Patent Publication Number: US-2020297987-A1

Title: Needleless connector with in-line filter

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims benefit of priority under 35 U.S.C. § 119 from U.S. Patent Application 62/820,514 filed Mar. 19, 2019, which is incorporated herein by reference in its entirety. 
    
    
     FIELD OF THE INVENTION 
     The present disclosure generally relates to connectors, and, in particular, to needleless connectors. 
     BACKGROUND 
     Medical treatments often include the infusion of a medical fluid (e.g., 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. Certain needleless connectors may be used in an IV set and may have a self-sealing port to prevent leakage of fluid when a mating medical implement is decoupled from such a needleless connector. Additionally, a needleless connector may include a mechanical valve, for example, a collapsible valve comprising a flexible material for providing the self-sealing port and controlling the flow of fluid within the IV set. 
     In some applications, during the use of IV catheters, blood infections may be caused by bacteria and other microorganisms that may be introduced into the IV set. 
     SUMMARY 
     The disclosed subject matter relates to connectors having filters. In certain embodiments, a needleless connector is disclosed that comprises a housing comprising a cavity and a proximal fluid port in fluid communication with the cavity; a filter support disposed at least partially within the cavity, the filter support comprising a distal fluid port in fluid communication with the proximal fluid port; and a filter disposed circumferentially around the filter support and between the proximal fluid port and the distal fluid port. 
     In certain embodiments, a needleless connector is disclosed that comprises a housing comprising a cavity and a proximal fluid port in fluid communication with the cavity; a filter support disposed at least partially within the cavity, the filter support comprising a distal fluid port in fluid communication with the proximal fluid port, the housing and the filter support defining a flow path between the proximal fluid port and the distal fluid port; and a filter disposed around the filter support, wherein the filter is selectively removed from the flow path. 
     In certain embodiments, a method to selectively filter a fluid flow is disclosed that comprises introducing a first fluid flow from a first fluid port into a needleless connector; directing the first fluid flow through a filter disposed within the needleless connector; and directing the first fluid flow to a second fluid port out of the needleless connector. 
     It is understood that various configurations of the subject technology will become readily apparent to those skilled in the art from the disclosure, wherein various configurations of the subject technology are shown and described by way of illustration. As will be realized, the subject technology is capable of other and different configurations and its several details are capable of modification in various other respects, all without departing from the scope of the subject technology. Accordingly, the summary, drawings and detailed description are to be regarded as illustrative in nature and not as restrictive. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       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: 
         FIG. 1  is an elevation view of a needleless connector, in accordance with various aspects of the present disclosure. 
         FIG. 2  is an exploded view of the needleless connector of  FIG. 1 , in accordance with various aspects of the present disclosure. 
         FIG. 3  is a cross-sectional view of the needleless connector of  FIG. 1  in a sealing configuration, in accordance with various aspects of the present disclosure. 
         FIG. 4  is a cross-sectional view of the needleless connector of  FIG. 1  in a flowing configuration, in accordance with various aspects of the present disclosure. 
         FIG. 5  is a cross-sectional view of the needleless connector of  FIG. 4  with flow directed from a generally proximal to distal direction, in accordance with various aspects of the present disclosure. 
         FIG. 6  is a detail view of the proximal end of the filter of  FIG. 5 , in accordance with various aspects of the present disclosure. 
         FIG. 7  is a cross-sectional view of the needleless connector of  FIG. 4  with flow directed from a generally distal to proximal direction, in accordance with various aspects of the present disclosure. 
         FIG. 8  is a detail view of the proximal end of the filter of  FIG. 7 , in accordance with various aspects of the present disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     The disclosed filtering, needleless connector incorporates a filter disposed within a body of the connector. An in-line filter can be disposed within the needleless connector to permit the filtration of fluids delivered via the connector. By filtering fluids and medicines delivered via the connector, the transfer of bacteria, microorganisms, and other pathogens to the patient can be reduced. Further, the in-line filter can be configured to bypassed during the draw of blood or other fluids from the patient to permit fluid flow of viscous fluids through the connector. 
     The detailed description set forth below is intended as a description of various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of the subject technology. However, it will be apparent to those skilled in the art that the subject technology may be practiced without these specific details. In some instances, well-known structures and components are shown in block diagram form in order to avoid obscuring the concepts of the subject technology. Like components are labeled with identical element numbers for ease of understanding. 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. 
