Pressure-driven flow control valve

Abstract

To provide a valve for maintaining a desired flow rate and / or preventing the occurrence of an undesired flow rate.SOLUTION: A diaphragm disposed within an interior of the housing, the diaphragm including a first configuration at a first fluid pressure within the interior and a second configuration at a second fluid pressure within the interior; a primary fluid path extending from the inlet to the outlet, the primary fluid path being open when the diaphragm is in the first configuration; Wherein the primary fluid path is closed when the septum is in the second configuration, and a secondary fluid path extending from the inlet to the outlet, wherein the secondary fluid path is open when the septum is in the second configuration, and wherein the primary fluid path comprises a primary flow capacity that is greater than a secondary flow capacity of the secondary fluid path.SELECTED DRAWING: Figure 5A

Description

[Technical Field]

[0001] The present invention relates generally to valves for use in systems configured to collect or distribute fluids at desired flow rates. In particular, the present invention relates to control valves that include various components configured to maintain a desired flow rate and / or prevent undesired flow rates. The control valves of the present invention can be incorporated into a variety of devices for use with flow-rate-sensitive fluids, such as biological fluids, including live cells, shear-sensitive fluids, emulsions, and chemically unstable fluids. [Background technology]

[0002] There are many instances where it is desirable to transfer flow-sensitive fluids. In these cases, it is essential to maintain a safe flow rate of the fluid while transferring it; failure to do so can result in a compromised fluid quality. When fluids are needed for medical or diagnostic purposes, failure to maintain a safe flow rate can result in misdiagnosis, lost time and resources, delayed treatment, serious injury, and death.

[0003] In medical settings, clinicians often draw blood from patients immediately after successful catheter insertion. These blood samples are often collected using vacuum containers, where the vacuum pressure within the vacuum container is configured to draw blood into the container as soon as the container is connected to an intravenous access device. Vacuum containers are not designed for use with intravenous catheters; rather, they are designed for use with intravenous needles, whose fluid path diameters are generally larger than the diameter of the intravenous catheter. In some instances, vacuum containers are incompatible for use with intravenous catheter lines. For example, the vacuum pressure of a vacuum container may draw the blood sample through the intravenous catheter at a flow rate that damages viable blood cells. Alternatively, the vacuum pressure may be insufficient for a particular intravenous catheter, thereby unnecessarily extending the fill time.

[0004] Clinicians often choose to use a manual syringe to draw blood from a patient's intravenous catheter. Syringes offer a level of draw control that automated vacuum containers cannot match. While the use of a syringe increases the opportunity for control over blood collection, sample quality can be compromised if the clinician introduces significant vacuum to reduce fill time.

[0005] Thus, while systems and methods currently exist for collecting or dispensing fluids at desired flow rates, challenges remain. The present invention addresses and overcomes these challenges. Summary of the Invention

[0006] The present invention relates generally to valves for use in systems configured to collect or distribute fluids at desired flow rates. In particular, the present invention relates to control valves that include various components configured to maintain a desired flow rate and / or prevent undesired flow rates. The control valves of the present invention can be incorporated into a variety of devices for use with flow-rate-sensitive fluids, such as biological fluids, including live cells, shear-sensitive fluids, emulsions, and chemically unstable fluids.

[0007] In some examples, the present invention provides a valve for controlling a flow of a fluid at a desired rate, the valve comprising: an enclosure having an inlet and an outlet; a primary fluid path; and a septum disposed within an interior of the enclosure and proximate to the primary fluid path, the septum having a first configuration at a first fluid pressure within the interior and a second configuration at a second fluid pressure within the interior. In some examples, the septum further comprises a fluid pressure threshold at which the septum switches from the first configuration to the second configuration. In some examples, the first configuration is an open configuration. In some examples, the first fluid pressure is equal to or less than the fluid pressure threshold. In some examples, the second configuration is a closed configuration. In some examples, the second fluid pressure is greater than the fluid pressure threshold.

[0008] In some embodiments of the invention, the fluid pressure threshold is a fluid vacuum pressure threshold and a vacuum pressure is applied to the output end of the valve. In some embodiments of the invention, the first fluid pressure is a first fluid vacuum pressure and the second fluid pressure is a second fluid vacuum pressure.

[0009] In some examples, the first configuration of the septum is an open configuration and the first fluid vacuum pressure experienced by the septum is less than or equal to the fluid vacuum pressure threshold of the septum, hi some examples, the second configuration of the septum is a closed configuration and the second fluid vacuum pressure experienced by the septum is greater than the fluid vacuum pressure threshold of the septum.

