Patent Description:
Large-scale production of pharmaceuticals, fluids for use in medical applications, and food grade products relies on maintenance of sanitary environments. Exposure of such products to bacteria or contaminants results in a reduced quality and, in some cases, toxic byproducts. As such, food and medical product manufacturers attempt to reduce points of contamination and have turned to sanitary hoses and connectors as part of an effort to maintain a sanitary environment. There exists a need for improved sanitary hoses and connectors Document <CIT> discloses a connector which provides connection of conduits between a plurality of sampling devices situated in a sealed environment and a measurement device situated exterior of the environment.

Skilled artisans appreciate that elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions of some of the elements in the figures may be exaggerated relative to other elements to help to improve understanding of embodiments of the invention.

The following description in combination with the figures is provided to assist in understanding the teachings disclosed herein. The following discussion will focus on specific implementations and embodiments of the teachings. This focus is provided to assist in describing the teachings and should not be interpreted as a limitation on the scope or applicability of the teachings. However, other embodiments can be used based on the teachings as disclosed in this application.

The materials, methods, and examples are illustrative only and not intended to be limiting. To the extent not described herein, many details regarding specific materials and processing acts are conventional and may be found in textbooks and other sources within the fluid transport arts.

The present disclosure is directed to fluid transport coupling according to claim <NUM>.

A particular advantage of certain embodiments of the present disclosure is the ability to form and secure a fluid connection between a plurality of fluid conduits simultaneously. Previously, a fluid connection between a plurality of fluid conduits required separately-formed fluid connections with a fluid connecting element for each individual fluid conduit. By contrast, embodiments of the present disclosure include a single overmolding step that forms a fluid connection between a plurality of fluid conduits simultaneously and with the same fluid connector. For example, as disclosed herein, a fluid connector can be formed onto the fluid conduits via overmolding. The concepts are better understood in view of the embodiments described below that illustrate and do not limit the scope of the present invention.

Referring now to <FIG>, a fluid transport coupling <NUM> can include first fluid conduits <NUM>, each first fluid conduit having a distal end <NUM> and a proximal end <NUM>, and a fluid connector <NUM> disposed adjacent the proximal ends of the first fluid conduits <NUM>. The fluid connector <NUM> can have a body <NUM> and a connecting end <NUM>, where the connecting end <NUM> is the end farthest from the distal end <NUM> of the fluid conduits <NUM>.

Further, referring to <FIG>, the fluid connector <NUM> can be a composite comprising a support element <NUM> and a connector element <NUM> overmolded onto the support element. The support element <NUM> can be adapted to arrange and secure a spaced relationship between the first fluid conduits <NUM>, and the connector element <NUM> can be disposed over the support element to sure a fluid connection between the fluid conduits <NUM> and the connecting end <NUM> of the fluid transport coupling <NUM>. Furthermore, as will be discussed in more detail later in the application, the fluid connector <NUM> can be formed by overmolding the connector element material about both the support element <NUM> and the proximal ends <NUM> of the fluid conduits <NUM> to secure the fluid connection. In other words, the connector element <NUM> can be an overmolded connector element.

As discussed above, the fluid conduits <NUM> can each have a distal end <NUM>, a proximal end <NUM>, and a length <NUM> extending from the distal end <NUM> to the proximal end <NUM>. In certain embodiments, the fluid conduits <NUM> can include inner and outer diameter profiles that are concentric and congruous. However, the profiles of the inner and outer diameters of the fluid conduits <NUM> can vary depending on the desired application.

In certain embodiments, the fluid conduits <NUM> can be composed of a flexible material. As used herein, the term "flexible material" refers to a material that is capable of undergoing strain, such as bending or stretching, without adverse impact of physical characteristics, such as irreversible break-down associated with material fracture, for example.

