Drip-free multi-connect fluid path device

Abstract

The invention relates to a connector assembly 100 for making aseptic fluid connections in 5 bioprocessing systems, the connector assembly 100 comprising: a first deformable element 10 having a first channel 30 therethrough; a second deformable element 20 having a second channel 40 therethrough; and a fluid flow element 60 having at least one opening 70, wherein the fluid flow element 60 is adjustable between: a closed position in which the at least one opening of the fluid flow element 60 is in the first channel 30, wherein when the fluid flow 0 element 60 is in the closed position, the first deformable element 10 is configured to seal the at least one opening 70, and the second deformable element 20 is configured to seal the second channel 40; and an open position in which the fluid flow element 60 extends through the first channel 30 and the second channel 40 and the at least one opening70 is at a side of the second deformable element 20 opposite from the first deformable element 10, such that 5 the fluid flow element 60 provides a fluid flow path across the first and second deformable elements 10, 20.

Description

[0001] DRIP-FREE MULTI-CONNECT FLUID PATH DEVICE

[0002] FIELD

[0003] The present invention relates to connector assemblies for making aseptic fluid connections, and associated methods for opening and closing flow paths. The invention is of particular relevance to bioprocessing systems involving biological fluids, in industries including the biopharmaceutical, biotechnology, food, beverage, cosmetic, and medical industries.

[0004] BACKGROUND

[0005] It is often required in bioprocessing systems for biological fluids to be transferred between sterile locations. Many of these systems are subject to strict requirements for sterility. The introduction into the fluid of unwanted contaminants, including biological contaminants, such as viruses or minute organisms, e.g. bacteria, and environmental contaminants, such as dust and dirt, can be highly detrimental for a great variety of reasons. Moreover, such systems may contain biological fluids that are harmful to humans or the environment, such that any leakage from the system can detriment the safety of those operating the system or the environment. It is often necessary to make fluid connections in these systems, for example, to connect or disconnect existing conduits or components of the system, to install additional conduits for new fluid pathways, to add new components or replace existing components, or even to piece together an entirely new system. It is important to ensure that such connections and disconnections are made aseptically and with minimal risk of leakage.

[0006] Aseptic connectors and disconnectors are used extensively to manage fluid flow paths in bioprocessing systems, such as systems for biopharmaceutical manufacturing. Such systems often employ single-use technologies (SUT) to connect and disconnect locations to a fluid flow path. Typically, only a single connection or disconnection to the fluid flow path is possible and the connector devices cannot be subsequently relocated to an alternative flow path. If multiple connections or disconnections are required then a typical solution is to resort to complex and cumbersome silicone tubular manifolds.

[0007] An example of a known connector assembly is that disclosed in EP 3 225 895 Al, wherein a removable anti-actuation assembly comprising at least one peel strip is interposedbetween a first hollow connector body and a second hollow connector body. Removal of the anti -actuation assembly from between the hollow connector bodies allows the hollow connector bodies to enter an actuation position in which the interiors of the connector bodies fluidly communicate with one another, thereby opening a flow path. With such an assembly, however, subsequently disconnecting the flow path in an aseptic manner requires cumbersome additional steps such as clamping off the tubing either side of the connector assembly, and / or using a separate sterile disconnector device to catch leakage from the disconnected parts.

[0008] In another known configuration, a septum may be present to block fluid flow between two locations, wherein a sharp needle having a lumen therethrough may be pierced through the septum to open a flow path between the locations. However, such assemblies also require cumbersome additional steps and / or extra devices to disconnect the flow path aseptically, due to the irreversible puncturing of the septum material by the needle which also generally limits the device to a single use. Moreover, the puncturing of a septum with a needle may form micro tears in the septum material, which in turn may cause leakage during operation of the flow path.

[0009] Accordingly, there exists a need for devices that enable the simple connection and disconnection of fluid flow paths in an aseptic manner, and that are readily re-usable.

[0010] SUMMARY

[0011] The present invention aims to ameliorate at least some of the disadvantages of the prior art. In particular, the invention provides a new configuration of a connector assembly which comprises a combination of a first deformable element, a second deformable element and a fluid flow element, the fluid flow element being adjustable relative to the deformable elements to enable the opening and closing of a fluid flow path in an aseptic and substantially drip-free manner.

[0012] A first aspect of the present invention is a connector assembly for making aseptic fluid connections in bioprocessing systems, the connector assembly comprising: a first deformable element having a first channel therethrough; a second deformable element having a second channel therethrough; and a fluid flow element having at least one opening, wherein the fluid flow element is adjustable between: a closed position in which the at least one opening of the fluid flow element is in the first channel, wherein when the fluid flowelement is in the closed position, the first deformable element is configured to seal the at least one opening, and the second deformable element is configured to seal the second channel; and an open position in which the fluid flow element extends through the first channel and the second channel and the at least one opening is at a side of the second deformable element opposite from the first deformable element, such that the fluid flow element provides a fluid flow path across the first and second deformable elements.

[0013] Accordingly, adjustment of the fluid flow element between the closed position and the open position allows the selective closing and opening of a fluid flow path across the first and second deformable elements. That is, with the connector assembly disposed between a fluid source and a fluid destination, fluid flow from the source to the destination may be initiated by adjusting the fluid flow element from the closed position to the open position such that a flow path across the deformable elements is provided by the fluid flow element. The flow may be stopped by adjusting the fluid flow element back to the closed position, such that the opening of the fluid flow element is sealed by the first deformable element, and the second channel is sealed by the second deformable element. Advantageously, the adjustment of the fluid flow element may be performed without exposing the fluid-containing interior of the assembly to the outside environment, thus enabling the flow path to be opened and closed aseptically with minimal or no leakage.

[0014] The first deformable element may be compressed by a first external compressive force. The first external compressive force may be lateral to the first channel.

[0015] The second deformable element may be compressed by a second external compressive force. The second external compressive force may be lateral to the second channel.

[0016] The first deformable element may comprise a first bung.

[0017] The second deformable element may comprise a second bung.

[0018] In a relaxed state of the first deformable element, the first channel may be open, wherein the first deformable element is configured to seal the first channel by being deformed relative to the relaxed state by lateral compression.

[0019] In a relaxed state of the second deformable element, the second channel may be open, wherein the second deformable element is configured to seal the second channel by being deformed relative to the relaxed state by lateral compression.The first deformable element may be configured to exert lateral compression on the fluid flow element when the fluid flow element is in the closed position.

[0020] The first deformable element may have a thickness, in the direction of the first channel, of from about 5 mm to about 30 mm.

[0021] A diameter of the first channel when the first deformable element is in a relaxed state may be about 2 mm or less. The first channel may be of uniform diameter when the first deformable element is in a relaxed state.

[0022] The second deformable element may have a thickness, in the direction of the second channel, of from about 5 mm to about 30 mm.

