Patent Description:
International Standard Organization (ISO) <NUM> 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.

Related art includes <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT> and <CIT>, which disclose various different caps and connection systems.

In one aspect, there is provided a flexible cap for a male connector of a medical fitting, as claimed in claim <NUM>. 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.

The inner sealing surface includes a dome-shaped protrusion configured to fit at least partially within the fluid passageway so as to seal the fluid passageway. Thus, the protrusion is configured to seal the fluid passageway when fluid pressure is applied. The protrusion has a hollow cross-section which extends 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 is 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, there is provided a medical fitting for a medical device, as claimed in claim <NUM>. It should be understood that the medical fitting may further include any of the additional features as described herein.

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 of the invention as set out in the appended claims.

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, the inner sealing surface includes a dome-shaped protrusion 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, <FIG> and <FIG> illustrates a medical device <NUM> for delivering a discrete amount of medication, gas, enternal nutrition, drug, or other fluid to a patient, e.g. in order to raise its concentration in the patient's blood to an effective level. Thus, the medical device <NUM> 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 <NUM>. More specifically, as shown the medical fittings <NUM> are luer-lock fittings that are configured to transport the treatment fluid or gas through a tube <NUM> and subsequently to a catheter or syringe (not shown). For example, as shown, the medical device <NUM> includes two luer fittings <NUM>, i.e. to deliver two separate treatment fluids to a patient. In alternative embodiments, the medical device <NUM> may include a single luer fitting <NUM>. It should be understood that a medical device <NUM> having any number of luer fittings <NUM> is also possible.

Referring now to <FIG>, <FIG>, and <FIG>, the medical fitting <NUM> includes a male connector <NUM> having an outer locking collar <NUM> and an internal tapered sealing wall <NUM>. As shown, the outer locking collar <NUM> and the tapered sealing wall <NUM> define an internal cavity <NUM> therebetween. Thus, the tapered sealing wall <NUM> of the male connector <NUM> can be inserted into a female connector (not shown) and the female connector may be secured within the internal cavity <NUM> of the male connector <NUM>. More specifically, as shown, the outer locking collar <NUM> of the male connector <NUM> may have internal threads <NUM>. Thus, in such embodiments, the male connector <NUM> may be secured within the female connector via the threads <NUM> during use. In addition, the tapered sealing wall <NUM> is generally tapered so that it can be easily inserted to the female connector during use. Further, the tapered sealing wall <NUM> defines a fluid passageway <NUM> 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 <NUM> via a fluid delivery device to the patient.

When the medical device <NUM> is not in use, i.e. the female connector is not engaged with the male connector <NUM>, the medical fitting <NUM> may include a flexible cap <NUM> configured to fit within the internal cavity <NUM> of the male connector <NUM>. For example, as shown in <FIG>, the flexible cap <NUM> includes a cap component <NUM> defining a top surface <NUM>. Further, as shown, the flexible cap <NUM> includes a cylindrical wall <NUM> extending opposite from the top surface <NUM> of the cap component <NUM>. In addition, as shown, the cylindrical wall <NUM> defines a hollow interior <NUM> configured to receive the tapered sealing wall <NUM> of the male connector <NUM>. Thus, when engaged with the tapered sealing wall <NUM>, the cylindrical wall <NUM> is configured expand so as to form a seal with an outer surface <NUM> of the tapered sealing wall <NUM>. Thus, the flexible cap <NUM> is configured to resist unintentional dislodgement of the cap <NUM>.

In addition, the flexible cap <NUM> may include a second sealing surface <NUM> having a protrusion <NUM> configured to fit within the fluid passageway <NUM> of the internal tapered sealing wall <NUM>. The protrusion <NUM> has a domed geometry that fits within the fluid passageway <NUM> of the internal tapered sealing wall <NUM>. More specifically, the inner sealing surface <NUM> includes a dome <NUM> 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 <NUM> is configured to create a wedge around the full circumference of the male connector <NUM>, thereby providing a robust and effective seal against fluid or gas leakage.