[0010] In some embodiments, the septum of the present invention includes an opening. In some instances, the opening in the septum is open when the septum is in a first configuration and closed when the septum is in a second configuration. In some embodiments, the opening in the septum is closed when the septum is in the first configuration and open when the septum is in the second configuration. In some embodiments, the opening in the septum includes at least one of a primary fluid path and a secondary fluid path of the valve.

[0011] In some examples, the opening in the septum is open to a first width in the first configuration of the septum and is reduced to a second width in the second configuration of the septum, the second width reducing fluid flow or velocity of fluid flow through the opening. In some embodiments, the second width of the opening completely prevents fluid flow through the opening and / or valve.

[0012] In some embodiments of the present invention, the primary fluid path of the valve is unobstructed when the septum is in the first configuration and is obstructed when the septum is in the second configuration. In some examples, contact between the septum and an inner surface of the valve enclosure obstructs the primary fluid path. In some examples, contact between opposing surfaces of the septum, including, but not limited to, opposing surfaces of an opening in the septum, obstructs the primary fluid path of the valve. In some examples, the secondary fluid path of the valve is unobstructed by the septum when the septum is in the second configuration. In some examples, the secondary fluid path of the valve is unobstructed by the septum when the septum is in the first configuration.

[0013] In some embodiments, the septum of the present invention comprises a secondary fluid pathway. In some examples, the septum of the present invention comprises a primary fluid pathway and a secondary fluid pathway. In some examples, the primary fluid pathway of the septum comprises a primary flow capacity that is greater than the secondary flow capacity of the secondary fluid pathway.

[0014] In some instances, the septum of the present invention is fixedly positioned within the interior of the valve. In some instances, the septum of the present invention is movably positioned within the interior of the valve.

[0015] It is to be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed. [Brief explanation of the drawings]

