Male Cap

Abstract

To provide transfusion devices and methods for preventing infection and microbial entry into medical device connections.SOLUTION: The transfusion device includes a male connector, and the male connector includes a male luer including an antimicrobial agent. In some implementations, the male luer includes a tapered sealing member that further includes a recess containing chlorhexidine acetate.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to infusion devices and methods for killing microorganisms and providing in situ antimicrobial properties to medical devices. [Background technology]

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS This application is filed with Pursuit Vascular, Inc. (a U.S. corporation) as applicant in all designated states, and Robert J. Ziebol (a U.S. citizen) and Matthew David Beilke as inventors in all designated states. Filed as a PCT international patent application on November 7, 2019 in the name of Robert Beilke, a U.S. citizen, and claims the benefit of U.S. Provisional Patent Application No. 62 / 756,967, filed November 7, 2018; U.S. Patent Application No. 16 / 404,378, filed May 6, 2019; U.S. Patent Application No. 16 / 444,486, filed June 18, 2019; U.S. Patent Application No. 16 / 447,671, filed June 20, 2019; U.S. Patent Application No. 16 / 449,180, filed June 21, 2019; U.S. Patent Application No. 16 / 553,704, filed August 28, 2019; and U.S. Patent Application No. 16,558,921, filed September 3, 2019, the contents of each of which are incorporated herein by reference in their entirety.

[0003] Infusion equipment, such as catheters and on-catheter devices, are commonly used in providing modern medical care to patients. For example, catheters such as hemodialysis catheters, peritoneal dialysis catheters, peripherally inserted central catheters, midline catheters, and drainage catheters are all commonly used in providing modern medical care to patients. Other infusion equipment used in providing medical care includes needleless connectors, intravenous (IV) administration sets, peritoneal dialysis lines, blood lines, syringes, valves, and filters.

[0004] These infusion devices are useful for treating a variety of medical conditions. For example, peritoneal catheters allow patients with kidney disease to drain and remove fluids from their bodies. Therefore, catheters and other infusion devices are often essential for enabling critical medical care and improving health care outcomes. Summary of the Invention [Problem to be solved by the invention]

[0005] However, long-term catheter use has significant drawbacks in that a significant percentage of catheters fail due to infection, resulting in increased mortality and significantly increasing medical costs associated with treatment. Furthermore, infection is a leading cause of death in the United States, and many of these infections are attributable to infusion devices. The mortality rate associated with such infections is substantial. Therefore, there is a need for ways to reduce infections associated with the use of infusion devices. [Means for solving the problem]

[0006] The present disclosure relates, in part, to an infusion device including a coupling portion, the coupling portion generally including both a male connector or cap and a female connector, the male connector or cap including an antimicrobial. In some implementations, the male connector or cap includes a male luer that inserts into a female luer. Male luers, such as those commonly used in medical devices, generally include a tapered surface. In some implementations, the male connector or cap includes a male luer with a tapered sealing surface having a truncated conical geometry. In some implementations, the male connector or cap includes a male luer with a tapered sealing surface having a non-conical geometry.

[0007] Infectious organisms are constantly present in the environment; they inhabit the skin of patients and survive and are transmitted in the air and water. Conventional medical device connectors and caps, such as male and female connectors with tapered luers, include threaded regions with tapered sealing areas, such as the overlapping sealing areas of the tapered portions of the male and female connectors. The overlapping sealing areas seal fluids within the medical device and keep air and organisms out. However, the inventors' testing has shown that organisms can still migrate through the threaded regions and partially penetrate their way into the sealing areas. This results in organisms residing along the walls of the tapered portions of the male and female luers in the narrow gap spaces of the sealing areas. When the male and female connectors are separated from each other, small amounts of organisms may remain on the walls of the male and female connectors, including on the tapered portions of the male and female luers of the male and female connectors that formed a seal before separation. When the connection is then made, some of the organisms on the wall of the female Luer may be forced past the sealing surface and into the fluid pathway (during insertion of the male Luer into the female Luer). Once organisms are in the fluid pathway, they can multiply and spread, causing infection.

[0008] The walls of the male and female luers are generally tapered or at least partially tapered and can also be contaminated by airborne organisms on surfaces or by contamination by touch. Inserting the male luer into the female luer can force organisms into the fluid pathway where they can also multiply and spread, causing infection.

[0009] Because catheters are generally tubular in construction, they may be characterized as "medical tubing." Similarly, other infusion devices may also be characterized as "medical tubing."

[0010] In some embodiments of the present subject matter described herein, the distal end of the male Luer, as well as the intermediate portion of the male Luer (the portion between the distal and proximal ends), contain an antimicrobial agent. The terms "proximal" and "distal" are used herein to refer to the relative positions of an article. With respect to a catheter, for example, the proximal end is the end closest to the person manipulating the catheter's female connector, while the distal end is closest to the patient. For example, the distal end of a hemodialysis catheter is within the patient's body, while the proximal end is outside the patient's body and has a female Luer at the female connector. Similarly, the proximal end of a male cap containing a male Luer is outside the female connector when mated to the female connector, while the distal end of the male cap is within the female connector when mated to the female connector. As discussed below, FIGS. 2 and 3A show arrows indicating distal and proximal directions (the intermediate point is between the distal and proximal directions). FIG. 3A also shows a male cap 30, indicating the proximal and distal ends of the cap. Therefore, "proximal" and "distal" are relative terms that indicate location relative to the patient and the ends of the device.

[0011] The present disclosure includes a method for delivering an antimicrobial composition into an infusion device, the method comprising inserting a male connector having a male tapered surface into a female connector of the infusion device, the female connector having a female tapered surface such that the male tapered surface engages with the female tapered surface to form a fluid-tight seal, the male connector having: i) a distal tip; ii) a recess proximal to the distal tip, the recess having a concave surface at a first taper angle relative to a central longitudinal axis of the male connector and radially inward of a line of taper extending distally along the male tapered surface; and iii) a water-soluble antimicrobial composition positioned in the concave surface; wherein inserting the male connector into the female connector forms a cavity between the concave surface and the female tapered surface, and fluid within the infusion device is at least partially contained in the cavity, such that at least a portion of the antimicrobial composition is dispersed in the fluid within the cavity.

[0012] The present disclosure relates to a method for delivering an antimicrobial composition into an infusion device, the method comprising inserting a male connector having a male tapered surface into a female connector of the infusion device, the female connector having a female tapered surface such that the male tapered surface engages with the female tapered surface to form a substantially fluid-tight seal, the male connector having: i) a distal tip; ii) a concave surface proximal to the distal tip, the concave surface being at a first taper angle relative to a central longitudinal axis of the male connector and radially inward of a line of taper extending along and distally of the male tapered surface; and iii) a water-soluble antimicrobial composition positioned on the concave surface; wherein inserting the male connector into the female connector forms a cavity between the concave surface and the female tapered surface, and fluid within the infusion device is at least partially contained in the cavity, such that at least a portion of the antimicrobial composition is dispersed into the fluid within the cavity.

[0013] In some embodiments, the male connector further comprises a tapered surface leading edge proximal to the distal tip of the male connector, the tapered surface leading edge being at the most distal end of the male tapered surface.

[0014] In some embodiments, the tapered surface leading edge is proximal to at least a portion of the recess in the male connector. In some embodiments, the tapered surface leading edge has an outer diameter, the distal tip has an outer diameter, and the outer diameter of the tapered surface leading edge is greater than the outer diameter of the distal tip.

[0015] In some embodiments, during insertion of the male connector into the female connector, the tapered surface leading edge of the male connector contacts the tapered surface of the female connector and the tapered surface edge of the male connector, and both rotate and move distally along the female tapered surface.

[0016] In some embodiments, the fluid flow channel extends through the male connector. In some embodiments, the antimicrobial composition comprises chlorhexidine. In some embodiments, a portion of the antimicrobial composition dissolves in the fluid to form a chlorhexidine precipitate on a portion of the female tapered surface.

[0017] In some embodiments, the chlorhexidine precipitate forms on a portion of the female tapered surface that defines a cavity between the concave surface and the female tapered surface. In some embodiments, the distal tip of the male connector has an outer diameter that is less than 95 percent of the inner diameter of the radially outer female tapered surface portion of the distal tip.

[0018] In some embodiments, the cavity defines an annular volume between the male connector and the female connector. In some embodiments, the volume of the annular volume is between 1 and 10 microliters.

[0019] In some embodiments, a plurality of blades extend radially outward from the male concave surface into the cavity to at least partially divide the cavity. In some embodiments, the first taper angle is equal to the second taper angle of the concave surface relative to the central longitudinal axis.

[0020] In some embodiments, a proximal trap is included. In some embodiments, the tapered surface leading edge defines a portion of the recess. In some embodiments, a portion of the aqueous antimicrobial composition is contained within the proximal trap.

[0021] Also disclosed is a method for delivering an antimicrobial composition into an infusion device, the method comprising inserting a male connector having a male tapered surface into a female connector of the infusion device, the female connector having a female tapered surface such that the male tapered surface engages with the female tapered surface to form a fluid-tight seal, the male connector having: i) a conical taper defined in part by the male tapered surface; ii) a distal tip having a diameter that is less than 95 percent of the diameter of the female tapered surface immediately adjacent the distal tip; and iii) a recess in the male connector proximal to the distal tip of the male connector. wherein the recess has a concave surface inside the conical taper, the proximal portion of the recess further defining a proximal trap; iv) a tapered surface leading edge proximal to the distal tip, the tapered surface leading edge having a diameter greater than a diameter of the distal tip; v) a fluid flow channel through the male connector; and vi) a water-soluble antimicrobial composition positioned in the concave surface; wherein upon insertion of the male connector into the female connector, an annular cavity is formed between the concave surface and the female tapered surface of the female connector, and fluid within the infusion device is at least partially contained in the annular cavity, such that at least a portion of the antimicrobial composition is dispersed into the fluid within the annular cavity.

[0022] Also disclosed is a method for delivering an antimicrobial composition into an infusion device, the method comprising inserting a male connector having a male tapered surface into a female connector of the infusion device, the female connector having a female tapered surface such that the male tapered surface engages with the female tapered surface to form a fluid-tight seal, the male connector having: i) a conical taper defined in part by the male tapered surface; ii) a distal tip having, at a radially outer point of the distal tip, an outer diameter that is less than 95 percent of the inner diameter of the female tapered surface; and iii) a concave surface proximal to the distal tip of the male connector. iv) a tapered surface distal edge proximal to the distal tip, the tapered surface distal edge having an outer diameter greater than the outer diameter of the distal tip; v) a fluid flow channel through the male connector; and vi) a water-soluble antimicrobial composition positioned in the concave surface; upon insertion of the male connector into the female connector, an annular cavity is formed between the concave surface and the female tapered surface of the female connector, and fluid within the infusion device is at least partially contained in the annular cavity, such that at least a portion of the antimicrobial composition is dispersed into the fluid within the annular cavity; and the proximal portion of the annular cavity is configured to collect microbes.

[0023] In some embodiments, the annular cavity defines an annular volume between the male connector and the female connector, and a portion of the antimicrobial composition dissolves in the fluid to form a chlorhexidine precipitate on a portion of the female tapered surface.

[0024] In some embodiments, a plurality of blades extend radially outward from the concave surface into the annular cavity, at least partially dividing the annular cavity. Also disclosed is a method for delivering an antimicrobial composition into an infusion device, the method comprising inserting a male connector having a male tapered surface into a female connector of the infusion device, the female connector having a female tapered surface such that the male tapered surface engages with the female tapered surface to form a fluid-tight seal, the male connector having: i) a conical taper defined in part by the male tapered surface; ii) a distal tip having a diameter that is less than 95 percent of the diameter of the female tapered surface immediately adjacent the distal tip; iii) a recess in the male connector proximal to the distal tip, the recess having a concave surface interior to the conical taper, and a proximal portion of the recess further defining the recess; and iv) a tapered surface distal edge proximal to the distal tip, the tapered surface distal edge having a radius that is greater than the radius of the distal tip. v) a fluid flow channel through the male connector; vi) a water-soluble antimicrobial composition positioned in the recess; c) insertion of the male connector into the female connector such that the male tapered surface forms a fluid-tight seal with the female tapered surface; upon insertion of the male connector into the female connector, an annular cavity is formed between the recessed surface and the interior surface of the female connector, the annular cavity having proximal and distal ends, a volume between the proximal and distal ends, a width measured radially, and a length measured axially; the tapered surface distal edge at least partially forms the proximal end of the cavity, and the distal end to the annular cavity has an open face whose radial width is less than 50 percent of the axial depth of the cavity; the length of the annular cavity is at least twice the width of the annular cavity; and fluid within the infusion device is at least partially contained within the cavity such that at least a portion of the antimicrobial composition is dispersed into the fluid within the cavity. In some embodiments, a proximal trap is included.

[0025] A further embodiment relates to a method for delivering an antimicrobial composition into an infusion device, the method comprising inserting a male connector having a male tapered surface into a female connector of the infusion device, the female connector having a female tapered surface such that the male tapered surface engages with the female tapered surface to form a fluid-tight seal, the male connector having: i) a conical taper defined in part by the male tapered surface; ii) a distal tip having an outer diameter at a point radially outward of the distal tip that is less than 95 percent of the inner diameter of the female tapered surface; iii) a concave surface proximal to the distal tip and inside the conical taper; and iv) a distal edge of the tapered surface proximal to the distal tip, the tapered surface having a radius greater than the radius of the distal tip. a tapered surface leading edge having a diameter; v) a fluid flow channel through the male connector; vi) a water-soluble antimicrobial composition positioned in the concave surface; upon insertion of the male connector into the female connector, an annular cavity is formed between the concave surface and the female tapered surface of the female connector, the annular cavity having proximal and distal ends, a volume between the proximal and distal ends, a width measured radially, and a length measured axially; the tapered surface leading edge at least partially defines the proximal end of the annular cavity, the distal end of the annular cavity being in fluid communication with the fluid lumen of the infusion device, and the width of the annular cavity is less than 50 percent of the length of the annular cavity; and fluid within the infusion device is at least partially contained within the annular cavity, such that at least a portion of the antimicrobial composition is dispersed within the fluid within the annular cavity.

[0026] In some embodiments, a plurality of blades extend radially outward from the concave surface into the annular cavity, at least partially dividing the annular cavity. In some embodiments, a portion of the antimicrobial composition dissolves in the fluid to form a chlorhexidine precipitate on a portion of the female tapered surface.

[0027] A method is described for delivering an antimicrobial composition into medical tubing having a female connector with a female tapered surface, the method comprising inserting a male connector into the female connector such that the male tapered surface of the male connector forms a fluid-tight seal with the female tapered surface, the male connector comprising: i) an end face; ii) a radially outwardly facing concave surface proximal to the end face and radially inward of the male tapered surface; iii) a fluid flow channel; and iv) a water-soluble antimicrobial composition on the concave surface, wherein insertion of the male connector into the female connector defines a cavity by the concave surface and the female tapered surface; and insertion of the male connector into an infusion device at least partially deposits fluid into the cavity, dispersing at least a portion of the antimicrobial composition into the fluid within the cavity.

[0028] In some embodiments, the male connector further comprises a tapered surface leading edge proximal to the distal tip of the male connector. In some embodiments, the tapered surface leading edge is proximal to the concave surface within the male connector. In some embodiments, a proximal trap is included.

[0029] In some embodiments, a plurality of blades extend radially outward from the concave surface into the cavity to at least partially divide the cavity. In some embodiments, a portion of the antimicrobial composition dissolves in the fluid to form a chlorhexidine precipitate on a portion of the female tapered surface.

[0030] The term "female connector" is used herein to refer to portions of an infusion device that include the female connector, and the female connector generally includes a void region, referred to herein as a "female luer." The void that forms the female luer generally has a tapered surface. The female connector also includes immediately surrounding elements, such as a threaded outer portion. The term "female connector" is also sometimes referred to herein interchangeably with "female connector," "adapter," "hub," and "fitting" in the medical field when describing elements that include a female luer. The terms "male connector" and "male cap" are used herein to refer to a connector that has a sealing extension called a male luer, and this male luer generally has a tapered surface (although in some implementations, only portions of the male luer are tapered). The male connector has a fluid flow path therethrough (along its axis), while the male cap is sealed and does not have a fluid flow path therethrough. Thus, a male connector is meant to allow fluid flow through the male connector, while a male cap is meant to form a fluid-tight seal and stop fluid flow within the catheter. In many implementations, the male connector and cap have similar or identical internal configurations other than a central conduit for fluid flow, and therefore, in this disclosure, the term "connector" may be used to refer to both connectors with fluid paths therethrough and caps without fluid flow paths therethrough. When describing particular embodiments, the terms "connector" or "cap" may be used to describe the particular embodiment, but this is generally not meant to be limiting.

[0031] The term "coupling" is used herein to describe a mated pair of devices, such as a female connector mated with a male connector. Alternatively, a female connector may be mated with a male cap, which is also referred to herein as a "coupling." In summary, a coupling herein is a female connector mated with either a male connector or a male cap. The female connector is likewise a part of an infusion device, and the female connector includes a cavity or volume known as a female Luer. This cavity or volume, known as the female Luer, generally has a tapered inner surface. The male connector and male cap each include a sealing extension, called a male Luer, that fits into the female Luer. The male Luer generally has a tapered outer surface. A seal is formed when the tapered surface of the male Luer of the male connector or cap contacts the tapered surface of the female Luer of the female connector. When these tapered surfaces contact each other, the female connector and male connector or cap mate to form a coupling. This connection may allow flow between the infusion device (such as when a female connector and a male connector mate) or may prevent flow (such as when a female connector and a male cap mate). In either case, it is highly desirable to create a seal between the female and male luers to prevent the entry of pathogens such as bacteria and fungi.

[0032] In some implementations described herein, the male luer of the male connector or cap delivers an antimicrobial to the female luer of the female connector. In one embodiment, the male luer has a recess near its tip, the recess containing the antimicrobial. In some implementations, the male luer includes a recess in an intermediate portion of its tapered outer surface (the portion between the proximal and distal ends of the tapered outer surface, but still in the tapered portion of the male luer), the recess containing the antimicrobial. In some implementations, the male luer includes a recessed tip portion (at the distal end of the male luer) and a recessed intermediate portion, both recesses containing the antimicrobial. In some implementations, the male luer includes a flat end surface at its distal end. In some implementations, the male luer includes an antimicrobial coating on the distal edge region. In some implementations, the male luer includes an antimicrobial coating on the outer region of the tip.

[0033] In some implementations, the antimicrobial agent includes chlorhexidine. In some implementations, the antimicrobial agent includes chlorhexidine base. In some implementations, the antimicrobial agent includes chlorhexidine acetate. In some implementations, the antimicrobial agent includes chlorhexidine gluconate. In some implementations, the antimicrobial agent is a dry coating.

[0034] In some implementations, the antimicrobial is water soluble at greater than 1 mg / mL. In some implementations, the antimicrobial is water soluble at greater than 10 mg / mL. In some implementations, a first antimicrobial is water soluble at less than 1 mg / mL and a second antimicrobial is soluble at greater than 10 mg / mL. In some implementations, the antimicrobial is impregnated into the luer surface. In some implementations, the antimicrobial is a broad-spectrum compound capable of killing gram-positive bacteria, gram-negative bacteria, and fungi. In some implementations, the antimicrobial is a non-antibiotic antimicrobial. In some implementations, the antimicrobial converts to chlorhexidine dihydrochloride in the presence of saline.

[0035] In some implementations, the antimicrobial agent includes silver. In some implementations, the antimicrobial agent includes silver sulfadiazine. In some implementations, the antimicrobial agent includes two or more compounds. In some implementations, the antimicrobial agent includes chlorhexidine and silver sulfadiazine. In some implementations, the antimicrobial agent includes the antibiotics minocycline and rifampin.

[0036] In some implementations, the antimicrobial agent is applied using a solvent-based coating method. In some implementations, the antimicrobial agent is applied using a spraying method. In some implementations, the antimicrobial agent is applied using a dipping method. In some implementations, the antimicrobial agent is dispersed in bulk material in an injection molding method. In some implementations, the antimicrobial agent is part of an antimicrobial solution that contains a solvent that swells the device material, thereby allowing the antimicrobial agent to penetrate the device material, where it remains after the solvent evaporates.

[0037] In some implementations described herein, the male luer of the male connector or cap delivers the antimicrobial composition to the female luer of the female connector. In one embodiment, the male luer has a distal tip near its distal end, and the distal tip surface comprises an antimicrobial composition. In some implementations, the male luer comprises a recess in an intermediate portion of its tapered outer sealing surface (the portion between the proximal and distal ends of the tapered outer surface, but still in the tapered portion of the male luer), and the recessed surface comprises an antimicrobial composition. In some implementations, the male luer comprises a recessed distal portion (at the distal end of the male luer) and a recessed intermediate portion, and both recessed surfaces comprise an antimicrobial composition. In some implementations, the male luer comprises a flat end surface at its distal end. In some implementations, the male luer comprises an antimicrobial coating in the end surface region. In some implementations, the male luer comprises an antimicrobial coating in the distal tip region.

[0038] Some examples of the disclosed technology provide a device for delivering an antimicrobial composition to an infusion device, and the device includes a male connector having a male tapered surface, the male connector having a distal tip having a distal end; the distal tip having a concave surface proximal to the distal end, the concave surface at a first taper angle relative to a central longitudinal axis of the male connector and radially inward of a line of taper extending along and distal to the male tapered surface; and a water-soluble antimicrobial composition positioned in the concave surface.

[0039] In some examples, the male connector further includes a tapered surface leading edge proximal to the distal tip of the male connector, and the tapered surface leading edge is at the most distal portion of the male tapered surface. In some examples, the tapered surface leading edge is proximal to at least a portion of a recess defined by the concave surface of the male connector. In some examples, the distal tip has a proximal edge abutting the tapered surface leading edge, and the tapered surface leading edge has an outer diameter, the proximal edge of the distal tip has an outer diameter, and the outer diameter of the tapered surface leading edge is larger than the outer diameter of the proximal edge of the distal tip. In some examples, the tapered surface leading edge defines a portion of the recess. In some examples, the device includes a fluid flow channel through the male connector. In some examples, the antimicrobial composition includes chlorhexidine.

[0040] In some examples, the device further includes a plurality of blades extending radially outward from the concave surface. In some examples, the plurality of blades have a plurality of blade surfaces. In some examples, the blade surfaces include at least a portion of the water-soluble antimicrobial composition. In some examples, the blades are arranged substantially parallel to the central longitudinal axis.

[0041] In some examples, the first taper angle is equal to the second taper angle of the concave surface relative to the central longitudinal axis. In some examples, the distal tip defines a recess, and the device further includes a proximal trap including a cavity at least partially opening into the recess. In some examples, at least a portion of the water-soluble antimicrobial composition is contained within the proximal trap.

[0042] Some aspects of the disclosed technology provide a device for delivering an antimicrobial composition to an infusion device, the device including a male connector having a male tapered surface configured to mate with a female connector of the infusion device, the female connector having a female tapered surface such that the male tapered surface mates with the female tapered surface to form a fluid-tight seal, the male connector further including a conical taper defined in part by the male tapered surface, a distal tip having a concave surface proximal to a distal end of the male connector, the concave surface residing within the conical taper, a distal edge of the tapered surface proximal to the distal tip, the distal end of the tapered surface having an outer diameter greater than an outer diameter of the distal tip, a fluid flow channel through the male connector, and a water-soluble antimicrobial composition positioned in the concave surface; wherein an annular cavity is formed between the concave surface and the female tapered surface of the female connector upon insertion of the male connector into the female connector.

[0043] In some examples, the device is configured such that the annular cavity defines an annular volume between the male connector and the female connector, and a portion of the antimicrobial composition is soluble in a fluid to form a chlorhexidine precipitate on a portion of the female tapered surface. In some examples, the device further includes a plurality of blades extending radially outward from the concave surface into the annular cavity and at least partially dividing the annular cavity.

[0044] A further example of the disclosed technology provides a device for delivering an antimicrobial composition to an infusion device, the device having a male connector with a male tapered surface configured for insertion into a female connector of the infusion device, the female connector having a female tapered surface such that the male tapered surface engages with the female tapered surface to form a fluid-tight seal; and the male connector having a conical taper defined in part by the male tapered surface; a distal tip having an outer diameter at a radially outer point of the distal tip that is less than 95 percent of the inner diameter of the female tapered surface; a concave surface proximal to the distal tip and inside the conical taper; a fluid flow channel through the male connector; and a water-soluble antimicrobial composition positioned in the concave surface. the annular cavity has a composition; when the male connector is inserted into the female connector, an annular cavity is formed between the concave surface and the female tapered surface of the female connector, the annular cavity having proximal and distal ends, a volume between the proximal and distal ends, a width measured radially, and a length measured axially; the male tapered surface has a distal edge that at least partially defines the proximal end of the annular cavity, the distal end of the annular cavity being in fluid communication with a fluid lumen of the infusion device, and the width of the annular cavity is less than 50 percent of the length of the annular cavity; and fluid within the infusion device is at least partially contained within the annular cavity, such that at least a portion of the antimicrobial composition is dispersed within the fluid within the annular cavity.

[0045] In some examples, the distal tip defines a recess, and the instrument further includes a proximal trap including a cavity at least partially open to the recess. In some examples, the instrument further includes a plurality of blades extending radially outward from the concave surface into the annular cavity and at least partially dividing the annular cavity.

[0046] While the embodiments are susceptible to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It is to be understood, however, that the scope of this specification is not limited to the particular embodiments described. On the contrary, it is intended to cover modifications, equivalents, and alternatives falling within the spirit and scope of the specification.

[0047] Some examples of the technology herein provide a needleless connector comprising a male connector having a male tapered surface, the male connector further comprising a distal tip having a distal portion; the distal tip having a concave surface proximal to the distal portion, the concave surface at a first taper angle relative to a central longitudinal axis of the male connector, the concave surface being radially inward of a line of taper extending along and distal to the male tapered surface; and a water-soluble antimicrobial composition positioned on the concave surface.

[0048] In some examples, the male connector further includes a tapered surface leading edge proximal to the distal tip of the male connector, the tapered surface leading edge being at the most distal portion of the male tapered surface. In some examples, the tapered surface leading edge is proximal to at least a portion of a recess defined by the concave surface of the male connector. In some examples, the distal tip has a proximal edge abutting the tapered surface leading edge; the tapered surface leading edge has an outer diameter, the proximal edge of the distal tip has an outer diameter, and the outer diameter of the tapered surface leading edge is greater than the outer diameter of the proximal edge of the distal tip. In some examples, the tapered surface leading edge defines a portion of the recess.

[0049] In further examples, the needleless connector also has a fluid flow channel through the male connector. In some examples, the antimicrobial composition comprises chlorhexidine. In some examples, a plurality of blades extend radially outward from the concave surface. In some examples, the plurality of blades have a plurality of blade surfaces. In some examples, the blade surfaces comprise at least a portion of the water-soluble antimicrobial composition. In some examples, the blades are arranged substantially parallel to the central longitudinal axis.

[0050] In further examples, the first taper angle is equal to the second taper angle of the concave surface relative to the central longitudinal axis. In some examples, the distal tip defines a recess, and the device further includes a proximal trap including a cavity at least partially open to the recess. In some examples, at least a portion of the water-soluble antimicrobial composition is contained within the proximal trap.

[0051] Some examples of the technology herein provide a needleless connector including a male connector having a male tapered surface configured to engage with a female connector, the female connector having a female tapered surface such that the male tapered surface engages with the female tapered surface to form a fluid-tight seal, the male connector further comprising: a conical taper defined in part by the male tapered surface; a distal tip having a concave surface proximal to a distal end of the male connector, the concave surface being inside the conical taper; a tapered surface distal edge proximal to the distal tip, the tapered surface distal edge having an outer diameter greater than an outer diameter of the distal tip; a fluid flow channel through the male connector; and a water-soluble antimicrobial composition positioned in the concave surface; wherein upon insertion of the male connector into the female connector, an annular cavity is formed between the concave surface and the female tapered surface of the female connector.

[0052] In some examples, the device is configured such that the annular cavity defines an annular volume between the male connector and the female connector, and a portion of the antimicrobial composition is soluble in a fluid to form a chlorhexidine precipitate on a portion of the female tapered surface. In some examples, a plurality of blades extend radially outward from the concave surface into the annular cavity and at least partially divide the annular cavity.

[0053] Some examples of the technology herein provide a needleless connector for delivering an antimicrobial composition to an infusion device, the needleless connector including a male connector having a male tapered surface configured for insertion into a female connector of the infusion device, the female connector having a female tapered surface such that the male tapered surface engages with the female tapered surface to form a fluid-tight seal, the male connector having a conical taper defined in part by the male tapered surface; a distal tip having an outer diameter at a radially outer point of the distal tip that is less than 95 percent of the inner diameter of the female tapered surface; a concave surface proximal to the distal tip and interior to the conical taper; the male connector a fluid flow channel through the male connector; a water-soluble antimicrobial composition positioned in the concave surface; upon insertion of the male connector into the female connector, an annular cavity is formed between the concave surface and the female tapered surface of the female connector, the annular cavity having proximal and distal ends, a volume between the proximal and distal ends, a width measured radially, and a length measured axially; the male tapered surface has a distal edge at least partially defining the proximal end of the annular cavity, the distal end of the annular cavity being in fluid communication with a fluid lumen of the infusion device, and the width of the annular cavity is less than 50 percent of the length of the annular cavity; and fluid within the infusion device is at least partially contained within the annular cavity, such that at least a portion of the antimicrobial composition is dispersed within the fluid within the annular cavity.

[0054] In some examples, the distal tip defines a recess and the device further includes a proximal trap including a cavity at least partially open to the recess. In some examples, a plurality of blades extend radially outward from the concave surface into the annular cavity and at least partially divide the annular cavity.

[0055] Some examples herein provide a method for delivering an antimicrobial composition from a medical tubing set to a medical device, the method comprising inserting a male connector of the medical tubing set into a female connector of an infusion device; the male connector having a male tapered surface and the female connector having a female tapered surface such that the male tapered surface engages with the female tapered surface to form a substantially fluid-tight seal, the male connector having a distal tip with a distal end surface; the distal tip having a concave surface proximal to the distal end surface, the concave surface at a first taper angle relative to a central longitudinal axis of the male connector and radially inward of a line of taper extending along and distally of the male tapered surface; and a water-soluble antimicrobial composition positioned on the concave surface; upon insertion of the male connector into the female connector, the concave surface and the female tapered surface form a cavity, wherein fluid is at least partially contained in the cavity and at least a portion of the antimicrobial composition is dispersed in the fluid within the cavity.

[0056] In some examples, the male connector further includes a tapered surface leading edge proximal to the distal end surface of the male connector. In some examples, the tapered surface leading edge is at the most distal end of the male tapered surface. In some examples, the tapered surface leading edge is proximal to at least a portion of the cavity formed between the female tapered surface and the concave surface. In some examples, the tapered surface leading edge has an inner diameter, the distal tip has an outer diameter, and the inner diameter of the tapered surface leading edge is larger than the outer diameter of the distal tip. In some examples, the male connector further includes a fluid flow channel through the male connector. In some examples, the antimicrobial composition includes chlorhexidine. In some examples, a portion of the antimicrobial composition dissolves in the fluid to form a chlorhexidine precipitate on a portion of the female tapered surface. In some examples, after a portion of the antimicrobial composition is dispersed in the fluid within the cavity, the dispersed antimicrobial composition maintains a concentration of at least 200 micrograms per milliliter within the cavity for a period of at least one hour. In some examples, the cavity defines a volume within a range of 1 microliter to 25 microliters. In some examples, a plurality of blades extend radially outward from the concave surface into the cavity to at least partially divide the cavity. In some examples, the first taper angle is equal to a second taper angle of the concave surface relative to the central longitudinal axis. In some examples, the male connector further includes a proximal trap including an annular cavity at least partially open to the cavity formed between the female tapered surface and the concave surface.

