Closed Male Luer Connector Cap

Abstract

A cap for a closed male luer connector having a housing and a male luer, the closed male luer connector having a closed position in which a fluid path through the closed male luer connector is closed and an open position in which the fluid path through the closed male luer connector is open, the cap including a body having the first end and a second end disposed opposite the first end, the body defining an opening configured to receive a portion of the male luer of the closed male luer connector, the body configured to actuate the closed male luer connector from the closed position to the open position when the cap is fully inserted into the closed male luer connector, and the body configured to expand radially.

Description

[Technical Field]

[0001] This invention claims priority to U.S. Provisional Application No. 63 / 404,370, filed September 7, 2022, entitled "Cap for Closed Male Luer Connector," the entire disclosure of which is incorporated herein by reference in its entirety.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates generally to a cap for a closed male luer connector. [Background technology]

[0003] Healthcare providers who reconstitute, transport, and administer hazardous medications, such as cancer treatments, put themselves at risk for exposure to these medications and pose a risk to the healthcare environment. Unintentional chemotherapy exposure can affect the nervous system, impair the reproductive system, and increase the risk of developing blood cancers in the future. Some medications must be dissolved or diluted before they are administered, which involves transferring a solvent from one container to a sealed vial containing the drug in powder or liquid form via a needle. The drug can be inadvertently released into the atmosphere during needle withdrawal from the vial and while the needle is in the vial if a pressure differential exists between the interior of the vial and the surrounding atmosphere, either in gas form or by aerosolization. To reduce the risk of healthcare provider exposure to toxic drugs, the transfer of these medications is accomplished using a closed-system transfer device or system. A closed-system transfer device or system may include a syringe adapter, patient connector, IV bag spike, and vial adapter. Summary of the Invention

[0004] In one aspect or embodiment, a cap for a closed male luer connector having a housing and a male luer, the closed male luer connector having a closed position in which a fluid path through the closed male luer connector is closed and an open position in which the fluid path through the closed male luer connector is open, includes a body having a first end and a second end disposed opposite the first end, the body defining an opening configured to receive a portion of the male luer of the closed male luer connector. The body is configured to actuate the closed male luer connector from the closed position to the open position when the cap is fully inserted into the closed male luer connector. The body is configured to expand radially.

[0005] The second end of the body may be configured to engage with a valve member of the closed male luer connector to actuate the closed male luer connector from a closed position to an open position when the cap is fully inserted into the closed male luer connector. The cap may include an engagement member configured to engage with the male luer and a portion of the housing of the closed male luer connector when the cap is partially and fully inserted into the closed male luer connector. The engagement member may be a tab extending from the second end of the body. The engagement member may include first and second tabs extending from the body, the first tab being spaced apart from the second tab. The body may define a slit extending in a direction parallel to the longitudinal axis of the cap. The body may define a first slit and a second slit disposed opposite the first slit, the first slit and the second slit each extending in a direction parallel to the longitudinal axis of the cap. The body may define a recess on an inner surface thereof defining an opening. The body may include a plurality of external ribs extending in a direction parallel to the longitudinal axis of the cap.

[0006] In a further aspect or embodiment, a closed male luer connector includes a housing, a male luer, and a female luer, the closed male luer connector having a closed position in which a fluid path through the closed male luer connector is closed, an open position in which the fluid path through the closed male luer connector is open, and a cap according to any of the above aspects or embodiments. The cap has a first position in which the cap engages with the male luer, a portion of the male luer is received within an opening in the cap, and the closed male luer connector is in the closed position, and a second position in which the closed male luer connection is in the open position. The second position is spaced from the first position in a direction extending parallel to the longitudinal axis of the cap.

