Patent ID: 12233231

DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS

The present invention may be understood more readily by reference to the following detailed description taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this invention is not limited to the specific devices, methods, conditions, or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting of the claimed invention. Any and all patents and other publications identified in this specification are incorporated by reference as though fully set forth herein.

Also, as used in the specification including the appended claims, the singular forms “a,” “an,” and “the” include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” one particular value and/or to “about” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment.

With reference now to the drawing figures, wherein like reference numbers represent corresponding parts throughout the several views,FIGS.1-9show a vented connector30according to a first example embodiment of the invention. The connector30attaches to a medical fluid vessel10and mates with a cooperating connector20attached to an inline medical fluid vessel12, with the connectors collectively forming a connector-set or coupling that detachably couples the vessels together for fluid flow therethrough. The connectors20and30can be made of conventional materials (e.g., as silicone or polyurethane) by conventional fabrication techniques and equipment (e.g., molding).

In the depicted embodiment, the vented connector30is attached to a vessel10that is a tube, though the term “vessel” is intended to be broadly construed to include any carrier or container for a fluid as well as any fluid-delivery device, and as such in other embodiments the vessel is a catheter, hose, bottle, bag, syringe, pump, or the like. As such, the connectors20and30can be used to couple together two vessels (with one vessel in/at the patient and the other vessel connected to an upstream medical fluid-delivery device such as a syringe) or to couple one vessel to a medical device (with one vessel in/at the patient and the other vessel being or a part of an upstream medical fluid-delivery device such as a syringe). In the depicted embodiment, the vented connector30is used for a vessel10for enteral feeding, with the term “vessel” in the “enteral feeding” context intended to be broadly construed to include not just feeding bags but also breast pumps, food bottles, other food-storage containers, extension sets, and the like. In the depicted embodiment, the vented connector30is an ENFIT connector for enteral feeding tubes, though in other embodiments the innovative features are included in connectors for fluid vessels for non-enteral and/or non-small-bore (medical or other) applications. And in the depicted embodiment, the vented connector30is a male connector and the cooperating connector20is a mating female connector, though in other embodiments this is reversed to provide a vented and/or capped female connector with an outer housing defining an annular space. In addition, the vented connector30is described herein for use with fluids, which as used herein means liquids and gases.

The connector30includes a vessel-attaching portion32defining a rear end34, a coupling-attaching portion36defining a front end38, and a lumen40extending longitudinally therethrough from end to end. The vessel-attaching portion32attaches to (e.g., receives and secures) the vessel10and secures it in place with a good seal by conventional structures such as crimps or adhesives so that the vessel extends longitudinally from the rear end34. The coupling-attaching portion36and the cooperating connector20detachably couple together mechanically by mating attachment fittings such as the depicted screw threads42and22(of the connector30and the cooperating connector20, respectively) or other conventional mating mechanical fasteners as are known to persons of ordinary skill in the art such as bayonet fitting, snap-fit couplings, and the like. And the coupling-attaching portion36and the cooperating connector20sealingly mate together for fluid conveyance by mating male and female fittings such as the depicted male plug44and female receptacle24(of the connector30and the cooperating connector20, respectively) or other conventional fluid-sealing structures as are known to persons of ordinary skill in the art such other friction fittings. In the depicted embodiment, the male plug44includes a peripheral wall that defines the lumen40extending axially all the way through it to convey the fluid through the connector30. In some embodiments, the mating male and female seal fittings are designed to provide sufficient mechanical/frictional retention forces that the connectors30and20are securely coupled together and the connectors30and20thus do not include any separate screw threading or other mechanical fasteners.

In addition, the connector30includes an outer housing46surrounding its plug44, for example including a peripheral sidewall48and an endwall50. The outer-housing sidewall48is arranged coaxially with and surrounding the plug44thereby forming an annular space52therebetween with an access opening51at the front end38of the connector30(opposite the endwall). In this way, when the two connectors are coupled together with the male plug44of the connector30inserted into the female receptacle24of the cooperating connector20, the peripheral sidewall or barrel26(defining the receptacle24) of the cooperating connector20is coaxially received in the annular space52(between the outer-housing peripheral sidewall48and the plug44) of the connector30. And the connectors30and20can be coupled together by the screw threads42being inner threads on the outer-housing sidewall48and the mating threads22being outer threads on the receptacle sidewall26, by mating threads between the plug and the receptacle sidewall, or by other threading arrangements. The outer-housing sidewall48of the connector30and the receptacle sidewall26of the cooperating connector20are typically generally cylindrical in shape and solid in structure (i.e., not fluid permeable).