[0057] Some further examples provide a method for delivering an antimicrobial composition from a medical tubing set to a medical device, the method comprising inserting a male connector of the medical tubing set having a male tapered surface into a female connector of the infusion device, the female connector having a female tapered surface such that the male tapered surface engages with the female tapered surface to form a fluid-tight seal, the male connector having a conical taper defined in part by the male tapered surface; a distal tip having a distal end surface and a concave surface proximal to the distal end surface and interior to the conical taper; a tapered surface distal edge of the male tapered surface proximal to the distal tip; a fluid flow channel through the male connector. a recessed surface having a water-soluble antimicrobial composition positioned therein; upon insertion of the male connector into the female connector, an annular cavity is formed between and at least partially defined by the recessed surface and the female tapered surface of the female connector, the annular cavity having a proximal end coincident with the distal edge of the tapered surface and a distal end coincident with the distal tip end face, a volume between the proximal and distal ends, a depth measured radially, and a length measured axially; the distal end of the annular cavity is in fluid communication with a fluid lumen of the infusion device, and the length of the annular cavity is at least twice the depth of the annular cavity; and a fluid is at least partially disposed in the annular cavity, such that at least a portion of the antimicrobial composition is dispersed in the fluid within the annular cavity.

[0058] Some further examples provide a medical tubing set configured to deliver an antimicrobial composition to a medical device, the medical tubing set including: a medical tubing; a male connector secured to the medical tubing, the male connector having a male tapered surface, the male connector further including a distal tip having a distal end surface; a radially outwardly facing concave surface proximal to the distal end surface, the concave surface at a first taper angle relative to a central longitudinal axis of the male connector and radially inward of a line of taper extending along and distally of the male tapered surface; and a water-soluble antimicrobial composition positioned in the concave surface.

[0059] Some examples of the disclosed technology provide a method for delivering an antimicrobial composition from a peritoneal dialysis transfer set to a medical device. The method includes inserting a male connector of a peritoneal dialysis transfer set into a female connector of a peritoneal dialysis catheter; the male connector has a male tapered surface, and the female connector has a female tapered surface such that the male tapered surface engages with the female tapered surface to form a substantially fluid-tight seal. A fluid flow channel is present through the male connector. The male connector has a distal tip with a distal end surface. The distal tip has a concave surface proximal to the distal end surface, and the concave surface is radially inward of a line of taper extending along and distal to the male tapered surface at a first taper angle relative to a central longitudinal axis of the male connector. A water-soluble antimicrobial composition is positioned in the concave surface, and upon insertion of the male connector into the female connector, the concave surface and the female tapered surface form a cavity. Fluid at least partially fills the cavity, and at least a portion of the antimicrobial composition is dispersed into the fluid within the cavity.

[0060] In some examples, the width of the concave surface is greater than 0.5 mm. In some examples, the male connector further includes a tapered surface leading edge proximal to the distal tip of the male connector. In some examples, the tapered surface leading edge is positioned at the most distal portion of the male tapered surface. In some examples, the tapered surface leading edge is proximal to at least a portion of the cavity formed between the female tapered surface and the concave surface. In some examples, the tapered surface leading edge has an inner diameter, the distal tip has an outer diameter, and the inner diameter of the tapered surface leading edge is greater than the outer diameter of the distal tip.

[0061] In some examples, the male connector is a tip portion of a peritoneal dialysis transfer set. In some examples, the antimicrobial composition includes chlorhexidine. In some examples, a portion of the antimicrobial composition dissolves in the fluid to form a chlorhexidine precipitate on a portion of the female tapered surface. In some examples, after the portion of the antimicrobial composition is dispersed into the fluid in the cavity, the dispersed antimicrobial composition maintains a concentration of at least 200 micrograms per milliliter within the cavity for a period of at least 1 minute. In some examples, the cavity defines a volume within a range of 1 microliter to 25 microliters.

[0062] In some examples, a plurality of blades extend radially outward from the concave surface into the cavity to at least partially divide the cavity. In some examples, the first taper angle is equal to a second taper angle of the concave surface relative to the central longitudinal axis. Some examples further include a proximal trap including an annular cavity at least partially open to the cavity formed between the female tapered surface and the concave surface.

[0063] A further example of the disclosed technology provides a method for delivering an antimicrobial composition from a peritoneal dialysis transfer set to a medical device. The method includes inserting a male connector of a peritoneal dialysis transfer set having a male tapered surface into a female connector of a peritoneal dialysis catheter, the female connector having a female tapered surface such that the male tapered surface engages with the female tapered surface to form a fluid-tight seal. The male connector has a conical taper defined in part by the male tapered surface; a distal tip having a distal end surface and a concave surface proximal to the distal end surface and interior to the conical taper; a tapered surface distal edge of the male tapered surface proximal to the distal tip; a fluid flow channel through the male connector; and a water-soluble antimicrobial composition positioned in the concave surface. Inserting the male connector into the female connector forms an annular cavity between the concave surface and the female tapered surface of the female connector. The annular cavity has a proximal end coincident with the tapered surface distal edge, a distal end coincident with the distal end face, a volume between the proximal and distal ends, a depth measured radially, and a length measured axially. The distal end of the annular cavity is in fluid communication with the fluid lumen of the peritoneal dialysis catheter, and the length of the annular cavity is at least twice the depth of the annular cavity. A fluid is at least partially placed in the annular cavity, and at least a portion of the antimicrobial composition is dispersed in the fluid within the annular cavity.

[0064] A further example of the disclosed technology provides a peritoneal dialysis transfer set configured to deliver an antimicrobial composition to a medical device. The peritoneal dialysis transfer set includes medical tubing and a male connector secured to the medical tubing. The male connector has a male tapered surface and further includes a distal tip having a distal end surface; a radially outwardly facing concave surface proximal to the distal end surface, the concave surface being radially inward of a line of taper extending along and distal to the male tapered surface; a water-soluble antimicrobial composition positioned in the concave surface; and a fluid flow channel passing through the male connector.

[0065] Infection-causing organisms are constantly present in the environment; they can live on a patient's skin, survive in the air, and transmit infection in water. Conventional medical device connectors and caps, such as male and female connectors with tapered luers, include threaded regions with tapered sealing areas, such as the overlapping sealing areas of the tapered portions of the male and female connectors. The overlapping sealing areas seal fluids within the medical device and keep air and organisms out. However, the inventors' testing has shown that organisms can still migrate through the threaded regions and partially penetrate their way into the sealing areas. This results in organisms residing along the walls of the tapered portions of the male and female luers in the narrow gap spaces of the sealing areas. When the male and female connectors are separated from each other, small amounts of organisms can remain on the walls of the male and female connectors, including on the tapered portions of the male and female luers that previously formed a seal. When the syringe is then inserted into the female luer, some of the organisms on the wall of the female luer may be forced past the sealing surface and into the fluid pathway (during the insertion of the male luer of the syringe into the female luer). Once organisms are in the fluid pathway, they can multiply and spread, causing an infection.

[0066] The walls of the male and female luers are generally tapered or at least partially tapered and can also be contaminated by airborne organisms on surfaces or by contamination from touch. Inserting the male luer of the syringe into the female luer can force organisms into the fluid pathway where they can also multiply and spread, causing infection.

[0067] In some embodiments of the present subject matter described herein, the distal end of the male luer, as well as the intermediate portion of the male luer (the portion between the distal and proximal ends), contain an antimicrobial composition. The terms "proximal" and "distal" are used herein to refer to the relative locations of an article. With respect to a catheter, for example, the proximal end is the end closest to the person manipulating the catheter's female connector, while the distal end is closest to the patient. For example, the distal end of a hemodialysis catheter is within the patient's body, while the proximal end is outside the patient's body and has a female luer at the female connector. As discussed below, FIGS. 1C, 2D, and 3A show arrows indicating distal and proximal directions (the intermediate point is between the distal and proximal directions). FIG. 3A further illustrates the male cap 30, showing the proximal and distal ends of the cap. Therefore, "proximal" and "distal" are relative terms that indicate the location of a structure relative to the two ends of the device.

[0068] The present disclosure relates, in part, to syringes used to form connections with medical devices, the connections generally including both male and female connectors. In some embodiments, the male connector of the syringe forms a fluid-tight seal with a female connector that conforms to International Standard ISO 80369-7, Connectors for Intravascular or Hypodermic Applications.

[0069] In other applications, the male connector forms a fluid-tight seal with a female connector that does not comply with ISO 80369-7, such as the female end of a needleless connector; in this application, the syringe makes a fluid-tight seal with the silicone septum of the needleless connector. Organisms often reside on the septum and adjacent surfaces, and this seal occasionally leaks. Therefore, it is useful to have an antimicrobial composition along the syringe luer tip, creating an antimicrobial solution that kills organisms and creates a durable barrier to organisms within the female connector.

[0070] It should be understood that the various embodiments disclosed herein may also be applied to male connectors of other types of medical devices. Examples disclosed herein include needleless connectors and caps. While these examples are used to illustrate the broader application of the present invention, it should be further understood that specific aspects of these embodiments may also be applied to syringes.

[0071] The term "female connector" is used herein to refer to portions of medical devices having a female connector, and the female connector generally includes a frustoconical taper, referred to herein as a "female luer." The frustoconical taper forming the female luer generally has a tapered surface. Alternatively, the female connector may be composed of a different sealing means, such as the silicone septum of a needleless connector. The female connector also includes the immediately surrounding element, such as the threaded outer portion. The term "female connector" is also sometimes referred to interchangeably in the medical field as "female connector," "adapter," "hub," and "fitting" when describing an element having a female luer. The terms "male connector" and "male cap" are used herein to refer to a connector having a sealing extension referred to as a male luer, and the male luer generally has a tapered surface (although in some implementations, only portions of the male luer are tapered). The male connector has a fluid flow path (along its axis) passing through it, while the male cap is sealed and does not have a fluid flow path passing through it. Thus, the male connector is meant to allow fluid flow through the fluid flow path extending through the male connector, while the male cap is meant to prevent fluid from exiting the medical device having the female connector. In many implementations, the male connector and cap have similar or identical internal configurations other than a central conduit for fluid flow, and therefore, in this disclosure, the term "connector" may be used to refer to both connectors with a fluid path passing through them and caps without a fluid flow path passing through them. When describing particular embodiments, the terms "connector" or "cap" may be used to describe the particular embodiment, but this is generally not meant to be limiting.

[0072] The term "coupling" is used herein to describe a mated pair of devices, such as a female connector mated with a male connector. Alternatively, a female connector may be mated with a male cap, which is also referred to herein as a "coupling." In summary, a coupling herein is a female connector mated with either a male connector or a male cap. The female connector is likewise a part of an infusion device, and the female connector includes a cavity or volume known as a female luer. This cavity or volume, known as a female luer, generally has a tapered inner surface, although the female connector may also use other sealing means, such as the silicone septum of a needleless connector. The male connector and male cap each include a sealing extension, called a male luer, that fits into the female luer. The male luer generally has a tapered outer sealing surface. A seal is formed when the tapered surface of the male luer of the male connector or cap contacts the tapered surface of the female luer of the female connector. When these tapered surfaces contact one another, the female connector and male connector or cap mate to form a joint that can allow flow between the infusion device (such as when a female connector and a male connector mate) or prevent flow (such as when a female connector and a male cap mate). In either case, it is desirable to create a seal between the female and male luers to form a fluid-tight seal and prevent the entry of pathogens such as bacteria and fungi.

[0073] In some implementations described herein, the male luer of the male connector or cap delivers the antimicrobial composition to the female luer of the female connector. In one embodiment, the male luer has a distal tip near its distal end, and the distal tip surface comprises an antimicrobial composition. In some implementations, the male luer comprises a recess in an intermediate portion of its tapered outer sealing surface (the portion between the proximal and distal ends of the tapered outer surface, but still in the tapered portion of the male luer), and the recessed surface comprises an antimicrobial composition. In some implementations, the male luer comprises a recessed distal portion (at the distal end of the male luer) and a recessed intermediate portion, and both recessed surfaces comprise an antimicrobial composition. In some implementations, the male luer comprises a flat end surface at its distal end. In some implementations, the male luer comprises an antimicrobial coating in the end surface region. In some implementations, the male luer comprises an antimicrobial coating in the distal tip region.

[0074] Examples herein provide a syringe comprising: a fluid reservoir; and a male connector comprising a fluid flow channel in fluid communication with the fluid reservoir, the male connector comprising: a tapered sealing surface configured to mate with a female tapered surface of a female connector to form a substantially fluid-tight seal; a distal tip having a recess defined by a concave surface distal to the tapered sealing surface; and a male luer having a water-soluble antimicrobial composition disposed on the concave surface; the male luer configured such that when the male connector is mated with the female connector to form a substantially fluid-tight seal, a cavity is formed between the female tapered surface and the concave surface.

[0075] In some examples, the male luer further includes a tapered surface leading edge disposed between the tapered sealing surface and the concave surface. In some examples, the male luer is configured such that the tapered surface leading edge is proximal to at least a portion of a cavity formed between the female tapered surface and the concave surface. In some examples, the male luer is configured such that the cavity has a volume in the range of 1 microliter to 25 microliters.

[0076] In some examples, the distal tip further comprises a plurality of blades separated by a plurality of channels, the blades comprising elongated protrusions and the plurality of channels comprising elongated recesses disposed between the blades, hi some examples, the antimicrobial composition is stored between the blades.

[0077] In some examples, the antimicrobial composition includes chlorhexidine. In some examples, the antimicrobial composition is configured to dissolve in the fluid and form a chlorhexidine precipitate on a portion of the female tapered surface. In some examples, the male connector is configured to allow the antimicrobial composition to be dispersed or sprinkled into the cavity at a concentration of at least 200 micrograms per milliliter for a period of at least one minute.

[0078] Some examples further include a fluid-soluble time-release material coating the antimicrobial composition, hi some examples, the time-release material is configured to dissolve in the fluid and expose the antimicrobial composition to the fluid for a time interval between 1 second and 60 seconds.

[0079] Some examples further include an annular cavity in the male luer. In some examples, the annular cavity is proximal to the most distal end of the tapered sealing surface. A further example herein provides a syringe including a male connector having a male tapered surface configured to engage a female tapered surface of a female connector to form a fluid-tight seal, the male connector having: i) a conical taper defined by the male tapered surface; ii) a distal tip having a distal end surface and a concave surface proximal to the distal end surface, the concave surface being interior to the conical taper; iii) a male tapered surface having a distal edge tapered proximal to the distal tip; iv) a fluid flow channel through the male connector; and v) a water-soluble antimicrobial composition positioned in the concave surface; wherein upon insertion of the male connector into the female connector, an annular cavity is formed between, and is at least partially defined by, the concave surface and the female tapered surface of the female connector.

[0080] Further examples herein provide a syringe comprising: a barrel surrounding a fluid reservoir; a male connector secured to the barrel, the male connector having a male tapered surface, the male connector further comprising: i) a distal tip having a distal end surface; ii) a radially outwardly facing concave surface proximal to the distal end surface, the concave surface at a first taper angle relative to a central longitudinal axis of the male connector and radially inward of a line of taper extending along and distally of the male tapered surface; and iii) a water-soluble antimicrobial composition positioned in the concave surface; and iv) a fluid flow channel in fluid communication with the fluid reservoir.

[0081] In some examples, the male connector further includes a tapered surface leading edge proximal to the distal end face of the male connector, the tapered surface leading edge being at the most distal end of the male tapered surface. In some examples, the tapered surface leading edge is proximal to at least a portion of the concave surface.

[0082] In some examples, the distal tip further comprises a plurality of blades separated by a plurality of channels, the blades comprising elongated protrusions and the plurality of channels comprising elongated recesses disposed between the blades, hi some examples, the plurality of blades comprises a plurality of blade surfaces, and at least a portion of the antimicrobial composition is on the plurality of blade surfaces.

[0083] In some examples, the syringe further comprises a proximal trap comprising one or more cavities proximal to the distal end of the male tapered surface, the proximal trap containing an antimicrobial composition. In some examples, the syringe further comprises a proximal trap comprising at least one radially recessed cavity at the distal tip, the proximal trap containing an antimicrobial composition.

[0084] While the embodiments are susceptible to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It is to be understood, however, that the scope of this specification is not limited to the particular embodiments described. On the contrary, it is intended to cover modifications, equivalents, and alternatives falling within the spirit and scope of the specification.

[0085] The device may be more fully understood in connection with the following drawings. [Brief explanation of the drawings]

[0086] [Figure 1] 1 is a schematic diagram showing a peritoneal catheter extending into the peritoneal cavity of a patient undergoing peritoneal dialysis, into which dialysate is infused and then removed. [Figure 2] Figure 2A is a perspective view of the proximal end of a peritoneal catheter with a male cap attached to the female connector, Figure 2B is a perspective view of the proximal end of the peritoneal catheter of Figure 2A showing the female connector after the male cap has been removed, and Figure 2C is a perspective view of the proximal end of the peritoneal catheter of Figure 2B connected to a transfer set at the junction formed by the female and male connectors. [Figure 3-1] Figure 3A is a cross-sectional view of the proximal end of a peritoneal catheter with a male cap attached to a female connector, and Figure 3A' is an enlarged cross-sectional view of the proximal end of the peritoneal catheter of Figure 3A and a portion of the female connector and male cap. [Figure 3-2] Figure 3B is a cross-sectional view of the proximal end of a peritoneal catheter with a male cap attached to the female connector of Figure 3A after pathogens have entered along the pathway. Figure 3B' is an enlarged cross-sectional view of the proximal end of the peritoneal catheter, specifically the female connector of Figure 3B and a portion of the male cap. [Figure 3-3] Figure 3C is a cross-sectional view of the proximal end of the peritoneal catheter including the female connector of Figure 3B with the male cap removed. Figure 3C' is an enlarged cross-sectional view of a portion of the proximal end of the peritoneal catheter including the female connector of Figure 3C. [Figure 3-4] Figure 3D is a cross-sectional view of the proximal end of the peritoneal catheter, including the female connector, of Figure 3C after flushing. Figure 3D' is an enlarged cross-sectional view of a portion of the proximal end of the peritoneal catheter, including the female connector, of Figure 3D. [Figure 3-5] Figure 3E is a cross-sectional view of the proximal end of the peritoneal catheter of Figure 3D with a new male cap coupled to the female connector. Figure 3E' is an enlarged cross-sectional view of a portion of the proximal end of the peritoneal catheter of Figure 3E, including the male luer of the male cap. [Figure 3-6] Figure 3F is a cross-sectional view of the proximal end of the peritoneal catheter some time after the new male cap of Figure 3E has been installed. Figure 3F' is an enlarged cross-sectional view of a portion of the proximal end of the peritoneal catheter with the new male cap of Figure 3F installed, including the male luer of the male cap. [Figure 4-1] Figure 4A is a cross-sectional view of the proximal end of a peritoneal catheter with the male cap attached to a female connector, the male cap including a male luer configured for delivery of an antimicrobial agent. Figure 4A' is an enlarged cross-sectional view of a portion of the proximal end of the peritoneal catheter with the male cap of Figure 4A attached to the female connector. [Figure 4-2] Figure 4B is a cross-sectional view of the proximal end of a peritoneal catheter including a female connector with the male cap of Figure 4A attached after a pathogen has entered along the way. Figure 4B' is an enlarged cross-sectional view of a portion of the proximal end of a peritoneal catheter with the male cap of Figure 4B attached. [Figure 4-3] Figure 4C is a cross-sectional view of the proximal end of a peritoneal catheter including the female connector of Figure 4B with the male cap removed. Figure 4C' is an enlarged cross-sectional view of a portion of the proximal end of the peritoneal catheter of Figure 4C. [Figure 4-4] Figure 4D is a cross-sectional view of the proximal end of the peritoneal catheter of Figure 4C, including the female connector, after flushing. Figure 4D' is an enlarged cross-sectional view of a portion of the proximal end of the peritoneal catheter of Figure 4D. [Figure 4-5]Figure 4E is a cross-sectional view of the proximal end of the peritoneal catheter of Figure 4D including a female connector with a new male cap coupled to the female connector, the male cap including a male luer configured for delivery of an antimicrobial agent. Figure 4E' is an enlarged cross-sectional view of a portion of the proximal end of the peritoneal catheter of Figure 4E including the female connector. [Figure 4-6] Figure 4F is a cross-sectional view of the proximal end of the peritoneal catheter some time after the new male cap of Figure 4E has been attached. Figure 4F' is an enlarged cross-sectional view of a portion of the proximal end of the peritoneal catheter with the new male cap of Figure 4F attached. [Figure 5] FIG. 10 is an enlarged cross-sectional view of the coupling showing the female connector at the proximal end of the peritoneal catheter together with the male connector at the distal end of the transfer set. [Figure 6A] FIG. 1 is a perspective view of a hemodialysis catheter showing the hemodialysis catheter with two female connectors to which a male cap is joined. [Figure 6B] FIG. 6B is a perspective view of the hemodialysis catheter of FIG. 6A showing the hemodialysis catheter with two female connectors with the male cap removed. [Figure 7-1] Figure 7A is a cross-sectional view of a female connector to which an infusion set is connected, the infusion set including a male connector having a male luer with a distal recess configured for delivery of an antimicrobial agent. Figure 7A' is an enlarged cross-sectional view of a portion of a female connector to which an infusion set is coupled, the infusion set including a male connector having a male luer with a distal recess configured for delivery of an antimicrobial agent of Figure 7A. [Figure 7-2] Figure 7B is a cross-sectional view of the female connector after an infusion set has been connected thereto, the infusion set including the male Luer with a distal recess configured for delivery of an antimicrobial agent of Figure 7A. Figure 7B' is an enlarged cross-sectional view of a portion of the female connector and the male Luer with a distal recess configured for delivery of an antimicrobial agent of Figure 7B. [Figure 8-1]Figure 8 is a cross-sectional view of an infusion set including a male connector to which tubing is connected, the male connector including a male luer having a distal recess and an intermediate recess configured for delivery of an antimicrobial agent. Figure 8' is an enlarged cross-sectional view of the male luer of Figure 8 showing the intermediate recess configured for delivery of an antimicrobial agent. [Figure 9-1] Figure 9 is a cross-sectional view of a female connector to which an infusion device is connected, the infusion device including a male luer including a distal recess and a middle recess, both recesses containing and configured for delivery of an antimicrobial agent. Figure 9' is an enlarged cross-sectional view of the female connector and male luer of Figure 9, showing an enlarged view of the distal recess of the male luer. Figure 9" is an enlarged cross-sectional view of the female connector and male luer of Figure 9, showing an enlarged view of the proximal end of the female connector and the middle recess of the male luer. [Figure 10] FIG. 1 is a cross-sectional view of a female connector with a male cap attached, the male cap including a male luer including a tip recess containing an antimicrobial agent and configured for delivery of the antimicrobial agent. [Figure 11] A cross-sectional view of a female connector to which an infusion set is connected, the infusion set including a male connector having a male luer including a distal recess containing an antimicrobial agent and a middle recess containing an antimicrobial agent. [Figure 12] FIG. 1 is a cross-sectional view of a female connector to which an infusion set is connected, the infusion set having a male connector with a male luer including an intermediate recess containing an antimicrobial agent. [Figure 13-1] Figure 13 is a cross-sectional view of a female connector connected to an infusion set having a male connector with a male luer including a central recess containing an antimicrobial agent. Figure 13' is an enlarged cross-sectional view of the female connector and male luer of Figure 13. [Figure 14A] 1 is an isometric view of a needleless connector, according to some examples. [Figure 14B] FIG. 14B is a side view of the needleless connector of FIG. 14A. [Figure 14C] FIG. 14B is an end view of the needleless connector of FIG. 14A. [Figure 15A]1 is an isometric view of a male connector according to some examples. [Figure 15B] FIG. 15B is a side view of the male connector of FIG. 15A. [Figure 15C] 15B is a cross-sectional view of the male connector of FIG. 15A taken along line CC of FIG. 15B. [Figure 15D] 15B is a cross-sectional view of the male connector of FIG. 15A taken along line DD of FIG. 15B. [Figure 15E] FIG. 15B is an end view of the male connector of FIG. 15A. [Figure 15F] 15E is a cross-sectional view of the male connector of FIG. 15A taken along line FF of FIG. 15E. [Figure 16] 10A-10C are cross-sectional views of male connectors according to some examples. [Figure 17A] 1 is an isometric view of a male connector according to some examples. [Figure 17B] FIG. 17B is a side view of the male connector of FIG. 17A. [Figure 17C] 17B is a cross-sectional view of the male connector of FIG. 17A taken along line CC of FIG. 17B. [Figure 17D] FIG. 17B is an end view of the male connector of FIG. 17A. [Figure 17E] 17D is a cross-sectional view of the male connector of FIG. 17A taken along line EE of FIG. 17D. [Figure 17F] 17D is a cross-sectional view of the male connector of FIG. 17A taken along line FF of FIG. 17D. [Figure 18A] 1 is an isometric view of a male connector according to some examples. [Figure 18B] FIG. 18B is a side view of the male connector of FIG. 18A. [Figure 18C] 18B is a cross-sectional view of the male connector of FIG. 18A taken along line CC of FIG. 18B. [Figure 18D] FIG. 18B is an end view of the male connector of FIG. 18A. [Figure 18E] 18D is a cross-sectional view of the male connector of FIG. 18A taken along line EE of FIG. 18D. [Figure 18F]18D is a cross-sectional view of the male connector of FIG. 18A taken along line FF of FIG. 18D. [Figure 19A] 1 is an isometric view of a male connector according to some examples. [Figure 19B] FIG. 19B is a side view of the male connector of FIG. 19A. [Figure 19C] 19B is a cross-sectional view of the male connector of FIG. 19A taken along line CC of FIG. 19B. [Figure 19D] FIG. 19B is an end view of the male connector of FIG. 19A. [Figure 19E] 19D is a cross-sectional view of the male connector of FIG. 19A taken along line EE of FIG. 19D. [Figure 19F] 19D is a cross-sectional view of the male connector of FIG. 19A taken along line FF of FIG. 19D. [Figure 20A] 1 is an isometric view of a male connector according to some examples. [Figure 20B] FIG. 20B is a side view of the male connector of FIG. 20A. [Figure 20C] 20B is a cross-sectional view of the male connector of FIG. 20A taken along line CC of FIG. 20B. [Figure 20D] 20B is a cross-sectional view of the male connector of FIG. 20A taken along line DD of FIG. 20B. [Figure 20E] FIG. 20B is an end view of the male connector of FIG. 20A. [Figure 20F] 20E is a cross-sectional view of the male connector of FIG. 20A taken along line FF of FIG. 20E. [Figure 20G] 20E is a cross-sectional view of the male connector of FIG. 20A taken along line GG of FIG. 20E. [Figure 21A] 1 is an isometric view of a male connector according to some examples. [Figure 21B] FIG. 21B is a side view of the male connector of FIG. 21A. [Figure 21C] 21B is a cross-sectional view of the male connector of FIG. 21A taken along line CC of FIG. 21B. [Figure 21D] FIG. 21B is an end view of the male connector of FIG. 21A. [Figure 21E]21D is a cross-sectional view of the male connector of FIG. 21A taken along line EE of FIG. 21D. [Figure 21F] 21D is a cross-sectional view of the male connector of FIG. 21A taken along line FF of FIG. 21D. [Figure 22A] 1 is an isometric view of a male connector according to some examples. [Figure 22B] FIG. 22B is a side view of the male connector of FIG. 22A. [Figure 22C] 22B is a cross-sectional view of the male connector of FIG. 22A taken along line CC of FIG. 22B. [Figure 22D] FIG. 22B is an end view of the male connector of FIG. 22A. [Figure 22E] 22D is a cross-sectional view of the male connector of FIG. 22A taken along line EE of FIG. 22D. [Figure 22F] 22D is a cross-sectional view of the male connector of FIG. 22A taken along line FF of FIG. 22D. [Figure 23A] 1 is an isometric view of a male connector according to some examples. [Figure 23B] FIG. 23B is a side view of the male connector of FIG. 23A. [Figure 23C] 23B is a cross-sectional view of the male connector of FIG. 23A taken along line CC of FIG. 23B. [Figure 23D] FIG. 23B is an end view of the male connector of FIG. 23A. [Figure 23E] 23D is a cross-sectional view of the male connector of FIG. 23A taken along line EE of FIG. 23D. [Figure 23F] 23D is a cross-sectional view of the male connector of FIG. 23A taken along line FF of FIG. 23D. [Figure 23G] 23D is a cross-sectional view of the male connector of FIG. 23A taken along line GG of FIG. 23D. [Figure 24A] 1 is an isometric view of a male connector according to some examples. [Figure 24B] FIG. 24B is a side view of the male connector of FIG. 24A. [Figure 24C] 24B is a cross-sectional view of the male connector of FIG. 24A taken along line CC of FIG. 24B. [Figure 24D] 24B is a cross-sectional view of the male connector of FIG. 24A taken along line DD of FIG. 24B. [Figure 24E] 24B is a cross-sectional view of the male connector of FIG. 24A taken along line EE of FIG. 24B. [Figure 24F] FIG. 24B is an end view of the male connector of FIG. 24A. [Figure 24G] 24F is a cross-sectional view of the male connector of FIG. 24A taken along line GG of FIG. 24F. [Figure 24H] 24F is a cross-sectional view of the male connector of FIG. 24A taken along line HH of FIG. 24F. [Figure 25A] 1 is an isometric view of a male connector according to some examples. [Figure 25B] FIG. 25B is a side view of the male connector of FIG. 25A. [Figure 25C] 25B is a cross-sectional view of the male connector of FIG. 25A taken along line CC of FIG. 25B. [Figure 25D] 25B is a cross-sectional view of the male connector of FIG. 25A taken along line DD of FIG. 25B. [Figure 25E] FIG. 25B is an end view of the male connector of FIG. 25A. [Figure 25F] 25E is a cross-sectional view of the male connector of FIG. 25A taken along line FF of FIG. 25E. [Figure 25G] 25E is a cross-sectional view of the male connector of FIG. 25A taken along line GG of FIG. 25E. [Figure 26A] 1 is an isometric view of a male connector according to some examples. [Figure 26B] FIG. 26B is a side view of the male connector of FIG. 26A. [Figure 26C] 26B is a cross-sectional view of the male connector of FIG. 26A taken along line CC of FIG. 26B. [Figure 26D] 26B is a cross-sectional view of the male connector of FIG. 26A taken along line DD of FIG. 26B. [Figure 26E] FIG. 26B is an end view of the male connector of FIG. 26A. [Figure 26F]26E is a cross-sectional view of the male connector of FIG. 26A taken along line FF of FIG. 26E. [Figure 26G] 26E is a cross-sectional view of the male connector of FIG. 26A taken along line GG of FIG. 26E. [Figure 27A] 1 is an isometric view of a male connector according to some examples. [Figure 27B] FIG. 27B is a side view of the male connector of FIG. 27A. [Figure 27C] 27B is a cross-sectional view of the male connector of FIG. 27A taken along line CC of FIG. 27B. [Figure 27D] 27B is a cross-sectional view of the male connector of FIG. 27A taken along line DD of FIG. 27B. [Figure 27E] FIG. 27B is an end view of the male connector of FIG. 27A. [Figure 27F] 27E is a cross-sectional view of the male connector of FIG. 27A taken along line FF of FIG. 27E. [Figure 27G] 27E is a cross-sectional view of the male connector of FIG. 27A taken along line GG of FIG. 27E. [Figure 28A] 1 is an isometric view of a male connector according to some examples. [Figure 28B] FIG. 28B is a side view of the male connector of FIG. 28A. [Figure 28C] 28B is a cross-sectional view of the male connector of FIG. 28A taken along line CC of FIG. 28B. [Figure 28D] FIG. 28B is an end view of the male connector of FIG. 28A. [Figure 28E] 28D is a cross-sectional view of the male connector of FIG. 28A taken along line EE of FIG. 28D. [Figure 28F] 28D is a cross-sectional view of the male connector of FIG. 28A taken along line FF of FIG. 28D. [Figure 29A] 1 is an isometric view of a male connector according to some examples. [Figure 29B] FIG. 29B is a side view of the male connector of FIG. 29A. [Figure 29C] 29B is a cross-sectional view of the male connector of FIG. 29A taken along line CC of FIG. 29B. [Figure 29D] 29B is a cross-sectional view of the male connector of FIG. 29A taken along line DD of FIG. 29B. [Figure 29E] FIG. 29B is an end view of the male connector of FIG. 29A. [Figure 29F] 29E is a cross-sectional view of the male connector of FIG. 29A taken along line FF of FIG. 29E. [Figure 29G] 29E is a cross-sectional view of the male connector of FIG. 29A taken along line GG of FIG. 29E. [Figure 30A] 1 is an isometric view of a male connector according to some examples. [Figure 30B] FIG. 30B is a side view of the male connector of FIG. 30A. [Figure 30C] 30B is a cross-sectional view of the male connector of FIG. 30A taken along line CC of FIG. 30B. [Figure 30D] 30B is a cross-sectional view of the male connector of FIG. 30A taken along line DD of FIG. 30B. [Figure 30E] FIG. 30B is an end view of the male connector of FIG. 30A. [Figure 30F] 30E is a cross-sectional view of the male connector of FIG. 30A taken along line FF of FIG. 30E. [Figure 30G] 30E is an enlarged cross-sectional view of the male connector of FIG. 30A taken along line FF of FIG. 30E. [Figure 31A] 1 is an isometric view of a male connector according to some examples. [Figure 31B] FIG. 31B is a side view of the male connector of FIG. 31A. [Figure 31C] 31B is a cross-sectional view of the male connector of FIG. 31A taken along line CC of FIG. 31B. [Figure 31D] 31B is a cross-sectional view of the male connector of FIG. 31A taken along line DD of FIG. 31B. [Figure 31E] FIG. 31B is an end view of the male connector of FIG. 31A. [Figure 31F] 31B is a cross-sectional view of the male connector of FIG. 31A taken along line FF of FIG. 31E. [Figure 31G]31E is a cross-sectional view of the male connector of FIG. 31A taken along line GG of FIG. 31E. [Figure 32A] 1 is an isometric view of a male connector according to some examples. [Figure 32B] FIG. 32B is a side view of the male connector of FIG. 32A. [Figure 32C] 32B is a cross-sectional view of the male connector of FIG. 32A taken along line CC of FIG. 32B. [Figure 32D] 32B is a cross-sectional view of the male connector of FIG. 32A taken along line DD of FIG. 32B. [Figure 32E] FIG. 32B is an end view of the male connector of FIG. 32A. [Figure 32F] 32E is a cross-sectional view of the male connector of FIG. 32A taken along line FF of FIG. 32E. [Figure 32G] 32E is a cross-sectional view of the male connector of FIG. 32A taken along line GG of FIG. 32E. [Figure 33A] 1A-1C are isometric views of male luer caps according to some examples. [Figure 33B] FIG. 33B is a side view of the male luer cap of FIG. 33A. [Figure 33C] 33B is a cross-sectional view of the male luer cap of FIG. 33A taken along line CC of FIG. 33B. [Figure 33D] FIG. 33B is an end view of the male luer cap of FIG. 33A. [Figure 33E] FIG. 33D is a cross-sectional view of the male luer cap of FIG. 33A taken along line EE of FIG. 33D. [Figure 33F] FIG. 33D is a cross-sectional view of the male luer cap of FIG. 33A taken along line FF of FIG. 33D. [Figure 34A] 1 is an isometric view of a luer coupler, according to some examples. [Figure 34B] FIG. 34B is a side view of the luer coupler of FIG. 34A. [Figure 34C] FIG. 34B is an end view of the luer coupler of FIG. 34A. [Figure 34D] 34C is a cross-sectional view of the luer coupler of FIG. 34A taken along line DD of FIG. 34C. [Figure 34E] This is an enlarged view of the area within circle E in Figure 34D. [Figure 34F] FIG. 34B is an enlarged view of the circle F in FIG. 34D. [Figure 35A] 1 is an isometric view of a luer coupler, according to some examples. [Figure 35B] FIG. 35B is a side view of the luer coupler of FIG. 35A. [Figure 35C] FIG. 35B is an end view of the luer coupler of FIG. 35A. [Figure 35D] 35C is a cross-sectional view of the luer coupler of FIG. 35A taken along line DD of FIG. 35C. [Figure 35E] This is an enlarged view of the area within circle E in Figure 35D. [Figure 35F] FIG. 35B is an enlarged view of the circle F in FIG. 35D. [Figure 36] 34B is a cross-sectional view of the luer coupler of FIG. 34A installed between a female connector and a male connector, according to some examples. [Figure 37] 35B is a cross-sectional view of the luer coupler of FIG. 35A installed between a female connector and a male connector, according to some examples. [Figure 38] 1 is a fluid flow model showing recirculating flow within a male-female Luer connection under syringe loading conditions. [Figure 39] 1 is a fluid flow model showing recirculating flow within a male-female Luer connection under IV drip conditions. [Figure 40A] FIG. 1 is an isometric view of a male luer connector, according to some examples. [Figure 40B] FIG. 40B is a cross-sectional view of the male luer connector of FIG. 40A. [Figure 40C] FIG. 40C is an enlarged view of the area within circle C in FIG. 40B. [Figure 41A] FIG. 1 is an isometric view of a male luer connector, according to some examples. [Figure 41B] FIG. 41B is a cross-sectional view of the male luer connector of FIG. 41A. [Figure 41C] FIG. 41C is an enlarged view of the area within circle C in FIG. 41B. [Figure 42A]FIG. 1 is an isometric view of a male luer connector, according to some examples. [Figure 42B] FIG. 42B is a side view of the male luer connector of FIG. 42A. [Figure 42C] FIG. 42B is a cross-sectional view of the male luer connector of FIG. 42A. [Figure 42D] This is an enlarged view of the area within circle D in Figure 42C. [Figure 43A] FIG. 1 is an isometric view of a male luer connector, according to some examples. [Figure 43B] FIG. 43B is a side view of the male luer connector of FIG. 43A. [Figure 43C] FIG. 43B is a first cross-sectional view bisecting the valley of the blade of the male luer connector of FIG. 43A. [Figure 43D] This is an enlarged view of the area within circle D in Figure 43C. [Figure 43E] FIG. 43B is a second cross-sectional view bisecting the top of the blade of the male luer connector of FIG. 43A. [Figure 43F] FIG. 43B is an enlarged view of the circle F in FIG. 43E. [Figure 44A] FIG. 1 is an isometric view of a male luer connector, according to some examples. [Figure 44B] FIG. 44B is a cross-sectional view of the male luer connector of FIG. 44A. [Figure 44C] FIG. 44C is an enlarged view of the area within circle C in FIG. 44B. [Figure 45A] FIG. 1 is an isometric view of a male luer connector, according to some examples. [Figure 45B] FIG. 45B is a side view of the male luer connector of FIG. 45A. [Figure 45C] FIG. 45B is a cross-sectional view of the male luer connector of FIG. 45A. [Figure 45D] FIG. 45C is a cross-sectional view of the male luer connector of FIG. 45A within circle D of FIG. [Figure 46A] 1 is a perspective view of a needleless connector according to some examples. [Figure 46B] FIG. 46B is a longitudinal cross-sectional view of the needleless connector of FIG. 46A. [Figure 46C] FIG. 1C is an enlarged view of the area within circle C in FIG. 1B. [Figure 47A] FIG. 1 is a perspective view of a medical tubing set. [Figure 47B] FIG. 47B is a cross-sectional view of the medical tubing set of FIG. 47A. [Figure 47C] FIG. 47B is a perspective view of the medical tubing set of FIG. 47A. [Figure 48A] FIG. 1 is a perspective view of a peritoneal dialysis transfer set. [Figure 48B] FIG. 48B is a cross-sectional view of the male connector of the peritoneal dialysis transfer set of FIG. 48A. [Figure 48C] FIG. 48B is a cross-sectional view of the peritoneal dialysis transfer set of FIG. 48A. [Figure 48D] FIG. 48D is an enlarged cross-sectional view of the male connector of FIG. 48C. [Figure 49A] 1 is a perspective view of a syringe with antimicrobial properties, according to some examples. [Figure 49B] FIG. 49B is an enlarged view of the syringe of FIG. 49A. [Figure 49C] FIG. 49B is a cross-sectional view of the syringe of FIG. 49A. [Figure 49D] FIG. 49D is an enlarged cross-sectional view of the area within circle D in FIG. 49C. [Figure 49E] 1 is a perspective view of an alternative syringe with antimicrobial properties, according to some examples. [Figure 49F] FIG. 49F is a cross-sectional view of the syringe of FIG. 49E. [Figure 49G] This is an enlarged view of the area within circle G in Figure 49F. DETAILED DESCRIPTION OF THE INVENTION

