Patent Description:
To filter liquids and/or gases of undesired contaminants or impurities, filters and/or purification material, e.g., filter membranes, are used in enclosed filter housings to effectuate contaminant or impurity removal. As used herein, "filter and/or purification material" and/or "filtration material" shall mean any filter membrane, filter media, or any other material or substance used to filter fluids including liquids and gases. To deliver fluids and/or gases to the filter material for filtering, conduits in the form of tubes or pipes are used to deliver the materials to be filtered to a filter capsule containing filter material. As used herein, "filter capsule" shall mean any structure, including, but not limited to, housings, shells, disc filters, filter cages, filter cartridges and the like used to enclose filter material. The conduits can be rigid pipe or pliable tubes made from such materials as thermoplastic elastomers (TPE). For rigid pipe, connectors such as clamps, threaded couplings and the like can be used. For soft pliable tubes, hose bards are the conventional connection choice. Each form of connection includes several drawbacks.

Rigid connectors add considerable cost and spatial inflexibility to the filter assembly, particularly with the use of tri-clamp arrangements that use a clamp to secure flanged ports with flanged tubes. The use of flanged tubes creates at least two potential contamination points. The first is the junction of the flange to the tube. In some available versions, such as those offered by Saint-Gobain, if the seal between the hard plastic or metallic flange and relatively soft tube is in any way compromised, contaminants, such as bacteria, could potentially enter the filter assembly, or, depending upon the application, permit the exit of bacterial contaminants from the filter assembly,.

A second point of potential contamination is the clamp/flange juncture. Any damage to the seal between the two adjoining surfaces also could lead to potential contaminant infiltration of the filter assembly. Such events can occur with multiple filter sterilization cycles that may involve high heat or gamma radiation. The use of different materials for the tubes and connectors, each material having different characteristics, e.g., melting points, can have different reactions to sterilization procedures and lead to compromised seals.

Barbs are notoriously prone to connection failure. By design, a barb, over which a tube is secured, exposes an inner wall of a tube to defined annular or segmented acute edges that dig or bite into the tube material. This inevitably weakens the tube at the connection point and can lead to tube failure, particularly if the filter assembly and tube(s) are pressurized. Barb accessory components such as barb lock systems can further add to the mechanical stress placed on the tube at the barb connection. Pressurization of a filter system can add additional stress to the tube/barb connection and can lead to tube deterioration and connection failure. Mechanical stress on the barb connection may also occur with movement of the filter assembly while the tube is connected to the assembly. Any of these potential sources of stress on the tube/barb connection can lead to contaminant infiltration or exit, depending upon the location of the tube and its assigned purpose (inlet, outlet or vent). What is needed is a soft tube filter assembly connection that eliminates the need for any clamping or barb connection systems so as to eliminate potential contamination points. Document <CIT> discloses a filter capsule-tube assembly according to the preamble of claim <NUM>.

What is needed is a tube/tube connector/capsule combination that eliminates a connection point between a relatively soft tube and a relatively rigid port that can withstand manufacturing processes as well as post-use sterilization procedures so as to maintain structural and seal integrity. What is also needed is a tube connector that improves the structural integrity of the tube/capsule connection point so as to rigidify the tube end secured to the capsule. These and other objects of the disclosure will become apparent from a reading of the following summary and detailed description of the disclosure as well as a review of the appended drawings.

The present invention is disclosed in the appended set of claims. In one aspect of the disclosure, a capsule apparatus for enclosing filters includes a plurality of ports extending from the capsule body to receive liquid and/or gas delivery and exit tubes. The ports are dimensioned to receive the inner and/or outer diameters of the tubes. The dimensions of the port passages are further set to maintain a consistent, continual cross-sectional diameter substantially the same as the cross-sectional diameter of the tube lumen at a relaxed, or unstressed, portion of the tube to be secured to the port.

In another aspect of the disclosure, a tube connector is formed with an annular channel dimensioned to receive an end of a tube. The interior and exterior walls of the channel register against the interior and exterior walls of the tube so as to provide maximal support to the tube end. The tube is bonded to the connector to from a tube/connector subassembly for subsequent bonding to a capsule assembly.

In a further aspect of the disclosure, a tube, tube connector and filter capsule are bonded together in a single step. The connector has portions defining a first bore to receive the outer wall of the tube and a second bore dimensioned to receive a filter capsule port. In an alternative embodiment, the outer wall of the connector is dimensioned to receive the inner wall of a tube as well as an inner wall of the capsule port. In a further alternative embodiment, the connector has a bore to receive a tube end and has an outer diameter dimensioned to receive and register against an inner wall of a port. In a still further alternative embodiment, the connector has an outer diameter dimensioned to receive an inner wall of a tube and a bore to receive an outer wall of the capsule port.

In a still further aspect of the disclosure, a tube connector/barb has portions defining a tube receiving annular channel at a proximal end whereby the inner and outer walls defining the channel are dimensioned to receive the inner and outer walls of a tube. A distal end of the connector is formed in the shape of a barb. In an alternate embodiment, the inner wall defining the annular channel is formed with an increasing diameter at an end distal from the main body of the connector, frustoconical in cross-section, to provide a tube binding surface for a combination mechanical/friction fit to further secure the tube engaged to the connector. In yet another alternate embodiment, a bore is formed in the connector dimensioned to receive and register against an outer wall of the tube.

In yet a further aspect of the disclosure, a tube/connector/capsule port connection is formed in a single step. The connector is formed with an annular channel dimensioned to receive the annular wall of a capsule port. The connector further defines a through bore having a cross-sectional diameter dimensioned to maintain a consistent, continual channel similar in dimension to the cross-sectional diameter of the tube lumen at a portion of the attached tube measured at a relaxed, or unstressed, portion of the tube. In one embodiment, the connector defines a tube bore dimensioned to receive the outer wall of a tube end. In an alternative embodiment, the connector defines a second annular channel, the walls of which are spaced to receive and register against the inner and outer wall of a tube end. In a yet further alternative embodiment, the connector has an outer wall dimensioned to receive the inner wall of a tube end.