[0007] The closed male luer connector may include a valve member having an extension disposed radially outward from the male luer, and the second end of the cap engages with the extension when the cap is in the first and second positions. A portion of the valve member may be configured to extend through the seal when the closed male luer connector is moved from the closed position to the open position. When the cap is moved from the first position to the second position, the second end of the cap moves the valve member, causing a portion of the valve member to extend through the seal. The body of the cap engages with the male luer and can expand radially as the cap is moved from the first position to the second position. [Brief explanation of the drawings]

[0008] The above and other features and advantages of the present disclosure, and the manner in which they are achieved, will become more apparent, and the disclosure itself will be better understood, by reference to the following description of embodiments of the disclosure taken in conjunction with the accompanying drawings. [Figure 1] FIG. 1 is a schematic diagram of a conventional infusion set and closed male luer connector. [Figure 2] 2 is a top view of the closed male luer connector of FIG. 1. FIG. [Figure 3] 3 is a side view of the closed male luer connector of FIG. 1. FIG. [Figure 4]4 is a cross-sectional view of the closed male luer connector of FIG. 1 showing the closed position of the closed male luer connector. [Figure 5] 5 is a cross-sectional view of the closed male luer connector of FIG. 4 showing the closed male luer connector in an open position. [Figure 6] FIG. 6 is a perspective view of a cap for a closed male luer connector according to one aspect or embodiment of the present application. [Figure 7] 7 is a cross-sectional view of the cap of FIG. 6 showing the cap in a first position relative to the closed male luer connector. [Figure 8] 8 is a perspective view of the cap of FIG. 6 showing the cap in a second position relative to the closed male luer connector. [Figure 9] 9 is a side view of the cap of FIG. 6 showing the cap in a second position relative to the closed male luer connector. [Figure 10] 10 is a cross-sectional view of the cap of FIG. 6 showing the cap in a second position relative to the closed male luer connector.

[0009] Corresponding reference characters indicate corresponding parts throughout the several views. The illustrations presented herein illustrate exemplary embodiments of the present disclosure, and such illustrations should not be construed as limiting the scope of the present disclosure in any way. DETAILED DESCRIPTION OF THE INVENTION

[0010] The following description is provided to enable any person skilled in the art to make and use the described embodiments contemplated for practicing the invention. However, various modifications, equivalents, variations, and alternatives will be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the present invention.

[0011] Hereinafter, for purposes of explanation, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "transverse," "longitudinal," and derivatives thereof, refer to the present invention as oriented in the drawings. However, it will be understood that the present invention may assume various alternative modifications unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. As such, specific dimensions and other physical characteristics relating to aspects disclosed herein are not to be considered limiting.

[0012] 1, to prevent leakage or dripping of dangerous medication, an infusion line set 8 may include a closed male luer connector 10 that remains closed until engaged with a corresponding female luer connector. Such an infusion set 8 may include an intravenous bag spike adapter 12, a drip chamber 14, a line clamp 16, and a length of tubing 18.

[0013] 2-5, the closed male luer connector 10 includes a housing 20, a male luer 22, a female luer 24, and a valve member 26. The valve member 26 is movable or actuable from a closed position (FIG. 4) to an open position (FIG. 5). A portion of the valve member 26 extends through a seal 28 when the valve member 26 moves from the closed position to the open position, thereby opening a fluid path extending through the closed male luer connector 10. A portion of the valve member 26 is received within the male luer 22 such that movement of the valve member 26 from the closed position to the open position opens and closes a passageway extending through the closed male luer connector 10. The valve member 26 includes an extension 30 that engages with a corresponding female luer 32, as shown in FIG. 5, to move the valve member 26 to the open position when the corresponding female luer 32 is connected to the closed male luer connector 10. The extension 30 and the valve member 26 may be integrally formed. The closed male luer 10 may be a Texium™ closed male luer available from Becton, Dickinson and Company.

[0014] 1 and 5, the closed male luer connector 10 may include a cap 34 to maintain sterility and avoid contamination of the fluid pathway. However, to prime the infusion set, a separate priming cap 36 must be used, which activates the closed male luer connector 10 to move the male luer 22 from a closed position to an open position to open the fluid pathway, thereby allowing the infusion set 8 and closed male luer connector 10 to be primed.

[0015] 6-10 , in accordance with one aspect or embodiment of the present application, a cap 50 for use with a closed male luer connector 10 includes a body 52 having a first end 54 and a second end 56 disposed opposite the first end 54. As described in more detail below, the cap 50 is configured to maintain the sterility of the closed male luer connector 10 prior to use of the closed male luer connector 10 and also to allow the cap 50 to be utilized to prime the closed male luer connector 10 and any associated components of an infusion set.