[0087] It should be noted that in some cross-sectional views, simplifications, such as removal of background threads on a sealing cover, have been made to make various aspects of the invention more apparent. While the embodiments are susceptible to various modifications and alternative forms, details thereof have been shown in the drawings by way of example and will be described in detail. It should be understood, however, that the scope of the present specification is not limited to the particular embodiments described. On the contrary, it is intended to cover modifications, equivalents, and alternatives falling within the spirit and scope of the present specification. For example, the term "infusion device" in FIG. 9 was chosen to indicate that the illustration is not limited to a particular infusion device. The infusion device may be a syringe, needleless connector, transfer set, infusion set, or other infusion device having a male connector.

[0088] Numerous challenges exist for the safe use of medical devices incorporating male and female connectors. For example, medical devices such as catheters used in intravenous fluid administration, hemodialysis, peritoneal dialysis, parenteral nutrition, and chemotherapy are often worn for extended periods in a moist environment adjacent to a patient's skin. This provides an ideal environment for bacterial growth. Peripherally inserted central venous catheters and midline catheters typically undergo numerous connections between male and female luers during use, and each time the device is connected, it presents an opportunity for infection due to the introduction of organisms along the female luer. In contrast, the connection between the female connector of a peritoneal dialysis catheter and the male connector of a transfer set is typically disconnected and reconnected once every one to six months. While the time frame between connections varies depending on the application, any infusion device with a female connector is susceptible to the introduction of microorganisms onto the female connector surface, in part because the internal surface of the female connector is not easily accessible to disinfectant wipes. Traditional sterilization methods cannot reliably kill microorganisms once they have invaded the female connector surface. Therefore, these organisms remain free to invade until they reach the body and eventually cause peritonitis or bloodstream infections. Furthermore, drug-resistant organisms are becoming more prevalent in hospitals and outpatient medical facilities, making bloodstream infections more difficult to treat.

[0089] Several entry routes can cause contamination of the female Luer surface. One source of female Luer contamination occurs when the female Luer is open without a male Luer inserted. When the female Luer is open, airborne organisms (such as from a person's breath or other sources) can easily settle on the surface. Another source of female Luer contamination is along the threads and proximal end of the female hub, where organisms can enter the very small gap that exists between the proximal ends of the male and female Luer surfaces where the two surfaces meet.

[0090] Those skilled in the art understand that organisms can enter the proximal end of the hub, but it is not widely known that a gap exists between the male and female luers, and organisms can enter this gap where standard cleaning methods are ineffective. Therefore, the general view is that cleaning the end of the female connector is sufficient to stop this organism's entry route. The inventors have discovered that this is not sufficient; standard alcohol wipe / cleaning methods are not effective at killing organisms that enter the female luer. Once inside the female luer, organisms can be forced by the end face of the male luer into the lumen of the female luer device.

[0091] For example, the use of syringes in infusion devices is common. The syringe generally comes into contact with the infusion device for a relatively short period of time, but because the female luer must be left open when mating the female connector on the infusion device with the male connector on the syringe, contamination within the open female luer can occur, which can ultimately lead to infection, as discussed above.

[0092] In another example, a syringe connects to a female connector at the proximal end of a needleless connector. The female connector includes a septum designed to create a fluid-tight seal with the male connector. In this example, bacteria reside on the septum of the needleless connector and on surfaces adjacent to the septum. The seal between the male luer of the male connector and the septum often leaks, allowing fluid to be transferred between the intended fluid flow path and extraluminal regions (unintended fluid flow paths), and thus allowing the transfer of organisms between these regions via fluid or mechanical transfer.

[0093] The technology disclosed herein provides a distal recess at the distal tip of the male Luer member. The distal tip surface contains a concentrated antimicrobial composition trapped within a cavity between the distal tip surface of the male Luer and the tapered sealing surface of the female Luer. Organisms within the female Luer remain within the cavity proximal to the lumen of the male Luer. Various examples provided herein can create an environment that traps the antimicrobial agent near the distal end of the male Luer.

[0094] FIG. 1 is a schematic diagram of a patient undergoing peritoneal dialysis, showing a catheter 10 (peritoneal catheter) extending into the patient's peritoneal cavity 12 (surrounded by a peritoneal membrane 13), with dialysate from a source bag 15a flowing to the patient and into the peritoneal cavity, where it is subsequently drained to a drain bag 15b. Catheter 10 is in fluid communication with bags 15a and 15b by way of a transfer set 14 and an infusion set 16. Connectors 17 and 18 are positioned on either end of transfer set 14. Connector 17 connects transfer set 14 to catheter 10, while connector 18 connects transfer set 14 to infusion set 16. Typically, catheter 10 and transfer set 14 remain connected at connector 17 for extended periods (weeks and months), while transfer set 14 and infusion set 16 are connected at connector 18 only during the dialysate exchange process. This dialysate exchange process can occur, for example, for 30 minutes up to four times a day in continuous ambulatory peritoneal dialysis (CAPD) or once a day overnight in automated peritoneal dialysis (APD).

[0095] Throughout the CAPD exchange process, effluent dialysate flows from peritoneal cavity 12, through catheter 10, to junction 17 and transfer set 14, then through junction 18, and finally through the lower portion of infusion set 16 and into drain bag 15b. After completion of the exchange process, infusion set 16 is disconnected from transfer set 14 at junction 18, and the female connector of transfer set 14 is capped (not shown) until the next dialysate exchange is initiated. Thus, in typical peritoneal dialysis, the exchange process is initiated by removing a male cap from the female connector of transfer set 14 and then connecting it to infusion set 16 to form junction 18; this process is reversed at the end of the exchange process by removing infusion set 16 from junction 18 and installing a new male cap.

[0096] It is understood that Figure 1 is simplified for clarity. An automated machine or different tubing arrangements may be used to transfer dialysate from source bag 15a to peritoneal cavity 12 or from peritoneal cavity 12 to drain bag 15b. The movement of dialysate may be driven by gravity, a pump, or other mechanism.

[0097] Referring now to FIG. 2A, a perspective view of the proximal end of a peritoneal catheter 24 is shown with a male cap 30 attached to a female connector 40, while FIG. 2B is a perspective view of the proximal end of the peritoneal catheter 24 of FIG. 2A with the male cap removed, and FIG. 2C is a perspective view of the proximal end of the peritoneal catheter 24 of FIG. 2B connected to a transfer set 14. FIG. 2A specifically illustrates a perspective view of the proximal end of a peritoneal catheter 24 having a tube 22 with a female connector 40 to which a male cap 30 is attached. Generally, the female connector 40 includes a female luer therein (not shown), while the male cap 30 includes a male luer (not shown). The proximal end of the peritoneal catheter 24 (the portion furthest from the patient) is shown along with the female connector 40 and male cap 30. Also, the transfer set 14 in FIG. 2C is shown in reduced form for ease of illustration. Typically, transfer sets 14 are approximately 6 to 18 inches in length, but can be longer or shorter; therefore, end 27 of tubing 21 of transfer set 14 often includes a length extension before connection to a second connector (not shown), which is generally capped between dialysis treatments but is uncapped and connected to an infusion set during dialysis.

[0098] Figure 2B shows a perspective view of the proximal end of the peritoneal catheter 24 of Figure 2A with the male cap removed from the female connector 40, which includes a female luer 42. The female luer 42 is a volume within the interior region of the female connector 40 that receives and seals the male luer from the male cap or male connector. Figure 2C shows a perspective view of the proximal end of the peritoneal catheter 24 of Figures 2A and 2B connected to a transfer set 14 by a male connector 50 that includes a male luer (the male luer is part of the male connector 50 within the end of the female connector 40 of the peritoneal catheter 24 (not shown), but it is understood that within the female connector 40 is a tapered male luer that forms a seal with the female luer).

[0099] Referring now to Figures 3A-3F', various stages of attachment and detachment of a traditional cap and connector are shown, along with characteristics of microbial growth on the cap and connector. It should be noted that in some cross-sectional views, the illustrations have been simplified to make various aspects of the embodiments more clear. Figure 3A is a cross-sectional view of the proximal end of the peritoneal catheter 24 with the male cap 30 attached. Figure 3A' provides an enlarged cross-sectional view of the proximal end of the peritoneal catheter 24 with the male cap 30 attached, corresponding to the configuration of Figure 2B, for example, showing the female connector 40 with the male cap 30. Figure 3A shows arrows indicating the distal and proximal directions (the midpoint is between the distal and proximal directions). Figure 3A further shows the male cap 30, showing the proximal and distal ends of the male cap 30. Therefore, "proximal" and "distal" are relative terms, indicating positions relative to the ends of the patient and the device.

[0100] As shown in FIG. 3A , the male cap 30 includes a male luer 32 having a tapered outer surface 33, while the female connector 40 includes a female luer 42 with a tapered inner sealing surface 43 designed to seal against the tapered outer surface 33 of the male luer 32. The end face 34 of the male luer 32 (at the tip of the male cap 30) is exposed to the interior of a lumen 38 (open channel) through the female connector 40. In FIG. 3A , the male cap 30 is shown with threads 19 that engage with corresponding threads 23 of the female connector 40. The female connector 40 includes a female luer 42 that is a volume within the female connector 40. In this embodiment, the female luer 42 includes a tapered sealing surface 43. The female luer 42 of the female connector 40 and the male luer 32 of the male cap 30 form a fluid-tight connection at an overlap region 41. When the female connector 40 and male cap 30 are threaded together, they may still provide an access path to the clearance space or gap 35 (and subsequently to the lumen 38) as shown in Figures 3A and 3A', which show an access path over the threads 19, 23 and into the clearance space or gap 35 between the female connector 40 and the male cap 30, more specifically (but not exclusively) between the tapered inner sealing surface 43 of the female luer 42 of the female connector 40 and the tapered outer surface 33 of the male luer 32 of the male cap 30. This clearance space or gap 35 in the overlap region 41 between the tapered sealing surfaces 33, 43 of the male and female luers 32, 42 exists during installation and removal of the male cap 30, but the inventors' testing has shown that the gap 35 often exists even after the male cap 30 is coupled to the female connector 40. When the male cap 30 is inserted into the female connector 40, the male and female luers 32, 42 typically form a fluid-tight seal somewhere in the overlap region 41 between them. However, an interstitial space or gap 35 typically exists along at least a portion of the overlap region 41, allowing pathogens 28 to enter the gap 35 from the female connector end face 48 of the female connector 40.

[0101] Figures 3B and 3B' show the cross-sections of Figures 3A and 3A', but with pathogenic bacteria 28 penetrating beyond threads 19 and 23 (the threads do not form a seal) and colonizing multiple portions of the interface between female connector 40 and male cap 30 in gap 35. This penetration and proliferation of pathogenic bacteria 28 is shown diagrammatically (the size of the pathogenic bacteria may actually be much smaller and the distribution may be irregular).

[0102] FIG. 3C is a cross-sectional view of the peritoneal catheter 24 of FIGS. 3A and 3B with the male cap 30 removed to expose the female luer 42, into which the male luer 32 of a male cap or male connector can be inserted (not shown), and FIG. 3C' is an enlarged cross-sectional view of a portion of the proximal end of the peritoneal catheter of FIG. 3C, including the female connector end face 48 of the female connector 40. In FIGS. 3C and 3C', pathogenic bacteria 28 are present on the female connector end face 48 of the female connector 40, and many of the pathogenic bacteria 28 remain even after the male cap 30 is removed. Therefore, between dialysis treatments or other processes, the female connector 40 often has high levels of pathogenic bacteria, including on the exposed female connector end face 48 and threads 23, and on the tapered inner sealing surface 43 of the female luer 42 of the female connector 40. Therefore, FIGS. 3C and 3C' are essentially representations of the female connector 40 after the male cap has been removed.

[0103] Figure 3D is a cross-sectional view of the peritoneal catheter of Figure 3C with the male cap removed, and Figure 3D' is an enlarged cross-sectional view of a portion of the proximal end of the peritoneal catheter of Figure 3D. In Figures 3D and 3D', the female connector 40 has been cleaned, such as with an alcohol wipe, but the cleaning wipe does not fully reach the inside of the female luer 42 of the female connector 40 when using industry-standard cleaning methods, so that pathogens remain, particularly (in this embodiment) on the tapered inner sealing surface 43 of the female luer 42 of the female connector 40.

[0104] FIG. 3E is a cross-sectional view of the peritoneal catheter 24 of FIG. 3D with a new male cap 30′ attached, and FIG. 3E′ is an enlarged cross-sectional view of the peritoneal catheter of FIG. 3E. The new male cap 30′ is typically a new sterile cap and is not the same male cap 30 shown in FIGS. 3A and 3B because caps are typically not reused. FIGS. 3E and 3E′ show how pathogens 28 are pushed into the lumen 38 when the new male cap 30′ is attached. This occurs, in part, because the leading edge 36 of the end face 34 of the male Luer 32 of the new male cap 30′ can push pathogens into the lumen 38 during attachment of the male cap 30′. These pathogens, which are on the tapered sealing surface 43 of the female connector 40 in FIG. 3D, are in a more distal position in FIG. 3E than their position in FIG. 3D. The pathogens are pushed in by the leading edge 36 of the male Luer 32. Even when great care is taken to avoid scraping the walls of the tapered inner sealing surface 43 of the female luer 42, some pathogenic bacteria 28 may be forced into the lumen 38. Once a new male cap 30' is installed, the catheter or other infusion device is often left in place for hours, days, or weeks, during which time the pathogenic bacteria 28 may grow and spread further into the lumen 38, as shown in Figures 3F and 3F'. Figures 3F and 3F' show a cross-sectional view of the peritoneal catheter 24 some time after the new male cap 30' of Figures 3E and 3E' has been installed, during which the population of pathogenic bacteria 28 has grown and begun to colonize the walls of the lumen 38, where the pathogenic bacteria may eventually reach the patient, either by continuing to grow and / or by beginning to be released from the walls of the lumen 38 during fluid flow and thus being shed into the patient, thereby promoting patient infection and even death.

[0105] FIG. 4A is a cross-sectional view of a peritoneal catheter with a female connector 40, with the male cap 30 attached to the female connector 40, which has an antimicrobial agent 29 on the male luer 32 of the male cap 30. More specifically, the antimicrobial agent 29 is on the tapered sealing surface 33 of the male luer 32. The antimicrobial agent 29 extends to a gap 35 (similar to the gap 35 of FIGS. 3A-3F, but now with the antimicrobial agent 29 present). FIG. 4A' is an enlarged cross-sectional view of a portion of the proximal end of the peritoneal catheter of FIG. 4A.

[0106] Figure 4B is a subsequent (temporal) cross-sectional view of the peritoneal catheter of Figure 4A with the male cap 30 attached, and Figure 4B' is an enlarged cross-sectional view of a portion of the proximal end of the peritoneal catheter of Figure 4B. In Figures 4B and 4B', the pathogens 28 that come into contact with the antimicrobial agent 29 are represented as killed pathogens 28x. Therefore, the number of surviving pathogens 28 present is significantly reduced thanks to the antimicrobial agent 29. The pathogens 28 and the killed pathogens 28x are shown as schematic diagrams rather than representing actual live or killed pathogens to scale. Therefore, the killed pathogens 28x represent either the killed pathogens themselves or sites where pathogens have entered and died (and perhaps subsequently shed or otherwise moved). Therefore, Figures 4B and 4B' show how the presence of an antimicrobial agent on the entry path can reduce pathogens at the interface between the tapered sealing surfaces 33 and 43 of the male and female Luers 32, 42, thereby preventing the migration and proliferation of pathogens 28 into the entry path.

[0107] 4C and 4C′ show the end of female connector 40 of FIGS. 4A and 4A′ after the male cap has been removed, showing dead pathogens 28x on tapered inner sealing surface 43 of female luer 42 of female connector 40. While there may be some pathogens 28 on female connector end surface 48 of female connector 40, the pathogens on the tapered portion of female luer 42 are shown as dead (i.e., they may be pathogens killed by an antimicrobial agent and / or may be areas where pathogens are not growing).

[0108] Figures 4D and 4D' show the female connector of Figures 4C and 4C' after cleaning of the end of female connector 40. In contrast to the previous Figures 3D and 3D', both the end and interior of female connector 40 are free (or substantially free) of live pathogens. When a new male cap is subsequently inserted, with the new male cap containing an antimicrobial agent on the male luer of the male cap, dead pathogens 28x are forced into lumen 38, as shown in Figures 4E and 4E'; however, these dead pathogens 28x do not grow, as shown in Figures 4F and 4F' (which represent a subsequent period, such as 48-72 hours after the time shown in Figures 4E and 4E').

[0109] FIG. 5 is a cross-sectional view of the peritoneal catheter 24 with the distal end of the transfer set 14 connected. FIG. 5 generally corresponds to the dialysis stage of FIG. 2D, where the transfer set allows fluid to flow between the inflow and outflow of dialysate to the patient's peritoneal cavity. In FIG. 5, the female connector 40 of the peritoneal catheter 24 is mated to the male connector 50 of the transfer set 14. The transfer set 14 further includes tubing 57 (such as tubing for transporting dialysate) attached to the male connector 50. The male connector 50 includes a male luer 52 with a tapered outer surface 53 and threads 23. The tubing 57 includes an inner lumen 58. The male luer 52 of the male connector 50 includes a tapered outer surface 53 with an end face 54, which has a truncated conical surface. This design, similar to that shown in FIGS. 3A-3F, is also prone to the ingress and ingrowth of pathogens, causing infection in the patient. The same principles of antimicrobial use of Figures 4A-4F, in which the male lure 52 contains an antimicrobial, can be used to control the entry and growth of microorganisms and subsequent infection, specifically including (for example) an antimicrobial coating on the exterior of the male lure 52, such as on the tip or middle portion of the male lure 52, or both.

[0110] Figures 6A and 6B show an alternative infusion device, in this case a hemodialysis catheter 60 with female connectors 62, 64 and two tubes 61, 63 with an internal lumen (not shown) that extend to a main section 65 of the catheter 60. Figure 6A is a perspective view of the hemodialysis catheter, showing the two female connectors 62, 64 with caps 66, 68 attached. The hemodialysis catheter 60 is also shown with clamps 67, 69, shown in a closed orientation. The clamps 67, 69 are open during dialysis but then closed between dialysis sessions and during removal and insertion of the caps 66, 68. Figure 6B is a perspective view of the hemodialysis catheter 60, showing the hemodialysis catheter with the caps on the two female connectors 62, 64 removed. The female connectors 62, 64 and female luers 71, 73 are shown.

[0111] FIG. 7A is a cross-sectional view of an infusion set 16 connected to a female connector 40. The infusion set 16 includes a male connector 50 and tubing 57. The male connector 50 includes a male luer 52, which includes a distal recess 80 configured for delivery of an antimicrobial agent 29 (shown in FIG. 7A'). The distal recess 80 forms a cavity 81 once the male luer 52 is attached to the female luer 42 of the female connector 40. The female connector 40 includes a lumen 38 that fluidly connects with a lumen 58 of the tubing 57. The male luer 52 includes a tapered outer surface 53 with a partial conical surface, along with an end face 54. Near the end face 54 is the distal recess 80, which contains an antimicrobial agent 29, such as chlorhexidine (shown in FIG. 7A'). The antimicrobial agent 29 is generally a dry antimicrobial agent and provides an antimicrobial effect to the inner surface of the female connector 40, particularly the area near the distal recess 80 of the male luer 52 and the area around the point where the female connector 40 contacts the tapered inner sealing surface 43 of the female luer 42. When the male luer 52 is inserted into the female connector 40, the pathogenic bacteria 28 are pushed by the tapered surface distal edge 55 of the male luer 52 rather than the end face 54, so the pathogenic bacteria 28 are concentrated in a cavity 81 formed between the distal recess 80 and the female luer 42. When the male connector 50 is connected to the female connector 40, the antimicrobial agent 29 can be wetted by fluid from the lumens 58 and 38. However, because the cavity 81 has only a small opening (near the end face 54, at the distal end of the distal recess 80), the fluid is substantially retained within the cavity 81 (in some embodiments) even when fluid flows through the male connector 50 (including the male luer 52). This results in a high concentration of antimicrobial agent in the fluid within cavity 81 without substantially depleting antimicrobial agent 29 from male luer 52. The antimicrobial agent in the fluid within cavity 81 is therefore at a lethal concentration long enough to kill pathogens 28 present in the female connector prior to connecting the male connector to the female connector.

[0112] Figure 7B is a cross-sectional view of the male and female connectors of 7A after a period of time. Figure 7B' is an enlarged cross-sectional view of a portion of the male and female luers of Figure 7B. After contacting the antimicrobial agent 29 in the cavity 81 for a period of time, the pathogenic bacteria 28x are killed. The killed pathogenic bacteria 28x do not multiply and do not cause infection to the patient.

[0113] FIG. 8 is a cross-sectional view of an infusion set 16, including a male connector 50 and tubing 57. The male connector 50 includes a male luer 52 including a distal recess 80, a distal surface 54, and an intermediate recess 82 configured for antimicrobial delivery. FIG. 8' is an enlarged cross-sectional view of the intermediate recess 82 of the male luer 52. The male luer 52 includes a tapered outer surface 53 having a frustoconical surface. The distal recess 80 contains an antimicrobial 29, and the intermediate recess 82 is proximally disposed from the distal surface 54. The antimicrobial 29 is typically a dry antimicrobial. FIG. 8' shows the intermediate recess 82 along with recess edges 83 and 84. In some implementations, the edges 83, 84 are a smooth transition with the tapered outer surface 53 of the male luer 52; however, in other implementations, the edges 83, 84 are more pronounced and defined, as shown in FIG. 8'. In one embodiment, the lip 83 is removed and the intermediate recess 82 continues distally until it reaches the unmodified tapered sealing surface 53 of the male luer 52 (shown in FIG. 9 ″), for ease of injection molding. The infusion set 16 can be used to connect to a female connector (not shown), thus providing the same infection prevention benefits described elsewhere herein.

[0114] FIG. 9 is a cross-sectional view of a portion of an infusion device 20 connected to a female connector 40. The infusion device 20 includes a tube 57 joined to a male connector 50, which includes a male luer 52 having a tapered outer surface 53. The male luer 52 of the male connector 50 includes a middle recess 82 in the tapered outer surface 53 that contains an antimicrobial agent 29 and is configured for antimicrobial delivery (the middle recess refers to the concave portion located between the distal and proximal ends of the tapered outer surface 53). The male luer 52 also includes a distal recess 80 at its distal end that contains the antimicrobial agent 29. Once the male luer 52 is attached to the female luer 42 of the female connector 40, the distal recess 80 forms a cavity 81. FIG. 9′ is an enlarged cross-sectional view of the male luer 52 and female connector 40 of FIG. 9, showing an enlarged view of the distal recess 80, the male luer 52, and the female connector 40 that form the cavity 81. The female connector 40 includes a lumen 38 that fluidly connects to a lumen 58 in the tubing 57 of the infusion set 16. The male luer 52 includes a tapered outer surface 53 having a partial conical surface (a surface that substantially corresponds to the base of a cone) along with an end surface 54. Near the end surface 54 is a tip recess 80 that contains the antimicrobial agent 29.

[0115] FIG. 9″ is an enlarged cross-sectional view of the male luer 52, the proximal end of the female connector 40, and the intermediate recess 82 of the male luer 52. In FIG. 9″, the proximal edge 84 of the intermediate recess 82 is visible. This proximal edge 84 may be, for example, a distinct notch or a simple taper. Because the intermediate recess 82 extends both proximally and distally from the proximal-most end of the tapered inner sealing surface 43 of the female connector 40, it provides an area to retain a high concentration of the antimicrobial agent, which is held by surface tension while the antimicrobial agent is in a dissolved or partially dissolved state in the fluid. The antimicrobial agent reverts to a dry antimicrobial agent after the fluid dries, with at least a portion of the antimicrobial agent being retained in the intermediate recess.