[0023] A diameter of the second channel when the second deformable element is in a relaxed state may be about 2 mm or less. The second channel may be of uniform diameter when the second deformable element is in a relaxed state.

[0024] When the at least one opening is in the first channel, a portion of the length of the fluid flow element that comprises the at least one opening may be enveloped by a portion of the length of the first channel.

[0025] The fluid flow element may be further adjustable to a retracted position in which the fluid flow element is outside the first channel and the second channel, wherein when the fluid flow element is in the retracted position, the first deformable element is configured to seal the first channel.

[0026] When the fluid flow element is in the open position, the first deformable element may be configured to make sealing contact with and around the fluid flow element.

[0027] When the fluid flow element is in the open position, the second deformable element may be configured to make sealing contact with and around the fluid flow element.

[0028] The first deformable element may be configured to contact the second deformable element to form a face seal around the fluid flow element when the fluid flow element is in the open position. For example, the first deformable element and the second deformable element may be configured to be pressed together when the fluid flow element is in the open position.

[0029] The second deformable element may be configured to seal the at least one opening of the fluid flow element when the at least one opening is in the second channel.The fluid flow element may be configured, when initially in the closed position, to be advanced into the second channel while the first deformable element is in contact with the second deformable element.

[0030] The fluid flow element may be configured, when advanced into the second channel, to deform the second deformable element so as to widen the second channel.

[0031] The fluid flow element may be configured, when initially in the open position, to be retracted through the second channel while the first deformable element is in contact with the second deformable element.

[0032] The second deformable element may be configured to deform to seal the second channel during retraction of the fluid flow element through the second channel.

[0033] When the fluid flow element is in the closed position, a portion of the first channel may be unobstructed by the fluid flow element. In such a case, the first deformable element may be configured to seal the unobstructed portion of the first channel.

[0034] The first deformable element may be resilient. For example, the first deformable element may be formed of an elastomer.

[0035] The second deformable element may be resilient. For example, the second deformable element may be formed of an elastomer.

[0036] The fluid flow element may be an elongate hollow element having a lumen therethrough.

[0037] The fluid flow element may be a lance.

[0038] The fluid flow element may be cylindrical.

[0039] The at least one opening may be positioned in a side wall of the fluid flow element. The fluid flow element may comprise a tapered end portion. In such a case, the at least one opening may be positioned in a tapered surface of the tapered end portion.

[0040] An end of the fluid flow element proximal to the at least one opening may be blunt. The fluid flow element may comprise a plurality of openings distributed about a perimeter of the fluid flow element.

[0041] The fluid flow element may be formed of steel. For example, the fluid flow element may be formed of stainless steel.

[0042] The first channel may be pre-bored in the first deformable element.

[0043] The second channel may be pre-bored in the second deformable element.The connector assembly may further comprise a first fitting holding the first deformable element and a second fitting holding the second deformable element, wherein the first fitting is connectable to the second fitting to bring the first deformable element into contact with the second deformable element. In such a case, the connector assembly optionally further comprises a stem coupled to the fluid flow element, the stem being axially movable along the first fitting to cause axial movement of the fluid flow element relative to the first fitting. In such a case, optionally, a range of axial motion of the stem along the first fitting is bounded by a withdrawn position and an advanced position, wherein when the first fitting is connected to the second fitting, the fluid flow element is in the closed position when the stem is in the withdrawn position and the fluid flow element is in the open position when the stem is in the advanced position. Optionally, the stem and the first fitting are engaged by a screw mechanism, such that rotation of the stem relative to the first fitting causes the axial movement of the stem along the first fitting.

[0044] The connector assembly may comprise a plurality of fluid flow elements and a plurality of first channels and a plurality of second channels, wherein each fluid flow element is individually adjustable between the closed position and the open position relative to a respective first channel and second channel. In one such example, the first deformable element comprises the plurality of first channels and the second deformable element comprises the plurality of second channels. In a further example, the connector assembly comprises a plurality of first deformable elements and a plurality of second deformable elements, each first deformable element comprising a respective first channel and each second deformable element comprising a respective second channel.

[0045] A second aspect of the present invention is a method of opening a flow path for biological fluids between a first location and a second location, the method comprising: disposing at least one opening of a fluid flow element within a first channel of a first deformable element such that the first deformable element seals the at least one opening; fluidly connecting the fluid flow element to the first location; contacting the first deformable element with a second deformable element having a second channel therethrough, the second channel sealed by the second deformable element; positioning the second deformable element between the first deformable element and the second location; and advancing the fluid flow element through the first channel and the second channel, thereby uncovering theopening to enable fluid flow therethrough. Such a method may utilize a connector assembly, such as the connector assembly according to the first aspect.

[0046] A third aspect of the present invention is a method of closing a flow path for biological fluids between a first location and a second location, the method comprising: disposing a fluid flow element through a first channel of a first deformable element and a second channel of a second deformable element, the fluid flow element having an opening, the first deformable element being in contact with the second deformable element, and the fluid flow element providing a fluid flow path across the first and second deformable elements between the first location and the second location; retracting the fluid flow element through the second deformable element and the first deformable element, until the opening is sealed by the first deformable element and the second channel is sealed by the second deformable element; and separating the first deformable element from the second deformable element. Such a method may utilize a connector assembly, such as the connector assembly according to the first aspect.

[0047] BRIEF DESCRIPTION OF THE FIGURES

[0048] The invention is described below, by way of example, with reference to the accompanying figures in which:

[0049] Figure 1 shows a connector assembly according to an embodiment, in a disconnected state with a flow path closed.

[0050] Figure 2 shows a connector assembly according to another embodiment, in a disconnected state with a flow path closed.

[0051] Figure 3 shows the connector assembly of figure 1 in a connected state with the flow path closed.

[0052] Figure 4 shows the connector assembly of figure 2 in a connected state with the flow path closed.

[0053] Figure 5 shows the connector assembly of figure 1 in a connected state with the flow path open.

[0054] Figure 6 shows the connector assembly of figure 2 in a connected state with the flow path open.

[0055] Figure 7 shows the connector assembly of figure 2 in a connected state with the flow path closed and with a quick-release mechanism actuated.Figure 8 shows a connector assembly according to another embodiment.

[0056] Figures 9A-9D show different initial positions of a connector assembly for opening a flow path between a fluid source and a fluid destination.

[0057] Figure 10 shows a configuration of a fluid flow element and a second fitting usable in an embodiment.

[0058] Figure 11 shows a configuration of a fluid flow element usable in an embodiment. Figures 12A and 12B depict an exemplary form of a deformable element in a relaxed state.

[0059] In the various figures, like parts are indicated by like references.