In yet another embodiment, a tube/connector/capsule port assembly is bonded in one step. The connector defines an annular channel with an inner wall having a frustoconical shape in cross-section whereby the wider portion of the inner wall extends away from the main body of the connector to provide a mechanical/friction fit to more securely engage the tube. The tube/connector/port assemblies can be dedicated to a particular function, e.g., ingress (inlet), egress (outlet) and exhaust (vent).

In a yet further aspect of the disclosure, a tube/connector/capsule port assembly is bonded in one step. The connector defines a bore with an annular wall dimensioned to receive an outer annular wall of a capsule port. An opposite end of the connector can be formed with an annular channel dimensioned to receive a tube, with an inner wall of the annular channel having a frustoconical cross-sectional shape with the larger diameter end extending toward a tube connecting end of the connector, with a bore dimensioned to receive an outer wall of the tube, or with an outer diameter dimensioned to be inserted into a tube. The connector further defines a channel dimensioned to have substantially the same cross-sectional diameter as the cross-sectional diameter of the tube lumen at a relaxed, or unstressed, portion of the attached tube.

In another aspect of the disclosure, a dual-walled, optionally reinforced tube is incorporated into the tube/connector/capsule embodiments disclosed herein. A connection end of the tube is modified to remove an end segment of the outer tube wall to maximize the tube sealing surface area and to minimize a potential contamination point in a dual-walled tube.

In yet another aspect of the disclosure, a tube connection reinforcement or support collar is formed on an end of a tube connector/over-mold to protect the connector/tube junction distal from the capsule. These and other aspects of the disclosure will become apparent from a review of the appended drawings and a reading of the following detailed description of the disclosure.

Referring to <FIG>, in one aspect of the disclosure, a tube/connector assembly shown designated generally as <NUM> includes a tube designated generally as <NUM> secured to a tube connector designated generally as <NUM>. Tube <NUM> has an annular wall <NUM> that defines a lumen <NUM>. The tube is constructed from a thermoplastic elastomer to take advantage of the multiple advantageous characteristics of this material that impart a combination of flexibility and resiliency. An additional advantage is that the material has no reactivity with respect to most liquids and gases that may be passed through the tube. The tube may or may not include reinforcement materials, e.g., fiberglass or metallic braids, on the exterior or embedded in the material to improve resiliency characteristics and to counter any torsional, compression and flexion stresses placed on the tubing.

Connector <NUM> has an annular wall <NUM> that defines a smooth tube bore <NUM> dimensioned to receive and register against an outer wall of tube <NUM>. An annular shoulder <NUM> is formed at a bottom end of bore <NUM> and extends radially inwardly from an inner surface of connector wall <NUM> to form a mechanical stop for the tube when inserted into connector <NUM>. A second capsule bore <NUM> is formed on a bottom end of connector <NUM> and dimensioned to receive a capsule port or port stem (disclosed in more detail below. Capsule bore <NUM> is in fluid communication with tube bore <NUM> and tube lumen <NUM> when the tube is secured to the connector.

Tube/tube connector assembly <NUM> is structured to be bonded directly to a capsule port and may be formed in a two-step process whereby the tube and connector are bonded (thermal, sonic and/or solvent bonding) in a one-process step and the tube/tube connector assembly is bonded to the capsule in a second process step (injection molded, insert molded, and/or any of the thermal, sonic and/or solvent bonding methods used to secure the tube to the tube connector). In an alternative embodiment, the tube, tube connector and capsule port are bonded together in a single processing step such as injection molding, whereby the material used to form the tube connector is over-molded onto the capsule, port and the tube.

It should be understood that any combination of bonding methods and steps can be used to achieve the final connection-free filter apparatus. For example, both thermal and solvent bonding methods may be used together to secure a soft flexible tube to a rigid plastic connector or filter capsule. It may also be advantageous to use a tube material with a lower melting point than that of the material used to make the relatively rigid plastic connector and/or filter capsule so as not to compromise the integrity of the rigid plastic connector with over-heating. It should be further understood that a soft, flexible tube (made from a thermoplastic elastomer or other pliable material) may be secured directly to a filter capsule using any of the molding/bonding methods disclosed herein.

Tube <NUM> may be constructed from materials including, but not limited to, thermoplastic elastomers (TPE), thermoplastic rubbers (TPR), silicone, PVC, PVS and the like, and any soft and flexible tubing currently used in the pharmaceutical and medical fields. The connector may be constructed from materials including, but not limited to, polyethylene (PE), polypropylene (PP), high density polyethylene (HDPE), nylon, polyvinylchloride (PVC), polyethylene terephthalate (PET), Hytrel type material, and the like. When materials such as TPE are used for the tubing, simple thermal bonding may be used to secure the tube to a tube connector or directly to the filter capsule. For materials such as PVC for the tubing, solvent bonding may be used to secure the tubing directly to the filter capsule.

Tube/connector assembly <NUM> may also be constructed with a dual-walled, reinforced tube such as tube <NUM>IV shown in <FIG>, particularly when the tube and larger assembly will be used in a high pressure system in which higher pressure tolerances are needed in the tube component. From a manufacturing perspective, the primary difference between single and dual-walled tubes is the dimensional considerations of using a tube with a different cross-sectional diameter. Each component is sized to accommodate a different tube diameter including the over-molding material used to form connector <NUM>.