In certain embodiments, the flexible material can include a polymer, such as an elastomeric polymer. In particular embodiments, the elastomeric polymer can comprise an ether, an olefin, a vinyl, a polyurethane, an acrylate, a vinyl alcohol, an ethylene copolymer, an ester, a silicone, a fluoropolymer, or any combination thereof. In particular embodiments, the flexible material can include a silicone or a thermoplastic elastomer. In particular embodiments, one or more of the plurality of fluid conduits <NUM> can include an elastomeric polymer comprising a silicone.

One or more of the fluid conduits <NUM> can be made from the same material or made from a different material. In particular embodiments, each of the fluid conduits <NUM> can be made from the same material. In more particular embodiments, each of the fluid conduits <NUM> can include an elastomeric polymer comprising a silicone, such as include the same elastomeric polymer comprising a silicone.

The fluid transport coupling <NUM> can include at least <NUM>, at least <NUM>, at least <NUM>, at least <NUM>, at least <NUM>, at least <NUM>, at least <NUM>, at least <NUM>, or even at least <NUM> distinct fluid conduits <NUM>. The conduits are distinct in that they are separated from each other prior to forming the fluid transport coupling <NUM>, such as prior to any overmolding step of forming the connector <NUM> about the fluid conduits <NUM>. In some embodiments, the plurality of fluid conduits <NUM> may include no greater than <NUM>, no greater than <NUM>, no greater than <NUM>, no greater than <NUM>, no greater than <NUM>, or even no greater than <NUM> distinct fluid conduits. In further embodiments, the plurality of fluid conduits <NUM> can include a number of distinct fluid conduits in a range of <NUM> to <NUM>, <NUM> to <NUM>, or even <NUM> to <NUM> distinct fluid conduits. The number of fluid conduits <NUM> in the fluid transport coupling <NUM> can vary depending on the application, and can include more or less than the numbers listed above.

The size of fluid conduits <NUM> can vary as a group or within the group of fluid conduits, depending on the application. In certain embodiments, each of the fluid conduits <NUM> can have essentially the same inner diameter, essentially the same outer diameter, essentially the same length, or any combination thereof. In particular embodiments, each of the fluid conduits <NUM> can have essentially the same inner diameter. In more particular embodiments, each of the fluid conduits <NUM> can have essentially the same outer diameter. In more particular embodiments, each of the fluid conduits <NUM> can have essentially the same length.

In further embodiments, at least two of the fluid conduits <NUM> can have a different inner diameter, a different outer diameter, a different length, or any combination thereof. In particular embodiments, at least two of the fluid conduits <NUM> can have a different inner diameter. In more particular embodiments, at least two of the fluid conduits <NUM> can have a different outer diameter. In more particular embodiments, at least two of the fluid conduits <NUM> can have a different length.

In certain embodiments, the inner diameter of the fluid conduits <NUM> can be at least <NUM>, at least <NUM>, at least <NUM>, at least <NUM>, or even at least <NUM>. In further embodiments, the inner diameter can be no greater than <NUM>, no greater than <NUM>, no greater than <NUM>, no greater than <NUM>, or even no greater than <NUM>. Moreover, the inner diameter of the fluid conduits <NUM> can be greater than or less than the above values depending on the desired application.

In certain embodiments, the outer diameter of the fluid conduits <NUM> can be at least <NUM>, at least <NUM>, at least <NUM>, at least <NUM>, at least <NUM>, or even at least <NUM>. In further embodiments, the outer diameter can be no greater than <NUM>, no greater than <NUM>, no greater than <NUM>, no greater than <NUM>, or even no greater than <NUM>. Moreover, the outer diameter of the fluid conduits <NUM> can be greater than or less than the above values depending on the desired application.

In certain embodiments, the length of the fluid conduits <NUM> can be at least <NUM>. However, the length can be less than <NUM> depending on the desired application.

The fluid connector <NUM> can form a fluid connection with the fluid conduits <NUM>. As discussed above, the fluid connector <NUM> can be disposed at the proximal ends <NUM> of the fluid conduits <NUM>. As will be discussed in more detail later in the application, the fluid connector <NUM> can also form a fluid connection with a fluid component to, for example, transport fluid to, from, or between the fluid conduits <NUM> and the fluid component.

