Patent Publication Number: US-2022226630-A1

Title: Flexible Cap for Conical Connectors

Description:
RELATED APPLICATIONS 
     The present application is a divisional of and claims priority to U.S. application Ser. No. 15/774,329, which was filed on May 8, 2018, which is the national stage entry of International Patent Application No. PCT/US2015/062977, which was filed on Nov. 30, 2015, the entire contents of which are incorporated herein in their entirety by reference hereto. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates in general to fittings or connectors for medical devices, and more particularly to a flexible cap for conical connectors of medical devices. 
     BACKGROUND OF THE INVENTION 
     International Standard Organization (ISO) 80369 is a new standard for medical device connections designed to prevent common connection errors in patient care. Many of the new connectors detailed in this standard utilize a conical sealing surface surrounded by a threaded collar. One example of this type of connector is a luer-lock fitting. 
     Luer-lock fittings for medical devices typically have a tubular body at one end a Luer cone connector at an opposing end. More specifically, medical fittings generally include threaded locking ‘luer’ designs having male and female connectors with corresponding threaded collars. The luer cone connector is coaxially surrounded by a cup-like inner threaded attachment element and a detachable cap sealingly connected axially over the Luer cone connector. 
     Thus, the detachable cap is configured to prevent undesirable flow of therapeutic fluids, gases, and/or bodily fluids from flowing from the fitting when not in use. Most existing cap designs utilize the geometry of the opposing connector. For example, a cap for the male connector generally corresponds to the geometry of the female connector design. Thus, a user is required to twist the cap into place on the male connector. Depending on the use, a twist cap can make certain medical procedures that utilize such luer-lock fittings more complex. Further, some twist caps include a tether which can prevent effective rotation of the cap. As such, in many instances, the tether must be a separate component from the cap. 
     In view of the above, push-caps are also known for preventing undesirable flow of therapeutic fluids, gases, and/or bodily fluids from flowing from such fittings when not in use. Though push caps can provide an enhanced user experience by simplifying use during a medical procedure, known push caps can become unintentionally dislodged. Further, known push caps may not provide proper sealing for medical fittings having a conical surface and locking collar. 
     In view of the aforementioned, an improved cap for a conical connector that prevents undesirable fluid and/or gas leaks would be welcomed in the art. Thus, the present disclosure is directed to a flexible cap for a conical fitting or connector that provides a robust and effective seal against fluid or gas leakage. 
     BRIEF SUMMARY OF THE INVENTION 
     Aspects and advantages of the invention will be set forth in part in the following description, or may be obvious from the description, or may be learned through practice of the invention. 
     In one aspect, the present disclosure is directed to a flexible cap for a male connector of a medical fitting. The male connector has an outer cylindrical locking collar and an internal tapered sealing wall having a fluid passageway therein. An internal cavity is defined between the outer locking collar and the tapered sealing wall. The flexible cap includes a cap component defining a top surface, a cylindrical wall, and an inner sealing surface. The cylindrical wall and the inner sealing surface are opposite from the top surface. Further, the cylindrical wall defines a hollow interior configured to receive the tapered sealing wall of the male connector so as to form a seal with an outer surface of the tapered sealing wall. In addition, the inner sealing surface is configured within the hollow interior of the cylindrical wall. Thus, when the tapered sealing wall of the male connector is received within the hollow interior of the cylindrical wall, the inner sealing surface is configured to seal the fluid passageway of the tapered sealing wall. In certain embodiments, the medical fitting may be a luer-lock fitting although it should be understood by those of ordinary skill in the art that the medical fitting may include any medical device connector having a tapered sealing surface and a threaded locking collar. 
     In one embodiment, the inner sealing surface may include a protrusion configured to fit at least partially within the fluid passageway so as to seal the fluid passageway. More specifically, the protrusion may be a dome, cone, cylinder, rib, or similar. Thus, the protrusion is configured to seal the fluid passageway when fluid pressure is applied. In addition, in certain embodiments, the protrusion may have a hollow cross-section or a solid cross-section. Thus, in such embodiments, the hollow cross-section of the protrusion may extend from the top surface of the cap component so as to define an open recess on the top surface of the cap component. As such, the recess may be open to the atmosphere such that it can deform in response to pressure from the fluid passageway so as to frictionally engage the walls thereof. 