[0116] The antimicrobial agent is generally a dry antimicrobial agent, and provides an antimicrobial effect to the interior of the female connector 40, particularly to the area near the distal recess 80 of the male luer 52, the intermediate recess 82, and the overlap region 41 (the overlap between the tapered inner sealing surface 43 and the tapered outer surface 53 of the female luer 42). When the male luer 52 of the male connector 50 is inserted into the female luer 42 of the female connector 40, the pathogenic bacteria 28 are pushed by the tapered surface distal edge 55 of the male luer 52, rather than the end surface 54, so the pathogenic bacteria 28 are concentrated in the cavity 81. The antimicrobial agent 29 can be wetted by the fluid in the lumens 38 and 58 when the fluid flows into the recesses while the male connector 50 is connected to the female connector 40. However, after connection, because the cavity 81 has only one opening (at the distal end of the distal tip), the fluid is substantially retained in the cavity 81 even when the fluid flows through the male connector 50. This results in a high concentration of antimicrobial agent in the fluid within cavity 81 without substantially depleting antimicrobial agent 29 from male connector 50. Therefore, the antimicrobial agent in the fluid is in a lethal concentration for a sufficient time to kill pathogenic bacteria 28.

[0117] Proximal edge 84 of intermediate recess 82 is located proximally from the proximal end of tapered inner sealing surface 43, but can optionally be located distal to the proximal end of tapered inner sealing surface 43 of female luer 42. Some advantages of intermediate recess 82 as shown in Figure 9 are that it provides a reservoir of antimicrobial agent 29 at the proximal end of female connector 40 (killing pathogens as they enter) and at the same time reduces stress on the proximal end of female connector 40, thus preventing stress cracking of the female connector.

[0118] In the exemplary embodiment, the antimicrobial agent is disposed within recesses 80, 82 along the entire tapered outer surface 53 of male connector 50 and along male connector threaded surface 39 of male connector 50 (including the proximal-most surface adjacent the proximal end of tapered outer surface 53). Fluid flow within lumen 38 is stopped by actuating a first clamp, valve, or other flow-stopping means (not shown) located distally from female connector 40, and fluid flow in lumen 58 is stopped by actuating a second clamp, valve, or other flow-stopping means (not shown) located proximally from male connector 50. Prior to connecting male connector 50 to female connector 40, the first and second clamps are actuated to prevent fluid from flowing within lumens 38, 58. After actuating the clamp, as male Luer 52 is inserted into female Luer 42, fluid within lumens 38, 58 is displaced, creating an outward fluid flow between tapered surfaces 43, 53 and into channel 59 located on the exterior of female connector 40 and the interior of male connector threaded surface 39. As the fluid flow contacts the antimicrobial agent, a portion of the antimicrobial agent is dissolved and incorporated into the fluid, creating an antimicrobial fluid. The antimicrobial fluid then flows into channel 59, where it contacts female connector end face 48 and female connector threaded surface 49, subsequently killing pathogens on female connector end face 48 and threaded surface 49 (similar to pathogens 28 shown in FIGS. 3B', 3C', and 4C', though not shown in FIG. 9). This is beneficial for killing pathogens that may remain after cleaning female connector end face 48 and threaded surface 49 with wipes, as described in the description of FIGS. 3D' and 4D'. Over time, the antimicrobial fluid dries, leaving a dry antimicrobial coating on the female connector end face 48 and threaded surface 49 on the female connector 40, thus forming an in-situ antimicrobial female connector. The antimicrobial may be, for example, chlorhexidine acetate, which dries and has sustained antimicrobial effectiveness. In comparison, alcohol antimicrobials, as found in many prior art devices, generally do not have sustained antimicrobial effectiveness after the alcohol antimicrobial dries.When saline contacts the chlorhexidine acetate, a portion of the chlorhexidine acetate is converted to chlorhexidine dihydrochloride, which adheres to the surface of the female connector, thereby providing the female connector with antimicrobial properties in situ.

[0119] In some embodiments, it may be desirable to apply a slowly dissolving (“time-release”) coating over the antimicrobial agent to delay or slow the time it takes for the antimicrobial agent to dissolve. A time-release coating, particularly when applied to the distal recess 80, is advantageous to ensure that the correct dose of antimicrobial agent is available within the cavity 81 once the connectors 40, 50 are mated. In another embodiment, it may be desirable to slow the dissolution rate of the antimicrobial agent using an antimicrobial mixture that includes the antimicrobial agent and a more slowly dissolving substance, such as a hydrophilic, water-soluble polymer. In yet another embodiment, it may be desirable to use chlorhexidine base (chlorhexidine acetate) with a chlorhexidine salt to achieve the intended dissolution rate, thereby providing a means and method for controlling the amount of antimicrobial agent removed from the recesses 80, 82 and tapered outer surface 53, transferring a portion of the antimicrobial agent to the female connector end face 48 and female connector threaded surface 49, where, upon drying, a portion of the antimicrobial agent remains on the female connector end face 48 and female connector threaded surface 49. The benefit of this is that it provides a long-lasting antimicrobial agent along the entry pathway (as shown in Figure 3A), preventing pathogen invasion and subsequent infection.

[0120] FIG. 10 is a cross-sectional view of a female connector 40 with an attached male cap 30, which includes a male luer 32 including a distal recess 80 containing an antimicrobial agent, the male cap 30 being configured for delivery of the antimicrobial agent. Once the male luer 32 is attached to the female luer 42 of the female connector 40, the distal recess 80 forms a cavity. The female connector 40 includes a lumen 38. The male luer 32 includes a tapered outer surface 33 having a frustoconical surface, an end surface 34, and near the end surface 34 is a distal recess 80 containing an antimicrobial agent, such as chlorhexidine. In one embodiment, the distal recess 80 is a frustoconical surface recessed 0.001" (0.0254 mm) to 0.015" (0.381 mm) below the protrusion of the tapered outer surface 33. The antimicrobial agent is generally a water-soluble dry antimicrobial agent and provides an antimicrobial effect to the overlap region 41 (the overlap between the tapered outer surface 33 of the male luer 32 of the male cap 30 and the tapered inner sealing surface 43 of the female luer 42 of the female connector 40), particularly in the area near the tip recess 80 of the male luer 32.

[0121] As the male Luer 32 is inserted into the female Luer 42 of the female connector 40, the pathogens are pushed by the tapered surface leading edge 55 of the male Luer 32 rather than the end face 34, so the pathogens are concentrated in the cavity. The antimicrobial agent in the cavity can be wetted by the fluid in the lumen 38 through which the male Luer 32 is displaced as it is inserted into the female Luer 42. In some embodiments, after the male Luer 32 is fully inserted into the female connector 40, the cavity has only one opening (at the tip of the recess), so the fluid is substantially trapped within the cavity. This results in a high concentration of the antimicrobial agent in the fluid within the cavity without substantial depletion of the antimicrobial agent. Therefore, the antimicrobial agent in the fluid remains at a lethal concentration long enough to kill the pathogens and prevent their ingrowth.

[0122] 11 is a cross-sectional view of a male connector 50 having a female connector 40 to which an infusion set 16 is connected, a male luer 52 including an intermediate recess 82 containing an antimicrobial agent 29 and configured for delivery of the antimicrobial agent. Near end face 54 is a cavity containing the antimicrobial agent 29, and intermediate recess 82 is recessed proximally from end face 54 and also contains the antimicrobial agent.

[0123] 12 is a cross-sectional view of a female connector 40 to which an infusion set 16 is connected. The tapered sealing surface 53 of the male luer 52 of the male connector 50 is bisected by an intermediate recess 82 containing an antimicrobial composition. The proximal and distal ends of the bisected tapered sealing surface 53 have the same conically tapered geometry to form a fluid-tight seal with the tapered sealing surface 43 of the female connector 40. The intermediate recess 82 of the male luer 52 contains an antimicrobial agent; the male luer 52 is configured for delivery of the antimicrobial agent. The female connector 40 includes a lumen 38 that fluidly connects with a tubing 57. The male luer 52 includes an end surface 54. The intermediate recess 82 is recessed proximally from the end surface 54.

[0124] FIG. 13 is a cross-sectional view of an infusion set 16 connected to a female connector 40. The male luer 52 of the male connector 50 of the infusion set 16 includes a medial recess 82 that bisects the tapered outer surface 53. The medial recess 82 contains and is configured for delivery of the antimicrobial agent 29. The tapered outer surface 53 also contains the antimicrobial agent 29. FIG. 13' is an enlarged cross-sectional view of the female connector 40 connected to the infusion set of FIG. 13, showing the female connector 40 and an enlarged view of the medial recess 82 of the male luer 52. The female connector 40 includes a lumen 38 that is in fluid communication with a lumen 58 of the tubing 57. The male luer 52 includes a tapered outer surface 53 having a frustoconical surface along with an end surface 54. As shown in FIG. 13', the medial recess 82 is recessed proximally from the end surface 54 and contains the antimicrobial agent 29.

[0125] It is understood that this is an illustrative example only, and that alternative forms of peritoneal dialysis are possible. It is also understood that peritoneal dialysis is only one example of the uses of the infusion connectors and systems disclosed herein, and that alternative uses and systems include hemodialysis catheters, peripherally inserted central catheters, midline catheters, drainage catheters, needleless connectors, intravenous (IV) administration sets, peritoneal dialysis lines, transfer sets, syringes, valves, and filters.

[0126] Examples of antibiotics The inventors have determined that it is desirable to use only small amounts of antibiotics for safety, as this reduces the risk to the patient if the antibiotic leaks into the body. What is considered a "low dose" varies from patient to patient. For example, a dose of 500 μg (micrograms) or more of chlorhexidine acetate may be considered safe for injection directly into the bloodstream of a 60-kilogram person, but doses significantly below this level are desirable for use in newborns.

[0127] Various embodiments herein have advantages over the prior art from a safety perspective because by delivering antimicrobial agents between Luer surfaces, only small amounts of antimicrobial agent are needed to kill pathogens. In various examples provided herein, when a male Luer is attached to a female Luer, an annular cavity is formed between the male Luer surface and the female Luer surface. The concentration of antimicrobial agent in the cavity between the male Luer surface and the female Luer surface is high (e.g., micrograms per milliliter), but the total dose (e.g., micrograms) is low because the gap between the Luer surfaces is very small (hence, the volume of the cavity is very small) and there is little to no fluid flow from this area, resulting in very low antimicrobial agent loss.

[0128] In some embodiments, the antibacterial agent can be chlorhexidine acetate. Chlorhexidine acetate at concentrations greater than 200 μg / mL (micrograms per milliliter) can rapidly kill most pathogens, including gram-positive and gram-negative bacteria and fungi. In many cases, this concentration kills pathogens in less than a minute.

[0129] In various embodiments, the male Luer has a concave surface (also referred to as the distal tip surface) containing approximately 25-250 μg of chlorhexidine acetate. For example, in embodiments, the concave has a radial depth of approximately 0.127 millimeters (0.005 inches) and an axial length of approximately 0.508 mm-1.016 mm (0.020 inches-0.040 inches). The annular cavity formed between the male Luer surface and the female Luer surface can have a volume of approximately 1 μL (microliter) or 0.001 mL. When 10 μg of chlorhexidine acetate is in a 1 μL volume, the concentration of the antimicrobial agent is 10,000 μg / mL, which is 50 times higher than the minimum desired level of 200 μg / mL to kill pathogens. This demonstrates how the present invention can produce very high pathogen killing efficacy while providing excellent patient safety; the 50 μg of chlorhexidine acetate distributed across the surface of the male lure is one-tenth the maximum total dose of 500 μg desired for patient safety.

[0130] In some embodiments, the volume of the annular cavity is between about 1 and 10 microliters. In some embodiments, the volume of the annular cavity may be between 1 microliter and 25 microliters, or between 5 microliters and 20 microliters, or between 10 microliters and 15 microliters, or may be about 10 microliters. In some embodiments, the volume of the annular cavity may be 1 microliter, 2 microliters, 3 microliters, 4 microliters, 5 microliters, 6 microliters, 7 microliters, 8 microliters, 9 microliters, or 10 microliters or more. In some embodiments, the volume of the annular cavity may be 25 microliters, 24 microliters, 22 microliters, 20 microliters, 19 microliters, 18 microliters, 16 microliters, 14 microliters, 13 microliters, 12 microliters, or 10 microliters or less.

[0131] Additionally, several different examples of antimicrobial agents can be used with the various embodiments described herein. The antimicrobial composition should kill and / or bring about stasis of Gram-positive and Gram-negative bacteria and fungi. The antimicrobial agent may also have the ability to kill organisms within an established biofilm and / or degrade the extracellular matrix of the biofilm. However, this is not necessary to be beneficial to the present invention, as the present invention is designed to kill organisms before they have a chance to form a biofilm. The antimicrobial composition can be chlorhexidine acetate, also known as chlorhexidine diacetate.

[0132] Other chlorhexidine-containing compounds may also be used, such as chlorhexidine free base, chlorhexidine gluconate, and chlorhexidine with dyes. Chlorhexidine acetate is superior to chlorhexidine gluconate because the risks associated with parachloroaniline can be minimized.

[0133] Other suitable antimicrobial compositions can also be used. Generally, the antimicrobial agent is water-soluble, has a history of clinical use with a demonstrated safety profile, does not contain antibiotics, can be provided on the medical device, and can subsequently be dissolved into a composition having an effective concentration for inhibiting the growth of bacterial and fungal organisms. Suitable materials include chlorhexidine, chlorhexidine salts (such as chlorhexidine acetate or chlorhexidine gluconate), tetrasodium ethylenediaminetetraacetic acid (tetrasodium EDTA), sodium citrate (yielding concentrations of 30% or greater), iodine, taurolidine, disodium EDTA, silver compounds (including silver nanoparticles and silver ions), silver sulfadiazine, and triclosan. In some instances, a portion of the antimicrobial composition is soluble, forming a chlorhexidine precipitate.

[0134] Although one drug or antimicrobial composition may combat a wide range of troublesome organisms that may lead to catheter-related bloodstream infections, two or more antimicrobial agents may be used to enhance efficacy against a variety of infectious organisms (bacteria and fungi).

[0135] In particular, catheter-associated infections arise from three broad classes of organisms: fungi, gram-negative bacteria, and gram-positive bacteria. While an antimicrobial composition can be proven to reduce one or two of these types of organisms, this is certainly beneficial, leaving the patient vulnerable to one or more of the remaining types. Combining multiple antimicrobial agents with different mechanisms of action can prevent infections caused by an expanded spectrum of organisms. This synergistic effect is likely to further reduce catheter-associated morbidity and mortality, lessening the impact of implanted catheters on patients' quality of life. Exemplary combinations of antimicrobial compositions are chlorhexidine acetate and EDTA, silver sulfadiazine and chlorhexidine acetate, and silver sulfadiazine and methylene blue.

[0136] In principle, antibiotics (such as rifampin or minocycline) are incorporated into Osluer or similar devices, and these are as effective as non-antibiotic antimicrobials. However, continuous exposure to one antibiotic can result in antibiotic-resistant strains, such as methicillin-resistant Staphylococcus aureus (MRSA). Therefore, exemplary embodiments use antibacterial compositions selected from a subset of non-antibiotics. If antibiotics are used for any reason, the risk of developing antibiotic-resistant strains of bacteria can be mitigated by preparing a second, complementary device containing a different antibiotic. By alternating the two devices in successive uses, infectious organisms resistant to one antibiotic can be killed by the other antibiotic.

[0137] In some implementations, the antimicrobial agent includes chlorhexidine, chlorhexidine base, chlorhexidine acetate, and / or chlorhexidine gluconate. In some implementations, the antimicrobial agent is a dry coating.

[0138] In some implementations, the antimicrobial is water soluble at greater than 1 mg / mL. In some implementations, the antimicrobial is water soluble at greater than 10 mg / mL. In some implementations, a first antimicrobial is water soluble at less than 1 mg / mL and a second antimicrobial is water soluble at greater than 10 mg / mL. In some implementations, the antimicrobial is impregnated into the luer surface. In some implementations, the antimicrobial is a broad-spectrum compound capable of killing gram-positive bacteria, gram-negative bacteria, and fungi. In some implementations, the antimicrobial is a non-antibiotic antimicrobial. In some implementations, the antimicrobial converts to chlorhexidine dihydrochloride in the presence of saline.

[0139] In some implementations, the antibacterial agent includes silver or silver sulfadiazine. In some implementations, the antibacterial agent includes two or more compounds. In some implementations, the antibacterial agent includes chlorhexidine and silver sulfadiazine. In some implementations, the antibacterial agent includes the antibiotics minocycline and rifampin.

[0140] In some implementations, the antimicrobial agent is applied via a solvent-based coating process. In some implementations, the antimicrobial agent is applied via a spraying process. In some implementations, the antimicrobial agent is applied via a dipping process. In some implementations, the antimicrobial agent is dispersed in bulk material via an injection molding process. In some implementations, the antimicrobial agent is part of an antimicrobial solution that contains a solvent that swells the device material, thereby allowing the antimicrobial agent to penetrate the device material, where it remains after the solvent evaporates.

[0141] Needleless connector (Figure 14A-C) 14A-C, one implementation of the technology of the present disclosure provides a needleless connector 1411 having a male connector 1401 at a distal end 1408, the male connector 1401 including a male luer 1441 and threads 1402. The male luer 1441 includes a tapered sealing member 1442 with a tapered sealing surface 1443. The needleless connector 1411 has a lumen 1412 extending therethrough, through which fluid can flow. A proximal end 1407 of the needleless connector 1411 includes threads 1405 for connecting the needleless connector 1411 to another medical device, such as a syringe. A distal end of the needleless connector 1411 includes threads 1402 for coupling the male luer 1441 to a medical device having a female luer, such as the proximal end of a catheter for hemodialysis, peritoneal dialysis, parenteral nutrition, or chemotherapy. Distal tip 1455 also includes a distal tip surface 1452 and an end face 1404. Tapered sealing member 1442 has a tapered surface leading edge 1461 adjacent and proximally to distal tip 1455. Tapered surface leading edge 1461 is located at the most distal end of tapered sealing surface 1443.

[0142] As described further below, the male luer 1441 includes a distal recess 1451, and the distal tip 1455 has a distal tip surface 1452. The distal tip surface 1452 may include an antimicrobial agent as described above. When the male luer 1441 is attached to a female luer (not shown), a cavity is created between the tapered sealing surface of the female luer and the distal tip surface 1452 of the male luer 1441. The distal tip 1455 is recessed within the line of taper of the tapered sealing surface 1443. As used herein, the line of taper represents an imaginary conical surface that defines a conical taper that extends beyond the tapered surface distal edge 1461 of the male luer 1441.

[0143] 14A-C, male luer 1441 further includes a plurality of blades 1463 at distal tip 1455. Between blades 1463 are a plurality of channels 1467. Blades 1463 and channels 1467 are further described below.

[0144] Several illustrative implementations will now be described with reference to Figures 15A-32G. It should be understood that each of the examples below can be combined with needleless connector proximal end 1407 to produce needleless connector 1411. Additionally, each of the male connectors described below is not limited to needleless connectors, but can be combined with other medical devices using luer couplings.

[0145] Male connector with a recessed tip (Figures 15A to 15F and 16) 15A-16, male connector 1501 includes a male luer 1541. Male luer 1541 includes a tapered sealing member 1542. Tapered sealing member 1542 has a frustoconical shape, tapering from a larger outer diameter at a proximal portion of tapered sealing member 1542 to a smaller outer diameter at a distal portion of tapered sealing member near tapered surface distal edge 1561. Tapered sealing member 1542 has a tapered sealing surface 1543 configured to mate with a female luer to create a fluid-tight fit. Male connector 1501 further includes threads 1502 that enable male connector 1501 to mate with a female connector. A lumen 1512 extends through male connector 1501.

[0146] Male luer 1541 includes a distal tip 1555 with an end surface 1504. Distal tip 1555 of male luer 1541 is recessed from the distal taper line of tapered sealing member 1542. FIG. 16 is a cross-sectional view of male connector 1501. FIG. 16 shows a distal taper line 1614 extending linearly from tapered sealing surface 1543. Tapered sealing member 1542's distal taper line 1614 represents an imaginary conical surface that defines a conical taper extending beyond tapered surface distal edge 1561 of male luer 1541. Tapered sealing surface 1543 has a taper angle. In some examples, the taper angle of the tapered sealing member is about 1.5 degrees to about 2 degrees relative to a central longitudinal axis 1610 of male luer 1541. In some examples, the taper angle is approximately 1.72 degrees relative to the central longitudinal axis 1610 of the male luer 1541 of the male connector 1501. The conical taper defined by the taper apex line 1614 symmetrically surrounds the central longitudinal axis 1610.

[0147] The tapered leading line 1614 defines the outer diameter of the extension of the tapered sealing surface 1543. The leading recess 1551 is a radially recessed portion of the leading tip 1555, i.e., the leading tip surface 1552 of the leading tip 1555 defines an outer diameter that is smaller than the outer diameter of the extension of the tapered sealing surface 1543. The leading recess 1551 defines a space between the leading line 1614 of the tapered and the leading tip surface 1552.

[0148] Figure 16 further shows antimicrobial composition 1621 coating distal tip surface 1552 of distal tip 1555. When male luer 1541 is mated with female luer, distal tip surface 1552 of distal tip 1555 does not contact the inner surface of the female luer, and a cavity is formed between distal tip surface 1552 and the female tapered surface, similar to that shown in Figure 7A. In this cavity, antimicrobial composition 1621 can distribute within the volume created between distal tip surface 1552 and the female tapered surface.

[0149] Male luer 1541 includes a tapered surface leading edge 1561 that defines the proximal end of distal tip 1555. Tapered surface leading edge 1561 is located at the most distal end of tapered sealing surface 1543 such that the proximal edge of distal tip 1555 abuts tapered surface leading edge 1561. Tapered surface leading edge 1561 has an outer diameter, the proximal edge of distal tip 1555 has an outer diameter, and the outer diameter of tapered surface leading edge 1561 is larger than the outer diameter of the proximal edge of distal tip 1555. Because tapered surface leading edge 1561 has a larger diameter than any outer diameter along distal tip 1555, when male luer 1541 is inserted into a female luer, tapered surface leading edge 1561 of tapered sealing member 1542 can capture pathogens that may have infiltrated the inner surface of the female luer. 7A, the antimicrobial composition 1621 kills pathogens in the cavity between the tapered sealing surface of the female luer and the distal tip surface 1552 of the male luer 1541. In some examples, the antimicrobial composition 1621 is provided to the distal tip surface 1552 by coating, spraying, or dipping the distal tip 1555, although other methods of providing the antimicrobial are contemplated and within the scope of the present technology. In some examples, the antimicrobial composition 1621 is also provided to the tapered sealing surface 1543. The antimicrobial composition 1621 may also be provided to the end surface 1504.

[0150] The distal recess 1551 (the space between the distal tip surface 1552 and the female luer surface, not shown) is designed to trap the antimicrobial agent between the inner surface of the female luer and the distal tip surface 1552, thereby exposing pathogens to a high concentration of the antimicrobial agent. The trapping is a way to keep the antimicrobial agent within the distal recess area while fluid is flowing through the lumen 1512 during use. The design of the distal recess 1551, which does not have a through channel for fluid flow, reduces fluid transfer between the lumen 1512 and the distal tip surface 1552.

[0151] Bladed male connector (Figures 17A-17F) 17A-17F, male connector 1701 includes a male luer 1741. Male luer 1741 includes a tapered sealing member 1742. Tapered sealing member 1742 has a tapered sealing surface 1743 that is configured to mate with a female luer to create a fluid-tight fit. Male connector 1701 further includes threads 1702 that allow male connector 1701 to mate with a female connector. A lumen 1712 extends through male connector 1701.

[0152] Male luer 1741 includes a distal tip 1755 with an end surface 1704. Distal tip 1755 of male luer 1741 is recessed from the distal line 1714 of the taper of tapered sealing member 1742. A distal recess 1751 is formed by the recessed portion of distal tip 1755. When male luer 1741 is sealed against a female luer and tapered sealing surface 1743 forms a fluid-tight fit with the inner surface of the female luer, distal tip surface 1752 of distal tip 1755 does not contact the inner surface of the female luer.

[0153] Male luer 1741 includes a tapered surface leading edge 1761 that defines the proximal end of distal tip 1755. Tapered surface leading edge 1761 is located at the most distal end of tapered sealing surface 1743. When male luer 1741 is inserted into a female luer, tapered surface leading edge 1761 of tapered sealing member 1742 can capture pathogens that may have made their way onto the interior surface of the female luer.

[0154] In some examples, the antimicrobial is provided to the distal tip surface 1752 by coating, spraying, or dipping the distal tip 1755 with the antimicrobial, although other methods of providing the antimicrobial are contemplated and within the scope of the present technology. In some examples, the antimicrobial is also provided to the tapered sealing surface 1743. As discussed above in connection with FIG. 7A , the antimicrobial on the distal tip surface 1752 of the distal tip 1755 kills pathogens in the tip recess 1751 between the surface of the female luer and the distal tip surface 1752.

[0155] The male luer 1741 further includes a plurality of blades 1763 disposed about the distal tip 1755 of the male luer 1741. In some examples, the blades 1763 are disposed substantially parallel to the central longitudinal axis of the male luer 1741. However, as described in more detail below, some embodiments may have blades that are not substantially parallel to the central longitudinal axis. Between the blades 1763 are a plurality of channels 1767. In the example of FIG. 17 , the blades 1763 are elongate protrusions disposed about the axis of the tapered sealing member 1742, and the channels 1767 are elongate recesses disposed between the blades 1763 and extending parallel to the lumen 1712. The blades 1763 and channels 1767 alternately form peaks 1764 and valleys 1768. The distal tip surface 1752 of the distal tip 1755 is defined by the blades 1763 and channels 1767, forming a plurality of blade surfaces. Additionally, the antimicrobial agent on the distal tip surface 1752 may be stored in the volume between the blades 1763, thereby increasing the amount of antimicrobial agent that may be stored at the distal tip 1755 of the male luer 1741.

[0156] The blade 1763 at the distal tip 1755 can be manufactured using current materials and manufacturing methods, such as injection molding of sterile bumpoff threads using polypropylene material.

[0157] In some examples, the length of the distal tip 1755 is about 1.52 mm (0.060 inches). The length of the distal tip 1755 is measured perpendicular to the diameter of the distal tip 1755. In some examples, the inner diameter of the lumen 1712 is about 1.65 mm (0.065 inches). In some examples, the outer diameter of the distal tip 1755 is about 2.41 mm (0.095 inches). In some examples, the wall thickness of the distal tip 1755 is about 0.38 mm (0.015 inches). In some examples, the outer diameter of the tapered surface distal edge 1761 is about 3.94 mm (0.155 inches).

[0158] At the crest 1764 of the blade 1763, the outer diameter of the distal tip 1755 is approximately 0.148 inches to 0.152 inches. At the valley 1768 of the channel 1767, the outer diameter of the distal tip 1755 is approximately 0.0118 inches to 0.0121 inches. Therefore, in this example, the difference in outer diameter from the valley 1768 to the crest 1764 is approximately 0.030 inches. The tip length of the distal tip 1755 as shown in Figures 17A-17F is 0.060 inches. In another example, the tip length is between about 0.025 and 0.125 inches, and in another example, the tip length is between about 0.050 and 0.090 inches. The surface area of ​​the distal tip surface 1752 (including the surface of the blades) of the distal tip 1755 is between about 0.0390 and 0.0370 square inches. The surface area of ​​the male luer distal tip 1755 without the blades 1763 and with an outer diameter equal to the root diameter is between about 0.0235 and 0.0215 square inches. Therefore, the blades 1763 and channels 1767 increase the surface area of ​​the distal tip 1755 by approximately 68 percent. In some instances, increasing the distal tip surface 1752 may reduce the amount of antimicrobial agent that is removed from the distal tip surface 1752 when the connector is inserted into an infusion device.

[0159] During insertion of the male Luer 1741 into the female Luer, portions of the distal tip 1755 may contact the inner surface of the female Luer. While the peaks 1764 of each blade 1763 may contact the female Luer surface, the valleys 1768 of the channels 1767 do not. For example, compared to the tapered surface leading edge 1761, the contact surface area of ​​the blades 1763 near the end face 1704 of the distal tip 1755 is relatively small. This minimizes the amount of pathogen intrusion, which may result from pathogens being pushed into the body of the female Luer by the blades 1763, compared to the tapered surface leading edge 1761 of the male Luer 1741. Therefore, in some cases, pathogens are more likely to be present at the tapered surface leading edge 1761 compared to the end face 1704. This is desirable because tapered surface leading edge 1761 has a higher concentration of antimicrobial composition (at a lethal concentration that kills pathogens) than end surface 1704 .

[0160] Channels 1767 affect pathogen entrapment within distal recess 1751 because they provide a restricted space in which pathogens can become trapped between distal tip surface 1752 and the inner surface of the female luer. The peaks 1764 of blades 1763 provide the maximum outer diameter of distal tip 1755, and the valleys 1768 of channels 1767 provide the minimum outer diameter of distal tip 1755. Although a small amount of fluid flow between adjacent channels 1767 is possible when male luer 1741 is mated with a female luer, blades 1763 provide a partial physical barrier. As shown in Figures 17D-17F, the outer diameter of distal tip 1755 is smaller at tapered surface leading edge 1761 than the outer diameter of tapered sealing member 1742, and the outer diameter of distal tip 1755 is smaller than the outer diameter of tapered leading line 1714 defined by conical tapered sealing member 1742.

[0161] The embodiment of male connector 1701 described in connection with FIGS. 17A-17F can be used in combination with the syringes shown in FIGS. 1A-1G. In the context of syringe 111, blade 1763 is desirable because it allows the antimicrobial composition to diffuse rapidly into the fluid within tip recess 1751, particularly when tip recess depth (defined below in connection with FIG. 30G) is less than 0.50 mm, or alternatively, less than 0.25 mm. Rapid diffusion of the antimicrobial composition results in rapid killing of microorganisms, which is beneficial in syringe applications because syringes are often connected to female connectors for a relatively short period of time (e.g., less than one minute). By comparison, other infusion devices may remain connected for several days.

[0162] Additionally, the antimicrobial composition in the valleys 1768 of the channels 1767 can be thicker or more dense than the antimicrobial composition at the peaks 1764 of the blades 1763. A thicker coating at or near the valleys 1768 of the channels 1767 provides an antimicrobial reservoir for a more persistent, highly concentrated antimicrobial solution within the tip recess 1751. In one example, the antimicrobial composition is more than twice as thick (or denser) in the valleys 1768 of the channels 1767 than at the peaks 1764 of the blades 1763. Having the antimicrobial reservoir extend along the length of the distal tip surface 1752, including to the end face 1704, is beneficial for killing microorganisms at the septum of the needleless connector, where fluid often leaks between the syringe tip and the septum. When the syringe 111 is coupled to the needleless connector, the end surface 1704 comes into contact with the septum of the needleless connector, and if a small amount of fluid leaks, the fluid will flow along the tip surface 1752 (along the valleys of the channel) due to capillary action caused by the geometry of the blade tip surface 1752, producing an antibacterial solution that can kill microorganisms.

[0163] Male connector with elongated blade (Figures 18A to 18F) 18A-F, male connector 1801 includes a male luer 1841. Male luer 1841 includes a tapered sealing member 1842. Tapered sealing member 1842 has a frustoconical shape that tapers from a larger outer diameter at a proximal portion of tapered sealing member 1842 to a smaller outer diameter at a distal portion of the tapered sealing member near tapered surface distal edge 1861. Tapered sealing member 1842 has a tapered sealing surface 1843 configured to mate with a female luer to create a fluid-tight fit. Male connector 1801 further includes threads 1802 that allow male connector 1801 to be coupled to a female connector. A lumen 1812 extends through male connector 1801.

[0164] Male luer 1841 includes a distal tip 1855 with an end surface 1804. Distal tip 1855 of male luer 1841 is recessed from the distal line of the taper of tapered sealing member 1842. A distal recess 1851 is formed by the recessed portion of distal tip 1855. Distal tip surface 1852 of distal tip 1855 defines an outer diameter that is smaller than the outer diameter of the extension of tapered sealing surface 1843.

