substantially" refers to the complete or nearly-complete extent or degree of an action, characteristic, property, state, structure, item, or result. For example, a composition that is "substantially free of" particles would either completely lack particles, or so nearly completely lack particles that the effect would be the same as if it completely lacked particles. In other words, a composition that is "substantially free of" an ingredient or element may still actually contain such item as long as there is no measurable effect thereof.

As used herein, the term "about" is used to provide flexibility to a numerical range endpoint by providing that a given value may be "a little above" or "a little below" the endpoint. Moreover, for references to approximations (which are made throughout this specification), such as by use of the terms "about" or "approximately," or other terms, it is to be understood that, in some embodiments, the value, feature, or characteristic may be specified without approximation. For example, where qualifiers such as "about," "substantially," and "generally" are used, these terms include within their scope the qualified words in the absence of their qualifiers. For example, where the term "substantially perpendicular" is recited with respect to a feature, it is understood that in further embodiments, the feature can have a precisely perpendicular orientation.

Concentrations, amounts, and other numerical data may be expressed or presented herein in a range format. It is to be understood that such a range format is used merely for convenience and brevity and thus should be interpreted flexibly to include not only the numerical values explicitly recited as the limits of the range, but also to include all the individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited. As an illustration, a numerical range of "about <NUM> to about <NUM>" should be interpreted to include not only the explicitly recited values of about <NUM> to about <NUM>, but also include individual values and sub-ranges within the indicated range. Thus, included in this numerical range are individual values such as <NUM>, <NUM>, and <NUM> and sub-ranges such as from <NUM>-<NUM>, from <NUM>-<NUM>, and from <NUM>-<NUM>, etc., as well as <NUM>, <NUM>, <NUM>, <NUM>, and <NUM>, individually.

This same principle applies to ranges reciting only one numerical value as a minimum or a maximum. Furthermore, such an interpretation should apply regardless of the breadth of the range or the characteristics being described.

References throughout this specification to "an example," if any, mean that a particular feature, structure, or characteristic described in connection with the example is included in at least one embodiment. Thus, appearances of the phrases "in an example" in various places throughout this specification are not necessarily all referring to the same embodiment.

Reference throughout this specification to "an embodiment" or "the embodiment" means that a particular feature, structure or characteristic described in connection with that embodiment is included in at least one embodiment.

Similarly, it should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than those expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment.

Claim 1:
A medical valve (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) comprising:
a housing (<NUM>, <NUM>) comprising a sidewall (<NUM>, <NUM>, <NUM>) and defining a chamber (<NUM>);
a connection interface (<NUM>, <NUM>) in fluid communication with the chamber (<NUM>), the connection interface (<NUM>, <NUM>) being configured to couple with one or more medical devices for infusion of fluid through the medical valve (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) in a distal direction and aspiration of fluid through the medical valve (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) in a proximal direction;
a septum (<NUM>, <NUM>, <NUM>) coupled to the housing (<NUM>, <NUM>), the septum (<NUM>, <NUM>, <NUM>) comprising a proximal surface, a distal surface, and a selectively openable closure (<NUM>, <NUM>, <NUM>) that extends through a full thickness of the septum (<NUM>, <NUM>, <NUM>) between the proximal surface and the distal surface, wherein the closure (<NUM>, <NUM>, <NUM>) is positioned within the chamber (<NUM>); and
a plurality of projections (<NUM>, <NUM>, <NUM>) that extend away from the sidewall (<NUM>, <NUM>, <NUM>), each projection (<NUM>, <NUM>, <NUM>) comprising a restriction surface (<NUM>, <NUM>) at a distal end thereof that is configured to contact the proximal surface of the septum (<NUM>, <NUM>, <NUM>) to oppose movement of a restricted portion (<NUM>) of the septum (<NUM>, <NUM>, <NUM>) in the proximal direction such that an aspiration cracking pressure required to open the closure (<NUM>, <NUM>, <NUM>) to permit fluid flow through the septum (<NUM>, <NUM>, <NUM>) in the proximal direction exceeds an infusion cracking pressure required to open the closure (<NUM>, <NUM>, <NUM>) to permit fluid flow through the septum (<NUM>, <NUM>, <NUM>) in the distal direction,
wherein the septum (<NUM>, <NUM>, <NUM>) further comprises contact regions (<NUM>) at which the septum (<NUM>, <NUM>, <NUM>) contacts the restriction surfaces (<NUM>, <NUM>) of the plurality of projections (<NUM>, <NUM>, <NUM>), the contact regions (<NUM>) defining the restricted portion (<NUM>) of the septum (<NUM>, <NUM>, <NUM>) and having a collective total area that represents only a portion of a total area of the restricted portion (<NUM>) of the septum (<NUM>, <NUM>, <NUM>).