     In another embodiment, the outer locking collar of the male connector has internal threads. Thus, in certain embodiments, the cylindrical wall of the flexible cap may include at least one rib on an exterior surface thereof. As such, the rib(s) of the flexible cap may be configured to engage the internal threads of the male connector. More specifically, in particular embodiments, the cylindrical wall of the flexible cap may include opposing ribs on opposite sides thereof. 
     In additional embodiments, the flexible cap may also have a tether. More specifically, in certain embodiments, the tether may be integral with the cap component or any other portion of the flexible cap. Alternatively, the tether may be a separate component that can be attached to the cap component. In still another embodiment, the cap component may include a pull tab configured to assist a user with removing the cap from the male connector. 
     In further embodiments, the flexible cap may be constructed of any suitable flexible or semi-flexible materials. For example, in certain embodiments, the flexible cap may be constructed of polyurethane, neoprene, synthetic rubber, latex, silicone, or similar, or combinations thereof. 
     In another aspect, the present disclosure is directed to a medical fitting for a medical device. The fitting includes a male connector and a flexible cap. The male connector has an outer locking collar and an internal tapered sealing wall. Further, the outer locking collar and the tapered sealing wall define an internal cavity therebetween. In addition, the tapered sealing wall defines a fluid passageway therethrough. Moreover, the internal cavity is configured to receive a female connector during use, and the flexible cap when not in use. The flexible cap includes a cap component defining a top surface, a cylindrical wall, and an inner sealing surface. Further, the cylindrical wall and the inner sealing surface are opposite from the top surface. Moreover, the cylindrical wall defines a hollow interior configured to receive the tapered sealing wall of the male connector so as to form a seal with an outer surface of the tapered sealing wall. In addition, the inner sealing surface is configured within the hollow interior of the cylindrical wall. Thus, when the tapered sealing wall of the male connector is received within the hollow interior of the cylindrical wall, the inner sealing surface seals the fluid passageway of the tapered sealing wall. It should also be understood that the medical fitting may further include any of the additional features as described herein. 
     These and other features, aspects and advantages of the present invention will become better understood with reference to the following description and appended claims. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the description, serve to explain the principles of the invention. 
    
    
     
       DESCRIPTION OF THE DRAWINGS 
       A full and enabling disclosure of the present invention, including the best mode thereof, directed to one of ordinary skill in the art, is set forth in the specification, which makes reference to the appended figures, in which: 
         FIG. 1  illustrates a perspective view of one embodiment of a medical device having double luer fittings according to the present disclosure; 
         FIG. 2  illustrates a detailed, perspective view of one embodiment of a medical device having double luer fittings according to the present disclosure; 
         FIG. 3  illustrates a perspective view of one embodiment of a male connector of a luer fitting according to the present disclosure; 
         FIG. 4  illustrates a cross-sectional view of the male connector of  FIG. 3 ; 
         FIG. 5  illustrates a perspective view of one embodiment of a flexible cap for a male connector of a luer fitting according to the present disclosure; 
         FIG. 6  illustrates a cross-sectional view of one embodiment of a flexible cap inserted into a male connector of a luer fitting according to the present disclosure; and 
         FIG. 7  illustrates a cross-sectional view of one embodiment of a flexible cap for a male connector of a luer fitting according to the present disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     Reference now will be made in detail to embodiments of the invention, one or more examples of which are illustrated in the drawings. Each example is provided by way of explanation of the invention, not limitation of the invention. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the scope or spirit of the invention. For instance, features illustrated or described as part of one embodiment can be used with another embodiment to yield a still further embodiment. Thus, it is intended that the present invention covers such modifications and variations as come within the scope of the appended claims and their equivalents. 