Tube <NUM>IV may be formed with any of the materials used to form tube <NUM> as disclosed herein. The tube reinforcement material may be any commonly used in the art to reinforce tubing material including illustratively, and not exhaustively, braided fiberglass, metallic materials, fibrous material such as cotton, and polymer materials such as polyester, nylon, polyethylene, polypropylene and the like. In one embodiment, tube <NUM>IV may be secured to tube connector <NUM>IV, as shown in <FIG>, with the same methods described for securing tube <NUM> to connector <NUM>. If secured in the form shown in <FIG>, the tube end is inserted into tube bore <NUM>IV and registered against connector wall <NUM>IV. <FIG> shows tube <NUM>IV secured in connector <NUM>IV, Connector <NUM>IV may be pre-formed and subsequently bonded to tube <NUM>IV, or may be formed in a mold about tube <NUM>IV using illustratively, conventional injection molding processes. It should be understood that the same processing options are available to join the tube and connector to a capsule port/port stem as disclosed herein.

if constructed with the dual-wall extending the entire length of the tube as shown in <FIG>, although a secure bond between the tube and connector may be formed, there is a potential for contamination between the tubes at the dual-tube end junction with the connector (designated gap <NUM>IV in <FIG>), particularly if the reinforcement material superposed about the tubes contributes to the formation of a gap between the tubes. The connector material should flow into the gap during connector formation and seal it off from any liquids or gases introduced to, and/or exiting from, the capsule through the tube. This requires, however, the bulk material of the braided section to have similar properties as the inner tube material and be thermally bonded by the over-molded connector material. If made of material with dissimilar properties, the reinforcement material should be removed before the over-molding process. This will improve the bond and further help prevent the potential release of undesirable extractables from the reinforcement material.

This problem is potentially exacerbated by the relatively small contact surface area <NUM>IV between the inner tube <NUM>IV end and an annular shoulder <NUM>IV of the connector that leaves little room for error in the molding process and is the only bonded section between the tube lumen and gap <NUM>IV. If there is any failure of the joint, liquids and/or gases can migrate into gap <NUM>IV, particularly if the system is pressurized. Fluid migrating into the gap under pressure potentially can create tube failure points (tube burst events) in the tubing. Moreover, exposure of the reinforcement material to the fluid may cause product changes on the wetted surfaces of the material that can affect chemical compatibility among the component materials and may negatively impact regulatory compliance if extractables from the reinforcement material leeches into the fluid and into the tube lumen. A modification of tube <NUM>IV significantly improves the contact surface area between inner tube <NUM>IV and connector <NUM>IV and significantly reduces the possibility of fluid migration into gap <NUM>IV.

As shown in <FIG>, tube <NUM>IV may be modified by removing a segment of outer tube <NUM>IV. This moves gap <NUM>IV between the tubes away from the end of inner tube <NUM>IV that bonds with an annular shoulder of a connector (shoulder <NUM>V shown in <FIG>). This may or may not include removal of the reinforcement material superposed about inner tube <NUM>IV as disclosed above. As shown in <FIG>, when secured to a connector <NUM>V, the surface area <NUM>V of inner tube <NUM>V that contacts connector <NUM>V includes the tube end and the outer wall up to the new end of outer tube <NUM>V. This maximizes the surface area of contact and moves the gap <NUM>V between the tubes away from the junction between inner tube <NUM>V and shoulder <NUM>V of connector <NUM>V.

To further increase the bond surface area and further eliminate the potential for leakage at the connector/tube junction, any reinforcement material, formed on the exterior of inner tube <NUM>V, on the inner tube section exposed by the removal of the outer tube segment, may be removed to present a smooth, maximized contact surface to bond to the connector material. This also is particularly warranted if the reinforcement material has chemical and/or processing properties incompatible with the tube material with respect to bonding to the connector material. It should be understood, however, that removal of the reinforcement material is not a mandatory requirement to form a secure bond between the inner tube and connector material. It is an optional measure that can be taken to reduce the probability of bond imperfections and the release of extractables at the connector/tube junction.

Referring now to <FIG>, in another aspect of the disclosure, a tube/barb connector assembly shown designated generally as <NUM> includes a tube designated generally as <NUM> secured to a barb connector designated generally as <NUM>. Like connector <NUM>, barb connector <NUM> has an annular wall <NUM> that defines a tube bore dimensioned to receive and register against the outer wall of tube <NUM>. A barb connector shoulder <NUM> extends radially inwardly from wall <NUM> to form a stop against which an end of tube <NUM> registers. A distal end of barb connector <NUM> is formed as a barb connection <NUM> with at least one radially extending barb <NUM>. Barb connection <NUM> defines a barb lumen <NUM> dimensioned to be substantially similar in dimension to lumen <NUM> of tube <NUM>.

Tube <NUM> is secured to barb connector <NUM> in the same manner disclosed for tube/tube connector assembly <NUM>. The materials used to construct barb connector <NUM> are the same materials disclosed for tube connector <NUM>. The methods used to secure tube <NUM> to barb connector <NUM> are the same as those disclosed for tube/tube connector assembly <NUM>. The barb permits connection to other tubes used to deliver or receive liquids and/or gases depending upon the functional assignment given to the tube/barb connector assembly, i.e., inlet, outlet, vent.

Like tube/tube connector assembly <NUM>, barb connector <NUM> may be secured to a dual-walled, reinforced tube such as dual-walled tube <NUM>IV shown in <FIG>. Again, the primary difference is the dimensional modifications needed to receive a tube with a different cross-sectional diameter. The materials and methods used to secure tube <NUM>IV to connector <NUM>, and the considerations that impact such a combination, are the same as those disclosed for the combination of tube <NUM>IV with connector <NUM>IV.

Referring now to <FIG>, in a further aspect of the disclosure, a tube/tube connector/capsule assembly shown designated generally as <NUM> includes a tube <NUM> secured to a tube connector <NUM> secured to a capsule port <NUM>. Tube <NUM> and connector <NUM> are identical in structure, materials and bonding methods to those disclosed for tube/tube connector assembly <NUM>. Tube connector <NUM> has a wall <NUM> that defines a tube bore <NUM> dimensioned to receive and register against the outer surface of tube wall <NUM>. A shoulder <NUM> that extends radially inwardly from an inner surface of wall <NUM> functions as a stop and registration surface for tube <NUM> when the tube is inserted into and bonded to connector <NUM>.

A port channel <NUM> defined by port <NUM> and port base <NUM> is in fluid communication with tube lumen <NUM> and with the filter chamber defined by capsule <NUM>. The cross-sectional diameter of channel <NUM> is dimensioned to be substantially the same as, or not less than the cross-sectional diameter of the tube lumen defined by an unstressed, relaxed segment of tube <NUM>. As shown in <FIG>, capsule <NUM> represents one end of a complete capsule, the remainder of which is not shown for purposes of simplicity. It should be understood that the remainder of the capsule housing will include additional ports that may be configured with tube/tube connector assemblies.