The outer-housing endwall50extends at least partially between the outer-housing sidewall48and the plug44, with at least one (e.g., two, as depicted) connecting portion54extending inwardly from the outer-housing sidewall to fix the outer-housing sidewall relative to the plug and thereby form the annular space52. Typically each connecting portion54extends all the way between (e.g., radially, as depicted) and fixes together the outer-housing sidewall48and the plug44. To provide for fluid drainage and airflow ventilation, the outer-housing endwall50of the connector30includes at least one (e.g., two, as depicted) vent openings56providing fluid communication between the annular space52and external to the annular space. The connector vent openings56can be in the form of two curved slots extending between two connecting portions54in the form of radial spokes, as depicted. Alternatively, the connector vent openings can be in the form of ports (e.g., holes in a circular, polygonal, frusto-conical, or other regular or irregular shape) extending axially through the endwall and/or radially through the outer sidewall, mesh openings in an endwall that is a mesh (e.g., a screen, grate, or lattice), or other types and arrangements of openings that provide for fluid drainage and airflow ventilation for the annular space. In addition, the outer-housing endwall50has an inner surface (partially defining the annular space52) that can be sloped (ramped or taper, all or only part of it) toward the connector vent openings56to help direct fluid toward them.

In this way, any residual fluid from the vessels10and12that might otherwise be retained in the annular space52resulting in bacteria colonization will instead tend to drain out through the connector vent openings56and be dried by airflow in and/or out of the vent openings. Furthermore, the connector vent openings56in the outer-housing endwall50provide better access to the annular space52for inspection and cleaning. Moreover, when the connector30is disconnected from the cooperating connector20, a vacuum can form in the lumen40and induce a backflow of the fluid into the connector30and/or the cooperating connector20, resulting in dosing inaccuracies, and the connector vent openings56can function to assist in breaking the vacuum to prevent fluid backflow and thus provide for more accurate dosing.

In addition, the connector30optionally includes a sanitary cap70for the lumen40at its front end38(opposite the attachment of the vessel10). The cap70can be attached to the connector30by a tether72such as an integral length of material (as shown) or a cord, string, band, chain, or the like. In addition, the cap70can include a handle73for gripping to move the cap between its unplugged (seeFIGS.1-7) and plugged positions (seeFIGS.8-9). In the plugged position the cap70seals off the lumen40and the vessel10from outside contamination, which can be advantageous for example in enteral feeding applications in which the vessel10is inserted into the patient and left there for future feedings.

The cap70includes a body or endwall74with a seal fitting (e.g., a plug)76and a peripheral sidewall78axially extending from it. The cap body/endwall74is typically a solid member such as a panel for sealing the annular space when capped. And the cap sidewall78can be a solid peripheral member such as a collar or flange, or two or more peripherally arranged prongs such as fingers or tabs, for reception and retention in the annular space when capped. In the plugged position, the cap plug76is received in the connector-plug lumen40at its front end38with a snug fit for sealing to prevent the escape of fluids from the vessel10. And the cap sidewall78is received in the annular space52through its access opening51so that it engages the connector30with a snug fit for mechanical/frictional retention to removably secure the cap70in place in the plugged position. In other embodiments, the cap seal fitting is a sleeve, recess, or other structural element that mates with the connector seal fitting to seal the lumen closed. And in yet other embodiments, the cap70and the connector30additionally or alternatively include mating screw threads or other fasteners for removably securing the parts together.