[0165] The male luer 1841 includes a tapered surface leading edge 1861 that defines the proximal end of the distal tip 1855. The tapered surface leading edge 1861 is located at the most distal end of the tapered sealing surface 1843. In some examples, the antimicrobial is provided to the distal tip surface 1852 by coating, spraying, or dipping the distal tip 1855 with the antimicrobial, although other methods of providing the antimicrobial are contemplated and within the scope of the present technology. In some examples, the antimicrobial is also provided to the tapered sealing surface 1843. The antimicrobial on the distal tip surface 1852 of the distal tip 1855 kills pathogens within the distal recess 1851 between the surface of the female luer and the distal tip surface 1852. The distal recess 1851 is designed to trap the antimicrobial between the inner surface of the female luer and the distal tip surface 1852, exposing the pathogens to a high concentration of the antimicrobial.

[0166] The male luer 1841 further includes a plurality of blades 1863 disposed about the distal tip 1855 of the male luer 1841. Between the blades 1863 are a plurality of channels 1867. In the example of FIG. 18 , the blades 1863 are elongate protrusions disposed about the axis of the tapered sealing member 1842, and the channels 1867 are elongate recesses disposed between the blades 1863 and extending parallel to the lumen 1812. The blades 1863 and channels 1867 alternately form peaks 1864 and valleys 1868. The distal tip surface 1852 of the distal tip 1855 is defined by the blades 1863 and the channels 1867. An antimicrobial agent on the distal tip surface 1852 may be stored in the volume between the blades 1863.

[0167] During insertion of the male Luer 1841 into the female Luer, portions of the distal tip 1855 may contact the inner surface of the female Luer. The peaks 1864 of each blade 1863 may contact the female Luer surface, but the valleys 1868 of the channels 1867 do not. For example, the surface area of ​​the blades 1863 near the end face 1804 of the distal tip 1855 is relatively small compared to the tapered surface leading edge 1861. This minimizes the amount of pathogen intrusion that may result from pathogens being forced into the body of the female Luer by the male Luer 1841.

[0168] Channels 1867 affect pathogen entrapment within the tip recess because they provide a restricted space in which pathogens can become trapped between distal tip surface 1852 and the inner surface of the female Luer. The peaks 1864 of blades 1863 provide the maximum outer diameter of distal tip 1855, and the valleys 1868 of channels 1867 provide the minimum outer diameter of distal tip 1855. Although a small amount of fluid flow between adjacent channels 1867 is possible when male Luer 1841 is coupled to a female Luer, blades 1863 provide a partial physical barrier. As shown in Figures 18D and 18E, distal tip 1855 has an outer diameter that is smaller than the outer diameter of tapered sealing member 1842 at tapered surface leading edge 1861, and the outer diameter of distal tip 1855 is smaller than the outer diameter of the tapered leading line defined by conical tapered sealing member 1842.

[0169] Distal tip 1855 has fourteen elongated blades 1863 that extend into threaded cavity 1839 of male connector 1801. Male luer 1841 of FIG. 18 has a shorter tapered sealing surface 1843 than male luer 1741 of FIG. 17, but distal recess 1851 is longer and the surface area of ​​distal tip surface 1852 of distal tip 1855 is larger than the example of FIG. 17. In some examples, the length of distal tip 1855, as measured perpendicular to the outer diameter of distal tip 1855, is approximately 0.025 to 0.125 inches.

[0170] Six-blade male connector (Figures 19A-19F) 19A-F, male connector 1901 includes a male luer 1941. Male luer 1941 includes a tapered sealing member 1942. Tapered sealing member 1942 has a frustoconical shape that tapers from a larger outer diameter at a proximal portion of tapered sealing member 1942 to a smaller outer diameter at a distal portion of the tapered sealing member near tapered surface distal edge 1961. Tapered sealing member 1942 has a tapered sealing surface 1943 configured to mate with a female luer to create a fluid-tight fit. Male connector 1901 further includes threads 1902 that allow male connector 1901 to mate with a female connector. A lumen 1912 extends through male connector 1901.

[0171] Male luer 1941 includes a distal tip 1955 with an end surface 1904. Distal tip 1955 of male luer 1941 is recessed from the distal line of the taper of tapered sealing member 1942. A distal recess 1951 is formed by the recessed portion of distal tip 1955. Distal tip surface 1952 of distal tip 1955 defines an outer diameter that is smaller than the outer diameter of the extension of tapered sealing surface 1943.

[0172] Male luer 1941 includes a tapered surface distal edge 1961 that defines the proximal end of distal tip 1955. In some examples, an antimicrobial is provided to distal tip surface 1952 by coating, spraying, or dipping distal tip 1955 with the antimicrobial, although other methods of providing the antimicrobial are contemplated and within the scope of the present technology. In some examples, an antimicrobial is also provided to tapered sealing surface 1943. The antimicrobial on distal tip surface 1952 of distal tip 1955 kills pathogens within distal recess 1951 between the surface of the female luer and distal tip surface 1952. Tip recess 1951 is designed to trap the antimicrobial between the inner surface of the female luer and distal tip surface 1952, exposing pathogens to a high concentration of the antimicrobial.

[0173] Male luer 1941 further includes a plurality of blades 1963 disposed about the distal tip 1955 of male luer 1941. Between the blades 1963 are a plurality of channels 1967. In the example of FIG. 19 , the blades 1963 are elongate protrusions disposed about the axis of tapered sealing member 1942, and the channels 1967 are elongate recesses disposed between the blades 1963 and extending parallel to the lumen 1912. The blades 1963 and channels 1967 alternately form peaks 1964 and valleys 1968. A distal tip surface 1952 of distal tip 1955 is defined by the blades 1963 and channels 1967. An antimicrobial agent on the distal tip surface 1952 may be stored in the volume between the blades 1963.

[0174] During insertion of the male Luer 1941 into the female Luer, portions of the distal tip 1955 may contact the inner surface of the female Luer. The peaks 1964 of each blade 1963 may contact the female Luer surface, but the valleys 1968 of the channels 1967 do not. For example, the surface area of ​​the blades 1963 near the end face 1904 of the distal tip 1955 is relatively small compared to the tapered surface leading edge 1961. This minimizes the amount of pathogen intrusion that may result from pathogens being forced into the body of the female Luer by the male Luer 1941.

[0175] Channels 1967 affect pathogen entrapment within the tip recess because they provide a restricted space in which pathogens can become trapped between distal tip surface 1952 and the inner surface of the female Luer. The peaks 1964 of blades 1963 provide the maximum outer diameter of distal tip 1955, and the valleys 1968 of channels 1967 provide the minimum outer diameter of distal tip 1955. Although a small amount of fluid flow between adjacent channels 1967 is possible when male Luer 1941 is coupled to a female Luer, blades 1963 provide a partial physical barrier. As shown in Figures 19D and 19E, distal tip 1955 has an outer diameter that is smaller than the outer diameter of tapered sealing member 1942 at tapered surface leading edge 1961, and the outer diameter of distal tip 1955 is smaller than the outer diameter of the tapered leading line defined by conical tapered sealing member 1942.

[0176] The distal tip 1955 of the male luer 1941 has six blades 1963 that define six channels 1967 with valleys 1968. In the example of FIG. 19C, the valleys 1968 are curved slightly outward, creating a distinct crease 1969 at the base of the blades 1963.

[0177] Male connector with blade and rounded tip (Figures 20A-G) 20A-G, male connector 2001 includes a male luer 2041. Male luer 2041 includes a tapered sealing member 2042. Tapered sealing member 2042 has a frustoconical shape that tapers from a larger outer diameter at a proximal portion of tapered sealing member 2042 to a smaller outer diameter at a distal portion of the tapered sealing member near tapered surface distal edge 2061. Tapered sealing member 2042 has a tapered sealing surface 2043 configured to mate with a female luer to create a fluid-tight fit. Male connector 2001 further includes threads 2002 that allow male connector 2001 to be mated with a female connector. A lumen 2012 extends through male connector 2001.

[0178] Male luer 2041 includes a distal tip 2055 with an end surface 2004. Distal tip 2055 of male luer 2041 is recessed from the distal line of the taper of tapered sealing member 2042. A distal recess 2051 is formed by the recessed portion of distal tip 2055. Distal tip surface 2052 of distal tip 2055 defines an outer diameter that is smaller than the outer diameter of the extension of tapered sealing surface 2043.

[0179] The male luer 2041 includes a tapered surface distal edge 2061 that defines the proximal end of the distal tip 2055. In some examples, the antimicrobial is provided to the distal tip surface 2052 by coating, spraying, or dipping the distal tip 2055 with the antimicrobial, although other methods of providing the antimicrobial are contemplated and within the scope of the present technology. In some examples, the antimicrobial is also provided to the tapered sealing surface 2043. The antimicrobial on the distal tip surface 2052 of the distal tip 2055 kills pathogens within the distal recess 2051 between the surface of the female luer and the distal tip surface 2052. The distal recess 2051 is designed to trap the antimicrobial between the inner surface of the female luer and the distal tip surface 2052, so that the pathogens are exposed to a high concentration of the antimicrobial.

[0180] The male luer 2041 further includes a plurality of blades 2063 disposed about the distal tip 2055 of the male luer 2041. Between the blades 2063 are a plurality of channels 2067. In the example of FIG. 20 , the blades 2063 are elongate protrusions disposed about the axis of the tapered sealing member 2042, and the channels 2067 are elongate recesses disposed between the blades 2063 and extending parallel to the lumen 2012. The blades 2063 and channels 2067 alternately form peaks 2064 and valleys 2068. The distal tip surface 2052 of the distal tip 2055 is defined by the blades 2063 and the channels 2067. An antimicrobial agent on the distal tip surface 2052 may be stored in the volume between the blades 2063.

[0181] During insertion of the male luer 2041 into the female luer, portions of the distal tip 2055 may contact the inner surface of the female luer. The peaks 2064 of each blade 2063 may contact the female luer surface, but the valleys 2068 of the channels 2067 do not. For example, the surface area of ​​the blades 2063 near the end face 2004 of the distal tip 2055 is relatively small compared to the tapered surface leading edge 2061. This minimizes the amount of pathogen intrusion that may result from pathogens being forced into the body of the female luer by the male luer 2041.

[0182] Channels 2067 affect pathogen entrapment within the tip recess because they provide a restricted space in which pathogens can become trapped between the distal tip surface 2052 and the inner surface of the female Luer. The peaks 2064 of the blades 2063 provide the maximum outer diameter of the distal tip 2055, and the valleys 2068 of the channels 2067 provide the minimum outer diameter of the distal tip 2055. When the male Luer 2041 is mated with the female Luer, a small amount of fluid flow between adjacent channels 2067 is possible, but the blades 2063 provide a partial physical barrier. As shown in Figures 20E and 20F, the distal tip 2055 has an outer diameter that is smaller than the outer diameter of the tapered sealing member 2042 at the tapered surface leading edge 2061, and the outer diameter of the distal tip 2055 is smaller than the outer diameter of the tapered leading line defined by the conical tapered sealing member 2042.

[0183] Distal tip 2055 has a plurality of blades 2063 that separate a plurality of channels 2067. Blade 2063 has a rounded blade tip 2082 that tapers in width from end face 1904 to apex 2064 of blade 2063. This structure rounds tip recess 2051 at the boundary between the tip recess region and the bulk flow region when male luer 2041 is mated with a female luer.

[0184] Male connector with increased clearance (Figures 21A-F) 21A-F, male connector 2101 includes a male luer 2141. Male luer 2141 includes a tapered sealing member 2142. Tapered sealing member 2142 has a frustoconical shape that tapers from a larger outer diameter at a proximal portion of tapered sealing member 2142 to a smaller outer diameter at a distal portion of the tapered sealing member near tapered surface distal edge 2161. Tapered sealing member 2142 has a tapered sealing surface 2143 configured to mate with a female luer to create a fluid-tight fit. Male connector 2101 further includes threads 2102 that allow male connector 2101 to be mated with a female connector. A lumen 2112 extends through male connector 2101.

[0185] Male luer 2141 includes a distal tip 2155 with an end surface 2104. Distal tip 2155 of male luer 2141 is recessed from the distal line of the taper of tapered sealing member 2142. A distal recess 2151 is formed by the recessed portion of distal tip 2155. Distal tip surface 2152 of distal tip 2155 defines an outer diameter that is smaller than the outer diameter of the extension of tapered sealing surface 2143.

[0186] Male luer 2141 includes a tapered surface distal edge 2161 that defines the proximal end of distal tip 2155. In some examples, an antimicrobial is provided to distal tip surface 2152 by coating, spraying, or dipping distal tip 2155 with the antimicrobial, although other methods of providing the antimicrobial are contemplated and within the scope of the present technology. In some examples, an antimicrobial is also provided to tapered sealing surface 2143. The antimicrobial on distal tip surface 2152 of distal tip 2155 kills pathogens within distal recess 2151 between the surface of the female luer and distal tip surface 2152. Tip recess 2151 is designed to trap the antimicrobial between the inner surface of the female luer and distal tip surface 2152, so that pathogens are exposed to a high concentration of the antimicrobial.

[0187] The male luer 2141 further includes a plurality of blades 2163 disposed about the distal tip 2155 of the male luer 2141. Between the blades 2163 are a plurality of channels 2167. In the example of FIG. 21 , the blades 2163 are elongate protrusions disposed about the axis of the tapered sealing member 2142, and the channels 2167 are elongate recesses disposed between the blades 2163 and extending parallel to the lumen 2112. The blades 2163 and channels 2167 alternately form peaks 2164 and valleys 2168. The distal tip surface 2152 of the distal tip 2155 is defined by the blades 2163 and the channels 2167. An antimicrobial agent on the distal tip surface 2152 may be stored in the volume between the blades 2163.

[0188] During insertion of the male luer 2141 into the female luer, portions of the distal tip 2155 may contact the inner surface of the female luer. The peaks 2164 of each blade 2163 may contact the female luer surface, but the valleys 2168 of the channels 2167 do not. For example, the surface area of ​​the blades 2163 near the end face 2104 of the distal tip 2155 is relatively small compared to the tapered surface distal edge 2161. This minimizes the amount of pathogen intrusion that may result from pathogens being forced into the body of the female luer by the male luer 2141.

[0189] Channels 2167 affect pathogen entrapment within the tip recess because channels 2167 provide a restricted space in which pathogens can become trapped between distal tip surface 2152 and the inner surface of the female luer. The peaks 2164 of blades 2163 provide the maximum outer diameter of distal tip 2155, and the valleys 2168 of channels 2167 provide the minimum outer diameter of distal tip 2155. When male luer 2141 is mated with a female luer, a small amount of fluid flow between adjacent channels 2167 is possible, but blades 2163 provide a partial physical barrier. As shown in FIGS. 21D and 21E , distal tip 2155 has an outer diameter that is smaller than the outer diameter of tapered sealing member 2142 at tapered surface leading edge 2161, and the outer diameter of distal tip 2155 is smaller than the outer diameter of the tapered distal line defined by conical tapered sealing member 2142.

[0190] Distal tip 2155 has a plurality of blades 2163 that separate a plurality of channels 2167. This example shows a large difference in height from peaks 2164 to valleys 2168. This in turn increases the surface area on which antimicrobial agent can be stored. Furthermore, the depth of channels 2167 allows for an increased load of antimicrobial agent to be stored in distal tip 2155.

[0191] Male connectors with irregular blade heights (Figures 22A-F) 22A-F, male connector 2201 includes a male luer 2241. Male luer 2241 includes a tapered sealing member 2242. Tapered sealing member 2242 has a frustoconical shape that tapers from a larger outer diameter at a proximal portion of tapered sealing member 2242 to a smaller outer diameter at a distal portion of the tapered sealing member near tapered surface distal edge 2261. Tapered sealing member 2242 has a tapered sealing surface 2243 configured to mate with a female luer to create a fluid-tight fit. Male connector 2201 further includes threads 2202 that allow male connector 2201 to be mated with a female connector. A lumen 2212 extends through male connector 2201.

[0192] Male luer 2241 includes a distal tip 2255 with an end surface 2204. Distal tip 2255 of male luer 2241 is recessed from the distal line of the taper of tapered sealing member 2242. A distal recess 2251 is formed by the recessed portion of distal tip 2255. Distal tip surface 2252 of distal tip 2255 defines an outer diameter that is smaller than the outer diameter of the extension of tapered sealing surface 2243.

[0193] Male luer 2241 includes a tapered surface distal edge 2261 that defines the proximal end of distal tip 2255. In some examples, an antimicrobial is provided to distal tip surface 2252 by coating, spraying, or dipping distal tip 2255 with the antimicrobial, although other methods of providing the antimicrobial are contemplated and within the scope of the present technology. In some examples, an antimicrobial is also provided to tapered sealing surface 2243. The antimicrobial on distal tip surface 2252 of distal tip 2255 kills pathogens within distal recess 2251 between the surface of the female luer and distal tip surface 2252. Tip recess 2251 is designed to trap the antimicrobial between the inner surface of the female luer and distal tip surface 2252, so that pathogens are exposed to a high concentration of the antimicrobial.

[0194] Male luer 2241 further includes a plurality of blades 2263 disposed about the distal tip 2255 of male luer 2241. Between the blades 2263 are a plurality of channels 2267. In the example of FIG. 22 , the blades 2263 are elongate protrusions disposed about the axis of tapered sealing member 2242, and the channels 2267 are elongate recesses disposed between the blades 2263 and extending parallel to lumen 2212. The blades 2263 and channels 2267 alternately form peaks 2264 and valleys 2268. A distal tip surface 2252 of distal tip 2255 is defined by the blades 2263 and channels 2267. An antimicrobial agent on the distal tip surface 2252 may be stored in the volume between the blades 2263.

[0195] During insertion of the male Luer 2241 into the female Luer, portions of the distal tip 2255 may contact the inner surface of the female Luer. While the peaks 2264 of each tall blade 2265 may contact the female Luer surface, the valleys 2268 of the channels 2267 and the low blades 2266 do not contact the female Luer surface. For example, compared to the tapered surface leading edge 2261, the surface area of ​​the blades 2265 near the end face 2204 of the tall distal tip 2255 is relatively small. This minimizes the amount of pathogen intrusion that may result from pathogens being forced into the body of the female Luer by the male Luer 2241.

[0196] Channels 2267 affect pathogen entrapment within the tip recess because they provide a restricted space in which pathogens can become trapped between distal tip surface 2252 and the inner surface of the female luer. The peaks 2264 of blades 2263 provide the maximum outer diameter of distal tip 2255, and the valleys 2268 of channels 2267 provide the minimum outer diameter of distal tip 2255. When male luer 2241 is mated with a female luer, a small amount of fluid flow between adjacent channels 2267 is possible, but blades 2263 provide a partial physical barrier. As shown in FIGS. 22D and 22E , distal tip 2255 has an outer diameter that is smaller than the outer diameter of tapered sealing member 2242 at tapered surface leading edge 2261, and the outer diameter of distal tip 2255 is smaller than the outer diameter of the tapered leading line defined by conical tapered sealing member 2242.

[0197] Distal tip 2255 has a plurality of blades 2263 separating a plurality of channels 2267. In this example, distal tip 2255 includes tall blades 2265 and short blades 2266. The outer diameter of the tall blades 2265 is larger than the outer diameter of the short blades 2266. In this example, valleys 2268 of channels 2267 each have the same outer diameter. As can be seen in FIG. 22D , in this example, each tall blade 2265 is on an opposite 180° circumferential side of the short blade 2266. As shown in FIG. 22E , male luer 2241 has a tapered surface leading edge 2261, and the apexes of blades 2263 are inside the line of the taper such that the outer diameter of blades 2263 is smaller than the outer diameter of tapered surface leading edge 2261.

[0198] Male connectors with irregular blade heights (Figures 23A-G) 23A-G, male connector 2301 includes a male luer 2341. Male luer 2341 includes a tapered sealing member 2342. Tapered sealing member 2342 has a frustoconical shape that tapers from a larger outer diameter at a proximal portion of tapered sealing member 2342 to a smaller outer diameter at a distal portion of the tapered sealing member near tapered surface distal edge 2361. Tapered sealing member 2342 has a tapered sealing surface 2343 configured to mate with a female luer to create a fluid-tight fit. Male connector 2301 further includes threads 2302 that allow male connector 2301 to mate with a female connector. A lumen 2312 extends through male connector 2301.

[0199] Male luer 2341 includes a distal tip 2355 with an end surface 2304. Distal tip 2355 of male luer 2341 is recessed from the distal line of the taper of tapered sealing member 2342. A distal recess 2351 is formed by the recessed portion of distal tip 2355. Distal tip surface 2352 of distal tip 2355 defines an outer diameter that is smaller than the outer diameter of the extension of tapered sealing surface 2343.

[0200] Male luer 2341 includes a tapered surface distal edge 2361 that defines the proximal end of distal tip 2355. In some examples, an antimicrobial is provided to distal tip surface 2352 by coating, spraying, or dipping distal tip 2355 with the antimicrobial, although other methods of providing the antimicrobial are contemplated and within the scope of the present technology. In some examples, an antimicrobial is also provided to tapered sealing surface 2343. The antimicrobial on distal tip surface 2352 of distal tip 2355 kills pathogens within distal recess 2351 between the surface of the female luer and distal tip surface 2352. Tip recess 2351 is designed to trap the antimicrobial between the inner surface of the female luer and distal tip surface 2352, so that pathogens are exposed to a high concentration of the antimicrobial.

[0201] The male luer 2341 further includes a plurality of blades 2363 disposed about the distal tip 2355 of the male luer 2341. Between the blades 2363 are a plurality of channels 2367. In the example of FIG. 23 , the blades 2363 are elongate protrusions disposed about the axis of the tapered sealing member 2342, and the channels 2367 are elongate recesses disposed between the blades 2363 and extending parallel to the lumen 2312. The blades 2363 and channels 2367 alternately form peaks 2364 and valleys 2368. The distal tip surface 2352 of the distal tip 2355 is defined by the blades 2363 and the channels 2367. An antimicrobial agent on the distal tip surface 2352 may be stored in the volume between the blades 2363.

[0202] Distal tip 2355 has a plurality of blades 2363 that separate a plurality of channels 2367. In this example, distal tip 2355 includes tall blades 2365 and short blades 2366. The outer diameter of tall blade 2365 is larger than the outer diameter of short blade 2366. As shown in FIG. 23E , male luer 2341 has a tapered surface leading edge 2361, and the apex 2364 of blade 2363 is inside the line of the taper such that the outer diameter of blade 2363 is smaller than the outer diameter of tapered surface leading edge 2361.

[0203] During insertion of the male luer 2341 into the female luer, portions of the distal tip 2355 may contact the inner surface of the female luer. The peaks 2364 of each tall blade 2365 may contact the female luer surface, but the valleys 2368 of the channels 2367 and the low blades 2366 do not. For example, compared to the tapered surface leading edge 2361, the surface area of ​​the blades 2365 near the end face 2304 of the tall distal tip 2355 is relatively small. This minimizes the amount of pathogen intrusion that may result from pathogens being forced into the body of the female luer by the male luer 2341.

[0204] Channels 2367 affect pathogen entrapment within the tip recess because they provide a restricted space in which pathogens can become trapped between distal tip surface 2352 and the inner surface of the female Luer. The peaks 2364 of blades 2363 provide the maximum outer diameter of distal tip 2355, and the valleys 2368 of channels 2367 provide the minimum outer diameter of distal tip 2355. When male Luer 2341 is mated with a female Luer, a small amount of fluid flow between adjacent channels 2367 is possible, but blades 2363 provide a partial physical barrier. As shown in Figures 23D and 23E, distal tip 2355 has an outer diameter that is smaller than the outer diameter of tapered sealing member 2342 at tapered surface leading edge 2361, and the outer diameter of distal tip 2355 is smaller than the outer diameter of the tapered leading line defined by conical tapered sealing member 2342.

[0205] Male connector with tapered blade and channel (Figure 24A-F) 24A-F, male connector 2401 includes a male luer 2441. Male luer 2441 includes a tapered sealing member 2442. Tapered sealing member 2442 has a frustoconical shape that tapers from a larger outer diameter at a proximal portion of tapered sealing member 2442 to a smaller outer diameter at a distal portion of the tapered sealing member near tapered surface distal edge 2461. Tapered sealing member 2442 has a tapered sealing surface 2443 configured to mate with a female luer to create a fluid-tight fit. Male connector 2401 further includes threads 2402 that allow male connector 2401 to mate with a female connector. A lumen 2412 extends through male connector 2401.

[0206] Male luer 2441 includes a distal tip 2455 with an end surface 2404. Distal tip 2455 of male luer 2441 is recessed from the distal line of the taper of tapered sealing member 2442. A distal recess 2451 is formed by the recessed portion of distal tip 2455. Distal tip surface 2452 of distal tip 2455 defines an outer diameter that is smaller than the outer diameter of the extension of tapered sealing surface 2443.

[0207] Male luer 2441 includes a tapered surface distal edge 2461 that defines the proximal end of distal tip 2455. In some examples, an antimicrobial is provided to distal tip surface 2452 by coating, spraying, or dipping distal tip 2455 with the antimicrobial, although other methods of providing the antimicrobial are contemplated and within the scope of the present technology. In some examples, an antimicrobial is also provided to tapered sealing surface 2443. The antimicrobial on distal tip surface 2452 of distal tip 2455 kills pathogens within distal recess 2451 between the surface of the female luer and distal tip surface 2452. Tip recess 2451 is designed to trap the antimicrobial between the inner surface of the female luer and distal tip surface 2452, so that pathogens are exposed to a high concentration of the antimicrobial.

[0208] The male luer 2441 further includes a plurality of blades 2463 disposed about the distal tip 2455 of the male luer 2441. Between the blades 2463 are a plurality of channels 2467. In the example of FIG. 24 , the blades 2463 are elongate protrusions disposed about the axis of the tapered sealing member 2442, and the channels 2467 are elongate recesses disposed between the blades 2463 and extending parallel to the lumen 2412. The blades 2463 and channels 2467 alternately form peaks 2464 and valleys 2468. The distal tip surface 2452 of the distal tip 2455 is defined by the blades 2463 and the channels 2467. An antimicrobial agent on the distal tip surface 2452 may be stored in the volume between the blades 2463.

[0209] During insertion of the male Luer 2441 into the female Luer, portions of the distal tip 2455 may contact the inner surface of the female Luer. The peaks 2464 of each blade 2463 may contact the female Luer surface, but the valleys 2468 of the channels 2467 do not. For example, the surface area of ​​the blades 2463 near the end face 2404 of the distal tip 2455 is relatively small compared to the tapered surface leading edge 2461. This minimizes the amount of pathogen intrusion that may result from pathogens being forced into the body of the female Luer by the male Luer 2441.

[0210] Channels 2467 affect pathogen entrapment within the tip recess because they provide a restricted space in which pathogens can become trapped between distal tip surface 2452 and the inner surface of the female luer. The peaks 2464 of blades 2463 provide the maximum outer diameter of distal tip 2455, and the valleys 2468 of channels 2467 provide the minimum outer diameter of distal tip 2455. When male luer 2441 is mated with a female luer, a small amount of fluid flow between adjacent channels 2467 is possible, but blades 2463 provide a partial physical barrier. As shown in Figures 24F and 24G, distal tip 2455 has an outer diameter that is smaller than the outer diameter of tapered sealing member 2442 at tapered surface leading edge 2461, and the outer diameter of distal tip 2455 is smaller than the outer diameter of the distal line of the taper defined by conical tapered sealing member 2442.

[0211] Distal tip 2455 has a plurality of blades 2463 that separate a plurality of channels 2467. The blades 2463 have peaks 2464 and the channels 2467 have valleys 2468. In this example, the peaks 2464 have a uniform outer diameter, while the width of the blades 2463 increases toward the end face 2404 of the distal tip 2455. The outer diameter of the valleys 2468 decreases from the proximal portion to the distal portion of the distal tip 2455, tapering the valleys 2468 as shown in FIG. 24H.

[0212] Male connector with tapered blade top (Figure 25A-G) 25A-G, male connector 2501 includes a male luer 2541. Male luer 2541 includes a tapered sealing member 2542. Tapered sealing member 2542 has a frustoconical shape that tapers from a larger outer diameter at a proximal portion of tapered sealing member 2542 to a smaller outer diameter at a distal portion of the tapered sealing member near tapered surface distal edge 2561. Tapered sealing member 2542 has a tapered sealing surface 2543 configured to mate with a female luer to create a fluid-tight fit. Male connector 2501 further includes threads 2502 that allow male connector 2501 to mate with a female connector. A lumen 2512 extends through male connector 2501.

[0213] Male luer 2541 includes a distal tip 2555 with an end surface 2504. Distal tip 2555 of male luer 2541 is recessed from the distal line of the taper of tapered sealing member 2542. A distal recess 2551 is formed by the recessed portion of distal tip 2555. Distal tip surface 2552 of distal tip 2555 defines an outer diameter that is smaller than the outer diameter of the extension of tapered sealing surface 2543.

[0214] Male luer 2541 includes a tapered surface distal edge 2561 that defines the proximal end of distal tip 2555. In some examples, an antimicrobial is provided to distal tip surface 2552 by coating, spraying, or dipping distal tip 2555 with the antimicrobial, although other methods of providing the antimicrobial are contemplated and within the scope of the present technology. In some examples, an antimicrobial is also provided to tapered sealing surface 2543. The antimicrobial on distal tip surface 2552 of distal tip 2555 kills pathogens within distal recess 2551 between the surface of the female luer and distal tip surface 2552. Tip recess 2551 is designed to trap the antimicrobial between the inner surface of the female luer and distal tip surface 2552, so that pathogens are exposed to a high concentration of the antimicrobial.

[0215] The male luer 2541 further includes a plurality of blades 2563 disposed about the distal tip 2555 of the male luer 2541. Between the blades 2563 are a plurality of channels 2567. In the example of FIG. 25 , the blades 2563 are elongate protrusions disposed about the axis of the tapered sealing member 2542, and the channels 2567 are elongate recesses disposed between the blades 2563 and extending parallel to the lumen 2512. The blades 2563 and channels 2567 alternately form peaks 2564 and valleys 2568. The distal tip surface 2552 of the distal tip 2555 is defined by the blades 2563 and the channels 2567. An antimicrobial agent on the distal tip surface 2552 may be stored in the volume between the blades 2563.

[0216] During insertion of the male luer 2541 into the female luer, portions of the distal tip 2555 may contact the interior surface of the female luer. The peaks 2564 of each blade 2563 may contact the female luer surface, but the valleys 2568 of the channels 2567 do not. For example, the surface area of ​​the blades 2563 near the end face 2504 of the distal tip 2555 is relatively small compared to the tapered surface leading edge 2561. This minimizes the amount of pathogen intrusion that may result from pathogens being forced into the body of the female luer by the male luer 2541.

[0217] Channels 2567 affect pathogen entrapment within the tip recess because channels 2567 provide a restricted space in which pathogens can become trapped between distal tip surface 2552 and the inner surface of the female luer. The peaks 2564 of blades 2563 provide the maximum outer diameter of distal tip 2555, and the valleys 2568 of channels 2567 provide the minimum outer diameter of distal tip 2555. When male luer 2541 is mated with a female luer, a small amount of fluid flow between adjacent channels 2567 is possible, but blades 2563 provide a partial physical barrier. As shown in FIGS. 25E and 25F , distal tip 2555 has an outer diameter that is smaller than the outer diameter of tapered sealing member 2542 at tapered surface leading edge 2561, and the outer diameter of distal tip 2555 is smaller than the outer diameter of the tapered leading line defined by conical tapered sealing member 2542.

[0218] Distal tip 2555 has a plurality of blades 2563 that separate a plurality of channels 2567. In this example, both the peaks 2564 of the blades 2563 and the valleys 2568 of the channels 2567 are tapered so that the outer diameter decreases toward the end face 2504 of the distal tip 2555.

