US20060161115A1 - Soft-grip medical connector - Google Patents

Abstract

A soft grip medical connector comprises a housing with an upstream end, a downstream end and a lumen extending through a central portion thereof. A flexible member comprises a valve portion integrally formed with a sleeve portion. The valve portion is positioned within a section of the housing and is configured to control a flow of fluid through the housing lumen. The sleeve is inverted to envelope at least a portion of the outer surface of the housing. In some embodiments the gripping portion is integrally formed with the valve portion. In some embodiments, the connector is also generally configured to create a positive pressure in a catheter lumen upon removal of a syringe or other medical device from the upstream end of the connector. Methods of making a medical fluid connector generally comprise forming a valve member with a sleeve extending there from, and assembling the valve, sleeve and housing.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application claims the benefit of U.S. Provisional Application No. 60/625,644, filed on Nov. 5, 2004, and U.S. Provisional Application No. 60/654,250, filed on Feb. 18, 2005, the entireties of which are hereby incorporated by reference.
BACKGROUND OF THE INVENTIONS
• 1. Field of the Invention
• The inventions disclosed herein relate in general to the field of medical connectors, and in particular to needle-less medical connectors.
• 2. Description of the Related Art
• The manipulation of fluids for parenteral administration in hospitals and medical settings routinely involves the use of connectors for selectively facilitating the movement of fluids to or from patients. For example, a connector may be attached to a catheter that leads to a tip positioned within a patient, and various connectors may be attached to one or more tubes and medical implements to control the fluid flow to or from the patient.
• Needle-less connectors are typically structured so that a medical implement without a needle can be selectively connected to such a connector for providing fluid flow between a patient and a fluid source or receptacle. When the medical implement is removed, the connector closes, effectively sealing the catheter connected to the patient without requiring multiple injections to the patient and without exposing health care professionals to the risk of inadvertent needle sticks. The medical implement used with the connector may be a tube or other medical device such as a conduit, syringe, IV set (both peripheral and central lines), piggyback line, or similar component which is adapted for connection to the medical valve.
• Many existing medical connectors can be relatively difficult to grasp by health care professionals during use. In most applications, medical connectors are designed to be relatively small to minimize the cost of manufacturing and to minimize the amount of fluid “dead space” inside the connectors. Moreover, most medical connectors include a housing with a hard, smooth outer surface. As a result, it is sometimes uncomfortable for health care professionals to tightly pinch their fingers around the connectors and firmly grasp them during medical procedures in a repetitious manner. Because health care professionals use such connectors very frequently during patient care, enhancements in their ability to effectively grasp the connectors can result in significant improvement in the time and effort required to use them. Additionally, the existing hard-surface medical connectors can be uncomfortable against a patient's skin. This discomfort can become especially pronounced when a patient requires frequent medical attention involving the use of medical connectors, such as hemodialysis.
• Additionally, many existing medical connectors at least partially obstruct fluid flow with complex flow passageways including various turns, bends, and corners. These obstructions can result in a fairly low flow rate. The obstructions can also damage blood platelets.
• Further, many existing connectors permit some degree of retrograde fluid flow upon the disconnection of these medical devices from the valve. These connectors typically include an internal space through which a fluid may flow from the medical implement to the catheter attached to the connector. When the medical implement is attached to the connector, it typically occupies a portion of this internal valve space, displacing a certain amount of fluid within the connector. When the medical implement is disconnected, a vacuum is created by the removal of the portion of the medical implement from the internal space of the connector, which tends to draw fluid up through the line from the patient toward the connector to fill the space left by the removal of the implement.
• This regression of fluid has certain disadvantages. When the connector is attached to a fluid line leading to a patient, retrograde movement of fluid through the line towards the space in the connector has the effect of drawing a small amount of blood away from the patient in the direction of the connector. The blood thus drawn into the catheter may, over time, result in a clog in the catheter near its tip, potentially limiting the effectiveness of the catheter tip.
• The likelihood of blood clogging the tip of a catheter is heightened when the inner diameter of the catheter is small. In parenteral applications, such smaller-diameter catheters are used frequently due to their numerous advantages. For example, smaller catheters reduce the trauma and discomfort caused by insertion into a patient. Because these catheters have small lumens, even a small suction force may draw fluid back a comparatively large distance through the catheter toward the connector.
• Further, in some existing medical connectors, there are gaps between an internal sealing member and the outer housing of the connector. These gaps may allow bacteria, debris, or disinfectant solution to enter through the opening into the interior of the connector and potentially reach the flow of fluid to or from the patient.
SUMMARY OF THE INVENTIONS
• Certain embodiments of the present invention provide a soft-grip medical connector comprising a housing with an upstream end, a downstream end, a lumen extending through a central portion of the housing, and a flexible member. In some embodiments, the flexible member has a valve portion integrally formed with a gripping portion. The valve portion is positioned within a portion of the housing. The valve portion is configured to control a flow of fluid through the housing lumen. The gripping portion covers at least a portion of an outer surface of the housing.
• In some embodiments, a medical fluid connector comprises a cylindrical body, a valve portion, and a sleeve portion. The cylindrical body has an outer wall with a plurality of flanges extending radially therefrom and a lumen extending through a portion thereof. The valve portion provides a closeable seal between a first end and a second end of the cylindrical body. The sleeve portion can be unitarily formed with the valve portion and can surround a substantial portion of an outer surface of the cylindrical body.
• Methods of forming a gripping and/or sealing portion of a medical device are also provided. In some embodiments, a method comprises injecting an uncured material into a mold, thereby molding a first preform from a substantially flexible material. The preform is removed from the preform mold, and a second preform is molded (though not necessarily in the same mold as the first). The first preform and the second preform are then inserted into a final mold, and an uncured material is injected into the final mold in order to over-mold the first and second pre-forms into a final structure having a valve member and a sleeve portion extending from the valve member.
• Methods of making a medical fluid connector are also provided. In some embodiments, the methods comprise the steps of forming a valve member with a sleeve extending therefrom, the valve and sleeve being integrally formed of a substantially flexible material and forming a relatively rigid housing. A portion of the valve member is inserted into a cavity of the housing such that the sleeve extends from the housing member. The sleeve is then inverted to cover or surround at least a portion of an outer surface of the housing member.
• In embodiments of a method of using a soft-grip connector, the downstream end is connected to a first medical implement such as a catheter. A second medical implement is inserted into an opening in the upstream end of the connector. Upon introduction of the second medical implement into the connector, in certain embodiments, the valve member expands, creating a larger internal volume. Fluid from the second medical implement is permitted to flow into the valve member. In some embodiments, this introduction of fluid causes further expansion of the volume inside the valve member, and as the fluid flow diminishes or stops, the inside volume of the valve member contracts.
• As the second medical implement is withdrawn from the connector, the internal volume of the valve member also decreases. In some embodiments, the valve member can rapidly return to its original state (i.e., before insertion of the second medical implement). A region inside of the valve member near the upstream end is narrower than a region near the downstream end to impede the flow of fluid in the upstream direction and encourage the flow of fluid in the downstream direction. In this way, fluid inside the connector is forced toward the downstream end of the connector in the direction of the patient, creating a positive flow effect and minimizing regression of fluid back into the valve. Various configurations of positive-flow valves are disclosed in U.S. Pat. No. 6,695,817 and U.S. Patent Application Publication No. 2004/0006330, owned by ICU Medical, Inc., and such documents are incorporated herein by reference and form a part of this specification for all that they disclose.