[0016] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Figure 1A] FIG. 1A is a cross-sectional view of a valve for controlling fluid flow, the valve shown in an open configuration according to an exemplary embodiment of the present invention. [Figure 1B] FIG. 1B is the valve of FIG. 1A shown in a closed configuration in accordance with an exemplary embodiment of the present invention. [Figure 2A]FIG. 2A is a cross-sectional view of a valve for controlling fluid flow, shown in a first configuration in which a first fluid path and a secondary fluid path of the valve are open, according to an exemplary embodiment of the present invention. [Figure 2B] FIG. 2B is the valve of FIG. 2A shown in a second configuration with the first fluid path closed and the secondary fluid path open in accordance with an exemplary embodiment of the present invention. [Figure 3A] FIG. 3A is a cross-sectional view of a valve for controlling fluid flow shown in a first configuration in which a first fluid path and a secondary fluid path of the valve are open in accordance with an exemplary embodiment of the present invention. [Figure 3B] FIG. 3B is the valve of FIG. 3A shown in a second configuration with the first fluid path closed and the secondary fluid path open in accordance with an exemplary embodiment of the present invention. [Figure 4A] FIG. 4A is a cross-sectional view of a valve for controlling fluid flow, the valve including a septum shown in a first configuration in which a fluid path of the valve is open, according to an exemplary embodiment of the present invention. [Figure 4B] FIG. 4B is the valve of FIG. 4A with the septum shown in a second configuration in which the fluid path of the valve is closed according to an exemplary embodiment of the present invention. [Figure 5A] FIG. 5A is a cross-sectional view of a valve for controlling fluid flow, the valve including a septum shown in a first configuration in which the fluid path of the valve is open and the fluid path of the septum is closed, in accordance with an exemplary embodiment of the present invention. [Figure 5B] FIG. 5B is the valve of FIG. 5A with the septum shown in a second configuration with the valve fluid path closed and the septum fluid path open according to an exemplary embodiment of the present invention. [Figure 6A] FIG. 6A is a cross-sectional view of a valve for controlling fluid flow, the valve including a septum shown in a first configuration in which a fluid path of the valve is open, according to an exemplary embodiment of the present invention. [Figure 6B]FIG. 6B is the valve of FIG. 6A with the septum shown in a second configuration in which the fluid path of the valve is closed according to an exemplary embodiment of the present invention. [Figure 7A] FIG. 7A is a cross-sectional view of a valve for controlling fluid flow, the valve including a septum shown in a first configuration in which the fluid path of the valve is open and the fluid path of the septum is open, according to an exemplary embodiment of the present invention. [Figure 7B] FIG. 7B is the valve of FIG. 7A with the septum shown in a second configuration in which the valve's fluid path is reduced by the septum's fluid path in accordance with an exemplary embodiment of the present invention. [Figure 8A] FIG. 8A is a cross-sectional view of a valve for controlling fluid flow, the valve including a septum shown in a first configuration in which a fluid path of the valve is open, according to an exemplary embodiment of the present invention. [Figure 8B] FIG. 8B is the valve of FIG. 8A with the septum shown in a second configuration in which the fluid path of the valve is closed according to an exemplary embodiment of the present invention. [Figure 8C] FIG. 8C is the valve of FIG. 8B, where the septum further includes an open fluid pathway according to an exemplary embodiment of the present invention. [Figure 8D] FIG. 8D is the valve of FIG. 8A further comprising a means for manually adjusting the position of a septum within the interior of the valve, the septum being shown in a position that allows a maximum desired flow rate of fluid through the fluid path of the valve, in accordance with an exemplary embodiment of the present invention. [Figure 8E] FIG. 8E is the valve of FIG. 8D with the septum shown in a position that minimizes the desired flow rate of fluid through the valve's fluid path, according to an exemplary embodiment of the present invention. [Figure 9A] FIG. 9A is a cross-sectional view of a valve for controlling fluid flow, the valve including a septum held in a first configuration by a biasing element, and a fluid path of the valve is open, according to an exemplary embodiment of the present invention. [Figure 9B]FIG. 9B is the valve of FIG. 9A with the septum shown in a second configuration in which the fluid path of the valve is closed according to an exemplary embodiment of the present invention. [Figure 10A] FIG. 10A is a cross-sectional view of a valve for controlling fluid flow, the valve including a septum held in a first configuration by a biasing element, and a fluid path of the valve is open, according to an exemplary embodiment of the present invention. [Figure 10B] FIG. 10B is the valve of FIG. 10A, where the septum is shown in a second configuration in which the fluid path of the valve is closed, and where the septum is shown with an alternative fluid path in accordance with one or more exemplary embodiments of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0017] The presently preferred embodiments of the present invention will be best understood by reference to the drawings, where like reference numbers indicate identical or functionally similar elements. It will be readily understood that the components of the present invention, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description, as represented in the figures, is not intended to limit the scope of the invention as claimed, but is merely representative of presently preferred embodiments of the invention.

[0018] Referring now to FIG. 1 , a valve 100 for controlling fluid flow is shown. Valve 100 generally comprises an enclosure having an inlet 102, an outlet 104, and an interior 106 interposed therebetween. Valve 100 may comprise any structural form, shape, dimension, or size as may be desired. In some embodiments, valve 100 comprises an in-line component, with inlet 102 coupled to an upstream fluid line and outlet 104 coupled to a downstream fluid line such that fluid flows through a primary fluid path 110 of the valve. In some embodiments, valve 100 is incorporated into a fluid processing component, such as an intravenous catheter, a catheter adapter, a vacuum reservoir, or a Luer connector, where features of the present invention are incorporated such that fluid flows through the primary fluid path 110 of the valve. In some embodiments, valve 100 is incorporated into a secondary component of the fluid line, such as a filter or fluid pump.

[0019] Valve 100 may comprise any material compatible for use with the desired fluid. In some embodiments, valve 100 comprises a polymeric material. In some embodiments, valve 100 comprises a metallic material. In some embodiments, valve 100 comprises a rigid material. In some embodiments, valve 100 comprises a semi-rigid or semi-flexible material. In some embodiments, valve 100 comprises a flexible material.

[0020] Valve 100 further includes a septum 120 or other compliant element (e.g., a piston, etc.) disposed within interior 106 and positioned proximate primary fluid path 110. In some embodiments, the position of septum 120 within interior 106 is fixed. In some embodiments, septum 120 is movably disposed within interior 106. For example, in some embodiments, septum 120 may slide forward and / or backward toward inlet 102 and outlet 104. In a further example, septum 120 may be pivotally coupled to interior 106 such that septum 120 may move between a vertical position and a horizontal position. In some embodiments, septum 120 may be freely movable within interior 106, such as by gravity and / or by fluid or vacuum fluid pressure within interior 106. In some embodiments, movement of septum 120 within interior 106 is controlled or otherwise limited, for example, by a tether or biasing element.