[0219] Male connector with tapered blade tip (Figure 26A-G) 26A-G, male connector 2601 includes a male luer 2641. Male luer 2641 includes a tapered sealing member 2642. Tapered sealing member 2642 has a frustoconical shape that tapers from a larger outer diameter at a proximal portion of tapered sealing member 2642 to a smaller outer diameter at a distal portion of the tapered sealing member near tapered surface distal edge 2661. Tapered sealing member 2642 has a tapered sealing surface 2643 configured to mate with a female luer to create a fluid-tight fit. Male connector 2601 further includes threads 2602 that allow male connector 2601 to mate with a female connector. A lumen 2612 extends through male connector 2601.

[0220] Male luer 2641 includes a distal tip 2655 with an end surface 2604. Distal tip 2655 of male luer 2641 is recessed from the distal line of the taper of tapered sealing member 2642. A distal recess 2651 is formed by the recessed portion of distal tip 2655. Distal tip surface 2652 of distal tip 2655 defines an outer diameter that is smaller than the outer diameter of the extension of tapered sealing surface 2643.

[0221] Male luer 2641 includes a tapered surface distal edge 2661 that defines the proximal end of distal tip 2655. In some examples, an antimicrobial is provided to distal tip surface 2652 by coating, spraying, or dipping distal tip 2655 with the antimicrobial, although other methods of providing the antimicrobial are contemplated and within the scope of the present technology. In some examples, an antimicrobial is also provided to tapered sealing surface 2643. The antimicrobial on distal tip surface 2652 of distal tip 2655 kills pathogens within distal recess 2651 between the surface of the female luer and distal tip surface 2652. Tip recess 2651 is designed to trap the antimicrobial between the inner surface of the female luer and distal tip surface 2652, exposing pathogens to a high concentration of the antimicrobial.

[0222] The male luer 2641 further includes a plurality of blades 2663 disposed about the distal tip 2655 of the male luer 2641. Between the blades 2663 are a plurality of channels 2667. In the example of FIG. 26 , the blades 2663 are elongate protrusions disposed about the axis of the tapered sealing member 2642, and the channels 2667 are elongate recesses disposed between the blades 2663 and extending parallel to the lumen 2612. The blades 2663 and channels 2667 alternately form peaks 2664 and valleys 2668. The distal tip surface 2652 of the distal tip 2655 is defined by the blades 2663 and the channels 2667. An antimicrobial agent on the distal tip surface 2652 may be stored in the volume between the blades 2663.

[0223] During insertion of the male Luer 2641 into the female Luer, portions of the distal tip 2655 may contact the interior surface of the female Luer. The peaks 2664 of each blade 2663 may contact the female Luer surface, but the valleys 2668 of the channels 2667 do not. For example, the surface area of ​​the blades 2663 near the end face 2604 of the distal tip 2655 is relatively small compared to the tapered surface leading edge 2661. This minimizes the amount of pathogen intrusion that may result from pathogens being forced into the body of the female Luer by the male Luer 2641.

[0224] Channels 2667 affect pathogen entrapment within the tip recess because they provide a restricted space in which pathogens can become trapped between the distal tip surface 2652 and the inner surface of the female Luer. The peaks 2664 of the blades 2663 provide the maximum outer diameter of the distal tip 2655, and the valleys 2668 of the channels 2667 provide the minimum outer diameter of the distal tip 2655. When the male Luer 2641 is mated with the female Luer, a small amount of fluid flow between adjacent channels 2667 is possible, but the blades 2663 provide a partial physical barrier. As shown in FIGS. 26E and 26F , the distal tip 2655 has an outer diameter that is smaller than the outer diameter of the tapered sealing member 2642 at the tapered surface leading edge 2661, and the outer diameter of the distal tip 2655 is smaller than the outer diameter of the tapered distal line defined by the conical tapered sealing member 2642.

[0225] The distal tip 2655 has a plurality of blades 2663 that separate a plurality of channels 2667. In this example, the bases of the blades 2663 are wide at the proximal end of the distal tip 2655 and gradually taper so that the blades 2663 narrow at the distal end of the distal tip 2655. Conversely, the channels 2667 are narrow at the proximal end and widen towards the distal end of the distal tip 2655. In some examples, the blades 2663 include a chamfer 2669 at their distal ends.

[0226] Male connectors with irregular blade lengths (Figures 27A-G) 27A-G, male connector 2701 includes a male luer 2741. Male luer 2741 includes a tapered sealing member 2742. Tapered sealing member 2742 has a frustoconical shape that tapers from a larger outer diameter at a proximal portion of tapered sealing member 2742 to a smaller outer diameter at a distal portion of the tapered sealing member near tapered surface distal edge 2761. Tapered sealing member 2742 has a tapered sealing surface 2743 configured to mate with a female luer to create a fluid-tight fit. Male connector 2701 further includes threads 2702 that allow male connector 2701 to mate with a female connector. A lumen 2712 extends through male connector 2701.

[0227] Male luer 2741 includes a distal tip 2755 with an end surface 2704. Distal tip 2755 of male luer 2741 is recessed from the distal line of the taper of tapered sealing member 2742. A distal recess 2751 is formed by the recessed portion of distal tip 2755. Distal tip surface 2752 of distal tip 2755 defines an outer diameter that is smaller than the outer diameter of the extension of tapered sealing surface 2743.

[0228] Male luer 2741 includes a tapered surface distal edge 2761 that defines the proximal end of distal tip 2755. In some examples, an antimicrobial is provided to distal tip surface 2752 by coating, spraying, or dipping distal tip 2755 with the antimicrobial, although other methods of providing the antimicrobial are contemplated and within the scope of the present technology. In some examples, an antimicrobial is also provided to tapered sealing surface 2743. The antimicrobial on distal tip surface 2752 of distal tip 2755 kills pathogens within distal recess 2751 between the surface of the female luer and distal tip surface 2752. Tip recess 2751 is designed to trap the antimicrobial between the inner surface of the female luer and distal tip surface 2752, so that pathogens are exposed to a high concentration of the antimicrobial.

[0229] The male luer 2741 further includes a plurality of blades 2763 disposed about the distal tip 2755 of the male luer 2741. Between the blades 2763 are a plurality of channels 2767. In the example of FIG. 27 , the blades 2763 are elongate protrusions disposed about the axis of the tapered sealing member 2742, and the channels 2767 are elongate recesses disposed between the blades 2763 and extending parallel to the lumen 2712. The blades 2763 and channels 2767 alternately form peaks 2764 and valleys 2768. The distal tip surface 2752 of the distal tip 2755 is defined by the blades 2763 and the channels 2767. An antimicrobial agent on the distal tip surface 2752 may be stored in the volume between the blades 2763.

[0230] During insertion of the male Luer 2741 into the female Luer, portions of the distal tip 2755 may contact the inner surface of the female Luer. While the peaks 2764 of each blade 2763 may contact the female Luer surface, the valleys 2768 of the channels 2767 do not. Thus, compared to the tapered surface leading edge 2761, the surface area of ​​the blades 2763 near the end face 2704 of the distal tip 2755 is relatively small. This minimizes the amount of pathogen intrusion that may result from pathogens being forced into the body of the female Luer by the male Luer 2741.

[0231] Channels 2767 affect pathogen entrapment within the tip recess because they provide a restricted space in which pathogens can become trapped between distal tip surface 2752 and the inner surface of the female luer. The peaks 2764 of blades 2763 provide the maximum outer diameter of distal tip 2755, and the valleys 2768 of channels 2767 provide the minimum outer diameter of distal tip 2755. When male luer 2741 is mated with a female luer, a small amount of fluid flow between adjacent channels 2767 is possible, but blades 2763 provide a partial physical barrier. As shown in Figures 27E and 27F, distal tip 2755 has an outer diameter that is smaller than the outer diameter of tapered sealing member 2742 at tapered surface leading edge 2761, and the outer diameter of distal tip 2755 is smaller than the outer diameter of the tapered distal line defined by conical tapered sealing member 2742.

[0232] In this example, the distal tip 2755 includes a plurality of elongated blades 2765 and a plurality of truncated blades 2766 . Zero-clearance bladed male connector (Figures 28A-F) 28A-F, male connector 2801 includes a male luer 2841. Male luer 2841 includes a tapered sealing member 2842. Tapered sealing member 2842 has a frustoconical shape that tapers from a larger outer diameter at a proximal portion of tapered sealing member 2842 to a smaller outer diameter at a distal portion of the tapered sealing member near tapered surface distal edge 2861. Tapered sealing member 2842 has a tapered sealing surface 2843 configured to mate with a female luer to create a fluid-tight fit. Male connector 2801 further includes threads 2802 that allow male connector 2801 to mate with a female connector. A lumen 2812 extends through male connector 2801.

[0233] Male luer 2841 includes a distal tip 2855 with an end surface 2804. A distal recess 2851 is formed by a recessed portion of distal tip 2855, as shown in Figure 28F.

[0234] Male luer 2841 includes a tapered surface distal edge 2861 that defines the proximal end of distal tip 2855. In some examples, an antimicrobial is provided to distal tip surface 2852 by coating, spraying, or dipping distal tip 2855 with the antimicrobial, although other methods of providing the antimicrobial are contemplated and within the scope of the present technology. In some examples, an antimicrobial is also provided to tapered sealing surface 2843. The antimicrobial on distal tip surface 2852 of distal tip 2855 kills pathogens trapped between the surface of the female luer and distal tip surface 2852. Distal recess 2851 is designed to trap the antimicrobial between the inner surface of the female luer and distal tip surface 2852, so that pathogens are exposed to a high concentration of the antimicrobial.

[0235] The male luer 2841 further includes a plurality of blades 2863 disposed about the distal tip 2855 of the male luer 2841. Between the blades 2863 are a plurality of channels 2867. In the example of FIG. 28 , the blades 2863 are elongate protrusions disposed about the axis of the tapered sealing member 2842, and the channels 2867 are elongate recesses disposed between the blades 2863 and extending parallel to the lumen 2812. The blades 2863 and channels 2867 alternately form peaks 2864 and valleys 2868. The distal tip surface 2852 of the distal tip 2855 is defined by the blades 2863 and the channels 2867. An antimicrobial agent on the distal tip surface 2852 may be stored in the volume between the blades 2863.

[0236] During insertion of the male Luer 2841 into the female Luer, portions of the distal tip 2855 may contact the inner surface of the female Luer. The peaks 2864 of each blade 2863 may contact the female Luer surface, but the valleys 2868 of the channels 2867 do not. For example, the surface area of ​​the blades 2863 near the end face 2804 of the distal tip 2855 is relatively small compared to the tapered surface leading edge 2861. This minimizes the amount of pathogen intrusion that may result from pathogens being forced into the body of the female Luer by the male Luer 2841.

[0237] Channel 2867 influences pathogen entrapment within the tip recess because channel 2867 provides a restricted space in which pathogens can become trapped between distal tip surface 2852 and the interior surface of the female luer. The peaks 2864 of blades 2863 provide the maximum outer diameter of distal tip 2855, and the valleys 2868 of channels 2867 provide the minimum outer diameter of distal tip 2855. Blades 2863 provide a physical barrier between adjacent channels 2867 when male luer 2841 is mated with a female luer. As shown in Figures 28D and 28E, the outer diameter of distal tip 2855 is the same as the outer diameter of tapered sealing member 2842 at the peaks 2864 of blades 2863. As shown in Figure 28F, the outer diameter of distal tip 2855 is smaller than the outer diameter of tapered sealing member 2842 at the valleys 2868 of channels 2867.

[0238] In this example, the outer diameter of the tip 2864 of each blade 2863 is on the line of the taper of the tapered sealing member 2842. When the male connector 2801 is mated with the female connector such that the male and female luers form a fluid-tight fit, the tip 2864 of each blade 2863 contacts the inner surface of the female luer.

[0239] Distal tip 2855 includes a distal recess 2851. In this example, the distal recess resides within the volume of channel 2867 created between blades 2863, where the outer diameter of distal tip 2855 is inside the line of the taper of tapered sealing member 2842.

[0240] Male connector with threaded blade (Figures 29A-G) 29A-G, male connector 2901 includes a male luer 2941. Male luer 2941 includes a tapered sealing member 2942. Tapered sealing member 2942 has a frustoconical shape that tapers from a larger outer diameter at a proximal portion of tapered sealing member 2942 to a smaller outer diameter at a distal portion of the tapered sealing member near tapered surface distal edge 2961. Tapered sealing member 2942 has a tapered sealing surface 2943 configured to mate with a female luer to create a fluid-tight fit. Male connector 2901 further includes threads 2902 that allow male connector 2901 to mate with a female connector. A lumen 2912 extends through male connector 2901.

[0241] The male luer 2941 includes a distal tip 2955 with an end surface 2904. A distal recess 2951 is formed by a recessed portion of the distal tip 2955, as shown in Figures 29F and 29G.

[0242] Male luer 2941 includes a tapered surface distal edge 2961 that defines the proximal end of distal tip 2955. In some examples, an antimicrobial is provided to distal tip surface 2952 by coating, spraying, or dipping distal tip 2955 with the antimicrobial, although other methods of providing the antimicrobial are contemplated and within the scope of the present technology. In some examples, an antimicrobial is also provided to tapered sealing surface 2943. The antimicrobial on distal tip surface 2952 of distal tip 2955 kills pathogens trapped between the surface of the female luer and distal tip surface 2952. Distal recess 2951 is designed to trap the antimicrobial between the inner surface of the female luer and distal tip surface 2952, so that pathogens are exposed to a high concentration of the antimicrobial.

[0243] An antimicrobial agent on the distal tip surface 2952 may be stored in the volume between the blades 2963 . Distal tip 2955 includes a plurality of blades 2963 that separate a plurality of channels 2967. The blades 2963 spiral around the axis of lumen 2912, and valleys 2968 of channels 2967 follow the spiral. In this example, the outer diameter of the apex 2964 of each blade 2963 is on the line of the taper of tapered sealing member 2942. Therefore, when male connector 2901 is mated with the female connector such that the male luer and female luer form a fluid-tight fit, apex 2964 of each blade 2963 contacts the inner surface of the female luer.

[0244] In some examples, the blade 2963 has the same thread pitch as the pitch of the internal thread 2902 of the male connector 2901. By rotating the male connector 2901 about the axis of the lumen 2912 when inserting the male luer 2941 into the female luer, the blade 2963 rotates along with the male luer 2941. From the perspective shown in FIG. 29E , the male connector 2901 moves in a counterclockwise direction. The blade 2963 has a leading edge 2981 that can contact the inner surface of the female luer. In this case, the apex 2964 acts as an extension of the tapered surface leading edge 2961. This rotation allows the leading edge 2981 of the blade 2963 to act like a ramp, pushing any particles (e.g., pathogens) on the surface of the female luer in a proximal direction.

[0245] Distal tip 2955 includes a distal recess 2951. In this example, distal recess 2951 resides within the volume of channel 2967 created between blades 2963. As discussed above, leading edge 2981 can act like a ramp to push particles proximally, away from end face 2904 of distal tip 2955. Antimicrobial agent present on distal tip surface 2952 of distal tip 2955 can be dispersed within channel 2967 that forms distal recess 2951.

[0246] Channel 2967 influences pathogen entrapment within tip recess 2951 because channel 2967 provides a restricted space in which pathogens can become trapped between distal tip surface 2952 and the interior surface of the female luer. The crest 2964 of blade 2963 provides the maximum outer diameter of distal tip 2955, and the valley 2968 of channel 2967 provides the minimum outer diameter of distal tip 2955. When male luer 2941 is connected to a female luer, blade 2963 provides a physical barrier between adjacent channels 2967. The outer diameter of distal tip 2955 is the same as the outer diameter of tapered sealing member 2942 at crest 2964 of blade 2963. As shown in FIGS. 29F and 29G , the outer diameter of distal tip 2955 is smaller than the outer diameter of tapered sealing member 2942 at valley 2968 of channel 2967.

[0247] Male connector with proximal trap (Figure 30A-G) 30A-G, male connector 3001 includes a male luer 3041. Male luer 3041 includes a tapered sealing member 3042. Tapered sealing member 3042 has a frustoconical shape that tapers from a larger outer diameter at a proximal portion of tapered sealing member 3042 to a smaller outer diameter at a distal portion of the tapered sealing member near tapered surface distal edge 3061. Tapered sealing member 3042 has a tapered sealing surface 3043 configured to mate with a female luer to create a fluid-tight fit. Male connector 3001 further includes threads 3002 that allow male connector 3001 to mate with a female connector. A lumen 3012 extends through male connector 3001.

[0248] Male luer 3041 includes a distal tip 3055 with an end surface 3004. Distal tip 3055 of male luer 3041 is recessed from the distal line of the taper of tapered sealing member 3042. Distal tip 3055 has a distal tip surface 3052 and a distal recess 3051. Distal recess 3051 is formed by a recessed portion of distal tip 3055. Distal tip surface 3052 of distal tip 3055 defines an outer diameter that is smaller than the outer diameter of the extension of tapered sealing surface 3043.

[0249] In some examples, the antimicrobial is provided to the distal tip surface 3052 by coating, spraying, or dipping the distal tip 3055 with the antimicrobial, although other methods of providing the antimicrobial are contemplated and within the scope of the present technology. In some examples, the antimicrobial is also provided to the tapered sealing surface 3043. The antimicrobial on the distal tip surface 3052 of the distal tip 3055 kills pathogens within the distal recess 3051 between the surface of the female luer and the distal tip surface 3052. The distal recess 3051 is designed to trap the antimicrobial between the inner surface of the female luer and the distal tip surface 3052, so that the pathogens are exposed to a high concentration of the antimicrobial.

[0250] Distal recess 3051 affects pathogen entrapment because it provides a restricted space in which pathogens can become trapped between distal tip surface 3052 and the interior surface of the female luer. As shown in Figures 30E and 30F, the outer diameter of distal tip 3055 is smaller than the outer diameter of tapered sealing member 3042 at tapered surface leading edge 3061, and the outer diameter of distal tip 3055 is smaller than the outer diameter of the distal line of the taper defined by conical tapered sealing member 3042.

[0251] In this example, the distal tip surface 3052 does not include a blade. The male luer 3041 has a tapered surface leading edge 3061 at the distal end of the tapered sealing member 3042. The tapered surface leading edge 3061 has a tapered surface leading edge surface 3062. A proximal trap 3071 is defined by a proximal trap wall 3073. The proximal trap 3071 is a cavity bounded on multiple sides by the proximal trap walls 3073 formed in the male luer 3041. In the example shown in FIG. 30G, the proximal trap 3071 is an annular cavity within the male luer defined by a proximal wall 3081, an outer wall 3082, and an inner wall 3083. The proximal trap 3071 opens into the distal recess 3051 and is adjacent to the tapered surface leading edge surface 3062. An antimicrobial agent may be contained within the proximal trap 3071, as described below in connection with Figures 38 and 39.

[0252] Proximal trap 3071 stores an antimicrobial agent within the annular cavity defined by proximal trap 3071. In some instances, pathogens reside near the interface between tapered surface leading edge 3061 and the surface of the female luer. The antimicrobial agent stored in proximal trap 3071 ensures that a high concentration of antimicrobial agent (up to saturation levels) remains in the vicinity of the pathogens.

[0253] Both the proximal trap 3071 and the distal recess 3051 are designed to trap pathogens, fluids, and antimicrobials near the female luer surface of the female connector. There is a difference between the trapping of fluids and antimicrobials in the proximal trap 3071 and the trapping of fluids and antimicrobials in the distal recess 3051. The trapping of fluids and antimicrobials in the proximal trap 3071 occurs independently of the female luer surface.

[0254] The proximal trap wall 3073 creates a cavity configured to prevent or minimize fluid escape from the proximal trap 3071. The antimicrobial agent is not easily washed out of the proximal trap 3071 during or after insertion of the male connector 3001 into the female connector. The shape of the cavity in the proximal trap 3071 allows for limited recirculation of fluid and antimicrobial agent within the proximal trap 3071 during multiple fluid flow conditions described in connection with Figures 38 and 39. The antimicrobial agent on the surface of the proximal trap wall 3073 may diffuse out of the proximal trap 3071 once the male luer 3041 is attached to the fluid-filled female luer or during multiple fluid flow conditions.

[0255] In contrast, containment of the antimicrobial agent within the distal recess 3051 relies on the female luer surface; this containment is optimized when the male connector 3001 is fully inserted into the female connector. When the male connector 3001 is mated with the female connector, the cavity formed between the distal tip surface 3052 and the female luer surface limits fluid circulation and transport of the antimicrobial agent into the lumen of the female luer. The limited fluid circulation, combined with the containment, keeps the antimicrobial agent highly concentrated within the cavity of the distal recess 3051, even when fluid is flowing through the lumen 3012.

[0256] Figure 30G is an enlarged cross-sectional view of the distal portion of the connector of Figure 30F. Proximal trap 3071 has a depth A, and distal recess 3051 has a depth B. Proximal trap 3071 has a width C, and distal recess 3051 has a width D. In Figure 30G, the term "width" refers to the distance measured parallel to the central longitudinal axis of the male lure, and the term "depth" refers to the distance measured perpendicular to the central longitudinal axis of the male lure.

[0257] In some embodiments, the proximal trapping depth A can be greater than or equal to 0.10 mm, 0.15 mm, 0.20 mm, 0.25 mm, 0.30 mm, 0.35 mm, 0.40 mm, or 0.45 mm. In some embodiments, the proximal trapping depth A can be less than or equal to 0.80 mm, 0.75 mm, 0.70 mm, 0.65 mm, 0.60 mm, 0.55 mm, 0.50 mm, or 0.45 mm. In some embodiments, the proximal trapping depth A can be in the range of 0.10 mm to 0.80 mm, or 0.15 mm to 0.75 mm, or 0.20 mm to 0.70 mm, or 0.25 mm to 0.65 mm, or 0.30 mm to 0.60 mm, or 0.35 mm to 0.55 mm, or 0.40 mm to 0.50 mm, or can be about 0.39 mm.

[0258] The distal recess depth B is greater than the proximal trap depth A. In some embodiments, the distal recess depth B can be 0.20 mm, 0.26 mm, 0.31 mm, 0.37 mm, 0.42 mm, 0.48 mm, 0.54 mm, 0.59 mm, or 0.65 mm or greater. In some embodiments, the distal recess depth B can be 1.00 mm, 0.96 mm, 0.91 mm, 0.87 mm, 0.82 mm, 0.78 mm, 0.74 mm, 0.69 mm, or 0.65 mm or less. In some embodiments, the tip recess depth B can be in the range of 0.20 mm to 1.00 mm, or 0.26 mm to 0.96 mm, or 0.31 mm to 0.91 mm, or 0.37 mm to 0.87 mm, or 0.42 mm to 0.82 mm, or 0.48 mm to 0.78 mm, or 0.54 mm to 0.74 mm, or 0.59 mm to 0.69 mm, or can be about 0.77 mm.

[0259] The distal recess depth B affects the depth of the cavity formed between the distal tip surface and the female tapered surface when the male luer is mated with the female luer. In some embodiments, the distal tip may have an outer diameter at a radially outer point of the distal tip that is less than 95 percent of the inner diameter of the female tapered surface. In some embodiments, the distal tip may have an outer diameter that is 50 to 95 percent of the inner diameter of the female tapered surface. In some embodiments, the distal tip outer diameter, expressed as a percentage of the inner diameter of the female tapered surface, may be 50%, 55%, 60%, 65%, 70%, 75%, or 80% or more of the inner diameter of the female tapered surface. In some embodiments, the distal tip outer diameter, expressed as a percentage of the inner diameter of the female tapered surface, may be 95%, 90%, 85%, or 80% or less of the inner diameter of the female tapered surface. In some embodiments, the outer diameter of the distal tip, expressed as a percentage of the inner diameter of the female tapered surface, may be within the range of 50%-95%, or 55%-90%, or 60%-90%, or 65%-85%, or 70%-85%, or 70%-80%, or 75%-85%, or may be approximately 80% of the inner diameter of the female tapered surface. Various alternatives are possible based on the particular application of the technology.

[0260] Furthermore, in examples where the distal tip includes a blade (e.g., the examples of Figures 17A-F), the outer diameter of the distal tip is variable around the periphery of the distal tip, and the outer diameter of the distal tip, expressed as a percentage of the inner diameter of the female tapered surface, is likewise variable.

[0261] In examples where the outer diameter of the apex of the blade is equal to the inner diameter of the female tapered surface (e.g., the examples of Figures 28A-F), the distal tip can have an outer diameter that varies from 50 percent of the inner diameter of the female tapered surface to 100 percent of the inner diameter of the female tapered surface. Other examples are possible and within the scope of the technology of the present disclosure.

[0262] In some embodiments, the proximal trap width C can be 0.10 mm, 0.18 mm, 0.26 mm, 0.34 mm, 0.41 mm, 0.49 mm, 0.57 mm, 0.65 mm, 0.73 mm, 0.81 mm, 0.89 mm, 0.96 mm, 1.04 mm, 1.12 mm, or 1.20 mm or more. In some embodiments, the proximal trap width C can be 2.50 mm, 2.41 mm, 2.31 mm, 2.22 mm, 2.13 mm, 2.04 mm, 1.94 mm, 1.85 mm, 1.76 mm, 1.66 mm, 1.57 mm, 1.48 mm, 1.39 mm, 1.29 mm, or 1.20 mm or less. In some embodiments, the proximal trap width C can be in the range of 0.10 mm to 2.50 mm, or 0.18 mm to 2.41 mm, or 0.26 mm to 2.31 mm, or 0.34 mm to 2.22 mm, or 0.41 mm to 2.13 mm, or 0.49 mm to 2.04 mm, or 0.57 mm to 1.94 mm, or 0.65 mm to 1.85 mm, or 0.73 mm to 1.76 mm, or 0.81 mm to 1.66 mm, or 0.89 mm to 1.57 mm, or 0.96 mm to 1.48 mm, or 1.04 mm to 1.39 mm, or 1.12 mm to 1.29 mm, or can be about 0.51 mm.

[0263] The distal tip width D can be greater than the proximal trap width C, or alternatively, can be less than or equal to the proximal trap width C. In some embodiments, the distal tip width D can be 0.50 mm, 0.70 mm, 0.90 mm, 1.10 mm, 1.30 mm, 1.50 mm, 1.70 mm, 1.90 mm, or 2.10 mm or greater. In some embodiments, the distal tip width D can be 4.00 mm, 3.81 mm, 3.62 mm, 3.43 mm, 3.24 mm, 3.05 mm, 2.86 mm, 2.67 mm, 2.48 mm, 2.29 mm, or 2.10 mm or less. In some embodiments, the distal tip width D can be within the range of 0.50 mm to 4.00 mm, or 0.60 mm to 3.62 mm, or 0.70 mm to 3.43 mm, or 0.90 mm to 3.24 mm, or 1.10 mm to 3.05 mm, or 1.30 mm to 2.86 mm, or 1.50 mm to 2.67 mm, or 1.70 mm to 2.48 mm, or 1.90 mm to 2.29 mm, or can be approximately 2.41 mm. Conventional male Luer connectors can have a radius or chamfer on the male tapered outer tip. International Standard ISO 80369-7: Connectors for Intravascular or Hypodermic Applications specifies a maximum radius or chamfer of 0.5 mm.

[0264] The distal tip 3055 has a wall thickness E. In some embodiments, the wall thickness E can be 0.10 mm, 0.15 mm, 0.20 mm, 0.25 mm, 0.30 mm, 0.35 mm, 0.40 mm, or 0.45 mm or greater. In some embodiments, the wall thickness E can be 0.80 mm, 0.75 mm, 0.70 mm, 0.65 mm, 0.60 mm, 0.55 mm, 0.50 mm, or 0.45 mm or less. In some embodiments, the wall thickness E can be in the range of 0.10 mm to 0.80 mm, or 0.15 mm to 0.75 mm, or 0.20 mm to 0.70 mm, or 0.25 mm to 0.65 mm, or 0.30 mm to 0.60 mm, or 0.35 mm to 0.55 mm, or 0.40 mm to 0.50 mm, or can be about 0.39 mm.

[0265] The lumen 3012 has an inner diameter F. In some embodiments, the inner lumen diameter F can be greater than or equal to 1.00 mm, 1.13 mm, 1.26 mm, 1.39 mm, 1.52 mm, or 1.65 mm. In some embodiments, the inner lumen diameter F can be less than or equal to 2.00 mm, 1.93 mm, 1.86 mm, 1.79 mm, 1.72 mm, or 1.65 mm. In some embodiments, the inner lumen diameter F can be within the range of 1.00 mm to 2.00 mm, or 1.13 mm to 1.93 mm, or 1.26 mm to 1.86 mm, or 1.39 mm to 1.79 mm, or 1.52 mm to 1.72 mm, or can be approximately 1.65 mm.

[0266] Male connector with multiple proximal cavities (Figures 31A-G) 31A-G, male connector 3101 includes a male luer 3141. Male luer 3141 includes a tapered sealing member 3142. Tapered sealing member 3142 has a frustoconical shape that tapers from a larger outer diameter at a proximal portion of tapered sealing member 3142 to a smaller outer diameter at a distal portion of the tapered sealing member near tapered surface distal edge 3161. Tapered sealing member 3142 has a tapered sealing surface 3143 configured to mate with a female luer to create a fluid-tight fit. Male connector 3101 further includes threads 3102 that allow male connector 3101 to mate with a female connector. A lumen 3112 extends through male connector 3101.

[0267] Male luer 3141 includes a distal tip 3155 with an end surface 3104. Distal tip 3155 of male luer 3141 is recessed from the distal line of the taper of tapered sealing member 3142. A distal recess 3151 is formed by the recessed portion of distal tip 3155. Distal tip surface 3152 of distal tip 3155 defines an outer diameter that is smaller than the outer diameter of the extension of tapered sealing surface 3143.

[0268] In some examples, the antimicrobial is provided to the distal tip surface 3152 by coating, spraying, or dipping the distal tip 3155 with the antimicrobial, although other methods of providing the antimicrobial are contemplated and are within the scope of the present technology. In some examples, the antimicrobial is also provided to the tapered sealing surface 3143. The antimicrobial on the distal tip surface 3152 of the distal tip 3155 kills pathogens within the distal recess 3151 between the surface of the female luer and the distal tip surface 3152. The distal recess 3151 is designed to trap the antimicrobial between the inner surface of the female luer and the distal tip surface 3152, so that the pathogens are exposed to a high concentration of the antimicrobial.

[0269] The distal recess 3151 affects pathogen entrapment because the distal recess 3151 provides a restricted space in which pathogens can become trapped between the distal tip surface 3152 and the interior surface of the female luer. As shown in FIG. 31F, the outer diameter of the distal tip 3155 is smaller than the outer diameter of the tapered sealing member 3142 at the tapered surface leading edge 3161, and the outer diameter of the distal tip 3155 is smaller than the outer diameter of the distal line of the taper defined by the conical tapered sealing member 3142.

[0270] 30, the tapered surface leading edge 3161 has a tapered surface leading edge surface 3162. However, the distal tip 3155 includes multiple proximal traps 3171 that are separated from each other by proximal trap walls 3173. The proximal traps 3171 do not have individual entrances or exits. The antimicrobial agent is stored on the surface of the proximal trap walls 3173, and the antimicrobial agent diffuses from the proximal traps 3171 after the male luer 3141 is attached within the female luer.

[0271] Male connector with blades and multiple proximal cavities (Figures 32A-G) 32A-G, male connector 3201 includes a male luer 3241. Male luer 3241 includes a tapered sealing member 3242. Tapered sealing member 3242 has a frustoconical shape that tapers from a larger outer diameter at a proximal portion of tapered sealing member 3242 to a smaller outer diameter at a distal portion of the tapered sealing member near tapered surface distal edge 3261. Tapered sealing member 3242 has a tapered sealing surface 3243 configured to mate with a female luer to create a fluid-tight fit. Male connector 3201 further includes threads 3202 that allow male connector 3201 to mate with a female connector. A lumen 3212 extends through male connector 3201.

[0272] Male luer 3241 includes a distal tip 3255 with an end surface 3204. Distal tip 3255 of male luer 3241 is recessed from the distal line of the taper of tapered sealing member 3242. A distal recess 3251 is formed by the recessed portion of distal tip 3255. Distal tip surface 3252 of distal tip 3255 defines an outer diameter that is smaller than the outer diameter of the extension of tapered sealing surface 3243.