     While the following description is directed to the administration of medical fluid to a patient by a medical practitioner using the disclosed needleless connector, it is to be understood that this description is only an example of usage and does not limit the scope of the claims. Various aspects of the disclosed needleless connectors may be used in any application where it is desirable to prevent the transfer of bacteria, microorganisms, and other pathogens while permitting the draw of blood and other fluids from the patient. 
     The disclosed needleless connector overcomes several challenges discovered with respect to certain conventional connectors. One challenge with certain conventional needleless self-sealing connectors is that bacteria, microorganisms, and other pathogens may be transferred to a patient during use of an IV set. Because such a transfer of pathogens may lead to an infection, such a transfer is undesirable. Another challenge with certain needleless self-sealing connectors is that the flow of blood or other fluids from a patient to a collection or conditioning device may be restricted or not possible. 
     Therefore, in accordance with the present disclosure, it is advantageous to provide a needleless connector as described herein that eliminates or substantially reduces the potential transfer of pathogens to the patient while permitting blood or other fluids from the patient to be drawn. The disclosed needleless connector provides an in-line filter that prevents the transfer of pathogens to the patient and that can be bypassed to allow patient fluids to be drawn. 
     An example of a needleless connector that eliminates or substantially reduces the transfer of pathogens while permitting the flow of patient fluid is now described. 
       FIG. 1  is an elevation view of a needleless connector  100 , in accordance with various aspects of the present disclosure. In the depicted example, the needleless connector  100  is a self-sealing port that provides IV access to a patient while further preventing leakage of fluid when the mating medical implement is decoupled from the needleless connector  100 . As illustrated, fluid flow from an IV set can be introduced into a patient via a proximal fluid port  104 , through a housing  102 , through the distal fluid port  110  and to a patient via a patient tubing  101 . Further, in some embodiments, blood and other fluids from the patient can be drawn from the distal fluid port  110  through the housing  102  to the proximal fluid port  104 . As shown, the proximal fluid port  104  and the distal fluid port  110  can include any suitable fitting, including, but not limited to Luer fittings. In the depicted example, the proximal fluid port  104  is shown as a female Luer fitting and the distal fluid port  110  is shown as a male Luer fitting. 
     Further, as described herein, fluid flow through the needleless connector  100  can be filtered to prevent the transfer of bacteria, microorganisms, and other pathogens to the patient, while permitting the draw of blood and other fluids from the patient. 
       FIG. 2  is an exploded view of the needleless connector  100  of  FIG. 1 , in accordance with various aspects of the present disclosure. As illustrated, the housing  102  of the needleless connector  100  contains the flexible valve element  130 , the filter  120 , and the filter support  111  within the cavity  103  of the housing  102 . In the depicted example, the proximal fluid port  104  is in fluid communication with the cavity  103  of the housing  102 . The proximal fluid port  104  can be threaded to facilitate connections with mating medical implements. 
     As illustrated, the flexible valve element  130  can permit or restrict flow through the proximal fluid port  104  by selectively sealing against the inner cavity  103  of the housing  102 . The flexible valve element  130  can have a body  131  with a sealing portion  132  disposed toward the proximal end  136  of the flexible valve element  130 . The sealing portion  132  can further include a cut portion  134  to facilitate flow past the flexible valve element  130  by readily deforming upon insertion of a mating medical implement. The body  131  of the flexible valve element  130  can be formed from silicone or other elastomeric materials to resiliently deform and reform to allow selective sealing of the proximal fluid port  104 . The flexible valve element  130  can be coupled with the filter support  111  via a distal flange  138 . 
     When flow through the housing  102  is permitted by the flexible valve element  130 , the filter  120  can selectively filter the flow through the needleless connector  100 . In some embodiments, the filter  120  can comprise a filter medium configured to prevent the transfer of bacteria, microorganisms, and/or other pathogens. The filter  120  can have an average filter opening of approximately 0.2 microns. Optionally, the average filter opening of the filter  120  can range between 0.1 microns to 10 microns. The filter  120  can be formed of a resilient or expandable material. 
     As illustrated, the filter  120  can have a generally cylindrical or frustroconical shape. For example, the proximal end  122  of the filter  120  tapers to a generally smaller radius than the distal end  124  of the filter  120 . In some embodiments, the proximal end  122  and the distal end  124  can have a same or similar radius. 