[0021] Diaphragm 120 may comprise any material compatible for use with a desired fluid. In some embodiments, septum 120 comprises a polymeric material. In some embodiments, septum 120 comprises a metallic material. In some embodiments, septum 120 comprises a rigid material. In some embodiments, septum 120 comprises a semi-rigid or semi-flexible material. In some embodiments, septum 120 comprises a flexible material.

[0022] In some embodiments, the septum 120 may be configured to have a fluid pressure threshold (f T). As used herein, the term "fluid pressure threshold" refers to the fluid pressure limit of septum 120. When the fluid pressure experienced by septum 120 is, in some examples, less than or approximately equal to the fluid pressure threshold of septum 120, septum 120 assumes and / or maintains a first configuration. However, when the fluid pressure experienced by septum 120 is equal to or greater than the fluid pressure threshold of septum 120, septum 120 assumes, transforms, or changes to a second configuration. As used herein and as applied to various embodiments of the present invention, the term "fluid pressure" may refer to positive fluid pressure and / or vacuum fluid pressure. In some embodiments, the "fluid pressure threshold" of the septum 120 may alternatively describe a flow rate limit of the septum 120, such that when the flow rate experienced by the septum 120 is less than the flow rate limit of the septum 120, the septum 120 assumes and / or maintains a first configuration, and when the flow rate experienced by the septum 120 is equal to or greater than the flow rate limit of the septum 120, the septum 120 assumes, transforms, or changes to a second configuration.

[0023] The diaphragm's fluid pressure threshold can be achieved through the design of the diaphragm and / or other components of the valve that include the diaphragm. For example, fluid dynamics can be used to increase or decrease the diaphragm's drag while in the primary fluid path, which in turn can increase or decrease the diaphragm's fluid pressure threshold. Similarly, fluid dynamics can be used to increase or decrease the flow efficiency of the primary fluid path. When the valve contains the intended orientation, the diaphragm's mass can be selected to match the desired flow rate and / or fluid pressure.

[0024] 1A , the diaphragm 120 is shown in a first configuration in which the primary fluid path 110 is open between the inlet 120 and the outlet 140. In some embodiments, the valve 100 is oriented parallel to the Earth's gravity, such that the fluid pressure threshold of the diaphragm 120 is equal to and opposite the Earth's gravity on the diaphragm 120. When the diaphragm 120 experiences a first fluid pressure (f1) approximately equal to the Earth's gravity on the diaphragm 120, the first configuration of the diaphragm 120 is maintained, thereby opening the primary fluid path 110 (i.e., the inlet 102 and the outlet 104 are in fluid communication with the primary fluid path 110). As used herein, the term “first fluid pressure” refers to a desired compatible fluid pressure for a flow-rate- and / or fluid-pressure-sensitive fluid. When diaphragm 120 experiences a second fluid pressure (f2) greater than the fluid pressure threshold of diaphragm 120 (i.e., the force of Earth's gravity on diaphragm 120), the fluid pressure threshold is overcome, diaphragm 120 assumes a second configuration, as shown in FIG. 1B, and diaphragm 120 occludes and closes primary fluid pathway 110. As used herein, the term "second fluid pressure" refers to an undesirable, incompatible fluid pressure for a flow-rate- and / or fluid-pressure-sensitive fluid. In this embodiment, the second configuration of diaphragm 120 prevents all fluid flow through valve 100. When the second fluid pressure decreases, diaphragm 120 resumes the first configuration, thereby reopening primary fluid pathway 110.

[0025] 2A, a valve 200 is shown having a septum 220 in a first configuration, the valve including a primary fluid path 210, defined in part by a space between an outer surface of the septum 220 and an inner wall of the interior 206, and the valve 200 including a secondary fluid path 212, defined in part by an aperture 222 in the septum 220. In the first configuration, the fluid pressure threshold (f T) is approximately equal to the first fluid pressure (@f1), such that the septum 220 maintains a position within the interior 206 that does not occlude or close the primary fluid path 210. When the septum 220 experiences a second fluid pressure (@f2) greater than the septum 220's fluid pressure threshold, the fluid pressure threshold is overcome, the septum 220 assumes the second configuration, and the septum 220 occludes the primary fluid path 210, as shown in FIG. 2B. Unlike the embodiment shown in FIGS. 1A and 1B, the second configuration of the septum 220 does not prevent all fluid flow through the valve 200. Rather, the open state of the secondary fluid path 212 is maintained in the septum 220's second configuration.