To provide for fluid drainage and airflow ventilation of the annular space52when the cap70is the plugged position, the cap includes at least one (e.g., three, as depicted) vent openings80providing fluid communication between the annular space and external to the annular space. The cap vent openings80can be in the form of one or more notches defined by gaps between one or more segments of the cap sidewall78, for example the three curved notches between the three segments of the cap sidewall formed by the undulating edge of the cap sidewall, as depicted. Alternatively, the cap vent openings can be in the form of ports (e.g., holes in a circular, polygonal, conical, or other regular or irregular shape) extending axially through the cap body/endwall and/or radially through the cap sidewall, mesh openings in a portion of the cap body that is a mesh (e.g., a screen, grate, or lattice), or other types and arrangements of openings that provide for fluid drainage and airflow ventilation for the annular space with the cap in the plugged position.

In this way, any residual fluid from the vessels10and12that might otherwise be retained in the annular space52(upon disconnection of the connectors30and20) resulting in bacteria colonization will instead tend to drain out through the cap vent openings80and be dried by airflow in and/or out of the vent openings. Furthermore, the cap vent openings80can facilitate better inspection and cleaning of the annular space52. Moreover, the connector vent openings56and the cap vent openings80, in combination with the annular space52, form a continuous passageway (seeFIG.9) for airflow to enter the annular space at one end and exit the other end for enhanced drying and to prevent an airlock that might restrict airflow in and out of the annular space. As such, as used herein reference to connector outer-housing vent openings being “at the outer-housing endwall” includes the vent opening being formed in or by the outer-housing endwall50as well as being formed in or by the outer-housing sidewall48but immediately adjacent the outer-housing endwall to provide the continuous airflow passageway along substantially the entire length of the annular space52.

In addition, to make sure that the cap vent openings80are at least partially exposed and uncovered (sufficiently for functioning for their intended purpose as described herein) when the cap70is in the plugged position on the connector30, engaging stop surfaces58and82can be provided on the connector and the cap, respectively, to define (and thus limit) the how far the cap fits onto the connector. In the depicted embodiment, for example, the connector stop surface58is formed by a rim of the connector plug44defining the lumen40, and the cap stop surface82is formed by a base of the cap plug76. As can be seen for example inFIGS.8-9, in the plugged position the cap vent openings80are partially covered but still partially exposed to permit fluid flow therethrough. Alternatively, the connector and cap stop surfaces can be formed by at least one inward-extending member (e.g., a collar, flange, rib, tab, or the like) of the outer-housing sidewall and by the rear (insertion) ends of the cap sidewall segments, respectively, so the inward-extending members limit how far into the annular space the cap sidewall segments can be inserted. Further alternatively, the connector stop surface can be in the form of an endwall, collar, flange, rib, tab, or the like on or adjacent the connector plug and/or lumen (e.g., within the lumen), and/or the cap stop surface can be in the form of a skirt, collar, flange, rib, tab, wing, or the like on or adjacent the cap plug.

It should be noted that the depicted embodiment includes the connector vent openings56and the cap vent openings80in combination, while other embodiments include only one of these two features. Furthermore, it should be noted that some embodiments include connector vent openings in the outer-housing sidewall as an addition or alternate to the depicted connector vent openings56in the outer-housing endwall48, while other embodiments include cap vent openings in the cap endwall as an addition or alternate to the depicted cap vent openings80in the cap sidewall78. As such, any of the vent openings disclosed herein can be implemented individually or in any combination with any other vent opening(s) disclosed herein or not disclosed herein.

FIG.10shows a vented connector130according to a second example embodiment of the present invention. The vented connector130is substantially similar to that of the first example embodiment described above, with exceptions as noted herein. In this embodiment, for example, the connector130includes one or more vent openings186formed in the outer-housing sidewall148, in addition to the one or more vent openings156formed in the outer-housing endwall (not shown) described above. The connector vent openings186in the outer-housing sidewall148provide for drainage and drying, vacuum breaking, and enhanced inspection and cleaning similarly to the venting in the first example embodiment.

In the depicted embodiment, the connector vent openings186are generally circular in shape, though in other embodiments the vent openings can have an oval, polygonal, conical, or other regular or irregular shape. The depicted connector vent openings186are positioned sufficiently away from the front/cooperating connector end of the connector130that they are not blocked by the cap sidewall segments when the cap170is plugged onto the connector (with the cooperating connector detached). In other embodiments, the vent openings are provided with deflectors (e.g., V-shaped members extending inward from the inner surface of the outer-housing sidewall and positioned between the vent openings and the front end) that are engaged by and induce rotation of the cap sidewall segments when the cap is plugged onto the connector so that the vent openings align with the cap sidewall vent openings. And in still other embodiments, an array or series of the sidewall vent openings are provided.