• In many embodiments, the connector is small yet easily grippable. The outer sleeve can be made, for example, of silicone rubber, which creates a desirable degree of anti-slip friction against standard rubber gloves worn by health care professionals. In some embodiments, the contours of the connector in the region near the upstream end are generally smooth and seamless due to the integral formation of the flexible outer sleeve and the valve member. In this configuration, it is less likely that bacteria or other debris will gather in areas where fluid flow passes through to the patient and it is easier and more effective to swab such areas with antiseptic. The integral formation of the valve member and outer sleeve also simplifies, and increases the cost-effectiveness, of the manufacturing processes.
BRIEF DESCRIPTION OF DRAWINGS
• Having thus summarized the general nature of the invention, certain preferred embodiments and modifications thereof will become apparent to those skilled in the art from the detailed description herein having reference to the figures that follow, of which:
• FIG. 1 is a perspective view of one embodiment of a soft-grip medical connector including an outer sleeve surrounding a housing member;
• FIG. 2 is a perspective view of one embodiment of a housing member of a soft-grip medical connector;
• FIG. 3 is a top plan view of the housing member ofFIG. 2;
• FIG. 4 is a bottom plan view of the housing member ofFIG. 2
• FIG. 5 is a transverse cross-sectional view of the housing member ofFIG. 2 taken through line5-5 (shown inFIG. 3);
• FIG. 6 is a transverse cross-sectional view of the housing member ofFIG. 2 taken through line6-6 (shown inFIG. 3);
• FIG. 7 is an exploded perspective view of another embodiment of housing member of a soft-grip medical connector;
• FIG. 8A is a perspective view of a first housing portion of the housing member of the housing member ofFIG. 7;
• FIG. 8B is a perspective view of the first housing portion ofFIG. 8A from a reverse angle;
• FIG. 9A is a perspective view of a second housing portion ofFIG. 7;
• FIG. 9B is a perspective view of the second housing portion ofFIG. 9A from a reverse angle;
• FIG. 10 is a transverse cross-sectional view of the housing member ofFIG. 7 taken through line10-10;
• FIG. 11 is a transverse cross-sectional view of the housing member ofFIG. 7 taken through line11-11;
• FIG. 12 is a perspective view of a flexible member including a valve member and a sleeve connected to the valve member;
• FIG. 13 is a cross-sectional view of the connector ofFIG. 12, taken through line13-13;
• FIG. 14 is a cross-sectional view of the flexible member ofFIG. 12, taken through line14-14;
• FIG. 15 is a perspective view of one embodiment of a preform for use in manufacturing some embodiments of a flexible member;
• FIG. 16 is a perspective view of another embodiment of a flexible member including a valve member and a sleeve connected to the valve member;
• FIG. 17 is a cross-sectional view of the flexible member ofFIG. 16, taken through line17-17;
• FIG. 18 is a cross-sectional view of the flexible member ofFIG. 16, taken through line18-18;
• FIG. 19 is a perspective view of a third embodiment of a flexible member having a valve member and a sleeve connected to the valve member;
• FIG. 20 is a cross-sectional view of the flexible member ofFIG. 19, taken through line20-20;
• FIG. 21 is a cross-sectional view of the flexible member ofFIG. 19, taken through line21-21;
• FIG. 22 is a perspective view illustrating an assembly of a flexible member with a housing member;
• FIG. 23 is a perspective view illustrating the sleeve of the flexible member adjacent to the housing member, with the valve member of the flexible member inserted into the housing member.
• FIG. 24 is a cross-sectional view of an assembled soft-grip medical connector;
• FIG. 25 is a cross-sectional view of a soft-grip medical connector taken at about 90° relative to the cross-section ofFIG. 24.
• FIG. 26 is a cross-sectional view of the connector ofFIG. 24 with a syringe connected thereto; and
• FIG. 27 is a cross-sectional view of the connector ofFIG. 24 taken at about 90° relative to the cross-section ofFIG. 26.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• With reference to the attached figures, certain embodiments and examples of soft-grip medical connectors will now be described. Although certain embodiments and examples of a soft-grip connector are shown and described as including positive-flow valves, certain aspects and advantages of the systems and methods described herein can be advantageously applied to numerous other fluid connector designs including those without positive-flow characteristics.
• Referring now toFIG. 1, the illustrated embodiment of amedical connector10 comprises a substantiallyrigid housing12 with aflexible member80 that has been stretched over the outer surface of thehousing12 to provide a soft, grippableouter surface22. Aslit opening100 is formed at anupstream end16 of theflexible member80. The upstream end of theflexible member80 surrounding thehousing12 provides a surface that is easily cleaned, and is substantially free from cavities or recesses in which contaminants may collect. While as illustrated, the upstream end of theflexible member80 surrounds the entire circumference of thehousing12, it is contemplated that in other embodiments, the upstream end of the flexible member may circumferentially surround substantially all of thehousing12, or can circumferentially surround a portion of thehousing12 such as approximately three-quarters, approximately one-half, or less. In other embodiments, theflexible member80 can be segmented to surround multiple portions of thehousing12. For example, theflexible member80 can have one or more openings or perforations that expose a portion of theunderlying housing12 beneath theflexible member80, and/or the portions of theflexible member80 on the outside of thehousing12 can be made of strips or bands that contact thehousing12. The outer surface of theflexible member80 can cover internal portions of theflexible member80, such as lateral extensions84 (discussed in further detail below), to prevent interference with those portions during use, thereby providing for more consistent functionality of theflexible member80.
• Referring now toFIGS. 2-11, embodiments of ahousing12 are described.FIGS. 2-6 depict one embodiment of ahousing12 for use in a soft-grip medical connector.FIGS. 7-11 depict another embodiment of a housing for use in a soft-grip medical connector. Many other embodiments can also be formed by using or combining one or more features of the disclosed embodiments.
• With reference to the housing depicted inFIGS. 2-6, thehousing12 comprises anupper cavity42 for receiving aflexible member80, and interfaces16,30 for joining the connector to a variety of medical devices. Anupper housing40 generally comprises acylindrical wall44 havinglongitudinal slots46 positioned on opposite sides, e.g., oriented at about 180° relative to one another. At a lower end, theupper housing40 joins abase member48 which comprises a lower Luer connector30 (see, e.g.,FIGS. 5 and 6). During storage and shipping of a sterilizedconnector10, a protective cap (not shown) can be attached to thelower Luer connector30 to maintain its sterility before use. The cap is generally removed by a health care professional immediately before connecting thelower Luer connector30 to a medical implement.
• As illustrated, embodiments of ahousing member12 can also include a plurality ofring sections60 extending radially outwards from the outer surface of thecylindrical wall44 of theupper housing40. In some embodiments, therings60 are progressively smaller in diameter from top60ato bottom60c. In still other embodiments, the number, size, and configuration of therings60 can be modified in many other ways.
• Flanges62 can also be provided at the intersections between therings60 and theslots46. Theflanges62 preventlateral extensions84 of the flexible member80 (see, e.g.,FIG. 23), when inserted into theupper housing40, from snagging or catching on the edges of therings60 at the points wheresuch rings60 are bisected by thelongitudinal slots46. Therings60 andflanges62 are generally configured to retain portions of asleeve20 on theflexible member80, as will be discussed in further detail below.
• As illustrated inFIGS. 1, 5 and6, the progressively smaller diameter rings60 coupled with a frustoconically shapedskirt52 generally result in an “hourglass” shaped housing. This advantageously assists in providing an easily grippable connector. The smaller-diameter region near the lower end of theupper housing40 can be grasped between the thumb and index finger of a health care professional. In the region of therings60, the progressively larger diameter regions above and below the smaller-diameter region make it less likely that the person's grip will slide along the outside surface of theconnector10 when other medical implements are attached to it or detached from it. In addition, other gripping surfaces such as bumps, ridges, and other types of indentations or protrusions can be provided on the outside surface of thesleeve20 in the region where the health care provider's fingers are expected to grasp theconnector10.