The shape and size of the fluid connector <NUM> can vary depending on the application in which the fluid transport coupling <NUM> is used. The fluid connector can include a body end <NUM>, a body <NUM>, a connecting end <NUM>, and ports <NUM> (see <FIG>) extending from the body end <NUM>, through the body <NUM> and connecting end <NUM>. The ports <NUM> can correspond to the fluid conduits <NUM>, such as in number and shape. For example, in certain embodiments, the number of ports <NUM> in the fluid connector <NUM> can be the same as the number of fluid conduits <NUM> in the fluid transport coupling <NUM>. Further, in certain embodiments, the ports <NUM> can have a circumference matching the inner or outer diameter of the corresponding fluid conduit <NUM>. Furthermore, the port <NUM> can make a watertight fluid connection with the corresponding fluid conduit <NUM>.

In certain embodiments, as mentioned previously, the ports <NUM> can be arranged such that the fluid conduits <NUM> are separated from each other. For example, a portion of the ports <NUM> can be distributed evenly and circumferentially forming a ring near an outer edge of the surface of the ends while remaining ports are distributed near the center of the end surfaces.

Further, the ports <NUM> can be arranged such that when the fluid conduits <NUM> are disposed in the fluid connector, the fluid conduits <NUM> can be arranged and secured in a spaced relationship. The term "spaced relationship" refers to an arrangement where the ends of the fluid conduits inserted into the fluid connector are not in contact with each other. Furthermore, the ports <NUM> can be configured such that, when the proximal ends of the fluid conduits <NUM> are inserted into their corresponding ports <NUM>, the fluid conduits <NUM> can extend away from the support element to their distal ends <NUM> in the same axial direction relative to the fluid connector <NUM>.

In certain embodiment, the body end <NUM> and the connecting end <NUM> are on opposite sides of the fluid connector <NUM>. For example, the connecting end <NUM> can refer to the end of the fluid connector <NUM> furthest from the distal end <NUM> of the fluid conduits <NUM>, whereas the body end can refer to the end of the fluid connector <NUM> nearest the distal end <NUM> of the conduits <NUM>, when the fluid transport coupling <NUM> is assembled and the fluid conduits <NUM> are extending in a single axial direction from the fluid connector <NUM>.

The opposing body and connecting ends <NUM>, <NUM> of the can have essentially the same or different shape, such as an arcuate shape, a polygonal, or an amorphous shape. In particular embodiments, the arcuate shape can include a circle or an ellipse where the eccentricity is greater than <NUM>. In more particular embodiments, the polygonal shape can include a triangle, a square, a pentagon, a hexagon, or a polygon having <NUM> or more sides. In more particular embodiments, the opposing body and connecting ends <NUM>, <NUM> of the fluid connector can have a circular shape, as illustrated in <FIG>.

The body <NUM> can include a sidewall extend a distance D between the body end <NUM> and the connecting end <NUM>. In certain embodiments, the distance D can be at least <NUM>. In further embodiments, the distance D may be no greater than <NUM>.

The sidewall of the body <NUM> can have a perimeter having a shape corresponding to the shape of the ends, particularly the body end <NUM>. For example, as illustrated in <FIG>, the sidewall can have the shape of a cylinder corresponding to the circular body end <NUM>. In certain embodiments, the diameter of the body can be at least <NUM>. In further embodiments, the diameter of the body may be no greater than <NUM>.

In certain embodiments, the connecting end <NUM> can define a fitting. For example, a fitting can refer to a structure adapted to form a fluid connection with another fluid component. A fitting can include, but is not limited to, a connector, such as a barbed sterile connector, over-molded connection, barbed filters, barbed valve fitting, vessels, bag ports, silicone molded sample bulbs. The fluid component can include a second fluid conduit, a fluid container, or an isolated environment. For example, in particular embodiments, the fitting can be attached to a bioreactor or other equipment for the pharmaceutical or life sciences industries. On the opposite end, the conduits <NUM> can be adapted to be coupled to a fluid container such as a multi-port bag, carboy, bottle, spinner flask, or seed vials The fluid connection can be adapted to transport fluid to, from, or between the equipment and the fluid container.