[0016] 6-10 , the body 52 of the cap 50 defines an opening 60 configured to receive a portion of the male luer 22 of the closed male luer connector 10. The body 52 is configured to actuate the closed male luer connector 10 from a closed position to an open position when the cap 50 is fully inserted into the closed male luer connector 10. The body 52 is configured to expand radially, which will be described in additional detail below. In one aspect or embodiment, the cap 50 includes an engagement member 58 configured to engage with the male luer 22 and a portion of the housing 20 of the closed male luer connector 10. In one aspect or embodiment, the engagement member 58 includes first and second tabs 62, 64 extending from the body 52, the first tab 62 being spaced apart from the second tab 64. The first and second tabs 62, 64 extend from the second end 56 of the body 52, although other suitable arrangements may be utilized. Additionally, although two tabs are shown, the engaging member 58 may include one or more tabs 62, 64. In one aspect or embodiment, the engaging member 58 is configured to increase the contact area with the male luer 22 to ensure that the cap 50 is securely retained on the closed male luer connector 10 during shipping and storage, and is also configured to limit axial movement of the cap 50. The second end 56 of the body 52 of the cap 50 is configured to engage the extension 30 of the closed male luer connector 10 when the cap 50 is inserted into the closed male luer connector 10.

[0017] The body 52 of the cap 50 is configured to expand radially outward to define a first slit 66 and a second slit 68 disposed opposite the first slit 66, with the first and second slits 66, 68 each extending in a direction parallel to the longitudinal axis A of the cap 50. In other words, the slits 66, 68 allow movement of a portion of the body 52 such that a portion of the cap 50 can expand radially outward in a direction perpendicular to the longitudinal axis A of the cap 50. The first and second slits 66, 68 each extend from the second end 56 of the cap 50 to a position intermediate the first and second ends 54, 56, although other suitable arrangements may be utilized. While two slits are shown, the body 52 may include one or more slits 66, 68. In a further aspect or embodiment, instead of providing slits 66, 68, cap 50 includes a thin plastic membrane that permanently breaks when cap 50 is fully inserted into closed male luer connector 10. The membrane may include initiation points, such as cracks or weakened portions, at second end 56 to reduce initial resistance to radial expansion. As shown in FIG. 6 , body 52 defines a recess 70 on the inner surface of body 52 that defines opening 60. Recess 70 is V-shaped, although other suitable arrangements may be utilized. Recess 70 is positioned adjacent to slits 66, 68. Body 52 also includes a plurality of external ribs 72 extending in a direction parallel to longitudinal axis A of cap 50. The plurality of ribs 72 provide a gripping surface for a person to grasp and manipulate cap 50.

[0018] 7-10, the cap 50 has a first position (FIG. 7) in which the cap 50 engages with the male luer 22, a portion of the male luer 22 is received within the opening 60 of the cap 50, and the closed male luer connector 10 is in a closed position, and a second position (FIGS. 8-10) in which the closed male luer connector 10 is in an open position. The second position is spaced from the first position in a direction extending parallel to the longitudinal axis A of the cap 50. The second end 56 of the cap 50 engages with the extension 30 of the male luer 22 when the cap 50 is in the first and second positions. When the cap 50 is moved from the first position to the second position, the second end 56 of the cap 50 moves the extension 30 and the valve member 26, and a portion of the valve member 26 extends through the seal 28. The body 52 of the cap 50 expands radially due to the increasing diameter of the male luer 22 as the cap 50 moves from the first position to the second position.

[0019] Thus, prior to packaging the closed male luer connector 10, the closed male luer connector 10 and cap 50 may be sterilized by partially inserting the cap 50 into the housing 20 of the closed male luer connector 10 until the cap 50 is in a first position. When the cap 50 is in the first position, the cap 50 and the closed male luer connector 10 are packaged. When the closed male luer connector 10 is ready for use, the closed male luer connector 10 and cap 50 are removed from the package and connected to the infusion set 8. The cap 50 remains in the first position to maintain the sterility of the male luer 22 of the closed male luer connector 10 and other components of the infusion set 8. Prior to priming the infusion set 8 and closed male luer connector 10, the cap 50 is moved to a second position by further pushing or moving the cap 50 into the housing 20 of the closed male luer connector 10 in a direction extending parallel to the longitudinal axis A of the cap 50. The cap 50 may be pushed into the closed male luer connector 10 until the engaging member 58 or other portion of the cap 50 engages with the flange 74 extending inwardly from the housing 20 and / or until the male luer 22 reaches the end of the opening 60. When the cap 50 is moved to the second position, the cap 50 engages with the extension 30 of the valve member 26 of the closed male luer connector 10, moving the closed male luer connector 10 to the open position, thereby allowing the closed male luer connector 10 and infusion set 8 to be primed. After priming, the cap 50 can be removed by pulling the cap 50 in a direction opposite to the direction utilized to move the cap 50 to the second position, and the male luer 22 of the closed male luer connector 10 can be connected to a patient catheter or primary infusion set.