• The dimensions of thehousing12 preferably allow for a compact connector. Advantageously, a compact connector is relatively low cost as it requires a relatively small amount of material to manufacture. Further, the compactness typically results in a lightweight connector, thus reducing irritation to a patient when a connector is rested on or hanging from the patient for a relatively long duration use. For example, in some embodiments, thehousing12 has a height from anupstream end16 to a downstream end of aLuer cannula32 of between about 0.400″ and 1.200″. In other embodiments, the height of thehousing12 can be between about 0.500″ and 1.000″. In still other embodiments, the height is less than 1.000″. The height of theupper housing40 from anupstream end16 to thelower Luer connector30 is between about 0.500″ and 0.750″. Preferably, theupper housing40 comprises approximately three-fourths to four-fifths of the overall height of thehousing12. ALuer cavity74 has a height extending from thelower end36 of thehousing12 to a lower surface of thebase member48. In certain embodiments, the height of the Luer cavity is between approximately 0.150″ and 0.350″. In other embodiments, the height of the Luer cavity is less than approximately 0.400″. In a certain embodiment, the height of the Luer cavity is approximately 0.220″. Preferably, the height of theLuer cavity74 corresponds to a length of a Luer connector to be inserted in theLuer cavity74 such that the Luer connector can be flushly inserted into theLuer cavity74. Preferably, the height of theLuer cavity74 comprises from between approximately one-eighth to approximately one-third of the height of thehousing12. In certain embodiments, aLuer cannula32 extends past thelower end36 of thehousing12 approximately 0.050″ to 0.150″. In other embodiments, theLuer cannula32 extends past thelower end36 approximately 0.80″ to 0.120″. In a certain embodiment, theLuer cannula32 extends past thelower end36 approximately 0.093″. Preferably, the Luer cannula is sized and configured to couple with a Luer connector to be inserted into theLuer cavity74
• The dimensions of therings60 and other housing structures correspond to features of thesleeve20 as will be further described below. For example, in some embodiments, thecylindrical wall44 has an outer diameter of between about 0.200″ and about 0.300″, preferably between about 0.250 and about 0.275, and in one particular embodiment, a diameter of about 0.265. In such embodiments, theupper ring60ahas a height ‘h’ (i.e. the difference between the outer diameter of the ring and the outer diameter of the cylindrical upper housing) of about 0.110″ (±0.02″), themiddle ring60bhas a height of about 0.093″ (±0.02″), and thelower ring60chas a height of about 0.073″ (±0.02″). Thus, in certain embodiments, thehousing12 includes a generally hourglass-shaped body defined by thecylindrical wall44 and therings60a,60b,60cand having a maximum diameter of between about 0.310″ and 0.410″, preferably between about 0.360″ and 0.385″, and in one particular embodiment, about 0.375″. Other dimensions within and outside of the above ranges can also be used depending on the particular application desired.
• As shown, for example, inFIGS. 1, 2 and5, thehousing12 can also includeprotrusions70 such as lugs for receiving a threaded medical connector such as a Luer connector of a medical device such as a syringe. In the illustrated embodiment, theprotrusions70 lugs are generally rectangular in shape. The lugs can also have substantially rounded or beveled edges so as to prevent damage to thesleeve20 of theflexible member80 after it is stretched over the outside of thehousing12, as described in greater detail below. Thesleeve20 can includewindows126 configured to allow theprotrusions70 to protrude through theflexible member80, while preferably tightly engaging the periphery of theprotrusions70, when thesleeve12 is inverted (as will be discussed in further detail below). In other embodiments, theprotrusions70 can comprise other shapes and configurations as desired. In some embodiments withoutwindows126, theprotrusions70 are sized to cooperate with a thickness of the sleeve, such that theprotrusions70 form a lump in the sleeve sufficient to engage a female thread of a Luer connector to be attached to theupstream end16 of theconnector10.
• In some embodiments, the lower housing interface comprises aLuer connector30 to facilitate joining theconnector10 to medical devices with female Luer connectors. TheLuer connector30 of thehousing12 can comprise ahard cannula32 extending downwardly from thelower end36 of thehousing12 to provide a connection with another medical device, such as a catheter hub. Other interfaces and connections can also be used in place of theLuer connector30, such as Luer slip connections, barbed hose fittings, etc.
• As shown inFIGS. 5 and 6, the housing also includes aninterior cannula50 extending into theupper housing cavity42. Theinterior cannula50 comprises alumen45 extending through thebase member48 and through theLuer cannula32 of thelower Luer connector30. Thelower Luer connector30 also includes askirt52 which extends downwards from thebase member48 and typically comprisesinternal threads56 or other features for securing theconnector10 to another medical device. Theskirt52 can comprise a taper from a narrower upper portion to a larger-diameter lower portion. In some embodiments, theskirt52 also includes an incutannular groove54 around the perimeter of theskirt52 at a lower portion thereof. Thisannular groove54 can be used to retain a portion of the sleeve as will be described in further detail below.
• In certain embodiments, it is desirable to provide vents72 (seeFIG. 4) between theupper housing cavity40 and thecavity74 defined by thelower Luer skirt52. Since the outer surfaces of thehousing12 are generally in contact with thesleeve20 in the final assembly (and, as discussed below in connection with assembly of themedical connector10, in certain embodiments, thesleeve20 can cover the entire outer surface, or nearly the entire outer surface, of the housing12), such ventilation between theupper housing40 and thecavity74 is helpful in allowing air, gaseous sterilizing agents or other gases to flow freely into and/or out of the upper housing cavity. This ventilation can be particularly helpful when and as a medical implement is inserted into the slit opening100 of theconnector10 and theflexible member80 expands, diminishing the volume between the outer surface of theflexible member80 and the inner wall of theupper housing40. Thevents72 may also allow moisture and other liquids to flow freely into and/or out of the upper housing cavity, thus reducing the risk that a volume of liquid could become trapped in theupper housing40 and restrict expansion of theflexible member80, provide a hospitable environment for the growth of unwanted bacteria, or otherwise adversely affect the operation of themedical connector10. Without venting, such insertion of the medical implement could be met with resistance, creating undue wear on theflexible member80 and requiring additional effort to use theconnector10. Similarly, recessed vents76 can be provided in thelower end36 of theLuer skirt52 to allow air or other gases to escape from the interior of theLuer cavity74 while theconnector10 is attached to another medical device. Additionally, the recessed vents76 allow air or other ambient gases to enter theLuer cavity74 while the other medical device is removed from themedical connector10 such that the medical device does not become vacuum locked to themedical connector10. The recessed vents76 also allow water, cleaning or disinfecting solutions, or other liquids to escape theLuer cavity74 while themedical connector10 is connected to another medical device. In some embodiments, it can be desirable to provide ventilation holes in thesleeve20 itself.
• With reference toFIGS. 7-11, in certain embodiments, the soft-grip medical connector comprises a housing formed of more than one housing portion. In the illustrated embodiments, the housing is formed of afirst housing portion41 and asecond housing portion51.FIG. 7 illustrates an exploded perspective view of a two-piece housing.FIGS. 8A and 8B are perspective views of thefirst housing portion41, andFIGS. 9A and 9B are perspective views of thesecond housing portion51.
• In some embodiments, a two-piece housing may include many or all of the structural features of the housing illustrated inFIGS. 2-6 and described above. In other embodiments, the housing may include more than two pieces. The two-piece housing illustrated inFIGS. 7-11 includes protruding lugs71 for receiving a threaded medical connector such as a Luer connector of a medical device such as a syringe. Thefirst housing portion41 also includeslongitudinal slots49 oriented at approximately 180° relative to each other. In some embodiments, a different number of slots or ridges can be provided and the slots or ridges can be of sizes or positions. Thefirst housing portion41 defines anupper cavity43 for receiving aflexible member80. Thesecond housing portion51 includes a threadedLuer cavity59. Additionally, the second housing portion may include recessedvents77 in the lower surface of theLuer cavity59. The second housing portion includes aninterior cannula53 comprising alumen55 extending through thesecond housing portion51. Moreover, the second housing portion may includevents57 between thefirst housing portion41 and thesecond housing portion51. Further, it is contemplated that a two-piece housing can have dimensions corresponding to the ranges discussed above with respect to the embodiments of one-piece housing12 illustrated inFIGS. 2-6. Therefore, in certain embodiments of medical connector, a two-piece housing could be used interchangeably with a one-piece housing