In addition, the cap170can have one or more vent openings184axially formed in the cap body or endwall174. The cap vent openings184are positioned radially outward from the cap plug176so that when the cap170is plugged onto the connector130they provide ventilation to the annular space152but they do not provide ventilation to the lumen140. The cap vent openings184can be in the form of curved slots (as depicted) or they can have a circular, polygonal, conical, or other regular or irregular shape. In other embodiments, the connector120includes only the cap vent openings184or only the connector vent openings186.

FIG.11shows a vented connector230according to a third example embodiment of the present invention. The vented connector230is substantially similar to those of the first and second example embodiments described above, with exceptions as noted herein. In this embodiment, for example, the connector230includes the one or more vent openings286formed in the outer-housing sidewall248, but not any vent openings formed in the outer-housing endwall. The connector vent openings286in the outer-housing sidewall148provide for drainage and drying, vacuum breaking, and enhanced inspection and cleaning similarly to the venting in the first and second example embodiments. It should be noted that the connector230is depicted without a cap, though in some embodiments a cap is provided, and the cap can include cap vent openings as described herein as an addition or alternate to the connector vent openings286.

As described above, the cap comprises a plug that is configured for sealing off the lumen of the connector from outside contamination. In example embodiments, the plug is generally substantially cylindrical with a generally uniform outer periphery having a generally consistent outer diameter. According to example embodiments, the plug is configured such that interference with the lumen occurs when the plug is fully inserted therein or for example within about 1 millimeter from being fully inserted. According to example embodiments, the lumen comprises a diameter of about 2.90 millimeters.

FIGS.12-15show a cap300according to another example embodiment of the present invention. In example embodiments, the cap300is substantially similar to the caps as described above, for example, comprising a body310, a sidewall320, and one or more vent openings350defined by gaps in the sidewall320. In addition, the cap300has a tether340extending from the cap body310. In example embodiments, the cap body310further comprises an upper surface312from which a handle330extends (e.g., for gripping) and a lower surface314from which a plug360extends. In example embodiments, the plug360comprises one or more projections, ribs or other surface features380provided thereon, for example, to provide for an interference fit with the lumen of the male connector (seeFIG.15).

As depicted inFIG.13, the plug360axially extends along an elongate axis X between a first end366(generally adjacent and abutting the lower surface314) and a second end367to define a length L1therebetween (seeFIG.14). In example embodiments, the plug360comprises a cylindrical body362and an outer peripheral surface364. According to example embodiments, the body362is not entirely cylindrical, for example, wherein an angle a is defined between the elongate axis X and the outer periphery364of the plug360. According to example embodiments, the plug360comprises at least some taper thereto, for example, wherein the angle a is generally between about 0.5-20 degrees, for example between about 7-15 degrees according to one example embodiment. In one example embodiment, a first radiused transition is provided where the lower surface314and the first end366abut or engage each other, and a second radiused transition372is provided for extending between the outer surface364and the second end367. According to example embodiments, the plug360is generally integrally formed with the lower surface314of the cap300. However, according to other example embodiments, the plug360can be movably mounted thereto, or can be a separate piece that is generally movably mounted or removably mountable to the lower surface314.

In example embodiments, one or more ribs, sealing features or projections380are provided on the outer surface364of the plug body362, for example, which generally extends outwardly therefrom and around the entire periphery thereof to define a generally raised abutment or seal ring for engagement with the lumen410of the male connector400(seeFIG.15). As such, the outermost periphery or outer surface of the one or more projections380provides for an interference fit with the lumen410of the male connector400. In example embodiments, the plug360comprises an array of about four spaced-apart projections380positioned along the length L1, for example, wherein each projection380generally extends around the entirety of the outer surface364of the plug body362.