[0060] DETAILED DESCRIPTION

[0061] Figure 1 depicts a form of a connector assembly 100 according to an exemplary embodiment. Connector assembly 100 comprises a first deformable element 10, a second deformable element 20, and a fluid flow element 60. In the arrangement shown in figure 1, fluid flow element 60 is in a closed position as described further below, and the first deformable element 10 and second deformable element 20 are not engaged with one another. Figure 3 shows the same connector assembly 100 as that of figure 1, also with fluid flow element 60 in a closed position, but with the first deformable element 10 and second deformable element 20 engaged in contact with one another. Figure 5 shows the same connector assembly 100 as that of figure 3, but with fluid flow element 60 advanced to an open position as described further below. By the selective adjustment of fluid flow element 60 between closed and open positions in the connector assembly 100, a fluid flow path may be selectively closed and opened.

[0062] Each of the first deformable element 10 and the second deformable element 20 are formed of a material that deforms under stress (e.g. compressive stress). One or both of the deformable elements 10, 20 may be resiliently deformable, and thereby configured to recover a previous shape upon removal of stress. For example, one or both of the deformable elements 10, 20 may be formed of an elastomeric material. In a preferred embodiment, both the first deformable element 10 and the second deformable element 20 are formed of an elastomeric material. Additionally, the material of the first deformable element 10 may be the same as the material of the second deformable element 20.One or both of the first deformable element 10 and the second deformable element may comprise a bung. In a preferred embodiment, the first deformable element 10 is a first bung and the second deformable element 20 is a second bung. The first bung and the second bung are preferably elastomeric bungs.

[0063] Figures 12A and 12B depict an exemplary form of a deformable element in a relaxed state (i.e. not under any deforming forces and with its channel unoccupied). Figure 12B shows a section taken along the line A- A in figure 12 A. The depicted deformable element may correspond to the first deformable element 10 having first channel 30, and / or the second deformable element 20 having second channel 40. It is to be understood that the relaxed-state properties and variants of deformable elements described herein with reference to figures 12A and 12B are applicable equally to the first deformable element 10 and the second deformable element 20. Thus, either or both of the first deformable element 10 and the second deformable element 20 may take the form depicted in figures 12A and 12B, and either or both may vary from the depicted form in any number of the ways described in the following paragraphs. In some embodiments, the dimensions of the first deformable element 10 when in a relaxed state are the same as those of the second deformable element 20 when in a relaxed state.

[0064] As shown, deformable element 10 / 20 comprises a channel 30 / 40 therethrough. Preferably the channel 30 / 40 is pre-bored through the deformable element 10 / 20, such as by being cut out from the material of the deformable element 10 / 20. Channel 30 / 40 extends across the deformable element 10 / 20 from one side thereof to another.

[0065] In figures 12A and 12B, deformable element 10 / 20 is depicted as a bung having a cylindrical shape, with channel 30 / 40 extending along an axial dimension from one circular face of the bung to the other. However, the relaxed-state shape of the deformable element 10 / 20 is not particularly limited, and may be for example a prism with a non-circular crosssection, an elliptical cylinder, a truncated cone, or any other regular or irregular three-dimensional shape, as long as channel 30 / 40 extends therethrough. Likewise, the relaxed-state dimensions of the deformable element 10 / 20 are not particularly limited.

[0066] In figures 12A and 12B, channel 30 / 40 is depicted as a straight cylindrical channel of uniform cross-section through the relaxed deformable element 10 / 20. However, the dimensions of the channel 30 / 40 are not particularly limited, as long as the fluid flow element 60 is able to extend through the channel 30 / 40 when the deformable element 10 / 20 is in theconnector assembly 100. For example, channel 30 / 40 may follow a curved path through the relaxed-state deformable element 10 / 20. Channel 30 / 40 may have a non-circular crosssection, such as a square or rectangular cross-section. Channel 30 / 40 may have a non-uniform cross-section along its length. In a preferred embodiment, channel 30 / 40 is straight and has a uniform cross-section when the deformable element 10 / 20 is in a relaxed state, as is the case in the example depicted in figures 12A and 12B.

[0067] As shown in figures 12A and 12B, in the relaxed state of the deformable element 10 / 20, the channel 30 / 40 is open. That is, the channel 30 / 40 is a void of the material of the deformable element 10 / 20, such that the channel 30 / 40 provides fluid communication between the two sides of the deformable element 10 / 20. In such cases, the channel 30 / 40 can be closed by deforming the deformable element 10 / 20 out of the relaxed state, such as by squeezing the deformable element 10 / 20 with an external compressive force that has a directional component lateral to the axis of the channel 30 / 40. However, in alternative embodiments, the channel 30 / 40 is closed even when the deformable element 10 / 20 is in the relaxed state. This may occur, for example, when the channel 30 / 40 is a substantially planar slit extending through the deformable element 10 / 20.

[0068] When first deformable element 10 and second deformable element 20 are present in connector assembly 100 (e.g., as shown in figures 1, 3 and 5), the deformable elements may not be in their relaxed states. Accordingly, when in the connector assembly 100, the first deformable element 10 and / or the second deformable element 20 may be under compressive stresses that change the shapes of the deformable elements and / or reduces their dimensions compared to their relaxed states. In some examples, the first deformable element 10 in connector assembly 100 may have a thickness in the direction of the first channel 30 of about 5 mm to about 30 mm. In some examples, the second deformable element 20 in connector assembly 100 may have a thickness in the direction of the second channel 40 of about 5 mm to about 30 mm.

[0069] For example, first deformable element 10 may be compressed by a first external compressive force when present in the connector assembly 100. The first external compressive force may be (or have a component that is) in a direction lateral to the direction of extension of the first channel 30. The first external compressive force may be applied across the full axial thickness of the first deformable element 10 or across a portion thereof. Likewise, second deformable element 20 may be compressed by a second externalcompressive force when present in the connector assembly 100. The second external compressive force may be (or have a component that is) in a direction lateral to the direction of extension of the second channel 40. The second external compressive force may be applied across the full axial thickness of the second deformable element 20 or across a portion thereof. The first and / or second external compressive forces may be exerted on the respective deformable elements by fittings 50, 140 that hold the respective deformable elements, as described further below.

[0070] The connector assembly 100 is generally configured such that the first deformable element 10 and the second deformable element 20 may be brought into contact with one another. As described herein, contacting the deformable elements together may facilitate adjustment of the fluid flow element 60 to an open position which permits fluid flow therethrough. In some embodiments, the first deformable element 10 and second deformable element 20 are configured to contact one another to form a face seal therebetween. In some embodiments, the first deformable element 10 and second deformable element 20 are configured to be pressed together, so as to apply axial compressive forces on the deformable elements.