• The two piece housing illustrated inFIGS. 7-11 also can also include additional features. For example, the two-piece housing can include various alignment and coupling features to ease assembly of thefirst housing portion41 with thesecond housing portion51 into a complete housing. For alignment, the second housing portion may include at least oneridge65, and the first housing portion at least onecorresponding recess63. As illustrated inFIG. 7, theridge65 andsidewall63 are configured to align thefirst housing portion41 in a desired orientation with thesecond housing portion51 during assembly of the housing. To retain the housing in a coupled orientation, thefirst housing portion41 includes at least onetab89, and thesecond housing portion51 includes at least onerecess85 configured to receive thetab89. As illustrated, thetab89 has a wedge-shaped profile including a lead-in surface and an interference surface such that the lead in surface facilitates insertion of thetab89 into the recess and the interference surface prevents withdrawal of thetab89 from therecess85. While described herein and illustrated in terms of certain structures, it is contemplated that other alignment and coupling features can be used to couple the twohousing portions41,51.
• In the housing illustrated inFIGS. 7-11, the assembly of first andsecond housing portions41,51 results in aspace61 between thehousing portions41,51. Advantageously, thespace61 may be sized and configured to retain an end of aflexible member81. Thus, in such a configuration, therings60 used in one-piece housing12 (FIGS. 2-6) need not be present on a two-piece housing to reduce slippage of the housing relative to aflexible member80 disposed thereon. In order to further reduce slippage of aflexible member80 relative to the housing, an area of the first housing portion adjacent thelugs71 may include arecess73 to receive an adhesive such that theflexible member80 may be adhered to the housing. The adhesive and housing materials should be chosen to be compatible. For example, a silicone-based adhesive may be applied to adhere a glass-reinforced thermoplastic polyester resin housing to asilicone rubber sleeve20. In addition to the slippage reduction noted above, the two-piece housing depicted inFIGS. 7-11 may be manufactured quickly and inexpensively in two separate one-step molding processes as opposed to a two-step molding process required to manufacture a more complex single-piece housing.
• As illustrated inFIGS. 12-14, in some embodiments, thevalve member14 andsleeve20 are unitarily formed in aflexible member80. Theflexible member80 is shown removed from thehousing12 to emphasize details. Some embodiments ofvalve member14 have aseal body82 which may take the form of a slab-like structure that is relatively thin in one dimension and relatively wide in another. Thevalve member14 is configured to selectively seal the connector. The term “seal” is used herein for convenience to refer to structures capable of impeding fluid flow but does not necessarily denote that such structures, either alone or in combination with other structures, form a barrier that is completely impermeable to fluid flow. In some embodiments, thebody82 compriseslateral extensions84 extending laterally from thebody82. Thebody82 can also comprise a flat, generallyrectangular neck86 and atransverse flange90. In some embodiments, thesleeve20 is integrally formed with theflange90 and extends axially away from theseal body82.
• Theneck86 is positioned between first and secondlateral extensions84, which each have shoulders92 comprising those portions of the lateral extensions nearest theflange90. Thebody82,neck86,flange90, andsleeve20 can thus form an integral unit. Thebody82 is generally configured to include a narrow passageway or slit94 extending through thebody82. Theslit94 generally extends through thebody82 including theneck86 and theflange90. InFIG. 14, the vertical cross-sectional plane of the drawings coincides with the vertical plane of theslit94, revealing the wide horizontal width of theslit94 on the downstream end in this dimension. Theslit94 also includes taperingsides95, and anarrower neck97.FIG. 13 demonstrates the narrowness of theslit94 in a cross-sectional plan orthogonal to the cross-sectional plane ofFIG. 14.
• As will be described more fully below, thevalve member14 is inserted into thecavity42 of thehousing12. Theslit94 is generally sized and shaped to permit insertion of a cannula of a syringe or other medical device therein. The connector can be adapted to receive an ANSI standard syringe Luer tip. In some embodiments, theslit94 is configured to assist in producing a valve that exhibits positive flow characteristics.
• Theslit94 extends from the slit opening100 in theflange90 to alead lumen102 formed in a the downstream end of thebody82 opposite theflange90. In some embodiments, thelead lumen102 can be substantially cylindrical and centered about an axis that is substantially parallel to or collinear with the longitudinal axis of thevalve member14. Thelead lumen102 can also be provided with an enlarged external diameter section104 (e.g. seeFIG. 14) configured to aid in positioning thelead lumen102 over theinterior cannula50 of thehousing12 and to avoid unduly diminishing the cross-sectional area for fluid flow after theflexible member80 is so positioned.
• As illustrated inFIG. 13, some embodiments of theslit94 can be substantially planar and have a very small thickness in the undisturbed state (i.e. when a syringe cannula is not inserted into the valve member14). Theslit94 thus forms a selectively restricted fluid flow path from the slit opening100 to thelead lumen102. Preferably, the flow path permits either no fluid, or a clinically negligible amount of fluid, to pass through theflexible member80 under the various standard fluid pressure conditions of patient treatment.
• Theslit94 is generally configured to provide a sealable fluid pathway between theslit opening100 and thelead lumen102. In some embodiments, theslit94 can be configured as shown and described herein or as shown and described in any of the patents and applications incorporated herein by reference. Theslit94 is typically made to have essentially no space between adjacent faces of the slit. Examples of methods for making a suitable seal are described in further detail below.
• In the embodiment illustrated inFIG. 12, thelateral extensions84 generally comprise polygonal, angular shapes, although other suitable shapes can be used in view of particular design objectives. Thelateral extensions84 are generally configured to provide structures that interact with portions of thehousing12 in order to retain thevalve member14 in thehousing12 at a desired orientation. As illustrated inFIG. 12,dimples110 can be formed in the flat surfaces of thelateral extensions84. In other embodiments,dimples110 can be formed on another surface of thevalve member14, and, in still other embodiments, thevalve member14 does not include dimples110. Thedimples110 can be used for retaining and positioning thevalve member14 andlateral extensions84 during molding and assembly of the connector as will be further described below.
• In the embodiments ofFIGS. 13 and 14, asleeve20 extends axially from thetransverse flange90 of thevalve member14 to the opposite end of theflexible element80. Thesleeve20 can comprise afirst section112 with a first diameter D1 substantially corresponding to the diameter of thetransverse flange90, and asecond section114 with a second diameter D2 that is slightly larger. In some embodiments, the length of thefirst section112 having the first diameter D1 is approximately equal to a distance between theupstream end16 of thehousing12, and theupper ring60aof thehousing12. Thesecond section114 of thesleeve20 is typically sized to be approximately the same diameter as, or slightly smaller than, the narrowest portion of the hourglass-shaped housing. Thus, when thesleeve20 is inverted and stretched to surround thehousing12, thesleeve20 will preferably cling tightly to the exterior surface of the housing along substantially the entire length of thehousing12.
• To retain thesleeve20 in an inverted position surrounding thehousing12, thesleeve20 can be provided with retaining structures to engage portions of thehousing12. Such retaining structures can include any of a variety of structures, such as protrusions, ribs, ridges, and constrictions. In the embodiments illustrated inFIGS. 12-14, thesleeve20 comprises a plurality ofprotrusions120. In other embodiments, continuous annular ribs can be used in place of the protrusions. Such annular ribs may tend to buckle when the sleeve is turned inside-out, thus causing ripples and irregularities in the outer surface of the finally assembled device. Thus, rows ofprotrusions120 such as those illustrated inFIG. 12 are used in many embodiments to allow thesleeve20 to lie more smoothly on the outer surface of thehousing12. The rows are generally configured such that adjacent protrusions abut one another without deforming thesleeve20 when thesleeve20 is inverted. Each of theprotrusions120 can have many shapes including rectangular, circular, and/or elliptical shapes.
• Theprotrusions120 can be provided in annular rows generally configured to correspond to the spaces between therings60 of thehousing12. The length of each row is generally also sized to allow the protrusions to lie between thelinear flanges62 adjacent theslots46. In other embodiments, thesleeve protrusions120 and/or therings60 andflanges62 of thehousing12 can be provided in any pattern of cooperating structures to allow thesleeve20 to be retained against axial and/or rotational movement relative to thehousing12. For example, in some embodiments, thesleeve20 further comprises recesses orwindows126 for receiving and surrounding portions of the housing, such as the Luer protrusions70 (seeFIG. 1). In other embodiments, as discussed above with reference to the two-piece housing ofFIGS. 7-11, the housing does not haverings60, so the flexible member need not have protrusions (seeFIGS. 16-18).