An annular port channel <NUM> is formed on a distal end of connector <NUM> and is dimensioned to receive the annular wall of port <NUM> such that the inner and outer surfaces of the wall register against the walls of annular bore <NUM>. A top surface of the port wall is further registered against a bottom surface of bore <NUM> so as to function as a stop and support surface for the joined components.

The materials used to manufacture the tube, tube connector and capsule are the same as those disclosed for tube <NUM> and tube connector <NUM> hereinabove. Tube/tube connector/capsule port assembly <NUM> may be formed in a one-step or two-step process. In the two-step process, the tube and connector are bonded together using thermal, sonic and/or solvent bonding techniques. The tube/tube connector sub-assembly is then secured in a mold used to make the capsule and is bonded to the capsule port during the capsule molding process. Alternatively, the tube/tube connector subassembly can be bonded to the pre-formed capsule via thermal, sonic and/or solvent bonding.

In the one-step process, the tube, pre-formed tube connector and capsule are bonded together in a single molding step, e.g., insert molding, wherein the tube and pre-formed tube connector are assembled together and placed in the capsule mold prior to the capsule molding process. Alternatively, the three components can be bonded together in a single thermal, sonic and/or solvent bonding method. Either the one-step or two-step processes produce tube/tube connector/capsule port connections that can withstand pressurized applications as well as post-use sterilization procedures using high heat and/or gamma radiation. The tube connector provides the added benefit of rigidifying and strengthening the end of the tube connected to the connector/port combination. This is in contrast to the weakening effect a barb has on the end of a tube connected to the barb.

Like tube/tube connector assembly <NUM>, barb connector <NUM> may be secured to a dual-walled, reinforced tube such as dual-walled tube <NUM>IV shown in <FIG>. The primary difference continues to be the dimensional modifications needed to receive a tube with a different cross-sectional diameter. The materials and methods used to secure tube <NUM>IV to connector <NUM>, and the considerations that impact such a combination, are the same as those disclosed for the combination of tube <NUM>IV with connector <NUM>IV,.

Referring now to <FIG>, in a still further aspect of the disclosure, a tube/tube connector/capsule port assembly is shown designated generally as <NUM>. Assembly <NUM> includes tube <NUM>, a tube connector designated generally as <NUM> and a capsule designated generally as <NUM>. Connector <NUM> has the same features and is structured in the same manner as tube connector <NUM> shown in <FIG>. Connector <NUM> has a connector wall <NUM> that defines a tube bore <NUM> dimensioned to receive and register against the outer surface of tube wall <NUM>. A shoulder <NUM> extends radially inwardly from connector wall <NUM> and forms a stop/registration surface for the end of tube <NUM>. The cross-sectional diameter of bore <NUM> substantially maintains the cross-sectional diameter of the lumen of tube <NUM> taken at a relaxed, unstressed portion of the tube.

A bottom end of connector <NUM> has an annular wall <NUM> that defines a bore dimensioned to receive the outer wall of capsule port <NUM>. This connector/port connection differs from the connector/port connection shown in <FIG> in that connector <NUM> does not define an annular channel to receive the inner and outer surfaces of the port wall, but just a bore to receive and register against the outer surface of the port wall. This provides a less robust connection, but an adequate one to handle the applications to which the capsule is put to use as well as the post-use sterilization procedures. Like tube/tube connector/capsule port assembly <NUM>, tube/tube connector/capsule port assembly <NUM> can be constructed from the same materials disclosed for the components of assembly <NUM> in either a one-step or two-step process such as those disclosed for assembly <NUM>. By way of illustration and not limitation, the tube may be injection molded directly onto the filter capsule.

Like tube/tube connector assembly <NUM>, barb connector <NUM> may be secured to a dual-walled, reinforced tube such as dual-walled tube <NUM>IV shown in <FIG>. The primary difference is the dimensional modifications needed to receive a tube with a different cross-sectional diameter. The materials and methods used to secure tube <NUM>IV to connector <NUM>, and the considerations that impact such a combination, are the same as those disclosed for the combination of tube <NUM>IV with connector <NUM>IV. <FIG> shows a dual-walled tube secured to the filter capsule configuration shown in <FIG>.

Referring to <FIG>, in a yet another aspect of the disclosure, a tube/tube connector/capsule port assembly is shown designated generally as <NUM>‴. Assembly <NUM>‴ includes dual-walled tube <NUM>‴ (with optional reinforcement material <NUM>‴), a tube connector designated generally as <NUM>‴ and a capsule designated generally as <NUM>‴. Tube <NUM>‴ comprises an inner tube <NUM>‴ and an outer tube <NUM>‴ superposed about inner tube <NUM>‴. Reinforcement material <NUM>‴ is formed about the tubes and creates a gap <NUM>‴ between the tubes where the reinforcement material of the respective tubes register against one another. It should be understood that the optional reinforcement material <NUM>‴ may be formed on one or both tubes, or may be imbedded in one or both tubes as well as configured with any combination of surface mounted and imbedded variations. A segment <NUM>‴ of inner tube <NUM>‴ is not superposed by outer tube <NUM>‴.

Connector <NUM>‴ has the same features and is structured in the same manner as tube connector <NUM> shown in <FIG> modified, however, to accommodate a stepped, dual-walled tube. Connector <NUM>‴ has a connector wall <NUM>‴ that defines a tube bore <NUM>‴ dimensioned to receive and register against the outer surface segment <NUM>‴ of inner tube wall <NUM>‴. An annular shoulder <NUM>‴ extends radially inwardly from connector wall <NUM>‴ and forms a stop/registration surface for the end of inner tube <NUM>‴. The cross-sectional diameter of bore <NUM>‴ substantially maintains the cross-sectional diameter of the lumen of tube <NUM>‴ taken at a relaxed, unstressed portion of the tube. A second annular shoulder 84a extends radially inwardly from connector wall <NUM>‴ and forms a stop/registration surface for the end of outer tube <NUM>‴. The bonding surfaces between the tubes, the connector shoulders and the exposed segment <NUM>‴ of inner tube <NUM>‴ create a significant structural separation of tube gap <NUM>‴ from the junction of the end of inner tube <NUM>‴ with shoulder <NUM>‴. This effectively eliminates the possibility of fluids in the tube lumen entering the inter-tube gap.