As depicted inFIG.14, the plug360comprises a first projection382near the second end367, a second projection384spaced apart from the first projection382, a third projection386spaced apart from the second projection384, and a fourth projection388spaced apart from the third projection386. In example embodiments, each of the projections382,384,386,388extend around the entirety of the plug body360, and thus, insertion within the lumen provides at least four separate sealing surfaces wherein outer surfaces of the projections engage with the interior surface of the lumen410(seeFIG.15). In example embodiments, only one, two or three, or more than four projections can be provided on the plug360so as to provide interference with the lumen410of the male connector400, for example, so as to provide at least one seal between at least a portion of the projection and the interior surface of the lumen410.

According to the depicted example embodiment ofFIG.14, the projections382,384,386,388define a thickness RT and an outer major radius RR. According to one example embodiment, the thickness RT of the projection382is about 0.250 millimeters and the radius RR is about 0.266 millimeters. According to example embodiments, the thickness and radius of the projection382(or the other projections384,386,388) can be chosen as desired, for example, at least between a thickness of between about 0.095-2.5 millimeters and a radius of between about 0.075-1.5 millimeters. Optionally, according to other example embodiments, the thickness and radius can be chosen as desired. In alternate example embodiments, one or more of the projections can be provided with various other projections, ribs, tabs or other sealing features or elements in various sizes and shapes, for example, so as to be configured to allow for a desired about of interference or engagement with the interior surface of the lumen410. For example, according to example embodiments, the projections are preferably configured so as to provide a desirable pull or removal force, for example, such that at least a minimum amount of force is required to disengage the plug from the lumen. In example embodiments, the removal force is generally configured to be between about 2.5-15 newtons (N). In example embodiments, the plug360(and projections382,384,386,388) generally provide for an interference fit such that a removal force of 6-8 newtons. In other example embodiments, the interference fit is such that continuous insertion and removal of the plug from the lumen at least provides for a removal force of about 2.5 N.

As described above, the plug360extends a length L1between the lower surface314and the second end367. In example embodiments, the length L1is generally between about 2.25-8.50 millimeters, more preferably between about 4-7 millimeters, for example about 5.03 millimeters according to one example embodiment. The plug comprises a first outer diameter D1that is generally near the first end366and a second outer diameter D2that is generally near the first projection382. According to one example embodiment, the first outer diameter D1is about 2.871 millimeters and the second outer diameter D2is about 2.478 millimeters, for example, such that at least some taper is provided along the length of the plug body362(e.g., defined by angle α). According to one example embodiment, the angle α is about 3.5 degrees. Accordingly, the entire angle between opposite sides of the outer surface364is about 7 degrees according to one example embodiment. According to another example embodiment, the angle α is between about 4-8 degrees. According to another example embodiment, the angle α can be chosen as desired, for example, between about 0.25 degrees to about 16 degrees.

According to example embodiments, the first projection382is generally spaced a length L5of about 1.389 millimeters from the second end367and comprises an outer diameter D3of about 3.024 millimeters. The second projection384is generally spaced a length L4of about 2.392 millimeters from the second end367and comprises an outer diameter D4of about 3.034 millimeters. The third projection386is generally spaced a length L3of about 3.392 millimeters from the second end367and comprises an outer diameter D5of about 3.051 millimeters. The fourth projection388is generally spaced a length L2of about 4.392 millimeters from the second end367and comprises an outer diameter D6of about 3.20 millimeters.

According to example embodiments, the diameters, lengths, radii or other dimensions of the plug can preferably be varied as desired, for example, so as to provide a desired interference fit with the lumen of the male connector while providing a desired removal force. According to example embodiments, the dimensions as described above can preferably comprise tolerances up to about 0.10 millimeters. Thus, according to some example embodiments, the diameters, lengths or other dimensions of the plug as described above can preferably vary at least by ±0.10 millimeters. According to other example embodiments, the dimensions can be chosen as desired.

According to example embodiments (as described above), the one or more projections can preferably comprise a desired amount of interference I with the lumen410. For example, as depicted inFIG.15, the first projection382defines the interference I provided between the lumen410. According to one example embodiment, with the lumen comprising an inner diameter D7of about 2.90 millimeters and with the first projection382comprising a diameter D3of about 3.024 millimeters, the interference I provided between the first projection382and the lumen410is about 0.062 millimeters. According to other example embodiments, the interference I can be between about 0.0125-0.350 millimeters, for example between about 0.040-0.180 millimeters according to one example embodiment.