[0071] The connector assembly 100 is configured such that fluid flow element 60 may be positioned in the first channel 30 and the second channel 40. As described herein, the fluid flow element 60 is movable between various positions such that at any one time the fluid flow element 60 may extend partially or wholly through the first and / or second channel. The first deformable element 10 may be generally configured such that the inner walls of the first channel 30 exert lateral compression (i.e. inward pressure) on a portion of the fluid flow element 60 that is in the first channel 30. Likewise, the second deformable element 20 may be generally configured such that the inner walls of the second channel 40 exert lateral compression on a portion of the fluid flow element 60 that is in the second channel 40. Such compression is lateral to the direction of the fluid flow element 60, and may be substantially perpendicular thereto. Such compression may result from first and / or second external compressive forces, as described herein. Such compression may additionally or alternatively result from energy stored in the material of the deformable elements due to resilient deformation thereof as a result of the fluid flow element 60 being inserted in the channels. The compressive force on the fluid flow element 60 by the first deformable element 10 and / or the second deformable element 20 may result from a combination of these factors.The first deformable element 10 may be generally configured such that the inner walls of the first channel 30 make sealing contact with and around a portion of the fluid flow element 60 that is in the first channel 30. Likewise, the second deformable element 20 may be generally configured such that the inner walls of the second channel 40 make sealing contact with and around a portion of the fluid flow element 60 that is in the second channel 40. Such sealing contact may be enabled or enhanced by lateral compression exerted on the fluid flow element 60 by the inner walls of the channels.

[0072] As described above, the second deformable element 20 may have a relaxed-state form in which the second channel 40 is open. In such cases, it is necessary for the second deformable element 20 to be compressed when in connector assembly 100 (e.g. by second external compressive force) so as to cause the material of the second deformable element 20 to seal the second channel 40 when the second channel 40 is unoccupied. In this way, when fluid flow element 60 is in the closed position as described herein, fluid flow through the second channel 40 is prevented at the working fluid pressure. When the second deformable element 20 has a relaxed-state form in which the second channel 40 is sealed, as described above, the second deformable element 20 may or may not be in the relaxed state in the connector assembly 100 when the fluid flow element 60 is in the closed position.

[0073] Figures 1, 3 and 5 depict fluid flow element 60 in the form of a lance. In general, fluid flow element 60 may be an elongate, hollow element having a lumen therethrough, the lumen providing a flow path for fluid through the fluid flow element. Fluid flow element 60 comprises an opening 70 which provides a path for exit (or entry) of fluid from (or to) the fluid flow element (depending on the direction of flow in connector assembly 100). Opening 70 may be disposed proximal to an end portion 80 of fluid flow element 60. In use of the connector assembly 100, an end of the fluid flow element 60 opposite to end portion 80 may be fluidly connected to a fluid source or a fluid destination, depending on the desired direction of flow.

[0074] Opening 70 may be positioned in a side wall of fluid flow element 60. This is depicted in figures 1, 3 and 5, in which the opening 70 is a port through a circumferential wall of the elongate lance 60, proximal to end portion 80. Positioning the opening 70 in a side wall facilitates effective sealing of opening 70 by the inner walls of the first channel 30, while the fluid flow element 60 is in the closed position. Although figures 1, 3 and 5 depict the opening 70 being positioned in a portion of the side wall that extends parallel to the axisof the fluid flow element 60, the opening 70 may instead be positioned in a portion of the side wall that is otherwise shaped. For example, the opening 70 may be positioned in a tapered portion of the side wall (such as in a tapered end portion 80, as described below). Even when the opening 70 is positioned in a portion of the side wall that is not parallel to the axis of the first channel 30, the inner walls of the first channel 30 may deform to complement the shape of the surface of said portion of the fluid flow element 60 so as to block the opening 70 when the fluid flow element 60 is in the closed position.

[0075] The shape of fluid flow element 60 is not particularly limited. For example, fluid flow element 60 may have a major portion (that is, the portion of the fluid flow element proximal to end portion 80) with a cylindrical shape. Alternatively, the major portion may have a non-circular cross-section, such as a substantially square cross-section. In preferred embodiments, end portion 80 may comprise a blunt end of the fluid flow element 60. That is, the end of the fluid flow element proximal to opening 70 is preferably rounded, flat or otherwise blunted so as not to have a sharp point. The bluntness of the end of the fluid flow element 60 may be defined in terms of its ability to pierce the material from which the first deformable element 10 and / or the second deformable element 20 is made. For example, in preferred embodiments, the end of the fluid flow element 60 proximal to the opening 70 is blunt such that the end would not pierce a surface of the material of either of the deformable elements when pressed into said material with a force of up to 10 N, preferably up to 30 N, more preferably up to 50 N. Providing fluid flow element 60 with a blunt end facilitates the fluid flow element 60 being pushed into the pre-existing first channel 30 and second channel 40 of the deformable elements, as opposed to piercing the material of the deformable elements.

[0076] The end portion 80 of the fluid flow element 60 may comprise a tapered surface. That is, the fluid flow element may taper inwards at the end proximal to the opening 70. This tapering may facilitate the deformation of the first and second deformable elements by the fluid flow element 60 when it is pushed through the first and second channels. For example, the fluid flow element depicted in figures 1, 3 and 5 comprises a tapered end portion 80 which also has a blunt end. Although not shown in figures 1, 3 and 5, the opening 70 may be positioned in a tapered surface of the tapered end portion 80, which may benefit the flow profile of fluid through the opening 70 as discussed further below.Although figures 1, 3 and 5 depict fluid flow element 60 having just one opening 70, the fluid flow element 60 may alternatively comprise a plurality of openings which each possess the properties described herein in relation to the opening 70. For example, the fluid flow element 60 may comprise a plurality of openings 70 distributed about a perimeter of the fluid flow element 60. The plurality of openings 70 may be positioned circumferentially around a side wall of the fluid flow element at a particular axial position, or circumferentially around a tapered wall of end portion 80, for example. Providing a plurality of openings may allow a higher flow rate through the connector assembly 100 and / or may benefit flow profiles therein. When a plurality of openings are provided, each opening 70 is configured to be sealed by the first deformable element 10 when the fluid flow element 60 is in the closed position.

[0077] Figure 10 shows a form of fluid flow element 60 according to some embodiments. In this form, the fluid flow element 60 comprises a tapered end portion, with a plurality of openings 70 in a tapered surface of the end portion. By positioning the openings 70 on tapered surfaces instead of surfaces parallel to the axis of the fluid flow element 60, the fluid flowing through the openings undergoes less angular deflection on its flow path. This may enable a flow regime of the fluid to remain laminar. This is advantageous in bioprocessing, where fluids often contain cellular matter that may be damaged by turbulent flow profiles. Figure 11 shows a similar fluid flow element 60, in which the end portion comprises a proximal protrusion that causes fluid to migrate to the outer periphery of the fluid flow element 60 before flowing out of openings 70, thereby further enhancing the laminar flow profile of the fluid.