[0026] 2B detects a change in flow rate or fill rate when septum 220 assumes the second configuration. Accordingly, the clinician may reduce the second fluid pressure to allow septum 220 to resume the first configuration. In some examples, the clinician may feel or hear contact between septum 220 and the inner wall of interior 206 when septum 220 assumes the second configuration, which may signal the clinician to reduce the second fluid pressure.

[0027] 3A, a valve 300 is shown having a septum 320 in a first configuration, the valve including a primary fluid path 310, defined in part by the space between the outer surface of the septum 320 and the inner wall of the interior 306, and the valve 300 including a secondary fluid path 312, defined in part by an opening 308 proximate to the outlet 304. In the first configuration, the fluid pressure threshold (f T) is approximately equal to the first fluid pressure (f1), such that the septum 320 maintains a position within the interior 306 that does not occlude or close the primary fluid pathway 310. When the septum 320 experiences a second fluid pressure (f2) that is greater than the fluid pressure threshold of the septum 320, the fluid pressure threshold is overcome and the septum 320 assumes the second configuration, as shown in FIG. 3B. When in the second configuration, the septum 320 occludes the primary fluid pathway 310 but does not occlude the secondary fluid pathway 312. Rather, the open state of the secondary fluid pathway 312 is maintained in the second configuration of the septum 320.

[0028] In some embodiments, the primary fluid path of the valve includes a single opening or aperture in the septum. In some embodiments, the primary fluid path includes multiple openings or apertures in the septum. In some embodiments, the primary fluid path includes openings that are open at a fluid pressure less than or equal to a first fluid pressure and that are partially or fully closed at a fluid pressure greater than the first fluid pressure.

[0029] 4A, a valve 400 is shown having a septum 420 in a first configuration, the valve including a primary fluid path 410, a portion of which is defined by an opening 422 in the septum 420. In the first configuration, the fluid pressure threshold (f T ) is greater than the first fluid pressure (f1), such that opening 422 is in an open configuration. When opening 422 is in the open configuration, primary fluid path 410 is unobstructed. When diaphragm 420 experiences a second fluid pressure (f2) that is greater than or equal to the fluid pressure threshold of diaphragm 420, diaphragm 420 assumes a second configuration in which opening 422 is in a closed configuration, as shown in FIG. 4B. When in the second configuration, diaphragm 420 occludes primary fluid path 410 such that all fluid flow through valve 400 is prevented.

[0030] In some embodiments, the septum of the present invention is configured to progressively restrict flow through the valve in response to increases in flow rate and / or fluid pressure. Thus, in some embodiments, the septum is configured to provide a linear response to increases in flow rate and / or fluid pressure, whereby the cross-sectional diameter of the septum opening is decreased or increased relative to the change in flow rate and / or fluid pressure experienced by the septum. In some embodiments, this is achieved by providing a septum with multiple fluid pressure thresholds. In some embodiments, this is achieved by providing multiple fluid paths that are progressively closed or opened as the septum moves through multiple configurations linked to multiple fluid pressure thresholds.

[0031] 5A, a valve 500 is shown having a septum 520 in a first configuration, the valve including a primary fluid path 510, defined in part by a first opening 522 in the septum 520. The septum 520 further includes a second opening 524. In the first configuration, the fluid pressure threshold (f T) is greater than the first fluid pressure (f1), such that the opening 522 is in an open configuration and the second opening 524 is in a closed configuration. When the first opening 522 is in the open configuration, the primary fluid pathway 510 is unobstructed. When the septum 520 experiences a second fluid pressure (f2) that is equal to or greater than the fluid pressure threshold of the septum 520, the septum 520 assumes a second configuration, as shown in FIG. 5B, with the first opening 522 in a closed configuration and the second opening 524 in an open configuration. When in the second configuration, the primary fluid pathway 510 is occluded and a secondary fluid pathway 512 is formed through the second opening 524. In some embodiments, the flow rate through the second opening 524 is less than the flow rate through the first opening 522. Thus, a clinician may detect a decrease in flow rate and / or fill rate when the septum 520 switches from the first configuration to the second configuration. In some embodiments, a change in the flow rate of the valve 500 will indicate to the clinician that a change in fluid pressure is necessary to maintain a desired quality of fluid flowing through the valve 500 .