[0020] While the present disclosure has been described having exemplary structures, the present disclosure can be further modified within the spirit and scope of the present disclosure. Accordingly, this application is intended to cover any variations, uses, or adaptations of the present disclosure using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which the disclosure pertains and fall within the scope of the appended claims. To the extent possible, one or more features of any aspect or embodiment described above may be combined with one or more features of any other aspect or embodiment.

Claims

1. A cap for a closed male luer connector having a housing and a male luer, the closed male luer connector having a closed position in which a fluid path through the closed male luer connector is closed, and an open position in which the fluid path through the closed male luer connector is open, the cap comprising: a body having a first end and a second end disposed opposite the first end, the body defining an opening configured to receive a portion of the male luer of the closed male luer connector, the body configured to actuate the closed male luer connector from the closed position to the open position when the cap is fully inserted into the closed male luer connector, the body configured to expand radially; A cap.

2. 2. The cap of claim 1, wherein the second end of the body is configured to engage a valve member of the closed male luer connector to actuate the closed male luer connector from the closed position to the open position when the cap is fully inserted into the closed male luer connector.

3. 10. The cap of claim 1, further comprising an engagement member configured to engage with the male luer and a portion of the housing of the closed male luer connector when the cap is partially and fully inserted into the closed male luer connector.

4. The cap of claim 3 , wherein the engagement member comprises a tab extending from the second end of the body.

5. The cap of claim 3 , wherein the engagement member includes first and second tabs extending from the body, the first tab being spaced from the second tab.

6. The cap of claim 1 , wherein the body defines a slit extending in a direction parallel to a longitudinal axis of the cap.

7. 2. The cap of claim 1, wherein the body defines a first slit and a second slit disposed opposite the first slit, the first slit and the second slit each extending in a direction parallel to a longitudinal axis of the cap.

8. The cap of claim 6 , wherein the body defines a recess on an inner surface of the body that defines the opening.

9. The cap of claim 1 , wherein the body comprises a plurality of external ribs extending in a direction parallel to the longitudinal axis of the cap.

10. A closed male luer connector, Housing and Closed male lures and a female luer, the closed male luer connector having a closed position in which a fluid path through the closed male luer connector is closed, and an open position in which a fluid path through the closed male luer connector is open; a cap having a body having a first end and a second end disposed opposite the first end, the body defining an opening configured to receive a portion of the closed male luer connector, the body configured to actuate the closed male luer connector from the closed position to the open position when the cap is fully inserted into the closed male luer connector, the body configured to expand radially; Including, The cap has a first position in which the cap engages with the male luer, a portion of the male luer is contained within the opening of the cap, and the closed male luer connector is in the closed position, and a second position in which the closed male luer connector is in the open position, the second position being spaced from the first position in a direction extending parallel to the longitudinal axis of the cap.

11. 11. The closed male luer connector of claim 10, further comprising a valve member having an extension disposed radially outward from said male luer, said second end of said cap engaging said extension when said cap is in said first and second positions.

12. 12. The closed male luer connector of claim 11, wherein a portion of the valve member is configured to extend through a seal when the closed male luer connector is moved from the closed position to the open position.

13. 13. The closed male luer connector of claim 12, wherein moving the cap from the first position to the second position causes the second end of the cap to move the valve member and extend a portion of the valve member through the seal.

14. 11. The closed male luer connector of claim 10, wherein the body of the cap engages the male luer and expands radially as the cap moves from the first position to the second position.

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