[0273] The male luer 3241 includes a tapered surface distal edge 3261 that defines the proximal end of the distal tip 3255. In some examples, the antimicrobial is provided to the distal tip surface 3252 by coating, spraying, or dipping the distal tip 3255 with the antimicrobial, although other methods of providing the antimicrobial are contemplated and within the scope of the present technology. In some examples, the antimicrobial is also provided to the tapered sealing surface 3243. The antimicrobial on the distal tip surface 3252 of the distal tip 3255 kills pathogens within the distal recess 3251 between the surface of the female luer and the distal tip surface 3252. The distal recess 3251 is designed to trap the antimicrobial between the inner surface of the female luer and the distal tip surface 3252, so that the pathogens are exposed to a high concentration of the antimicrobial.

[0274] The male luer 3241 further includes a plurality of blades 3263 disposed around the distal tip 3255 of the male luer 3241. Between the blades 3263 are a plurality of channels 3267. In the example of FIG. 32 , the blades 3263 are elongate protrusions disposed around the axis of the tapered sealing member 3242, and the channels 3267 are elongate recesses disposed between the blades 3263 and extending parallel to the lumen 3212. The blades 3263 and channels 3267 alternately form peaks 3264 and valleys 3268. The distal tip surface 3252 of the distal tip 3255 is defined by the blades 3263 and the channels 3267. An antimicrobial agent on the distal tip surface 3252 may be stored in the volume between the blades 3263.

[0275] During insertion of the male Luer 3241 into the female Luer, portions of the distal tip 3255 may contact the inner surface of the female Luer. The peaks 3264 of each blade 3263 may contact the female Luer surface, but the valleys 3268 of the channels 3267 do not. For example, the surface area of ​​the blades 3263 near the end face 3204 of the distal tip 3255 is relatively small compared to the tapered surface leading edge 3261. This minimizes the amount of pathogen intrusion that may result from pathogens being forced into the body of the female Luer by the male Luer 3241.

[0276] Channels 3267 affect pathogen entrapment within the tip recess because they provide a restricted space in which pathogens can become trapped between the distal tip surface 3252 and the inner surface of the female Luer. The peaks 3264 of the blades 3263 provide the maximum outer diameter of the distal tip 3255, and the valleys 3268 of the channels 3267 provide the minimum outer diameter of the distal tip 3255. When the male Luer 3241 is coupled to the female Luer, a small amount of fluid flow between adjacent channels 3267 is possible, but the blades 3263 provide a partial physical barrier. As shown in Figures 32E and 32F, the outer diameter of the distal tip 3255 is smaller than the outer diameter of the tapered sealing member 3242 at the tapered surface leading edge 3261, and the outer diameter of the distal tip 3255 is smaller than the outer diameter of the tapered leading line defined by the conical tapered sealing member 3242.

[0277] The male luer 3241 includes a tapered surface leading edge 3261 having a tapered surface leading edge surface 3262. As in the example of FIG. 31 , a plurality of proximal traps 3271 are formed within a plurality of proximal trap walls 3273 proximal to the tapered surface leading edge surface 3262. This can be best seen in FIG. 32G . Each proximal trap 3271 is isolated from the other proximal traps. Each proximal trap 3271 has only one entrance and exit, forming a cavity surrounded on all sides by the proximal trap walls 3273. The proximal traps 3271 are defined by the proximal trap walls 3273. The proximal traps 3271 are cavities bounded on multiple sides. The proximal traps 3271 open into the distal recess 3251. The proximal traps are adjacent to the tapered surface leading edge surface 3262. An antimicrobial agent may be trapped within the proximal traps 3271.

[0278] Bladed male luer cap (Figure 33A-F) 33A-F, the male luer cap 3301 includes a male luer 3341. The male luer 3341 includes a tapered sealing member 3342. The tapered sealing member 3342 has a frusto-conical shape that tapers from a larger outer diameter at a proximal portion of the tapered sealing member 3342 to a smaller outer diameter at a distal portion of the tapered sealing member near a tapered surface distal edge 3361. The tapered sealing member 3342 has a tapered sealing surface 3343 that is configured to mate with a female luer to create a fluid-tight fit. The male luer cap 3301 further includes threads 3302 that allow the male luer cap 3301 to be coupled with a female connector.

[0279] Male luer 3341 includes a distal tip 3355 with an end surface 3304. Distal tip 3355 of male luer 3341 is recessed from the distal line of the taper of tapered sealing member 3342. A distal recess 3351 is formed by the recessed portion of distal tip 3355. Distal tip surface 3352 of distal tip 3355 defines an outer diameter that is smaller than the outer diameter of the extension of tapered sealing surface 3343.

[0280] The male luer 3341 includes a tapered surface distal edge 3361 that defines the proximal end of the distal tip 3355. In some examples, the antimicrobial is provided to the distal tip surface 3352 by coating, spraying, or dipping the distal tip 3355 with the antimicrobial, although other methods of providing the antimicrobial are contemplated and within the scope of the present technology. In some examples, the antimicrobial is also provided to the tapered sealing surface 3343. The antimicrobial on the distal tip surface 3352 of the distal tip 3355 kills pathogens within the distal recess 3351 between the surface of the female luer and the distal tip surface 3352. The distal recess 3351 is designed to trap the antimicrobial between the inner surface of the female luer and the distal tip surface 3352, so that the pathogens are exposed to a high concentration of the antimicrobial.

[0281] The male luer 3341 further includes a plurality of blades 3363 disposed around the distal tip 3355 of the male luer 3341. Between the blades 3363 are a plurality of channels 3367. In the example of FIG. 33 , the blades 3363 are elongate protrusions disposed around the axis of the tapered sealing member 3342, and the channels 3367 are elongate recesses disposed between the blades 3363. The blades 3363 and channels 3367 alternately form peaks 3364 and valleys 3368. The distal tip surface 3352 of the distal tip 3355 is defined by the blades 3363 and the channels 3367. An antimicrobial agent on the distal tip surface 3352 may be stored in the volume between the blades 3363.

[0282] During insertion of the male Luer 3341 into the female Luer, portions of the distal tip 3355 may contact the inner surface of the female Luer. The peaks 3364 of each blade 3363 may contact the female Luer surface, but the valleys 3368 of the channels 3367 do not. For example, the surface area of ​​the blades 3363 near the end face 3304 of the distal tip 3355 is relatively small compared to the tapered surface leading edge 3361. This minimizes the amount of pathogen intrusion that may result from pathogens being forced into the body of the female Luer by the male Luer 3341.

[0283] Channel 3367 influences pathogen entrapment within the tip recess because channel 3367 provides a restricted space in which pathogens can become trapped between distal tip surface 3352 and the inner surface of the female Luer. The peak 3364 of blade 3363 provides the maximum outer diameter of distal tip 3355, and the valley 3368 of channel 3367 provides the minimum outer diameter of distal tip 3355. When male Luer 3341 is coupled to a female Luer, a small amount of fluid flow between adjacent channels 3367 is possible, but blade 3363 provides a partial physical barrier. As shown in Figures 33D and 33E, the outer diameter of distal tip 3355 is smaller than the outer diameter of tapered sealing member 3342 at tapered surface leading edge 3361, and the outer diameter of distal tip 3355 is smaller than the outer diameter of the tapered leading line defined by conical tapered sealing member 3342.

[0284] The male luer cap 3301 does not include a lumen because it is designed to prevent fluid escape from a medical device that has a female luer at the proximal end of the medical device. An antimicrobial agent may coat the distal tip surface 3352. In some examples, the antimicrobial agent may also coat the end face 3304. Although not shown in FIG. 33 , the male luer cap 3301 may further include one or more proximal traps similar to those described above.

[0285] Luer couplers with a bladed male tip (Figure 34A-F) 34A-F, luer coupler 3401 includes a male connector portion 3449 and a female connector portion 3489 that is integral with male connector portion 3449. A lumen 3412 extends through both female connector portion 3489 and male connector portion 3449. Female connector portion 3489 of luer coupler 3401 includes threads 3486 for mating with a male connector. Female connector portion 3489 further includes a female luer tapered sealing surface 3488.

[0286] The male luer 3441 includes a tapered sealing member 3442. The tapered sealing member 3442 has a frustoconical shape that tapers from a larger outer diameter at a proximal portion of the tapered sealing member 3442 to a smaller outer diameter at a distal portion of the tapered sealing member near a tapered surface distal edge 3461. The tapered sealing member 3442 has a tapered sealing surface 3443 that is configured to mate with a female luer to create a fluid-tight fit. The luer coupler 3401 further includes threads 3402 that allow the luer coupler 3401 to be coupled with a female connector.

[0287] Male luer 3441 includes a distal tip 3455 with an end surface 3404. Distal tip 3455 of male luer 3441 is recessed from the distal line of the taper of tapered sealing member 3442. A distal recess 3451 is formed by the recessed portion of distal tip 3455. Distal tip surface 3452 of distal tip 3455 defines an outer diameter that is smaller than the outer diameter of the extension of tapered sealing surface 3443.

[0288] The male luer 3441 includes a tapered surface distal edge 3461 that defines the proximal end of the distal tip 3455. In some examples, the antimicrobial is provided to the distal tip surface 3452 by coating, spraying, or dipping the distal tip 3455 with the antimicrobial, although other methods of providing the antimicrobial are contemplated and within the scope of the present technology. In some examples, the antimicrobial is also provided to the tapered sealing surface 3443. The antimicrobial on the distal tip surface 3452 of the distal tip 3455 kills pathogens within the distal recess 3451 between the surface of the female luer and the distal tip surface 3452. The distal recess 3451 is designed to trap the antimicrobial between the inner surface of the female luer and the distal tip surface 3452, so that the pathogens are exposed to a high concentration of the antimicrobial.

[0289] The male luer 3441 further includes a plurality of blades 3463 disposed around the distal tip 3455 of the male luer 3441. Between the blades 3463 are a plurality of channels 3467. In the example of FIG. 34 , the blades 3463 are elongate protrusions disposed around the axis of the tapered sealing member 3442, and the channels 3467 are elongate recesses disposed between the blades 3463 and extending parallel to the lumen 3412. The blades 3463 and channels 3467 alternately form peaks 3464 and valleys 3468. The distal tip surface 3452 of the distal tip 3455 is defined by the blades 3463 and the channels 3467. An antimicrobial agent on the distal tip surface 3452 may be stored in the volume between the blades 3463.

[0290] During insertion of the male Luer 3441 into the female Luer, portions of the distal tip 3455 may contact the inner surface of the female Luer. The peaks 3464 of each blade 3463 may contact the female Luer surface, but the valleys 3468 of the channels 3467 do not. For example, the surface area of ​​the blades 3463 near the end face 3404 of the distal tip 3455 is relatively small compared to the tapered surface leading edge 3461. This minimizes the amount of pathogen intrusion that may result from pathogens being forced into the body of the female Luer by the male Luer 3441.

[0291] The channels 3467 affect the entrapment of pathogens within the tip recess because they provide a restricted space in which pathogens can become trapped between the distal tip surface 3452 and the inner surface of the female Luer. The peaks 3464 of the blades 3463 provide the maximum outer diameter of the distal tip 3455, and the valleys 3468 of the channels 3467 provide the minimum outer diameter of the distal tip 3455. When the male Luer 3441 is coupled to the female Luer, a small amount of fluid flow between adjacent channels 3467 is possible, but the blades 3463 provide a partial physical barrier. As shown in Figures 34C and 34D, the outer diameter of the distal tip 3455 is smaller than the outer diameter of the tapered sealing member 3442 at the tapered surface leading edge 3461, and the outer diameter of the distal tip 3455 is smaller than the outer diameter of the tapered leading line defined by the conical tapered sealing member 3442.

[0292] Luer couplers with a male tip and a proximal trap (Figure 35A-F) 35A-F, a luer coupler 3501 includes a male connector portion 3549 and a female connector portion 3589 that is integral with the male connector portion 3549. A lumen 3512 extends through both the female connector portion 3589 and the male connector portion 3549. The female connector portion 3589 of the luer coupler 3501 includes threads 3586 for mating with a male connector. The female connector portion 3589 further includes a female luer tapered sealing surface 3588.

[0293] The male luer 3541 includes a tapered sealing member 3542. The tapered sealing member 3542 has a frustoconical shape that tapers from a larger outer diameter at a proximal portion of the tapered sealing member 3542 to a smaller outer diameter at a distal portion of the tapered sealing member near a tapered surface distal edge 3561. The tapered sealing member 3542 has a tapered sealing surface 3543 that is configured to mate with a female luer to create a fluid-tight fit. The luer coupler 3501 further includes threads 3502 that allow the luer coupler 3501 to be coupled with a female connector.

[0294] Male luer 3541 includes a distal tip 3555 with an end surface 3504. Distal tip 3555 of male luer 3541 is recessed from the distal line of the taper of tapered sealing member 3542. A distal recess 3551 is formed by the recessed portion of distal tip 3555. Distal tip surface 3552 of distal tip 3555 defines an outer diameter that is smaller than the outer diameter of the extension of tapered sealing surface 3543.

[0295] The male luer 3541 includes a tapered surface distal edge 3561 that defines the proximal end of the distal tip 3555. In some examples, the antimicrobial is provided to the distal tip surface 3552 by coating, spraying, or dipping the distal tip 3555 with the antimicrobial, although other methods of providing the antimicrobial are contemplated and within the scope of the present technology. In some examples, the antimicrobial is also provided to the tapered sealing surface 3543. The antimicrobial on the distal tip surface 3552 of the distal tip 3555 kills pathogens within the distal recess 3551 between the surface of the female luer and the distal tip surface 3552. The distal recess 3551 is designed to trap the antimicrobial between the inner surface of the female luer and the distal tip surface 3552, thereby exposing pathogens to a high concentration of the antimicrobial.

[0296] The tapered surface leading edge 3561 has a tapered surface leading edge surface 3562. A proximal trap 3571 is defined by a proximal trap wall 3573. The proximal trap 3571 is a cavity bounded on multiple sides. The proximal trap 3571 opens into the distal recess 3551. The proximal trap is adjacent the tapered surface leading edge surface 3562. As described below in connection with Figures 38 and 39, an antimicrobial agent can be contained within the proximal trap 3571.

[0297] The proximal trap 3571 stores an antimicrobial agent within the annular cavity defined by the proximal trap 3571. In some instances, pathogens reside near the interface between the tapered surface leading edge 3561 and the surface of the female luer. The antimicrobial agent stored in the proximal trap 3571 ensures that a high concentration of antimicrobial agent (up to saturation levels) remains in close proximity to the pathogens.

[0298] Both the proximal trap 3571 and the distal recess 3551 are designed to minimize washout of the antimicrobial agent from the volume created between the female luer surface and the distal tip surface 3552. The proximal trap 3571 provides an isolated fluid flow region within the volume defined by the proximal trap wall 3573. The antimicrobial agent on the surface of the proximal trap wall 3573 diffuses out of the proximal trap 3571 after the male luer 3541 is attached into the female luer. The proximal trap 3571 prevents or minimizes fluid flow within the volume of the proximal trap 3571. Therefore, the antimicrobial agent is not easily washed out of the proximal trap 3571.

[0299] As shown in FIG. 35D, the outer diameter of the distal tip 3555 is smaller than the outer diameter of the tapered sealing member 3542 at the tapered surface distal edge 3561, and the outer diameter of the distal tip 3555 is smaller than the outer diameter of the distal line of the taper defined by the conical tapered sealing member 3542.

[0300] Luer coupler combined with male and female Luers (Figures 36-37) Figure 36 shows luer coupler 3501 coupled between male connector 3611 and female luer 3691. Figure 37 shows luer coupler 3701 coupled between male connector 3611 and female luer 3691. Male connector 3611 has male luer 3641 and lumen 3621. Male luer 3641 connects to female luer tapered sealing surface 3588 of luer coupler 3501. Female luer 3691 has female luer tapered sealing surface 3688 and lumen 3695.

[0301] Luer coupler 3701 is similar to, and has similar features and functionality as, luer coupler 3501. Male connector portion 3749 of luer coupler 3501 is similar to male connector 2001 described in connection with Figures 20A-G above.

[0302] Luer coupler 3701 includes a male connector portion 3749 and a female connector portion 3789 that is integral with male connector portion 3749. A lumen 3712 extends through both female connector portion 3789 and male connector portion 3749. Female connector portion 3789 further includes a female luer tapered surface 3788.

[0303] The luer coupler 3701 includes a male luer 3741. The male luer 3741 includes a tapered sealing member 3742 with a tapered face leading edge 3761. The luer coupler 3701 further includes threads 3702 that allow the luer coupler 3701 to mate with a female connector. A lumen 3712 extends through the luer coupler 3701.

[0304] The male luer 3741 includes a distal tip 3755 with a distal recess 3751 and an end face 3704. A distal tip surface 3752 of the distal tip 3755 defines an outer diameter that is smaller than the outer diameter of the extension of the tapered sealing surface 3743. Once the male luer 3741 is attached to the female luer 3691, the distal recess 3751 forms a cavity.

[0305] A tapered surface distal edge 3761 defines the proximal end of the distal tip 3755. In some examples, an antimicrobial agent is provided on the distal tip surface 3752 by coating, spraying, or dipping the distal tip 3755 with the antimicrobial agent, although other methods of providing the antimicrobial agent are contemplated and within the scope of the present technology. In some examples, an antimicrobial agent is also provided on the tapered sealing surface 3743.

[0306] The male luer 3741 further includes a plurality of blades 3763 disposed around the distal tip 3755 of the male luer 3741. Between the blades 3763 are a plurality of channels 3767.

[0307] Analysis of fluid flow through the male connector (Figures 38-39) Figures 38-39 are visual representations of mathematical modeling of a steady-state flow simulation of fluid flowing through a mated male and female Luer. Without wishing to be bound by theory, these models simulate a syringe delivering fluid to a female connector (Figure 38) and an IV-drip delivery system (Figure 39). The syringe load is characterized as a flow of 2 milliliters / second for 5 seconds. The IV drip load is characterized as a flow of 1 liter / hour for 1 hour. The simulations can be applied to systems such as the mated male connector portion 3549 and female Luer 3691 of Figure 36.

[0308] Figure 38 illustrates the operation of the system shown in Figure 36. In Figure 38, male luer 3541 is inserted into lumen 3695 of female luer 3691. The tapered sealing surface 3543 of male luer 3541 and the tapered sealing surface 3688 of female luer 3691 form a male-female luer interface in a fluid-tight seal. The distal tip 3555 of male luer 3541 is recessed from the female luer tapered sealing surface 3688.

[0309] The male luer 3541 has a distal recess 3551. The male luer 3541 includes a distal tip 3555 having a distal tip surface 3552. A cavity is formed between the distal tip surface 3552 and the tapered sealing surface 3688 of the female luer 3691. The cavity 3802 is also bounded by a tapered surface distal edge surface 3562 adjacent to the tapered surface distal edge 3561. In the example of FIG. 38 , the male luer 3541 further includes a proximal trap 3571 defined by a proximal trap wall 3573.

[0310] A fluid pathway is defined within the lumen 3512 of the male luer 3541 and the lumen 3695 of the female luer 3691. The fluid pathway has multiple fluid flow regions. The space through which fluid travels through the connection between the male luer and the female luer is the bulk flow region 3801. A cavity 3802 is formed between the distal tip surface 3552 and the female luer tapered sealing surface 3688. A boundary region 3803 is located between the bulk flow region 3801 and the cavity 3802. A proximal trapping region 3804 is located proximally from the tapered surface distal edge surface 3562.

[0311] The distal tip surface 3552 contains a solid deposit of antimicrobial agent, referred to as the load. The antimicrobial composition is deposited within the proximal trap 3571 and on one or more of the walls, surfaces, or faces of the female connector. The distal tip surface 3552 may be a primary location for surface-bound pathogens to reside within the luer connection.

[0312] The cavity 3802 limits recirculation of the fluid as the fluid load passes through the luer connection. The antimicrobial composition is dispersed within the recirculating fluid. The recirculating fluid within the cavity 3802 recirculates the antimicrobial composition, thereby increasing the concentration of the antimicrobial in this area and distributing the antimicrobial to the interior surface of the female connector. The presence of the antimicrobial along the interior surface of the female connector within the cavity 3802 prevents pathogens at the male-female interface from growing along the walls of the female luer tapered sealing surface 3688.

[0313] The fluid flow by design generates a set of three fluid recirculations, or vortices. These vortices create a fluid boundary between the passing fluid and the microbial load located at the edge of the male-female interface. The three vortices can be described by their location. The proximal trap vortex, contained within the proximal trap 3571, contains the bulk of the antimicrobial load. The cavity vortex is located adjacent to the proximal trap vortex. The boundary vortex is sandwiched between the cavity vortex and the stream of fluid passing through the bulk flow region 3801.

[0314] In the example of FIG. 38 , flow within the lumen is modeled at 2 mL / sec (milliliters per second), and vortices occur within boundary region 3803, cavity 3802, and proximal trapping region 3804. Antimicrobial agent is contained and recirculated within each of these regions. In some examples, proximal trapping region 3804 contains a greater antimicrobial load than can be dissolved into cavity 3802 at saturation concentrations; therefore, proximal trap 3571 acts as an antimicrobial reservoir, maintaining a high concentration of antimicrobial agent. In some examples, including this one, the antimicrobial agent concentration within cavity 3802 can be maintained at a minimum of 200 micrograms per milliliter (μg / ml) or more of chlorhexidine for one minute or more, even with lumen flows of 2 mL / sec or more, which is sufficient to produce a 4-log or greater reduction in microorganisms (i.e., a 99.99 percent reduction).

[0315] Figure 39 illustrates operation of the system shown in Figure 36 as described above under intravenous drip (IV drip) conditions. The space through which fluid travels through the male and female Luer connection is bulk flow region 3901. A cavity 3902 is formed between distal tip surface 3552 and female Luer tapered sealing surface 3688. A boundary region 3903 is located between bulk flow region 3901 and the recessed region. A proximal trapping region 3904 is located proximally from tapered surface distal edge surface 3562.

[0316] In the example of Figure 39, vortices are created in boundary region 3903, cavity 3902, and proximal trapping region 3904. Antimicrobial agent is contained and recirculated in each of these regions. In this example, the concentration of antimicrobial agent in cavity 3902 is similarly maintained well in excess of the minimum 200 micrograms per milliliter (µg / ml) or more of chlorhexidine required for over one minute to produce a 4-log reduction in microorganisms.

[0317] Male Luer connector with a wide-mouth proximal trap (Figure 40A-C) 40A-C, male connector 4001 includes a male luer 4041. Male luer 4041 includes a tapered sealing member 4042. Tapered sealing member 4042 has a frustoconical shape that tapers from a larger outer diameter at a proximal portion of tapered sealing member 4042 to a smaller outer diameter at a distal portion of the tapered sealing member near tapered surface distal edge 4061. Tapered sealing member 4042 has a tapered sealing surface 4043 configured to mate with a female luer to create a fluid-tight fit. Male connector 4001 further includes threads 4002 that allow male connector 4001 to mate with a female connector. A lumen 4012 provides a fluid flow channel through male connector 4001.

[0318] The male luer 4041 includes a distal tip 4055 with a distal end surface 4004. The distal tip 4055 of the male luer 4041 is recessed from a distal line of the taper of the tapered sealing surface 4043 (not shown, but similar to 1614 in FIG. 16 ). The distal tip 4055 has a distal tip surface 4052 and a distal recess 4051. The distal recess 4051 is formed by the distal tip 4055, which is the recessed portion of the male luer 4041. The distal tip surface 4052 of the distal tip 4055 defines an outer diameter that is smaller than the outer diameter of the extension of the tapered sealing surface 4043 along the distal line of the taper.

[0319] In some examples, the antimicrobial is provided to the distal tip surface 4052 by coating, spraying, or dipping the distal tip 4055 with the antimicrobial, although other methods of providing the antimicrobial are contemplated and within the scope of the present technology. In some examples, the antimicrobial is also provided to the tapered sealing surface 4043. The male connector 4001 is configured to connect to a female connector. When the male luer 4041 is connected to the female luer, a cavity is formed between the distal tip surface 4052 and the female luer surface.

[0320] An antimicrobial agent on the distal tip surface 4052 of the distal tip 4055 is configured to dissolve in the fluid, forming an antimicrobial solution that kills pathogens within the cavity formed between the surface of the female luer and the distal tip surface 4052. The distal recess 4051 is designed to trap the antimicrobial agent between the inner surface of the female luer and the distal tip surface 4052, thereby exposing the pathogens to a high concentration of the antimicrobial agent.

[0321] Distal recess 4051 affects pathogen entrapment because distal recess 4051 provides a restricted space in which pathogens can become trapped between distal tip surface 4052 and the interior surface of the female luer. Similar to the example shown in FIG. 30G, the outer diameter of distal tip 4055 is smaller than the outer diameter of tapered sealing member 4042 at tapered surface leading edge 4061, and the outer diameter of distal tip 4055 is smaller than the outer diameter of the distal line of the taper defined by conical tapered sealing member 4042.

[0322] The male luer 4041 has a tapered surface leading edge 4061 at the distal end of the tapered sealing member 4042. A proximal trap 4071 is defined by a proximal trap wall 4073. The proximal trap 4071 is a cavity bounded on multiple sides by the proximal trap wall 4073 formed in the male luer 4041. In the example shown in FIGS. 40A-C, the proximal trap 4071 is an annular cavity within the male luer 4041 defined by the proximal trap wall 4073, which includes a proximal wall 4081, an inner wall 4082, and an outer wall 4083. The cavity of the proximal trap 4071 opens into the distal recess 4051. The proximal trap is adjacent to a tapered surface leading edge surface 4062. As shown more clearly in FIG. 40C, the depth of the proximal trap 4071 increases toward the tapered surface leading edge 4061. Antimicrobial agents may be trapped within the proximal trap 4071 .

[0323] Proximal trap 4071 stores an antimicrobial agent within the annular cavity defined by proximal trap 4071. In some instances, pathogens reside near the interface between tapered surface leading edge 4061 and the surface of the female luer. The antimicrobial agent stored in proximal trap 4071 ensures that a high concentration of antimicrobial agent (up to saturation levels) remains in close proximity to the pathogens.

[0324] When the male luer is mated with the female luer, the tapered sealing surface 4043 is configured to contact the female luer surface. Therefore, the tapered sealing surface 4043 is susceptible to contamination by microorganisms from the female luer surface, as described above in connection with FIG. 3B. The tapered surface leading edge 4061 may also contact and scrape the female luer surface during insertion, potentially allowing entry of pathogens, as described in connection with FIG. 3F. The containment of the antimicrobial composition within the proximal trap 4071 provides a region of high antimicrobial concentration near the tapered surface leading edge 4061.

[0325] Furthermore, because tapered surface distal edge 4061 has a larger diameter than distal tip 4055, distal tip 4055 is less likely to scrape against the female luer surface during insertion of male connector 4001 into the female connector. This reduced amount of scraping by the distal tip minimizes microbial contamination from the introduction of pathogens near distal tip 4055 when male connector 4001 is mated with the female connector, as discussed above in connection with FIG. 7A. Therefore, proximal trap 4071 and distal recess 4051 act in combination to concentrate both pathogens and the antimicrobial composition within the cavity formed between distal tip surface 4052 and the female luer surface.

[0326] Both the proximal trap 4071 and the distal recess 4051 are designed to minimize washout of antimicrobial agents from the cavity created between the female luer surface and the distal tip surface 4052.

[0327] Both the proximal trap 4071 and the distal recess 4051 are designed to trap pathogens, fluids, and antimicrobials near the female luer surface of the female connector. There is a difference between the trapping of fluids and antimicrobials in the proximal trap 4071 and the trapping of fluids and antimicrobials in the distal recess 4051. The trapping of fluids and antimicrobials in the proximal trap 4071 occurs independently of the female luer surface.

[0328] The proximal trap wall 4073 creates a cavity configured to prevent or minimize fluid escape from the proximal trap 4071. The antimicrobial agent is not easily washed out of the proximal trap 4071 during or after insertion of the male connector 4001 into the female connector. The cavity shape of the proximal trap 4071 allows for limited recirculation of fluid and antimicrobial agent within the proximal trap 4071 during the fluid-flow conditions described in connection with FIGS. 38 and 39 . The antimicrobial agent on the surface of the proximal trap wall 4073 may diffuse out of the proximal trap 4071 once the male luer 4041 is attached to the fluid-filled female luer or during the fluid-flow conditions.

[0329] In contrast, containment of the antimicrobial agent within distal recess 4051 relies on the female luer surface; this containment is optimized when male connector 4001 is fully inserted into the female connector. When male connector 4001 is mated with the female connector, the cavity formed between distal tip surface 4052 and the female luer surface limits fluid circulation and transport of the antimicrobial agent into the lumen of the female luer. The limited fluid circulation, combined with the containment, keeps the antimicrobial agent highly concentrated within the cavity of distal recess 4051, even when fluid is flowing through lumen 4012.

[0330] As used herein, the term "width" refers to the distance measured parallel to the central longitudinal axis of the male lure, and the term "depth" refers to the distance measured perpendicular to the central longitudinal axis of the male lure.

[0331] As in the example of Figure 30G, proximal trap 4071 has a depth and distal recess 4051 has a depth. Although not explicitly symbolized in Figure 40C, the depth of proximal trap 4071 is similar to depth A of proximal trap 3071 in Figure 30G, and the depth of distal recess 4051 is similar to depth B of distal recess 3051 in Figure 30G.

[0332] Proximal trap 4071 has a width, and distal tip 4055 has a width. Although not explicitly symbolized in Figure 40C, the width of proximal trap 4071 is similar to width C of proximal trap 3071 in Figure 30G, and the width of distal tip 4055 is similar to width D of distal tip 3055 in Figure 30G.

[0333] In some embodiments, the depth of the proximal trap 4071 can be 0.10 mm, 0.15 mm, 0.20 mm, 0.25 mm, 0.30 mm, 0.35 mm, 0.40 mm, or 0.45 mm or more, hi some embodiments, the depth of the proximal trap 4071 can be 0.80 mm, 0.75 mm, 0.70 mm, 0.65 mm, 0.60 mm, 0.55 mm, 0.50 mm, or 0.45 mm or less. In some embodiments, the depth of the proximal trap 4071 can be in the range of 0.10 mm to 0.80 mm, or 0.15 mm to 0.75 mm, or 0.20 mm to 0.70 mm, or 0.25 mm to 0.65 mm, or 0.40 mm to 0.60 mm, or 0.35 mm to 0.55 mm, or 0.40 mm to 0.50 mm, or can be approximately 0.39 mm.

[0334] The depth of the distal recess 4051 is greater than the depth of the proximal trap 4071. In some embodiments, the depth of the distal recess 4051 can be 0.20 mm, 0.26 mm, 0.31 mm, 0.37 mm, 0.42 mm, 0.48 mm, 0.54 mm, 0.59 mm, or 0.65 mm or greater. In some embodiments, the depth of the distal recess 4051 can be 1.12 mm, 1.08 mm, 1.04 mm, 1.00 mm, 0.96 mm, 0.91 mm, 0.87 mm, 0.82 mm, 0.78 mm, 0.74 mm, 0.69 mm, or 0.65 mm or less. In some embodiments, the depth of the tip recess 4051 can be in the range of 0.20 mm to 1.00 mm, or 0.26 mm to 0.96 mm, or 0.31 mm to 0.91 mm, or 0.37 mm to 0.87 mm, or 0.42 mm to 0.82 mm, or 0.48 mm to 0.78 mm, or 0.54 mm to 0.74 mm, or 0.59 mm to 0.69 mm, or can be approximately 0.77 mm.