[0078] The material of fluid flow element 60 is not particularly limited. The fluid flow element 60 is generally a rigid component able to cause deformation of the deformable elements 10, 20 when forced against them. For example, the fluid flow element 60 may be made from a metal such as steel, particularly such as stainless steel. Stainless steel is a suitable material due to its longevity, resistance to corrosion and general compliance with biological materials.

[0079] The connector assembly 100 may comprise additional components that facilitate positioning of the deformable elements 10, 20 and the fluid flow element 60 in use. For example, and as shown in figures 1, 3 and 5, the connector assembly 100 may comprise a first fitting 50 that holds the first deformable element 10. The first fitting 50 may be ahousing that surrounds the lateral periphery of the first deformable element 10, leaving exposed a side of the first deformable element 10 that includes one end of the first channel 30. Likewise, the connector assembly 100 may comprise a second fitting 140 that holds the second deformable element 20. The second fitting 140 may be a housing that surrounds the lateral periphery of the second deformable element 20, leaving exposed a side of the second deformable element 20 that includes one end of the second channel 40. The first fitting 50 may be connectable with the second fitting 140 in a way that brings the exposed sides of the first deformable element 10 and second deformable element 20 into contact, with the respective ends of the first channel 30 and second channel 40 aligned with one another. First fitting 50 may comprise a first fluid port 110 (inlet or outlet, depending on flow direction) and second fitting 140 may comprise a second fluid port 150 (outlet or inlet, depending on flow direction).

[0080] The portion of the first fitting 50 housing the first deformable element 10 may have a dimension smaller than a corresponding relaxed-state dimension of the first deformable element 10, such that placing the first deformable element 10 in the first fitting 50 results in inward compression of the first deformable element 10 relative to its relaxed state. That is, the first fitting 50 may provide or contribute to a first external compressive force exerted on the first deformable element 10. Similarly, the portion of the second fitting 140 housing the second deformable element 20 may have a dimension smaller than a corresponding relaxed-state dimension of the second deformable element 20, such that placing the second deformable element 20 in the second fitting 140 results in inward compression of the second deformable element 20 relative to its relaxed state. That is, the second fitting 140 may provide or contribute to a second external compressive force exerted on the second deformable element 20. In the arrangement shown in figures 1, 3 and 5, the first fitting 50 and the second fitting 140 compress the respective deformable elements only along a portion of their thicknesses (i.e. the magnitudes of the external compressive forces are non-uniform along the axial dimensions of the respective deformable elements).

[0081] The second fitting 140 may be shaped so as to substantially complement a shape of the end portion of the fluid flow element 60. As such, the second fitting 140 may facilitate a laminar flow profile of fluid after it exits the opening 70 into the second fitting (or prior to entry to the opening 70, if the flow direction is reversed). This is shown in figure 10, in which the fluid flow element 60 encourages laminar flow due to the positioning of theopenings 70 as discussed herein. As shown, the shape of the second fitting conforms to and complements the curved shape of the end of the fluid flow element 60. Accordingly, fluid flowing through the second fitting 140 and around the end portion of the fluid flow element 60 may be kept free of sharp angular deflections that may cause damage to biological components of the fluid.

[0082] The connector assembly 100 may comprise an engagement means 130 which facilitates the connection of the first fitting 50 to the second fitting 140 with the deformable elements in contact. The first fitting 50, second fitting 140 and engagement means 130 may be configured such that upon engagement of the fittings, the first deformable element 10 and second deformable element 20 are pressed together. This is represented in figures 3 and 5, in which the engagement of the fittings results in compression of the first and second deformable elements in an axial direction. Due to the presence of the rigid fittings preventing outward expansion of the deformable elements, the addition of this axial compression may further improve the inward sealing forces exerted by the deformable elements.

[0083] Although the engagement means 130 is illustrated as an integral part of the connector assembly 100, the connection of the first fitting 50 to the second fitting 140 may instead be achieved using an external device such as a clamp (e.g. a tri-clover clamp). The fittings may be held together using a combination of integral engagement means 130 and an external device.

[0084] The connector assembly 100 may further comprise a stem 90 that is coupled to the fluid flow element 60. For example, as shown in figures 1, 3 and 5, the stem may be telescopically housed in the first fitting 50. The stem 90 is configured to be moved axially along the first fitting 50, thereby causing axial movement of the fluid flow element 60 relative to the first fitting (hence relative to the first deformable element 10). Accordingly, axial movement of the stem 90 may be used to effect adjustment of the fluid flow element 60 between various axial positions, such as between the closed position and the open position. For example, the stem 90 may be placed in a withdrawn position which corresponds to the fluid flow element 60 being in the closed position (as shown in figures 1 and 3), or an advanced position which corresponds to the fluid flow element 60 being in the open position if the second fitting 140 is engaged with the first fitting 50 (as shown in figure 5). The stem 90 may be dimensioned so as to allow easy actuation thereof by an operator. Accordingly, the operator may readily effect movement of the fluid flow element 60 withoutdirectly interacting with the fluid flow element 60. The stem 90 may comprise a handle to further facilitate actuation.

[0085] The connector assembly 100 may include a stem guide 120 which bounds axial movement of the stem 90 along the first fitting 50 between the withdrawn position and the advanced position, so as to restrict a range of movement of the fluid flow element 60 to between the closed position and the open position. Accordingly, an operator may easily position the fluid flow element 60 precisely in the open position or the closed position as desired. For example, in embodiments where the axial movement of the stem 90 along the first fitting 50 is purely linear, stem guide 120 may include an axial groove formed in the body of either the stem 90 or the first fitting 50, with the other comprising a protrusion configured to slide axially within the groove. The stem 90 may then be moved along the first fitting 50 by a pushing or pulling action by an operator. A stem guide 120 according to such an embodiment is depicted in figures 1, 3 and 5. In other embodiments, stem guide 120 may take the form of a screw engagement between the first fitting 50 and the stem 90, such that rotation of the stem 90 relative to the axis of the first fitting 50 causes the relative axial movement. The stem 90 may then be moved along the first fitting 50 by a rotation action by an operator. Such actions may be facilitated by a handle on the stem 90.

[0086] Figure 1 depicts fluid flow element 60 in a closed position. In the closed position, the opening 70 is in the first channel 30 of the first deformable element 10, such that the first deformable element 10 seals the opening 70. By “in the first channel” it is meant, for example, that a portion of the axial length of the fluid flow element 60 that comprises the opening 70 is enveloped by a portion of the axial length of the first channel 30. This is shown in figure 1, in which opening 70 occupies a portion of the axial length of fluid flow element 60 which is fully concealed within the first channel 30, such that none of the opening 70 is exposed outside the first channel 30. In this position, an inner wall of the first channel 30 is in contact with (e.g. pressed against) a surface of the fluid flow element around the opening 70 so as to seal the opening 70. For instance, the seal formed at the opening 70 in this position may resist fluid flow through the opening 70 up to a fluid pressure differential across the seal of 1 bar, preferably up to 2 bar, more preferably up to 3 bar, more preferably up to 4 bar. As a result of this seal, the first deformable element 10 combined with the fluid flow element 60 in the closed position can provide an effective resistance to fluid flow.Herein, “seal” refers to a seal that is resistant to fluid flow therethrough up to the usual working pressure in the art, for example a fluid pressure differential across the seal of 1 bar, preferably up to 2 bar, more preferably up to 3 bar, more preferably up to 4 bar.