A bottom end of connector <NUM>‴ has an annular wall <NUM>‴ that defines a bore dimensioned to receive the outer wall of capsule port <NUM>‴ and register against port base <NUM>‴. This connector/port connection differs from the connector/port connection shown in <FIG> in that connector <NUM>‴ does not define an annular channel to receive the inner and outer surfaces of the port wall, but just a bore to receive and register against the outer surface of the port wall. This provides a less robust connection, but an adequate one to handle the applications to which the capsule is put to use as well as the post-use sterilization procedures. Like tube/tube connector/capsule port assembly <NUM>, tube/tube connector/capsule port assembly <NUM>‴ can be constructed from the same materials disclosed for the components of assembly <NUM> in either a one-step or two-step process such as those disclosed for assembly <NUM>. By way of illustration and not limitation, the tube may be injection molded directly onto the pre-formed filter capsule.

Referring to <FIG>, in another aspect of the disclosure, a tube/connector assembly shown designated generally as <NUM>' includes a tube designated generally as <NUM>' secured to a tube connector designated generally as <NUM>'. As used herein, elements referenced with primed numbers in one embodiment correspond to elements in other embodiments referenced with the same number either unprimed or primed differently, Tube <NUM>' has an annular wall <NUM>' that defines a lumen <NUM>' like tube <NUM> disclosed herein.

Connector <NUM>' has an annular wall <NUM>' that defines a tube bore dimensioned to receive and register against an outer wall of tube <NUM>'. A bottom end of the tube bore is formed as an annular tube channel <NUM> that includes an annular channel bottom <NUM>' that extends radially inwardly from an inner surface of connector wall <NUM>' to form a mechanical stop for the tube when inserted into connector <NUM>'. An inner channel wall designated generally as <NUM>' defines the inner portion of the tube receiving channel and is formed to have a frustoconical profile in cross-section whereby the larger diameter end of the wall, designated <NUM>, extends upwardly toward the tube bore and the smaller diameter end of the inner wall, designated <NUM>, connects to channel bottom <NUM>'. This configuration creates a mechanical restriction surface that mechanically locks tube <NUM>' into the tube channel and bore. When thermal bonding is applied and the tube material is allowed to flow and expand in the channel, the tube is mechanically locked to connector <NUM>' by virtue of the restricting surface of inner channel wall <NUM>'. The cross-sectional diameter of a tube bore <NUM> defined by an inner surface of inner wall channel <NUM>' may be dimensioned at its most narrow point to be substantially similar to, or essentially not less than the cross-sectional diameter of the tube lumen at a relaxed or unstressed segment of tube <NUM>'.

A second capsule bore <NUM>' is formed on a bottom end of connector <NUM>' and dimensioned to receive a capsule port (disclosed in more detail below. Capsule bore <NUM>' is in fluid communication with a tube bore <NUM> (defined by an inner surface of channel inner wall <NUM>') and tube lumen <NUM>' when the tube is secured to the connector. Tube/tube connector assembly <NUM>' is structured to be bonded directly to a capsule port and is formed in a two-step process whereby the tube and connector are bonded in one process step and the tube/tube connector assembly is bonded to the capsule in a second process step. In an alternative embodiment, the tube, tube connector and capsule port are bonded together in a single processing step when the capsule is molded as disclosed more fully herein.

Tube <NUM>' may be constructed from same materials disclosed for tube <NUM>. Tube connector <NUM>' may be constructed from the same materials disclosed for tube connector <NUM>.

Like tube/tube connector assembly <NUM>, barb connector <NUM>' may be secured to a dual-walled, reinforced tube such as dual-walled tube <NUM>IV shown in <FIG>. The primary difference is the dimensional modifications needed to receive a tube with a different cross-sectional diameter. The materials and methods used to secure tube <NUM>IV to connector <NUM>', and the considerations that impact such a combination, are the same as those disclosed for the combination of tube <NUM>IV with connector <NUM>IV.

Referring now to <FIG>, in another aspect of the disclosure, a tube/barb connector assembly shown designated generally as <NUM>' includes a tube designated generally as <NUM>' secured to a barb connector designated generally as <NUM>'. Like connector <NUM>', barb connector <NUM>' has an annular wall <NUM>' that defines a tube bore dimensioned to receive and register against the outer wall of tube <NUM>'. A bottom end of the tube bore is formed as an annular channel, designated generally as <NUM>, and is similar in construction and function to channel <NUM>' of connector <NUM>' in that it has an inner channel wall having a frustoconical shape in cross-section that creates a restriction surface to mechanically lock tube <NUM>' to the connector when bonded to the connector.

A distal end of barb connector <NUM>' is formed as a barb connection <NUM>' with at least one radially extending barb <NUM>'. Barb connection <NUM>' defines a barb lumen <NUM>' that may be dimensioned to be substantially similar in dimension to lumen <NUM>' of tube <NUM>'.

Tube <NUM>' is secured to barb connector <NUM>' in the same manner disclosed for tube/tube connector assembly <NUM>. The materials used to construct barb connector <NUM>' are the same materials disclosed for tube connector <NUM>. The methods used to secure tube <NUM>' to barb connector <NUM>' are the same as those disclosed for tube/tube connector assembly <NUM>. The barb permits connection to other tubes used to deliver or receive liquids and/or gases depending upon the functional assignment given to the tube/barb connector assembly, i.e., inlet, outlet, vent.