According to the depicted example embodiment, the second projection384comprises an interference I of about 0.067 millimeters (D4=3.034 mm and D7=2.90 mm), the third projection386comprises an interference I of about 0.076 millimeters (D5=3.051 mm and D7=2.90 mm), and the fourth projection388comprises an interference I of about 0.150 millimeters (D6=3.20 mm and D7=2.90 mm). Thus, according to one example embodiment, the fourth projection388comprises greater interference with the lumen410than the third projection386, the third projection comprises greater interference with the lumen410than the second projection384, and the second projection comprises greater interference with the lumen410than the first projection382. Optionally, according to other example embodiments, the projections can be dimensioned to provide a desired amount of interference with the lumen.

According to another example embodiment, the projections382,384,386,388can be thickened such that the width thereof is increased while generally keeping the outer diameters the same. For example, the cap500as depicted inFIG.16comprises a plug560comprising a plurality of projections580as is described above with respect to the cap300. In example embodiments, the projections582,584,586,588comprise substantially similar diameters in comparison to the projections382,384,386,388of the plug360. However, the first projection582comprises a thickness RT2of about 0.650 millimeters, for example, about 0.400 millimeters greater than the thickness RT of the projection382. In example embodiments and in a similar manner as described above, the second projection584comprises a thickness that is about 0.300 millimeters greater than the thickness of the projection384, the third projection586comprises a thickness that is about 0.200 millimeters greater than the thickness of the projection386, and the fourth projection588comprises a thickness that is about 0.100 millimeters greater than the thickness of the projection388.

According to yet another example embodiment of the present invention, an annular recess or undercut can be provided with a portion of the lumen or male connector, for example, so as to provide for engagement with one or more projections of the plug. For example, as depicted inFIGS.17-18, a cap600comprising a plug360and one or more projections680is provided for sealing engagement within a lumen710of a male connector700. In example embodiments, an internal surface720that is defined within the lumen710comprises an annular undercut or recess722to provide for engagement with the fourth projection688. In example embodiments, the undercut722is generally shaped similarly to the profile of the projection688, or for example, can be shaped as desired to provide for at least some interference or engagement when the plug is fully inserted within the lumen710. According to some example embodiments, the undercut722is at least slightly larger than the profile of the projection688so as to provide minimal interference when the plug660is seated within the lumen710. However, upon removal or insertion, the projection688must overcome the engagement or interference with the entrance of the undercut722and along the internal surface720. Accordingly, while the undercut722can be configured to have substantially small amounts of interference when the plug is fully inserted, insertion and removal of the plug can be configured so as to provide a desired removal force, for example, such that the plug is not unintentionally removed causing unintentional exposure of the lumen710to the elements.

According to some example embodiments, the undercut can be configured so as to provide less resistance when the plug is fully inserted and rotating about the lumen710. In some example embodiments, the plug can comprise one or more projections intended for an interference fit with the internal surface720of the lumen710and one or more projections intended for seating within one or more undercuts provided within the lumen710. In this manner, the amount of interference can be chosen as desired so as to provide a sufficient seal and a desired removal force. Furthermore, the amount of interference can be chosen as desired to additional provide for at least some rotational movement of the plug relative to the lumen710while maintaining a desired removal force.

According to example embodiments, the cap (and plug thereof) in addition to the connector and the hub of the lumen can be formed from any desirable material including plastics, thermoplastics, polymers, or other desirable materials. In example embodiments, the cap (and plug thereof) is formed from a polyvinyl chloride material. Optionally, other materials may be chosen as desired. According to example embodiments, the male connector and lumen thereof can be formed from a polymer material including polypropylene (PP), acrylonitrile butadiene styrene (ABS), or thermoplastic polyurethane (TPU). In additional example embodiments, the cap, plug, projections, male connector or lumen thereof can preferably be formed from any available desired material (or a combination of two or more materials).

While the invention has been described with reference to preferred and example embodiments, it will be understood by those skilled in the art that a variety of modifications, additions and deletions are within the scope of the invention, as defined by the following claims.