[0087] With the fluid flow element 60 in the closed position in the connector assembly 100, the first deformable element 10 may be configured such that the inner walls of the first channel 30 exert lateral compression on the fluid flow element 60. As described herein, this compression may result from a first external compressive force, resilient deformation of the first deformable element 10, or a combination of these factors. The lateral compressive force exerted on the fluid flow element 60 has the effect of improving the sealing of the opening 70 by the first deformable element 10, while the fluid flow element 60 is in the closed position.

[0088] With the fluid flow element 60 in the closed position in the connector assembly 100, a portion of the first channel 30 may be unobstructed by the fluid flow element 60. This is shown in figure 1, in which the fluid flow element 60 is inserted partially into the one side of the first channel 30, such that the opening 70 is concealed by the first deformable element 10 but the end portion 80 of the fluid flow element 60 does not protrude from the other side of the first channel 30. In such cases, the unobstructed portion of the first channel 30 (the right-hand side of the first channel as depicted in figure 1) may be sealed by the material of the first deformable element 10. That is, the first deformable element 10 may be configured, such as by action of a first external compressive force lateral to the first channel 30, to close the unobstructed portion of the first channel 30 and thereby seal said portion of the first channel 30. This seal, combined with the seal formed by the inner wall of the first channel 30 at the opening 70, provides further resistance to fluid flow across the first deformable element 10 while the fluid flow element 60 is in the closed position.

[0089] Figure 3 depicts the connector assembly 100 with the fluid flow element 60 still in the closed position, but with the first deformable element 10 now brought into contact with the second deformable element 20. As described herein, such contact may be caused by connecting the first fitting 50 and the second fitting 140 via engagement means 130 and / or an external device such as a clamp. In this arrangement, the first channel 30 and the second channel 40 are aligned at the contacting surfaces of the first deformable element 10 and the second deformable element 20.When the fluid flow element 60 is in the closed position, the connector assembly 100 may be utilized to block a flow path for fluid from a source to a destination. That is, the fluid source may be connected to the fluid flow element 60, and the fluid destination may be connected to a space on the side of the second deformable element 20 opposite to the first deformable element, or vice versa. The sealing of the opening 70 by the first deformable element 10, and the sealing of the second channel 40 by the second deformable element 20, act to prevent fluid flow from source to destination.

[0090] When the first deformable element 10 and the second deformable element 20 are in contact and the fluid flow element 60 is in the closed position, the fluid flow element 60 is configured to be advanced into the second channel 40. Because the second channel 40 is sealed by the second deformable element 20 when the fluid flow element 60 is in the closed position, advancing the fluid flow element 60 through the second channel 40 forces the second channel 40 to widen to accommodate the fluid flow element 40. A blunt end of the fluid flow element 60 may facilitate the fluid flow element 60 entering the second channel 40 without piercing the material of the second deformable element 40. Moreover, the advancement of the fluid flow element 60 through the channels may be facilitated by a tapered end portion 80.

[0091] From the position shown in figure 3, the fluid flow element 60 may be advanced to an open position, which is shown in figure 5. In the open position, the fluid flow element 60 extends through both the first channel 30 and the second channel 40, and the opening 70 is at the side of the second deformable element 40 opposite from the first deformable element. With the fluid flow element 60 in the open position, as shown in figure 5, the opening 70 is exposed to a space adjacent the second deformable element 40.

[0092] When the fluid flow element 60 is in the open position, the first deformable element 10 may be configured to make sealing contact with and around the fluid flow element 60. Likewise, when the fluid flow element 60 is in the open position, the second deformable element 20 may be configured to make sealing contact with and around the fluid flow element 60. Additionally, contact between the first deformable element 10 and the second deformable element 20 may form a face seal around the fluid flow element 60, further enhancing sealing of the connector assembly. The face seal may be enhanced by the deformable elements being pressed together.When the fluid flow element 60 is in the open position, the connector assembly 100 may provide a flow path for fluid from a source to a destination. That is, the fluid source may be connected to the fluid flow element 60, and the fluid destination may be connected to a space on the side of the second deformable element 20 opposite to the first deformable element, or vice versa. The opening 70 is unsealed such that fluid may flow therethrough. Thus, the fluid flow element 60 provides a fluid flow path across the first deformable element 10 and the second deformable element 20 (through their respective channels) from source to destination.

[0093] When the fluid flow element 60 is in the open position, the fluid flow element 60 is configured to be retracted through the second channel. For example, this may be done to disconnect a fluid flow path using the connector assembly 100. The first deformable element 10 and second deformable element 20 may remain in contact during the retraction. The fluid flow element 60 may be retracted ultimately back to the closed position as shown in figure 3, in which the first deformable element 10 seals the opening 70. Additionally, during retraction of the fluid flow element 60 through the second channel 40, the second deformable element may be configured to deform to seal the second channel. That is, the second channel 40, which has previously been forced open by the fluid flow element 60, may close again upon removal of the fluid flow element 60. This closure may occur due to a second external compressive force acting on the second deformable element 20, and / or due to resilience of the second deformable element 20. Accordingly, retraction of the fluid flow element 60 to the closed position closes the flow path across the deformable elements.

[0094] During advancement of the fluid flow element 60 from the closed position to the open position, and during retraction of the fluid flow element 60 from the open position to the closed position, the opening 70 enters the second channel 40. In some embodiments, when the opening 70 is in the second channel 40, the second deformable element 20 is configured to seal the opening 70, in a similar way to how the first deformable element 10 seals the opening 70 when the opening 70 is in the first channel 30. In some embodiments, during advancement or retraction of the fluid flow element 60, the opening 70 may at certain points be partially in the first channel 30 and partially in the second channel 40. In such scenarios, the first deformable element 10 and the second deformable element 20 may be configured together to seal the opening 70. The contact between the first deformable element 10 and second deformable element 20 may also form a face seal around the fluid flowelement 60. Accordingly, leakage of fluid through the channels and / or between the deformable elements is minimized or prevented during adjustment of the fluid flow element 60.