[0335] The depth of the distal recess 4051 affects the depth of the cavity formed between the distal tip surface 4052 and the female tapered surface when the male luer is mated with the female luer. In some embodiments, the distal tip may have an outer diameter, at a radially outer point of the distal tip, that is less than 95 percent of the inner diameter of the female tapered surface. In some embodiments, the distal tip may have an outer diameter that is between 50 percent and 95 percent of the inner diameter of the female tapered surface. In some embodiments, the distal tip outer diameter, expressed as a percentage of the inner diameter of the female tapered surface, may be 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, or 80% or more of the inner diameter of the female tapered surface. In some embodiments, the distal tip outer diameter, expressed as a percentage of the inner diameter of the female tapered surface, may be 95%, 90%, 85%, or 80% or less of the inner diameter of the female tapered surface. In some embodiments, the outer diameter of the distal tip, expressed as a percentage of the inner diameter of the female tapered surface, may be within the range of 50%-95%, or 55%-90%, or 60%-90%, or 65%-85%, or 70%-85%, or 70%-80%, or 75%-85%, or may be approximately 80% of the inner diameter of the female tapered surface. Various alternatives are possible based on the particular application of the technology.

[0336] In some embodiments, the width of the proximal trap 4071 can be 0.10 mm, 0.18 mm, 0.26 mm, 0.34 mm, 0.41 mm, 0.49 mm, 0.57 mm, 0.65 mm, 0.73 mm, 0.81 mm, 0.89 mm, 0.96 mm, 1.04 mm, 1.12 mm, or 1.20 mm or more. In some embodiments, the width of the proximal trap 4071 can be 2.50 mm, 2.41 mm, 2.31 mm, 2.22 mm, 2.13 mm, 2.04 mm, 1.94 mm, 1.85 mm, 1.76 mm, 1.66 mm, 1.57 mm, 1.48 mm, 1.39 mm, 1.29 mm, or 1.20 mm or less. In some embodiments, the width of the proximal trap 4071 can be in the range of 0.10 mm to 2.50 mm, or 0.18 mm to 2.41 mm, or 0.26 mm to 2.31 mm, or 0.34 mm to 2.22 mm, or 0.41 mm to 2.13 mm, or 0.49 mm to 2.04 mm, or 0.57 mm to 1.94 mm, or 0.65 mm to 1.85 mm, or 0.73 mm to 1.76 mm, or 0.81 mm to 1.66 mm, or 0.89 mm to 1.57 mm, or 0.96 mm to 1.48 mm, or 1.04 mm to 1.39 mm, or 1.12 mm to 1.29 mm, or can be about 0.51 mm.

[0337] The width of the distal tip 4055 can be wider than the width of the proximal trap 4071, but instead can be less than or equal to the width of the proximal trap 4071. In some embodiments, the width of the distal tip 4055 can be 0.10 mm, 0.40 mm, 0.50 mm, 0.70 mm, 0.90 mm, 1.10 mm, 1.40 mm, 1.50 mm, 1.70 mm, 1.90 mm, or 2.10 mm or more. In some embodiments, the width of the distal tip 4055 can be 4.00 mm, 3.81 mm, 3.62 mm, 3.43 mm, 3.24 mm, 3.05 mm, 2.86 mm, 2.67 mm, 2.48 mm, 2.29 mm, or 2.10 mm or less. In some embodiments, the width of the distal tip 4055 can be in the range of 0.10 mm to 4.00 mm, or 0.40 mm to 3.81 mm, or 0.50 mm to 3.62 mm, or 0.70 mm to 3.43 mm, or 0.90 mm to 3.24 mm, or 1.10 mm to 3.05 mm, or 1.40 mm to 2.86 mm, or 1.50 mm to 2.67 mm, or 1.70 mm to 2.48 mm, or 1.90 mm to 2.29 mm, or can be approximately 2.41 mm.

[0338] The distal tip 4055 has a wall thickness. Although not explicitly symbolized in FIG. 40C , the wall thickness of the distal tip 4055 can be similar to the wall thickness E of the distal tip 3055 as shown in FIG. 30G . In some embodiments, the wall thickness of the distal tip 4055 can be 0.10 mm, 0.15 mm, 0.20 mm, 0.25 mm, 0.40 mm, 0.35 mm, 0.40 mm, or 0.45 mm or greater. In some embodiments, the wall thickness of the distal tip 4055 can be 0.80 mm, 0.75 mm, 0.70 mm, 0.65 mm, 0.60 mm, 0.55 mm, 0.50 mm, or 0.45 mm or less. In some embodiments, the wall thickness of the distal tip 4055 can be in the range of 0.10 mm to 0.80 mm, or 0.15 mm to 0.75 mm, or 0.20 mm to 0.70 mm, or 0.25 mm to 0.65 mm, or 0.40 mm to 0.60 mm, or 0.35 mm to 0.55 mm, or 0.40 mm to 0.50 mm, or can be about 0.39 mm.

[0339] The lumen 4012 has an inner diameter similar to inner diameter F shown in FIG. 30G. In some embodiments, the inner diameter of the lumen 4012 can be greater than or equal to 1.00 mm, 1.13 mm, 1.26 mm, 1.39 mm, 1.52 mm, or 1.65 mm. In some embodiments, the inner diameter of the lumen 4012 can be less than or equal to 2.00 mm, 1.93 mm, 1.86 mm, 1.79 mm, 1.72 mm, or 1.65 mm. In some embodiments, the inner diameter of the lumen 4012 can be within the range of 1.00 mm to 2.00 mm, or 1.13 mm to 1.93 mm, or 1.26 mm to 1.86 mm, or 1.39 mm to 1.79 mm, or 1.52 mm to 1.72 mm, or can be approximately 1.65 mm.

[0340] Male Luer connector with a tapered proximal trap (Figure 41A-C) 41A-C, male connector 4101 includes a male luer 4141. Male luer 4141 includes a tapered sealing member 4142. Tapered sealing member 4142 has a frustoconical shape that tapers from a larger outer diameter at a proximal portion of tapered sealing member 4142 to a smaller outer diameter at a distal portion of the tapered sealing member near tapered surface distal edge 4161. Tapered sealing member 4142 has a tapered sealing surface 4143 configured to mate with a female luer to create a fluid-tight fit. Male connector 4101 further includes threads 4102 that allow male connector 4101 to mate with a female connector. A lumen 4112 extends through male connector 4101.

[0341] The male luer 4141 includes a distal tip 4155 with an end surface 4104. The distal tip 4155 of the male luer 4141 is recessed from the distal line of the taper of the tapered sealing member 4142. The distal tip 4155 has a distal tip surface 4152 and a distal recess 4151. The distal recess 4151 is formed by a recessed portion of the distal tip 4155. The distal tip surface 4152 of the distal tip 4155 defines an outer diameter that is smaller than the outer diameter of the extension of the tapered sealing surface 4143.

[0342] In some examples, the antimicrobial is provided to the distal tip surface 4152 by coating, spraying, or dipping the distal tip 4155 with the antimicrobial, although other methods of providing the antimicrobial are contemplated and within the scope of the present technology. In some examples, the antimicrobial is also provided to the tapered sealing surface 4143. The antimicrobial on the distal tip surface 4152 of the distal tip 4155 kills pathogens within the distal recess 4151 between the surface of the female luer and the distal tip surface 4152. The distal recess 4151 is designed to trap the antimicrobial between the inner surface of the female luer and the distal tip surface 4152, so that the pathogens are exposed to a high concentration of the antimicrobial.

[0343] The distal recess 4151 affects pathogen entrapment because it provides a limited space between the distal tip surface 4152 and the interior surface of the female luer in which pathogens can be trapped. The outer diameter of the distal tip 4155 is smaller than the outer diameter of the tapered sealing member 4142 at the tapered surface leading edge 4161, and the outer diameter of the distal tip 4155 is smaller than the outer diameter of the tapered leading line (not shown, but similar to the tapered leading line 1614 in FIG. 16 ) defined by the conical tapered sealing member 4142.

[0344] In this example, the distal tip surface 4152 does not include a blade. The male luer 4141 has a tapered surface distal edge 4161 at the distal end of the tapered sealing member 4142. The tapered surface distal edge 4161 has a tapered surface distal edge surface 4162. A proximal trap 4171 is defined by a proximal trap wall 4173. The proximal trap 4171 is a cavity bounded on multiple sides by the proximal trap wall 4173 formed in the male luer 4141. In the example shown in FIGS. 41A-C, the proximal trap 4171 is an annular cavity within the male luer, defined by a proximal wall 4181 and an inner wall 4183. The proximal trap 4171 opens into the distal recess 4151. An antimicrobial agent may be trapped within the proximal trap 4171.

[0345] The proximal trap 4171 stores an antimicrobial agent within the annular cavity defined by the proximal trap 4171. In some instances, pathogens reside near the interface between the tapered surface leading edge 4161 and the surface of the female luer. The antimicrobial agent stored in the proximal trap 4171 ensures that a high concentration of antimicrobial agent (up to saturation levels) remains in the vicinity of the pathogens.

[0346] Both the proximal trap 4171 and the distal recess 4151 are designed to trap pathogens, fluids, and antimicrobials near the female luer surface of the female connector. There is a difference between trapping fluids and antimicrobials in the proximal trap 4171 and trapping them in the distal recess 4151. The trapping of fluids and antimicrobials in the proximal trap 4171 occurs independently of the female luer surface.

[0347] The proximal trap wall 4173 creates a cavity configured to prevent or minimize fluid escape from the proximal trap 4171. The antimicrobial agent is not easily washed out of the proximal trap 4171 during or after insertion of the male connector 4101 into the female connector. The shape of the cavity in the proximal trap 4171 allows for limited recirculation of fluid and antimicrobial agent within the proximal trap 4171 during the multiple fluid flow conditions described in connection with FIGS. 38 and 39 . The antimicrobial agent on the surface of the proximal trap wall 4173 may diffuse out of the proximal trap 4171 once the male luer 4141 is attached to the fluid-filled female luer or during the multiple fluid flow conditions.

[0348] In contrast, containment of the antimicrobial agent within the distal recess 4151 relies on the female luer surface; this containment is optimized when the male connector 4101 is fully inserted into the female connector. When the male connector 4101 is mated with the female connector, the cavity formed between the distal tip surface 4152 and the female luer surface limits fluid circulation and transport of the antimicrobial agent into the lumen of the female luer. The limited fluid circulation, combined with the containment, keeps the antimicrobial agent highly concentrated within the cavity of the distal recess 4151, even when fluid is flowing through the lumen 4112.

[0349] As used herein, the term "width" refers to the distance measured parallel to the central longitudinal axis of the male lure, and the term "depth" refers to the distance measured perpendicular to the central longitudinal axis of the male lure.

[0350] As in the example of FIG. 40C , the proximal trap 4171 has a depth, and the distal recess 4151 has a depth. Although not explicitly symbolized in FIG. 41C , the depth of the proximal trap 4171 is similar to depth A of the proximal trap 3071 in FIG. 30G , and the depth of the distal recess 4151 is similar to depth B of the distal recess 3051 in FIG. 30G . In the example of FIG. 41C , the depth of the proximal trap is tapered. This tapered geometry terminates at a tapered face leading edge 4161; because the proximal wall 4181 of the proximal trap 4171 extends all the way to the tapered face leading edge 4161, the tapered sealing member 4142 does not substantially have an end face. At the tapered face leading edge 4161, the depth of the proximal trap 4171 is approximately equal to the depth of the distal recess 4151.

[0351] Proximal trap 4171 has a width, and distal tip 4155 has a width. Although not explicitly symbolized in Figure 41C, the width of proximal trap 4171 is similar to width C of proximal trap 3071 in Figure 30G, and the width of distal tip 4155 is similar to width D of distal tip 3055 in Figure 30G.

[0352] The depth of the proximal trap 4171 and the depth of the distal recess 4151 may be similar to the depths of the proximal trap 4071 and distal recess 4051 described above in connection with Figures 40A-C. The width of the proximal trap 4171 and the width of the distal tip 4155 may be similar to the widths of the proximal trap 4071 and distal tip 4055 shown in and described above in connection with Figures 40A-C. The ratio of the outer diameter of the distal tip to the inner diameter of the female tapered surface may be similar to that described above in connection with Figures 30G and 40C. The wall thickness of the distal tip 4155 and the inner diameter of the lumen 4112 may be similar to that described above in connection with the distal tip 4055 and lumen 4012 of Figures 40A-C.

[0353] Male Luer connector with a radially recessed proximal trap (Figure 42A-D) 42A-D, male connector 4201 includes a male luer 4241. Male luer 4241 includes a tapered sealing member 4242. Male luer 4241 has a tapered surface leading edge 4261 with a tapered surface leading edge surface 4262 at the distal end of tapered sealing member 4242. Tapered sealing member 4242 has a frustoconical shape that tapers from a larger outer diameter at a proximal portion of tapered sealing member 4242 to a smaller outer diameter at the distal portion of the tapered sealing member near tapered surface leading edge 4261. Tapered sealing member 4242 has a tapered sealing surface 4243 configured to mate with a female luer to create a fluid-tight fit. Male connector 4201 further includes threads 4202 that allow male connector 4201 to be mated with a female connector. A lumen 4212 extends through the male connector 4201 .

[0354] The male luer 4241 includes a distal tip 4255 with an end surface 4204. The distal tip 4255 of the male luer 4241 is recessed from the distal line of the taper of the tapered sealing member 4242. The distal tip 4255 has a distal tip surface 4252 and a distal recess 4251. The distal recess 4251 is formed by the recessed portion of the distal tip 4255. The distal tip surface 4252 of the distal tip 4255 defines an outer diameter that is smaller than the outer diameter of the extended portion of the tapered sealing surface 4243. In the example of FIGS. 42A-D, the male luer 4241 is made in two pieces. An insert 4291 is placed within the tapered sealing member 4242. A lumen 4212 extends through both the insert 4291 and the tapered sealing member 4242.

[0355] In some examples, the antimicrobial is provided to the distal tip surface 4252 by coating, spraying, or dipping the distal tip 4255 with the antimicrobial, although other methods of providing the antimicrobial are contemplated and within the scope of the present technology. In some examples, the antimicrobial is also provided to the tapered sealing surface 4243. The antimicrobial on the distal tip surface 4252 of the distal tip 4255 kills pathogens within the distal recess 4251 between the surface of the female luer and the distal tip surface 4252. The distal recess 4251 is designed to trap the antimicrobial between the inner surface of the female luer and the distal tip surface 4252, so that the pathogens are exposed to a high concentration of the antimicrobial.

[0356] The distal recess 4251 affects pathogen entrapment because it provides a limited space between the distal tip surface 4252 and the interior surface of the female luer in which pathogens can be trapped. The outer diameter of the distal tip 4255 is smaller than the outer diameter of the tapered sealing member 4242 at the tapered surface leading edge 4261, and the outer diameter of the distal tip 4255 is smaller than the outer diameter of the distal line of the taper defined by the conical tapered sealing member 4242.

[0357] Figure 42D shows an enlarged view within circle D in Figure 42C. Proximal trap 4271 is defined by proximal trap wall 4273. Proximal trap 4271 is a cavity between tapered sealing member 4242 and insert 4291 that is bounded on multiple sides by proximal trap wall 4273 formed in male luer 4241.

[0358] The proximal trap 4271 is an annular cavity in the male luer 4241 defined by a proximal trap wall 4273 which includes a proximal wall 4281, a distal wall 4284, and an inner wall 4283, the proximal trap wall 4273 being a tapered surface distal edge surface 4262. In this example, the distal wall 4284 and the inner wall 4283 are respective surfaces of the insert 4291. In an alternative example, the male luer 4241 may be a unitary structure, in which case the proximal wall 4281, distal wall 4284, and inner wall 4283 of the proximal trap 4271 are formed by multiple surfaces of the distal tip 4255.

[0359] The proximal trap 4271 stores an antimicrobial agent within a cavity defined by the proximal trap 4271. The proximal trap 4271 opens into the distal recess 4251 and does not have a separate entrance or exit. The antimicrobial agent stored in the proximal trap 4271 ensures that a high concentration of the antimicrobial agent remains (up to a saturation level) in the vicinity of the pathogenic bacteria.

[0360] Both the proximal trap 4271 and the distal recess 4251 are designed to trap pathogens, fluids, and antimicrobials near the female luer surface of the female connector. There is a difference between trapping fluids and antimicrobials in the proximal trap 4271 and trapping them in the distal recess 4251. The trapping of fluids and antimicrobials in the proximal trap 4271 occurs independently of the female luer surface.

[0361] The proximal trap wall 4273 creates a cavity configured to prevent or minimize fluid escape from the proximal trap 4271. The antimicrobial agent is not easily washed out of the proximal trap 4271 during or after insertion of the male connector 4201 into the female connector. The shape of the cavity in the proximal trap 4271 allows for limited recirculation of fluid and antimicrobial agent within the proximal trap 4271 during the multiple fluid flow conditions described in connection with FIGS. 38 and 39 . The antimicrobial agent on the surface of the proximal trap wall 4273 may diffuse out of the proximal trap 4271 once the tapered sealing member 4242 is attached to a fluid-filled female luer or during the multiple fluid flow conditions.

[0362] In contrast, containment of the antimicrobial agent within distal recess 4251 relies on the female luer surface; this containment is optimized when male connector 4201 is fully inserted into the female connector. When male connector 4201 is mated with the female connector, the cavity formed between distal tip surface 4252 and the female luer surface limits fluid circulation and transport of the antimicrobial agent into the lumen of the female luer. The limited fluid circulation, combined with the containment, keeps the antimicrobial agent highly concentrated within the cavity of distal recess 4251 even when fluid is flowing through lumen 4212.

[0363] As used herein, the term "width" refers to the distance measured parallel to the central longitudinal axis of the male lure, and the term "depth" refers to the distance measured perpendicular to the central longitudinal axis of the male lure.

[0364] The proximal trap 4271 has a depth and the distal recess 4251 has a depth. In this example, the depth of the proximal trap is greater than the depth of the distal recess 4251. Conceptually, this can be described as a radially recessed cavity in the distal tip 4255. This can also be described as a radial variation in wall thickness of the distal tip 4255. The proximal trap 4271 provides an isolated fluid flow region within the volume defined by the proximal trap wall 4273.

[0365] The proximal trap 4271 has a width, and the distal tip 4255 has a width. The width of the distal tip 4255 is defined between the tapered surface distal edge surface 4262 and the distal end face 4204 of the distal tip 4255. The width of the proximal trap 4271 is defined between the proximal wall 4281 and the distal wall 4284. In this example, the width of the proximal trap 4271 is narrower than the width of the distal tip 4255.

[0366] Male Luer connector with blades and a radially recessed proximal trap (Figure 43A-F) 43A-F, male connector 4301 includes a male luer 4341. Male luer 4341 includes a tapered sealing member 4342. Male luer 4341 has a tapered surface leading edge 4361 with a tapered surface leading edge surface 4362 at the distal end of tapered sealing member 4342. Tapered sealing member 4342 has a frustoconical shape that tapers from a larger outer diameter at a proximal portion of tapered sealing member 4342 to a smaller outer diameter at the distal portion of the tapered sealing member near tapered surface leading edge 4361. Tapered sealing member 4342 has a tapered sealing surface 4343 configured to mate with a female luer to create a fluid-tight fit. Male connector 4301 further includes threads 4302 that allow male connector 4301 to mate with a female connector. A lumen 4312 extends through the male connector 4301 .

[0367] The male luer 4341 includes a distal tip 4355 with an end surface 4304. The distal tip 4355 of the male luer 4341 is recessed from the distal line of the taper of the tapered sealing member 4342. The distal tip 4355 has a distal tip surface 4352 and a distal recess 4351. The distal recess 4351 is formed by the recessed portion of the distal tip 4355. The distal tip surface 4352 of the distal tip 4355 defines an outer diameter that is smaller than the outer diameter of the extended portion of the tapered sealing surface 4343. In the example of Figures 43A-D, the male luer 4341 is made in two pieces. An insert 4391 is placed within the tapered sealing member 4342. The lumen 4312 extends through both the insert 4391 and the tapered sealing member 4342.

[0368] In some examples, the antimicrobial is provided to the distal tip surface 4352 by coating, spraying, or dipping the distal tip 4355 with the antimicrobial, although other methods of providing the antimicrobial are contemplated and within the scope of the present technology. In some examples, the antimicrobial is also provided to the tapered sealing surface 4343. The antimicrobial on the distal tip surface 4352 of the distal tip 4355 kills pathogens within the distal recess 4351 between the surface of the female luer and the distal tip surface 4352. The distal recess 4351 is designed to trap the antimicrobial between the inner surface of the female luer and the distal tip surface 4352, so that the pathogens are exposed to a high concentration of the antimicrobial.

[0369] The distal recess 4351 affects pathogen entrapment because it provides a limited space between the distal tip surface 4352 and the interior surface of the female luer in which pathogens can be trapped. The outer diameter of the distal tip 4355 is smaller than the outer diameter of the tapered sealing member 4342 at the tapered surface leading edge 4361, and the outer diameter of the distal tip 4355 is smaller than the outer diameter of the distal line of the taper defined by the conical tapered sealing member 4342.

[0370] Figure 43D shows an enlarged view of circle D in Figure 43C. Figure 43F is an enlarged view of circle F in Figure 43E. Both Figures 43C and 43E show cross sections of Figure 43B, with Figure 43C showing a cross section bisecting the valley 4368 of blade 4363 and Figure 43E showing a cross section bisecting the peak 4364 of blade 4363. Proximal trap 4371 is defined by proximal trap wall 4373. Proximal trap 4371 is a cavity between tapered sealing member 4342 and insert 4391, bounded on multiple sides by proximal trap walls 4373 formed in male luer 4341.

[0371] The proximal trap 4371 is an annular cavity within the male luer 4341 defined by a proximal trap wall 4373 including a proximal wall 4381, a distal wall 4384, and an inner wall 4383, the proximal trap wall 4373 being a tapered surface distal edge surface 4362. In this example, the distal wall 4384 and the inner wall 4383 are respective surfaces of the insert 4391. In an alternative example, the male luer 4341 may be a unitary structure, in which case the proximal wall 4381, distal wall 4384, and inner wall 4383 of the proximal trap 4371 are formed by multiple surfaces of the distal tip 4355.

[0372] The proximal trap 4371 stores the antimicrobial agent within a cavity defined by the proximal trap 4371. The proximal trap 4371 opens into the distal recess 4351 and does not have a separate entrance or exit. The antimicrobial agent stored in the proximal trap 4371 ensures that a high concentration of the antimicrobial agent remains (up to a saturation level) in the vicinity of the pathogenic bacteria.

[0373] Both the proximal trap 4371 and the distal recess 4351 are designed to trap pathogens, fluids, and antimicrobials near the female luer surface of the female connector. There is a difference between trapping fluids and antimicrobials in the proximal trap 4371 and trapping them in the distal recess 4351. The trapping of fluids and antimicrobials in the proximal trap 4371 occurs independently of the female luer surface.

[0374] The proximal trap wall 4373 creates a cavity configured to prevent or minimize fluid escape from the proximal trap 4371. The antimicrobial agent is not easily washed out of the proximal trap 4371 during or after insertion of the male connector 4301 into the female connector. The cavity shape of the proximal trap 4371 allows for limited recirculation of fluid and antimicrobial agent within the proximal trap 4371 during the fluid flow conditions described in connection with Figures 38 and 39. The antimicrobial agent on the surface of the proximal trap wall 4373 may diffuse out of the proximal trap 4371 once the male luer is attached to the fluid-filled female luer or during the fluid flow conditions.

[0375] In contrast, containment of the antimicrobial agent within distal recess 4351 relies on the female luer surface; this containment is optimized when male connector 4301 is fully inserted into the female connector. When male connector 4301 is mated with the female connector, the cavity formed between distal tip surface 4352 and the female luer surface limits fluid circulation and transport of the antimicrobial agent into the lumen of the female luer. The limited fluid circulation, combined with the containment, keeps the antimicrobial agent highly concentrated within the cavity of distal recess 4351 even when fluid is flowing through lumen 4312.

[0376] As used herein, the term "width" refers to the distance measured parallel to the central longitudinal axis of the male lure, and the term "depth" refers to the distance measured perpendicular to the central longitudinal axis of the male lure.

[0377] The proximal trap 4371 has a depth, and the distal recess 4351 has a depth. Although not explicitly symbolized in FIG. 43C , the depth of the distal recess 4351 is similar to the depth B of the distal recess 3051 in FIG. 30G . In the example of FIG. 43C , the depth of the proximal trap is deeper than the depth of the distal recess 4351. Conceptually, this can be described as a radially recessed cavity in the distal tip 4355. This can also be described as a radial variation in wall thickness of the distal tip 4355. The proximal trap 4371 provides an isolated fluid flow region within the volume defined by the proximal trap wall 4373.

[0378] The proximal trap 4171 has a width, and the distal tip 4155 has a width. The width of the distal tip 4155 is defined between the tapered surface distal edge surface 4362 and the distal end surface 4304 of the distal tip 4355. The width of the proximal trap 4171 is defined between the proximal wall 4381 and the distal wall 4384.

[0379] The depth of the proximal trap 4171 and the depth of the distal recess 4151 may be similar to the depths of the proximal trap 4071 and distal recess 4051 described above in connection with Figures 40A-C. The width of the proximal trap 4171 and the width of the distal tip 4155 may be similar to the widths of the proximal trap 4071 and distal tip 4055 as shown in and described above in connection with Figures 40A-C. The ratio of the outer diameter of the distal tip to the inner diameter of the female tapered surface may be similar to that described above in connection with Figures 30G and 40C. The wall thickness of the distal tip 4155 and the inner diameter of the lumen 4112 may be similar to that described above in connection with the distal tip 4055 and lumen 4012 of Figures 40A-C.

[0380] The distal tip 4355 includes a plurality of blades 4363 arranged around the distal tip 4355 of the male luer 4341. Between the blades 4363 are a plurality of channels 4367. In the example of FIG. 43 , the blades 4363 are elongated protrusions arranged around the axis of the tapered sealing member 4342, and the channels 4367 are elongated recesses arranged between the blades 4363 and extending parallel to the lumen 4312. The blades 4363 and channels 4367 alternately form peaks 4364 and valleys 4368. The distal tip surface 4352 of the distal tip 4355 is defined by the blades 4363 and channels 4367, forming a multi-bladed surface. Furthermore, the antimicrobial agent on the distal tip surface 4352 can be stored within the volume between the blades 4363. This can increase the amount of antimicrobial agent that can be stored in the distal tip 4355 of the male luer 4341.

[0381] During insertion of the male luer 4341 into the female luer, multiple portions of the distal tip 4355 may contact the inner surface of the female luer. The peaks 4364 of each blade 4363 may contact the female luer surface, but the valleys 4368 of the channels 4367 do not. For example, the contact surface area of ​​the blades 4363 near the end face 4304 of the distal tip 4355 is relatively small compared to the tapered surface edge 4361. This minimizes the amount of pathogen intrusion that may result from pathogens being pushed into the body of the female luer by the blades 4363 compared to the tapered surface edge 4361 of the male luer 4341. Therefore, in some cases, there is a higher probability of pathogens being present on the tapered surface edge 4361 compared to the end face 4304. This is desirable because the tapered surface leading edge 4361 will have a higher concentration of antimicrobial composition (a lethal concentration that will kill pathogens) than the end surface 4304 .

[0382] Male Luer connector with a contoured proximal trap (Figure 44A-C) 44A-C, male connector 4401 includes a male luer 4441. Male luer 4441 includes a tapered sealing member 4442. Male luer 4441 has a tapered surface leading edge 4461 with a tapered surface leading edge surface 4462 at the distal end of tapered sealing member 4442. Tapered sealing member 4442 has a frustoconical shape that tapers from a larger outer diameter at a proximal portion of tapered sealing member 4442 to a smaller outer diameter at the distal portion of the tapered sealing member near tapered surface leading edge 4461. Tapered sealing member 4442 has a tapered sealing surface 4443 configured to mate with a female luer to create a fluid-tight fit. Male connector 4401 further includes threads 4402 that allow male connector 4401 to mate with a female connector. A lumen 4412 extends through the male connector 4401 .

[0383] The male luer 4441 includes a distal tip 4455 with an end surface 4404. The distal tip 4455 of the male luer 4441 is recessed from the distal line of the taper of the tapered sealing member 4442. The distal tip 4455 has a distal tip surface 4452 and a distal recess 4451. The distal recess 4451 is formed by a recessed portion of the distal tip 4455. The distal tip surface 4452 of the distal tip 4455 defines an outer diameter that...

Claims

1. A male cap having a male extension, the male extension comprising: a male tapered outer surface configured to mate with a female luer to form a fluid-tight fit; The tip and a distal end recess formed by a recessed portion of the distal tip, the distal end recess including a concave surface; a water-soluble antimicrobial composition disposed on the male extension portion including the concave surface; a fluid soluble, more slowly dissolving material coated on or incorporated into said water-soluble antimicrobial composition; Equipped with A male cap, wherein the more slowly dissolving material is configured to slow dissolution of the water-soluble antimicrobial composition of the male cap into the female lure.

2. 10. The male cap of claim 1, wherein the more slowly dissolving material is configured to dissolve in a fluid within one minute to expose the antimicrobial composition to the fluid.

3. 10. The male cap of claim 1, wherein the slower dissolving substance is configured to dissolve over a period of several seconds.

4. 10. The male cap of claim 1, wherein the more slowly dissolving material is configured to dissolve in a fluid within 10 minutes to expose the antimicrobial composition to the fluid.

5. 5. The male cap of claim 1, wherein the more slowly soluble substance coats the water-soluble antimicrobial composition.

6. The male cap of claim 1 , wherein the more slowly dissolving substance comprises at least one of biocompatible cellulose, dextrose, and sodium chloride.

7. The male cap according to any one of claims 1 to 6, wherein the more slowly dissolving substance comprises polyvinyl alcohol or polyurethane hydrogel.

8. The male cap according to any one of claims 1 to 7, wherein the more slowly dissolving substance comprises microspheres.

9. 9. The male cap according to claim 1, wherein the male tapered outer surface is configured such that a cavity is formed between the female tapered surface of the female luer and the concave surface when the male cap is mated with the female luer to form a substantially fluid-tight seal.

10. 2. The male cap according to claim 1, wherein the concave surface has a diameter of less than 3.97 mm at a distance of 0.75 mm proximally from the end surface.

11. 10. The male cap according to claim 9, further comprising a proximal trap, the proximal trap comprising an annular cavity at least partially opening into the cavity between the female tapered surface and the concave surface of the female luer.

12. 12. The male cap according to claim 1, wherein a first taper angle of the male tapered outer surface is equal to a second taper angle of the concave surface relative to a central longitudinal axis of the male cap.

13. 13. The male cap according to claim 1, wherein the male tapered outer surface includes a tapered surface leading edge proximal to the end face of the male cap.

14. 12. The male cap of claim 9 or 11, wherein the water-soluble antimicrobial composition comprises chlorhexidine, and after a portion of the chlorhexidine is dispersed into the solution fluid trapped within the cavity, the dispersed water-soluble antimicrobial composition maintains a concentration of at least 200 micrograms per milliliter within the cavity for a period of at least 1 minute.

15. The male cap of any one of claims 1 to 14, wherein the water-soluble antibacterial composition comprises chlorhexidine.

16. A male cap, a male extension including a male tapered outer surface configured to mate with a female luer to form a fluid-tight fit; a tapered surface leading edge at the leading end of the male tapered outer surface; an elongated protrusion extending distally from the distal edge of the tapered surface, the elongated protrusion having an outer diameter smaller than the outer diameter of the male tapered outer surface; a water-soluble antibacterial composition provided on the outer surface of the elongated projection; a fluid soluble, more slowly dissolving material coating said water-soluble antimicrobial composition; Equipped with The male cap, wherein the more slowly dissolving material is configured to dissolve to expose the underlying water-soluble antimicrobial composition for a desired period of time, thereby slowing the dissolution of the water-soluble antimicrobial composition of the male cap into the female lure.

17. A male cap as described in claim 16, wherein the more slowly dissolving substance is configured to dissolve in the fluid within one minute to expose the antibacterial composition to the fluid.

18. A male cap as described in claim 16, wherein the more slowly dissolving substance is configured to dissolve over a period of several seconds.

19. A male cap as described in claim 16, wherein the more slowly dissolving substance is configured to dissolve in the fluid within 10 minutes to expose the antibacterial composition to the fluid.

20. The male cap described in claim 16, wherein the more slowly dissolving substance includes at least one of biocompatible cellulose, dextrose, and sodium chloride.

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