     Generally, the present disclosure is directed to a flexible cap for a medical fitting, such as luer fitting. More specifically, the cap includes a cap component defining a top surface, a cylindrical wall extending opposite from the top surface of the cap component, and an inner sealing surface. The cylindrical wall defines a hollow interior configured to receive an internal tapered sealing wall of a male connector of the medical fitting so as to form a first seal with the tapered sealing wall. Further, the inner sealing surface is configured within the hollow interior of the cylindrical wall such that, when the tapered sealing wall of the male connector is received within the hollow interior, the inner sealing surface provides a second seal with the fluid passageway of the tapered sealing wall. More specifically, in one embodiment, the inner sealing surface may include a protrusion, e.g. a dome, configured to fit at least partially within the fluid passageway so as to seal the fluid passageway when fluid pressure is applied. 
     The present disclosure provides many advantages not present in the prior art. For example, the push-in cap of the present disclosure reduces cost and complexity of typical medical devices that utilize medical fitting, such as luer-lock fittings. In addition, the flexible cap of the present disclosure provides an enhanced user experience that requires less effort during use over twist-on caps. Moreover, the flexible cap of the present disclosure effectively seals to the tapered surfaces of the conical male connector of medical fittings while also remaining resistant to unintentional dislodgement. 
     Referring now to the drawings,  FIGS. 1 and 2  illustrates a medical device  10  for delivering a discrete amount of medication, gas, internal nutrition, drug, or other fluid to a patient, e.g. in order to raise its concentration in the patient&#39;s blood to an effective level. Thus, the medical device  10  may be connected to a fluid or gas delivery device (not shown) that delivers a treatment fluid to a patient via one or more ports or medical fittings  12 . More specifically, as shown the medical fittings  12  are luer-lock fittings that are configured to transport the treatment fluid or gas through a tube  15  and subsequently to a catheter or syringe (not shown). For example, as shown, the medical device  10  includes two luer fittings  12 , i.e. to deliver two separate treatment fluids to a patient. In alternative embodiments, the medical device  10  may include a single luer fitting  12 . It should be understood that a medical device  10  having any number of luer fittings  12  is within the spirit and scope of the invention. 
     Referring now to  FIGS. 3, 4, and 6 , the medical fitting  12  includes a male connector  14  having an outer locking collar  16  and an internal tapered sealing wall  20 . As shown, the outer locking collar  16  and the tapered sealing wall  20  define an internal cavity  22  therebetween. Thus, the tapered sealing wall  20  of the male connector  14  can be inserted into a female connector (not shown) and the female connector may be secured within the internal cavity  22  of the male connector  14 . More specifically, as shown, the outer locking collar  16  of the male connector  14  may have internal threads  18 . Thus, in such embodiments, the male connector  14  may be secured within the female connector via the threads  18  during use. In addition, the tapered sealing wall  20  is generally tapered so that it can be easily inserted to the female connector during use. Further, the tapered sealing wall  20  defines a fluid passageway  24  therethrough, i.e. for delivering treatment fluid to a patient. As such, when the male and female connectors are engaged, treatment fluid is delivered through the medical fitting  12  via a fluid delivery device to the patient. 
     When the medical device  10  is not in use, i.e. the female connector is not engaged with the male connector  14 , the medical fitting  12  may include a flexible cap  25  configured to fit within the internal cavity  22  of the male connector  14 . For example, as shown in  FIGS. 5-7 , the flexible cap  25  includes a cap component  26  defining a top surface  27 . Further, as shown, the flexible cap  25  includes a cylindrical wall  28  extending opposite from the top surface  27  of the cap component  26 . In addition, as shown, the cylindrical wall  28  defines a hollow interior  32  configured to receive the tapered sealing wall  20  of the male connector  14 . Thus, when engaged with the tapered sealing wall  20 , the cylindrical wall  28  is configured expand so as to form a seal with an outer surface  21  of the tapered sealing wall  20 . Thus, the flexible cap  25  is configured to resist unintentional dislodgement of the cap  25 . 