[0095] To illustrate additional features that may be present in the connector assembly 100, a form of a connector assembly 100 according to another exemplary embodiment is depicted in figure 2. In figure 2, the fluid flow element 60 is in a closed position. Figure 4 shows the same connector assembly 100 as that of figure 2, also with fluid flow element 60 in a closed position, but with the first deformable element 10 and second deformable element 20 engaged in contact with one another. Figure 6 shows the same connector assembly 100 as that of figure 4, but with fluid flow element 60 advanced to an open position. Figure 7 shows the same connector assembly as that of figure 4, but with a quick-release mechanism 160 actuated.

[0096] As shown in figure 2, the connector assembly 100 may comprise resilient sealing members 170 at numerous locations, to enhance overall sealing of the assembly. Figure 2 shows resilient sealing members 170 placed between the stem 90 and fluid flow element 60, and at a portion of the second fitting 140 configured to engage with the first fitting 50.

[0097] The connector assembly 100 may comprise a quick-release mechanism 160. Figure 2 shows quick-release mechanism 160 coupled with the first fitting 50. As shown, the quickrelease mechanism 160 comprises inward protrusions 190 to engage with complementary slots in the second fitting 140. The quick-release mechanism 160 may be spring-loaded. As shown in figure 7, actuation of the quick-release mechanism 160 may enable easy disconnection of the second fitting 140 from the first fitting 50. Figure 8 shows another embodiment of connector assembly 100 including detail of the quick-release mechanism.

[0098] The connector assemblies described herein may be used in methods of opening and closing flow paths between locations. The locations may be a fluid source and a fluid destination. For example, the fluid source may be a bioreactor and the fluid destination may be a sampling container, such as a sampling bag. Such methods are described below, wherein the flow direction in the connector assembly is from the first deformable element 10 to the second deformable element. However, it will be appreciated that the connector assembly 100 is not limited to a specific flow direction, and the following methods may be modified for flow in the opposite direction by switching the fluid source and fluid destination.In a method for opening a flow path between a fluid source and a fluid destination, the connector assembly 100 may initially be configured as depicted in figure 1, with the fluid flow element 60 in the closed position and the deformable elements physically separated. The fluid flow element 60 is fluidly connected to the fluid source, and the fluid destination is fluidly connected to a space adjacent to one end of the second channel 40. The sealing of the opening 70 by the first deformable element 10 prevents flow of fluid from the fluid source. If the fluid source and fluid destination were swapped, then the sealing of the second channel 40 by the second deformable element 20 would prevent flow of fluid from the fluid source.

[0099] Then, the deformable elements are brought into contact as shown in figure 3. The surface of the second deformable element 20 that contacts the first deformable element 10 comprises the other end of the second channel 40. This step may comprise connecting first fitting 50 and second fitting 140 with engagement means 130 and / or an external device such as a clamp. Flow from the fluid source is still prevented.

[0100] Then, the fluid flow element 60 is advanced through the first channel 30 and the second channel 40, to uncover the opening 70 in the aforementioned space that is fluidly connected to the fluid destination. A fluid path is thereby created across the deformable elements. Accordingly, fluid is enabled to flow from the fluid source to the fluid destination.

[0101] The order of steps in the foregoing method is not particularly limited. For example, the deformable elements may be brought into contact (as shown in figure 3) prior to fluidly connecting the fluid source and / or fluid destination to the respective sides of the assembly. In some embodiments, the connector assembly 100 may be provided in a state where the deformable elements are already in contact.

[0102] For example, figure 9 shows four exemplary ways of initially configuring the connector assembly for opening a flow path from a fluid source (bioreactor) to a fluid destination (bag). As shown in figure 9A, the first deformable element and second deformable element may be initially physically separate, with the first fitting connected to a tube leading to the fluid destination, and with the second fitting connected to a tube leading to the fluid source. As shown in figure 9B, the first deformable element and second deformable element may be initially physically separate, with the first fitting connected to a tube leading to the fluid destination, and with the second fitting connected directly to the fluid source (e.g. welded thereto). As shown in figure 9C, the first deformable element andsecond deformable element may be initially physically separate, with the first fitting directly connected to the fluid source (e.g. welded thereto), and with the second fitting directly connected to the fluid destination (e.g. welded thereto). As shown in figure 9D, the first deformable element and second deformable element may be initially in contact, with the first fitting directly connected to the fluid destination, and with the second fitting not fitted to any component. In the example of figure 9D, the tube attached to the fluid source may then be connected to the second fitting and the flow path opened.

[0103] In a method of closing a flow path between a fluid source and a fluid destination, the connector assembly may initially be configured as depicted in figure 5, with the fluid flow element 60 in the open position. An end of the fluid flow element 60 opposite to the end proximal to the opening 70 is fluidly connected to the fluid source. The fluid destination is fluidly connected to a space adjacent to the end of the second channel 40 that is on a side of the second deformable element 20 opposite from the first deformable element 10. Accordingly, the fluid flow element 60 provides a flow path from the fluid source to the fluid destination.

[0104] Then, the fluid flow element 60 is retracted through the channels until it is in the closed position, as shown in figure 3. The opening 70 becomes sealed by the first deformable element 10, and the second channel becomes sealed by the second deformable element 20. Accordingly, fluid is no longer able to flow from the fluid source to the fluid destination. The sealing of the opening 70 prevents fluid flow from the fluid source across the first deformable element. Meanwhile, the sealing of the second channel 40 prevents backflow of any residual fluid in the aforementioned space fluidly connected to the fluid destination. If the fluid source and fluid destination were swapped, flow from the fluid source would be prevented by the sealing of the second channel 40, while backflow would be prevented by the sealing of the opening 70. As described herein, the opening 70 may remain sealed while it traverses the second channel 40 and the first channel 30, and the contact of the deformable elements may form a face seal therebetween. Accordingly, the presence of residual fluid in the channels and in between the deformable elements is minimized or prevented.

[0105] Then, the deformable elements may be separated as shown in figure 1. The fluid source and fluid destination may thereby be physically separated as well as fluidly separated. For instance, the fluid source and / or the fluid destination may be transported to different locations. Due to the prevention of residual fluid in the channels and in between thedeformable elements, the separation of the deformable elements may be substantially drip-free. The fluid source and fluid destination may later be reconnected, or may each be connected to different components as desired.

[0106] Accordingly, the connector assembly 100 enables opening or closing of a flow path via straightforward axial advancement or retraction of a fluid flow element 60 through deformable elements. The sealing provided by the deformable elements minimizes risk of leakage or contamination during such procedures. Moreover, due to the use of deformable elements that may not be permanently altered in the opening and closing of flow paths, the connector assembly 100 is advantageously re-usable. For example, the connector assembly 100 may be used to open and close a flow path up to 10 times, up to 15 times, up to 20 times, or more.

[0107] The foregoing description is exemplary in nature only. Those skilled in the art will understand that changes and variations on the disclosed embodiments are possible within the scope of the claims. It will also be understood that features described with reference to specific embodiments herein may be combined with those described with reference to other embodiments.