More specifically, as shown in <FIG>, the dome <NUM> of the second or inner sealing surface <NUM> extends within the hollow interior <NUM> of the cylindrical wall <NUM>. As such, when the tapered sealing wall <NUM> of the male connector <NUM> is received within the hollow interior <NUM> of the cylindrical wall <NUM>, the dome <NUM> of the inner sealing surface <NUM> is configured to seal the fluid passageway <NUM> of the tapered sealing wall <NUM>, e.g. when fluid pressure is applied to the cap <NUM>. Thus, in certain embodiments, the dome <NUM> of the inner sealing surface <NUM> is configured to seal the fluid passageway <NUM> so as to prevent liquids or gases from exiting therefrom.

In addition, in particular embodiments, the dome <NUM> has a substantially hollow cross-section <NUM>. Thus, the hollow cross-section <NUM> of the dome <NUM> extends from the top surface <NUM> of the cap component <NUM> so as to define an open recess <NUM> on the top surface <NUM>. In other words, the recess <NUM> is open to the atmosphere such that the dome <NUM> can deform in response to pressure from the fluid passageway so as to frictionally engage the walls of the fluid passageway <NUM>.

Additionally, as shown in <FIG> and <FIG>, the cylindrical wall <NUM> of the flexible cap <NUM> may include at least one rib <NUM> on an exterior surface <NUM> thereof. As such, the rib(s) <NUM> of the flexible cap <NUM> may be configured to engage or mate with the internal threads <NUM> of the male connector <NUM>. More specifically, in particular embodiments, the cylindrical wall <NUM> of the flexible cap <NUM> may include opposing ribs <NUM> on opposite sides thereof. Thus, the rib(s) <NUM> are configured to provide tactile feedback to a user during insertion of the cap <NUM> within the internal cavity <NUM> of the male connector <NUM>.

Referring specifically to <FIG>, <FIG>, and <FIG>, the flexible cap <NUM> may also have a tether <NUM> configured to maintain attachment of the flexible cap <NUM> to the medical device <NUM>. In certain embodiments, as shown, the tether <NUM> may be integral with the cap component <NUM> of the flexible cap <NUM> (or any other portion of the flexible cap <NUM>).

In alternative embodiments, the tether <NUM> may be a separate component from the cap component <NUM> of the flexible cap <NUM> that is later attached to the cap <NUM>.

In another embodiment, as shown in <FIG>, <FIG>, and <FIG>, the cap component <NUM> of the flexible cap <NUM> may also include a pull tab <NUM> configured to facilitate removal of the cap <NUM> from the male connector <NUM> of the medical fitting <NUM>, e.g. by a user.

Claim 1:
A flexible cap (<NUM>) for a male connector (<NUM>) of a medical fitting (<NUM>), the male connector having an outer locking collar (<NUM>) and an internal tapered sealing wall (<NUM>) that defines an internal cavity (<NUM>) therebetween, the tapered sealing wall defining a fluid passageway (<NUM>), the cap comprising:
a cap component (<NUM>) defining a top surface (<NUM>);
a cylindrical wall (<NUM>) extending opposite from the top surface (<NUM>) of the cap component, the cylindrical wall (<NUM>) defining a hollow interior (<NUM>) configured to receive the tapered sealing wall (<NUM>) of the male connector (<NUM>) so as to form a seal with an outer surface of the tapered sealing wall (<NUM>); and characterized in that it further comprises
an inner sealing surface (<NUM>) configured within the hollow interior (<NUM>) wherein, when the tapered sealing wall (<NUM>) of the male connector of the medical fitting is received within the hollow interior (<NUM>) of the cylindrical wall (<NUM>), the inner sealing (<NUM>) surface seals the fluid passageway (<NUM>) of the internal tapered sealing wall (<NUM>);
wherein the inner sealing surface (<NUM>) comprises a dome-shaped protrusion (<NUM>) configured to fit at least partially within the fluid passageway (<NUM>) so as to seal the fluid passageway (<NUM>), wherein the dome-shaped protrusion (<NUM>) comprises a hollow cross-section (<NUM>), wherein the hollow cross-section (<NUM>) extends from the top surface (<NUM>) of the cap component (<NUM>) so as to define an open recess (<NUM>) on the top surface (<NUM>) of the cap component (<NUM>).