Abstract:
A needleless connector includes a body having a fluid path, a vent path, and a male fitting. The needleless connector also includes a valve disposed within the male fitting. The valve is configured to move between a first configuration, in which the fluid path is blocked, and a second configuration, in which the fluid path is open. The needleless connector further includes a seal disposed around the valve. The seal is configured to separate the fluid path from the vent path in the first and second configurations. Moving the valve from the first configuration to the second configuration also opens the vent path. The seal maintains the separation between the fluid path and the vent path when the valve moves from the first configuration to the second configuration.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation of U.S. patent application Ser. No. 13/797,688, entitled ‘MALE LUER WITH FLUID PATH AND VENT PATH SEALS,” filed Mar. 12, 2013. The entire content of this application is incorporated by referenced herein. 
     
    
     BACKGROUND 
       [0002]    1. Field 
         [0003]    The present disclosure generally relates to needleless connectors, and, in particular, to self-sealing male needleless connectors. 
         [0004]    2. Description of the Related Art 
         [0005]    Medical treatments often include the infusion of a medical fluid, for example a saline solution or a liquid medication, to patients using an intravenous (IV) catheter that is connected though an arrangement of flexible tubing and fittings, commonly referred to as an “IV set,” to a source of fluid, for example an IV bag. Needleless fittings commonly include male and female needleless connectors having a “Luer taper” conforming to an International Standards Organization (ISO) standard wherein mating of Luer fittings forms a liquid-tight connection. 
         [0006]    Certain connectors have a self-sealing feature to prevent leakage of fluid from the attached tubing when the connector is decoupled from a mating connector. Typical self-sealing needleless connectors provide only a fluid path and, therefore, provide a self-sealing capability only for the fluid path. 
       SUMMARY 
       [0007]    The needleless male connector disclosed herein provides both a fluid path and a vent path, each having a self-sealing feature wherein connection of the disclosed male connector to a compatible female connector opens both the fluid and vent paths and disconnection closes both paths. 
         [0008]    In certain embodiments, a male needleless connector is disclosed that includes a body having a male fitting with a distal port, a valve disposed within the body and having a first position wherein the valve seals the port and a second position wherein the valve does not seal the port, and a sliding seal disposed over a portion of the male fitting and having a first configuration wherein a first portion of the sliding seal is in sealing contact with the male fitting and a second configuration wherein the first portion is not in sealing contact with the male fitting. Moving the sliding seal to the second configuration opens the seal between the sliding seal and the male fitting and displaces the valve to the second position, thereby opening the seal between the valve and the port. 
         [0009]    In certain embodiments, a needleless connector set is disclosed that includes male connector having a body having a male fitting with a distal port, a valve disposed within the body and having a first position wherein the valve seals the port and a second position wherein the valve does not seal the port, and a sliding seal disposed over a portion of the male fitting and having a first configuration wherein a first portion of the sliding seal is in sealing contact with the male fitting and a second configuration wherein the first portion is not in sealing contact with the male fitting. Moving the sliding seal to the second configuration opens the seal between the sliding seal and the male fitting and displaces the valve to the second position, thereby opening the seal between the valve and the port. The set also includes a female connector having a body having a distal surface, an opening on the distal surface having a first diameter, a first internal passage extending from the opening, and a cavity extending from a proximal end of the first internal passage. The cavity has a second diameter that is greater than the first diameter. The female connector also has a collapsible valve disposed within the body and having first and second positions. The collapsible valve has a distal end with a diameter that is greater than the first diameter and less than the second diameter, a second internal passage, and a slit passing from the distal end to the second internal passage. The distal end of the collapsible valve is approximately flush with the distal surface of the body and the slit is closed when the collapsible valve is in the first position. The distal end of the collapsible valve is disposed within the cavity and the slit is open when the collapsible valve is in the second position. The male and female connectors are disposed in their respective first positions when not mated and disposed in their respective second positions when mated. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]    The accompanying drawings, which are included to provide further understanding and are incorporated in and constitute a part of this specification, illustrate disclosed embodiments and together with the description serve to explain the principles of the disclosed embodiments. In the drawings: 
           [0011]      FIGS. 1A-1C  are cross-sections of a conventional needleless male connector. 
           [0012]      FIGS. 2A-2B  are cross-sections of an exemplary male needleless connector and a compatible female connector according to certain aspects of the present disclosure. 
           [0013]      FIG. 3  is a cross-section depicting the male and female connectors of  FIGS. 2A-2B  in an engaged configuration according to certain aspects of the present disclosure. 
       
    
    
     DETAILED DESCRIPTION 
       [0014]    The needleless male connector disclosed herein provides both a fluid path and a vent path, each having a self-sealing feature wherein connection of the disclosed male connector to a compatible female connector opens both the fluid and vent paths and disconnection closes both paths. 