[0032] 6A, a valve 600 is shown having a septum 620 in a first configuration, the valve including a primary fluid path 610, a portion of which is defined by the space between the outer surface of the septum 620 and the inner surface of the interior 606. In the first configuration, the fluid pressure threshold (f T ) is greater than the first fluid pressure (f1), thereby causing septum 620 to maintain a position within interior 606 that does not occlude or close primary fluid pathway 610. When septum 620 experiences a second fluid pressure (f2) greater than the fluid pressure threshold of septum 620, the fluid pressure threshold is overcome and septum 620 assumes the second configuration, as shown in FIG. 6B , where septum 620 occludes primary fluid pathway 610. In some embodiments, septum 620 is pivotally coupled to an inner surface of interior 606 such that it pivots from the first configuration to the second configuration. When in the second configuration, septum 620 occludes primary fluid pathway 610 such that all fluid flow through valve 600 is prevented.

[0033] 7A , a valve 700 is shown having a septum 720 in a first configuration, the valve including a primary fluid pathway 710, a portion of which is defined by a space between an outer surface of the septum 720 and an inner surface of the interior 706. The septum 720 further includes an opening 722. In some embodiments, the primary fluid pathway 710 does not include the opening 722 when the septum 720 is in the first configuration. In some embodiments, the primary fluid pathway 710 includes the opening 722 when the septum 720 is in the first configuration. In the first configuration, the fluid pressure threshold (f T ) is greater than the first fluid pressure (f1), causing the septum 720 to maintain a position within the interior 706 that does not occlude or close the primary fluid pathway 710. When the septum 720 experiences a second fluid pressure (f2) that is greater than the fluid pressure threshold of the septum 720, the fluid pressure threshold is overcome and the septum 720 assumes the second configuration, as shown in FIG. 7B, and the septum 720 occludes the primary fluid pathway 710. When in the second configuration, a secondary fluid pathway 712 is formed through the opening 722, providing a reduced flow rate through the valve 700.

[0034] 8A-8E, a valve 800 is shown having a conical or wedge-shaped septum 820 and a conical or wedge-shaped inner surface 806 that tapers inwardly from an input 802 to an output 804, the valve including a primary fluid path 810 defined in part by the space between the outer septum 820 and the inner surface 806. Referring to FIG. 8A, the septum 820 is shown in a first configuration. In the first configuration, the fluid pressure threshold (f T ) is greater than the first fluid pressure (f1), such that diaphragm 820 maintains a position within the interior of valve 800 that does not occlude or close primary fluid path 810. In some embodiments, diaphragm 820 includes a structural element 821 that contributes to the fluid pressure threshold of diaphragm 820. For example, in some embodiments, diaphragm 820 includes a structural element that includes a concave surface configured to increase the surface area of ​​the diaphragm that is in communication with primary fluid path 810. In some embodiments, diaphragm 820 includes a structural element configured to increase the drag of diaphragm 820 within primary fluid path 810.

[0035] When septum 820 experiences a second fluid pressure (f2) that is equal to or greater than the fluid pressure threshold of septum 820, the fluid pressure threshold is overcome and septum 820 assumes a second configuration, as shown in FIG. 3B. When in the second configuration, septum 820 forms a fluid-tight seal with interior 806, thereby occluding primary fluid path 810 such that all fluid flow through valve 800 is prevented. In some embodiments, septum 820 forms an irreversible fluid-tight seal with interior 806. In other embodiments, septum 820 forms a temporary fluid-tight seal with interior 806, and the fluid-tight seal is removed when the first fluid pressure is resumed.

[0036] 8C , the septum 820 further comprises a groove or channel 823 formed in or otherwise disposed on the outer surface of the septum 820. When the septum 820 is in the second configuration, the channel 823 forms a secondary fluid pathway 812 with the inner surface 806, and such fluid may continue to flow through the valve 800 via the secondary fluid pathway 812.

[0037] 8D and 8E, some embodiments of the present invention further include an external control 850 whereby the position of the septum 820 is adjusted to control the desired flow rate (F ) in response to an undesired fluid pressure (f ). p1 and F p2 ) can be manually selected by a clinician to achieve the desired position. External control 850 may include any features or structures that allow a clinician to manipulate and / or set the position of septum 820 within the interior of valve 800. In some embodiments, control 850 includes a button operably coupled to septum 820. In some embodiments, the position of control 850 is adjustable between multiple set positions. In some embodiments, the position of control 850 is infinitely adjustable.