Referring now to <FIG>, in a further aspect of the disclosure, a tube/tube connector/capsule assembly shown designated generally as <NUM>' includes a tube <NUM>' secured to a tube connector <NUM>' secured to a capsule port <NUM>'. Tube <NUM>' and connector <NUM>' are identical in structure, materials and bonding methods to those disclosed for tube/tube connector assembly <NUM>. Tube connector <NUM>' has a wall <NUM>' that defines a tube bore <NUM>' dimensioned to receive and register against the outer surface of tube wall <NUM>'. A bottom end of the tube bore is formed as an annular channel, designated generally as <NUM>, and is similar in construction and function to channel <NUM>' of connector <NUM>' in that it has an inner channel wall having a frustoconical shape in cross-section that creates a restriction surface to mechanically lock tube <NUM>' to the connector when bonded to the connector. The bottom surface of channel <NUM>' functions as a stop and registration surface for tube <NUM>' when the tube is inserted into and bonded to connector <NUM>'.

A port channel <NUM>' defined by port <NUM>' and a port base <NUM>' is in fluid communication with tube lumen <NUM>' and with the filter chamber defined by capsule <NUM>'. The cross-sectional diameter of channel <NUM>' is dimensioned to be substantially the same as, or not less than the cross-sectional diameter of the tube lumen defined by an unstressed, relaxed segment of tube <NUM>'. As shown in <FIG>, capsule <NUM>' represents one end of a complete capsule, the remainder of which is not shown for purposes of simplicity. It should be understood that the remainder of the capsule housing will include additional ports that may be configured with tube/tube connector assemblies.

An annular port channel <NUM> is formed on a distal end of connector <NUM>' and is dimensioned to receive the annular wall of port <NUM>' such that the inner and outer surfaces of the wall register against the walls of annular bore <NUM>'. A top surface of the port wall is further registered against a bottom surface of bore <NUM>' so as to function as a stop and support/registration surface for the joined components.

The materials used to manufacture the tube, tube connector and capsule are the same as those disclosed for tube <NUM>, tube connector <NUM> and capsule <NUM> hereinabove. Tube/tube connector/capsule port assembly <NUM>' may be formed in a one-step or two-step process such as those described for assembly <NUM> herein.

Like tube/tube connector assembly <NUM>, barb connector <NUM>' may be secured to a dual-walled, reinforced tube such as dual-walled tube <NUM>IV shown in <FIG>. The primary difference is the dimensional modifications needed to receive a tube with a different cross-sectional diameter. The materials and methods used to secure tube <NUM>IV to connector <NUM>', and the considerations that impact such a combination, are the same as those disclosed for the combination of tube <NUM>I\/ with connector <NUM>IV.

Referring now to <FIG>, in a still further aspect of the disclosure, a tube/tube connector/capsule port assembly is shown designated generally as <NUM>'. Assembly <NUM>' includes tube <NUM>', a tube connector designated generally as <NUM>' and a capsule designated generally as <NUM>'. Connector <NUM>' has the same features and is structured in the same manner as tube connector <NUM>' shown in <FIG>. Connector <NUM>' has a connector wall <NUM>' that defines a tube bore <NUM>' and is dimensioned to receive and register against the outer surface of tube wall <NUM>'. A bottom end of tube bore <NUM>' is formed as an annular channel, designated generally as <NUM>, and is similar in construction and function to channel <NUM>' of connector <NUM>' in that it has an inner channel wall having a frustoconical shape in cross-section that creates a restriction surface to mechanically lock tube <NUM>' to the connector when bonded to the connector. The bottom surface <NUM> of channel <NUM> functions as a stop and registration surface for and end of tube <NUM>' when the tube is inserted into and bonded to connector <NUM>'.

An inner annular surface of the inner wall of annular channel <NUM> defines a connector channel <NUM> in fluid communication with a port channel defined by port wall <NUM>' and port base <NUM>' as well of the chamber defined by capsule <NUM>'. The cross-sectional diameter of the narrowest portion of connector channel <NUM> may be substantially the same as, or not substantially less than the cross-sectional diameter of the lumen of tube <NUM>' taken at a relaxed, unstressed portion of the tube.

A bottom end of connector <NUM>' has an annular wall <NUM>' that defines a bore dimensioned to receive the outer wall of capsule port <NUM>'. This connector/port connection differs from the connector/port connection shown in <FIG> in that connector <NUM>' does not define an annular channel to receive the inner and outer surfaces of the port wall, but just a bore to receive and register against the outer surface of the port wall. This provides a less robust connection, but an adequate one to handle the applications to which the capsule is put to use as well as the post-use sterilization procedures. Like tube/tube connector/capsule port assembly <NUM>', tube/tube connector/capsule port assembly <NUM>' can be constructed from the same materials disclosed for the components of assembly <NUM> in either a one-step or two-step process such as those disclosed for assembly <NUM>.

Referring to <FIG>, in one aspect of the disclosure, a tube/connector assembly shown designated generally as <NUM>" includes a tube designated generally as <NUM>" secured to a tube connector designated generally as <NUM>". Tube <NUM><NUM>" has an annular wall <NUM>" that defines a lumen <NUM>" like tube <NUM> disclosed herein.

Connector <NUM>" has an annular wall <NUM> that defines a tube channel designated generally as <NUM>" dimensioned to receive and register against the inner and outer walls of tube <NUM>". Tube channel <NUM>" comprises a channel outer wall <NUM>", an annular channel bottom <NUM>" and a channel inner wall <NUM>". Annular channel bottom <NUM>" forms a mechanical stop for the tube end when inserted into connector <NUM>". This configuration creates a tube rigidifying structure that mechanically enhances the segment of the tube secured in the channel. When thermal bonding is applied and the tube material is allowed to flow and expand in the channel, the tube is radially restricted by the walls of the channel to maintain the cross-sectional dimensional integrity of tube <NUM>". The cross-sectional diameter of a tube bore <NUM> defined by an inner surface of inner wall channel <NUM>" may be dimensioned to be substantially similar to, or essentially not less than the cross-sectional diameter of the lumen of a relaxed or unstressed segment of tube <NUM>".

A second capsule bore <NUM>" is formed on a bottom end of connector <NUM>" and dimensioned to receive a capsule port (disclosed in more detail below. Capsule bore <NUM>" is in fluid communication with tube bore <NUM> (defined by an inner surface of channel inner wall <NUM>") and tube lumen <NUM>" when the tube is secured to the connector. Tube/tube connector assembly <NUM>" is structured to be bonded directly to a capsule port and is formed in a two-step process like assembly <NUM> whereby the tube and connector are bonded in one process step and the tube/tube connector assembly is bonded to the capsule in a second process step. In an alternative embodiment, the tube, tube connector and capsule port are bonded together in a single processing step when the capsule is molded as disclosed more fully herein.