Claims

Claims:

1. A connector assembly (100) for making aseptic fluid connections in bioprocessing systems, the connector assembly comprising:a first deformable element (10) having a first channel (30) therethrough; a second deformable element (20) having a second channel (40) therethrough; anda fluid flow element (60) having at least one opening (70),wherein the fluid flow element (60) is adjustable between:a closed position in which the at least one opening (70) of the fluid flow element (60) is in the first channel (30), wherein when the fluid flow element (60) is in the closed position, the first deformable element (10) is configured to seal the at least one opening (70), and the second deformable element (20) is configured to seal the second channel (40); and an open position in which the fluid flow element (60) extends through the first channel (30) and the second channel (40) and the at least one opening (70) is at a side of the second deformable element (20) opposite from the first deformable element (10), such that the fluid flow element (60) provides a fluid flow path across the first and second deformable elements (10, 20).

2. The connector assembly (100) of claim 1, wherein the first deformable element (10) is compressed by a first external compressive force, and / or the second deformable element (20) is compressed by a second external compressive force.

3. The connector assembly (100) of claim 2, wherein the first external compressive force is lateral to the first channel (30), and / or the second external compressive force is lateral to the second channel (40).

4. The connector assembly (100) of any preceding claim, wherein the first deformable element (10) comprises a first bung, and / or the second deformable element (20) comprises a second bung.

255. The connector assembly (100) of any preceding claim, wherein:in a relaxed state of the first deformable element (10), the first channel (30) is open, wherein the first deformable element (10) is configured to seal the first channel (30) by being deformed relative to the relaxed state by lateral compression; and / orin a relaxed state of the second deformable element (20), the second channel (40) is open, wherein the second deformable element (20) is configured to seal the second channel (40) by being deformed relative to the relaxed state by lateral compression.

6. The connector assembly (100) of any preceding claim, wherein the first deformable element (10) is configured to exert lateral compression on the fluid flow element (60) when the fluid flow element (60) is in the closed position.

7. The connector assembly (100) of any preceding claim, wherein:the first deformable element (10) has a thickness, in the direction of the first channel (30), of from about 5 mm to about 30 mm; and / orthe second deformable element (20) has a thickness, in the direction of the second channel (40), of from about 5 mm to about 30 mm.

8. The connector assembly (100) of any preceding claim, wherein when the at least one opening (70) is in the first channel (30), a portion of the length of the fluid flow element (60) that comprises the at least one opening (70) is enveloped by a portion of the length of the first channel (30).

9. The connector assembly (100) of any preceding claim, wherein the fluid flow element (60) is further adjustable to a retracted position in which the fluid flow element (60) is outside the first channel (30) and the second channel (40), wherein when the fluid flow element (60) is in the retracted position, the first deformable element (10) is configured to seal the first channel (30).

10. The connector assembly (100) of any preceding claim, wherein when the fluid flow element (60) is in the open position, the first deformable element (10) and / or second deformable element (20) is configured to make sealing contact with and around the fluid flow element (60).

11. The connector assembly (100) of any preceding claim, wherein the first deformable element (10) is configured to contact the second deformable element (20) to form a face seal around the fluid flow element (60) when the fluid flow element (60) is in the open position.

12. The connector assembly (100) of any preceding claim, wherein when the fluid flow element (60) is in the closed position, a portion of the first channel (30) is unobstructed by the fluid flow element (60), optionally wherein the first deformable element (10) is configured to seal the unobstructed portion of the first channel (30).

13. The connector assembly (100) of any preceding claim, wherein the first deformable element (10) and / or the second deformable element (20) is resilient, and optionally formed of an elastomer.

14. The connector assembly (100) of any preceding claim, wherein the fluid flow element (60) is a lance.

15. The connector assembly (100) of any preceding claim, wherein the at least one opening (70) is positioned in a side wall of the fluid flow element (60).

16. The connector assembly (100) of any preceding claim, wherein the fluid flow element (60) comprises a tapered end portion (80), optionally wherein the at least one opening (70) is positioned in a tapered surface of the tapered end portion (80).

17. The connector assembly (100) of any preceding claim, wherein an end of the fluid flow element (60) proximal to the at least one opening (70) is blunt.

18. The connector assembly (100) of any preceding claim, wherein the fluid flow element (60) comprises a plurality of openings (70) distributed about a perimeter of the fluid flow element (60).

19. The connector assembly (100) of any preceding claim, wherein the fluid flow element (60) is formed of steel, optionally stainless steel.

20. The connector assembly (100) of any preceding claim, wherein the first channel (30) is pre-bored in the first deformable element (10) and / or the second channel (40) is pre-bored in the second deformable element (20).

21. The connector assembly (100) of any preceding claim, further comprising a first fitting holding the first deformable element (10) and a second fitting holding the second deformable element (20), wherein the first fitting is connectable to the second fitting to bring the first deformable element (10) into contact with the second deformable element (20).

22. The connector assembly (100) of claim 21, further comprising a stem (90) coupled to the fluid flow element (60), the stem (90) being axially movable along the first fitting to cause axial movement of the fluid flow element (60) relative to the first fitting.

23. The connector assembly (100) of any preceding claim, comprising a plurality of fluid flow elements (60) and a plurality of first channels (30) and a plurality of second channels (40), wherein each fluid flow element (60) is individually adjustable between the closed position and the open position relative to a respective first channel (30) and second channel (40).

24. A method of opening a flow path for biological fluids between a first location and a second location, the method comprising:28disposing at least one opening (70) of a fluid flow element (60) within a first channel (30) of a first deformable element (10) such that the first deformable element (10) seals the at least one opening (70);fluidly connecting the fluid flow element (60) to the first location; contacting the first deformable element (10) with a second deformable element (20) having a second channel (40) therethrough, the second channel (40) sealed by the second deformable element (20);positioning the second deformable element (20) between the first deformable element (10) and the second location; andadvancing the fluid flow element (60) through the first channel (30) and the second channel (40), thereby uncovering the opening (70) to enable fluid flow therethrough.

25. A method of closing a flow path for biological fluids between a first location and a second location, the method comprising:disposing a fluid flow element (60) through a first channel (30) of a first deformable element (10) and a second channel (40) of a second deformable element (20), the fluid flow element (60) having an opening (70), the first deformable element (10) being in contact with the second deformable element (20), and the fluid flow element (60) providing a fluid flow path across the first and second deformable elements (10, 20) between the first location and the second location;retracting the fluid flow element (60) through the second deformable element (20) and the first deformable element (10), until the opening (70) is sealed by the first deformable element (10) and the second channel (40) is sealed by the second deformable element (20); andseparating the first deformable element (10) from the second deformable element (20).29

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