• In the illustrated embodiment, thesleeve20 comprises aconstriction122 surrounding theopening124 of thesleeve20. Theconstriction122 generally comprises a section of the sleeve with a reduced diameter as compared to thesecond section114. Theconstriction122 can be configured to engage a feature on thehousing12 such as the annular groove54 (see e.g.FIGS. 24 and 25) when thesleeve20 is inverted over thehousing12. In other embodiments, theconstriction122 can be configured to engage and be retained by aspace61 between afirst housing portion41 and a second housing portion51 (seeFIGS. 10 and 11).
• As described previously, some embodiments of asleeve20 can be provided with one ormore windows126 to accommodate and surround one or more structures on the housing such as protrusions70 (also referred to as Luer lugs) or sized to receive a standard Luer connector. In such embodiments, thewindows126 can be molded to include thicker edges to prevent undesirable tearing of the sleeve material during assembly or use.
• Moreover, as previously described, in some embodiments thesleeve20 is not formed integrally with thevalve member14. Thesleeve20 can also be formed by adhering, coating, or otherwise providing an outside surface on thehousing12 with a suitable gripping region (instead of mechanically stretching a separately formed sleeve member over the outside surface of the housing12). Thesleeve20 can also be formed as a band or clip that extends around only the portion of thehousing12 where the fingers of the health care provider are expected to grip theconnector10. Also, in certain embodiments, theconnector10 may be constructed without asleeve20.
• In the embodiments depicted inFIGS. 16-18, aflexible member81 includes at least one stiffeningrib87 oriented substantially along a longitudinal axis of thevalve member14 and protruding transversely to the flat surfaces of thelateral extensions84.FIG. 16 illustrates a perspective view of various embodiments offlexible member81 including two stiffeningribs87, andFIGS. 17 and 18 illustrate cut-away views of theflexible member81 ofFIG. 16. In the illustrated embodiments, theflexible member81 is configured to be assembled with a housing lacking rings60 as theflexible member81 does not include any protrusions120 (seeFIGS. 12-14). In other embodiments, a flexible member can include both a stiffeningrib87 andprotrusions120 for application to ahousing having rings60 such as is illustrated inFIG. 2.
• The stiffeningribs87 can provide resiliency and durability to thevalve member14. In some embodiments, theribs87 can help thevalve member14 to resist crumpling in a substantially longitudinal direction upon insertion of a medical implement into theslit opening100. Such crumpling could block or restrict fluid flow, prevent the connector from closing, or otherwise result in some degree of inconsistent performance. Since the crumpling tendency could be exacerbated by aging of a medical connector and repeated usage cycles, the stiffening ribs can greatly extend the lifespan of avalve member14 in a medical connector. In some embodiments, additional structures and/or materials can be used in themedical connector10, either in combination with orabsent stiffening ribs87, to resist crumpling of thevalve member14. For example, thevalve member14 may be constructed of a material selected to be flexible enough to permit insertion of a medical implement into theslit opening100, but stiff enough to resist crumpling over repeated usage cycles. Likewise, a desired balance between flexibility and valve longevity and resistance to crumpling may be achieved by selecting a desired thickness of the valve member14 (with relatively thicker material used in thevalve member14 increasing the valve longevity and crumple resistance at the expense of flexibility and ease of insertion of medical implements into the slit opening100). For example, in some embodiments, the thickness of the wall of thevalve member14 across most, nearly all, or all of its outside surface area can be about as thick as the wall of thevalve member14 plus a stiffeningrib87. In some embodiments, the thickness of the wall of thevalve member14, in at least some regions, is at least as large as, or at least about 1½-2 times as large as, the diameter of thelead lumen102.
• Another embodiment offlexible member83 for use in a soft-grip medical connector that is configured to extend the usage lifespan of a valve member is illustrated inFIGS. 19-21.FIG. 19 illustrates a perspective view of theflexible member83. As illustrated inFIG. 19, theflexible member83 may share many external features with other embodiments offlexible member80,81 as previously discussed (including but not limited to those that are illustrated inFIGS. 19-21). For example, theflexible member83 includes avalve member153 and asleeve165. In certain embodiments, thesleeve165 includesprotrusions157 for coupling with corresponding flanges on a housing. Thesleeve165 includes aconstriction161 surrounding anopening163. The sleeve can include one ormore windows159 to accommodate and surround one ormore protrusions70 or other structures on the housing. The flexible member includes atransverse flange155, aneck167, andlateral extensions169. As illustrated inFIGS. 20 and 21, theflexible member83 includes alead lumen173 having adownstream opening151.
• As illustrated inFIGS. 20 and 21, which present cut-away views of theflexible member83 ofFIG. 19, the internal structure of the embodiments offlexible member83 illustrated inFIGS. 19-21 can include features absent from other embodiments offlexible member80,81 illustrated herein. Thevalve member153 of the flexible member comprises a pair of opposingsidewalls177,179 that intersect at an upstream end of thevalve member153 to form aslit171 configured for insertion of a medical implement. In an undisturbed state, theslit171 provides a sealed closure of the medical device to prevent the passage of fluid therethrough. In the downstream direction, thesidewalls177,179 diverge such that in an undisturbed state, apassage175 defined by the valve member has a non-zero volume. Thus, unlike the previously-describedflexible member80,81 embodiments, thisflexible member83 does not have a passage that is substantially planar in an undisturbed state.
• In some embodiments, this non-zero volume of thepassage175 in an undisturbed state can prevent the illustrated embodiment offlexible member83 from exhibiting positive flow characteristics when a medical implement inserted completely into theslit171 is removed under certain circumstances. Thispassage175 configuration has certain other advantages. As previously noted, theflexible member83 resists crumpling. The divergence of thesidewalls177,179 enhances the durability of thevalve member153 as compared with planar sidewalls of otherflexible member80,81 embodiments.
• Additionally, theslit171 of theflexible member83 has a relatively small region of contact between thesidewalls177,179. The small region of contact results in a corresponding small resistance to flow in an undisturbed state. Thus, the flow through the valve member can be quickly initiated by inserting a medical implement only partially into the passage, or even merely positioning the medical implement adjacent to, but not within, theslit171. Thus, either the tip of the implement or the pressure of the fluid flow breaks contact of thesidewalls177,179 at theslit171 to open the valve. Advantageously, where partial insertion of, or merely adjacent contact with, a medical implement is performed, thevalve member153 may exhibit positive flow characteristics as the interior volume of thepassage175 in the undisturbed state is smaller than the interior volume of thepassage175 in the partially inserted state.
• Furthermore, if, as in the illustratedflexible member83, thepassage175 does not configured to provide positive flow characteristics on complete insertion of a medical implement, thepassage175 of theflexible member83 need not include a region of relatively larger width. Thus, thepassage175 and thelateral extensions169 of theflexible member83 can be relatively narrow. Correspondingly, the housing can have a relatively smaller diameter as compared with a positive flow medical connector. Thus, a reduction in materials costs and connector weight could be achieved with a non-positive flow embodiment offlexible member83.
• Embodiments of methods for making thevalve member14 of theflexible connectors80,81 will now be discussed with reference toFIGS. 12-18. In general, avalve member14 for use in the present system can be made according to any suitable process available to those of skill in this field. In some advantageous embodiments, thevalve member14 is built by molding first and second “pre-forms”130 which are then placed face to face within a second mold. The pre-forms130 are then over-molded in a separate molding process to form an integralflexible member80 withvalve member14 andsleeve20 portions such as those shown and described herein.
• In one embodiment, avalve member14 can be molded according to the general process described in U.S. Patent Application Publication No. 2004/0006330. A pair of preforms are molded between first and second mold pairs. After this initial molding step, the mold halves with the preforms still positioned therein, are pressed together with an overmold plate positioned between the mold halves. The overmold plate is generally configured to produce the final shape of thevalve member14. With the mold apparatus (including the preform mold halves and overmold plate) fully assembled, additional uncured material is then injected into the mold apparatus to fill the additional space in the mold cavity created by the overmold plate, thereby forming the remainder of thevalve member14. In some embodiments, the overmolding method described in the '330 publication can be adapted to form avalve member14 with an integral sleeve as described herein. Alternatively, avalve member14 can be molded according to the method of the '330 patent, and asleeve20 can be subsequently joined to thevalve member14 by any suitable process such as molding, welding, or adhesives.