Tube <NUM>" may be constructed from same materials disclosed for tube <NUM>. Tube connector <NUM>" may be constructed from the same materials disclosed for tube connector <NUM>.

Like tube/tube connector assembly <NUM>, barb connector <NUM>" may be secured to a dual-walled, reinforced tube such as dual-walled tube <NUM>IV shown in <FIG>. The primary difference is the dimensional modifications needed to receive a tube with a different cross-sectional diameter. The materials and methods used to secure tube <NUM>IV to connector <NUM>", and the considerations that impact such a combination, are the same as those disclosed for the combination of tube <NUM>1V with connector <NUM>IV.

Referring now to <FIG>, in another aspect of the disclosure, a tube/barb connector assembly shown designated generally as <NUM>" includes a tube designated generally as <NUM>" secured to a barb connector designated generally as <NUM>". Like connector <NUM>", barb connector <NUM>" has an annular wall <NUM> that defines a tube channel designated generally as <NUM> dimensioned to receive and register against the inner and outer walls of tube <NUM>". Tube channel <NUM> comprises a channel outer wall <NUM>, an annular channel bottom <NUM> and a channel inner wall <NUM>. Annular channel bottom <NUM> forms a mechanical stop for the tube end when inserted into connector <NUM>". Again, this configuration creates a tube rigidifying structure that mechanically enhances the segment of the tube secured in the channel.

When thermal bonding is applied and the tube material is allowed to flow and expand in the channel, the tube is radially restricted by the walls of the channel to maintain the cross-sectional dimensional integrity of tube <NUM>". The cross-sectional diameter of a tube bore <NUM> defined by an inner surface of inner wall channel <NUM> may be dimensioned to be substantially similar to, or essentially not less than the cross-sectional diameter of the tube lumen at a relaxed or unstressed segment of tube <NUM>".

A distal end of barb connector <NUM>" is formed as a barb connection <NUM> with at least one radially extending barb <NUM>". Barb connection <NUM> defines a barb lumen <NUM>" that may have a cross-sectional diameter substantially similar to the cross-sectional diameter of lumen <NUM>" at a relaxed or unstressed portion of tube <NUM>".

Tube <NUM>" is secured to barb connector <NUM>" in the same manner disclosed for tube/tube connector assembly <NUM>. The materials used to construct barb connector <NUM>" are the same materials disclosed for tube connector <NUM>. The methods used to secure tube <NUM>" to barb connector <NUM>" are the same as those disclosed for tube/tube connector assembly <NUM>. The barb permits connection to other tubes used to deliver or receive liquids and/or gases depending upon the functional assignment given to the tube/barb connector assembly, i.e., inlet, outlet, vent,.

Like tube/tube connector assembly <NUM>, barb connector <NUM>" may be secured to a dual-walled, reinforced tube such as dual-walled tube <NUM>IV shown in <FIG>. The primary difference is the dimensional modifications needed to receive a tube with a different cross-sectional diameter. The materials and methods used to secure tube <NUM>IV to connector <NUM>", and the considerations that impact such a combination, are the same as those disclosed for the combination of tube <NUM>IV with connector <NUM>IV.

Referring now to <FIG>, in a further aspect of the disclosure, a tube/tube connector/capsule assembly shown designated generally as <NUM>" includes a tube <NUM>" secured to a tube connector <NUM>" secured to a capsule port <NUM>". Tube <NUM>" and connector <NUM>" are identical in structure, materials and bonding methods to those disclosed for tube/tube connector assembly <NUM>". Tube connector <NUM>" has an annular wall <NUM> that defines an annular tube channel designated generally as <NUM> dimensioned to receive and register against the inner and outer walls of tube <NUM>". Tube channel <NUM> comprises a channel outer wall <NUM>, an annular channel bottom <NUM> and a channel inner wall <NUM>, Annular channel bottom <NUM> forms a mechanical stop and registration surface for the tube end when inserted into, and bonded to, connector <NUM>",.

Like the similar structures disclosed herein for assembly <NUM>", this configuration creates a tube rigidifying structure that mechanically enhances the segment of the tube secured in the channel, When thermal bonding is applied and the tube material is allowed to flow and expand in the channel, the tube is radially restricted by the walls of the channel to maintain the cross-sectional dimensional integrity of tube <NUM>". The cross-sectional diameter of a tube bore <NUM> defined by an inner surface of inner wall channel <NUM> may be dimensioned to be substantially similar to, or essentially not less than the cross-sectional diameter of the tube lumen at a relaxed or unstressed segment of tube <NUM>",.

A port channel <NUM>" defined by port <NUM>" and a port base <NUM>" is in fluid communication with tube lumen <NUM>" and with the filter chamber defined by capsule <NUM>". The cross-sectional diameter of channel <NUM>" may be dimensioned to be substantially the same as, or not less than the cross-sectional diameter of tube lumen <NUM>" defined at an unstressed, relaxed segment of tube <NUM>'. As shown in <FIG>, capsule <NUM>" represents one end of a complete capsule, the remainder of which is not shown for purposes of simplicity. It should be understood that the remainder of the capsule housing will include additional ports that may be configured with tube/tube connector assemblies.

An annular port bore <NUM> is formed on a distal end of connector <NUM>" and is dimensioned to receive the annular wall of port <NUM>" such that the inner and outer surfaces of the wall register against the walls of port bore <NUM>. A top surface of the port wall is further registered against a bottom surface of bore <NUM> so as to function as a stop and support/registration surface for the joined components.

The materials used to manufacture the tube/ tube connector/capsule assembly <NUM>" are the same as those disclosed for tube <NUM>, tube connector <NUM> and capsule <NUM> hereinabove. Assembly <NUM>' may be formed in a one-step or two-step process such as those described for assembly <NUM> herein.