The fitting can comprise a flange, such as a flange extending radially outward, such as the flange formed by the connecting end diameter extending beyond the sidewall such that a portion of the connecting end <NUM> extends radially beyond the perimeter of the body <NUM>, forming an external ridge at the connecting end <NUM> of the fluid transport coupling <NUM>. In certain embodiments, the connecting end <NUM> can have a diameter of at least <NUM>, at least <NUM>, at least <NUM>, or at least <NUM>. In further embodiments, the connecting end <NUM> can have a diameter of no greater than <NUM>, no greater than <NUM>, no greater than <NUM>, or no greater than <NUM>.

As discussed above, the fluid connector <NUM> can be a composite including a support element <NUM> and a connector element <NUM>. The connector element <NUM> can be disposed about the support element <NUM>, and a portion of each of the fluid conduits <NUM>, to form the fluid connector <NUM>, such as overmolded onto the fluid conduits <NUM>. In certain embodiments, the support element <NUM> can function as a spacer securing and maintaining the fluid conduits <NUM> in the spaced relationship discussed above, including before, during, or after overmolding the connector element <NUM> onto the support element <NUM>.

In certain embodiments, the support element <NUM> can have a diameter of at least <NUM>, at least <NUM>, at least <NUM>, or at least <NUM>. In further embodiments, the support element <NUM> can have a diameter of no greater than <NUM>, no greater than <NUM>, no greater than <NUM>, or no greater than <NUM>. In certain embodiments, the support element <NUM> can have a length of at least <NUM>, at least <NUM>, at least <NUM>, or at least <NUM>. In further embodiments, the support element <NUM> can have a length of no greater than <NUM>, no greater than <NUM>, no greater than <NUM>, no greater than <NUM>, or no greater than <NUM>.

In certain embodiments, the support element <NUM> can include a flexible material comprising a polymer, such as an elastomeric polymer. In particular embodiments, the elastomeric polymer can comprise an ether, an olefin, a vinyl, a polyurethane, an acrylate, a vinyl alcohol, an ethylene copolymer, an ester, a silicone, a fluoropolymer, or any combination thereof. In a more particular embodiment, the support element <NUM> can include an elastomeric polymer comprising a silicone.

In further embodiments, the support element <NUM> can be composed of the same material as the fluid conduits <NUM> or as at least one of the fluid conduits <NUM>. In further embodiments, the support element <NUM> can be composed of a different material than at least one of the fluid conduits <NUM> or each of the fluid conduits <NUM>. In particular embodiments where the support element <NUM> is composed of a different material, the different material can be a more rigid material. The stiffness of the materials can be measured according to ASTM D1043 - <NUM>.

In certain embodiments, the connector element <NUM> can be composed of a material essentially the same as or different than the support element <NUM> or the fluid conduits <NUM>. In particular embodiments, the connector element <NUM> can include a flexible material comprising a polymer, such as an elastomeric polymer. In particular embodiments, the elastomeric polymer can comprise an ether, an olefin, a vinyl, a polyurethane, an acrylate, a vinyl alcohol, an ethylene copolymer, an ester, a silicone, a fluoropolymer, or any combination thereof. In a more particular embodiment, the connector element <NUM> can include an elastomeric polymer comprising a silicone.