• Another embodiment of an overmolding method is provided with reference toFIG. 15. According to this method, preforms130 are molded and completely removed from their molds prior to performing an overmolding or joining step.FIG. 15 illustrates one embodiment of apreform130 for use in forming avalve member14. Eachpreform130 has a generallyplanar face132 that, in the completedvalve member14, forms a wall of theslit94. Aflange portion134 is also integrally molded with eachpreform132. The sides of theflange portion134 can be set back from theface132 of the planar portion in order to provide aspace136 for overmold material to flow between and connect theflange portions134 of twopreforms130. The molding of thepreforms130 is typically accomplished by injecting a thermoset material into the cavity formed between the mold pairs and heating the molds and/or material to the set temperature of the specific material used. Pressure may be applied as needed to prevent material from leaking between the halves of the preform mold (not shown). In some embodiments, thepreforms130 can be provided withdimples110 on aback side138 opposite theface132.
• After eachpreform130 is molded, it can be removed from the preform mold and placed into an over-mold. The over-mold is generally configured to form a final desired valve member/sleeve structure80. In some embodiments, an overmold comprises first and second halves. Each half can comprise pins configured to locate thepreforms130 in the overmold by aligning the pins withdimples110 in thepreforms130.
• Once the preforms are properly located in the overmold halves, the overmold halves can be brought together and an uncured overmolding material can be injected into the mold cavity. In some embodiments, the additional (overmolding) material is injected soon (i.e., a few seconds) after thepreforms130 are molded and while they are still somewhat hot from their initial molding. The additional material injected into the mold cavity bonds to the edges of thepreforms130 and forms the edges of theslit94 in the completedvalve member14 andsleeve20. In this way, the remainder of thevalve member14 and thesleeve20 are overmolded and integrally formed with one another and with a pair of preforms during the over-molding step.
• In some embodiments, thepreforms130 are pressed together with sufficient force during the overmolding process to prevent the overmolding material from migrating between the contacting surfaces of thepreforms130. This preserves the patency of theslit94 by preventing the contacting faces of thepreforms130 from bonding to each other during the overmold step.
• In other embodiments of this method, additional material is allowed to flow between and bond the contacting faces of the preforms to one another. Subsequently, thevalve member14 can be re-opened by inserting a blade between the preforms, thereby cutting open theslit94. In still another embodiment, the entire valve member/sleeve structure can be molded in a single process (i.e. without a pre-formed slit), and aslit94 can be subsequently formed by inserting a blade into a solid valve member section. In another alternative embodiment, asleeve20 andvalve member14 can be individually pre-formed and subsequently attached to one another, such as by overmolding, welding or with adhesives.
• In some embodiments, the material added in the overmold step is similar to that utilized in molding thepreforms130. However, in other embodiments the preform material and the overmold material may comprise different but nonetheless suitable materials for manufacturing thevalve member14 andsleeve20.
• In general, thesleeve20 is typically made of a material with sufficient flexibility to allow thesleeve20 to be inverted and stretched around thehousing12, and sufficient resilience to tightly grip thehousing12 in the inverted orientation. Similarly, thevalve member14 is typically made of a material that is sufficiently flexible to allow a cannula to be inserted therein to open the slit, and also has sufficient resilience to re-close thevalve member14 once the cannula is withdrawn. In some embodiments, thevalve member14 and thesleeve20 are unitarily formed of an elastomeric material such as silicone rubber. In one preferred embodiment, thevalve member14 andsleeve20 are integrally molded from 50 durometer silicone rubber. Alternatively, thevalve member14 andsleeve20 can be made of synthetic polyisoprene, other silicone rubber and/or urethane formulations, or other materials acceptable for medical use. In some embodiments, thesleeve20 can be molded from a first material, and thevalve member14 can be molded from a second, different material.
• Some embodiments of a flexible member83 (FIGS. 19-21) not including positive flow characteristics can be more efficiently manufactured. The manufacture of aflexible member83 as illustrated inFIGS. 19-21 can be accomplished with fewer steps and, accordingly, lower costs than other embodiments featuring positive flow functionality. The relatively small region of contact between thesidewalls177,179 facilitates manufacture of theflexible member83 embodiments illustrated inFIGS. 19-21.
• With reference now toFIGS. 22-25, embodiments of a method of assembling a soft gripmedical connector10 will be described. Thevalve member14 can be inserted into theupper housing cavity42 portion of thehousing12 by partially folding or compressing thelateral extensions84 inwards and pushing thevalve member14 into theupper housing cavity42 until the compressed or foldedlateral extensions84 reach theslots46 and are permitted to uncompress or unfold and extend through theslots46 to the outside of thehousing12. In some embodiments, tooling can be employed to grasp thelateral extensions84 and pull thevalve member14 into theupper housing cavity42. In some of these embodiments, the tool can be configured to engage thedimples110 in thelateral extensions84 to grasp and pull thevalve member14. As thelateral extensions84 are aligned and pulled or pushed through theslots46, an additional downward force can be applied to slightly stretch thevalve member14 and allow theshoulders92 to engage thetop edges140 of theslots46. In this way, a preload (discussed in further detail below) can be applied to thevalve member14. This downward force also allows the lead lumen to more securely engage theinterior cannula50 within thehousing12.
• Once thevalve member14 is fully inserted into the upper housing40 (e.g. as shown inFIG. 25), thesleeve portion20 can be inverted and stretched over thehousing12. This can be accomplished using any suitable tooling. Thesleeve20 can also be grasped by a person's fingers and pulled outwards and downwards in the direction of thearrows146 inFIG. 23. As thesleeve20 is inverted, theprotrusions120 will generally align with the spaces between therings60 of thehousing12. If provided, thewindows126 will also be aligned with theprotrusions70 so that theprotrusions70 pass through and extend beyond theflexible member80.
• When a cleaning solution or other liquid is applied to themedical connector10, the liquid may seep around theprotrusions70 between thesleeve20 and thehousing12, thus causing the sleeve to slip relative to thehousing12 and making it more difficult for a health care professional to grip the outside surface of themedical connector10. To reduce the risk that thesleeve20 will slide or separate from thehousing12, thesleeve20 can be adhered to thehousing12. Additionally, in various embodiments, thesleeve20 may be stretched over an annular groove54 (FIG. 24) or sandwiched in aspace61 betweenhousing portions41,51 (FIGS. 10, 11) to reduce the risk of slippage. Before thesleeve20 is inverted and stretched over thehousing12, an adhesive can be applied to thehousing12 or thesleeve20 in a location of contact between thesleeve20 and thehousing12 of an assembledconnector10. For example, in certain embodiments, the housing may include a recess73 (FIG. 11) adjacent the Luer lugs71 to which adhesive may be applied. Alternatively, adhesive may be spread over an outer surface of thehousing12.
• Preferably, thehousing12,sleeve20, and adhesive are chosen of compatible materials to reduce the risk of material degradation due to the application of adhesive. For example, thesleeve20 can be constructed of a silicone rubber, to be bonded with thehousing12 with a silicone-based adhesive such as an adhesive comprising dimethylpolysiloxane. In certain embodiments, the adhesive may require the mixture of two components, at least one of which includes a catalyst such as a platinum-based catalyst. In certain embodiments, the adhesive may require curing such as, for example, by heating the adhesive to a predetermined temperature for a predetermined time. For material compatibility with a silicone-based adhesive, thehousing12 can be constructed of a glass-reinforced thermoplastic polyester resin, such as, for example, glass-filled Valox® including approximately 30% glass fill, produced by General Electric Company. In some embodiments, thehousing12 can be constructed of a polycarbonate material, although in some situations the polycarbonate may not be compatible with a silicone-based adhesive.
• FIGS. 24 and 25 illustrate cross-sectional views of embodiments of a fully assembled soft gripmedical connector10. In the illustrated embodiment, thesleeve20 fully surrounds thehousing12 including theupper housing40, therings60, and a substantial portion of theLuer skirt52. But, it is contemplated that in other embodiments, thesleeve20 may extend over a portion of thehousing12. For example, in certain embodiments, the sleeve may extend from theupstream end16 of thehousing12 downward over between approximately one-half a height of theupper housing40 and the entireupper housing40. In other embodiments, thesleeve20 may extend from theupstream end16 of thehousing12 downward over between approximately one-fourth the height of theupper housing40 to one-half the height of theupper housing40. Likewise, in embodiments ofmedical connector10 including a two-piece housing, as illustrated inFIGS. 7-11, in various embodiments, thesleeve20 can surround a portion of thefirst housing portion41, substantially all of thefirst housing portion41, all of the first housing portion and a portion of thesecond housing portion51, or all of the first housing portion and substantially all of thesecond housing portion51. Thesleeve20 can also surround thelateral extensions84 extending through theslots46 of thehousing12.
• FIGS. 24 and 25 illustrate an example of an assembled connector in a sealed state (i.e., in which fluid flow through the connector is impeded). Thevalve member14 is positioned within theupper housing cavity42 of thehousing12, with the first and secondlateral extensions84 of thevalve member14 protruding from the first andsecond slots46 in thehousing12. Thelead lumen102 of thevalve member14 is positioned so that theinterior cannula50 extends at least partway into thelead lumen102 of thevalve member14, facilitating fluid communication between thevalve member14 and theLuer cannula32 when the connector is in the open state (as illustrated inFIGS. 15 and 16). Theflange90 covers the axial opening at theupstream end16 of thehousing12.
• Thesleeve20 on the outside surface of thehousing12 allows health care providers to more comfortably and effectively grasp theconnector10. The flexible material of thesleeve20 provides a softer surface for the fingers. There is preferably a high-friction interface between the flexible material of thesleeve20 and the rubber gloves typically worn by health care providers, requiring less finger-pinching effort to screw theconnector10 onto a catheter or other medical implement and to maintain theconnector10 in a desired position and orientation during the connection and fluid-administration processes.
• In addition to providing a soft, easily grippable outer surface, thesleeve20 surrounding the exterior of thehousing12 protects the lateral extensions from being pinched or otherwise undesirably manipulated during handling and use of the connector. In one embodiment, thevalve member14 andhousing12 are constructed such that the distance between theupstream end16 and thetop edges140 of theslots46 of thehousing12 is slightly larger than the distance between theflange90 and theshoulders92 of thelateral extensions84 of thevalve member14. This arrangement results in the application of a tensile force or preload to thevalve member14 between theflange90 and thelateral extensions84.
• The preload arises as theshoulders92 bear against thetop edges140 of the housing and theseal flange90 bears against theupstream end16 and/or theshoulder142 of the axial opening at the upstream end of the housing. In some embodiments, the preload causes theflange90 to assume a slightly bowl-shaped or concave configuration as the edges of theupstream housing end16 bear against the underside of theflange90. The bowl-shapedflange90 tends to more tightly pinch closed theslit opening100 and thus enhances the ability of thevalve member14 to prevent fluid flow. The preload also prevents buckling of thevalve member14 along its longitudinal axis and maintains the sides of theslit94 in close proximity to each other along their entire length. The preload thus promotes a relativelythin slit94 below theflange90, which enhances the sealing performance of theslit94. In some embodiments, a distance between theshoulders92 and theopening148 of theinterior cannula50 is sized such that thelead lumen102 of thevalve member14 will be engaged with and sealed to theinterior cannula50 of thehousing12.
• Referring now toFIGS. 26 and 27, during use of theconnector10, acannula200 of amedical device202, such a syringe , can be inserted into thevalve member14 of theconnector10, thereby opening thevalve member14 tofluid flow204 between themedical device202 and theLuer cannula32 of theconnector10.
• Before thecannula200 is inserted, theconnector10 is in a sealed state (see, e.g.,FIGS. 24 and 25). In this state, theslit94 defines a substantially closed or highly restricted flow path through thevalve member14. As illustrated inFIG. 16, when thecannula200 is inserted through theslit94, thevalve member14 opens a fluid flow path within theconnector10 while exerting an inwardly directed force against thecannula200 of themedical device202, preferably forming a tight seal around the circumference of thecannula200 to prevent leakage of fluid through the upstream end of theconnector10. The insertion of thecannula200 into thevalve member14 also causes thevalve member14 to stretch in the downstream direction over theinterior cannula50.
• As fluid is injected from themedical device202, through thecannula200, and into the interior space within thevalve member14, the space between theslits walls206 increases further and theslit walls206 expand further and lengthen further in the downstream direction. Thevalve member14 thus selectively permits fluid204 to flow between amedical device202 on the upstream end of theconnector10 and a medical implement (not shown) to which thelower Luer connector30 is attached.
• As shown inFIGS. 26 and 27, when in an open state, theconnector10 permitsfluid flow204 that is preferably substantially unobstructed and linear. This generally allows the connector to achieve higher flow rates. In some embodiments, the fluid flow rates through theconnector10 can exceed 600 cubic centimeters per minute. In addition, the unobstructed andlinear fluid flow204 interferes less with the inherent qualities of the flowingfluid204. For example, if thefluid flow204 is blood, the various blood cells and other constituents are less likely to break down within the illustratedconnector10 as compared to a connector in which there is a circuitous fluid flow path with fluid turbulently strikes against hard and/or angular internal surfaces.
• As thefluid flow204 diminishes and/or thecannula200 of themedical device202 is withdrawn from thevalve member14, theslit walls206 retract and return to their original configuration to once again define a narrow, restrictive path width between them (as illustrated, for example, inFIGS. 24 and 25). This retraction of theslit walls206 causes the volume within theslit94 to decrease to a certain minimum. The retracting action of theslit walls206 also forces out the remaining fluid in the area between thewalls206. As thesyringe cannula200 is being withdrawn, the displaced fluid cannot flow out of theslit94 through the upstream end of thevalve member14 because this space is occupied by thesyringe cannula200. The resilientnarrow neck97 of theslit94 preferably blocks any significant flow of fluid between the outer surface of thecannula200 and the inner surface of theflexible member80 by forming a tight seal around the circumference of thecannula200. Thus, the displaced fluid is instead forced downwardly from theslit94, through theinterior cannula50 and downwardly directedcannula32, and ultimately out of thehousing12. This advantageously results in automatic positive flow from theconnector10 toward the patient upon withdrawal of themedical device202 from the upstream end of theconnector10, and avoids or minimizes retrograde fluid flow toward theconnector10 and away from the patient.
• Although the foregoing description refers to a syringe, it is contemplated that any type of suitable medical devices may be joined to either end of theconnector10, such as IV bags, other connectors, and tubing, for the purposes of fluid transfer or for any other desired purpose. An auxiliary connector also may be connected to the soft grip connector, and both connectors can be placed in fluid communication with a catheter with an end positioned within a patient. This arrangement can provide several advantages in situations which call for the use of a unique auxiliary connector. For example, when it is necessary to replace or reconfigure fluid lines connected to auxiliary connectors, such lines may be removed from fluid communication with the catheter without creating a backflow in the catheter, and replaced with a similar connector or any other medical implement. In some embodiments, one such auxiliary connector may be the CLAVE® connector sold by ICU Medical, Inc. However, any connector or other medical implement or device may be placed in fluid communication with thesoft grip connector10 to introduce fluid to the patient or to withdraw blood from the patient including, but not limited to, pierceable connectors, needle-less connectors, medical tubing, syringes or any other medical implement or device.
• Although certain embodiments and examples have been described herein, it will be understood by those skilled in the art that many aspects of the methods and devices shown and described in the present disclosure may be differently combined and/or modified to form still further embodiments. For example, the various embodiments of housing may be interchangeable applied to the various embodiments of flexible member to achieve multiple embodiments of soft-grip medical connector. Additionally, it will be recognized that the methods described herein may be practiced using any device suitable for performing the recited steps. Such alternative embodiments and/or uses of the methods and devices described above and obvious modifications and equivalents thereof are intended to be within the scope of the present disclosure. Thus, it is intended that the scope of the present invention should not be limited by the particular embodiments described above, but should be determined only by a fair reading of the claims that follow.

Claims (42)

1. A soft grip medical connector comprising:

a housing with an upstream end, a downstream end and a lumen extending through a central portion thereof;

a flexible member having a valve portion integrally formed with a gripping portion, the valve portion being positioned within a portion of the housing and configured to control a flow of fluid through the housing lumen, and the gripping portion substantially surrounding at least a portion of an outer surface of the housing.

2. The connector ofclaim 1, wherein the housing comprises a substantially hourglass-shaped profile

3. The connector ofclaim 1, wherein the housing comprises an upstream housing portion containing the flexible member and a downstream housing portion configured to be mateably coupled to the upstream housing portion.

4. The connector ofclaim 3, wherein an end of the gripping portion of the flexible member is retained between the upstream housing portion and the downstream housing portion when the upstream housing portion and the downstream housing portion are coupled.

5. The connector ofclaim 1, wherein the housing comprises a generally cylindrical member having a pair of slots oriented at about 180° with respect to one another.

6. The connector ofclaim 5, wherein the housing further comprises a plurality of rings extending radially from an outer surface of the cylindrical portion.

7. The connector ofclaim 6, wherein the gripping portion comprises structures which engage the rings to limit movement of the gripping portion relative to the housing.

8. The connector ofclaim 1, wherein the housing comprises protrusions on an upper portion thereof, the protrusions configured to engage internal threads of a Luer connector for securing a medical device to an upstream end of the connector.

9. The connector ofclaim 8, wherein the gripping portion comprises windows configured to surround the protrusions.

10. The connector ofclaim 1, wherein the housing is constructed of a polycarbonate material.

11. The connector ofclaim 1, wherein the housing is constructed of a glass-reinforced thermoplastic polyester resin.

12. The connector ofclaim 1, wherein the connector comprises a substantially hourglass-shaped profile.

13. The connector ofclaim 1, wherein the flexible member is made of silicone rubber.

14. The connector ofclaim 1, wherein the flexible member comprises features arranged to interact with features of the housing in order to limit movement of the flexible member relative to the housing.

15. The connector ofclaim 1, wherein at least a portion of the housing further comprises at least one vent between an un-stretched state.

16. The connector ofclaim 1, wherein the housing member further comprises at least one vent between a upper housing cavity and a Luer lock cavity in the housing.

17. The connector ofclaim 1, wherein a lower surface of the housing comprises at least one vent configured to allow air flow into and out of an interior cavity within the housing when a lower portion of the connector is joined to a medical device.

18. The connector ofclaim 1, wherein the valve portion comprises a planar surface at the upstream end of the housing, the planar surface having a slit therein.

19. The connector ofclaim 1, wherein the flexible member is constructed of silicone rubber.

20. The connector ofclaim 1, wherein the valve portion is configured to force a volume of fluid downwards through the lumen upon removal of a medical device from the upstream end of the connector.

21. The connector ofclaim 20, wherein the valve portion comprises a seal element made of a flexible material, the seal element having a downstream end, an upstream end suitable for receiving at least a portion of a medical device, and a normally substantially closed passage in fluid communication with the downstream end and the upstream end, and a neck portion positioned in a region near the upstream end, the passage being relatively wide in the region of the upstream end and the passage being relatively narrow in the region of the downstream end, the passage adapted to have a relatively small interior volume when in an undisturbed state and a larger interior volume upon the introduction of the medical device into the upstream end of the passage, the passage adapted to retract to define a restricted flow path and a relatively small interior volume upon the withdrawal of the medical device from the seal element, at least a portion of the upstream end adapted to initially press against the inserted portion of the medical device as the medical device is withdrawn, so that a fluid occupying the interior volume is forced toward the downstream end as the passage retracts.

22. The connector ofclaim 21, wherein the passage is substantially planar in the undisturbed state and the seal element further comprises at least one rib on an outer surface of the seal element, the rib extending transversely relative to the plane defined by the passage and spanning longitudinally from the region near the upstream end to the region near the downstream end.

23. The connector ofclaim 1, wherein the valve portion comprises a seal element made of a flexible material, the seal element having a downstream end, an upstream end suitable for receiving at least a portion of a medical device, and a normally closed passage in fluid communication with the downstream end and the upstream end, the passage having a height being defined by a first interior wall and a second interior wall, the first interior wall and the interior wall being in sealable contact in a region near the upstream end such that the height of the passage is zero and the passage is substantially closed in an undisturbed state, and the first interior wall and the second interior wall diverging towards a region near the downstream end such that the passage has an increasing nonzero height towards the region near the downstream end.

24. The connector ofclaim 23, wherein the passage has a width tapering from a maximum width at the upstream end to a minimum width at the downstream end.

25. The connector ofclaim 1, wherein the flexible member comprises features arranged to interact with features of the housing in order to limit movement of the flexible member relative to the housing.

26. The connector ofclaim 25, wherein the flexible member comprises windows arranged to interact with tabs on the housing.

27. The connector ofclaim 1, wherein the flexible member is adhered to the housing in order to limit movement of the flexible member relative to the housing.

28. The connector ofclaim 1, wherein at least a portion of the housing comprises a dimension that is larger than a corresponding dimension of the flexible member in an un-stretched state.

29. A medical fluid connector comprising:

a cylindrical body having an outer wall with a plurality of flanges extending radially therefrom and a lumen extending through a portion thereof; and

a valve portion providing a closable seal between a first end and a second end of the cylindrical body; and

a sleeve portion unitarily formed with the valve portion and surrounding a substantial portion of an outer surface of the cylindrical body.

30. The medical connector ofclaim 29, wherein the valve portion comprises wings extending through slots in the cylindrical body.

31. The connector ofclaim 29, wherein the valve portion comprises a slit of substantially zero internal volume in a relaxed position.

32. The connector ofclaim 31, wherein the slit is sized and configured to open upon insertion of a medical device cannula therein.

33. The connector ofclaim 29, wherein the valve portion comprises a passage having an upstream end, a downstream end, a height, and a width, and wherein with the valve in an undisturbed position, the height of the passage tapers from substantially zero at the upstream end to a non-zero value at the downstream end such that the passage has a nonzero interior volume with the valve in an undisturbed position.

34. A method of forming a medical device, the method comprising:

injecting an uncured material into a preform mold, thereby molding a first preform from a substantially flexible material;

removing the preform from the preform mold;

molding a second preform;

inserting the first preform and the second preform into a final mold; and

injecting an uncured material into the final mold, and overmolding the first and second pre-forms into a final structure having a valve portion and a sleeve portion extending there from.

35. The method ofclaim 33, wherein said overmolding further comprises inserting the valve portion into a housing and inverting the sleeve portion to surround at least a portion of an outer surface of the housing.

36. The method ofclaim 33, further comprising inserting a blade between the first and second preforms after said overmolding step.

37. A method of making a medical fluid connector comprising:

forming a valve member with a sleeve extending there from, the valve and sleeve being integrally formed of a substantially flexible material;

forming a relatively rigid housing;

inserting a portion of the valve member into a cavity of the housing such that the sleeve extends from the housing member; and

inverting the sleeve to surround an outer surface of the housing member.

38. The method ofclaim 37, wherein inverting the sleeve further comprises aligning features on the sleeve with features on the housing, whereby said aligned features prevent unwanted movement of the sleeve relative to the housing.

39. The method ofclaim 37, wherein inverting the sleeve further comprises adhering the sleeve to the housing.

40. The method ofclaim 37, wherein forming the relatively rigid housing comprises the steps of forming a first housing portion; forming a second housing portion configured to be coupled with the first housing portion; and coupling the first housing portion with the second housing portion.

41. The method ofclaim 37, further comprising joining a downstream end of the housing in fluid communication with a catheter.

42. The method ofclaim 37, further comprising inserting a rigid cannula into an upstream end of the valve member, thereby joining the rigid cannula and the catheter in fluid communication.

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