[0038] In some embodiments, the position of control 850 adjusts the volume, capacity, and / or dimensions of primary fluid path 810. Thus, control 850 may increase or decrease the flow rate through primary fluid path 810. In some embodiments, the structural features of septum 820 and inner surface 806, in combination with the proximity between these surfaces, determine the flow rate through valve 800. For example, as shown in FIG. 8D , the tapered conical structure of septum 820 and inner surface 806 of valve 800 provides a first flow rate (C1) when control 850 is in a first position, which is equal to or greater than a first preferred flow rate (F p1 When the control 850 is moved to a second position, the distance between the opposing surface of the septum 820 and the inner surface 806 is decreased (C2) to provide a second flow rate, which provides a second preferred flow rate (F p1 In some embodiments, the clinician selects a position for the control 850 that provides a flow rate that prevents undesired damage to the fluid flowing through the valve 800.

[0039] Some embodiments of the present invention provide a valve including a biasing element configured to control movement of a septum in response to fluid pressure within the valve. The biasing element may include any structure, feature, or effect that contributes to the position of the septum within the valve. In some examples, the biasing element biases the septum toward the input end of the valve. In some embodiments, the biasing element biases the septum toward the output end of the valve. In some embodiments, the biasing element biases the septum toward a position between the input and output ends of the valve. In some embodiments, the biasing element biases the septum toward an inner wall surface of the valve. In some embodiments, the biasing element is a spring. In some embodiments, the biasing element is a tether. In some embodiments, the biasing element is deformable. In some embodiments, the biasing element is elastic. In some embodiments, the biasing member is flexible. In some embodiments, the biasing member is rigid.

[0040] 9A, a valve 900 is shown having a septum 920 in a first configuration, the valve including a primary fluid path 910, a portion of which is defined by a space between the septum 920 and an inner surface 906 of the valve 900. The valve 900 further includes a spring biasing element 930 interposed between the septum 920 and the inner surface 906, the biasing element maintaining the position of the septum 920 within the valve 900. In the first configuration, a fluid pressure threshold (f T 9B ) is greater than the first fluid pressure (f1), causing the biasing element 930 to bias the diaphragm 920 toward the input end 902, maintaining a position of the diaphragm 920 that does not occlude or close the primary fluid path 910. When the diaphragm 920 experiences a second fluid pressure (f2) that is equal to or greater than the fluid pressure threshold of the diaphragm 920 and the biasing element 930, the fluid pressure threshold is overcome, the diaphragm 920 assumes the second configuration, the biasing element 930 collapses, and the diaphragm 920 occludes the primary fluid path 910, as shown in FIG. 9B . When in the second configuration, the diaphragm 920 is moved by the second fluid pressure toward the output 904, causing the diaphragm 920 to contact the output 904 and occlude the primary fluid path 910 such that all fluid flow through the valve 900 is prevented. In some embodiments, the valve 900 may include a secondary fluid path that provides restricted fluid flow through the valve 900 when the septum 920 is in the second configuration.

[0041] 10A , there is shown a valve 1000 having a septum 1020 in a first configuration, the valve including a primary fluid path 1010, a portion of which is defined by a space between the septum 1020 and an inner surface 1006 of the valve 1000. The valve 1000 further includes a spring biasing element 1030 interposed between the septum 1020 and the inner surface 1006, the biasing element maintaining the position of the septum 1020 within the valve 1000. In the first configuration, the fluid pressure threshold (f T) is greater than the first fluid pressure (f1), causing the biasing element 1030 to bias the diaphragm 920 away from the input 1002 and toward the output 1004, to a position that does not occlude or close the primary fluid path 1010. When the diaphragm 1020 experiences a second fluid pressure (f2) that is equal to or greater than the fluid pressure threshold of the diaphragm 1020 and the biasing element 1030, the fluid pressure threshold is overcome and the diaphragm 1030 assumes the second configuration, as shown in FIG. 10B , causing the biasing element to collapse the diaphragm 1020 and occlude the primary fluid path 1010. When in the second configuration, the diaphragm 1020 is moved by the second fluid pressure toward the output 1004, causing the diaphragm 1020 to contact the output 1004 and occlude the primary fluid path 1010 such that all fluid flow through the valve 900 is prevented. In some embodiments, the valve 1000 may include a secondary fluid pathway 1022 that provides restricted fluid flow through the valve 1000 when the septum 1020 is in the second configuration.