         [0015]    In the following detailed description, numerous specific details are set forth to provide a full understanding of the present disclosure. It will be apparent, however, to one ordinarily skilled in the art that embodiments of the present disclosure may be practiced without some of the specific details. In other instances, well-known structures and techniques have not been shown in detail so as not to obscure the disclosure. In the referenced drawings, like numbered elements are the same or essentially similar. Reference numbers may have letter suffixes appended to indicate separate instances of a common element while being referred to generically by the same number without a suffix letter. 
         [0016]      FIGS. 1A-1C  are cross-sections of a conventional needleless male connector  4  as disclosed in U.S. Pat. No. 8,182,452.  FIG. 1A  depicts the male connector  4  and a compatible female connector  2  prior to being mated. The connector  4  has a male fitting  5  with a port  7  on the tip. An internal valve  6  slides relative to the fitting  5  and is biased toward the proximal direction such that the tip of the valve  6  seals the port  7  when the male connector  4  is not mated with female connector  2 . 
         [0017]      FIGS. 1B and 1C  are cross-sections taken on perpendicular planes through the mated connectors  2  and  4 . In this configuration, the face  3  of the female connector  2  has contacted posts  8  that are connected to the valve  6  and displaced the posts  8 , and therefore the valve  6 , in a distal direction. This motion displaces the tip of valve  6  from the port  7 , thereby allowing fluid to flow through the mated connectors  2  and  4  along the flow path  9 . 
         [0018]    It can be seen from the  FIGS. 1A-1C  that there is no gas flow path through the connectors  2  and  4 , nor is there a closable vent path to the ambient atmosphere of any gas-filled portion of the male connector  4 . This is typical of conventional fluid needleless connectors in that they are generally intended for connecting fluid lines, for example the fluid lines of a medical intravenous (IV) set. 
         [0019]      FIGS. 2A-2B  are cross-sections of an exemplary male needleless connector  100  and a compatible female connector  20  according to certain aspects of the present disclosure. The male needleless connector  100  shown in  FIG. 2A  has a body  110  with a male Luer fitting  112  with a port  114  at a proximal end of the fitting  112 . In certain embodiments, the male fitting  112  does not have a Luer taper. A valve  120  is slidably disposed within the body  110  and partially within the male fitting  112 . A sealing tip  140  is disposed over a proximal tip  124  of the valve  120 . The valve  120  is biased in the proximal direction by the action of an accordion bellows  130  disposed within cavity  104  distal to the valve  120  such that the sealing tip  140  sealingly contacts the port  114  of the male fitting  112 . In this configuration, the external surface  142  of the sealing tip  140  is approximately flush with the external surface of the male fitting  112  around the port  114 . The sealing tip  140  includes a second seal  144  that forms a sliding seal between the valve  120  and the male fitting  112 . 
         [0020]    A passage  122  passes through the valve  120  and the sealing tip  140  and comprises, in this example, a longitudinal fluid passage  122 B that passes from the open internal cavity  102  of the bellows  130  to a lateral fluid passage  122 A that is open to the interior of the male fitting  112 . The internal cavity  102  connects to a fluid passage of an attached fluid line or fitting (not shown in  FIG. 2A ). 
         [0021]    The valve  120  has a plurality of fingers  124  that extend toward the proximal end of the valve  120 . In this example, there are four fingers  124  while, in other embodiments, there may be fewer or greater than four fingers  124 . 
         [0022]    A sliding seal  150  is disposed over a portion of the male fitting  112  and the fingers  124  with a tip  152  of the sliding seal  150  in sealing contact with a recess  113  in the male fitting  112 . A distal end of the sliding seal  150  is captured, in this example, between two components that form the body  110 . The sliding seal  150  also has a shoulder  154  disposed proximate to the proximal tips of the fingers  124 . In certain embodiments, the sliding seal comprises an elastomeric material. In certain embodiments, the sliding seal comprises a flexible material. 
         [0023]      FIG. 2B  illustrates certain features of a compatible female fitting  20  that, in this example, is a female Luer fitting that is compatible with the example male Luer fitting of  FIG. 2A . In certain embodiments, the connector  20  does not have a Luer taper. The connector  20  has a body  30  with a distal surface  32  and an opening  34 . A collapsible valve  40  is disposed within the body  30  and has a distal end  42  that, in this configuration, is disposed within the opening  34  such that the distal face  46  is approximately flush with the distal surface  32  of the body  30 . The tip  42  comprises a slit  44  that is forced closed when the tip  42  is positioned as shown in  FIG. 2B  and will self-open when the collapsible valve  40  is displaced in a proximal direction such that the tip  42  is displaced into the wider cavity  24  of the body  30 . The slit  44  passes from the distal face  46  into the internal passage  22  that connects to a fluid passage of an attached fluid line or fitting (not shown in  FIG. 2B ). 