Referring now to <FIG>, in a still further aspect of the disclosure, a tube/tube connector/capsule port assembly is shown designated generally as <NUM>". Assembly <NUM>" includes tube <NUM>", a tube connector designated generally as <NUM>" and a capsule designated generally as <NUM>", Connector <NUM>" has the same features and is structured in the same manner as tube connector <NUM>" shown in <FIG>.

Connector <NUM>' has a connector wall <NUM>' that an annular tube channel designated generally as <NUM> dimensioned to receive and register against the inner and outer walls of tube <NUM>". Tube channel <NUM> comprises a channel outer wall <NUM>, an annular channel bottom <NUM> and a channel inner wall <NUM>. Annular channel bottom <NUM> forms a mechanical stop and registration surface for the tube end when inserted into, and bonded to, connector <NUM>". Like the similar structures disclosed herein for assembly <NUM>", this configuration creates a tube rigidifying structure that mechanically enhances the segment of the tube secured in the channel. When thermal bonding is applied and the tube material is allowed to flow and expand in the channel, the tube is radially restricted by the walls of the channel to maintain the cross-sectional dimensional integrity of tube <NUM>". The cross-sectional diameter of a tube bore <NUM> defined by an inner surface of inner wall channel <NUM> may be dimensioned to be substantially similar to, or essentially not less than the cross-sectional diameter of the tube lumen at a relaxed or unstressed segment of tube <NUM>".

A bottom end of connector <NUM>" has an annular wall <NUM> that defines a bore dimensioned to receive the outer wall of capsule port <NUM>". This connector/port connection differs from the connector/port connection shown in <FIG> in that connector <NUM>" does not define an annular channel to receive the inner and outer surfaces of the port wall, but just a bore to receive and register against the outer surface of the port wall. This provides a less robust connection, but an adequate one to handle the applications to which the capsule is put to use as well as the post-use sterilization procedures. Like tube/tube connector/capsule port assembly <NUM>", tube/tube connector/capsule port assembly <NUM>" can be constructed from the same materials disclosed for the components of assembly <NUM> in either a one-step or two-step process such as those disclosed for assembly <NUM>.

Referring now to <FIG>, in another aspect of the disclosure, a connector modification is formed to provide stress relief to the connector/tube junction. As shown in the figures, a connector/tube assembly shown designated generally as <NUM> includes a connector <NUM> secured about a tube <NUM>. As highlighted in <FIG>, the connector/tube junction <NUM> creates a weak zone where the support of connector <NUM> ends. This is a flexion point with the connector functioning as an anchor <NUM> to the supported segment of the tube <NUM> against which the unsupported segment of the tube <NUM> particularly as the junction, can bend and become weakened.

To limit the degree of flexion, as shown in <FIG>, a modified connector/tube assembly designated generally as <NUM>' has the same basic features as assembly <NUM>. A connector <NUM>' is secured to a segment <NUM>' of a tube <NUM>'. A flexion zone is formed at the connector/tube junction <NUM>'. This leaves an unsupported tube segment <NUM>'. To support the flexion zone, an annular tube support collar <NUM>' is formed extending from the peripheral end of connector <NUM>'. The gap <NUM>' between collar <NUM>' and tube <NUM>' permits some flexion and range of motion for the tube to accommodate any need to direct the tube away from a perpendicular orientation to the connector when connected to a larger assembly (not shown). The length of support collar <NUM>' can be adjusted to increase or decrease the range of tube flexion permitted. A shorter collar will permit a greater range of flexion while a longer collar will permit a relatively shorter range of tube flexion. Optionally, an additional ring (not shown) may be formed about the collar from reinforcing material, e.g., metal, to provide additional rigidity, if needed.

Claim 1:
A filter capsule-tube assembly (<NUM>', <NUM>", <NUM>‴) comprising:
a shell (<NUM>', <NUM>", <NUM>‴) having a housing wall defining a filter chamber with at least one port stem defining a port channel formed on the shell (<NUM>', <NUM>", <NUM>‴) wherein the port channel is in fluid communication with the filter chamber;
a rigid tube connector (<NUM>', <NUM>", <NUM>‴) secured to the at least one port stem; and,
a flexible tube (<NUM>', <NUM>", <NUM>‴) defining a lumen;
characterized by
the tube connector (<NUM>', <NUM>", <NUM>‴) having a connector wall (<NUM>') that defines a tube bore (<NUM>') dimensioned to receive and register against an outer surface of the flexible tube (<NUM>', <NUM>", <NUM>‴), wherein a bottom end of tube bore (<NUM>') is formed as an annular channel (<NUM>) with a bottom surface (<NUM>), and
wherein the tube connector (<NUM>', <NUM>", <NUM>‴) has portions defining a capsule port receiving bore (<NUM>'),
wherein an inner channel wall that partially defines a tube receiving channel (<NUM>) defines a connector bore, said tube receiving channel (<NUM>) having an inner channel wall with a frustoconical shape in cross-section that is adapted to create a restriction surface to mechanically lock tube (<NUM>') to the connector when bonded to the connector,
wherein the tube connector (<NUM>', <NUM>", <NUM>‴) is secured to the at least one port stem via the capsule port receiving bore (<NUM>'),
wherein the flexible tube (<NUM>', <NUM>", <NUM>‴) is bonded to the tube connector (<NUM>', <NUM>", <NUM>‴) with an end of the tube (<NUM>', <NUM>", <NUM>‴) secured in the tube receiving channel (<NUM>), wherein an end of the flexible tube registers against the bottom surface (<NUM>) that functions as a tube stop, and wherein the connector bore, tube lumen and port channel are in fluid communication, said filter capsule-tube assembly being characterized in that
an inner annular surface of the inner wall of the annular channel (<NUM>) defines a connector channel (<NUM>) in fluid communication with a port channel defined by port wall (<NUM>') and port base (<NUM>') as well of the chamber defined by capsule (<NUM>'),
wherein the cross-sectional diameter of the narrowest portion of connector channel (<NUM>) is the same as, or not less than the cross-sectional diameter of the lumen of tube (<NUM>') taken at a relaxed, unstressed portion of the tube.