[0042] The present invention may be embodied in other specific forms without departing from its structure, methods, or other essential characteristics broadly described herein and claimed below. The described embodiments and examples are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is therefore indicated by the appended claims rather than by the foregoing specification. All changes that come within the meaning and range of equivalency of the claims are to be embraced within the scope of the invention.

[0043] All examples and conditional language recited herein are intended for educational purposes to aid the reader in understanding the invention and concepts provided by the inventor to further the art, and should not be construed as being limited to such specifically recited examples and conditions. While the implementation of the invention has been described in detail, it should be understood that various changes, substitutions, and alterations can be made without departing from the spirit and scope of the invention.

Claims

1. a housing having an inlet and an outlet; a partition disposed within an interior of the housing, the partition including a first configuration at a first fluid pressure within the interior and a second configuration at a second fluid pressure within the interior; a primary fluid path extending from the inlet to the outlet, the primary fluid path being open when the septum is in the first configuration and closed when the septum is in the second configuration; and a secondary fluid path extending from the inlet to the outlet, the secondary fluid path being open when the partition is in the second configuration, the primary fluid path having a primary flow capacity greater than a secondary flow capacity of the secondary fluid path; Including, valve.

2. The valve of claim 1 , wherein the secondary fluid path is open when the septum is in either the first configuration or the second configuration.

3. The valve of claim 1 , wherein the diaphragm further comprises a fluid pressure threshold at which the diaphragm switches from the first configuration to the second configuration.

4. 4. The valve of claim 3, wherein the first configuration is an open configuration, wherein the first fluid pressure is less than or equal to the fluid pressure threshold, and the second configuration is a closed configuration, wherein the second fluid pressure is greater than the fluid pressure threshold.

5. The valve of claim 3 , wherein the fluid pressure threshold is a fluid vacuum pressure threshold, the first fluid pressure is a first fluid vacuum pressure, and the second fluid pressure is a second fluid vacuum pressure.

6. 6. The valve of claim 5, wherein the first configuration is an open configuration, and the first fluid vacuum pressure is less than or equal to the fluid vacuum pressure threshold of the diaphragm, and the second configuration is a closed configuration, and the second fluid vacuum pressure is greater than the fluid vacuum pressure threshold.

7. 2. The valve of claim 1, wherein the septum includes a second opening, and in the first configuration, the second opening is open and in the second configuration, the second opening is closed.

8. The valve of claim 1 , wherein the septum defines an opening that forms part of the secondary fluid path.

9. The valve of claim 8 , wherein the opening is closed when the septum is in the first configuration.

10. The valve of claim 1 , wherein the septum defines a channel on an outer surface thereof that forms part of the secondary fluid path.

11. The valve of claim 1 , wherein the primary fluid path includes a space between an outer surface of the septum and one or more interior walls of the housing.

12. The valve of claim 1 , wherein at least a portion of the septum moves relative to the housing when transitioning from the first configuration to the second configuration.

13. The valve of claim 1 , wherein at least a portion of the septum pivots relative to the housing when transitioning from the first configuration to the second configuration.

14. 10. The valve of claim 1, wherein the septum moves axially toward the outlet when transitioning from the first configuration to the second configuration.

15. a housing having an inlet, an outlet, and an opening adjacent to the outlet; a primary fluid path through the outlet; a secondary fluid path through the opening; a partition disposed within the housing, the partition having a first configuration at a first fluid pressure within the housing and a second configuration at a second fluid pressure within the housing; Including, the primary fluid path is open when the septum is in the first configuration and closed when the septum is in the second configuration; The valve, wherein the secondary fluid path is open when the septum is in either the first configuration or the second configuration.

16. 16. The valve of claim 15, wherein in the first configuration, the septum is spaced apart from all interior walls of the housing and is unconstrained within the housing.

17. 16. The valve of claim 15, wherein the primary fluid path comprises a primary flow capacity greater than a secondary flow capacity of the secondary fluid path.

18. 16. The valve of claim 15, wherein the primary fluid path includes a space between an outer surface of the septum and one or more interior walls of the housing.

19. 16. The valve of claim 15, wherein the diaphragm further comprises a fluid pressure threshold at which the diaphragm switches from the first configuration to the second configuration.

20. 20. The valve of claim 19, wherein the first configuration is an open configuration, wherein the first fluid pressure is less than or equal to the fluid pressure threshold, and the second configuration is a closed configuration, wherein the second fluid pressure is greater than the fluid pressure threshold.

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