In certain embodiments, the fluid conduits <NUM>, the support element <NUM>, and the connector element <NUM> can be composed of compatible materials. For example, the fluid conduits <NUM>, the support element <NUM>, and the connector element <NUM> can be composed of materials that can form an attachment with each other when the overmolded connector element <NUM> is formed. In certain embodiments, the overmolded connector element <NUM> can be mechanically attached the support element <NUM> and one or more of the fluid conduits <NUM>, such as by adhesion or electrostatic interaction. In further embodiments, the overmolded connector element <NUM> can be covalently attached or bonded to the support element <NUM>, one or more of the fluid conduits <NUM>, such as each of the fluid conduits <NUM>, or both. As used herein, the term "covalently attached" or "covalently bonded" refers to the forming of a chemical bond that is characterized by the sharing of pairs of electrons between atoms. For example, a covalently attached overmolded connector element <NUM> can refer to an overmolded connector element <NUM> that forms chemical bonds with one or more of the fluid conduits <NUM>, as compared to attachment to the fluid conduits <NUM> via other means, for example, adhesion or electrostatic interaction. It will be appreciated that polymers that are attached covalently to a surface can also be bonded via means in addition to covalent attachment, such as by adhesion and electrostatic interaction.

In further embodiments, fluid transport coupling <NUM> can be coupled to a fluid component having fluid connection capabilities. It is to be understood that the fluid component can include a single fluid conduit <NUM>, or in other embodiments, can include a plurality of fluid conduits <NUM>. In certain embodiments, the second fluid component can include a fluid conduit, a vessel, or any other structure to which a fluid connection is desired. In particular embodiments, the vessel can include a rigid vessel, such as a drum, a carboy, a tank; a flexible vessel such as a storage bag, a mixing bag, or an isolation bag; or a combination thereof.

The fluid component can have a distal end and a proximal end. The proximal end of the fluid component can be adapted to couple with the proximal end <NUM> of the fluid conduits <NUM>. In certain embodiments, the overmolded connector element <NUM> can be covalently bonded to the fluid component. In very particular embodiments, the vessel can include a flexible bag and the overmolded connector element <NUM> can be covalently bonded to the vessel.

Another aspect of the present disclosure is directed to a method of forming a fluid transport coupling according to claim <NUM>.

In particular embodiments, the method can further include providing the support element <NUM>, and engaging the fluid conduits <NUM> with the support element <NUM>. When engaged, the fluid conduits <NUM> can form a spaced relationship with one another such that when overmolded, the overmolding material can surround the support element <NUM> and each of the fluid conduits <NUM>.

As discussed above, it is a particular advantage of the fluid transport coupling <NUM> and method of making a fluid transport coupling <NUM> that a sanitary, watertight fluid connection can be made between a plurality of fluid conduits <NUM> and a separate fluid component via a fluid connector where the plurality of fluid conduits <NUM> and the fluid connector are joined simultaneously using the overmolded element. The ovemolded fluid connector can provide a single sanitary fluid connection that provides options for multiple outlets or inlets without having to connect each port individually. In addition, the overmolded fluid connector can provide a single material construction and, thus, does not include seams, which are vulnerable to leaking.

Claim 1:
A sanitary fluid transport coupling (<NUM>) comprising:
a plurality of fluid conduits (<NUM>), each fluid conduit (<NUM>) having a distal end (<NUM>) and a proximal end (<NUM>), and a length (<NUM>) extending from the distal end to the proximal end; and
a fluid connector (<NUM>) comprising a body end (<NUM>), and a connecting end (<NUM>),
wherein the fluid connector (<NUM>) is overmolded to secure the plurality of fluid conduits (<NUM>) at the proximal ends (<NUM>) of the plurality of fluid conduits (<NUM>), wherein the connecting end (<NUM>) of the fluid connector (<NUM>) comprises a fitting that forms or is adapted to form a fluid connection with another fluid conduit (<NUM>), fluid container, or isolated environment, wherein the body end (<NUM>) of the fluid connector (<NUM>) comprises at least one port (<NUM>) extending from the body end (<NUM>) to the connecting end (<NUM>), wherein the at least one port (<NUM>) makes a watertight fluid connection with a corresponding fluid conduit (<NUM>), wherein the fitting comprises a flange extending outwardly from the body, and
characterized in that the connecting end (<NUM>) is overmolded onto a support element (<NUM>) and the support element (<NUM>) is configured to arrange and secure a spaced relationship between the plurality of fluid conduits (<NUM>).