     In addition, the flexible cap  25  may include a second sealing surface  34  having a protrusion  35  configured to fit within the fluid passageway  24  of the internal tapered sealing wall  20 . For example, in one embodiment, the protrusion  35  may have a domed geometry that fits within the fluid passageway  24  of the internal tapered sealing wall  20 . More specifically, in one embodiment, the inner sealing surface  34  may include a dome  35  configured to fit at least partially within the fluid passageway so as to seal the fluid passageway when fluid pressure is applied. Thus, the double-seal configuration of the flexible cap  25  is configured to create a wedge around the full circumference of the male connector  14 , thereby providing a robust and effective seal against fluid or gas leakage. 
     More specifically, as shown in  FIGS. 5-7 , the dome  35  of the second or inner sealing surface  34  extends within the hollow interior  32  of the cylindrical wall  28 . As such, when the tapered sealing wall  20  of the male connector  14  is received within the hollow interior  32  of the cylindrical wall  28 , the dome  35  of the inner sealing surface  34  is configured to seal the fluid passageway  24  of the tapered sealing wall  20 , e.g. when fluid pressure is applied to the cap  25 . Thus, in certain embodiments, the dome  35  of the inner sealing surface  34  is configured to seal the fluid passageway  24  so as to prevent liquids or gases from exiting therefrom. 
     In addition, in particular embodiments, the dome  35  may have a substantially hollow cross-section  36 . Thus, in such embodiments, the hollow cross-section  36  of the dome  35  may extend from the top surface  27  of the cap component  26  so as to define an open recess  38  on the top surface  27 . In other words, in certain embodiments, the recess  38  is open to the atmosphere such that the dome  35  can deform in response to pressure from the fluid passageway so as to frictionally engage the walls of the fluid passageway  24 . In alternative embodiments, the protrusion  35  may have a solid cross-section. 
     Additionally, as shown in  FIGS. 2 and 5-7 , the cylindrical wall  28  of the flexible cap  25  may include at least one rib  30  on an exterior surface  29  thereof. As such, the rib(s)  30  of the flexible cap  25  may be configured to engage or mate with the internal threads  18  of the male connector  14 . More specifically, in particular embodiments, the cylindrical wall  28  of the flexible cap  25  may include opposing ribs  30  on opposite sides thereof. Thus, the rib(s)  30  are configured to provide tactile feedback to a user during insertion of the cap  25  within the internal cavity  22  of the male connector  14 . 
     Referring specifically to  FIGS. 1, 2, and 5 , the flexible cap  25  may also have a tether  40  configured to maintain attachment of the flexible cap  25  to the medical device  10 . In certain embodiments, as shown, the tether  40  may be integral with the cap component  26  of the flexible cap  25  (or any other portion of the flexible cap  25 ). In alternative embodiments, the tether  40  may be a separate component from the cap component  26  of the flexible cap  25  that is later attached to the cap  25 . 
     In another embodiment, as shown in  FIGS. 1, 2, and 5 , the cap component  26  of the flexible cap  25  may also include a pull tab  42  configured to facilitate removal of the cap  25  from the male connector  14  of the medical fitting  12 , e.g. by a user. 
     In further embodiments, the flexible cap  25  may be constructed of any suitable flexible or semi-flexible materials. For example, in certain embodiments, the flexible cap  25  may be constructed of polyurethane, neoprene, synthetic rubber, latex, silicone, or similar, or combinations thereof. In addition, the flexible cap  25  of the present disclosure can be constructed of the same molded part as the tether and/or the male connector  14 , thereby reducing the cost and number of components required to manufacture a medical fitting  12 . As such, the present disclosure provides an enhanced user experience as less dexterity is required to activate the flexible cap  25  as compared to a twist-on cap. 
     While various patents have been incorporated herein by reference, to the extent there is any inconsistency between incorporated material and that of the written specification, the written specification shall control. In addition, while the disclosure has been described in detail with respect to specific embodiments thereof, it will be apparent to those skilled in the art that various alterations, modifications and other changes may be made to the disclosure without departing from the spirit and scope of the present disclosure. It is therefore intended that the claims cover all such modifications, alterations and other changes encompassed by the appended claims.