     As shown, the filter  120  can be supported by the filter support  111  to allow a flow path through the filter  120 . In the depicted example, the filter support  111  can have a rigid construction and can include axial ribs  112  and circumferential ribs  113  to support the filter  120  while facilitating flow through the filter. Therefore, the filter  120  can be radially spaced apart from the body of the filter support  111 . 
     Optionally, the proximal end  116  of the filter support  111  can engage the distal flange  138  of the flexible valve element  130 . Accordingly, the filter  120  can be axially retained between the support flange  114  of the support frame  111  and the distal flange  138  of the flexible valve element  130 . 
     As illustrated, the filter support  111  can further facilitate fluid flow through the distal end  118  of the filter support  111 . In the depicted example, the filter support  111  includes the distal fluid port  110  disposed on the distal end  118  of the filter support  111 . The distal fluid port  110  can be in fluid communication with the interior surface of the filter  120  and the cavity  103  generally. The distal fluid port  110  can be coupled to the patient tubing  101 . As described herein, a flow from the proximal fluid port  104  to the distal fluid port  110  may flow through the filter  120  while a flow from the distal fluid port  110  to the proximal fluid port  104  may bypass the filter  120 . 
       FIG. 3  is a cross-sectional view of the needleless connector of  FIG. 1  in a sealing configuration, in accordance with various aspects of the present disclosure. In the depicted example, the flexible valve element  130  forms a seal to prohibit the flow of fluid through the proximal fluid port  104  and the needleless connector  100  generally when a mating medical implement is not connected to the proximal fluid port  104 , thereby preventing leakage. Accordingly, when the needleless connector  100  is not being accessed, the sealing portion  132  and the flexible body  131  of the flexible valve element  130  generally seal against the interior cavity  103  to prevent fluid flow therethrough. 
       FIG. 4  is a cross-sectional view of the needleless connector of  FIG. 1  in a flowing configuration, in accordance with various aspects of the present disclosure. As illustrated, a mating medical implement  150  can be attached to the needleless connector  100 . The medical implement  150  can be used to introduce a fluid or medicine to the patient or to draw blood or other fluids from the patient via the needleless connector  100 . The medical implement  150  can be connected to the proximal flow port  104  via a threaded connection  152 . 
     During operation, the male fitting  154  of the medical implement  150  can be introduced into the cavity  103  of the housing  102 . Upon introduction of the male fitting  154  into the cavity  103 , the flexible valve element  130  can be sufficiently elastic to deform or bend out of sealing engagement with the cavity  103  to permit fluid flow between the needleless connector  100  and the medical implement  150 . The flexible valve element  130  can return to its original shape upon disconnection of the male fitting  154 . The flexible valve element  130  is shown in a collapsed position, allowing fluid flow between the distal fluid port  110  and the proximal flow port  104 . 
     In the depicted example, the needleless connector  100  can be a positive displacement device. For example, when a new connection is made at the proximal fluid port  104 , the volume of the internal cavity  103  is reduced, and the needleless connector  100  draws fluid in from the proximal fluid port  104  or the distal fluid port  110 . Accordingly, when disconnection is made at the proximal fluid port  104 , the needleless connector  100  expels fluid from the cavity  103 , effectively flushing the needleless connector  100 . Advantageously, the filter  120  can dampen or otherwise control the expulsion of fluid from the cavity  103 . 
       FIG. 5  is a cross-sectional view of the needleless connector of  FIG. 4  with flow  160  directed from a generally proximal to distal direction, in accordance with various aspects of the present disclosure. As illustrated, when fluid is introduced from the medical implement  150  into the patient such as when introducing saline or medicine into a patient, the flow  160  illustrates the path of the fluid from the proximal fluid port  104  to the distal fluid port  110  and into the patient tubing  101 . In the depicted example, the flow  160  is directed from the medical implement  150  towards the cavity  103 . The bent or deformed flexible valve element  130  allows for the flow to pass beyond the proximal fluid port  104  and continue towards the filter  120 . 
       FIG. 6  is a detail view of the proximal end  122  of the filter  120  of  FIG. 5 , in accordance with various aspects of the present disclosure. As shown in  FIG. 6 , the fluid flow  160  passes through the filter  120 . The resulting filtered flow  162  continues through the filter support  111 , through the distal flow port  110  to the patient tubing  101 . 
     In the depicted example, as the fluid flow  160  flows in a general proximal to distal direction, the force imparted against the outer surface of the filter  120  by the fluid flow  160  urges the filter  120  against the axial ribs  112  and the circumferential ribs  113  of the filter support  111 . Advantageously, this ensures that the fluid of the flow path  160  is filtered via the filter  120 , permitting introduced fluids such as saline and/or medications to be filtered to prevent the transfer of bacteria to a patient. 
       FIG. 7  is a cross-sectional view of the needleless connector  100  of  FIG. 4  with flow  170  directed from a generally distal to proximal direction, in accordance with various aspects of the present disclosure. As illustrated, when fluid is drawn from the patient, such as when blood is drawn, the flow  170  illustrates the path of the fluid from the distal fluid port  110  to the proximal fluid port  104  and further to the medical implement  150 . In the depicted example, drawn fluid from the patient is directed from the distal fluid port  110  toward the filter  120 . The drawn fluid may bypass the filter  120  and continue past the bent or deformed flexible valve element  130  to allow the flow to continue to the proximal fluid port  104 . 
       FIG. 8  is a detail view of the proximal end  122  of the filter  120  of  FIG. 7 , in accordance with various aspects of the present disclosure. In the depicted example, the fluid flow  170  bypasses the filter  120 . In some embodiments, the filter  120  may be bypassed in response to the direction of flow  170  through the needleless connector  100 . For example, the filter  120  may be bypassed when blood or other patient fluids flow from the distal fluid port  110  to the proximal fluid port  104 , as shown in fluid flow  170 . Optionally, other characteristics of the fluid flow  170 , such as fluid viscosity can be utilized to bypass the filter  120 . 
     Advantageously, the filter  120  can be bypassed by radially expanding the filter  120 , creating an alternative flow path toward the proximal flow port  104  without filtration. For example, the force imparted against the inner surface of the filter  120  by the fluid flow  170  may urge the filter  120  to radially expand away from the filter support  111 . In particular, the filter  120  may be urged, expanded, or stretched radially away from the axial ribs  112  and/or the circumferential ribs  113 , creating an alternative flow path toward the proximal flow port  104 . In some embodiments, the proximal end  122  of the filter  120  can radially expand to permit bypass flow. Optionally, fluid flows  170  with increased viscosity may further expand the filter  120 . 
     The present disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. The disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. 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. 
     A 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 term “some” refers 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. 
     The word “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. In one aspect, various alternative configurations and operations described herein may be considered to be at least equivalent. 
     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. An aspect may provide one or more examples. 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. An embodiment may provide one or more examples. A phrase such an embodiment may refer to one or more embodiments and vice versa. A phrase such as a “configuration” does not imply that such configuration is essential to the subject technology or that such configuration applies to all configurations of the subject technology. A disclosure relating to a configuration may apply to all configurations, or one or more configurations. A configuration may provide one or more examples. A phrase such a configuration may refer to one or more configurations and vice versa. 
     In one aspect, unless otherwise stated, all measurements, values, ratings, positions, magnitudes, sizes, and other specifications that are set forth in this specification, including in the claims that follow, are approximate, not exact. In one aspect, they are intended to have a reasonable range that is consistent with the functions to which they relate and with what is customary in the art to which they pertain. 
     In one aspect, the term “coupled” or the like may refer to being directly coupled. In another aspect, the term “coupled” or the like may refer to being indirectly coupled. 
     Terms such as “top,” “bottom,” “front,” “rear” and the like if 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. 
     Various items may be arranged differently (e.g., arranged in a different order, or partitioned in a different way) all without departing from the scope of the subject technology. 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. 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.” Furthermore, to the extent that the term “include,” “have,” or the like is used, such term is 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. 
     The Title, Background, Summary, Brief Description of the Drawings and Abstract of the disclosure are hereby incorporated into the disclosure and are provided as illustrative examples of the disclosure, not as restrictive descriptions. It is submitted with the understanding that they will not be used to limit the scope or meaning of the claims. In addition, in the Detailed Description, it can be seen that the description provides illustrative examples and the various features are grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed configuration or operation. The following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separately claimed subject matter. 
     The claims are not intended to be limited to the aspects described herein, but is to be accorded the full scope consistent with the language claims and to encompass all legal equivalents. Notwithstanding, none of the claims are intended to embrace subject matter that fails to satisfy the requirement of 35 U.S.C. § 101, 102, or 103, nor should they be interpreted in such a way.