         [0024]      FIG. 3  is a cross-section depicting the male and female connectors  100 ,  20  of  FIGS. 2A-2B  in an engaged configuration according to certain aspects of the present disclosure. The body  30  of the female connector  20  has been threaded into the body  110  of the male fitting  112  such that the connectors  100 ,  20  are retained in the engaged configuration. As the body  30  was threaded into the body  110 , the distal surface  32  of the body  30  came into contact with the shoulder  154  of the sliding seal  150  and, as the body  30  advanced into the body  110 , displaced the shoulder  154  and the adjacent fingers  124  in a distal direction. As the distal end of the sliding seal  150  is captured by the body  110 , the displacement of the shoulder  154  collapses the sliding seal  150  generally as shown, as an example, in  FIG. 3 . The displacement of the shoulder  154  also draws the tip  152  of the sliding seal  150  away from the recess  113 , thereby opening a vent path  160  from the cavity  104  between the sliding seal  150  and the male fitting  114  into the internal cavity  24 , indicated in  FIG. 3  by the dashed line labeled “ 160 .” 
         [0025]    The distal displacement of the finger  124  causes the entire valve  120  to move in the distal direction, thereby distally displacing the second seal  144  within the male fitting  112  and the sealing tip  140  from the port  114 . At the same time, the male fitting  112  displaced the collapsible valve  40  such that the slit  44  self-opened. As the second seal  144  maintains the seal between the valve  120  and male fitting  112 , a fluid path  170  is now provided from the internal cavity  102  through the mated connectors  100 ,  20  to the internal passage  22 , as indicated by the solid line labeled “ 170 .” It can be seen that the fluid path  170  and the vent path  160  are separated by seals between the male fitting  112  and the collapsible valve  40 , between the second seal  144  of the sealing tip  140  and the male fitting  112 , and between the accordion bellows  130  and the valve  120 . In certain embodiments, the vent path  160  may open before the fluid path  170 . In other embodiments, the fluid path  170  may open before the vent path  160 . In other embodiments, the fluid path  170  and the vent path  160  may open at approximately the same time. 
         [0026]    In certain embodiments, the sliding seal  150  may form a sealing contact with the male fitting  112  in locations other than tip  152 . In certain embodiments, the recess  113  may be absent and the tip  152  seals against a smooth external surface of the male fitting  112 . In certain embodiments, the male fitting  112  may have external features (not shown), for example ridges running in a distal-proximal direction, that expand, as the sliding seal is displaced, a portion of the sliding seal  150  that sealingly contacts the fitting  112  when in an undisplaced configuration. 
         [0027]    In summary, it can be seen that the disclosed embodiments of the needleless connector provide a fluid path and a vent path that are each sealed when the male and female connectors are not mated and are opened automatically as the connectors are mated. 
         [0028]    The previous description is provided to enable any person skilled in the art to practice the various aspects described herein. While the foregoing has described what are considered to be the best mode and/or other examples, it is understood that various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects. Thus, the claims are not intended to be limited to the aspects shown herein, but is to be accorded the full scope consistent with the language claims, wherein reference to an element in the singular is not intended to mean “one and only one” unless specifically so stated, but rather “one or more.” Unless specifically stated otherwise, the terms “a set” and “some” refer to one or more. Pronouns in the masculine (e.g., his) include the feminine and neuter gender (e.g., her and its) and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit the invention. 
         [0029]    It is understood that the specific order or hierarchy of steps in the processes disclosed is an illustration of exemplary approaches. Based upon design preferences, it is understood that the specific order or hierarchy of steps in the processes may be rearranged. Some of the steps may be performed simultaneously. The accompanying method claims present elements of the various steps in a sample order, and are not meant to be limited to the specific order or hierarchy presented. 
         [0030]    Terms such as “top,” “bottom,” “front,” “rear” and the like as used in this disclosure should be understood as referring to an arbitrary frame of reference, rather than to the ordinary gravitational frame of reference. Thus, a top surface, a bottom surface, a front surface, and a rear surface may extend upwardly, downwardly, diagonally, or horizontally in a gravitational frame of reference. 
         [0031]    A phrase such as an “aspect” does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. A disclosure relating to an aspect may apply to all configurations, or one or more configurations. A phrase such as an aspect may refer to one or more aspects and vice versa. A phrase such as an “embodiment” does not imply that such embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. A disclosure relating to an embodiment may apply to all embodiments, or one or more embodiments. A phrase such an embodiment may refer to one or more embodiments and vice versa. 
         [0032]    The term “exemplary” is used herein to mean “serving as an example or illustration.” Any aspect or design described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other aspects or designs. 
         [0033]    The terms “include,” “have,” “with,” and the like are intended to be inclusive in a manner similar to the term “comprise” as “comprise” is interpreted when employed as a transitional word in a claim. 
         [0034]    No claim element is to be construed under the provisions of 35 U.S.C. §112, sixth paragraph, unless the element is expressly recited using the phrase “means for” or, in the case of a method claim, the element is recited using the phrase “step for.” 
         [0035]    All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims.